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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, 422, and 495
CMS-0033-F
RIN 0938-AP78
Medicare and Medicaid Programs; Electronic Health Record Incentive Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
SUMMARY: This final rule implements the provisions of the American Recovery and
Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible
professionals (EPs), eligible hospitals and critical access hospitals (CAHs) participating in
Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of
certified electronic health record (EHR) technology. This final rule specifies—the initial criteria
EPs, eligible hospitals, and CAHs must meet in order to qualify for an incentive payment;
calculation of the incentive payment amounts; payment adjustments under Medicare for covered
professional services and inpatient hospital services provided by EPs, eligible hospitals and
CAHs failing to demonstrate meaningful use of certified EHR technology; and other program
participation requirements. Also, the Office of the National Coordinator for Health Information
Technology (ONC) will be issuing a closely related final rule that specifies the Secretary’s
adoption of an initial set of standards, implementation, specifications, and certification criteria
for electronic health records. ONC has also issued a separate final rule on the establishment of
certification programs for health information technology.
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EFFECTIVE DATE: These regulations are effective on [insert 60 days after the date of
publication in the Federal Register].
FOR FURTHER INFORMATION CONTACT:
Elizabeth Holland, (410) 786-1309, EHR incentive program issues.
Edward Gendron, (410) 786-1064, Medicaid incentive payment issues.
Jim Hart, (410) 786-9520, Medicare fee for service payment issues.
Bob Kuhl or Susan Burris, (410) 786-5594, Medicare CAH payment and charity care issues.
Frank Szeflinski, (303) 844-7119, Medicare Advantage issues.
SUPPLEMENTARY INFORMATION:
Acronyms
ARRA
American Recovery and Reinvestment Act of 2009
AAC
Average Allowable Cost (of certified EHR technology)
AIU
Adopt, Implement, Upgrade (certified EHR technology)
CAH
Critical Access Hospital
CAHPS
Consumer Assessment of Healthcare Providers and Systems
CCN
CMS Certification Number
CFR
Code of Federal Regulations
CHIP
Children’s Health Insurance Program
CHIPRA
Children's Health Insurance Program Reauthorization Act of 2009
CMS
Centers for Medicare & Medicaid Services
CPOE
Computerized Physician Order Entry
CY
Calendar Year
EHR
Electronic Health Record
CMS-0033-F
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EP
Eligible Professional
EPO
Exclusive Provider Organization
FACA
Federal Advisory Committee Act
FFP
Federal Financial Participation
FFY
Federal Fiscal Year
FFS
Fee-For-Service
FQHC
Federally Qualified Health Center
FTE
Full-Time Equivalent
FY
Fiscal Year
HEDIS
Healthcare Effectiveness Data and Information Set
HHS
Department of Health and Human Services
HIE
Health Information Exchange
HIT
Health Information Technology
HIPAA
Health Insurance Portability and Accountability Act of 1996
HITECH
Health Information Technology for Economic and Clinical Health Act
HMO
Health Maintenance Organization
HOS
Health Outcomes Survey
HPSA
Health Professional Shortage Area
HRSA
Health Resource and Services Administration
IAPD
Implementation Advance Planning Document
ICR
Information Collection Requirement
IHS
Indian Health Service
IPA
Independent Practice Association
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IT
Information Technology
MA
Medicare Advantage
MAC
Medicare Administrative Contractor
MAO
Medicare Advantage Organization
MCO
Managed Care Organization
MITA
Medicaid Information Technology Architecture
MMIS
Medicaid Management Information Systems
MSA
Medical Savings Account
NAAC
Net Average Allowable Cost (of certified EHR technology)
NCQA
National Committee for Quality Assurance
NCVHS
National Committee on Vital and Health Statistics
NPI
National Provider Identifier
NPRM
Notice of Proposed Rulemaking
ONC
Office of the National Coordinator for Health Information Technology
PAHP
Prepaid Ambulatory Health Plan
PAPD
Planning Advance Planning Document
PFFS
Private Fee-For-Service
PHO
Physician Hospital Organization
PHS
Public Health Service
PHSA
Public Health Service Act
PIHP
Prepaid Inpatient Health Plan
POS
Place of Service
PPO
Preferred Provider Organization
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PQRI
Physician Quality Reporting Initiative
PSO
Provider Sponsored Organization
RHC
Rural Health Clinic
RHQDAPU
Reporting Hospital Quality Data for Annual Payment Update
RPPO
Regional Preferred Provider Organization
SMHP
State Medicaid Health Information Technology Plan
TIN
Tax Identification Number
Table of Contents
I. Background
A. Overview of the HITECH Programs Created by the American Recovery and
Reinvestment Act of 2009
B. Statutory Basis for the Medicare & Medicaid EHR Incentive Programs
II. Provisions of the Proposed Regulations and Response and Analysis of Comments
A. Definitions Across the Medicare FFS, Medicare Advantage, and Medicaid Programs
1. Definitions
a. Certified Electronic Health Record (EHR) Technology
b. Qualified Electronic Health Record
c. Payment Year
d. First, Second, Third, Fourth, Fifth and Sixth Payment Year
e. EHR Reporting Period
f. Meaningful EHR User
2. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
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b. Common Definition of Meaningful Use under Medicare and Medicaid
c. Stage 1 Criteria for Meaningful Use
3. Sections 4101(a) and 4102(a)(1) of HITECH Act: Reporting on Clinical Quality
Measures Using EHR by EPs, Eligible Hospitals and CAHs
a. General
b. Requirements for the Submission of Clinical Quality Measures by EPs, Eligible
Hospitals and CAHs
c. Statutory Requirements and Other Considerations for the Selection of Clinical Quality
Measures for Electronic Submission by EPs, Eligible Hospitals and CAHs
(1) Statutory Requirements for the Selection of Clinical Quality Measures for Electronic
Submission by EPs, Eligible Hospitals and CAHs
(2) Other Considerations for the Selection of Clinical Quality Measures for Electronic
Submission by EPs, Eligible Hospitals and CAHs
d. Clinical Quality Measures for EPs
e. Clinical Quality Measures Reporting Criteria for EPs
f. Clinical Quality Measures for Electronic Submission by Eligible Hospitals
g. Potential Measures for EPs, Eligible Hospitals and CAHs in Stage 2 and Subsequent
Years
h. Reporting Method for Clinical Quality Measures for 2011 and Beginning with the
2012 Payment Years
(1) Reporting Method for 2011 Payment Year
(2) Reporting Method Beginning in 2012
i. Alternative Reporting Methods for Clinical Quality Measures
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j. Reporting Period for Reporting Clinical Quality Measures
4. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use
5. Data Collection for Online Posting, Program Coordination, and Accurate Payments
a. Online Posting
b. Program Election between Medicare FFS/MA and Medicaid for EPs
c. Data to be Collected
6. Hospital-based Eligible Professionals
7. Interaction with other Programs
B. Medicare Fee-for-Service Incentives
1. Incentive Payments for Eligible Professionals
a. Definitions
b. Incentive Payment Limits
c. Increase in Incentive Payment for EPs who Predominantly Furnish Services in a
Geographic Health Professional Shortage Area
d. Form and Timing of Payment
e. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs who are not
Meaningful Users of Certified EHR Technology
2. Incentive Payments for Hospitals
a. Definition of Eligible Hospital for Medicare
b. Incentive Payment Calculation for Eligible Hospitals
c. Medicare Share
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d. Charity Care
e. Transition Factor
f. Duration and Timing of Incentive Payments
g. Incentive Payment Adjustment Effective in Federal FY 2015 and Subsequent Years
for Eligible Hospitals who are not Meaningful EHR Users
3. Incentive Payments for Critical Access Hospitals
a. Definition of CAHs for Medicare
b. Current Medicare Payment of Reasonable Cost for CAHs
c. Changes made by the HITECH Act
d. Incentive Payment Calculation for CAHs
e. Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years for CAHs
that are not Meaningful EHR Users
4. Process for Making Incentive Payments under the Medicare FFS Program
a. Incentive Payments to EPs
b. Incentive Payments to Eligible Hospitals
c. Incentive Payments to CAHs
d. Payment Accounting under Medicare
C. Medicare Advantage Organization Incentive Payments
1. Definitions
a. Qualifying MA Organization
b. Qualifying MA Eligible Professional
c. Qualifying MA-Affiliated Eligible Hospital
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2. Identification of Qualifying MA Organizations, MA EPs, and MA-Affiliated Eligible
Hospitals
3. Computation of Incentives to Qualifying MA Organizations for MA EPs and
Hospitals
4. Timeframe for Payment
5. Avoiding Duplicate Payment
6. Meaningful User Attestation
7. Posting Information on the CMS Website
8. Limitation on Review
9. Conforming Changes
10. Payment Adjustment and Future Rulemaking
D. Medicaid Incentives
1. Overview of Health Information Technology in Medicaid
2. General Medicaid Provisions
3. Identification of Qualifying Medicaid EPs and Eligible Hospitals
a. Overview
b. Program Participation
1. Acute Care Hospitals
2. Children’s Hospitals
c. Medicaid Professionals Program Eligibility
d. Calculating Patient Volume Requirements
e. Entities Promoting the Adoption of Certified EHR Technology
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4. Computation of Amount Payable to Qualifying Medicaid EPs and Eligible Hospitals
a. Payment Methodology for EPs
(1) General Overview
(2) Average Allowable Costs
(3) Net Average Allowable Costs
(4) Payments for Medicaid Eligible Professionals
(5) Basis for Medicaid EHR Incentive Program First Payment Year and Subsequent
Payment Years
(i) Medicaid EP Who Begins Adopting, Implementing or Upgrading Certified EHR
Technology in the First Year
(ii) Medicaid EP who has Already Adopted, Implemented or Upgraded Certified EHR
Technology and Meaningfully Uses EHR Technology
b. Payment Methodology for Eligible Hospitals
c. Alternative and Optional Early State Implementation to Make Incentive Payments for
Adopting, Implementing or Upgrading Certified EHR Technology
d. Process for Making and Receiving Medicaid Incentive Payments
e. Avoiding Duplicate Payment
f. Flexibility to Alternate Between Medicare and Medicaid EHR Incentive Programs One
Time
g. One State Selection
5. Single Provider Election Repository and State Data Collection
6. Collection of Information Related to the Eligible Professional's National Provider
Identifier (NPI) and the Tax Identification Number (TIN)
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7. Activities Required to Receive Incentive Payments
a. General Overview
b. Definitions Related to Certified EHR Technology and Adopting, Implementing or
Upgrading Such Technology
(1) Certified EHR Technology
(2) Adopting, Implementing or Upgrading
c. Other General Terminology
d. Quality Measures
8. Overview of Conditions for States to Receive Federal Financial Participation (FFP)
for Incentive Payments and Implementation Funding
9. Financial Oversight, Program Integrity and Provider Appeals
III. Collection of Information Requirements
A. ICRs Regarding Demonstration of Meaningful Use Criteria (§495.8)
B. ICRs Regarding Participation Requirements for EPs, Eligible Hospitals, and
Qualifying CAHs (§495.10)
C. ICRs Regarding Identification of Qualifying MA Organizations, MA-EPs and MAaffiliated Eligible Hospitals (§495.202)
D. ICRs Regarding Incentive Payments to Qualifying MA Organizations for MA-EPs
and Hospitals (§495.204)
E. ICRs Regarding Meaningful User Attestation (§495.210)
F. ICRs Regarding Incentive payments to qualifying MA organizations for MA-eligible
Professionals and Hospitals (§495.220)
G. ICRs Regarding Process for Payments (§495.312)
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H. ICRs Regarding Activities Required to Receive an Incentive Payment (§495.314)
I. ICRs Regarding State Monitoring and Reporting Regarding Activities Required to
Receive an Incentive Payment (§495.316)
J. ICRs Regarding State Responsibilities for Receiving FFP (§495.318)
K. ICRs Regarding Prior Approval Conditions (§495.324)
L. ICRs Regarding Termination of Federal Financial Participation (FFP) for Failure to
Provide Access to Information (§495.330)
M. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital Activities
(§495.332 through §495.338)
N. ICRs Regarding Access to Systems and Records (§495.342)
O. ICRs Regarding Procurement Standards (§495.344)
P. ICRs Regarding State Medicaid Agency Attestations (§495.346)
Q. ICRs Regarding Reporting Requirements (§495.348)
R. ICRs Regarding Retroactive Approval of FFP with an Effective Date of February 18,
2009 (§495.358)
S. ICRs Regarding Financial Oversight and Monitoring Expenditures (§495.362)
T. ICRs Regarding Appeals Process for a Medicaid Provider Receiving Electronic
Health Record Incentive Payments (§495.366)
IV. Regulatory Impact Analysis
A. Overall Impact
B. Regulatory Flexibility Analysis
C. Small Rural Hospitals
D. Unfunded Mandates Reform Act
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E. Federalism
F. Anticipated Effects
G. HITECH Impact Analysis
H. Accounting Statement
I.
Background
A. Overview of the HITECH Programs Created by the American Recovery and Reinvestment
Act of 2009
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) was
enacted on February 17, 2009. Title IV of Division B of ARRA amends Titles XVIII and XIX of
the Social Security Act (the Act) by establishing incentive payments to eligible professionals
(EPs), eligible hospitals, and critical access hospitals (CAHs), and Medicare Advantage
Organizations to promote the adoption and meaningful use of interoperable health information
technology (HIT) and qualified electronic health records (EHRs). These provisions, together
with Title XIII of Division A of ARRA, may be cited as the “Health Information Technology for
Economic and Clinical Health Act” or the “HITECH Act.” These incentive payments are part of
a broader effort under the HITECH Act to accelerate the adoption of HIT and utilization of
qualified EHRs.
On January 13, 2010 we published a proposed rule (75 FR 1844), entitled “Medicare and
Medicaid Programs; Electronic Health Record Incentive Program” to implement the provisions
of ARRA that provide incentive payments to EPs, eligible hospitals, and CAHs participating in
Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of
“certified EHR technology,” and incentive payments to certain Medicare Advantage
Organizations for their affiliated EPs and eligible hospitals that meaningfully use certified EHR
CMS-0033-F
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technology. Through this final rule, we are developing the incentive programs which are
outlined in Division B, Title IV of the HITECH Act. This final rule sets forth the definition of
“meaningful use of certified EHR technology.”
Section 13101 of the HITECH Act adds a new section 3000 to the Public Health Service
Act (PHSA), which defines “certified EHR technology” as a qualified EHR that has been
properly certified as meeting standards adopted under section 3004 of the PHSA. CMS and
ONC have been working closely to ensure that the definition of meaningful use of certified EHR
technology and the standards for certified EHR technology are coordinated. In the interim final
rule published on January 13, 2010 (75 FR 2014) entitled “Health Information Technology:
Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic
Health Record Technology,” ONC defined the term “certified EHR technology,” identified the
initial set of standards and implementation specifications that such EHR technology would need
to support the achievement of the proposed meaningful use Stage 1, as well as the certification
criteria that will be used to certify EHR technology. ONC is also issuing a final rule on the
standards, implementation specifications, and certification criteria elsewhere in this issue of the
Federal Register.
In a related proposed rule published on March 10, 2010, (75 FR 11328) entitled
“Proposed Establishment of Certification Programs for Health Information Technology” ONC
proposed the establishment of two certification programs for purpose of testing and certifying
health information technology. In the June 24, 2010 Federal Register (75 FR 36157), ONC
published a final rule to establish a temporary certification program whereby the National
Coordinator would authorize organizations to test and certify complete EHRs and EHR Modules,
and plans to issue a separate final rule to establish a permanent certification program to replace
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the temporary certification program. Specifically, this final rule will ensure that the definition of
meaningful use of certified EHR technology does not require EPs, eligible hospitals, and CAHs
to perform functions for which standards have not been recognized or established. Similarly, the
functionality of certified EHR technology should enable and advance the definition of
meaningful use.
We urge those interested in this final rule to also review the ONC interim final rule on
standards and implementation specifications for certified EHR technology and the related final
rule as well as the final rule on the establishment of a temporary certification program. Readers
may also visit http://healthit.hhs.gov and
http://www.cms.hhs.gov/Recovery/11_HealthIT.asp#TopOfPage for more information on the
efforts at the Department of Health and Human Services (HHS) to advance HIT initiatives.
B. Statutory Basis for the Medicare & Medicaid EHR Incentive Programs
Section 4101(a) of the HITECH Act adds a new subsection (o) to section 1848 of the Act.
Section 1848(o) of the Act establishes incentive payments for demonstration of meaningful use
of certified EHR technology by EPs participating in the original Medicare program (hereinafter
referred to as the Medicare Fee-for-Service (FFS) program) beginning in calendar year (CY)
2011. Section 4101(b) of the HITECH Act also adds a new paragraph (7) to section 1848(a) of
the Act. Section 1848(a)(7) of the Act provides that beginning in CY 2015, EPs who do not
demonstrate that they are meaningful users of certified EHR technology will receive an
adjustment to their fee schedule for their professional services of 99 percent for 2015 (or, in the
case of an eligible professional who was subject to the application of the payment adjustment
under section 1848(a)(5) of the Act, 98 percent for 2014), 98 percent for 2016, and 97 percent for
2017 and each subsequent years. Section 4101(c) of the HITECH Act adds a new subsection (l)
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to section 1853 of the Act to provide incentive payments to certain Medicare Advantage (MA)
organizations for their affiliated EPs who meaningfully use certified EHR technology and meet
certain other requirements, and requires a downward adjustment to Medicare payments to certain
MA organizations for professional services provided by any of their affiliated EPs who are not
meaningful users of certified EHR technology, beginning in 2015. Section 1853(l) of the Act
also requires us to establish a process that ensures that there are no duplicate payments made to
MA organizations under section 1853(l) of the Act and to their affiliated EPs under the FFS EHR
incentive program established under section 1848(o)(1)(A) of the Act.
Section 4102(a) of the HITECH Act adds a new subsection (n) to section 1886 of the Act.
Section 1886(n) of the Act establishes incentives payments for demonstration of meaningful use
of certified EHR technology by subsection (d) hospitals, as defined under section 1886(d)(1)(B)
of the Act, participating in the Medicare FFS program beginning in Federal fiscal year (FFY)
2011. Section 4102(b)(1) of the HITECH Act amends section 1886(b)(3)(B) of the Act to
provide that, beginning in FY 2015, subsection (d) hospitals that are not meaningful users of
certified EHR technology will receive a reduced annual payment update for their inpatient
hospital services. Section 4102(a)(2) of the HITECH Act amends section 1814(l) of the Act to
provide an incentive payment to critical access hospitals (CAHs) who meaningfully use certified
EHR technology based on the hospitals’ reasonable costs for the purchase of certified EHR
technology beginning in FY 2011. In addition, section 4102(b)(2) of the HITECH Act amends
section 1814(l) of the Act to provide for a downward payment adjustment for hospital services
provided by CAHs that are not meaningful users of certified EHR technology for cost reporting
periods beginning in FY 2015. Section 4102(c) of the HITECH Act adds a new subsection (m)
to section 1853 of the Act to provide incentive payments to qualifying MA organizations for
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certain affiliated hospitals that meaningfully use certified EHR technology to make a downward
adjustment to payments to certain MA organizations for inpatient hospital services provided by
its affiliated hospitals that are not meaningful users of certified EHR technology beginning in
FY 2015. Section 1853(m) of the Act also requires us to establish a process that ensures that
there are no duplicate payments made to MA organizations under section 1853(m) of the Act and
to their affiliated hospitals under the FFS EHR incentive program established under section
1886(n) of the Act.
Section 4103 of the HITECH Act provides for implementation funding for the EHR
incentives program under Medicare.
Section 4201 of the HITECH Act amends section 1903 of the Act to provide 100 percent
Federal financial participation (FFP) to States for incentive payments to certain eligible providers
participating in the Medicaid program to purchase, implement, operate (including support
services and training for staff) and meaningfully use certified EHR technology and 90 percent
FFP for State administrative expenses related to the program outlined in 1903(t) of the Act.
Section 4201(a)(2) of the HITECH Act adds a new subsection (t) to section 1903 of the Act to
establish a program with input from the States to provide incentives for the adoption and
subsequent meaningful use of certified EHR technology for providers participating in the
Medicaid program.
II.
Provisions of the Proposed Rule and Analysis of and Responses to Public Comments
We proposed to add a new part 495 to title 42 of the Code of Federal Regulations to
implement the provisions of Title IV of Division B of ARRA providing for incentive payments
to EPs, eligible hospitals, CAHs and certain Medicare Advantage organizations for the adoption
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and demonstration of meaningful use of certified EHR technology under the Medicare program
or the Medicaid program.
The HITECH Act creates incentives under the Medicare Fee-for-Service (FFS), Medicare
Advantage (MA), and Medicaid programs for EPs, eligible hospitals and CAHs to adopt and
demonstrate meaningful use of certified EHR technology, and payment adjustments under the
Medicare FFS and MA programs for EPs, eligible hospitals, and CAHs who fail to adopt and
demonstrate meaningful use of certified EHR technology. The three incentive programs contain
many common elements and certain provisions of the HITECH Act encourage avoiding
duplication of payments, reporting, and other requirements, particularly in the area of
demonstration meaningful use of certified EHR technology. Eligible hospitals and CAHs may
participate in both the Medicare program and the Medicaid program, assuming they meet each
program’s eligibility requirements, which vary across the two programs. In certain cases, the
HITECH Act has used nearly identical or identical language in defining terms that are used in the
Medicare FFS, MA, and Medicaid programs, including such terms as ‘‘hospital-based EPs’’ and
‘‘certified EHR technology.’’ For these reasons, we seek to create as much commonality
between the three programs as possible and have structured this final rule, as we did the
proposed rule, based on the premise by beginning with those provisions that cut across the three
programs before moving on to discuss the provisions specific to Medicare FFS, MA and
Medicaid.
A. Definitions across the Medicare FFS, MA, and Medicaid Programs
Title IV, Division B of ARRA establishes incentive payments under the Medicare and
Medicaid programs for certain professionals and hospitals that meaningfully use certified EHR
technology, and for certain MA organizations whose affiliated EPs and hospitals meaningfully
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use certified EHR technology. We refer to the incentive payments made under the original
Medicare program to EPs, eligible hospitals, and CAHs as the Medicare FFS EHR incentive
program, the incentive payments made to qualifying MA organizations as the MA EHR incentive
program, and the incentive payments made under Medicaid to eligible professionals and eligible
hospitals as the Medicaid EHR incentive program. When referring to the Medicare EHR
incentive program, we are generally referring to both the Medicare FFS EHR and the MA EHR
incentive programs.
1. Definitions
Sections 4101, 4102, and 4201 of the HITECH Act use many identical or similar terms.
In this section of the preamble, we discuss terms for which we are finalizing uniform definitions
for the Medicare FFS, MA, and Medicaid EHR incentive programs. These definitions are set
forth in part 495 subpart A of the regulations. For definitions specific to an individual program,
the definition is set forth and discussed in the applicable EHR incentive program section.
The incentive payments are available to EPs which are non-hospital-based physicians, as
defined in section 1861(r) of the Act, who either receive reimbursement for services under the
Medicare FFS program or have an employment or contractual relationship with a qualifying MA
organization meeting the criteria under section 1853(l)(2) of the Act; or healthcare professionals
meeting the definition of “eligible professional” under section 1903(t)(3)(B) of the Act as well as
the patient-volume and non-hospital-based criteria of section 1903(t)(2)(A) of the Act) and
eligible hospitals which are subsection (d) hospitals as defined under subsection 1886(d)(1)(B) of
the Act that either receive reimbursement for services under the Medicare FFS program or are
affiliated with a qualifying MA organization as described in section 1853(m)(2) of the Act;
critical access hospitals (CAHs); or acute care or children's hospitals described under section
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1903(t)(2)(B) of the Act).
a. Certified Electronic Health Record (EHR) Technology
Under all three EHR incentive programs, EPs, eligible hospitals, and CAHs must utilize
“certified EHR technology” if they are to be considered eligible for the incentive payments. In
the Medicare FFS EHR incentive program this requirement for EPs is found in section
1848(o)(2)(A)(i) of the Act, and for eligible hospitals and CAHs in section 1886(n)(3)(A)(i) of
the Act. In the MA EHR incentive program this requirement for EPs is found in section
1853(l)(1) of the Act, and for eligible hospitals and CAHs, in section 1853(m)(1) of the Act. In
the Medicaid EHR incentive program this requirement for EPs and Medicaid eligible hospitals is
found throughout section 1903(t) of the Act, including in section 1903(t)(6)(C) of the Act.
Certified EHR technology is a critical component of the EHR incentive programs, and the
Secretary has charged ONC, under the authority given to her in the HITECH Act, with
developing the criteria and mechanisms for certification of EHR technology. Therefore, we
finalize our proposal to use the definition of certified EHR technology adopted by ONC. ONC
issued an interim final rule with comment for the standards and certification criteria for certified
EHR technology at the same time our proposed rule was issued. After reviewing the comments
they received and to address changes made in this final rule, ONC will be issuing a final rule in
conjunction with this final rule. When we refer to the ONC final rule, we are referring to this
final rule titled “Health Information Technology: Initial Set of Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record Technology. When we
refer to the ONC IFR, we are referring to the interim final rule with comment period published in
the Federal Register on January 13, 2010.
Comment: Several commenters asked for clarification on the definition of certified EHR
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technology. Currently, hospitals utilize multiple systems to operate electronically. For example,
some electronic operating systems feed EHR data and some systems pull EHR data. Data from
the two systems are then extracted and manipulated to create a quality measure calculation. The
commenters’ inquired as to how these systems can continue to be utilized even though,
independently, these systems will not meet all certification standards. Some commenters
expressed concern the ONC IFR did not include generation of the data needed to demonstrate
meaningful use as a certification requirement and that certified EHR technology requirements
should also include compliance with HIPAA standards as well as all relevant state statutes for
the state or states where it is installed. Commenters recommended various approaches to
defining certified technology especially in the early stages of the program. Some suggestions
included, grandfathering existing systems for a period of three years as long as the provider
could meet specific meaningful use objectives while requiring all upgrades to existing systems to
be certified, allowing all EHR products certified by the Certification Commission for Health
Information Technology (CCHIT) at the criteria established for 2008 or later be deemed as
meeting Stage 1 certification requirements or alternatively CMS provide a process that can verify
compliance of required features at no cost to providers or vendors as is done now with Enterprise
Data Interchange (EDI) claims processing. Some commenters also offered other thoughts on
potential unintended consequences of defining the EHR certification software process to include
certifying agencies that charge for the process. The commenters believed this could result in
continued new and revised requirements to justify the certifying entities’ existence and increase
its revenue.
Response: We have referred those comments to ONC who addresses them in their final
rule.
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We are adopting the ONC definition of certified EHR technology at 45 CFR 170.102 in
this final rule.
b. Qualified Electronic Health Record
In order for an EHR technology to be eligible for certification, it must first meet the
definition of a Qualified Electronic Health Record. This term was defined by ONC in its in its
IFR and finalized by ONC in their final rule, and we are finalizing our proposal to use the
definition of qualified electronic health record adopted by ONC in their final rule to be published
concurrently with this rule.
Comment: We received a few comments on the definition of qualified EHR technology.
Commenters expressed concerns regarding perceived gaps in defining an EHR as qualified such
as a lack of the requirement for a narrative text for physicians (also known as progress note).
Another comment requested further clarification regarding the requirement for a qualified EHR
to “capture and query information relevant to health care quality” and “exchange electronic
health information with and integrate such information from other sources.” For example, some
might believe that these requirements apply strictly to information contained within the EHR or
closed proprietary hospital systems and not to information that would have to be obtained from
outside the four walls of the practice or the extended (but closed) system.
Response: We have referred those comments to ONC who addresses them in their final
rule.
We are adopting the ONC definition of Qualified Electronic Health Record at45 CFR 170.102.
c. Payment Year
As discussed in the proposed rule, under section 1848(o)(1)(A)(i) of the Act the Medicare
FFS EHR incentive payment is available to EPs for a “payment year.” Section 1848(o)(1)(E) of
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the Act defines the term “payment year” as a year beginning with 2011. While the Act does not
use the term, “payment year,” for the Medicaid EHR incentive program, it does use the term
“year of payment” throughout section 1903(t) of the Act, for example, at sections 1903(t)(3)(C),
1903(t)(4)(A), and 1903(t)(6)(C) of the Act. For all EPs in the Medicare and Medicaid EHR
incentive programs, we are proposing a common definition for both “payment year” and “year of
payment,” as “any calendar year beginning with 2011” at §495.4. In the proposed rule, we
explained that this definition, which is consistent with the statutory definition of “payment year”
under Medicare FFS, would simplify the EHR incentive programs for EPs. As discussed later in
this preamble, EPs will have the opportunity to participate in either the Medicare or Medicaid
incentive programs, and once an EP has selected a program, they are permitted to make a onetime switch from one program to the other. A common definition will allow EPs to more easily
understand both incentive programs, and inform their decisions regarding participation in either
program.
Under section 1886(n)(1) of the Act, the Medicare FFS EHR incentive payment is
available to eligible hospitals and CAHs for a “payment year.” Section 1886(n)(2)(G) of the Act
defines the term “payment year” as a fiscal year beginning in 2011. As hospitals are paid based
on the 12-month Federal fiscal year, we interpret the reference to a “fiscal year” means the fiscal
year beginning on October 1 of the prior calendar year and extending to September 30 of the
relevant year. Again, for the Medicaid EHR incentive program, the HITECH Act uses the term,
“year of payment” (see section 1903)(t)(5)(D)(ii) of the Act), rather than “payment year.” For
the same reasons expressed in the proposed rule and summarized above for proposing a common
definition of “payment year” for EPs, and because hospitals will have the opportunity to
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simultaneously participate in both the Medicare and Medicaid EHR incentive programs, we
propose a common definition of “payment year” and “year of payment” for both programs.
For purposes of the incentive payments made to eligible hospitals and CAHs under the
Medicare FFS, MA and Medicaid EHR incentive programs, we proposed to define payment year
and year of payment at §495.4, consistent with the statutory definition, as “any fiscal year
beginning with 2011.”
Comment: A commenter asked CMS to identify the first possible payment year for EPs,
and hospitals and CAHs.
Response: The first payment year for EPs is any calendar year (CY) beginning with
CY 2011 and for eligible hospitals and CAHs is any fiscal year (FY) beginning with 2011.
Comment: The majority of commenters favored our definition of “payment year” based
on the different existing fiscal periods for eligible professionals and hospitals. Additional
support was received from some commenters whom explained that they participated in
performance-based initiatives, which define a payment year the same as the proposed rule.
Response: After consideration of the public comments received, we are adopting our
proposed definition of “payment year” in the Medicare and Medicaid EHR incentive programs as
described above.
Comment: The majority of comments received regarding the definition of a payment
year asked whether payment years must be consecutive for an EP or eligible hospital to receive
all years of incentive payments.
Response: In the proposed rule, we defined the second, third, fourth, fifth, and sixth
payment year, respectively, to mean "the second, third, fourth, fifth, and sixth calendar or
Federal fiscal year, respectively, for which an EP or eligible hospital receives an incentive
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payment." However, section 1848(o)(1)(E) of Act defines the second through fifth payment
years for an EP as each successive year immediately following the first payment year for such
professional for the Medicare FFS and MA EHR incentive programs. Similarly, section
1886(n)(2)(G)(ii) of the Act defines the second through fourth payment years for an eligible
hospital or CAH as requiring the years to be "successive" and "immediately following" the prior
year. This requirement, that each payment year "immediately follow" the prior year, means that
every year subsequent to the first payment year is a payment year regardless of whether an
incentive payment is received by the EP, eligible hospital or CAH. For example, if a Medicare
EP receives an incentive in CY 2011, but does not successfully demonstrate meaningful use or
otherwise fails to qualify for the incentive in CY 2012, CY 2012 still counts as one of the EP's
five payment years and they would only be able to receive an incentive under the Medicare EHR
incentive program for three more years as CY 2013 would be there third payment year. In this
example, the maximum incentive payment that would apply for this Medicare EP not practicing
predominately in a health professional shortage area (HPSA) would be $18,000 in 2011, and
$8,000 in 2013 as outlined in section 1848(o)(1)(B) of the Act. The EP would have qualified for
a maximum incentive payment of $12,000 in 2012, but did not qualify as a meaningful user for
this year. No incentives may be made under the Medicare EHR incentive program after 2016.
The same rule, however, does not apply to the Medicaid EHR incentive program. For
that program, payments may generally be non-consecutive. If an EP or eligible hospital does not
receive an incentive payment for a given CY or FY then that year would not constitute a
payment year. For example, if a Medicaid EP receives incentives in CY 2011 and CY 2012, but
fails to qualify for an incentive in CY 2013, they would still be eligible to receive incentives for
an additional four payment years. For hospitals, however, starting with FY 2017 payments must
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be consecutive. This rule is required by section 1903(t)(5)(D) of the Act, which states that after
2016, no Medicaid incentive payment may be made to an eligible hospital unless "the provider
has been provided payment . . . for the previous year." As a result, Medicaid eligible hospitals
must receive an incentive in FY 2016 to receive an incentive in FY 2017 and later years.
Starting in FY 2016, incentive payments must be made every year in order to continue
participation in the program. In no case may any Medicaid EP or eligible hospital receive an
incentive after 2021. We have revised our regulations at §495.4 to incorporate these statutory
requirements.
Comment: Some commenters requested that CMS clarify the impact on EPs when they
change practices in the middle of the incentive payment program; in other words, if an EP leaves
a practice in year two of the incentive payment program and goes to another practice, does that
EP forfeit the ability to continue collecting incentive payments for years 3 through 5?
Response: A qualifying EP that leaves one practice for another may still be eligible to
receive subsequent incentive payments if the EP is a meaningful EHR user in the new practice.
The incentive payment is tied to the individual EP, and not to his or her place of practice.
d. First, Second, Third, Fourth, Fifth, and Sixth Payment Year
In accordance with sections 1848(o)(1)(A)(ii), 1886(n)(2)(E), 1814(l)(3)(A),
1903(t)(4)(B), and 1903(t)(5)(A) of the Act, for EPs, eligible hospitals, and CAHs that qualify
for EHR incentive payments in a payment year, the amount of the payment will depend in part
on whether the EP or hospital previously received an incentive payment and, if so (for the
Medicare EHR incentive program) when the EP or hospital received his or her first payment.
We proposed to define the first payment year to mean the first CY or Federal fiscal year (FY) for
which an EP, eligible hospital, or CAH receives an incentive payment. Likewise, we proposed
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to define the second, third, fourth, fifth ,and sixth payment year, respectively, to mean the
second, third, fourth, fifth, and sixth CY or FY, respectively, for which an EP, eligible hospital,
or CAH receives an incentive payment.
Comment: As stated above, many commenters requested clarification on nonconsecutive payment.
Response: This comment is addressed above.
Comment: A commenter requested CMS to clarify the consequences for a hospital that
originally qualified and received incentive payments the first year, but in a subsequent year
failed to qualify as a meaningful user of certified EHR technology.
Response: Meaningful use will be assessed on a year-by-year basis as we establish
different Stages of meaningful use criteria for different years. If an EP or an eligible hospital
including a CAH has failed to demonstrate meaningful use of certified EHR technology for a
certain payment year, the EP, eligible hospital, or CAH will not be qualified for incentive
payments for that payment year. However, upon successful demonstration as a meaningful EHR
user in subsequent years, an EP, eligible hospital or CAH may be eligible to receive an incentive
payment. As discussed above, however, for the Medicare program, the failure of the eligible
hospital or CAH to demonstrate meaningful use in the subsequent year, will affect the total
payments that hospital is eligible to receive, as, pursuant to the statute, the hospital is treated as
skipping a payment year. Payment adjustments apply to Medicare providers who are unable to
demonstrate meaningful use starting in 2015.
Comment: One commenter asked if CMS could apply the same Medicaid EP’s first year
incentive eligibility requirements of adopting, implementing or upgrading to certified EHR
technology to Medicare physicians instead of demonstration of meaningful use.
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Response: The HITECH Act allows Medicaid EPs and eligible hospitals to receive an
incentive for the adoption, implementation, or upgrade of certified EHR technology in their first
participation year. In subsequent years, these EPs and eligible hospitals must demonstrate that
they are meaningful users. There are no parallel provisions under the Medicare EHR incentive
program that would authorize us to make payments to Medicare EPs, eligible hospitals, and
CAHs for the adoption, implementation or upgrade of certified EHR technology. Rather, in
accordance with sections 1848(o)(2), 1886(n)(3)(A), and 1814(l)(3)(A) of the Act, Medicare
incentive payments are only made to EPs, eligible hospitals, and CAHs for the demonstration of
meaningful use of certified EHR technology.
After consideration of the public comments received, we are finalizing the definitions of
First payment year as proposed. For the Medicare EHR incentive programs, we are modifying
the definitions of second, third, fourth, fifth payment year to make clear that these years are
“each successive year following the first payment year.” For the Medicaid EHR incentive
program, we included definitions of first, second, third, fourth, fifth and sixth payment year that
make clear that these are the years for which payment is received. The regulations can now be
found at §495.4 of our regulations.
e. EHR Reporting Period
In the proposed rule, we proposed a definition of EHR Reporting Period for purposes of
the Medicare and Medicaid incentive payments under sections 1848(o), 1853(l)(3), 1886(n),
1853(m)(3), 1814(l) and 1903(t) of the Act. For these sections, we proposed that the EHR
reporting period would be any continuous 90-day period within the first payment year and the
entire payment year for all subsequent payment years. In our proposed rule, we did not make
any proposals regarding the reporting period that will be used for purposes of the payment
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adjustments that begin in 2015. We intend to address this issue in future rulemaking, for
purposes of Medicare incentive payment adjustments under sections 1848(a)(7), 1853(l)(4),
1886(b)(3)(B)(ix), 1853(m)(4), and 1814(l)(4) of the Act.
For the first payment year only, we proposed to define the term EHR reporting period at
§495.4 of our regulations to mean any continuous 90-day period within a payment year in which
an EP, eligible hospital or CAH successfully demonstrates meaningful use of certified EHR
technology. The EHR reporting period therefore could be any continuous period beginning and
ending within the relevant payment year. Starting with the second payment year and any
subsequent payment years for a given EP, eligible hospital or CAH, we proposed to define the
term EHR reporting period at §495.4 to mean the entire payment year. In our discussion of
considerations in defining meaningful use later in this section we discuss how this policy may be
affected by subsequent revisions to the definition of meaningful use.
For the first payment year, we stated in the proposed rule our belief that giving EPs,
eligible hospitals and CAHs flexibility as to the start date of the EHR reporting period is
important, as unforeseen circumstances, such as delays in implementation, higher than expected
training needs and other unexpected hindrances, may cause an EP, eligible hospital, or CAH to
potentially miss a target start date.
Comment: Some commenters supported the 90-day reporting period proposed for the
first payment year. One commenter requested that exceptions, per the provider request, be
considered individually in cases of compliance for less than the 90 days (for example, 85 days).
Commenters preferred the 90-day reporting period overall and many suggested it be used for
subsequent years as well. We also received comments questioning why Medicaid providers
would need to conform to the 90-day reporting period in order to adopt, implement or upgrade
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certified EHR technology.
Response: We do believe that for program integrity it is crucial to maintain a consistent
reporting period. Basing the incentive payments on meaningful use implies a minimum level of
use in order to receive the incentive payment. The timeframe is part of the determination of
whether use is meaningful and therefore requires a minimum as well. Given the short time period
as compared to the entire year, we do not believe an exception process is needed. However, we
agree with commenters that an EHR reporting period for demonstrating adoption,
implementation or upgrading certified EHR technology by Medicaid EPs and eligible hospitals is
unnecessary and are removing it for the final rule in this instance. Similarly, Medicaid EPs and
eligible hospitals who are demonstrating meaningful use for the first time in their second
payment year, will have a 90-day reporting period to maintain parity with Medicare providers’
first meaningful use payment year. We do not believe that after successfully demonstrating
meaningful use, a 90-day period is appropriate for subsequent years. The reasons for using the
90-day period instead of the full year are based on potential delays in implementing certifying
EHR technology. Once certified EHR technology is implemented these are no longer applicable.
After consideration of the public comments received and with the clarification described
above for adopting, implementing or upgrading, we are finalizing the 90-day reporting period for
the first payment year based on meaningful use as proposed for Medicare EPs, eligible hospitals
and CAHs and full year EHR reporting periods for subsequent payment years. For Medicaid EPs
and eligible hospitals, the EHR reporting period will be a 90-day period for the first year a
Medicaid EP or eligible hospital demonstrates meaningful use and full year EHR reporting
periods for subsequent payment years.
f. Meaningful EHR User
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Section 1848(o)(1)(A)(i) of the Act, limits incentive payments under the Medicare FFS
EHR incentive program to an EP who is a “meaningful EHR user.” Similarly, section 1886(n)(1)
and 1814(l) of the Act, limits incentive payments under the Medicare FFS EHR incentive
program to an eligible hospital or CAH, respectively, who is a “meaningful EHR user.” Section
1903(t)(6)(C)(i)(II) of the Act limits incentive payments for payment years other than the first
payment year to a Medicaid EP or eligible hospital who “demonstrates meaningful use of
certified EHR technology.” We proposed to define at §495.4 the term “meaningful EHR user”
as an EP, eligible hospital, or CAH who, for an EHR reporting period for a payment year,
demonstrates meaningful use of certified EHR technology in the form and manner consistent
with our standards (discussed below).
Comment: Several commenters indicated there is a need to align measures and programs,
to avoid having to report similar measure standards to different federal, state and other entities.
Response: We concur with the goal of alignment to avoid redundant and duplicative
reporting and seek to accomplish this to the extent possible now and in future rulemaking.
Comment: Several commenters suggested that CMS considers EPs, eligible hospitals,
and CAHs who are participating in certain existing programs as meaningful EHR users. The
commenters contended that the standards followed by participants in these programs are
equivalent to those we proposed to adopt for purposes of demonstrating meaningful use. The
programs recommended by commenters are-• Qualified Health Information Exchange Networks; and
• Medicare Electronic Health Record Demonstration Program.
Response: We do not agree that participation in these programs would be the equivalent
to demonstrating meaningful use in accordance with the criteria under the EHR incentive
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programs. Most of these programs place a heavy focus on one of the five priorities of
meaningful use discussed in the next section such as reporting clinical quality measures or the
exchange of health information, tailored to the individual program’s goals. For example, the
goal of the Medicare Electronic Health Record Demonstration Program, for example, which was
started in 2009 and pre-dates passage of the HITECH Act, is to reward delivery of high-quality
care supported by the adoption and use of electronic health records in physician small to
medium-size primary care practices. The purpose of this program is to encourage adoption and
increasingly sophisticated use of EHRs by small to medium-sized primary care practices. While
this goal is similar to the overall objective of the HITECH Act, the requirements for the
demonstration are not as broad-based as that of the HITECH Act, and payment incentives are
based on the level of use over the duration of the program, which will vary by practice.
Therefore, it is not appropriate to deem practices participating in the EHR Demonstration as
meaningful users for purposes of the HITECH Act. The HITECH Act also requires use certified
EHR technology as defined by ONC to qualify for incentive payments. While CCHIT has
certified EHR technology in the past, the ONC regulation “Establishment of the Temporary
Certification Program for Health Information Technology; Final Rule” (see 75 FR 36157) which
establishes a temporary certifying body has yet to be established. Where possible, we have
aligned the criteria required to demonstrate meaningful use with existing programs like PQRI
and RHQDAPU as discussed in section II.A.3 of this final rule. After consideration of the public
comments received, we are finalizing our definition of a meaningful EHR user as proposed.
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2. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the Congress identified the broad
goal of expanding the use of EHRs through the term meaningful use. In section 1903(t)(6)(C) of
the Act, Congress applies the definition of meaningful use to Medicaid eligible professionals and
eligible hospitals as well. Certified EHR technology used in a meaningful way is one piece of a
broader HIT infrastructure needed to reform the health care system and improve health care
quality, efficiency, and patient safety. HHS believes this ultimate vision of reforming the health
care system and improving health care quality, efficiency and patient safety should drive the
definition of meaningful use consistent with the applicable provisions of Medicare and Medicaid
law.
In the proposed rule we explained that in defining meaningful use we sought to balance
the sometimes competing considerations of improving health care quality, encouraging
widespread EHR adoption, promoting innovation, and avoiding imposing excessive or
unnecessary burdens on health care providers, while at the same time recognizing the short timeframe available under the HITECH Act for providers to begin using certified EHR technology.
Based on public and stakeholder input received prior to publishing the proposed rule, we
consider a phased approach to be most appropriate. Such a phased approach encompasses
reasonable criteria for meaningful use based on currently available technology capabilities and
provider practice experience, and builds up to a more robust definition of meaningful use, based
on anticipated technology and capabilities development. The HITECH Act acknowledges the
need for this balance by granting the Secretary the discretion to require more stringent measures
of meaningful use over time. Ultimately, consistent with other provisions of law, meaningful use
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of certified EHR technology should result in health care that is patient centered, evidence-based,
prevention-oriented, efficient, and equitable.
Under this phased approach to meaningful use, we intend to update the criteria of
meaningful use through future rulemaking. We refer to the initial meaningful use criteria as
“Stage 1.” We currently anticipate two additional updates, which we refer to as Stage 2 and
Stage 3, respectively. We expect to update the meaningful use criteria on a biennial basis, with
the Stage 2 criteria by the end of 2011 and the Stage 3 criteria by the end of 2013. The stages
represent an initial graduated approach to arriving at the ultimate goal.
• Stage 1: The Stage 1 meaningful use criteria, consistent with other provisions of
Medicare and Medicaid law, focuses on electronically capturing health information in a
structured format; using that information to track key clinical conditions and communicating that
information for care coordination purposes (whether that information is structured or
unstructured, but in structured format whenever feasible); implementing clinical decision support
tools to facilitate disease and medication management; using EHRs to engage patients and
families and reporting clinical quality measures and public health information. Stage 1 focuses
heavily on establishing the functionalities in certified EHR technology that will allow for
continuous quality improvement and ease of information exchange. By having these
functionalities in certified EHR technology at the onset of the program and requiring that the EP,
eligible hospital or CAH become familiar with them through the varying levels of engagement
required by Stage 1, we believe we will create a strong foundation to build on in later years.
Though some functionalities are optional in Stage 1, as outlined in discussions later in this rule,
all of the functionalities are considered crucial to maximize the value to the health care system
provided by certified EHR technology. We encourage all EPs, eligible hospitals and CAHs to be
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proactive in implementing all of the functionalities of Stage 1 in order to prepare for later stages
of meaningful use, particularly functionalities that improve patient care, the efficiency of the
health care system and public and population health. The specific criteria for Stage 1 of
meaningful use are discussed at section II.2.c of this final rule.
• Stage 2: Our goals for the Stage 2 meaningful use criteria, consistent with other
provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use
of health IT for continuous quality improvement at the point of care and the exchange of
information in the most structured format possible, such as the electronic transmission of orders
entered using computerized provider order entry (CPOE) and the electronic transmission of
diagnostic test results (such as blood tests, microbiology, urinalysis, pathology tests, radiology,
cardiac imaging, nuclear medicine tests, pulmonary function tests, genetic tests, genomic tests
and other such data needed to diagnose and treat disease). For the final rule, we elaborate on our
plans for Stage 2. We expect that stage two meaningful use requirements will include rigorous
expectations for health information exchange, including more demanding requirements for
e-prescribing and incorporating structured laboratory results and the expectation that providers
will electronically transmit patient care summaries to support transitions in care across
unaffiliated providers, settings and EHR systems. Increasingly robust expectations for health
information exchange in stage two and stage three will support and make real the goal that
information follows the patient. We expect that Stage 2 will build upon Stage 1 by both altering
the expectations of the functionalities in Stage 1 and likely adding new functionalities which are
not yet ready for inclusion in Stage 1, but whose provision is necessary to maximize the potential
of EHR technology. As discussed later in this final rule, we are making some objectives of the
Stage 1 of meaningful use optional and other required. We will consider every objective that is
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optional for Stage 1 to be required in Stage 2 as well as revaluate the thresholds and exclusions
of all the measures both percentage based and those currently a yes/no attestation. Additionally,
we may consider applying the criteria more broadly to all outpatient hospital settings (not just the
emergency department).
• Stage 3: Our goals for the Stage 3 meaningful use criteria are, consistent with other
provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety
and efficiency leading to improved health outcomes, focusing on decision support for national
high priority conditions, patient access to self management tools, access to comprehensive
patient data through robust, patient-centered health information exchange and improving
population health.
We did not include regulatory provisions for Stage 2 or Stage 3 in our proposal and with
one exception discussed under the CPOE objective, we are not finalizing Stage 2 or Stage 3
requirements at this time. However, we plan to build upon Stage 1 by increasing the
expectations of the functionalities in Stage 1 and adding new objectives for Stage 2. In our next
rulemaking, we currently intend to propose that every objective in the menu set for Stage 1 (as
described later in this section) be included in Stage 2 as part of the core set. While allowing
providers flexibility in setting priorities for EHR implementation takes into account their unique
circumstances, we maintain that all the objectives are crucial to building a strong foundation for
health IT and to meeting the statutory objectives of the Act. In addition, as indicated in our
proposed rule, we anticipate raising the threshold for these objectives in both Stage 2 and 3 as the
capabilities of HIT infrastructure increases. For Stage 2, we intend to review the thresholds and
measures associated with all Stage 1 objectives considering advances in technology, changes in
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standard practice, and changes in the marketplace (for example, wider adoption of information
technology by pharmacies) and propose, as appropriate, increases in these requirements.
We recognize that the thresholds included in the final regulation are ambitious for the
current state of technology and standards of care. However, we expect the delivery of health
care to evolve through the inception of the HITECH incentive programs and implementation of
the Affordable Care Act prior to finalizing Stage 2. Furthermore, data collected from the initial
attestations of meaningful use will be used to ensure that the thresholds of the measures that
accompany the objectives in Stage 2 are continue to aggressively advance the use of certified
EHR technology. Finally, we continue to anticipate redefining our objectives to include not only
the capturing of data in electronic format but also the exchange (both transmission and receipt)
of that data in increasingly structured formats. As appropriate, we intend to propose the addition
of new objectives to capture new functions that are necessary to maximize the potential of EHR
technology, but were not ready for Stage 1. For instance, we would consider adding measures
related to CPOE orders for services beyond medication orders. The intent and policy goal for
raising these thresholds and expectations is to ensure that meaningful use encourages patientcentric, interoperable health information exchange across provider organizations.
We will continue to evaluate the progression of the meaningful use definition for
consistency with the HITECH ACT and any future statutory requirements relating to quality
measurement and administrative simplification. As the purpose of these incentives is to
encourage the adoption and meaningful use of certified EHR technology, we believe it is
desirable to account for whether an EP, eligible hospital or CAH is in their first, second, third,
fourth, fifth, or sixth payment year when deciding which definition of meaningful use to apply in
the beginning years of the program. The HIT Policy Committee in its public meeting on
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July 16, 2009 also voiced its approval of this approach. However, such considerations are
dependent on future rulemaking, so for this final rule Stage 1 criteria for meaningful use are
valid for all payments years until updated by future rulemaking.
We proposed that Medicare EPs, eligible hospitals, and CAHs whose first payment year
is 2011 must satisfy the requirements of the Stage 1 criteria of meaningful use in their first and
second payment years (2011 and 2012) to receive the incentive payments. We anticipate
updating the criteria of meaningful use to Stage 2 in time for the 2013 payment year and
therefore anticipate for their third and fourth payment years (2013 and 2014), an EP, eligible
hospital, or CAH whose first payment year is 2011 would have to satisfy the Stage 2 criteria of
meaningful use to receive the incentive payments. We proposed that Medicare EPs, eligible
hospitals, and CAHs whose first payment year is 2012 must satisfy the Stage 1 criteria of
meaningful use in their first and second payment years (2012 and 2013) to receive the incentive
payments. We anticipate updating the criteria of meaningful use to Stage 2 in time for the 2013
payment year and anticipate for their third payment year (2014), an EP, eligible hospital, or CAH
whose first payment year is 2012 would have to satisfy the Stage 2 criteria of meaningful use to
receive the incentive payments. We discussed in the proposed rule that Medicare EPs, eligible
hospitals, and CAHs whose first payment year is 2013 must satisfy the Stage 1 criteria of
meaningful use in their first payment year (2013) to receive the incentive payments. We
anticipate updating the criteria of meaningful use to Stage 2 in time for the 2013 payment year
and therefore anticipate for their second payment year (2014), an EP, eligible hospital, or CAH
whose first payment year is 2013 would have to satisfy the Stage 2 criteria of meaningful use to
receive the incentive payments. We discussed in the proposed rule that Medicare EPs, eligible
hospitals, and CAHs whose first payment year is 2014 must satisfy the Stage 1 criteria of
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meaningful use in their first payment year (2014) to receive the incentive payments. In the
proposed rule, we discussed the idea that alignment of stage of meaningful use and payment year
should synchronize for all providers in 2015, and requested comment on the need to create such
alignment. After reviewing public comment on this issue, our goal remains to align the stages of
meaningful use across all providers in 2015. However, we acknowledge the concerns regarding
the different Medicare and Medicaid incentive timelines, as well as concerns about whether
Stage 3 would be appropriate for an EP’s, eligible hospital’s or CAH’s first payment year at any
point in the future and believe the issue needs additional review and discussion before we lay out
a clear path forward for 2015 and beyond. Therefore, we have decided to remove language in
the final rule discussing our possible directions for any year beyond 2014. We will address the
years beyond 2014 in later rulemaking. Table 1 outlines how we anticipate applying the
respective criteria of meaningful use in the first years of the program, and how we anticipate
applying such criteria for subsequent payment years, through 2014. Please note that nothing in
this discussion restricts us from requiring additional stages of meaningful use (beyond stage 3)
through future rulemaking. In addition, as we expect to engage in rulemaking to adopt the
criteria that will accompany Stages 2 and 3 of meaningful use, stakeholders should wait for those
rulemakings to determine what will be required for those Stages and should not view the
discussions in this preamble or final rule as binding the agency to any specific definition for
those future stages.
TABLE 1: Stage of Meaningful Use Criteria by Payment Year
First
Payment Year
2011
2012
2013
2014
2011
Stage 1
Payment Year
2012
2013
2014
Stage 1
Stage 2 Stage 2
Stage 1
Stage 1 Stage 2
Stage 1 Stage 1
Stage 1
2015
TBD
TBD
TBD
TBD
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Please note that each of the EHR incentive programs has different rules regarding the
number of payment years available, the last year for which incentives may be received, and the
last payment year that can be the first payment year for an EP, eligible hospital, or CAH. The
applicable payment years and the incentive payments available for each program are also
discussed in section II.C. of this final rule for the Medicare FFS EHR incentive program, in
section II.D. of this final rule for the MA EHR incentive program, and in section II.E. of this
final rule for the Medicaid EHR incentive program.
Comment: Numerous commenters noted that it is inappropriate to align the Medicaid
EHR incentive payment program with the Medicare program due to the lack of penalties in the
Medicaid program and due to the option for Medicaid providers to participate in their first year
by adopting, implementing, or upgrading certified EHR technology.
Response: This was not the only reason for having all EPs, eligible hospitals, and CAHs
align by 2015. However, as we are not addressing stages of meaningful use beyond 2014 in this
final rule, potential alignment is not discussed. We will reconsider this comment in future
rulemaking.
The stages of criteria of meaningful use and how they are demonstrated are described
further in this final rule and will be updated in subsequent rulemaking to reflect advances in HIT
products and infrastructure. We note that such future rulemaking might also include updates to
the Stage 1 criteria.
We invited comment on our alignment between payment year and the criteria of
meaningful use particularly in regards to the need to create alignment across all EPs, eligible
hospitals, and CAHs in all EHR incentive programs in 2015.
Comment: Many commenters requested that if there continued to be a year where all
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EPs, eligible hospitals and CAHs must meet the same stage of meaningful use that that year be
2017, rather than 2015 as we had discussed in the proposed rule. These commenters asserted
that EPs, eligible hospitals, and CAHs whose first payment year is after 2011 might not have
sufficient time to reach the Stage 3 of meaningful use criteria by 2015. Some commenters
pointed out that while the HITECH Act states that 2015 is the first year of payment adjustments,
it provides for escalation of the payment adjustments so that they do not reach their full levels
until 2017.
Response: As we explained in the proposed rule, equity in the level of meaningful use
across all EPs, eligible hospitals, and CAHs subject to the payment adjustment was not the only
reason for our plan that all EPs, eligible hospitals, and CAHs satisfy the Stage 3 criteria for either
the Medicare or Medicaid EHR incentive programs. The achievement of many of the ultimate
goals of meaningful use of certified EHR technology are dependent on a critical mass of EPs,
eligible hospitals, and CAHs all being meaningful EHR users. Exchange of health information is
most valuable when it is so robust that it can be relied upon to provide a complete or nearly
complete picture of a patient’s health. For example, robust Stage 3 meaningful use by an EP does
not assist that EP in avoiding ordering a duplicative test, if the EP with information on the
original test is only a Stage 1 meaningful EHR user and is not yet exchanging that information.
This dependency is key to the need to get to Stage 3 for all providers. Another reason for
alignment at Stage 3 in 2015 is that many of the barriers to functionalities of EHRs that exist
today as may no longer exist in 2015. The existence of these barriers today is one of the primary
reasons for having a staged approach as opposed to requiring more robust meaningful use at the
beginning of the program. Providers, developers of EHRs, government and non -governmental
organizations are all working to remove these barriers. We believe it is likely there will be
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success in removing many of these barriers, which would make many of the compromises made
in Stage 1 no longer necessary by 2015. However, due to the many comments on alignment
starting in 2015 and our plan to engage in additional more rounds of rulemaking, we are
removing discussion of actual alignment between the first payment year of an EP, eligible
hospital, or CAH and the Stage of meaningful use they will be expected to meet for all years
after 2014. Our policies for 2015 and subsequent years will be determined through future
rulemaking.
Comment: Several commenters requested that CMS base the payment adjustments on
Stage 1 of meaningful use regardless of the EP, eligible hospital, or CAH’s prior participation in
the incentive program.
Response: We thank commenters for the thoughtful comments received, and will take
their input into consideration when in future rulemaking when we consider whether to require
that EPs, eligible hospitals, and CAHs satisfy the stage 3 definition of meaningful use in order to
avoid reduced payments under Medicare for their professional services and inpatient hospital
services beginning 2015. We reiterate, however, that in this final rule we are only adopting
criteria that we expect will apply in 2011 and 2012. We have also outlined the expected
progression of stages of meaningful use criteria until 2014. However, we are not in this rule
finalizing regulations that address the meaningful use standards that apply in 2015 and thereafter.
Comment: Numerous commenters requested that we specifically propose objectives and
measures for Stage 2 and 3. We also received recommendations on what those objectives and, in
rare cases, measures should be. We discussed some of these objectives in the proposed rule and
discuss them again in this final rule in section II.d. Others are highly related to existing
objectives, while still others were not discussed in any way in the proposed rule. The suggested
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objectives and measures for Stages 2 and 3 include the following:
•
Use of evidence-based order sets
•
Electronic medication administration record (eMAR)
•
Bedside medication administration support (barcode/RFID)
•
Record nursing assessment in EHR
•
Record nursing plan of care in EHR
•
Record physician assessment in EHR
•
Record physician notes in EHR
•
Multimedia/Imaging integration
•
Generate permissible discharge prescriptions electronically
•
Contribute data to a PHR
•
Record patient preferences (language, etc)
•
Provide electronic access to patient-specific educational resources
•
Asking patients about their experience of care
Response: With one exception discussed under the CPOE objective, we continue to
believe that finalizing specific objectives and measures for later stages is inappropriate. One of
the greatest benefits of the phased stage approach is the ability to consider the impact and lessons
of the prior stage when formulating a new stage. Many commenters supported our discussion of
later stages for this very reason. In addition, we do not believe it is appropriate to finalize
objectives for any stage of meaningful use that were not specifically discussed in the proposed
rule, as doing so would deprive the public the opportunity to comment on the objective in
question. Nevertheless, we thank commenters for the thoughtful comments received, and expect
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to take their input into consideration when in future rulemaking we consider additional or revised
criteria and measures to adopt for the stage 2 and stage 3 definitions of meaningful use.
Comment: A commenter indicated that attestation is an insufficient means to hold
providers accountable for the expenditure of public funds and to protect against fraud and abuse.
Response: We likewise are concerned with the potential fraud and abuse. However,
Congress for the HITECH Act specifically authorized submission of information as to
meaningful use through attestation. CMS is developing an audit strategy to ameliorate and
address the risk of fraud and abuse.
b. Common Definition of Meaningful Use under Medicare and Medicaid
Under sections 1848(o)(1)(A)(i), 1814(l)(3)(A), and 1886(n)(1) of the Act, an EP,
eligible hospital or CAH must be a meaningful EHR user for the relevant EHR reporting period
in order to qualify for the incentive payment for a payment year in the Medicare FFS EHR
incentive program. Sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act provide that an EP and
an eligible hospital shall be considered a meaningful EHR user for an EHR reporting period for a
payment year if they meet the following three requirements: (1) demonstrates use of certified
EHR technology in a meaningful manner; (2) demonstrates to the satisfaction of the Secretary
that certified EHR technology is connected in a manner that provides for the electronic exchange
of health information to improve the quality of health care such as promoting care coordination,
in accordance with all laws and standards applicable to the exchange of information; and (3)
using its certified EHR technology, submits to the Secretary, in a form and manner specified by
the Secretary, information on clinical quality measures and other measures specified by the
Secretary. The HITECH Act requires that to receive a Medicaid incentive payment in the initial
year of payment, an EP or eligible hospital may demonstrate that they have engaged in efforts to
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“adopt, implement, or upgrade certified EHR technology.” Details, including special timeframes,
on how we define and implement “adopt, implement, and upgrade” are in section II.D.7.b.2 of
this final rule. For subsequent payment years, or the first payment year if an EP or eligible
hospital chooses, section 1903(t)(6)(C)(i)(II) of the Act, prohibits receipt of an incentive
payment, unless “the Medicaid provider demonstrates meaningful use of certified EHR
technology through a means that is approved by the State and acceptable to the Secretary, and
that may be based upon the methodologies applied under section 1848(o) or 1886(n).” (Sections
1848(o) and 1886(n) of the Act refer to the Medicare EHR incentive programs for EPs and
eligible hospitals/CAHs respectively.) Under section 1903(t)(8) of the Act to the maximum
extent practicable, we are directed to avoid duplicative requirements from Federal and State
governments to demonstrate meaningful use of certified EHR technology. Provisions included at
section 1848(o)(1)(D)(iii) of the Act also contain a Congressional mandate to avoid duplicative
requirements for meaningful use, to the extent practicable. Finally, section 1903(t)(8) of the Act
allows the Secretary to deem satisfaction of the requirements for meaningful use of certified
EHR technology for a payment year under Medicare to qualify as meaningful use under
Medicaid.
We stated in the proposed rule that we believe that given the strong level of interaction on
meaningful use encouraged by the HITECH Act, there would need to be a compelling reason to
create separate definitions for Medicare and Medicaid. We declared in the proposed rule that we
had found no such reasons for disparate definitions in our internal or external discussions. To
the contrary, stakeholders have expressed strong preferences to link the Medicare and Medicaid
EHR incentive programs wherever possible. Hospitals are entitled to participate in both
programs, and we proposed to offer EPs an opportunity to switch between the Medicare and
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Medicaid EHR incentive programs. Therefore, we proposed to create a common definition of
meaningful use that would serve as the definition for EPs, eligible hospitals and CAHs
participating in the Medicare FFS and MA EHR incentive program, and the minimum standard
for EPs and eligible hospitals participating in the Medicaid EHR incentive program. We
clarified that under Medicaid this proposed common definition would be the minimum standard.
We proposed to allow States to add additional objectives to the definition of meaningful use or
modify how the existing objectives are measured; the Secretary would not accept any State
alternative that does not further promote the use of EHRs and healthcare quality or that would
require additional functionality beyond that of certified EHR technology. See section II.D.8. of
this final rule for further details.
For hospitals, we proposed to exercise the option granted under section 1903(t)(8) of the
Act and deem any Medicare eligible hospital or CAH who is a meaningful EHR user under the
Medicare EHR incentive program and is otherwise eligible for the Medicaid incentive payment
to be classified as a meaningful EHR user under the Medicaid EHR incentive program. This is
applicable only to eligible hospitals and CAHs, as EPs cannot simultaneously receive an
incentive payment under both Medicare and Medicaid.
We solicited comments as to whether there are compelling reasons to give the States
additional flexibility in creating disparate definitions beyond what was proposed. In addition, if
commenting in favor of such disparate definitions, we also asked interested parties to comment
on whether the proposal of deeming meeting the Medicare definition as sufficient for meeting the
Medicaid definition remains appropriate under the disparate definitions. This is applicable only
to hospitals eligible for both the Medicare and Medicaid incentive programs. Furthermore, if a
State has CMS-approved additional meaningful use requirements, hospitals deemed as
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meaningful users by Medicare would not have to meet the State-specific additional meaningful
use requirements in order to qualify for the Medicaid incentive payment.
Comment: Most commenters believe that States should not be allowed the option to add
to or change the meaningful use requirements for the Medicaid EHR incentive program. The
commenters’ main reason for standardizing the meaningful use requirements for both Medicare
and Medicaid is to eliminate administrative burden on both providers and EHR vendors to
accommodate programming and reporting using different technical specifications for the same or
similar measures.
Response: After consideration of the comments received, we are finalizing the
provisions regarding possible differences in the definition of meaningful use between Medicare
and Medicaid with the following revisions. We believe that over time the option to add to or
change the floor definition of meaningful use might represent an important policy tool for States
and therefore CMS plans to review and adjudicate these requests over the duration of the
program. For Stage 1 of meaningful use, we have revised the definition of meaningful use in
response to the many comments and are requiring an overall lower bar and an approach that is
more flexible. On the other hand, we wish to support the ability for States to reinforce their
public health priorities and goals based upon their existing public health infrastructure and
maturity. For that reason, we, for Stage 1, will only entertain States' requests to tailor the Stage 1
meaningful use definition as it pertains specifically to public health objectives and data registries.
For purposes of the Medicaid EHR incentive program during Stage 1 of meaningful use, these
are limited to:
Objective: Generate lists of patients by specific conditions to use for quality improvement,
reduction of disparities, research, or outreach.
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Measure: Generate at least one report listing patients of the EP or eligible hospital with a
specific condition.
Example: Generate lists of patients with the following conditions: depression, diabetes,
obesity, etc. This would not be for reporting to the State but to draw EPs’ or eligible
hospitals’ attention in order to better manage their patient population. States would also
be permitted to request CMS approval to include this in the core set for all EPs and/or
eligible hospitals.
Objective: Capability to submit electronic data to immunization registries of
Immunization Information Systems and actual submission in accordance with applicable
law and practice.
Measure: Performed at least one test of certified EHR technology's capacity to submit
electronic data to immunization registries and follow up submission if the test is
successful (unless none of the immunization registries to which the EP or eligible
hospital submits such information have the capacity to received the information
electronically).
Example: State could point to a specific immunization registry that supports standardsbased transmission of data and dictate how that information is transmitted. States would
also be permitted to request CMS approval to include this objective in the core list for all
EPs and eligible hospitals. The justification for this request in their State Medicaid HIT
Plan, should address any potential barriers for providers in achieving this objective.
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Objective: Capability to submit electronic data on reportable (as required by state or local law)
lab results to public health agencies and actual submission in accordance with applicable law and
practice.
Measure: Performed at least one test of certified EHR technology's capacity to submit electronic
data on reportable lab results to public health agencies and follow-up submission if the test is
successful (unless none of the public health agencies to which an eligible hospital submits such
information have the capacity to receive the information electronically).
Example: State could specify the standards-based means of transmission and/or the destination
of this data. States would also be permitted to request CMS approval to include this objective in
the core list for all and eligible hospitals. The justification for this request in their State
Medicaid HIT Plan, should address any potential barriers for providers in achieving this
objective.
Objective: Capability to submit electronic syndromic surveillance data to public health agencies
and actual transmission according to applicable law and practice.
Measure: Performed at least one test of certified EHR technology's capacity to submit electronic
syndromic surveillance data to public health agencies and follow-up submission if the test is
successful (unless none of the public health agencies to which an EP or eligible hospital submits
such information have the capacity to receive the information electronically).
Example: State could specify the standards-based means of transmission and/or the destination
of this data. States would also be permitted to request CMS approval to include this objective in
the core list for all EPs and eligible hospitals. The justification for this request in their State
Medicaid HIT Plan, should address any potential barriers for providers in achieving this
objective.
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We reiterate that we will not approve any requests that would require EHR functionality
above and beyond that included in the ONC EHR certification criteria as finalized for Stage 1 of
meaningful use.
Comment: Several commenters requested that CMS affirm the ability of States to require
additional meaningful use criteria for all eligible professionals and hospitals (pursuant to
§§495.316(a), 495.316(d)(2)), regardless of whether those entities were deemed eligible through
Medicare.
Response: Section 1903(t)(8) provides authority for the Secretary to “deem satisfaction
of requirements for . . . meaningful use for a payment year under title XVIII to be sufficient to
qualify as meaningful use under [1903(t)].” We continue to believe that allowing deeming
ensures that hospitals eligible for both programs are able to focus on only one set of measures,
without requiring duplication of effort or confusion regarding meaningful use standards. Thus,
hospitals eligible for both Medicare and Medicaid incentive payments will be deemed for
Medicaid if they have met the meaningful use definition through Medicare, even if a State has an
approved State-specific definition of meaningful use. States cannot withhold a Medicaid EHR
incentive payment from dually eligible hospitals if they have met all the eligibility criteria for
Medicaid, and have met the Medicare definition for meaningful use.
Because of this comment, we are revising section §495.4 of our regulations to indicate
that eligible hospitals who are meaningful users under the Medicare EHR incentive payment
program are deemed as meaningful users under the Medicaid EHR incentive payment program,
and need not meet additional criteria imposed by the State. While this is not a new requirement,
it was not previously listed in regulations.
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Comment: A commenter asked that CMS adopt and affirm the deeming approach in its
final rule and ensure that the regulatory language reflects this approach.
Response: We agree and have included in the final rule regulation language that
hospitals that are meaningful users under the Medicare EHR Incentive Program are deemed
meaningful users under the Medicaid EHR Program.
Comment: Several commenters requested that CMS not deem hospitals having met the
meaningful use requirements for the Medicare EHR Incentive Payment, as having fulfilled the
meaningful use requirements for the State’s Medicaid EHR Incentive Payment. The commenters
noted that if a State sought for acute care hospitals to participate in their statewide health
information exchange and yet those hospitals did not have to do so in order to qualify for both
the Medicare and Medicaid EHR Incentive Payments, then they would have no motivation to do
so. The commenters would like acute care hospitals eligible for both the Medicare and Medicaid
EHR Incentive Program to have to comply with any State-specific meaningful use requirements,
in addition to the Medicare floor definition.
Response: In consideration of the comments received, CMS adopts its proposed
preamble language about deeming hospitals and adds the corresponding regulation text. This is
necessary for Stage 1 of meaningful use in particular, where we believe it is crucial to prevent
additional burden on providers and foster eligible hospitals’ path to successful EHR adoption and
meaningful use. In addition, as already noted, for Stage 1, we will not entertain States’ requests
to alter the floor definition of meaningful use as codified in this final rule except for specific
public health objectives. That thereby reduces the possible differences between the Medicare
and Medicaid definitions of meaningful use. As part of Stage 2 of meaningful use, CMS might
consider States requests to tailor meaningful use as it pertains to health information exchange,
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for example. Further details about this policy option will be included in future rulemaking and
subject to public comment.
c. Stage 1 Criteria for Meaningful Use
In the proposed rule we proposed that to qualify as a meaningful EHR user for 2011, EPs,
eligible hospitals or CAHs must demonstrate that they meet all of the objectives and their
associated measures as set forth in proposed §495.6. We further proposed and finalize in this
final rule that except where otherwise indicated, each objective and its associated measure must
be satisfied by an individual EP as determined by unique National Provider Identifiers (NPIs)
and an individual hospital as determined by unique CMS certification numbers (CCN).
Discussion of whether an EP, eligible hospital or CAH must meet all Stage 1 Meaningful
Use Objectives and their Associated Measures
Comment: Commenters almost unanimously said that requiring an EP, eligible hospital
or CAH to meet all of the objectives and their associated measures in order to qualify as a
meaningful EHR user was too ambitious given the current state of EHR technology, adoption
levels, the timeline for certification of EHR technologies, the realities of implementing EHR
technology and the timeline proposed for Stage 1 of meaningful use in our proposed rule.
Most of the commenters suggested alternatives that they believed would support the
health care policy priorities of Stage 1. Several different alternatives were proposed. The first
alternative would be to require a specified percentage of the Stage 1 meaningful use objectives
and associated measures, with an EP, eligible hospital or CAH free to select which of the
objectives and associated measures it would satisfy. For example under our proposed objectives
and associated measures, if an EP were required to meet 20 percent, then an EP would be
considered a meaningful EHR user if he or she satisfied any five of the proposed twenty–five
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objectives and associated measures. Most commenters suggesting this alternative envisioned
that later stages of meaningful use would require that EPs, eligible hospitals, and CAHs satisfy a
higher of the percentage of the objectives and associated measures. For example if 20 percent of
the objectives and associated measures were required for Stage 1, then 50 percent might be
required in Stage 2.
After a fixed percentage, the suggestion next favored by commenters, including the HIT
Policy Committee and MedPAC, was to divide the meaningful use objectives into two
categories, a “core set” of objectives and “menu set” of objectives. To be a considered a
meaningful user under this approach, an EP, eligible hospital, or CAH would be required to
satisfy (1) all core set of objectives, and (2) a specified percentage of the menu set of objectives,
with the EP, eligible hospital, or CAH free to select which of the menu set of objectives it would
satisfy. For example, if five objectives were in the core set all EPs, eligible hospitals, and CAHs
would have to meet those objectives. If twenty objectives were in the menu set, then EPs,
eligible hospitals, and CAHs would not have to meet one or more of those objectives.
Commenters varied widely as to which objectives should be included in the core set of
objectives, as well as the percentage of menu set objectives an EP, eligible hospital, or CAH
must satisfy.
Some commenters suggested that we simply reduce the number of objectives required for
Stage 1 of meaningful use. Recommendations in this regard varied from reducing the required
objectives to only just a few (the lowest number being three), limiting the required objectives to
only to those objectives that affect health outcomes of individual patients, to targeted elimination
of a few objectives.
Finally, some commenters suggested that we eliminate all of the measures associated
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with the Stage 1 meaningful use objectives and only require that EPs, eligible hospitals, and
CAHs attest that they have attempted to meet each of the objectives.
Response: After reviewing the comments, we agree that requiring that EPs, eligible
hospitals, and CAHs satisfy all of the objectives and their associated measures in order to be
considered a meaningful EHR user would impose too great a burden and would result in an
unacceptably low number of EPs, eligible hospitals, and CAHs being able to qualify as
meaningful EHR users in the first two years of the program. In considering an alternative
approach, we have sought to develop an alternative that is responsive to some degree to all the
concerns raised by the commenters. We have tried to reduce the requirements both in number
required and in the thresholds of the associated measures and provide some flexibility as well.
At the same time, however, we must be mindful of the relevant statutory requirements. Sections
1848 (o)(2)(A) and 1886(n)(3) of the Act, specify three requirements for meaningful use: (1) use
of certified EHR technology in a meaningful manner (for example, electronic prescribing); (2)
that the certified EHR technology is connected in a manner that provides for the electronic
exchange of health information to improve the quality of care; and (3) that, in using certified
EHR technology, the provider submits to the Secretary information on clinical quality measures
and such other measures selected by the Secretary. We believe that each EP, eligible hospital,
and CAH must meet at least one objective within each of the three requirements for meaningful
use. We are concerned that if we were to give EPs, eligible hospitals, and CAHs full discretion
to select which meaningful use objectives they will satisfy, some providers would not choose one
or more objectives within each of the three statutory requirements for meaningful use.
Furthermore, we are concerned that affording EPs, eligible hospitals, and CAHs such flexibility
as to which meaningful use objectives to meet would delay many of the goals outlined for
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meaningful use in section II.a.2. of this final rule. If in choosing what objectives to defer, one
provider chooses to focus on improving processes to improve healthcare quality, another chooses
to focus on being able to exchange health information and yet another on engaging patients and
families it is possible that we would fail to accomplish any of these goals at a population level.
For these reasons, we do not believe it would be appropriate to afford providers the unlimited
flexibility to select which of the meaningful use objectives they will meet. Rather, as explained
below, we believe providers at a minimum should have to satisfy a core set of objectives in order
to qualify as meaningful EHR users.
Similarly, while we agree that merely reducing the number of objectives would make
meaningful use easier to achieve for most providers, we believe that this reduction does not
affords the same flexibility to all providers to account for their individual difficulties in meeting
meaningful use that some of the other alternatives do as allowing a provider to choose certain
objectives to defer. Due to any number of circumstances such as EHR adoption level,
availability of health information exchange network, size of practice or hospital, etc, an objective
that is easy for one EP to achieve might be very difficult for another EP. Under this alternative,
no allowance is made for those differences. Finally, we disagree that meaningful use should be
limited to improving the health outcomes of individual patients. There are significant gains that
meaningful use can achieve in the areas of public health, privacy and security, engagement of
patients and their families and efficiency of care that may not improve health outcomes, but have
significant other benefits such as engaging patients more fully in decisions affecting their health
and reducing costs through increased efficiency of care. We believe that all of these have a
significant impact on health outcome priorities. Therefore, we do not categorically reduce the
number of objectives for Stage 1 definition of meaningful use. We consider requests to defer an
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objective to later stages of the meaningful use criteria or eliminate a specific objective below in
our discussion of each objective.
Comment: Another alternative that was recommended by a significant number of
commenters was that we base the incentive payment amount on the number of stage 1
meaningful use objectives satisfied by an EP or eligible hospital, with those satisfying more
objectives eligible for a higher incentive payment amount. While some commenters varied in
the specifics or did not provide specifics, generally we take this to mean that if an EP, eligible
hospital, or CAH met half of the objectives then they would receive half of the incentive
payment they would have received had they met all the objectives.
Response: The HITECH Act does not give us the authority to award partial payments.
As discussed elsewhere in this final rule, sections 1848(o)(1)(A) of the Act specifies the payment
incentive amount to which an EP who is a meaningful EHR user is entitled. Similarly, section
1886(n)(2) of the Act sets forth a formula for calculation of incentive payment amount to which
an eligible hospital that is a meaningful EHR user is entitled. Similarly, section 1814(l)(3)(A) of
the Act sets forth a formula for calculation of incentive payment amount to which an eligible
hospital that is a meaningful EHR user is entitled. Similarly, section 1903(t)(4)(B) of the Act
sets parameters for determining the Medicaid EHR incentive for Medicaid EP. None of these
parameters are related to meaningful use. Similarly, section 1903(t)(5)(A) of the Act sets forth a
formula for calculation of the incentive payment amount to which a Medicaid eligible hospital is
entitled. As we do not have the authority to alter these statutory formulas for calculating the
incentive payment amounts under Medicare and Medicaid, we cannot pro rate the incentive
payment amount based on the number of meaningful use objectives satisfied by an EP, eligible
hospital, or CAH.
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After consideration of the public comments received, we are establishing a core set of
objectives with associated measures and a menu set of objectives with associated measures. In
order to qualify as a meaningful EHR user, an EP, eligible hospital, or CAH must successfully
meet the measure for each objective in the core set and all but five of the objectives in the menu
set. With one limitation, an EP, eligible hospital, or CAH may select any five objectives from
the menu set to be removed from consideration for the determination of qualifying as a
meaningful EHR user. Further discussion of the objectives, including additional details about
their inclusion in the core set, can be found at each objective.
We believe that establishing both a core and a menu set adds flexibility and allows the
minimum statutory set to be met. In determining the objectives to include in the core set, we
looked at all comments, especially those of the HIT Policy Committee and other commenters
who recommended some required and optional elements. The HITECH Act requires the use of
health information technology in improving the quality of health care, reducing medical errors,
reducing health disparities, increasing prevention and improving the continuity of care among
health care settings. In defining the core set of meaningful use objective, we believe the most
crucial aspect to consider is meeting the three statutory guidelines provided in the HITECH Act
and discussed in section II.A.2.a of this final rule. Second is to identify those objectives that are
most crucial to laying the foundation for obtaining value from meaningful use of certified EHR
technology. Third, we believe that meaningful use should be patient-centered so we focus on
getting the most value to the patient. We believe the recommendation of the HIT Policy
Committee accomplishes third criteria, but falls short of the first and second. To accomplish the
first criteria, we add the objective of submitting clinical quality measures to CMS or the States
and the objective of exchanging key clinical information among providers of care and patient
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authorized entities. To accomplish the second, we add several additional objectives to the core
set of measures as critical elements pertinent to the management of patients. We have received a
number of comments in support of these particular measures as critical to the management of
patients (maintaining an up-to-date problem list, active medication list, active allergy list,
smoking history and incorporate clinical lab tests into EHR as structured data) in comparison to
other requirements. The addition of two other functional objectives (drug-drug and drug-allergy
features) as core measures are for improved patient-safety. All of the listed elements are integral
to the initial or on-going management of a patient’s current or future healthcare. While each
element is important in the management of patients in and of itself, the aggregate of the elements
elevates the importance of clinical information to not only the primary provider but for all
members of the interdisciplinary team involved in the patient’s care. The HITECH Act
statutorily requires the use of health information technology in improving the quality of health
care, reducing medical errors, reducing health disparities, increasing prevention, and improving
the continuity of care among health care settings. These core set of measures are also
foundational and aligned with each other. For example, electronic copies of health information
given to patient will be useless if it does not contain basic information such as a problem list,
medication list or allergy list. Exchange of information to other members of the health care team
across settings will depend on having structured data of these elements. Therefore, in support of
the HITECH Act in meeting the statutory requirements, we have expanded the core set of
measures include these fundamental elements to improve patient care. Below we list the
objectives included in the core set of meaningful use objectives.
Ͳ
Use CPOE
Ͳ
Implement drug to drug and drug allergy interaction checks
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Ͳ
E-Prescribing (EP only)
Ͳ
Record demographics
Ͳ
Maintain an up-to-date problem list
Ͳ
Maintain active medication list
Ͳ
Maintain active medication allergy list
Ͳ
Record and chart changes in vital signs
Ͳ
Record smoking status
Ͳ
Implement one clinical decision support rule
Ͳ
Report CQM as specified by the Secretary
Ͳ
Electronically exchange key clinical information
Ͳ
Provide patients with an electronic copy of their health information
Ͳ
Provide patients with an electronic copy of their discharge instructions (Eligible
Hospital/CAH Only)
Ͳ
Provide clinical summaries for patients for each office visit (EP Only)
Ͳ
Protect electronic health information created or maintained by certified EHR
In addition, achieving Stage 1 meaningful use means demonstration of progress in each of the
five healthcare outcome priorities outlined in the proposed rule and discussed again later in this
section. Only one of these priorities is not represented in the core set, population and public
health. As we have discussed in this section we do not want any priority to be overlooked due to
the flexibility we have added to Stage 1 of meaningful use; therefore, all EPs and hospitals must
choose at least one of the population and public health measures to demonstrate as part of the
menu set. This is the only limitation placed on which five objectives can be deferred from the
menu set.
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Discussion on whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful
use objectives given established scopes of practice
In the proposed rule, we specifically encouraged comments on whether certain providers may
have difficulty meeting one or more of the objectives due to their provider type or chosen
specialties
Comment: We received many comments, both general and specific, that certain
providers or specialists may not be able to comply with certain objectives because they are
beyond the scope of their licensing authority or because they are outside the scope of their
standard of practice. For example, chiropractors do not have prescribing authority and thus may
not make use of an EHR technology’s e-prescribing function and rheumatologists may not
require information on vital signs. While comments on this potential non-applicability primarily
focused on EPs, we did receive comments that some objectives may not be relevant to smaller or
specialized eligible hospitals as well.
Response: We believe the division of the meaningful use objectives into a core set and a
menu set may minimize the impact of including among the meaningful use objectives one or
more objectives that certain providers or specialists may be unable to satisfy as the EP, eligible
hospital, or CAH can defer five objectives from the menu set. However, if the EP, eligible
hospital or CAH has an insurmountable barrier to meeting an objective in the core set or a
significant number in the menu set then the problem remains. For example, without any
consideration on an EP, eligible hospital or CAH’s capability to meet the measure associated
with a core objective any EP that could not order medications requiring a prescription would not
be able to become a meaningful EHR user as e-prescribing is a core set objective. Similarly, any
eligible hospital or CAH that did not have any requests for electronic copy of discharge
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instructions would not be able to become a meaningful EHR user. In addition, if this were to
occur for a significant number of menu set objectives, the flexibility for the EP, eligible hospital,
or CAH to use the five objectives to account for other concerns such as implementation struggles
or workflow process redesign would be curtailed. To account for this possibility, we have
modified each objective and measure to indicate when there is an option for an EP, eligible
hospital, or CAH to report that the objective/measure is inapplicable to them, because they have
no patients or no or insufficient number of actions that would allow calculation of the
meaningful use measure. This will allow an EP, eligible hospital, or CAH to qualify as a
meaningful EHR user without being required to meet objectives we have specified as potentially
inapplicable. We note that the exclusions to meaningful use objectives/measures are specific to
each objective/measure. In our discussion of each specific objective/measure (which occurs later
in this preamble), we have identified specific exclusions where they exist. Providers wishing to
claim that an objective/measure is inapplicable to them would need to meet the criteria of such
an exception.
After consideration of the public comments received, we have identified, for each
meaningful use objective, whether the EP, eligible hospital, or CAH may attest that they did not
have any patients or insufficient actions on which to base a measurement of a meaningful use for
the EHR reporting period. For objectives in the core set, such an attestation would remove the
objective from consideration when determining whether an EP, eligible hospital, or CAH is a
meaningful EHR user. In other words, the EP, eligible hospital, or CAH could satisfy the core
set objectives by satisfying all remaining objectives included in the core set. For objectives in
the menu set, such an attestation would also remove the objective from consideration when
determining whether an EP, eligible hospital, or CAH is a meaningful EHR user. For example, if
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for one objective included in the menu set an EP attests that he or she did not have any patients
or insufficient actions during the EHR reporting period on which to base a measurement of a
meaningful use objective, rather than satisfy 5 of the 10 meaningful use objectives included in
the menu set for EPs, the EP need only satisfy 4 of the 9 remaining meaningful use objectives
included in the menu set for EPs
EPs practicing in multiple practices
Another situation where flexibility may be needed in order for an EP to become a
meaningful EHR user is the situation where an EP may provide care in multiple practices or
multiple locations. We proposed a policy to account for EPs practicing in multiple practices and
settings. We discussed in the proposed rule that we believe it is unlikely for an EP to use one
record keeping system for one patient population and another system for another patient
population at one location. We are concerned about the application of the measures associated
with the meaningful use objectives for EPs who see patients in multiple practices or multiple
locations. If an EP does not have certified EHR technology available at each location/practice
where they see patients it could become impossible for the EP to successfully become a
meaningful EHR user based on the measures associated with the meaningful use objectives. We
do not seek to exclude EPs who meaningfully use certified EHR technology when it is available
because they also provide care in another practice where certified EHR technology is not
available. Therefore, we proposed that all measures be limited to actions taken at
practices/locations equipped with certified EHR technology. A practice is equipped if certified
EHR technology is available at the beginning of the EHR reporting period for a given geographic
location. Equipped does not mean the certified EHR technology is functioning on any given day
during the EHR reporting period. Allowances for downtime and other technical issues with
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certified EHR technology are made on an objective-by-objective basis as discussed later in this
section. We are concerned that seeing a patient without certified EHR technology available does
not advance the health care policy priorities of the definition of meaningful use. We are also
concerned about possible inequality of different EPs receiving the same incentive, but using
certified EHR technology for different proportions of their patient population. We believe that
an EP would have the greatest control of whether certified EHR technology is available in the
practice in which they see the greatest proportion of their patients. We proposed that to be a
meaningful EHR user an EP must have 50 percent or more of their patient encounters during the
EHR reporting period at a practice/location or practices/locations equipped with certified EHR
technology. An EP for who does not conduct 50 percent of their patient encounters in any one
practice/location would have to meet the 50 percent threshold through a combination of
practices/locations equipped with certified EHR technology. For example, if the EP practices at
both a Federally Qualified Health Center (FQHC) and within his or her individual practice, we
would include in our review both of these locations and certified EHR technology would have to
be available at the location where the EP has at least 50 percent of their patient encounters.
Comment: Some commenters recommended that 50 percent or more of the patient
encounters must occur at the practice location that receives the incentive payment.
Response: As discussed in section II.A.4 of this final rule, an EP may assign their
incentive payment to other practices. We do not believe that limiting practices and EPs to only
considering the location that receives an incentive payment provides advantages to the program.
The requirement suggested by commenters would potentially cause some EPs not to meet the
50 percent threshold even if through a combination of practices they may use certified EHR
technology for far more than 50 percent of their patient encounters.
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Comment: Some commenters requested clarification of our proposed statement
“Therefore, we proposed that all measures be limited to actions taken at practices/locations
equipped with certified EHR technology”
Response: We mean this statement to be that as long as an EP has certified EHR
technology available for 50 percent or more of their patient encounters during the EHR reporting
period they only have to include those encounters where certified EHR technology is available at
the start of the EHR reporting period. We discuss the measures later in this section of the final
rule, but an illustrative example would be the objective of maintain an up-to-date problem list.
The measure associated with this objective is “More than 80% of all unique patients seen by the
EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS 21
or 23) have at least one entry or an indication that no problems are known for the patient
recorded as structured data.” Therefore, if an EP only practices at one location or has certified
EHR technology available at all practice locations then the denominator would be all unique
patients seen during the EHR reporting period. However, if an EP practices at multiple locations
and only has certified EHR technology for 80 percent of their patient encounters, then the
denominator is only those unique patients seen at locations where certified EHR technology is
available. We reiterate that this is not to account for certified EHR technology downtime,
Certified EHR technology is available at a location if it is available at the start of the EHR
reporting period regardless of its actual availability for any given day during the EHR reporting
period.
After consideration of the comments received, we are finalizing this requirement as
proposed.
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Discussion of the Burden Created by the Measures associated with the Stage 1 Meaningful
Use Objectives
Comment: Many commenters expressed concerns about the difficulties of capturing the
denominators for the measures that are expressed as percentages. They pointed out that the
formulas in the proposed rule would require providers to conduct labor-intensive counts of paper
documents such as prescriptions or laboratory results in order to compute the denominators of
the percentage based measures. Some commenters suggested that we adopt alternative
measurement mechanisms, for example establishing simple counts of electronic occurrences,
while others proposed that denominators be computed utilizing only data collected in the
certified EHR technology.
Response: We acknowledge that the percentage-based measures, as expressed in the
proposed rule, would create a reporting burden for EPs, eligible hospitals, and CAHs, and we
examined a number of alternatives that potentially reduce the burden of reporting.
In the proposed rule, we discussed the option of counts instead of percentages and due to
comments received have reassessed this option in the final rule. This approach clearly has the
advantage of simplifying the process. For example, rather than counting the number of
prescriptions transmitted electronically and then dividing by the total number of prescriptions,
the EP would simply need to count the number of electronically transmitted prescriptions until a
benchmark number is passed. If the benchmark number is exceeded, then the provider meets the
measure. However, there are several shortcomings to this approach. First, we received little
input from commenters as to where the benchmark numbers for the various objectives should be
set and any benchmark set now would not benefit from public comment without significantly
delaying the Medicare and Medicaid EHR incentive programs. (One exception was that a
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number of commenters suggested using the PQRI measure for e-prescribing, which is the
generation of at least one eRx associated with a patient visit on 25 or more unique events during
the reporting period.) Setting the limit too high would disadvantage small providers, since they
would have smaller patient populations, while setting the limit too low would create
requirements for larger providers that would be so limited as to be meaningless. A larger
provider could implement the functionality for a much shorter period than the EHR reporting
period and meet the count. In either case, it would be difficult to establish a trajectory in later
stages that would result in meaningful progress being made by both small and large providers.
We then assessed the option of limiting the occurrences counted in the denominator to
those included in the provider’s certified EHR technology. As an example, if an EP captures
1,000 prescriptions as structured data in certified EHR technology, and electronically transmits
500 of these prescriptions, the EP’s certified EHR technology generated score would be
50 percent. This approach does simplify the computation process, since this approach does not
have to take into account whether some prescriptions were not included or included as
unstructured data in the certified EHR technology. However, it does not demonstrate the extent
to which the provider has used the certified EHR technology. For example, a provider that has
captured only 10 prescriptions in the certified EHR technology as structured data, but writes
1,000 prescriptions because the provider achieved only a limited use of their certified EHR
technology would also score 50 percent by electronically transmitting only 5 prescriptions
according to an automatic report from the certified EHR technology. Again, this methodology
does not lead providers toward an upward trajectory of both certified EHR technology
deployment and accomplishment of meaningful use.
We selected a third option, which we believe addresses the shortcomings of the second
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option while still preserving much of the simplicity of that approach. In our approach, we focus
on those measures whose denominator is not based on all patients, but rather a subset of patients
or actions such as the ordering of a lab test or the recording of a patient’s request for an
electronic copy of their discharge instructions. We believe that it is reasonable to require an EP,
eligible hospital, or CAH to know how many unique patients they care for in the EHR reporting
period and therefore maintain that denominator where it applies. The maintenance of measures
using the patient as the denominator as encompassing all patients ensures a certain level of
utilization of certified EHR technology by the EP, eligible hospital, or CAH. If a measure
encompassing all patients has a threshold of 80 percent, then at least 80 percent of the patients’
records must be maintained using certified EHR technology otherwise the EP, eligible hospital or
CAH could not possibly meet the threshold. We note a number of measures included in the core
set (such as “Record Demographics” and “Maintain an Up-to-Date Problem List”) require an
analysis of all unique patients, and not just patients whose records are maintained in certified
EHR technology As discussed later the thresholds for maintaining an up-to-date problem list,
medication list and medication allergy list are set at 80 percent. We believe these thresholds will
create a baseline that ensures that EPs, eligible hospitals and CAHS are maintain a minimum
percentage of patient records in certified EHR technology, and allows the provider community to
advance toward the longer-term objective of capturing all patient data in certified EHR
technology. For those measures that focus on the recording of actions or subset of patients to
generate the denominator, we limit the measures to the information for patients whose records
are maintained in certified EHR technology. We offer the following examples that relate to the
e-prescribing and the provision of electronic copy of a patient’s health information:
E-Prescribing Example: An EP orders 1,000 prescriptions for patients whose records are
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maintained in their certified EHR technology and 500 of those are transmitted electronically.
The EP’s denominator is 1,000 prescriptions, the numerator is 500 prescriptions, and their score
is 50 percent. If the EP captures all 1,000 prescriptions as structured data the calculation could
be automated by the certified EHR technology. If the EP does not capture all 1,000 prescriptions
as structured data than more manual review may be required. We would define “records
maintained in the certified EHR technology” to include any patient for which sufficient data was
entered in the certified EHR technology to allow the record to be saved, and not rejected due to
incomplete data. This may be a more limited set of data, but an EP, eligible hospital, or CAH
would still have to have sufficient information in certified EHR technology to meet the measures
associated with Stage 1 of meaningful use. For example, an EP might be able to save a record
with just a patient’s name, but as the record would lack any information this patient would count
in the denominator, but not the numerator for many objectives. Electronic Copy of a Patient’s
Health Information Provided upon Request Example: An EP maintains 1,000 patient records in
their certified EHR technology. Of those patients, fifty make requests for electronic copies of
their health information. The EP provides all of the electronic copies within three business days.
The denominator is 50, the numerator is 50, and the EP’s percentage is 100 percent. If the EP
captures requests for information as structured data, the calculation could be automated by the
certified EHR technology. If the EP does not capture all the requests as structured data then more
manual review may be required. We will likely revisit the methodology in Stage 2, where we
would expect that at least basic EHR functionality has been implemented throughout the
provider enterprise.
After consideration of public comments, we are limiting the following objectives and
their associated measures to patients whose records are maintained using certified EHR
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technology. Specific information on how to determine inclusion in the denominator and
numerator is discussed in the full discussion of each objective later in this final rule.
•
Use CPOE
•
Generate and transmit permissible prescriptions electronically (eRx)
•
Record and chart changes in vital signs
•
Record smoking status for patients 13 years old or older
•
Record advance directives for patients 65 years old or older
•
Incorporate clinical lab-test results into certified EHR technology as structured data
•
Provide patients with an electronic copy of their health information (including diagnostic
test results, problem list, medication lists, medication allergies), upon request
•
Provide patients with an electronic copy of their discharge instructions at time of
discharge, upon request
•
Provide clinical summaries for patients for each office visit
•
Send reminders to patients per patient preference for preventive/follow-up care
•
Perform medication reconciliation at relevant encounters and each transition of care
•
Provide summary care record for each transition of care and referral
Discussion on Meaningful Use Relationship to Certified EHR Technology
Comment: We received several comments requesting more specific information of how
certified EHR technology will accomplish meaningful use. Some commenters expressed
concern that patient clinical outcome measurement and improvement was not addressed
explicitly in the requirements of certified EHR technology, but rather the requirements focused
data entry and provision of data electronically.
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Response: One of the main purposes of certifying EHR technology is to provide the EP,
eligible hospital, or CAH with confidence that the technology will not be the limiting factor in
the achievement of meaningful use. As such, all questions of how or will certified EHR
technology be able to accomplish meaningful use broadly or at a specific objective level are best
answered by ONC. CMS and ONC have worked closely since the enactment of the HITECH Act
to ensure certification fully supports meaningful use. We explicitly link each meaningful use
objective to certification criteria for certified EHR technology. The capabilities and standards
that are certified are those that are used to meet the Stage 1 objectives of meaningful use. This
way we ensure that certified EHR technology can accomplish meaningful use and meaningful
use has the intended consequences of improving the healthcare priorities that make up
meaningful use.
Discussion on the Relationship between a Stage 1 Meaningful Use Objective and its
Associated Measure
Comment: Many commenters pointed out gaps between what they believed were the
anticipated results from an objective and the results that are measured by the associated measure.
A particular concern of some of these commenters is cases where the certification criteria
supports the measure, but in their view fell short of supporting the objective.
Response: In the proposed rule, we attempted to draw a clear distinction between the
objective and the associated measure. The objectives represent a wide range of activities some of
which are commonplace for EPs, eligible hospitals, and CAHs using EHRs today, while others
are ambitious goals even for the most sophisticated EHR user of today. For some objectives, all
aspects of the objective are within the control of the EP, eligible hospital, or CAH. Other
objectives rely on electronic exchange with partners or external infrastructure over which EPs,
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eligible hospitals and CAHs may have little influence and no control. We have attempted to
accommodate these differences when we select the Stage 1 measure for a given objective. The
measure more accurately reflects our view of what is feasible for Stage 1 than the objective
itself. The certification criteria necessarily reflect more on the measure than the objective, as full
compliance with an objective is beyond the scope of what can be accomplished for a significant
number of EPs, eligible hospitals or CAHs in our timeframe for Stage 1. This rationale was our
assertion in the proposed rule as the justification for measures that represent less than full
achievement of their objective. This is further supported by some of the comments received
although for any given objective the comments addressing that objective were a small fraction of
the total number of comments received and views on how much a measure should allow for less
than full achievement varied widely among those commenting. Although we received over
2,000 public comments, the number of specific comments addressing an individual objective
were relatively small ranging from 40 to 200. We reviewed those comments and made specific
changes to measures in the discussion of each objective. We reiterate that achievement of the
measure always equates to achievement of the objective for Stage 1 of meaningful use. We also
reiterate that certified EHR technology will always be able to support achievement of the
measure by including the necessary functionalities. However, as with any technology, certified
EHR technology is only as good as the information it contains and getting information into
certified EHR technology is heavily dependent on processes developed by the EP, eligible
hospital, or CAH. It is for this reason that all measures, even those for objective whose aspects
are fully under the control of the EP, eligible hospital, or CAH, represent less than full
fulfillment of the objective to varying degrees. As stated, for demonstrating meaningful use and
any follow up review by CMS or the States, successfully meeting the associated measure always
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equates to successfully meeting the objective. Updated information on the associated measures
including the numerator, denominator, thresholds and exclusions are as discussed in the
following section. More detailed specifications and guidance on calculating the measures will be
issued soon after the publication of this final rule.
As we described in the proposed rule, in discussing the objectives that constitute the
Stage 1 criteria of meaningful use, we adopted a structure derived from recommendations of the
HIT Policy Committee of grouping the objectives under care goals, which are in turn grouped
under health outcomes policy priorities. We believe this structural grouping provides context to
the individual objectives; however, the grouping is not itself an aspect of meaningful use. The
criteria for meaningful use are based on the objectives and their associated measures.
We will now review the comments for each objective and measure and make changes to
our original proposal or finalize as proposed.
(1) Objectives and Their Associated Measures
The HIT Policy Committee identified as its first health outcomes policy priority
improving quality, safety, efficiency and reducing health disparities. The HIT Policy Committee
also identified the following care goals to address this priority:
● Provide access to comprehensive patient health data for patient's healthcare team
● Use evidence-based order sets and CPOE.
● Apply clinical decision support at the point of care.
● Generate lists of patients who need care and use them to reach out to those patients.
● Report information for quality improvement and public reporting
As we explained in the proposed rule, for the last care goal, the HIT Policy Committee proposed
the goal as “Report to patient registries for quality improvement, public reporting, etc.” We have
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modified this care goal, because we believe that patient registries are too narrow a reporting
requirement to accomplish the goals of quality improvement and public reporting. We note that
the HIT Policy Committee's recommended objectives include the reporting of quality measures
to CMS. We do not believe that CMS would normally be considered a “patient registry”. We
also removed the phrase “etc.” We believe that the level of ambiguity created by “etc” is not
appropriate for Federal regulations.
NPRM EP Objective: Use CPOE
NPRM Eligible Hospital Objective: Use CPOE for orders (any type) directly entered by the
authorizing provider (for example, MD, DO, RN, PA, NP).
In the proposed rule, we described CPOE as entailing the provider's use of computer
assistance to directly enter medical orders (for example, medications, consultations with other
providers, laboratory services, imaging studies, and other auxiliary services) from a computer or
mobile device. The order is also documented or captured in a digital, structured, and computable
format for use in improving safety and organization. We said that for Stage 1 criteria, it will not
include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic imaging
center.
Comment: A majority of commenters recommended that EPs, eligible hospitals, and
CAHs be allowed to defer CPOE for varying lengths of time ranging from 2012 to 2017. The
commenters cited various reasons for deferment including that CPOE is an advanced clinical
function that typically is the last process to be implemented due to the need to build the entire
infrastructure to support the CPOE process. Other commenters noted an increased burden as if
the orders cannot be transmitted, then duplicate paper orders will have to be produced which can
lead to patient safety risks. Commenters also noted that CPOE appears in the latter stages of the
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Certification Commission for Healthcare Information Technology (CCHIT) EHR
implementation process. A minority, but significant number of comments encouraged CMS to
maintain CPOE for 2011. Those commenters in favor of retaining CPOE in 2011 believed that
CPOE is a basic EHR feature that should be a standard offering of a certified EHR technology
and is critical to improving quality of care through audit trails and alerting of delinquent order
and/or delinquent deferred orders.
Response: We have determined that CPOE should be included in the core set of
measures for Stage 1 in order to advance meaningful use. CPOE is a foundational element to
many of the other objectives of meaningful use including exchange of information and clinical
decision support. Many commenters, including several physician associations, the HIT Policy
Committee and members of Congress through their endorsement of the HIT Policy Committee’s
recommendation, recommended that CPOE be required in Stage 1. CPOE has been a major
initiative of US hospitals for over a decade and is a foundational functionality to many of the
activities that further the health care policy priorities of meaningful use. For example, entering a
medication order using CPOE allows the EHR to provide feedback on whether the medication
may have adverse reactions with other medications the patient is taking. Another benefit of
CPOE is that greatly simplifies the workflow process of inputting information into certified EHR
technology in a structured way to populate the patient record.
Comment: Several commenters asked that we further specify who could enter the order
using CPOE. Some commenters stated that only the ordering provider should be permitted to
enter the order. These commenters stated that the ordering professional needs to be presented
with clinical decision support at the time of entry and that the relay of an order to another
individual is a source of potential error. Other commenters recommended that any licensed
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healthcare professional or indeed any individual (licensed or not) who receives the order from
the ordering provider be permitted to perform the CPOE. The most common argument presented
by these commenters is that this is currently how CPOE is handled in practice and a shift to entry
by only the ordering provider would be too disruptive to workflow.
Response: We agree with those commenters who recommend allowing any licensed
healthcare professional to enter orders using CPOE. We further refine this recommendation to
be that any licensed healthcare professional can enter orders into the medical record per state,
local and professional guidelines. While we understand that this policy may decrease
opportunities for clinical decision support and adverse interaction, we believe it balances the
potential workflow implications of requiring the ordering provider to enter every order directly,
especially in the hospital setting. We disagree with commenters that anyone should be allowed
to enter orders using CPOE. This potentially removes the possibility of clinical decision support
and advance interaction alerts being presented to someone with clinical judgment, which negates
many of the benefits of CPOE.
Comment: We received requests for clarification of this objective and what types of
orders would meet this requirement.
Response: Our intent in the proposed rule was to capture orders for medications,
laboratory or diagnostic imaging.
However, after careful consideration of the comments, we are adopting an incremental
approach by only requiring medication orders for Stage 1. First, this supports the objectives of eprescribing, drug-drug and drug-allergy checks. Second, this requirement will improve patientsafety because of the alignment of ordering medications in a structured data format will enable
providers to create registries of patients for potential medical recalls, participate in surveillance
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for potential sentinel events and life-threatening side effects of new medications. Third, other
measures involving transitions of care documents and summary of care document will require
the entry of an active medication list. After consideration of the public comments received, we
are finalizing the meaningful use objective for EPs at 495.6(d)(1)(i) and for eligible hospitals,
and CAHs at 495.6(f)(1)(i) as “Use CPOE for medication orders directly entered by any licensed
healthcare professional who can enter orders into the medical record per state, local and
professional guidelines”.
NPRM EP Measure: CPOE is used for at least 80 percent of all orders
NPRM Eligible Hospital or CAH Measure: For eligible hospitals, CPOE is used for 10
percent of all orders
In the proposed rule under CPOE, we discussed several concepts related to any associated
measure of any objective that relies on a percentage calculation. These are the use of a
percentage versus a count; setting a threshold for measures not requiring the electronic exchange
of information; EPs practicing in multiple locations, some of which may not have certified EHR
technology available, and the patient population to which the measure would apply. All except
the last of these received extensive comments and are addressed in comment and response
sections earlier in this section. In the proposed rule, we said that we would base the measures
associated with the objectives on both the Medicare/Medicaid patient population and all other
patients as well. We said that we believe it is unlikely that an EP would use one record keeping
system for one patient population and another system for another patient population at one
location and that requiring reporting differences based on payers would actually increase the
burden of meeting meaningful use. We received very few comments on this aspect of our
proposed rule and those that were received were generally supportive of this proposal.
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Therefore, we are finalizing the policy that all meaningful use measures be calculated based on
the eligible provider’s entire patient population (except where otherwise noted).
Comment: Nearly every commenter who commented on CPOE objected to our proposal
to limit this measure to the inpatient department (Place of Service Code 21) for the eligible
hospital or CAH. Commenters stated that this limitation was inappropriate given the manner in
which hospitals use EHR technology. To account for current practice, the commenters
recommended the measures be expanded to include the emergency department (ED) (POS 23).
Other reasons cited by commenters were that orders begin in the ED and remain open as the
patient transitions to inpatient (for example, infusions), transitioning from paper documentation
in the ED to electronic for subsequent care is unsafe as it can result in missed information, and/or
transcription errors as the initial allergies and medications are entered into the system, significant
data collection occurs in the ED that would not be included in the system, the exclusion of the
ED creates disincentives to adoption and that the ED is a hybrid of temporal and functional
services that are neither purely ambulatory nor inpatient.
Response: We agree with the commenters, and therefore are expanding this objective
and its associated measure to the emergency room (POS 23). More information on place of
service codes is available at http://www.cms.gov/PlaceofServiceCodes/. Furthermore, given the
revision to the HITECH Act that changed hospital based eligible professionals to include only
the setting of inpatient and emergency departments and all of the benefits of integration of these
two departments spelled out by commenters we will adopt both departments when considering
the measure of eligible hospitals or CAHs unless we find there are unique circumstances of a
objective and its associated measure that would preclude the inclusion of the emergency
department for meaningful use. This change does not affect the incentive payment calculation
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described in section II.B. of this final rule
Comment: We received several recommendations from commenters that the requirement
of a percentage measurement for determining whether an EP, eligible hospital or CAH meets this
objective should be replaced with a numerical count for CPOE and many other measures
associated with percentage thresholds. The two main reasons given for switching to numerical
counts are the burden of calculating the percentage if it cannot be done automatically using
certified EHR technology and the assertion that if an EP, eligible hospital, or CAH does
something a specific number of times it can be assumed that it is done often enough to constitute
meeting the objective for Stage 1 of meaningful use.
Response: We have previously discussed the merits of a percentage based measure over
a count based measure earlier in this section under the discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives. However, we do try to seek a
balance reducing the burden on providers while still ensuring the progression of meaningful use
of certified EHR technology. In the next comment/response, we discuss changes to this measure
that respond to concerns regarding burden.
Comment: Many commenters representing EPs as well as other commenters
recommended lowering the CPOE threshold for EPs. Those commenters representing EPs
generally recommended parity with eligible hospitals at 10 percent, while other commenters
recommending a reduction generally recommended 50 percent.
Response: With CPOE, we had a unique situation of disparate thresholds between EPs
and hospitals. This was due to recommendations prior to the proposed rule by the HIT Policy
Committee. Eligible hospitals were granted an even lower threshold for this particular
requirement. The reason given for this recommendation was that CPOE is one of the last
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functionalities to be implemented in the hospital setting. Commenters point out that holds true
for EPs as well. As discussed above, given the limitations we are placing on the numerator and
denominator for calculating the CPOE percentage, we e no longer see a compelling reason to
maintain disparate thresholds for the EPs and the eligible hospital/CAH.
Comment: Commenters have suggested that our proposal to count an action per unique
patients could be applied to the measure for CPOE as well through a revised measure of “[a]t
least 10% of unique patients seen by the EP or admitted to the eligible hospital or CAH have at
least one order entered using CPOE.” Commenters also pointed to CPOE as an example of a
case where adequate lead time is necessary to implement certified EHR technology.
Response: At the heart of this new basis for this measure is the assumption that every
patient would have at least one order that could be entered using CPOE. We believe this is a
reasonable assumption for EPs, eligible hospitals and CAHs. According to analysis of 25,665
office-based visits in the 2005 National Ambulatory Medical Care Survey, 31 percent of visits
included a new medication order, and 44 percent included at least one refill; 66 percent had any
type of medication order. However, whether a medication order is appropriate for every practice
could vary significantly by scope of practice; therefore, for the final rule, we are further limiting
the denominator to patients with at least one medication listed in their medication list. We
believe that this limitation will reduce providers’ burden as compared to accounting for all
orders. To further reduce the burden on providers, we also will limit the numerator to unique
patients with at least one medication order entered using CPOE. Because we have reduced
provider burden by limiting the denominator and numerator as discussed above, we believe that a
corresponding increase in the CPOE threshold is appropriate for hospitals and CAHs. For stage
1, we are finalizing a threshold for CPOE of 30 percent for EPs, eligible hospitals, and CAHS.
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We believe this relatively low threshold, in combination with the limitation to only medication
orders, will allow hospitals and EPs to gain experience with CPOE. However, as providers gain
greater experience with CPOE, we believe it is reasonable to expect greater use of the function.
As explained above, we also believe CPOE is foundational to many other objectives of
meaningful use. For these reasons, we believe it is reasonable to expect providers to move to a
60 percent threshold at Stage 2 of meaningful use. Thus, for this measure, we are finalizing, for
Stage 2 of meaningful use, that EPs, eligible hospitals and CAHs must meet a 60 percent
threshold for CPOE. Therefore, we are finalizing a Stage 2 measure for CPOE at §495.6(h) for
EPs and §495.6(i) for eligible hospitals and CAHs as “More than 60 percent of all unique
patients with at least one medication in their medication list seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR
reporting period have at least medication one order entered using CPOE”.
Comment: We received several comments asking for clarification of the term unique
patient in response to various objectives.
Response: In the proposed rule, we state, “the reason we propose to base the measure on
unique patients as opposed to every patient encounter, is that a problem list would not
necessarily have to be updated at every visit.” To further describe the concept of “unique
patient” we mean that if a patient is seen by an EP or admitted to an eligible hospital’s or CAH’s
inpatient or emergency department (POS 21 or 23) more than once during the EHR reporting
period then for purposes of measurement they only count once in the denominator for the
measure. All the measures relying on the term “unique patient” relate to what is contained in the
patient’s medical record. Not all of this information will need to be updated or even be needed by
the provider at every patient encounter. This is especially true for patients whose encounter
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frequency is such that they would see the same provider multiple times in the same EHR
reporting period. Measuring by every patient encounter places an undue burden on the EPs,
eligible hospitals and CAHs and may have unintended consequences of affecting the provision of
care to patients merely to comply with meaningful use. Given the emphasis placed on the
reporting burden by commenters as described in the beginning of this section, we believe that our
concerns about the burden of measurement were well founded. We also continue to believe that
the use of patient encounters could have unintended consequences on the provision of care by
providers.
Comment: Some commenters asked whether the CPOE objective and associated measure
require transmission of the order. Most of these commenters were opposed to such transmission
in Stage 1 for various reasons such as the cost of developing interfaces between EHRs and
laboratory and radiology service providers, the volume of transmissions would outpace the
capacity to connect, HIE infrastructure is not yet mature enough and the lack of the requirement
for non-eligible entities to participate (for example, laboratory vendors, pharmacies). Some
commenters supported the inclusion of the transmission of the order as they believed this would
provide better outcomes than if the transmission was not required.
Response: In the proposed rule, we stated, “For Stage 1 criteria, we propose that it will
not include the electronic transmittal of that order to the pharmacy, laboratory, or diagnostic
imaging center.” While a few commenters recommended that this objective be changed to
require transmission, given the large opposition to the objective and measure as proposed and
the reasons commenters presented against transmission, it would not be responsive to the vast
majority of commenters to expand this objective beyond our proposal. We agree with the
commenters that said the HIE infrastructure is still being developed in most parts of the country.
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Furthermore, we note that in the hospital setting, most medication orders would not require
transmission outside of the certified EHR technology of the hospital. For EPs, we already
address transmission of the medication order in a separate objective for e-prescribing.
Therefore, we finalize the proposal that the transmission of the order is not included in the
objective or the associated measure for Stage 1.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at 495.6(d)(1)(ii) of our regulations and for eligible hospitals, and CAHs at
§495.6(f)(1)(ii) of our regulations to “More than 30 percent of all unique patients with at least
one medication in their medication list seen by the EP or admitted to the eligible hospital’s or
CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period have
at least medication one order entered using CPOE”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(a) for EPs and 45 CF170.306(a) for eligible hospitals and CAHs.
The ability to calculate the measure is included in certified EHR technology. Thus, for example,
an EP, eligible hospital or CAH must use a certified functionality in entering the medication
order, and could not use a functionality that has been added by the EHR vendor, but that is
outside the scope of the certification. We believe this rule is necessary to ensure that the EP,
eligible hospital, or CAH is actually making meaningful use of “certified” EHR technology, and
is not using non-certified technology. In addition, requiring providers to use functionalities that
are certified will ensure the interoperability of information maintained in the EHR as providers
will be able to operate according to consistent standards. We believe this standardization and
consistency is key to realizing the goal of using EHR technology to improve health care.
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As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the only patients that are
included in the denominator are those patients whose records are maintained using certified EHR
technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients with at least one medication in their medication
list seen by the EP or admitted to an eligible hospital’s or CAH’s inpatient or emergency
department (POS 21 or 23) during the EHR reporting period
•
Numerator: The number of patients in the denominator that have at least one medication
order entered using CPOE.
•
Threshold: The resulting percentage must be more than 30 percent in order for an EP,
eligible hospital or CAH to meet this measure.
Exclusion: If an EP’s writes fewer than one hundred prescriptions during the EHR reporting
period they would be excluded from this requirement as described previously in this section in
our discussion whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use
objectives given established scopes of practices. We do not believe that any eligible hospital or
CAH would have less than one hundred prescriptions written for patients admitted to their
inpatient and emergency departments during the EHR reporting period.
NPRM EP/Eligible Hospital Objective: Implement drug-drug, drug-allergy, drug-formulary
checks
In the proposed rule, we did not elaborate on this objective.
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Comment: Many commenters requested clarification as to what formulary the checks
would be conducted against.
Response: Ideally, this check would be performed against any formulary that may affect
the patient’s welfare, inform the provider as to the best drug to prescribe or provide the patient
and provider information on the drug’s cost to both the patient and any third party payer. We
recognize, however, that not every available third party payer, pharmacy benefit management,
preferred drug list is standardized and made available for query through certified EHR
technology. As we cannot through this regulation impose such a requirement on every developer
of a formulary, we do not require that an EP/eligible hospital/CAH would have to accommodate
every formulary in their implementation. However, at a minimum an EP/eligible hospital/CAH
must have at least one formulary that can be queried. This may be an internally developed
formulary or an external formulary. The formularies should be relevant for patient care during
the prescribing process. To further address this, we expect that this measure will be expanded to
be counted on a transactional basis for future stages.
Comment: Commenters suggested separating the objective into one objective for the
clinical checks (drug-drug and drug-allergy) and a second objective for the administrative check
(drug-formulary). The rationale stated for the division was that clinical measures are focused on
preventing medication errors versus encouraging consideration of cost when prescribing
medications. In addition, the two types involve connections to different kinds of resources (drug
safety information versus formulary information).
Response: We agree that these should be separate objectives for the reasons stated by the
commenters and split them accordingly.
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Comment: We received comments that these functions were really part of CPOE and
electronic prescribing. Commenters most commonly noted that the drug formulary is part of
electronic prescribing, as is currently the case under the Medicare e-Prescribing program.
Response: While we agree that the drug-drug, drug-allergy, drug-formulary checks,
CPOE, e-prescribing meaningful use objectives all serve the same broader goal of ensuring
accurate ordering and prescribing that takes into account all available information about the
patient the functions and their readiness for Stage 1 of meaningful use are distinct. In terms of
functions, CPOE and e-prescribing could be performed without the drug to drug, drug-allergy or
drug formulary checks. Similarly, it is not necessary for CPOE or e-Prescribing to take place in
order for a drug to drug allergy check to occur. In terms of readiness and ability to measure
progress for Stage 1 of meaningful use, CPOE and e-prescribing both are percentage based
measures of a distinct activity that creates a record even in today’s EHR’s and paper patient
records. The viewing and consideration of information presented to the provider on possible
drug interactions is not a similarly distinct activity and does not currently create a record. So
while the goal of these functionalities is similar, we believe drug-drug, drug-allergy, drugformulary checks create unique concerns for implementation and demonstration of meaningful
use, and therefore we maintain them as separate objectives.
Comments: Several commenters expressed concern of “alert fatigue” occurring with
drug-drug interaction checks. Alert fatigue or otherwise known as “pop-up” fatigue is a
commonly perceived occurrence with electronic medical records and clinical decision support
tools in which alerts are presented to the user when a potential safety issue is identified by the
system (for example, drug to drug interaction). The alerts, while beneficial in some cases, can
result in a type of "fatigue" whereby the provider, after receiving too many alerts, begins to
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ignore and/or override the alerts. Receiving too many alerts can result in slowing the provider
down rendering the alert useless. Commenters recommended some changes to the objective and
associated measure to mitigate the risk of “alert fatigue” such as limiting the checks for
interactions to only the most critical medications or allowing for adjustment of risk levels rather
than an on/off functionality.
Response: We recognize “alert fatigue” is a potential occurrence with drug-drug and
drug-allergy checks. However, meaningful use seeks to utilize the capabilities of certified EHR
technology and any means to address alert fatigue requires a critical evaluation of each alert. We
believe this is beyond the scope of the definition of meaningful use. We believe these checks are
valuable and improve patient care and therefore do not remove them to address alert fatigue.
Comment: Commenters recommended food allergies be included in the drug-allergy
check as some drugs contain ingredients that are contraindicated in individuals with certain
allergies.
Response: We certainly agree that some allergies other than drug can interact with drugs;
however, as we stated under our discussion of the objective “Medication Allergy List”, the
ability to identify other types of allergies in a useful way are not yet available to the extent
necessary to require them in Stage 1 of meaningful use. This certainly does not preclude any EP,
eligible hospital, or CAH from working with the designers of their certified EHR technology to
include this functionality.
Comment: A commenter requested clarification as to whether the drug-drug, drugallergy and drug-formulary checks are required for contrast media and imaging agents used by
radiologists.
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Response: We do not link the checks to specific drugs or agents. However, we note that
is common practice in radiology to identify a patient’s past drug and food allergies and take
appropriate interventions if necessary. Therefore, the drug-drug, drug-allergy and drugformulary checks would be appropriate prior to administration of contrast media and imaging
agents to patients.
After consideration of the public comments received, we are finalizing the meaningful
use objective for EPs at §495.6(d)(2)(i) and for eligible hospitals and CAHs at §495.6(f)(2)(i) as
“Implement drug-drug and drug-allergy checks.” We include this objective in the core set as it is
integral to the initial or on-going management of a patient's current or future healthcare and
would give providers the necessary information to make informed clinical decisions for
improved delivery of patient care.
In addition, we are finalizing the meaningful use objective at for EPs at §495.6(e)(1)(i)
and for eligible hospitals and CAHs at §495.6(g)(1)(i) of our regulations as “Implement drugformulary checks.”
NPRM EP/Eligible Hospital Measure: The EP/eligible hospital/CAH has enabled the drugdrug, drug-allergy, and drug-formulary check functionality
In the proposed rule we discussed that the capability of conducting automated drug-drug,
drug-allergy, and drug-formulary checks is included in the certification criteria for certified EHR
technology. This automated check provides information to advise the EP, eligible hospital, or
CAH's decisions in prescribing drugs to a patient. The only action taken by the EP, eligible
hospital, or CAH is to consider this information. Many current EHR technologies have the
option to disable these checks and the certification process does not require the removal of this
option. Therefore, in order to meet this objective, an EP, eligible hospital, or CAH would be
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required to enable this functionality and ensure they have access to at least one drug formulary.
While this does not ensure that an EP, eligible hospital or CAH is considering the information
provided by the check, it does ensure that the information is available.
After consideration of the public comments received on the objective, we believe the
measure as proposed requires more clarity on the length of time for which the functionality must
be enabled, which we clarify to be the entire EHR reporting period. Therefore, we are modifying
the meaningful use measure for “Implement drug-drug and drug-allergy checks for the entire
EHR reporting period” for EPs at §495.6(d)(2)(ii) and for eligible hospitals and CAHs at
§495.6(f)(2)(ii) of our regulations to “The EP/eligible hospital/CAH has enabled this
functionality for the entire EHR reporting period.”
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(a). The ability to calculate the measure is included in certified
EHR technology.
As this objective only requires that functionalities of certified EHR technology be
enabled, we do not believe that any EP, eligible hospital or CAH would need an exclusion for
this objective and its associated measure.
After consideration of the public comments received on the objective, we are modifying
the meaningful use measure for “Implement drug-formulary checks” at for EPs at
§495.6(e)(1)(ii) and for eligible hospitals and CAHs at §495.6(g)(1)(ii) of our regulations to
“The EP/eligible hospital/CAH has enabled this functionality and has access to at least one
internal or external formulary for the entire EHR reporting period.”
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We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(b). The ability to calculate the measure is included in certified
EHR technology.
The consideration of whether a drug is in a formulary or not only applies when
considering what drug to prescribe. Therefore, we believe that any EP who writes fewer than
one hundred prescriptions during the EHR reporting period should be excluded from this
objective and associated measure as described previously in our discussion of whether certain
EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established
scopes of practices.
NPRM EP/Eligible Hospital Objective: Maintain an up-to-date problem list of current and
active diagnoses based on ICD-9-CM-CM or SNOMED CT®
In the proposed rule, we described the term “problem list” as a list of current and active
diagnoses as well as past diagnoses relevant to the current care of the patient.
Comment: Several commenters noted that the coding of problem lists at the point of care
is outside the normal workflow process and would be disruptive.
Response: We did not and do not intend that coding of the diagnosis be done at the point
of care. This coding could be done later and by individuals other than the diagnosing provider.
Comment: Commenters suggested including ICD-10-CM, the Diagnostic and Statistical
Manual of Mental Disorders and explicitly allowing subsets of SNOMED CT®.
Response: We have removed the references to specific standards, as we believe
specifying the relevant standards falls within the purview of ONC. For ONC’s discussion of this
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functionality and the relevant standards including response to the above comment, we refer
readers to ONC’s final rule.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(d)(3)(i) and for eligible hospitals at §495.6(f)(3)(i) of our
regulations to “Maintain an up-to-date problem list of current and active diagnoses”.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare and would give providers the necessary
information to make informed clinical decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the
EP or admitted to the eligible hospital or CAH have at least one entry or an indication of none
recorded as structured data.
In the proposed rule, we introduced the concept of “unique patients” in the discussion of
this objective. We received many comments requesting clarification of this term and address
those in the comment and response section under our discussion of the CPOE measure.
Comment: A few commenters stated that “None” is not a clinically relevant term and
should be replaced with no known problem or no problem.
Response: Our intent is not to dictate the exact wording of the specific value. Rather we
are focused on the overall goal of making a distinction between a blank list because a patient
does not have known problems and a blank list because either no inquiry of the patient has been
made, or problems have been recorded through other means. As long as the indication
accomplishes this goal and is structured data, we do not believe it is necessary to prescribe the
exact terminology, thus leaving that level of detail to the designers and users of certified EHR
technology.
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Comment: Commenters requested clarification of the term “up-to-date”.
Response: The term “up-to-date” means the list is populated with the most recent
diagnosis known by the EP, eligible hospital, or CAH. This knowledge could be ascertained
from previous records, transfer of information from other providers, or querying the patient.
However, not every EP has direct contact with the patient and therefore has the opportunity to
update the list. Nor do we believe that an EP, eligible hospital, or CAH should be required
through meaningful use to update the list at every contact with the patient. There is also the
consideration of the burden that reporting places on the EP, eligible hospital, or CAH. The
measure, as finalized, ensures the EP, eligible hospital, or CAH has a problem list for patients
seen during the EHR reporting period, and that at least one piece of information is presented to
the EP, eligible hospital, or CAH. The EP, eligible hospital, or CAH can then use their judgment
in deciding what further probing or updating may be required given the clinical circumstances.
Comment: Commenters stated that this measure should be replaced with either a simple
attestation of yes, the problem list exists or the percentage of the measure should be replaced
with a count. Alternatively, that the percentage should be maintained, but that the threshold
should be lowered. Commenters generally supported this lowering of the threshold for one or all
of the following reasons: it may require a change in traditional workflow; implementation and
rollout of certified EHR technology creates unforeseeable system downtimes, complications, and
the required clinical classification systems are not geared toward clinical information.
Response: For reasons discussed earlier in this section under our discussion of the
burden created by the measures associated with the Stage 1 meaningful use objectives, we
believe a percentage is a more appropriate measure than those suggested by comments. As this
objective relies solely on a capability included as part of certified EHR technology and is not, for
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purposes of Stage 1 criteria, reliant on the electronic exchange of information, we believe it is
appropriate to set a high percentage threshold. In the proposed rule, we set the percentage
required for successful demonstration at 80 percent. Though full compliance (that is, 100
percent) is the ultimate goal, 80 percent seemed an appropriate standard for Stage 1 meaningful
use as it creates a high standard, while still allowing room for technical hindrances and other
barriers to reaching full compliance.” We proposed 80 percent for every measure with a
percentage that met the criteria of relying solely on a capability included as part of certified EHR
technology and are not, for purposes of Stage 1 meaningful use criteria, reliant on the electronic
exchange of information. Commenters generally agreed with this alignment; however, they
disagreed that 80 percent sufficiently allows for “technical hindrances and other barriers”.
Commenters have highlighted numerous barriers towards successfully meeting an 80 percent
threshold including technical barriers, barriers to implementation, applicability to all patients and
all provider types eligible for the EHR incentives, patient requested exclusions and others. We
address some of these with specific exclusions from the measure as discussed previously in this
section under our discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1
meaningful use objectives given established scopes of practices. Although some technical issues
exist, recording an up-to-date problem list remains largely within the individual provider’s
control and does not rely to a large degree on some external sender or receiver of structured
electronic health data. In addition, there is a standard of practice for collecting the elements
required for an up-to-date problem list. Although the commenters may be right that some
clinical workflow needs to change, that is an integral part of meaningful use of EHRs. Although
we do not expect all clinical workflow to adapt in Stage 1, there is an expectation that the clinical
workflow necessary to support the Stage 1 priority of data capture and sharing will be in place in
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order to effectively advance meaningful use of EHRs. In addition, given the wide range of
activities that must occur for meaningful use, we believe that most EPs, eligible hospitals and
CAHs will have fully rolled out the capabilities required by this objective and the others with an
80 percent threshold prior to the start of the EHR reporting period thereby reducing the
likelihood of unexpected system downtime and other implementation complications.
For situations in which there is an existing standard of practice and complying is
fundamentally within the provider’s control and where the objective relies solely on a capability
included as part of certified EHR technology and is not, for purposes of Stage 1 criteria, reliant
on the electronic exchange of information, for the final rule, we adopt, the reasonably high
threshold of 80 percent. We believe existing infrastructure and expectations support this
relatively high target. This foundational step of structured data capture is a prerequisite for many
of the more advanced functionalities (for example, clinical decision support, clinical quality
measurement, etc.) for which a solid evidence base exists for improved quality, safety and
efficiency of care. Without having most of a provider’s up-to-date problem lists in structured,
electronic data, that provider will have major challenges in building more advanced clinical
processes going forward.
For other situations, where the objective may not be fundamentally within the provider’s
control and is not an existing standard of practice, but where objective continues to rely solely on
a capability that is included as part of certified EHR technology and is not reliant on electronic
exchange of information, we are setting the percentage at 50 percent. This was the most
commonly recommended percentage for these objectives that rely solely on a capability included
as part of certified EHR technology and do not rely on the electronic exchange of information.
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After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(3)(i) and for eligible hospitals at §495.6(f)(3)(i) of our
regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least
one entry or an indication that no problems are known for the patient recorded as structured
data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(c). The ability to calculate the measure is included in certified EHR
technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP or admitted to an eligible hospital’s
or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting
period.
•
Numerator: The number of patients in the denominator who have at least one entry or an
indication that no problems are known for the patient recorded as structured data in their
problem list.
•
Threshold: The resulting percentage must be more than 80 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
We do not believe that any EP, eligible hospital, or CAH would be in a situation where they
would not need to know at least one active diagnosis for a patient they are seeing or admitting to
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their hospital. Therefore, there are no exclusions for this objective and its associated measure.
NPRM EP Objective: Generate and transmit permissible prescriptions electronically (eRx).
Comment: Some commenters requested clarification of the term “permissible
prescription.”
Response: As discussed in the proposed rule the concept of only permissible
prescriptions refers to the current restrictions established by the Department of Justice on
electronic prescribing for controlled substances in Schedule II. (The substances in Schedule II
can be found at http://www.deadiversion.usdoj.gov/schedules/orangebook/e_cs_sched.pdf).
Any prescription not subject to these restrictions would be permissible. We note that the
Department of Justice recently released a notice of proposed rulemaking that would allow the
electronic prescribing of these substances; however, given the already tight timeframe for Stage
1 of meaningful use we are unable to incorporate any final changes that may result from that
proposed rule. Therefore, the determination of whether a prescription is a “permissible
prescription” for purposes of the eRx meaningful use objective should be made based on the
guidelines for prescribing Schedule II controlled substances in effect when the notice of
proposed rulemaking was published on January 13, 2010. We define a prescription as the
authorization by an EP to a pharmacist to dispense a drug that the pharmacist would not dispense
to the patient without such authorization. We do not include authorizations for items such as
durable medical equipment or other items and services that may require EP authorization before
the patient could receive them. These are excluded from the numerator and the denominator of
the measure.
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Comment: Some commenters recommended combining this objective and measure with
other meaningful use objectives such as CPOE or the drug-drug, drug-allergy, drug-formulary
checks
Response: We addressed these comments under our discussion of the CPOE objective.
After consideration of the public comments received, we are finalizing the meaningful
use objective at 495.6(d)(4)(i) as proposed.
We have also included this objective in the core set. Section 1848 (o)(2)(A)(i) of the Act
specifically includes electronic prescribing in meaningful use for eligible professionals. This
function is the most widely adopted form of electronic exchange occurring and has been proven
to reduce medication errors. We included this objective in the core set based on the combination
of the maturity of this objective, the proven benefits and its specific mention as the only example
provided in the HITECH Act for what is meaningfully using certified EHR technology.
NPRM EP Measure: At least 75 percent of all permissible prescriptions written by the EP are
transmitted electronically using certified EHR technology.
In the proposed rule, we said that while this measure does rely on the electronic exchange
of information based on the public input previously discussed and our own experiences with
e-prescribing programs, we believe this is the most robust electronic exchange currently
occurring and proposed 75 percent as an achievable threshold for the Stage 1 criteria of
meaningful use. Though full compliance (that is, 100 percent) is the ultimate goal, 75 percent
seemed an appropriate standard for Stage 1 meaningful use as it creates a high standard, while
still allowing room for technical hindrances and other barriers to reaching full compliance.
Comment: A majority of commenters commenting on this measure believe the
75 percent threshold is too high. Several issues were raised to explain why the commenters
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believe the threshold is too high. The first is that barriers to e-prescribing exist at the pharmacies
and they must be brought into the process to ensure compliance on the receiving end. The second
represents the most common barrier cited by commenters and that is patient preference for a
paper prescription over e-prescribing. A patient could have this preference for any number of
reasons cited by commenters such as the desire to shop for the best price (especially for patients
in the Part D “donut hole”), the ability to obtain medications through the VA, lack of finances,
indecision to have the prescription filled locally or by mail order and desire to use a
manufacturer coupon to obtain a discount. Other barriers mentioned by individual commenters
were the limited functionality of current e prescribing systems such as the inability to distinguish
refills from new orders. Suggestions for addressing these difficulties were either to lower the
threshold (alternatives recommended ranged from ten to fifty percent) or replacing the
percentage with a numerical count of 25 to align with the 2010 Medicare e-Prescribing program.
Of the comments received that requested a specific lower threshold, about half of them suggested
a 50 percent threshold, and about half suggested a threshold of 25 percent to 30 percent.
Response: We are finalizing the use of a percentage threshold for the reasons discussed
previously in this section under our discussion of the burden created by the measures associated
with the Stage 1 meaningful use objectives. In the proposed rule, we pointed out that we “believe
this is the most robust electronic exchange currently occurring” to justify a high threshold of 75
percent given that this objective relies on electronic exchange. While we continue to believe this
is the case, two particular issues raised by commenters caused us to reconsider our threshold.
The first is the argument to include pharmacies in the Medicare and Medicaid EHR incentive
programs to ensure compliance on the receiving end. Non-participation by pharmacies was
presented by commenters as a major barrier to e-Prescribing. The second is patient preference for
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a paper prescription. In regards to the first argument, we do not have the ability to impose
requirements on pharmacies through the HITECH legislation. However, prescriptions
transmitted electronically have been growing at an exponential rate. The number of prescriptions
sent electronically increased by 181 percent from 2007 to 2008 according to comments received.
The number of pharmacies is also increasing rapidly. Yet this growth in uneven across the
country and we wish to accommodate all EPs and do lower the threshold based on this argument.
In regards to the second argument, we also have neither the ability nor the desire to limit patient
preference. We considered allowing an EP to exclude from the denominator those instances
where a patient requested a paper prescription. However, the burden of tracking when this
occurs, the disincentive it would create for EPs to work with patients on establishing a
relationship with a pharmacy and the hindrance to moving forward with e-prescribing, lead us to
address this through further reduction of the threshold as opposed to an exclusion. To address
these concerns we are lowering the threshold for the e-prescribing measure to 40 percent. As
pointed out by commenters, e-prescribing it is not yet standard of practice and there may be
important external barriers beyond the provider’s control. In particular, for e-prescribing,
providers are dependent upon an external receiver of electronic health data, and there are
significant variations depending on where the provider practices.
After consideration of the public comments received, we are modifying the meaningful
use measure at §495.6(d)(4)(ii) of our regulations to “More than 40 percent of all permissible
prescriptions written by the EP are transmitted electronically using certified EHR technology”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
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standards at 45 CFR 170.304(b). The ability to calculate the measure is included in certified
EHR technology.
As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the prescriptions in the
denominator are only those for patients whose records are maintained using certified EHR
technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of prescriptions written for drugs requiring a prescription in order
to be dispensed other than controlled substances during the EHR reporting period.
•
Numerator: The number of prescriptions in the denominator generated and transmitted
electronically.
•
Threshold: The resulting percentage must be more than 40 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
As addressed in other objectives and in comment response, this objective and associated measure
do not apply to any EP who writes fewer than one hundred prescriptions during the EHR
reporting period, as described previously in this section under our discussion of whether certain
EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established
scopes of practices.
NPRM EP/Eligible Hospital Objective: Maintain active medication list.
Comment: Commenters requested clarification of the term “active medication list.”
Response: We define an active medication list as a list of medications that a given
patient is currently taking.
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After consideration of the public comments received, we are finalizing this objective for
EPs at §495.6(d)(5)(i) and for eligible hospitals and CAHs at §495.6(f)(4)(i) of our regulations as
proposed.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare and would give providers the necessary
information to make informed clinical decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the
EP or admitted by the eligible hospital have at least one entry (or an indication of “none” if the
patient is not currently prescribed any medication) recorded as structured data.
As with the objective of maintaining a problem list, we clarify that the indication of
“none” should distinguish between a blank list that is blank because a patient is not on any
known medications and a blank list because no inquiry of the patient has been made. As long as
the indication accomplishes this goal and is structured data, we do not believe it is necessary to
prescribe the exact terminology preferring to leave that level of detail to the designers and users
of certified EHR technology.
Comment: Commenters stated that the measure should be replaced with a numerical
count or attestation and that the threshold was too high for reasons including the lack of current
electronic exchange of information, difficulty capturing information as structured data and lack
of readiness of HIE infrastructure.
Response: We are finalizing the use of a percentage for the reasons discussed previously
in this section under our discussion of the burden created by the measures associated with the
Stage 1 meaningful use objectives. For the same reasons we explained under the discussion of
up-to-date problem list, medication list is a functionality for which there is an existing standard
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of practice, it is foundational data capture function to make more advanced clinical processes
possible, and complying is fundamentally within the provider’s control. Therefore, we maintain
the reasonably high threshold of 80 percent because the existing infrastructure and expectations
support this target.
Comment: Commenters requested clarification as to whether the measure is limited to
patients seen during the EHR reporting period.
Response: Yes, the measure applies to all unique patients seen by the EP or admitted to
the eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the
EHR reporting period.
Comment: A few commenters expressed concern regarding the requirement that the
entry must be recorded as “structured data.” The commenters state that there may not be a code
for over the counter, homeopathic or herbal products and that would penalize the provider even
though the data is collected and recorded.
Response: The distinction between structured data and unstructured data applies to all
types of information. Structured data is not fully dependent on an established standard.
Established standards facilitate the exchange of the information across providers by ensuring
data is structured in the same way. However, structured data within certified EHR technology
merely requires the system to be able to identify the data as providing specific information. This
is commonly accomplished by creating fixed fields within a record or file, but not solely
accomplished in this manner. For example, in this case for it to be structured, if the patient is on
aspirin, then that information should be in the system so that it can be automatically identified as
a medication and not as an order, note, or anything else. An example of unstructured data would
be the word aspirin, but no ability of the system to identify it as a medication.
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Comment: A few commenters pointed out their current health information system vendor
does not utilize RxNorm as its standard.
Response: This is a certification issue best addressed in the ONC final rule. We therefore
have referred these comments to ONC for their consideration.
Comment: We received comments suggesting that this requirement could create
additional privacy/security concerns for patients who do not want all physicians and their clinical
staff to have access to their entire medication history. Examples provided included
antidepressant, antipsychotic or erectile dysfunction medications.
Response: We are only concerned with medications that are known to the provider
through querying the patient, their own records and the transfer of records from other providers.
Meaningful use cannot address situations where the information is withheld from the EP, eligible
hospital, or CAH by the patient or by other providers. We understand that some patients would
prefer not to have their entire medical history available to all physicians and clinical staff. We
also understand that laws in some states restrict the use and disclosure of information (including
that related to medication) that may reveal that a patient has a specific health condition (for
example, HIV). Recording data in a structured manner will facilitate the implementation of these
preferences and policies in an electronic environment. It is easier to identify and potentially
withhold specific data elements that have been recorded in a structured format than information
recorded as free text.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(5)(ii) and for eligible hospitals at §495.6(f)(4(ii) of our
regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least
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one entry (or an indication that the patient is not currently prescribed any medication) recorded
as structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(d). The ability to calculate the measure is included in certified
EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP or admitted to an eligible
hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR
reporting period. A definition of unique patient is discussed under the objective of CPOE.
•
Numerator: The number of patients in the denominator who have a medication (or an
indication that the patient is not currently prescribed any medication) recorded as structured data.
•
Threshold: The resulting percentage must be more than 80 percent in order for an EP,
eligible hospital, or CAH to meet this measure. Detailed discussion of the more than 80 percent
threshold can be found under the objective of maintaining an up-to-date problem list.
We do not believe that any EP, eligible hospital or CAH would be in a situation where they
would not need to know whether their patients are taking any medications. Therefore, there are
no exclusions for this objective and its associated measure.
NPRM EP/Eligible Hospital Objective: Maintain active medication allergy list.
Comment: We received comments that limiting this list to medication allergies instead of
all allergies was not consistent with efficient workflow and that all allergies should be housed in
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the same location within the EHR. Commenters also highlighted that lack of knowledge of other
allergies such as latex and food allergies could lead to significant harm to the patient.
Response: We agree that information on all allergies, including non-medication allergies,
provide relevant clinical quality data. However, while we agree that collecting all allergies would
be an improvement, current medication allergy standards exists in a structured data format that
may be implemented in Stage 1. We hope to expand this measurement to include all allergies as
the standards evolve and expand to include non-medication allergies. We believe EP/eligible
hospitals/CAHs should continue to document all allergies, regardless of origin, consistent with
standard of care practice for that EP/eligible hospital/CAH. We encourage them to work with the
designers of their certified EHR technology to make this documentation as efficient and
structured as possible.
Comment: A commenter inquired why the Substance Registration System Unique
Ingredient Identifier (UNII) was not indicated for use until 2013 yet the measure requires the
information to be recorded as structured data.
Response: Any standards for the structured vocabulary for medication allergies or other
aspects of meaningful use are included in ONC final rule. Structured data does not require an
established standard as discussed under the objective of maintaining a medication list.
Comment: We received a few comments requesting a definition of “allergy.”
Response: We adopt the commonly held definition of an allergy as an exaggerated
immune response or reaction to substances that are generally not harmful. The definition is
derived from Medline Plus, a service of the U.S. National Library of Medicine and the National
Institutes of Health.
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After consideration of the public comments received, we are finalizing the meaningful
use objective for EPs at 495.6(d)(6)(i) and for eligible hospitals and CAHs at 495.6(f)(5)(i)as
proposed.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare and would give providers the necessary
information to make informed clinical decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the
EP or admitted to the eligible hospital have at least one entry (or an indication of “none” if the
patient has no medication allergies) recorded as structured data.
Comment: Multiple commenters noted that “none” is not a typical value to describe the
absence of allergies in medical documentation and should be replaced with “no known allergies
(NKA),” “no known drug allergies (NKDA)” or “no known medication allergies (NKMA).”
Response: Our intent is not to dictate the exact wording of the specific value. Rather we
are focused on the overall goal of making a distinction between a blank list that is blank because
a patient does not have known allergies and a blank list because no inquiry of the patient has
been made or no information is available from other sources. As long as the indication
accomplishes this goal and is structured data, we do not believe it is necessary to prescribe the
exact terminology, preferring to leave that level of detail to the designers and users of certified
EHR technology.
Comment: Given that the measure is only a one time check for a single entry, one
commenter questioned whether this measure truly constitutes maintenance of an “active” list.
Response: We agree that this measure does not ensure that every patient under the care
of every EP, eligible hospital, or CAH has an active or up-to-date medication list. However, not
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every EP comes in contact with the patient, and therefore has the opportunity to update the list.
Nor do we believe that an EP, eligible hospital, or CAH should be required through meaningful
use to update the list at every contact with the patient. There is also the consideration of the
burden that reporting places on the EP, eligible hospital, or CAH. The measure as finalized
ensures that the EP, eligible hospital, or CAH has not ignored having a medication allergy list for
patients seen during the EHR reporting period and that at least one piece of information on
medication allergies is presented to the EP, eligible hospital, or CAH. The EP, eligible hospital,
or CAH can then use their judgment in deciding what further probing or updating may be
required given the clinical circumstances at hand. Therefore, we are maintaining the measure of a
onetime check for a single entry.
Comment: Several commenters recommended eliminating the percentage measurement
and allowing the provider to attest that active medication lists are maintained in the certified
EHR technology.
Response: We are retaining a percentage for the reasons discussed previously in this
section under our discussion of the burden created by the measures associated with the Stage 1
meaningful use objectives. For the same reasons we explained under the discussion of up-todate problem list, medication-allergy list is a functionality for which there is an existing standard
of practice, it is foundational data capture function to make more advanced clinical processes
possible, and complying is fundamentally within the provider’s control. Therefore, we maintain
the reasonably high threshold of 80 percent because the existing infrastructure and expectations
support this target.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(6)(ii) and for eligible hospitals at §495.6(f)(5)(ii) of our
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regulations to “More than 80 percent of all unique patients seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have at least
one entry (or an indication that the patient has no known medication allergies) recorded as
structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(e). The ability to calculate the measure is included in certified EHR
technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP or admitted to an eligible
hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR
reporting period. The definition of “a unique patient” is provided under the objective of CPOE.
•
Numerator: The number of unique patients in the denominator who have at least one
entry (or an indication that the patient has no known medication allergies) recorded as structured
data in their medication allergy list
•
Threshold: The percentage must be more than 80 percent in order for an EP, eligible
hospital, or CAH to meet this measure. Detailed discussion of the rationale more than 80 percent
threshold can be found at under the objective of maintain an up-to-date problem list.
We do not believe that any EP, eligible hospital or CAH would be in a situation where they
would not need to know whether their patients have medication allergies and therefore do not
establish an exclusion for this measure.
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NPRM EP Objective: Record the following demographics: preferred language, insurance type,
gender, race and ethnicity, and date of birth.
NPRM Eligible Hospital Objective: Record the following demographics: preferred language,
insurance type, gender, race and ethnicity, date of birth, and date and cause of death in the event
of mortality.
In the proposed rule, we noted that race and ethnicity codes should follow current federal
standards published by the Office of Management and Budget
(http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). We maintain that proposal for the
final rule.
Comment: Some commenters requested clarification of whether all of the demographics
are required and under what circumstances no indication might be acceptable. Examples of
acceptable circumstances from commenters include patient unwillingness to report, language
barriers, and requirement to report ethnicity and/or race contrary to some state laws.
Response: In general, we do require that all demographic elements that are listed in the
objective be included in a patient’s record in certified EHR technology. However, we do not
desire, nor could we require, that a patient provide this information if they are otherwise
unwilling to do so. Similarly, we do not seek to preempt any state laws prohibiting EPs, eligible
hospitals, or CAHs from collecting information on a patient’s ethnicity and race. Therefore if a
patient declines to provide the information or if capturing a patient’s ethnicity or race is
prohibited by state law, such a notation entered as structured data would count as an entry for
purposes of meeting the measure.
Comment: Several commenters asked for clarity on the definition of preferred language.
Commenters also indicated that standards are in development (ISO 639 and ANSIX12N
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Claim/Reporting Transaction). Some commenters also requested that we include the
requirement that the EP, eligible hospital or CAH also communicate with the patient in their
preferred language.
Response: Preferred language is the language by which the patient prefers to
communicate. This is just a record of the preference. We do not have the authority under the
HITECH Act to require providers to actually communicate with the patient in his or her
preferred language, and thus do not require EPs, eligible hospitals, and CAHs to do so in order to
qualify as a meaningful EHR user as suggested by some commenters. In regards to standards,
those would be adopted under the ONC final rule.
Comment: Some commenters also requested clarity on the definition of race and
ethnicity. Some commenters noted an Institute of Medicine report entitled “Race, Ethnicity and
Language Data: Standardization for Health Care Quality Improvement”, which makes
recommendations for how to ask questions to collect information and builds on the OMB
Standards for language, race and ethnicity. Some commenters were also concerned about
situations where the available choices were not granular enough, did not properly account for
mixed race and ethnicity, and when the patient did not know their ethnicity.
Response: In the proposed rule, we said that EPs, eligible hospitals and CAHs, should
use the race and ethnicity codes that follow current federal standards published by the Office of
Management and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). We
continue to believe that these standards should be applied for purposes of implementing the
Stage 1 meaningful use objectives, but will consider whether alternative standards or additional
clarification would be appropriate for future stages of meaningful use criteria. We believe it is
beyond the scope of the definition of meaningful use to provide additional definitions for race
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and ethnicity beyond what is established by OMB. In regards to patients who do not know their
ethnicity, EPs, eligible hospitals, and CAHs should treat these patients the same way as patients
who decline to provide the race or ethnicity, that is, they should identify in the patient record that
the patient declined to provide this information.
Comment: Some commenters requested additional clarity on insurance type and others
recommended the elimination of insurance type due to the complexity of insurance coverage, the
function of the EHR as a medical tool and not a financial one, the volatility of this information
due to patients frequently changing plans and concerns that information on a patient’s insurance
status will have a possible behavioral influence on the providers if this information were
presented.
Response: Classifying insurance involves two distinctions – the source of coverage and
insurance design. Source of coverage refers to the type of funding, such as public, private or selfpay. The design of the insurance program, such as health maintenance program (HMO),
preferred provider organization (PPO), high-deductible consumer directed plan, fee-for-service,
etc. Although not specified in the proposed rule, by insurance type we were referring to the first
distinction -- the source of funding for the insurance. We found two initiatives that could provide
clarity on type. The first is the “Source of Payment Typology” developed by the Public Health
Data Standards Consortium (http://www.phdsc.org/standards/payer-typology.asp). The
consortium is currently in the process of working with States to implement this typology. The
other initiative is established in the Uniform Data Set (UDS) collected by HRSA
(http://www.hrsa.gov/data-statistics/health-center-data/index.html). The information in the UDS
contains several caveats, however, that make it difficult to be used by all EPs, eligible hospitals
and CAHs, and it does not accommodate patients with multiple types of insurance such as those
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dually eligible for Medicare and Medicaid or who those with both Medicare and MediGap
coverage. Many EHRs that currently report on HRSA UDS Insurance Type standards account
for multiple types of insurance by maintaining separate Reporting Insurance Groups and deriving
the Insurance Type data from the primary insurance company on the encounter and mappings to
that Insurance Type Reporting Group. This information is documented at the patient
demographic level or the patient encounter/progress note. Given the complexity of defining
insurance type and attributing it to patients in an agreed upon way, we are eliminating “insurance
type” from this meaningful use objective.
Comment: A minority of commenters commenting on this objective recommended that
CMS remove cause of death from the objective for eligible hospitals. The most common
rationale is that the coroner or medical examiner officially determines cause of death when the
case is referred to them. By law, the hospital cannot declare a cause of death in these cases.
Response: When a patient expires, in the routine hospital workflow, a clinician evaluates
the patient to pronounce the patient’s death. The clinician typically documents in the patient’s
chart, the sequence of events leading to the patient’s death, conducts the physical exam and
makes a preliminary assessment of the cause of death. We are requiring that eligible hospitals
record in the patient’s EHR the clinical impression and preliminary assessment of the cause of
death, and not the cause of death as stated in any death certificate issued by the Department of
Health or the coroner’s office.
Comment: A few commenters requested inclusion of Advanced Directives under this
objective as recommended by the HIT Policy Committee.
Response: We discuss advance directives separately in this final rule under its own
objective.
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Comment: Several commenters recommended requiring the submission of the
demographic data to CMS.
Response: Stage 1 of meaningful use seeks to ensure certified EHR technology has the
capability to record demographic information and that those capabilities are utilized. We believe
the information recorded for this measure is for provider use in the treatment and care of their
patients and therefore should not be submitted to CMS at this time.
Comment: Commenters suggested requiring the use of the demographic data from this
measure to stratify clinical quality measure reporting and the generation of reports for patient
outreach and quality initiatives.
Response: While we encourage all providers and EHR developers to work together to
develop reporting from the EHR system for use in the improvement of population and public
health, for purposes of becoming a meaningful EHR user in Stage 1, we only require the
recording of the specified demographics.
After consideration of the public comments received, we are modifying meaningful use
objective at §495.6(d)(7)(i) of our regulations for EPs to “Record the following demographics:
preferred language, gender, race and ethnicity, and date of birth”.
After consideration of the public comments received, we are modifying meaningful use
objective at §495.6(f)(6)(i) of our regulations for eligible hospitals and CAHs to “Record the
following demographics: preferred language, gender, race and ethnicity, date of birth, and date
and preliminary cause of death in the event of mortality in the eligible hospital or CAH”.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare, recommended by the HIT Policy
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Committee and would give providers the necessary information to make informed clinical
decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients seen by the
EP or admitted to the eligible hospital have demographics recorded as structured data
Comment: Commenters said that this should be replaced with a count or attestation or
alternatively that the threshold was too high.
Response: We are maintaining a percentage for the reasons discussed previously in this
section under our discussion of the burden created by the measures associated with the Stage 1
meaningful use objectives. However, we do reduce the threshold to over 50 percent as this
objective meets the criteria of relying solely on a capability included as part of certified EHR
technology and is not, for purposes of Stage 1 criteria, reliant on the electronic exchange of
information In contrast to our discussion of maintaining an up-to-date problem list/medication
list/medication allergy list, we believe that some demographic elements (especially race,
ethnicity and language) are not as straightforward to collect as objective data elements and
therefore the standard of practice for demographic data is still evolving. As we believe this
measure may not be within current standard of practice, we are adopting the lower threshold of
50 percent (rather than 80 percent).
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(7)(ii) and for eligible hospitals at §495.6(f)(6)(ii) of our
regulations to “More than 50 percent of all unique patients seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) have
demographics recorded as structured data”.
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We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(c) for EPs and 45 CFR 170.304(b) for eligible hospitals and CAHs.
The ability to calculate the measure is included in certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP or admitted to an eligible
hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the EHR
reporting period. A unique patient is discussed under the objective of CPOE.
•
Numerator: The number of patients in the denominator who have all the elements of
demographics (or a specific exclusion if the patient declined to provide one or more elements or
if recording an element is contrary to state law) recorded as structured data.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital or CAH to meet this measure. Most EPs and all eligible hospitals and CAHs
would have access to this information through direct patient access. Some EPs without direct
patient access would have this information communicated as part of the referral from the EP
who identified the service as needed by the patient. Therefore, we did not include an exclusion
for this objective and associated measure.
NPRM EP/Eligible Hospital Objective: Record and chart changes in the following vital signs:
height, weight and blood pressure and calculate and display body mass index (BMI) for ages 2
and over; plot and display growth charts for children 2 - 20 years, including BMI.
In the proposed rule, we described why we included growth charts in this objective. The
reason given was that BMI was not a sufficient marker for younger children.
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Comment: Over two thirds of the commenters commenting on this objective expressed
concern about the applicability of the listed vital signs to all provider types and care settings.
Response: While this objective could be met by receiving this information from other
providers or non-provider data sources, we recognize that the only guaranteed way for a provider
to obtain this information is through direct patient interaction and that this information is not
always routinely provided from the EP ordering a service because of a direct patient interaction.
EPs who do not see patients 2 years or older would be excluded from this requirement as
described previously in this section under our discussion of whether certain EP, eligible hospital
or CAH can meet all Stage 1 meaningful use objectives given established scopes of practices.
We would also allow an EP who believes that measuring and recording height, weight and blood
pressure of their patients has no relevance to their scope of practice to so attest and be excluded.
Comment: Several commenters stated this objective should be removed in favor of
clinical quality measures addressing BMI and blood pressure as these measures serve the same
purpose and to require both is to require duplicative reporting.
Response: We disagree that these two measures serve the same purpose and therefore
that the measure should be eliminated in favor of clinical quality measures addressing BMI and
blood pressure. The objective included here seeks to ensure that information on height, weight
and blood pressure and the extractions based on them are included in the patient’s record.
Furthermore, the objective seeks to ensure that the data is stored in a structured format so that it
can be automatically identified by certified EHR technology for possible reporting or
exchanging. We also note that the clinical quality measure focuses on a smaller subset of the
patient population.
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After consideration of the public comments received, we are finalizing the objective for
EPs at 495.6(d)(8)(i) and for eligible hospitals and CAHs at 495.6(f)(7)(i)as proposed.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare and would give providers the necessary
information to make informed clinical decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: For at least 80 percent of all unique patients age 2 and
over seen by the EP or admitted to the eligible hospital, record blood pressure and BMI;
additionally, plot growth chart for children age 2 to 20.
Comment: Commenters suggested replacement of the percentage measurement with a
count or attestation or alternatively that that the threshold was too high.
Response: We are retaining a percentage for the reasons discussed previously in this
section under our discussion of the burden created by the measures associated with the Stage 1
meaningful use objectives. However, we did reduce the threshold from 80 percent to greater
than 50 percent as this objective meets the criteria of relying solely on a capability included as
part of certified EHR technology and is not, for purposes of Stage 1 criteria, reliant on the
electronic exchange of information. In addition, in contrast to the measures associated with
maintaining an up-to-date problem list, an active medication list, and an active medicationallergy list, we believe that for many specialties, the current practice on vital signs may not be as
well-established. We believe there may not be the same level of consensus regarding the
relevance to patient care of vital signs for many specialties and the frequency with which such
vital signs should be collected. Thus, for this measure, we adopt a percentage of 50 percent,
rather than 80 percent.
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Comment: Commenters requested clarification of the frequency and methods of
recording the vital signs included in the measure.
Response: As discussed in the objective, the EP/eligible hospital/CAH is responsible for
height, weight and blood pressure so we will focus our discussion on those items. First, we do
not believe that all three must be updated by a provider at every patient encounter nor even once
per patient seen during the EHR reporting period. For this objective we are primarily concerned
that some information is available to the EP/eligible hospital/CAH, who can then make the
determination based on the patient’s individual circumstances as to whether height, weight and
blood pressure needs to be updated. The information can get into the patient’s medical record as
structured data in a number of ways. Some examples include entry by the EP/eligible
hospital/CAH, entry by someone on the EP/eligible hospital/CAH’s staff, transfer of the
information electronically or otherwise from another provider or entered directly by the patient
through a portal or other means. The measure hinges on access of the information. Therefore,
any EP/eligible hospital/CAH that sees/admits the patient and has access to height, weight and
blood pressure information on the patient can put that patient in the numerator.
Comment: Some commenters requested clarification regarding the role of both the
EP/eligible hospital/CAH and the certified EHR technology for the calculation of BMI and the
plotting and displaying of growth charts. Other commenters recommended the exclusion of
growth charts for certain patients and care settings. Another commenter also expressed the
desire for the exclusion of growth charts for patients over the age of 18, inpatient care settings
and more specifically, non-pediatric inpatient care settings.
Response: We believe a clarification is in order about which of the listed vital signs are
data inputs to be collected by the EP/eligible hospital/CAH and which are calculations made by
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the certified EHR technology. The only information required to be inputted by the provider is
the height, weight and blood pressure of the patient. The certified EHR technology will calculate
BMI and the growth chart if applicable to patient based on age. As this requirement imposes no
duty or action on the provider, we see no reason to limit its availability to any EP, eligible
hospital, or CAH based on setting or other consideration. Concerns on presentation and interface
are best left to designers of certified EHR technology and users. Finally, as certified EHR
technology is able to automatically generate BMI and the growth chart if height and weight are
entered as structured data we see no reason to include BMI and growth chart in the measure. We
therefore will limit the final measure to data requiring provider data entry points.
Comment: A few commenters suggested that “reported height” by the patient should be
acceptable when measurement is not appropriate such as in the case of severe illness.
Response: We agree and would allow height self-reported by the patient to be used.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at 495.6(d)(8)(ii) and for eligible hospitals §495.6(f)(7)(ii) of our
regulations to “For more than 50 percent of all unique patients age 2 and over seen by the EP or
admitted to eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23),
height, weight and blood pressure are recorded as structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(f). The ability to calculate the measure is included in certified EHR
technology..
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As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the percentage is based on
patient records that are maintained using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients age 2 or over seen by the EP or admitted to an
eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR
reporting period. A unique patient is discussed under the objective of CPOE.
•
Numerator: The number of patients in the denominator who have at least one entry of
their height, weight and blood pressure are recorded as structure data.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this measure. As addressed in other objectives and in comment
response, an EP who sees no patients 2 years old or younger would be excluded from this
requirement as described previously in this section under our discussion of whether certain EP,
eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes
of practices. We would also allow an EP who believes that all three vital signs of height, weight
and blood pressure have no relevance to their scope of practice to so attest and be excluded.
However, we believe this attestation and exclusion from recording height, weight, and blood
pressure does not hold for other patient specific information collection objectives, like
maintaining an active medication allergy list. We do not believe that any EP would encounter a
situation where the patient's active medication and allergy list is not pertinent to care and
therefore would be outside of the scope of work for an EP. We believe the exclusion based on
EP determination of their scope of practice for the record vital signs objective, as written in
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Stage 1, should be studied for relevance in further stages. We do not believe eligible hospitals or
CAHs would ever only have a patient population for patients 2 years old or younger or that these
vital signs would have no relevance to their scope of practice. Therefore, we do not include an
exclusion for eligible hospitals or CAHs.
NPRM EP/Eligible Hospital Objective: Record smoking status for patients 13 years old or
older
In the proposed rule, we explained that we believe it is necessary to add an age restriction
to this objective as we do not believe this objective is applicable to patients of all ages and there
is no consensus in the health care community as to what the appropriate cut off age may be. We
encouraged comments on whether this age limit should be lowered or raised. We received many
comments on the age limit and address them below.
Comment: Several commenters requested a different age limitation. Commenters
suggested ages anywhere between 5 years old up to 18 years old.
Response: For the purposes of this objective and for meaningful use, our interest is
focused on when a record of smoking status should be in every patient’s medical record.
Recording smoking status for younger patients is certainly not precluded. We do believe there
would be situations where an EP/eligible hospital/CAH’s knowledge about other risk factors
would indicate that they should inquire about smoking status if it is unknown for patients under
13 years old. However, in order to accurately measure and thereby assure meaningful use, for
this objective we believe that the age limit needs to be high enough so that the inquiry is
appropriate for all patients. Therefore, we are maintaining the age limitation at 13 years old or
older.
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Comment: Some commenters suggested expanding smoking status to any type of
tobacco use.
Response: While we agree that an extended list covering other types of tobacco use may
provide valuable insight for clinical care for certified EHR technology ONC has adopted the
CDC's NHIS standard recodes for smoking status. This will provide a standard set of questions
across providers and standardize the data. The extended list does not make the collection of
multiple survey questions clear. For example, a patient may be a current tobacco user as well as
a smoker. For these reason in Stage 1 we will use the standards adopted by ONC for certified
EHR technology at 45 CFR 170.302(g). For future stages, we will review this measure for
possible inclusion of other questions. This is a minimum set. We do not intend to limit
developers of EHR technology from creating more specific fields or to limit EPs/eligible
hospitals/CAHs from recording more specific information.
Comment: We also received comments requesting that second-hand smoking be
included in the objective for children and adolescents.
Response: Including second-hand smoking introduces much more variability into the
objective as to what constitutes a level of exposure and difficulty in measuring it successfully
with different age limits to different aspects. For instance, how much exposure is acceptable for
a given age and how is such exposure determined? How would these differing requirements be
accounted for by certified EHR technology? As with the change from smoking status to tobacco
use, we believe this introduces an unacceptable level of complexity for Stage 1 of meaningful
use. For Stage 1 of meaningful use we are not adding second hand smoke exposure to this
objective. However, we remind EPs, eligible hospitals and CAHs that nothing about the criteria
for meaningful use prevents them from working with their EHR developer to ensure that their
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EHR system meets their needs and the needs of their patient population. We encourage all EPs,
eligible hospitals and CAHs to critically review their implementation in light of their current and
future needs both to maximize their own value and to prepare for future stages of meaningful
use.
Comment: We received comments asking at what frequency the information must be
recorded and whether the information can be collected by support staff.
Response: We clarify that this is a check of the medical record for patients 13 years old
or older. If this information is already in the medical record available through certified EHR
technology, we do not intend that an inquiry be made every time a provider sees a patient 13
years old or older. The frequency of updating this information is left to the provider and
guidance is provided already from several sources in the medical community. The information
could be collected by any member of the medical staff.
Comment: We received a number of comments recommending either removing this
objective to record smoking status from the HIT functionality objectives or removing the
smoking measure from the core clinical quality measures as these measures serve the same
purpose and to require both is to require duplicative reporting.
Response: We disagree that these two measures serve the same purpose and therefore
only one should be included. The objective included here seeks to ensure that information on
smoking status is included in the patient’s record. Furthermore, that the information is stored in
a structured format so that it can automatically be identified by certified EHR technology as
smoking status for possible reporting or exchanging. We also note that the clinical quality
measure only focuses on patients 18 years or older, while the objective focuses on patients
13 years or older. In addition, many quality measures related to smoking are coupled with
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follow-up actions by the provider such as counseling. We consider those follow-up actions to be
beyond the scope of what we hope to achieve for this objective for Stage 1 of meaningful use.
After consideration of the public comments received, we are finalizing the meaningful
use objective for EPs at §495.6(d)(9)(i) and for eligible hospitals at §495.6(f)(8)(i) of our
regulations as proposed.
We include this objective in the core set as it is integral to the initial or on-going
management of a patient's current or future healthcare and would give providers the necessary
information to make informed clinical decisions for improved delivery of patient care.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all unique patients 13 years old or
older seen by the EP or admitted to the eligible hospital have “smoking status” recorded
In the proposed rule, discussion of this measure referenced other sections exclusively.
Comment: We received comments recommending alternative thresholds for this
measure. Commenters provided thresholds ranging from anything greater than zero to 60 percent
in stage 1.
Response: In the proposed rule, we established a consistent threshold for measures not
requiring the exchange of information. For the final rule, (other than up-to-date problem list,
active medication list and active medication-allergy list), we have lowered the threshold
associated with these measures to 50 percent. In our discussion of the objective, we noted many
concerns by commenters over the appropriate age at which to inquire about smoking status.
There were also considerable differences among commenters as to what the appropriate inquiry
is and what it should include. Due to these concerns, we do not believe this objective and
measure fit into the threshold category described under up-to-date problem lists and therefore we
adopt a 50 percent (rather than an 80 percent) threshold for this measure. After consideration of
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the public comments received, we are modifying the meaningful use measure for EPs at
§495.6(d)(9)(ii) and for eligible hospitals at §495.6(f)(8)(ii) of our regulations to “More than 50
percent of all unique patients 13 years old or older seen by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) have smoking status
recorded as structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(g). The ability to calculate the measure is included in certified
EHR technology.
As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the percentage is based on
patient records that are maintained using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients age 13 or older seen by the EP or admitted to
an eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 or 23) during the
EHR reporting period. A unique patient is discussed under the objective of maintaining an upto-date problem list.
•
Numerator: The number of patients in the denominator with smoking status recorded as
structured data.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this measure. As addressed in other objectives, EPs, eligible
hospitals or CAHs who see no patients 13 years or older would be excluded from this
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requirement as described previously in this section under our discussion of whether certain EP,
eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes
of practices. Most EPs and all eligible hospitals and CAHs would have access to this
information through direct patient access. Some EPs without direct patient access would have
this information communicated as part of the referral from the EP who identified the service as
needed by the patient. Therefore, we did not include an exclusion based on applicability to scope
of practice or access to the information for this objective and associated measure.
NPRM EP/Eligible Hospital Objective: Record advance directives
In the proposed rule, we discussed this objective, but did not propose it as a requirement
for demonstrating meaningful use, for a number of reasons, including: (1) it was unclear whether
the objective would be met by indicating that an advance directive exists or by including the
contents of the advance directive; (2) the objective seems relevant only to a limited and
undefined patient population when compared to the patient populations to which other objectives
of Stage 1 of meaningful use apply; and (3) we believe that many EPs would not record this
information under current standards of practice. Dentists, pediatricians, optometrists,
chiropractors, dermatologists, and radiologists are just a few examples of EPs who would require
information about a patient's advance directive only in rare circumstances.
Comment: We received several comments including a comment from the HIT Policy
Committee that we should include advance directives in the final rule. The HIT Policy
Committee clarified that this would be an indication of whether a patient has an advanced
directive. Furthermore, they recommend limiting this measure to patients 65 and older. We
received other comments that said this should be a requirement for eligible hospitals. Other
commenters reported that having this information available for the patient would allow eligible
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hospitals to make decisions that were better aligned with the patient’s expressed wishes.
Response: In the proposed rule, we said that confusion as to whether this objective
would require an indication of the existence of an advanced directive or the contents of the
advance directive itself would be included in certified EHR technology was one of the reasons
for not including the objective in Stage 1 of meaningful use. We expressed concerns that the
latter would not be permissible in some states under existing state law. As commenters have
clarified that advance directives should be just an indication of existence of an advance directive
and recommended a population to apply the measure to, we reinstate this objective for eligible
hospitals and CAHs. We believe that the concern over potential conflicts with state law are
alleviated by limiting this to just an indication. We also believe that a restriction to a more at
risk population is appropriate for this measure. By restricting the population to those 65 years
old and older, we believe we focus this objective appropriately on a population likely to most
benefit from compliance with this objective and its measure. This objective is in the menu set so
if an eligible hospital or CAH finds they are unable to meet it then can defer it. However, we
believe many EPs would not record this information under current standards of practice.
Dentists, pediatricians, optometrists, chiropractors, dermatologists, and radiologists are just a few
examples of EPs who would only require information about a patient's advance directive in rare
circumstances. For other meaningful use objectives, we have focused our exclusions on rare
situations, which would not be the case for this objective. Therefore, we do not include this
objective for EPs.
After consideration of the public comments received, we are including this meaningful
use objective for eligible hospitals and CAHs at §495.6(g)(2)(i) of our regulations as “Record
whether a patient 65 years old or older has an advanced directive as structured data ”.
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NPRM EP/Eligible Hospital Measure: N/A
While we did not receive specific percentage recommendations from commenters, this
objective is the recording of a specific data element as structured data in the patient record. This
is identical to other objectives with established measures such as, recording vital signs, recording
demographics and recording smoking status. Therefore, we adopt the measure format and the
lower threshold (50 percent) from those objectives. We also believe that this information is a
level of detail that is not practical to collect on every patient admitted to the eligible hospital’s or
CAH’s emergency department, and therefore, have limited this measure only to the inpatient
department of the hospital.
In the final rule, this meaningful use measure for eligible hospitals at §495.6(g)(2)(ii) of
our regulations: “More than 50 percent of all unique patients 65 years old or older admitted to
the eligible hospital’s or CAH’s inpatient department (POS 21) have an indication of an advance
directive status recorded as structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.306(h). The ability to calculate the measure is included in certified
EHR technology.
As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the percentage is based on
patient records that are maintained using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
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Denominator: Number of unique patients age 65 or older admitted to an eligible
hospital’s or CAH’s inpatient department (POS 21) during the EHR reporting period. A unique
patient is discussed under the objective of CPOE.
•
Numerator: The number of patients in the denominator with an indication of an advanced
directive entered using structured data.
•
Threshold: The resulting percentage must be more than 50 percent in order for eligible
hospital or CAH to meet this measure. An exclusion, as described previously in this section
under our discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1
meaningful use objectives given established scopes of practices, would apply to an eligible
hospital or CAH who admits no patients 65 years old or older during the EHR reporting period.
NPRM EP/Eligible Hospital Objective: Incorporate clinical lab-test results into EHR as
structured data.
In the proposed rule, we defined structured data as data that has a specified data type and
response categories within an electronic record or file. We have revised that definition for the
final rule as discussed below.
Comment: Some commenters requested clarification on what constitutes structured data.
Response: The distinction between structured data and unstructured data applies to all
types of information. Structured data is not fully dependent on an established standard.
Established standards facilitate the exchange of the information across providers by ensuring
data is structured in the same way. However, structured data within certified EHR technology
merely requires the system to be able to identify the data as providing specific information. This
is commonly accomplished by creating fixed fields within a record or file, but not solely
accomplished in this manner.
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After consideration of the public comments received, we finalize the meaningful use
objective or EPs at §495.6(e)(2)(i) and eligible hospitals and CAHs at §495.6(g)(3)(i) as
proposed.
NPRM EP/ Eligible Hospital Measure: At least 50 percent of all clinical lab tests results
ordered by the EP or by an authorized provider of the eligible hospital during the EHR reporting
period whose results are either in a positive/negative or numerical format are incorporated in
certified EHR technology as structured data.
In the proposed rule, we identified this objective and associated measure as dependent on
electronic exchange and therefore requiring special consideration in establishing the threshold.
We said that we are cognizant that in most areas of the country, the infrastructure necessary to
support such exchange is still being developed. Therefore, we stated our belief that 80 percent is
too high a threshold for the Stage 1 criteria of meaningful use. As an alternative, we proposed
50 percent as the threshold based on our discussions with EHR vendors, current EHR users, and
laboratories. We then invited comment on whether 50 percent is feasible for the Stage 1 criteria
of meaningful use. Finally, we indicated that we anticipate raising the threshold in future stages
of meaningful use as the capabilities of HIT infrastructure increase. We received several
comments on the appropriateness of this 50 percent threshold and discuss them in the comment
and response section below.
Comment: Commenters requested clarification as to whether the measure includes only
electronic exchange of information with a laboratory or if it also includes manual entry.
Response: We encourage every EP, eligible hospital and CAH to utilize electronic
exchange of the results with the laboratory based on the certification and standards criteria in the
45 CFR 170.302(h). If results are not received in this manner, then they are presumably received
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in another form such as fax, telephone call, mail, etc. These results then must be incorporated
into the patient’s medical record in some way. We encourage that this way use structured data;
however, that raises the concerns about the possibility of recording the data twice; for example
scanning the results and then entering the results as structured data. Telephoned results could be
entered directly. We also recognize the risk of entry error, which is why we highly encourage
the electronic exchange of the results with the laboratory, instead of manual entry through
typing, option selecting, scanning or other means. Reducing the risk of entry error is one of the
primary reasons we lowered the measure threshold for Stage 1 during which providers are
changing their workflow processes to accurately incorporate information into EHRs through
either electronic exchange or manual entry. However, for this measure, we do not limit the EP,
eligible hospital or CAH to only counting structured data received via electronic exchange, but
count in the numerator all structured data. By entering these results into the patient’s medical
record as structured data, the EP, eligible hospital or CAH is accomplishing a task that must be
performed regardless of whether the provider is attempting to demonstrate meaningful use or not.
We believe that entering the data as structured data encourages future exchange of information.
Comment: A majority of commenters commenting on this measure believe the proposed
50 percent threshold is too high. Suggestions for alternative thresholds ranged from more than
zero to eighty percent. Some commenters suggested that the percentage calculation be replaced
with a numeric count.
Response: We are finalizing a percentage calculation for the reasons discussed
previously in this section under our discussion of the burden created by the measures associated
with the Stage 1 meaningful use objectives. We based the 50 percent threshold in the proposed
rule on our discussions with EHR vendors, current EHR users, and laboratories and specifically
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requested comment on whether the 50 percent threshold was feasible. While only a small
number of commenters commented on this objective, those that did were overwhelming in favor
of either a count or a lower threshold. EPs especially were concerned with our inability to
impose any requirements on laboratory vendors. Based on the comments received, we have
modified our assessment of the current environment for incorporating lab results into certified
EHR technology, and believe that a threshold lower than fifty percent is warranted. We want to
create a threshold that encourages, but does not require, the electronic exchange of this
information and commenters indicated that 50 percent was too high given the current state of
electronic exchange of lab results. Therefore, we lower the threshold to 40 percent.
Comment: Commenters requested clarification on what types of laboratories could
generate the lab results.
Response: The focus of this objective is to get as many lab results as possible into a
patient’s electronic health record as structured data. Limiting the objective to a specific type of
laboratory would not further this objective so therefore we leave it open to all lab tests and
laboratories.
Comment: Several commenters expressed concern regarding the financial burden of
establishing lab interfaces, especially for smaller hospitals and practices.
Response: The ability to exchange information is a critical capability of certified EHR
technology. Exchange between lab and provider and provider to provider of laboratory results
reduces errors in recording results and prevents the duplication of testing. Therefore, we
continue to include this objective within Stage 1 of meaningful use although as noted above the
measure does not rely on the electronic exchange of information between the lab and the
provider.
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Comment: We received comments requesting a listing of laboratory tests with results
that are in a numerical or positive/negative format.
Response: We consider it impractical to develop an exhaustive list of such tests.
Moreover, we believe further description of these tests is unnecessary. It should be self-evident
to providers when a test returns a positive or negative result or a result expressed in numeric
characters. In these case, the results should be incorporated into a patient’s EHR as structured
data.
Comment: Several commenters pointed out that many current EHR vendors do not
support the use of LOINC® codes and there is no federal regulatory requirement for labs to
transmit using this code set or for that matter, any structured code set.
Response: Standards such as LOINC® codes are included in the ONC final rule.
However, this measure requires incorporation of lab test results as structured data, but does not
include a requirement for transmission or electronic receipt of the results using certified EHR
technology.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(2)(ii) and eligible hospitals at §495.6(g)(3)(ii) of our
regulations to “More than 40 percent of all clinical lab tests results ordered by the EP or by an
authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or
emergency department (POS 21 or 23) during the EHR reporting period whose results are in
either in a positive/negative or numerical format are incorporated in certified EHR technology as
structured data”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
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standards at 45 CFR 170.302(h). The ability to calculate the measure is included in certified
EHR technology.
As noted previously in this section under our discussion of whether certain EP, eligible
hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes of
practices , the percentage is based on labs ordered for patients whose records are maintained
using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of lab tests ordered during the EHR reporting period by the EP or
authorized providers of the eligible hospital or CAH for patients admitted to an eligible
hospital’s or CAH’s inpatient or emergency department (POS 21 & 23) whose results are
expressed in a positive or negative affirmation or as a number.
•
Numerator: The number of lab test results whose results are expressed in a positive or
negative affirmation or as a number which are incorporated as structured data.
•
Threshold: The resulting percentage must be more than 40 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
If an EP orders no lab tests whose results are either in a positive/negative or numeric format
during the EHR reporting period they would be excluded from this requirement as described
previously in this section under our discussion of whether certain EP, eligible hospital or CAH
can meet all Stage 1 meaningful use objectives given established scopes of practices. We do not
believe any eligible hospital or CAH would order no lab tests whose results are either in a
positive/negative or numeric format during the EHR reporting period.
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NPRM EP/Eligible Hospital Objective: Generate lists of patients by specific conditions to use
for quality improvement, reduction of disparities, research, and outreach.
Comment: A few commenters recommended eliminating this requirement because they
believe it is redundant of clinical quality reporting.
Response: We disagree that this is redundant of clinical quality reporting. Clinical
quality reporting does not guarantee usability for all the purposes in the objective. One example
of such a use is a provider could not only generate list of patients with specific conditions, but
could stratify the output using other data elements in the certified EHR technology that are
entered as structured data. The lists could also be utilized at an aggregate level for purposes of
research into disparities, which could result in targeted outreach efforts.
Comment: Some commenters requested that if we finalize our proposal to only require
one report that we change the “and” in the objective to “or”.
Response: We are finalizing our measurement of only requiring one report for Stage 1 of
meaningful use and will change “and” to “or”. However, we note that all measures will be
reconsidered in later stages of meaningful use and multiple reports could be required in those
stages.
Comment: We received a few comments requesting the removal of the terms “reduction
of disparities” and “outreach” as there are no actionable items or measures associated with the
term. We also received comments that the measurement should include the requirement that the
lists be stratified by race, ethnicity, preferred language, and gender for initiatives targeted at
reducing disparities.
Response: We disagree that actions to reduce disparities or conduct outreach could not
be guided by this report, especially if stratified and aggregated reports of many providers are
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combined within large organizations or among organizations. While we do not require such
stratification or aggregation or specify specific uses, that does not preclude them.
Comment: Some commenters requested clarification of the term specific condition.
Response: Specific conditions are those conditions listed in the active patient problem
list.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(e)(3)(i) and for eligible hospitals at §495.6(g)(4)(i) of our
regulations to “Generate lists of patients by specific conditions to use for quality improvement,
reduction of disparities, research, or outreach”.
NPRM EP/Eligible Hospital Measure: Generate at least one report listing patients of the EP or
eligible hospital with a specific condition.
In the proposed rule, we said that an EP or eligible hospital is best positioned to
determine which reports are most useful to their care efforts. Therefore, we do not propose to
direct certain reports be created. However, in order to ensure the capability can be utilized we
proposed to require EPs and hospitals to attest to the ability of the EP or eligible hospital to
create a report listing patients by specific condition and to attest that they have actually done so
at least once. We received comments on this and address them and any revisions to the proposed
rule in the comment and response section below.
Comment: Commenters requested clarification that only one report per EHR reporting
period is required to meet the measure.
Response: Yes, only one report in required for any given EHR reporting period. The
report could cover every patient whose records are maintained using certified EHR technology or
a subset of those patients at the discretion of the EP, eligible hospital or CAH.
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Comment: A few commenters suggested the measure should be expanded to require
submission of the report to CMS or the States or to the local health department.
Response: Submission raises many questions about what types of information can be
sent to different entities, how the information is used, patient consent for sending the
information, and many of the issues, which add considerable complexity to this meaningful use
objective. Therefore, we are not requiring submission of the report to CMS, the States or local
health departments for Stage 1 of meaningful use. We do note that this is one of the objectives
for which a State can submit modifications to CMS for approval.
Comment: Several commenters requested a list of condition categories, a model report or
the core data elements required to satisfy the measure.
Response: As stated in the rule, we believe an EP, eligible hospital, or CAH is best
positioned to determine which reports are most useful to their care efforts. Therefore, we do not
propose to direct certain reports be created.
Comment: For eligible hospitals, commenters stated that the analysis of patient data is
derived from post-discharge coding of diagnosis and procedures and not problem lists.
Response: We do not specify that the list is limited to being generated from the data
problem list; rather, for the definition of conditions we refer providers to those conditions
contained in the problem list.
Comment: One commenter stated that for privacy and confidentiality reasons, patients
should be allowed to opt out of any provider outreach initiatives.
Response: Stage 1 of meaningful use does not require the submission of these reports to
other entities; rather, we require that the provider generate these reports for their own use. We
therefore do not believe the generation of such reports raises privacy and confidentiality
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concerns. We understand, however, that some patients may have concerns about such lists being
exchanged with others and will consider such concerns should future meaningful use
requirements focus on exchange of these reports.
After consideration of the public comments received, we are finalizing the meaningful
use measure for EPs at §495.6(e)(3)(ii) and for eligible hospitals and CAHs at §495.6(g)(4)(ii)
of our regulations as proposed.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(i). The ability to calculate the measure is included in certified
EHR technology.
As this measure relies on data contained in certified EHR technology the list would only
be required to include patients whose records are maintained using certified EHR technology as
discussed previously in this section under our discussion of the burden created by the measures
associated with the Stage 1 meaningful use objectives.
We do not believe anything included in this objective or measure limit any EP, eligible
hospital or CAH from completing the measure associated with this objective, therefore, we do
not include an exclusion.
NPRM EP Objective: Report ambulatory quality measures to CMS (or, for EPs seeking the
Medicaid incentive payment, the States).
Specific comments on the quality measures are discussed in section II.A.3 of this final rule.
We are finalizing this meaningful use objective at §495.6(d)(10)(i) of our regulations “Report
ambulatory clinical quality measures to CMS (or, for EPs seeking the Medicaid incentive
payment, the States)” to better align with the descriptions in section II.A.3.
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In response to our revised requirements for meeting meaningful use, we are including this
objective in the core set. Section 1848 (o)(2)(A)(iii) of the Act specifically includes submitting
clinical quality measures in meaningful use for EPs. Section 1903(t)(6)(D) of the Act also
anticipates that the demonstration of meaningful use may include quality reporting to the States
for the Medicaid program.
NPRM Eligible Hospital Objective: Report ambulatory quality measures to CMS (or, for
eligible hospitals seeking the Medicaid incentive payment, the States).
We make a technical correction to this objective from the proposed rule to ensure that it is clear
to the public that we were referring to hospital quality measures.
Specific comments on the quality measures are discussed in section II.A.3 of this final rule.
After consideration of the public comments received, we are finalizing this meaningful
use objective at §495.6(d)(9)(i) to account for our technical correction and to better align with
the descriptions in section II.A.3 as “Report hospital clinical quality measures to CMS (or, for
eligible hospitals seeking the Medicaid incentive payment, the States)”.
In response to our revised requirements for meeting meaningful use, we are including this
objective in the core set. Section 1886 (n)(3)(A)(iii) of the Act specifically includes submitting
clinical quality measures in meaningful use for eligible hospitals and CAHs. Section
1903(t)(6)(D) of the Act also anticipates that the demonstration of meaningful use may include
quality reporting to the States for the Medicaid program.
NPRM EP Measure: For 2011, an EP would provide the aggregate level data for the
numerator, denominator, and exclusions through attestation as discussed in section II.A.3 of this
final rule. For 2012, an EP would electronically submit the measures that are discussed in
section II.A.3. of this final rule.
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Specific comments on the quality measures themselves are discussed in section II.A.3 of this
final rule.
After consideration of the public comments received, we are finalizing this meaningful
use objective at §495.6(d)(10)(ii) as proposed.
NPRM Eligible Hospital Measure: For 2011, an eligible hospital or CAH would provide the
aggregate level data for the numerator, denominator, and exclusions through attestation as
discussed in section II.A.3 of this final rule. For 2012, an eligible hospital or CAH would
electronically submit the measures as discussed in section II.A.3. of this final rule.
Specific comments on the quality measures are discussed in section II.A.3 of this final rule.
After consideration of the public comments received, we are finalizing this meaningful use
objective at 495.6(f)(9)(ii) as proposed.
NPRM EP Objective: - Send reminders to patients per patient preference for
preventive/follow-up care.
In the proposed rule, we described patient preference as the patient’s choice between
internet based delivery or delivery not requiring internet access. We are revising that description
based on comments as discussed below.
Comment: Commenters have pointed out that requirements to accommodate reasonable
requests by individuals to receive communications by means other than the means preferred by
the provider already exist under HIPAA at 45 C.F.R. 164.522(b).
Response: As we stated in the proposed rule, patient preference refers to the patient’s
preferred means of transmission of the reminder from the provider to the patient, and not
inquiries by the provider as to whether the patient would like to receive reminders. In the
proposed rule, we had proposed that patient preference be limited to the choice between internet
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based or non-internet based. In order to avoid unnecessary confusion and duplication of
requirements, EPs meet the aspect of “per patient preference” of this objective if they are
accommodating reasonable requests as outlined in 45 C.F.R. 164.522(b), which are the guidance
established under HIPAA for accommodating patient requests.
After consideration of the public comments received, we are finalizing the meaningful
use objective at §495.6(e)(4)(i) of our regulations as proposed.
NPRM EP Measure: Reminder sent to at least 50 percent of all unique patients seen by the EP
or admitted to the eligible hospital that are 50 and over.
For the final rule, we are changing the measure to recognize that this is an EP only
objective. Therefore, we make the technical correction of striking “or admitted to the eligible
hospital”.
Comment: Commenters indicated that “practice management systems” or “patient
management systems” are commonly used for this function and that integrating them into
certified EHR technology would be expensive and time consuming for little value in return.
Response: While we disagree with commenters who suggest there is little to no value in
having information about reminders sent to patients available across all the systems used by the
provider, we do not assert that such integration of systems must be in place to meet this measure.
ONC provides for a modular approach that would allow these systems to be certified as part of
certified EHR technology.
Comment: Some commenters pointed out that many patients seen during an EHR
reporting period will not be sent a reminder during that same period. Commenters said this is
especially true for the 90-day EHR reporting period, but for some services could be true of the
full year EHR reporting period as well. Other commenters also pointed out that reminders are
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not limited to the older population and that children especially may require many reminders on
immunizations.
Response: We agree with commenters that many patients not seen during the EHR
reporting period would benefit from reminders. As the action in this objective is the sending of
reminders, we base the revised measure on that action. This focus is supported by numerous
public comments, including those by the HIT Policy Committee. Therefore, we are changing the
requirement to account for all patients whose records are maintained using certified EHR
technology regardless of whether they were seen by the EP during the EHR reporting period.
This greatly expanded denominator caused us to reconsider both our threshold and the age limit.
In order to increase the probability that a patient whose records are maintained in certified EHR
technology will be eligible for a reminder we change the age limit of the population to 65 years
old or older or 5 years old or under. We believe that older patient populations are more likely to
have health statuses that will indicate the need for reminders to be sent and this segment of the
population is have higher rates of chronic diseases which will require coordination in preventive
care such as vaccine reminders. Likewise, the 5 years old and under population will require a
multitude of childhood vaccinations such as influenza and will benefit from reminders.
However, we do not believe that changing the age limit of the affected population will result in
50 percent of every patient whose records maintained in certified EHR technology requiring a
reminder during the EHR reporting period. This is especially true for the first payment year
when the EHR reporting period is only 90 days. We are also concerned about the variability
among specialists’ scopes of practice that may affect the number of patients in the denominator
for which a reminder is appropriate. Therefore, we lower the threshold to 20 percent. The EP
has the discretion to determine the frequency, means of transmission and form of the reminder
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limited only by the requirements of 45 CFR 164.522(b) and any other applicable federal, state or
local regulations that apply to them. After consideration of the public comments received, we
are modifying the meaningful use measure at §495.6(e)(4)(ii) to “More than 20 percent of all
patients 65 years or older or 5 years old or younger were sent an appropriate reminder during the
EHR reporting period”.
We further specify that in order to meet this objective and measure, an EP must use the
capabilities Certified EHR Technology includes as specified and standards at 45 CFR
170.304(d). The ability to calculate the measure is included in certified EHR technology.
As noted previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, the denominator is based on
patients whose records are maintained using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients 65 years old or older or 5 years older or
younger.
•
Numerator: The number of patients in the denominator who were sent the appropriate
reminder.
•
Threshold: The resulting percentage must be more than 20 percent in order for an EP to
meet this measure.
As addressed in other objectives and in comment responses, if an EP has no patients 65 years old
or older or 5 years old or younger with records maintained using certified EHR technology that
EP is excluded from this requirement as described previously in this section under our discussion
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of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives
given established scopes of practices.
NPRM EP/Eligible Hospital Objective: Document a progress note for each encounter
In the proposed rule, we discussed this objective, but did not propose it for Stage 1 of meaningful
use. We noted our belief that documentation of progress notes is a medical-legal requirement
and a component of basic EHR functionality, and is not directly related to advanced processes of
care or improvements in quality, safety, or efficiency.
Comment: We received a limited number of comments regarding our decision not to
include documentation of progress notes as an objective. The commenters generally fell into
three categories: those who supported inclusion of this objective in the final rule, those who
supported its inclusion only if certain caveats are met and those who supported our proposal not
to include it as an objective for Stage 1 of meaningful use. Concerns raised by those supporting
the inclusion of this objective included the possibility that an EP may keep paper progress notes
in conjunction with use of certified EHR technology as prescribed by Stage 1 of meaningful use
and that such a choice by EPs would create the possibility of handwriting illegibility, loss of
information and reduced access to health information by both patients and other providers.
Another concern raised is that if the objective is not included in the criteria for the definition of
meaningful use designers of EHR technology will not include the function in their products. The
advocates in the second category agree with the above, but only support inclusion with certain
caveats. Some of these caveats include preserving the option of transcription, voice recognition
software, and direct entry by an EP or any combination of these. Another caveat is that progress
notes not be required to be entered as structured data. The third category supports exclusion of
progress notes as an objective for two fundamentally different reasons. Some commenters
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supported exclusion because they believe that the volume of objectives was already too high for
Stage 1 of meaningful use and therefore opposed anything that would increase the volume.
Other commenters agree with our proposal that progress notes is already a fundamental part of
current EHR products and did not represent a move that advances the use of EHRs.
Response: We predicated our discussion in the proposed rule on the assumption that
progress notes are a component of basic EHR functionality. We still believe this is the case and
have not received evidence to the contrary. However, we failed to clearly articulate the
ramifications of our belief. Our view continues to be that an EP who incorporates the use of
EHRs into a practice and complies with meaningful use criteria is unlikely to maintain separate
paper progress notes outside of the EHR system. We believe that the potential disruption in
workflow of the efforts to merge paper progress notes with the other records in certified EHR
technology in order to have a complete medical record far outweighs the burden of electronically
capturing progress notes. Moreover, we continue to believe this is a highly unlikely scenario.
As with any meaningful use objective, it is important to have clear, definitive definitions.
However, our observations of discussions held in public forums by the medical community and
review of literature have led us to conclude that it not possible to provider a clear, definitive
definition of a progress note at this time. We note that commenters recommending the
documentation of a progress note be included as an objective did not attempt to define the term.
Nor did commenters suggest an associated measure. We continue to believe that there is
insufficient need and upon review believe there is insufficient consensus regarding the term
progress note to include this objective for Stage 1 of meaningful use.
After consideration of the public comments received, we do not include this meaningful
use objective in the final rule.
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NPRM EP/Eligible Hospital Measure: N/A
NPRM EP Objective: Implement five clinical decision support rules relevant to specialty or
high clinical priority, including for diagnostic test ordering, along with the ability to track
compliance with those rules.
NPRM Eligible Hospital Objective: Implement 5 clinical decision support rules related to a
high priority hospital condition, including diagnostic test ordering, along with the ability to track
compliance with those rules.
First, we make a technical correction. On page 1856 of the proposed rule, we described
this objective for eligible hospitals as “Implement five clinical decision support rules relevant to
specialty or high clinical priority, including for diagnostic test ordering, along with the ability to
track compliance with those rules.” The underlined language was inappropriately carried over
from the EP objective in this instance and in the regulation text. The table contained our
intended language of “Implement 5 clinical decision support rules related to a high priority
hospital condition, including diagnostic test ordering, along with the ability to track compliance
with those rules.” Many commenters pointed this discrepancy out to us and we appreciate their
diligence.
Comment: Nearly half of the commenters mentioning clinical decision support suggested
that the term needed additional clarification. Some commenters said that the term was too vague
and open to interpretation while others said it was too specific. Other commenters provided
recommendations on what a clinical decision support rule should mean or which elements it
should include. These were evidence-based medicine templates, decision trees, reminders,
linked online resources, scientific evidence, and consensus.
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Response: In the proposed rule, we described clinical decision support as HIT
functionality that builds upon the foundation of an EHR to provide persons involved in care
processes with general and person-specific information, intelligently filtered and organized, at
appropriate times, to enhance health and health care. We purposefully used a description that
would allow a provider significant leeway in determining the clinical decision support rules that
are more relevant to their scope of practice and benefit their patients in the greatest way. In the
proposed rule, we asked providers to relate the rules they select to clinical priorities and
diagnostic test ordering. We do not believe that adding a more limiting description to the term
clinical decision support would increase the value of this objective. We believe that this
determination is best left to the provider taking into account their workflow and patient
population.
Comment: Several commenters objected to the requirement of five clinical decision
support rules when the HIT Policy Committee only recommended one. Others disagreed with
our proposed assertion that most EPs would report on at least five clinical quality measures from
section II.A.3 of the proposed rule and eligible hospitals will all report on at least five.
Response: We accept the argument that there is value in focusing initial CDS efforts on a
single CDS rule in order to get it right the first time and lay the foundation for future, broader
CDS implementation. This will help to prevent the unintended negative consequences associated
with poorly implemented CDS systems when providers have attempted to do too much too soon.
We agree that the appropriate balance is to require some degree of meaningful use of CDS in
Stage 1 without overburdening providers with too many areas to focus on at once. Since CDS is
one area of health IT in which significant evidence exists that it can have a substantial positive
impact on the quality, safety and efficiency of care delivery, it is important that it be included as
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a core objective with this more limited expectation. That requirement will assure that all
meaningful users have taken the first steps in CDS implementation but allow them to focus as
necessary on a single high-priority area at the outset in order to ensure that they can devote the
appropriate level of attention to their first CDS priority. We anticipate that this will set the
foundation for much more expansive CDS support in the near future.
Comment: A commenter inquired if modification of the clinical decision support tool
negates the EHR’s certification status.
Response: We believe this is a question on certification status and is outside of the scope
of this rule. ONC discusses what would affect Certified EHR Technology’s certified status in
their final rule (75 FR 36157) entitled "Establishment of the Temporary Certification Program
for Health Information Technology".
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at 495.6(d)(11)(i) to “Implement one clinical decision support rule relevant
to specialty or high clinical priority along with the ability to track compliance with that rule.”
After consideration of public comments received, we are modifying the meaningful use
objective for eligible hospitals and CAHs at §495.6(f)(10)(i) of our regulations as “Implement
one clinical decision support rule related to a high priority hospital condition along with the
ability to track compliance with that rule.”
We believe that clinical decision support is one of the most common tools that uses the
information collected as structured data included in the core set and therefore also include
clinical decision support in the core as the information needed to support it are already included
in the core set.
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NPRM EP/Eligible Hospital Measure: Implement five clinical decision support rules relevant
to the clinical quality metrics the EP/Eligible Hospital is responsible for as described further in
section II.A.3. of this final rule.
In the proposed rule, we said that clinical decision support at the point of care is a critical
aspect of improving quality, safety, and efficiency. Research has shown that decision support
must be targeted and actionable to be effective, and that “alert fatigue” must be avoided.
Establishing decision supports for a small set of high priority conditions, ideally linked to quality
measures being reported, is feasible and desirable. Meaningful use seeks to ensure that those
capabilities are utilized.
Comment: Commenters, both in the requests for clarification of the term clinical
decision support and explicitly in response to this measure, expressed concern about the linkage
to a particular quality measure.
Response: We agree that such linkage puts constraints on the provider and eliminates
many types of clinical decision support rules that may be beneficial. Therefore, we revise this
measure to require that at least one of the five rules be related to a clinical quality measure,
assuming the EP, eligible hospital or CAH has at least one clinical quality measure relevant to
their scope of practice. However, we strongly encourage EPs, eligible hospitals and CAHs to
consider the clinical quality measures as described in section II.A.3 when deciding which
additional rules to implement for this measure.
Comment: Several commenters, including the HIT Policy Committee, recommended that
we focus at least one clinical decision support rule on efficiency of care.
Response: In light of decision to limit the objective to one clinical decision support rule,
we do not believe that it is appropriate to further to link that rule to specific requirements and
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therefore give the EP, eligible hospital or CAH discretion on what to focus the clinical decision
support rule used to satisfy this measure.
Comment: A few commenters asked for clarification of how the “…with the ability to
track compliance with those rules” language of the proposed objective for clinical decision
support rules relates to the associated measures.
Response: While an integral part of the objective and certified EHR technology, we did
not include this aspect of the objective in the measure for Stage 1 of meaningful use. An EP,
eligible hospital, or CAH is not required to demonstrate to CMS or the States its compliance
efforts with the CDS recommendations or results for Stage 1 either at initial attestation or during
an subsequent review of that attestation.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(11)(ii) and for eligible hospitals and CAHs at §495.6(g)(10)(ii)
to “Implement one clinical decision support rule.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(e) for EPs and 45 CFR 170.306(c). The ability to calculate the
measure is included in certified EHR technology.
Given the added flexibility added to this measure in the final rule, we do not believe that
any EP, eligible hospital, or CAH would be in a situation where they could not implement one
clinical decision support rules as described in the measure. Therefore, there are no exclusions for
this objective and its associated measure.
NPRM EP/Eligible Hospital Objective: Submit claims electronically to public and private
payers.
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Comment: Over three quarters of those commenting on this objective recommended that
it be eliminated for various reasons. The majority of the other commenters requested a
modification. Reasons given are:
Ͳ
Electronic claims submission is already covered under HIPAA;
Ͳ
Electronic claims submission is not part of traditional EHR technology;
Ͳ
Billing systems would have to be certified adding to cost and burden of compliance with
meaningful use even though when electronic claims submission for Medicare is already
in place for all by the very smallest of providers;
Ͳ
Electronic claims submission falls outside of the scope of the statutory mandate given by
Congress to implement the HITECH legislation to improve care delivery through broad
scale adoption and utilization of Electronic Health Record technologies. This function
does not impact the quality of care delivered and relies on product components that are
traditionally part of practice management systems;
Ͳ
Private payers may customize the HIPAA-recognized standard transactions, which limits
the ability of practices to obtain accurate information prior to receiving an Explanation of
Benefits based on the actual services provided and negates many of the benefits of having
standardized transactions;
Ͳ
Workers’ compensation and auto insurers do not accept electronic claims; and
Ͳ
Many providers use clearinghouses and they requested that the burden of electronic
submission be shifted to the clearinghouse.
Response: In our proposed rule, we specifically cite that the existence of standard
transactions available under HIPAA for submitting claims as a reason for including this objective
as a meaningful use objective for Stage 1. We also disagree that this objective is outside the
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scope of meaningful use as defined by the HITECH legislation. The HITECH legislation states
the Secretary shall seek to improve not only health care quality, but also the use of electronic
health records. In addition, we note that sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act
provide that to be considered a meaningful EHR user, an EP, eligible hospital, or CAH must
demonstrate use of certified EHR technology in a meaningful manner as defined by the
Secretary. In the Medicaid context, any demonstration of meaningful use must be “acceptable to
the Secretary” under 1903(t)(6). We believe this language gives us broad discretion to require
the use of certified EHR technology in a manner that not only improves health care quality, but
results in gains in efficiency, patient engagement and enhances privacy and security. Under the
broad definition of electronic health record established by ONC in their final rule, electronic
exchange of eligibility information and claims submission could certainly improve the use of
electronic health records.
We believe that inclusion of administrative simplification in meaningful use is an
important long-term policy goal for several reasons. First, administrative simplification can
improve the efficiency and reduce unnecessary costs in the health care system as a whole; the
small percentage of paper claims submitted represent a disproportionate administrative cost for
health plans; the reconciliation of billing charges for services not eligible for payment creates a
significant burden for providers, health plans, and most significantly, for patients. Second, the
integration of administrative and clinical information systems is necessary to support effective
management and coordinated care in physician practices. The ability to leverage clinical
documentation in support of appropriate charge capture (for example, for preventive counseling,
or immunizations provided), the ability to link lists of patients needing clinical reminders with
patient contact information, the ability to stratify quality measures by patient demographic
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factors (for example, race/ethnicity) and insurer status (for example, Medicare beneficiaries), are
examples.
In addition, there are important benefits to the inclusion of administrative transactions in
criteria and standards for the certification of EHR technologies. The option of modular
certification provides an opportunity for eligible professionals and hospitals to use practice
management systems or clearinghouses that provide these functions as components of their
certified EHR technologies. However, we recognize there is not current agreement as to which
systems constitute an EHR and that many entities may view their billing system to be outside
their EHR and that the vendors of some practice management systems that provide these
functionalities in doctors’ offices today may not be prepared to seek certification for these legacy
products in 2010/ 2011. We also recognize that the introduction of the X12 5010 standards in
January 2012 would further complicate the certification process for stage 1. We also
acknowledge that we do not have the ability to impose additional requirements on third-party
payers or clearinghouses to participate in this exchange beyond what is required by HIPAA.
Based on these considerations, we are not including this objective in the final rule for Stage 1 of
meaningful use.
However, the introduction of these new X12 5010 standards, and the coming introduction
of ICD-10 in 2013 provides an opportunity for change in Stage 2 of meaningful use. In order to
meet these and other administrative simplification provisions, most providers will have to
upgrade their practice management systems or implement new ones. This provides an important
opportunity to achieve alignment of capabilities and standards for administrative transactions in
EHR technologies with the administrative simplification provisions that the Affordable Care Act
provides for health plans and health plan clearinghouses. We therefore intend to include
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administrative transactions as a part of Stage 2 of meaningful use, and expect providers and
vendors to take this into consideration in their decisions leading up to 2013.
Comment: Commenters focusing on how meaningful use would translate into the
Medicare Advantage program said that the measure of checking eligibility electronically and
submitting claims electronically for 80 percent of patients seen would not be possible. They
explained that for most of their visits, there is no insurance company with which to check, and
there is no insurance company to whom to submit claims. They described themselves as a
capitated system and for most of the patient visits, the concept of checking eligibility and
submitting claims in not relevant.
Response: This comment illustrates the difficulties in adopting FFS Medicare
meaningful use measures for qualifying MA organizations, MA-affiliated hospitals and MA EPs.
For purposes of determining meaningful use in a Medicare Advantage environment, we agree
that submitting claims electronically is not a useful standard in a capitated environment where
virtually all patients are members of the same insurance plan.
After consideration of the public comments received, we are not finalizing the objective
“Submit claims electronically to public and private payers”.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all claims filed electronically by
the EP or the eligible hospital.
We received many comments on the difficulty in calculating this measure. However, as
all measures are tied to objectives and we do not finalize this objective we also do not finalize
the measure.
NPRM EP/Eligible Hospital Objective: Check insurance eligibility electronically from public
and private payers.
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Comment: Over three quarters of those commenting on this objective recommended that it
be eliminated for various reasons. Some of the most common reasons for elimination are:
Ͳ
Electronic eligibility checks are already covered under HIPAA;
Ͳ
Electronic eligibility checks are not part of traditional EHR technology;
Ͳ
Billing and practice management systems that are used for electronic eligibility checks
would have to be certified as certified EHR technology adding to cost and burden;
Ͳ
Electronic eligibility checks is outside of the scope of the mandate given by Congress to
implement the HITECH legislation in such a way as to improve care delivery through
broad scale adoption and utilization of Electronic Health Record technologies. This
function does not impact the quality of care delivered and relies on product components
that are traditionally part of practice management systems;
Ͳ
Information returned on typical electronic eligibility checks is of little use to providers –
as responses are usually a yes/no answer on coverage, but not the specificity of coverage;
Ͳ
The current poor adoption rate of the use of electronic eligibility verification is indicative
of the deficiencies in current methods;
Ͳ
Once eligibility checking becomes easy to use and reliable, no incentive will be required
as providers will adopt the process readily;
Ͳ
Payers do not guarantee their eligibility results;
Ͳ
Many payers are still not in compliance with the HIPAA 270/271 electronic eligibility
standard. Therefore the objective should only be required if compliance with the standard
by health plans can be guaranteed; and
Ͳ
Private payers may customize the HIPAA-recognized standard transactions, which limits
the ability of practices to obtain accurate information prior to receiving an Explanation of
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Benefits based on the actual services provided and negates many of the benefits of having
standardized transactions.
Response: In our proposed rule, we specifically cite the existence of the standard
transaction for eligibility checks available under HIPAA as an enabling factor for the inclusion
this objective. As with the electronic claims submission objective discussed above, we disagree
that this objective is outside the scope of meaningful use as defined by the HITECH legislation.
The HITECH legislation requires the Secretary to seek to improve not only health care quality,
but also the use of electronic health records. Under the broad definition of electronic health
record established by ONC in their final rule, electronic exchange of eligibility information could
certainly improve the use of electronic health records. However, we recognize there is not
current agreement as to which systems constitute an EHR and that many entities may view their
practice management system to be outside their EHR. We also acknowledge that we do not have
the ability to impose additional requirements on third-party payers to participate in this exchange
beyond what is required by HIPAA. Third-party payers can provide simple yes/no responses,
modify the standard transactions and do not have to guarantee their results. We agree with
commenters that this significantly devalues the results of this objective. However, we do believe
that as electronic records and exchange based on this and considerations that commenters nearly
universally considered this to not be a function of EHR, we are not including this objective in the
final rule for Stage 1 of meaningful use. However, we do believe that inclusion of a robust
system to check insurance eligibility electronically is an important long term policy goal for
meaningful use of certified EHR technology and we intend to include this objective as well as
electronic claims submission Stage 2.
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After consideration of the public comments received, we are not finalizing the objective
to “Check insurance eligibility electronically from public and private payers” or any
modification thereof. Given that we are not finalizing the objective, we also are not finalizing
the associated EP and eligible hospital/CAH measures.
The second health outcomes policy priority identified by the HIT Policy Committee is to
engage patients and families in their healthcare. The following care goal for meaningful use
addresses this priority:
● Provide patients and families with timely access to data, knowledge, and tools to make
informed decisions and to manage their health
As explained in the proposed rule, we do not intend to preempt any existing Federal or
State law regarding the disclosure of information to minors, their parents, or their guardians in
setting the requirements for meaningful use. For this reason, we defer to existing Federal and
State laws as to what is appropriate for disclosure to the patient or their family. For purposes of
all objectives of the Stage 1 criteria of meaningful use involving the disclosure of information to
a patient, a disclosure made to a family member or a patient's guardian consistent with Federal
and State law may substitute for a disclosure to the patient.
Comment: Several commenters requested that all objectives under the health care policy
priority be combined, as they are redundant.
Response: We disagree that they are redundant and believe each serves a unique
purpose. We will more fully describe those purposes in the discussion of each objective.
NPRM EP Objective: Provide patients with an electronic copy of their health information
(including diagnostics test results, problem list, medication lists, allergies) upon request.
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NPRM Eligible Hospital Objective: Provide patients with an electronic copy of their health
information (including diagnostic test results, problem list, medication lists, allergies, discharge
summary, procedures), upon request
The purpose of this objective is to provide a patient’s health information to them
electronically and in a human readable format and in accordance with the standards specified in
the ONC final rule subject to its availability to the provider electronically and any withholding
under regulations related to the HIPAA Privacy Act at 45 C.F.R. 164.524, Access of individuals
to protected health information.
In the proposed rule, we indicated that electronic copies may be provided through a
number of secure electronic methods (for example, personal health record (PHR), patient portal,
CD, USB drive). We have changed this description in response to comments to that when
responding to patient requests for information, the EP, eligible hospital, or CAH should
accommodate patient requests in accordance with 45 C.F.R. 164.524, Access of individuals to
protected health information. The objective provides additional criteria for meeting meaningful
use concerning the electronic copy or provision of information that the EP, eligible hospital or
CAH maintains in or can access from the certified EHR technology and is maintained by or on
behalf of the EP, eligible hospital or CAH.
Comment: We received requests for clarification that only information that the EP,
eligible hospital, or CAH has available electronically must be provided to the patient.
Response: Yes, we limit the information that must be provided electronically to that
information that exists electronically in or accessible from the certified EHR technology and is
maintained by or on behalf of the EP, eligible hospital or CAH. We believe it is impractical to
require information maintained on paper to be transmitted electronically. Furthermore, given the
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other criteria of Stage 1 of meaningful use, we believe sufficient information will be available
through certified EHR technology, especially given the inclusion of many of the foundational
objectives that were included in the core set.
Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed
healthcare professionals to withhold certain information if its disclosure would cause substantial
harm to the patient or another individual.
Response: As previously discussed for patient preference, we do not seek to conflict with
or override HIPAA through meaningful use requirements. Therefore, an EP, eligible hospital, or
CAH may withhold information from the electronic copy of a patient’s health information in
accordance with the regulations at 45 C.F.R. 164.524, Access of individuals to protected health
information.
Comment: Commenters requested clarification of the term “health information” or
alternatively a list of elements required to satisfy the objective.
Response: Subject to the withholding described above, an EP, eligible hospital, or CAH
should provide a patient with all of the health information they have available electronically. At
a minimum, this would include the elements listed in the ONC final rule at 45 CFR 170.304(f)
for EPs and 45 CFR 170.306 (d) for eligible hospitals and CAHs as required for EHR technology
to become certified.
Comment: Several commenters indicated that a provider should be allowed to charge a
fee for providing an electronic copy of a patient’s health information.
Response: We do not have the authority under the HITECH Act to regulate fees in this
manner. Rather, the charging of fees for this information is governed by the HIPAA Privacy
Rule at 45 C.F.R. 164.524(c)(4) (which only permits HIPAA covered entities to charge an
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individual a reasonable, cost-based fee for a copy of the individual’s health information). We
would expect these costs to be very minimal considering that the ability to generate the copy is
included in certified EHR technology. Additional clarification on the fee that a HIPAA covered
entity may impose on an individual for an electronic copy of the individual’s health information
will be addressed in upcoming rulemaking.
Comment: Commenters pointed out that the general term “allergies” is inconsistent with
other objectives of Stage 1 and with the capabilities mandated by certification under the ONC
IFR, which address only medication allergies.
Response: As we have stated on several other objectives, we encourage all EPs, eligible
hospitals, and CAHs to work with their EHR technology designers to make capabilities most
relevant to their individual practices of care. However, we have maintained that at a minimum
the capabilities that are part of certification should be included and those should be the basis for
meaningful use so we do modify this objective to medication allergies to align it with other
objectives and certification.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(d)(12)(i) of our regulations to “Provide patients with an
electronic copy of their health information (including diagnostics test results, problem list,
medication lists, medication allergies) upon request” and for eligible hospitals and CAHs at
§495.6(f)(11)(i) of our regulations to “Provide patients with an electronic copy of their health
information (including diagnostic test results, problem list, medication lists, medication allergies,
discharge summary, procedures), upon request”.
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We include this objective in the core set as it is integral to involving patients and their
families in their provision of care and was recommended by the HIT Policy Committee for
inclusion in the core set.
NPRM EP/Eligible Hospital Measure: At least 80 percent of all patients who request an
electronic copy of their health information are provided it within 48 hours.
In the proposed rule, we pointed out that all patients have a right under ARRA to an
electronic copy of their health information. We said that our purpose for including it in
meaningful use was to ensure that this requirement in met in a timely fashion. We also said that
providing patients with an electronic copy of their health information demonstrates one of the
many benefits health information technology can provide and we believe that it is an important
part of becoming a meaningful EHR user. We received requests for clarifications on what must
be provided and in what timeframe. We address those requests in the comment and response
section below. We note here that participation in the Medicare and Medicaid EHR incentive
programs is voluntary. Nothing in the Stage 1 criteria of meaningful use supersedes or exempts
an EP, eligible hospital or CAH from complying with otherwise applicable requirements to
provide patients with their health information.
Comment: An overwhelming majority of commenters commenting on this objective
indicated that the 48-hour time frame is too short and inconsistent with the HIPAA Privacy Rule.
Response: We discuss the reasoning for the time frame in the proposed rule. We state
that this measure seeks to ensure that a patient’s request is met in a timely fashion. Providing
patients with an electronic copy of their health information demonstrates one of the many
benefits health information technology can provide. We also believe that certified EHR
technology will provide EPs, eligible hospitals, and CAHs more efficient means of providing
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copies of health information to patients, which is why we proposed that a request for an
electronic copy be provided to the patient within 48 hours.
In the final rule, we further point out that this objective is limited to health information
maintained and provided electronically while HIPAA can require the retrieval, copying and
mailing of paper documents. For this reason, we do not believe the timeframes under this
meaningful use objective and the HIPAA Privacy Rule must be aligned. However, we appreciate
that the 48-hour timeframe may be burdensome for some providers, particularly for those
providers who do not operate 24/7. We therefore are lengthening the timeframe to three
business days. Business days are defined as Monday through Friday excluding federal or state
holidays on which the EP, eligible hospital, or CAH or their respective administrative staffs are
unavailable. As an example if a patient made a request for an electronic copy of their health
information on Monday then the EP, eligible hospital, or CAH would have until the same time
on Thursday to provide the information assuming there were no intervening holidays. If
provision of the copy involves the mailing of physical electronic media, then it would need to be
mailed on the Thursday.
Comment: Some commenters believed the 80 percent threshold was too high or
introduced examples of extraordinary circumstances such as natural disasters or system crashes
that would indicate a lower threshold is needed to accommodate them.
Response: We reduce the threshold to over 50 percent as this objective meets the criteria
of relying solely on a capability included as part of certified EHR technology and is not, for
purposes of Stage 1 criteria, reliant on the electronic exchange of information, as explained under
our discussion of the objective of maintain an up-to-date problem list. As this is a relatively new
capability that was not available to either providers or patients before the introduction of EHRs,
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we do not believe it meets the same standard of practice as maintaining an up-to-date problem
list and therefore adopt a threshold of 50 percent (rather than 80 percent).
Comment: We received comments that were concerned about the reporting burden of
this requirement.
Response: We believe that as long as the request by the patient is accurately recorded in
the certified EHR technology then the certified EHR technology should be able to calculate the
measure. Recording patient requests for certain actions should be part of the expectations of
meaningful use of certified EHR technology. If the EP, eligible hospital, or CAH records the
requests using certified EHR technology, certified EHR technology will be able to assist in
calculating both the numerator and denominator. If the requests are recorded by another means at
the choice of the provider, the provider would be responsible for determining the denominator.
Comment: Commenters inquired if third-party requests for information are included in
the denominator.
Response: Only specific third party requests for information are included in the
denominator. As we stated in the opening discussion for this health care priority, providing the
copy to a family member or patient’s authorized representative consistent with federal and state
law may substitute for a disclosure of the information to the patient and count in the numerator.
A request from the same would count in the denominator. All other third party requests are not
included in the numerator or the denominator.
Comment: Commenters inquired if asking the patient to register for their own personal
health record (PHR) satisfies the intent of the objective.
Response: EPs, eligible hospitals and CAHs are to provide the information pursuant to
the reasonable accommodations for patient preference under 45 CFR164.522(b). To be included
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in this measure, the patient has already requested an electronic method. While having a third
party PHR certainly would be one method, assuming the provider could populate the PHR with
all the information required to meet this objective. The provider should provide the same level
of assistance to the patient that would be provided as if they maintained their own patient portal.
Comments: Comments were received requesting the format and media for the provision
of the health information.
Response: As this is for use by the patient, the form and format should be human
readable and comply with the HIPAA Privacy Rule, as specified at 45 CFR 164.524(c). In
addition, efforts should be made to make it easily understandable to the patient. The media
could be any electronic form such as patient portal, PHR, CD, USB fob, etc. As stated in the
previous response, EPs, eligible hospitals and CAHs are expected to make reasonable
accommodations for patient preference as outlined in 45 CFR 164.522(b).
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(12)(i) and for eligible hospitals at §495.6(f)(11)(i) of our
regulations to “More than 50 percent of all patients of the EP or the inpatient or emergency
departments of the eligible hospital or CAH (POS 21 or 23) who request an electronic copy of
their health information are provided it within 3 business days”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(f) for EPs and 45 CFR 170.306 (d) for eligible hospitals and
CAHs. The ability to calculate the measure is included in certified EHR technology.
As the provision of the electronic copy is limited to the information contained within
certified EHR technology, this measure is by definition limited to patients whose records are
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maintained using certified EHR technology as described previously in this section under our
discussion of the burden created by the measures associated with the Stage 1 meaningful use
objectives.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: The number of patients of the EP or eligible hospital’s or CAH’s inpatient
or emergency departments (POS 21 or 23) who request an electronic copy of their electronic
health information four business days prior to the end of the EHR reporting period.
•
Numerator: The number of patients in the denominator who receive an electronic copy of
their electronic health information within three business days.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this measure. As addressed in other objectives and in comment
response, if the EP, eligible hospital, or CAH has no requests from patients or their agents for an
electronic copy of patient health information during the EHR reporting period they would be
excluded from this requirement as described previously in this section under our discussion of
whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives
given established scopes of practices.
NPRM Eligible Hospital Objective: Provide patients with an electronic copy of their discharge
instructions and procedures at time of discharge, upon request.
The purpose of this objective is to provide the option to patients to receive their discharge
instructions electronically. Discharge instructions would not necessarily be included in a copy of
health information and it is unlikely that a patient would request a copy of their health
information at every discharge. This objective is unique to eligible hospitals and CAHs.
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Comment: We received several comments suggesting that we eliminate or clarify the
term “procedures”.
Response: As we believe the terms "instructions" and "procedures" are interchangeable
as used in this objective, we are removing the term “procedures” from the objective. We left this
term in the provision of electronic copy of health information as the term “instructions” is not in
that objective. We clarify that the term “instructions” means any directions that the patient must
follow after discharge to attend to any residual conditions that need to be addressed personally
by the patient, home care attendants, and other clinicians on an outpatient basis.
Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed
healthcare professionals to withhold certain information if its disclosure would cause substantial
harm to the patient or another individual.
Response: We reiterate that it is not our intent for the meaningful use objectives to
conflict or override the HIPAA Privacy Rule through meaningful use requirements. Therefore
an EP, eligible hospital, or CAH may withhold information from the electronic copy to the extent
they are permitted or required to do so in accordance with the regulations at 45 CFR 164.524.
Comment: Some commenters recommended that hospitals should be required to either
provide every patient an electronic copy of their discharge instructions or at least inform them of
the option to receive it electronically.
Response: We believe it would be too burdensome to provide every patient an electronic
copy of his or her discharge instructions. Furthermore, we anticipate that many, if not most,
patients will prefer a paper copy during the years of Stage 1. While we certainly encourage
eligible hospitals to inform their patients of the option to receive their discharge instructions
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electronically, we do not see requiring this as within the scope of meaningful use of certified
EHR technology for Stage 1.
Comment: Comments were received requesting a clarification of the data that should be
included in the discharge instructions.
Response: This objective simply refers to the option of the electronic provision of
instructions that would be provided to the patient. We believe eligible hospitals are the
appropriate entity to determine the information that should be included in the discharge
instructions.
Comment: Comments were received requesting the format and media for the discharge
instructions.
Response: As this is for use by the patient, the form and format should be human
readable and comply with the HIPAA Privacy Rule, as specified at 45 CFR 164.524(c). In
addition, efforts should be made to make it easily understandable to the patient. The media could
be any electronic form such as patient portal, PHR, CD, USB fob, etc. EPs, eligible hospitals and
CAHs are expected to make reasonable accommodations for patient preference as outlined in 45
CFR 164.522(b).
After consideration of the public comments received, we are finalizing the objective at
495.6(f)(12)(i) of our regulations as proposed.
We include this objective in the core set as it is integral to involving patients and their
families in their provision of care and was recommended by the HIT Policy Committee for
inclusion in the core set.
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NPRM Eligible Hospital Measure: At least 80 percent of all patients who are discharged from
an eligible hospital and who request an electronic copy of their discharge instructions and
procedures are provided it.
Comment: Some commenters believed the 80 percent threshold was too high or
introduced examples of extraordinary circumstances that would indicate that a lower threshold is
needed to accommodate them.
Response: We reduce the threshold to over 50 percent as this objective meets the criteria
of relying solely on a capability included as part of certified EHR technology and is not, for
purposes of Stage 1 criteria, reliant on the electronic exchange of information. However, as this
is a relatively new capability that was not available to either providers or patients before the
introduction of EHRs we do not believe it meets the same standard of practice as maintaining an
up-to-date problem list and therefore adopt a threshold of50 percent (rather than 80 percent).
Comment: Some commenters expressed concern about the reporting burden imposed by
this requirement.
Response: We believe that as long as the request by the patient is accurately recorded in
the certified EHR technology then the certified EHR technology should be able to calculate the
measure. We believe that recording patient requests for certain actions that involve the use of
certified EHR technology should be part of EPs, eligible hospitals and CAHs standard practice.
If the eligible hospital or CAH records the requests using certified EHR technology, certified
EHR technology will be able to assist in calculating both the numerator and denominator. If the
requests are recorded by another means at the choice of the provider, the provider would be
responsible for determining the denominator.
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Comment: Several of the comments requested clarification of the timeframe in which the
discharge instructions should be provided to the patient.
Response: As discussed previously, this objective simply refers to the option of the
electronic provision of instructions that would be provided to the patient at the time of discharge.
Therefore, we believe for the information to be useful to the patient, the instructions themselves
or instructions on how to access them electronically should be furnished at the time of discharge
from the eligible hospital or CAH.
Comment: Some comments expressed concern that providing an electronic copy of
discharge instructions to the patient at the time of discharge would disrupt workflows and
lengthen the discharge process resulting in reduced bed turnover in emergency departments.
Response: As discussed previously, this objective simply refers to the option of the
electronic provision of instructions that would be provided to the patient at the time of discharge.
We do not believe the provision of an electronic copy of the discharge instructions, upon request,
at the time of discharge alters current workflow or lengthens the discharge process. A patient
could be provided instructions on how to access an internet website where they can get the
instructions or asked to provide an email address or simply be handed electronic media instead of
or in addition to a paper copy.
After consideration of the public comments received, we are modifying the meaningful
use measure at §495.6(f)(12)(ii) of our regulations to “More than 50 percent of all patients who
are discharged1 from an eligible hospital’s or CAH’s inpatient or emergency department (POS 21
or 23) and who request an electronic copy of their discharge instructions are provided it”.
1
Please note that although the final rule meaningful use measures refer to patients discharged from an emergency
department, such emergency room releases are not eligible hospital discharges for purpose of determining hospital
payment incentives under section 1886(n) of the Act. Section 1886(n) payments are only with respect to “inpatient”
hospital services pursuant to section 1886(n)(1)(A) of the Act.
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We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.306(e). The ability to calculate the measure is included in certified EHR
technology.
As with the previous objective, the provision of the electronic copy of the discharge
summary is limited to the information contained within certified EHR technology; therefore this
measure is by definition limited to patients whose records are maintained using certified EHR
technology as described previously in this section under our discussion of the burden created by
the measures associated with the Stage 1 meaningful use objectives.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of patients discharged from an eligible hospital’s or CAH’s inpatient
or emergency department (POS 21 or 23) who request an electronic copy of their discharge
instructions and procedures during the EHR reporting period.
•
Numerator: The number of patients in the denominator who are provided an electronic copy
of discharge instructions.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP, eligible
hospital, or CAH to meet this measure.
As addressed in other objectives and in comment response, if the eligible hospital or CAH has no
requests from patients or their agents for an electronic copy during the EHR reporting period
they would be excluded from this requirement as described previously in this section under our
discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use
objectives given established scopes of practices..
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NPRM EP Objective: Provide patients with timely electronic access to their health information
(including lab results, problem list, medication lists, and allergies) within 96 hours of the
information being available to the EP.
In the proposed rule, we described timely as within 96 hours of the information being
available to the EP through either the receipt of final lab results or a patient interaction that
updates the EP's knowledge of the patient's health. We said we judged 96 hours to be a
reasonable amount of time to ensure that certified EHR technology is up to date and welcomed
comment on if a shorter or longer time is advantageous. We did receive comments on the time
frame and have revised it as discussed below in the comment and response section.
Comment: We received comments recommending that “access” be clarified to determine
whether this is online access as indicated in the ONC certification criteria for certified EHR
technology or just electronic access.
Response: We believe we inadvertently created confusion by listing the examples of
electronic media (CD or USB drive) in which this access could be provided. As many
commenters inferred, it was our intention that this be information that the patient could access on
demand such as through a patient portal or PHR. We did not intend for this to be another
objective for providing an electronic copy of health information upon request.
Comment: Several commenters requested that all objectives included in the health care
policy priority “engage patients and their families” be combined, as they are redundant.
Response: We disagree that they are redundant and believe each serves a unique
purpose. We regret any confusion created by the inclusion of CD or USB drive as examples of
electronic media caused in the intent of this measure. The difference between electronic access
and an electronic copy is that a patient with electronic access can access the information on
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demand at anytime while a patient must affirmatively request an electronic copy from the EP,
eligible hospital or CAH at a specific time and the information in the copy is current only as of
the time that the copy is transferred from the provider to the patient.
Comment: Some commenters asserted that some results and other sensitive information
are best communicated at a face-to-face encounter.
Response: We agree that there may be situations where a provider may decide that
electronic access of a portal or Personal Health Record is not the best forum to communicate
results. Within the confines of laws governing patient access to their medical records, we would
defer to EP’s, eligible hospital or CAH’s judgment as to whether to hold information back in
anticipation of an actual encounter between the provider and the patient. Furthermore just as in
the provision of electronic copy, an EP may withhold information from being accessible
electronically by the patient in accordance with regulations at 45 CFR 164.524. Any such
withholding would not affect the EP’s, eligible hospital’s or CAH’s ability to meet this objective
as that information would not be included. We do not believe there would be a circumstance
where all information about an encounter would be withheld from the patient and therefore no
information would be eligible for uploading for electronic access. If nothing else, the
information that the encounter occurred can be provided. Please note that providers must
comply with all applicable requirements under the HIPAA Privacy Rule, including 45 CFR
164.524.
Comment: We received several comments stating that the time frame of 96 hours is too
burdensome for EPs.
Response: While we believe that 96 hours is sufficient, most EPs do not operate 24/7.
Therefore, we will limit the timeframe to business days, in effect changing the timeframe from
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96 hours in the proposed rule to four business days. Business days are defined as Monday
through Friday excluding federal or state holidays on which the EP, eligible hospital or CAH or
their respective administrative staffs are unavailable.
Comment: Commenters pointed out that allergies is inconsistent with other objectives of
Stage 1 and with the capabilities mandated by certification under the ONC final rule.
Response: As we have stated on several other objectives, we encourage all EPs, eligible
hospitals, and CAHs to work with their EHR technology designers to make capabilities as
relevant to their individual practices of care as possible. However, we maintain that at a
minimum the capabilities that are part of certification should be included in certified EHR
technology so we do modify this objective to medication allergies to align it with other
objectives and certification.
After consideration of the public comments received, we are modifying the objective for
EPs at §495.6(d)(6)(i) of our regulations to “Provide patients with timely electronic access to
their health information (including lab results, problem list, medication lists, medication
allergies) within four business days of the information being available to the EP”.
NPRM EP Measure: At least 10 percent of all unique patients seen by the EP are provided
timely electronic access to their health information.
In the proposed rule, we said that we recognize that many patients may not have internet
access, may not be able or interested to use a patient portal. Health systems that have actively
promoted such technologies have been able to achieve active use by over 30 percent of their
patients, but this may not be realistic for many practices in the short term. We received
comments on this justification for the threshold and requests for clarification, which are
addressed in the comment and response section below.
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Comment: Some commenters expressed concern about the calculation of the percentage
and expressed the preference to use an absolute count instead of a percentage.
Response: We acknowledge there are unique concerns about calculating this percentage
as it involves determining the timeliness of the information. Certified EHR technology would be
able to ascertain the time from when the information was entered into its system to when the
information was available for electronic access. As certified EHR technology can provide the
access, any perceivable delay or requirement for affirmative action would be built in by the user
to allow for review of the information before posting. Certified EHR technology could not be
distinguish the difference in time when the information was available to the provider and when it
was entered into certified EHR technology. However, we see no reasonable way to track this
time frame that does not impose a heavy burden on the EP. Therefore, for the measure, we
define the four business days time frame as the time frame when the information is updated in
the certified EHR technology to when it is available electronically to the patient, unless the
provider indicates that the information should be withheld. It is acceptable for a provider to set
an automated withhold on certain information at their discretion. As we have discussed
previously in this section, we do not believe absolute counts are an adequate substitute for
percentage calculations.
Comment: We received comments requesting clarification on what data must be made
available.
Response: Certified EHR technology must be able to make certain data available
according to the ONC final rule. At a minimum, the data specified in the ONC final rule at 45
CFR 170.304(g) must be available subject to the ability of the provider to withhold it discussed
previously.
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Comment: Commenters suggested that some EPs might not have 10 percent of their
patient population who desire or could utilize such access.
Response: We agree that this is a possibility. We stated in the proposed rule that “we
recognize that many patients may not have internet access, may not be able or interested in the
use of a patient portal.” Health systems that have actively promoted such technologies have been
able to achieve active use by over 30 percent of their patients. However, this 30 percent
threshold may not be realistic for many practices in the short term and therefore serves
justification for the 10 percent threshold. However, the objective and measure focus on the
availability of the access and the timeliness of the data in it, not its utilization. Therefore, we
focus on the fact that more than 10 percent of unique patients seen during the EHR reporting
period could access it and that the information is timely. The EP is not responsible for ensuring
that 10 percent request access or have the means to access. However, we encourage EPs to make
the availability of electronic access known to their patients.
Comment: A commenter inquired about the provider’s liability versus the EHR
technology vendor for a security breach of the system.
Response: Depending on the facts surround the security breach, the provider may be
liable for a violation under the HIPAA Privacy and Security Rules, as well as under any other
applicable federal or state laws. Additionally, there may be circumstances where the EHR
technology vendor acted as a business associate and may potentially have liability under the
HIPAA Privacy and Security Rules. The issue of business associate liability under the HIPAA
Privacy and Security Rules will be addressed in upcoming rulemaking.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(6)(ii) of our regulations to “At least 10 percent of all unique
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patients seen by the EP are provided timely (available to the patient within four business days of
being updated in the certified EHR technology) electronic access to their health information
subject to the EP’s discretion to withhold certain information”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(g). The ability to calculate the measure is included in certified
EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP during the EHR reporting period.
A unique patient is discussed under the objective of CPOE.
•
Numerator: The number of patients in the denominator who have timely (available to the
patient within four business days of being updated in the certified EHR technology)
electronic access to their health information online.
•
Threshold: The resulting percentage must be at least 10 percent in order for an EP to meet
this measure.
As addressed in other objectives and in comment response, if an EP neither orders nor creates
any of the information listed in the ONC final rule 45 CFR 170.304(g) and therefore included in
the minimum data for this objective during the EHR reporting period they would be excluded
from this requirement as described previously in this section under our discussion of whether
certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given
established scopes of practices.
NPRM EP Objective: Provide clinical summaries for patients for each office visit.
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In the proposed rule, we discussed why we were basing the objective on office visits
rather than encounters. We said that we did want encounter to be construed to mean every time a
provider interacts with the patient. We received comments requesting that we further define
office visit and address those in the comment and response section below. In discussing the
measure in the proposed rule, we also said that the clinical summary can be provided through a
PHR, patient portal on the web site, secure email, electronic media such as CD or USB fob, or
printed copy. The after-visit clinical summary contains an updated medication list, laboratory
and other diagnostic test orders, procedures and other instructions based on clinical discussions
that took place during the office visit.
Comment: We received requests for clarification as to what constitutes an “office visit”.
Response: An office visit is defined as any billable visit that includes: 1) Concurrent care
or transfer of care visits, 2) Consultant visits and 3) Prolonged Physician Service without Direct
(Face-To-Face) Patient Contact (tele-health). A consultant visit occurs when a provider is asked
to render an expert opinion/service for a specific condition or problem by a referring provider.
Comment: Some commenters believed the requirement for the provision of a clinical
summary at an office visit should be linked to the type or purpose of the office visit. Samples of
the suggested visits are-Ͳ
Level 4 or level 5 evaluation and management services;
Ͳ
Visits conducted at the conclusion of an episode of care;
Ͳ
Visits conducted at each transition of care;
Ͳ
Visits relevant to specific conditions such as asthma; and
Ͳ
Provider to patient face-to-face visits.
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Response: We believe that a clinical summary should be provided at all office visits
included in the definition of office visit as defined in this final rule. We believe all of the office
visits described in our definition result in the EP rendering a clinical judgment that should be
communicated to the patient.
Comment: Commenters requested CMS define “clinical summary” and offered several
specific data elements that should be included in the definition such as patient name, provider
name, date of visit, location of visit, reason for visit, updated medication list, laboratory orders,
diagnostic orders, patient instructions based on discussions with the provider and a nutrition care
management plan.
Response: After reviewing the comments we define clinical summary as an after-visit
summary that provides a patient with relevant and actionable information and instructions
containing, but not limited to, the patient name, provider’s office contact information, date and
location of visit, an updated medication list and summary of current medications, updated vitals,
reason(s) for visit, procedures and other instructions based on clinical discussions that took place
during the office visit, any updates to a problem list, immunizations or medications administered
during visit, summary of topics covered/considered during visit, time and location of next
appointment/testing if scheduled, or a recommended appointment time if not scheduled, list of
other appointments and testing patient needs to schedule with contact information, recommended
patient decision aids, laboratory and other diagnostic test orders, test/laboratory results (if
received before 24 hours after visit), and symptoms.
Comment: Commenters pointed out that the HIPAA Privacy Rule permits licensed
healthcare professionals to withhold certain information if its disclosure would cause substantial
harm to the patient or another individual.
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Response: As the EP is proactively providing this information to the patient,
45 CFR 164.524 of the HIPAA Privacy rule does not apply to this situation. However, we still
believe that an EP should be able to withhold information if its disclosure would cause
substantial harm to the patient or another individual. Therefore, if in their judgment substantial
harm may arise from the disclosure of particular information, an EP may choose to withhold that
particular information from the clinical summary
Comment: Most commenters noted that other than "at the time of the visit", there was no
specific time period given in which to comply with this objective. If CMS intended "at the time
of the visit" to mean before the patient leaves the building or upon the patient's request, neither
are possible due to workflow and review processes. Most commenters assumed we would
associate the 48 hours related to the 'copy' requirement or the 96 hours related to the 'access'
requirement to address this comment and stated that both were too short a period for a clinical
visit summary. Others recommended the 30-day timeframe for the provision information set
forth under the HIPAA Privacy Rule.
Response: We agree that our proposed objective lacked specificity about the time to
comply. To provide such specificity, we adopt the timeframe of three business days from our
objective of providing electronic health information to the patient. That is three business days
following the day of the visit excluding holidays as described in the providing electronic health
information to the patient objective.
Comment: Several commenters requested changes to the media through which this
information could be provided. Differing commenters recommended eliminating the paper
option, while others recommended only the paper option.
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Response: We believe that more options give the EP needed flexibility. The EP could
choose any of the listed means from the proposed rule of PHR, patient portal on a web site,
secure email, electronic media such as CD or USB fob, or printed copy. If the EP chooses an
electronic media, they would be required to provide the patient a paper copy upon request. Both
forms can be and should be produced by certified EHR technology.
Comment: Several commenters indicated that a provider should be allowed to charge a
fee for providing the copy.
Response: As this is a proactive requirement on the part of the EP and not a response to a
request from the patient, we do not believe it is appropriate to charge the patient a fee for this
copy. We note that we give that we give the EP considerable flexibility in the manner in which
the copy is provided including the provision of a paper copy. The only accommodation an EP is
required to make is the provision of a paper copy that can be automatically generated certified
EHR technology. We therefore believe that costs of this will be negligible.
Comment: A number of commenters expressed concern regarding whether the current
available technology could produce a summary of the required information in a standardized
format, the use of clinical nomenclature rather than lay terms and the fact that some providers
use multiple modules to document the care of the patient.
Response: We believe it is appropriate to leave the design of EHR technology systems
and their outputs to the system developers and the EHR technology users. However, we note
that the capability to meet this objective is included in the ONC final rule at 45 CFR 170.304(h)
as a criteria for certified EHR technology and we are confident that vendors will be able to
produce certified EHR technologies.
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After consideration of the public comments received, we are finalizing the objective for
EPs at §495.6(d)(13)(i) of our regulations to as proposed.
We include this objective in the core set as it is integral to involving patients and their
families in their provision of care and was recommended by the HIT Policy Committee for
inclusion in the core set.
NPRM EP Measure: Clinical summaries provided to patients for at least 80 percent of all
office visits.
Comment: Some commenters believed the threshold was too high or should be replaced
with a numerical count or attestation.
Response: We reduce the threshold to over 50 percent as this objective meets the criteria
of relying solely on a capability included as part of certified EHR technology and is not, for
purposes of Stage 1 criteria, reliant on the electronic exchange of information. Also, as this is a
relatively new capability that was not available to either providers or patients before the
introduction of EHRs, we do not believe it meets the same standard of practice as maintaining an
up-to-date problem list and therefore adopt a threshold of 50 percent (rather than 80 percent).
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(13)(ii) of our regulation to “Clinical summaries provided to
patients for more than 50 percent of all office visits within 3 business days”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(h). The ability to calculate the measure is included in certified
EHR technology.
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As with the previous objective, the provision of the clinical summary is limited to the
information contained within certified EHR technology; therefore this measure is by definition
limited to patients whose records are maintained using certified EHR technology as described
previously in this section under our discussion of the burden created by the measures associated
with the Stage 1 meaningful use objectives.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP for an office during the EHR
reporting period. A unique patient is discussed under the objective of using CPOE.
•
Numerator: Number of patients in the denominator who are provided a clinical summary of
their visit within three business days.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
As addressed in other objectives, EPs who have no office visits during the EHR reporting period
would be excluded from this requirement as described previously in this section under our
discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use
objectives given established scopes of practices.
NPRM EP/Eligible Hospital Objective: “Provide access to patient-specific education resources
upon request.”
In the proposed rule, we discussed this objective, but did not propose it. We stated that there was
a paucity of knowledge resources that are integrated with EHR, and that also are widely
available. We also noted that the ability to provide education resources in multiple languages
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might be limited. We stated our intent to further explore the objective in subsequent stages of
meaningful use.
Comment: We received many comments, including comments from both the HIT Policy
Committee and MedPAC, to include this measure in the final rule. These commenters disagreed
with our assertion in the proposed rule that “there is currently a paucity of knowledge resources
that are integrated within EHRs, that are widely available, and that meet these criteria,
particularly in multiple languages.” Specific examples of the availability of knowledge resources
integrated with current EHRs were provided. The HIT Policy Committee amended their
recommendation in their comments on the proposed rule to:
Ͳ
EPs and hospitals should report on the percentage of patients for whom they use the EHR
to suggest patient-specific education resources.
Other recommended language for the objective includes
Ͳ
Provide patients educational information that is specific to their health needs as identified
by information contained in their EHR technology such as diagnoses and demographic
data, and
Ͳ
The original HIT Policy Committee objective of “Provide access to patient-specific
education resources upon request.”
Response: We are convinced by commenters that the availability of education resources
linked to EHRs is more widely available than we had indicated in the proposed rule. Therefore,
for the final rule we will include this objective for the Stage 1 of meaningful use.
We note that the new recommendation of the HIT Policy Committee is a hybrid of a measure and
an objective, whereas in developing the meaningful use criteria we consistently identify both an
objective and associated measure. However, we agree with the HIT Policy Committee and others
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that the objective and associated measure should make clear that the EP, eligible hospital or
CAH should utilize certified EHR technology in a manner where the technology suggests
patient-specific educational resources based on the information stored in the certified EHR
technology. Therefore, we are including a revised version of this objective in the final rule for
Stage 1 of meaningful use.
We also believe it is necessary to state what level of EP, eligible hospital and CAH
discretion is available when deciding whether to provide education resources identified by
certified EHR technology to the patient. Therefore, we include the phrase “if appropriate”,
which allows the EP or the authorized provider in the eligible hospital or CAH final decision on
whether the education resource is useful and relevant to a specific patient.
After consideration of the public comments received, we are including this meaningful
use objective for EPs at §495.6(e)(6)(i) and eligible hospitals and CAHs at §495.6(g)(5)(i) of our
regulations as “Use certified EHR technology to identify patient-specific education resources and
provide those resources to the patient if appropriate”.
NPRM EP/Eligible Hospital Measure: Not applicable
Comment: CMS received a comment requesting an 80 percent threshold of appropriate
patients and/or caregivers receiving patient-specific educational materials. In addition, the HIT
Policy Committee’s revised objective suggests a patient based percentage.
Response: As with the addition of the recording of advance directives, we are able to
relate this measure to one that is based on patients and can be accomplished solely using certified
EHR technology. As this objective requires more than just the recording of information in
certified EHR technology, we adopt a lower threshold of 10 percent.
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After consideration of the public comments received, we are including this meaningful
use measure for EPs at §495.6(e)(6)(ii) and eligible hospitals at §495.6(g)(5)(ii) of our
regulations as “More than 10 percent of all unique patients seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) are provided
patient-specific education resources”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(m). The ability to calculate the measure is included in certified
EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of unique patients seen by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR
reporting period. A unique patient is discussed under the CPOE objective.
•
Numerator: Number of patients in the denominator who are provided patient education
specific resources
•
Threshold: The resulting percentage must be more than 10 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
We do not believe that any EP, eligible hospital, or CAH will not have more than 10 percent of
their patients eligible to receive patient specific education resources and therefore do not believe
an exclusion is necessary for this objective.
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The third health outcomes policy priority identified by the HIT Policy Committee is to
improve care coordination. The HIT Policy Committee recommended the following care goals to
address this priority:
•
Exchange meaningful clinical information among professional health care team.
NPRM EP Objective - Capability to exchange key clinical information (for example, problem
list, medication list, allergies, and diagnostic test results), among providers of care and patient
authorized entities electronically.
NPRM Eligible Hospital Objective - Capability to exchange key clinical information (for
example, discharge summary, procedures, problem list, medication list, allergies, diagnostic test
results), among providers of care and patient authorized entities electronically.
In the proposed rule, we defined the term “diagnostic test results “ as all data needed to
diagnose and treat disease, such as blood tests, microbiology, urinalysis, pathology tests,
radiology, cardiac imaging, nuclear medicine tests, and pulmonary function tests. We maintain
this description for the final rule. We said that when the information was available in a structured
format we expected that it be transferred in a structured format. However, if it was unavailable
in a structured format, that the transmission of unstructured data was permissible. We provide
additional information on structured data in the comment and response section, but maintain for
the final rule the concept that the exchange can be of structured or unstructured data.
Comment: Commenters requested clarification of the term “key clinical information.”
Response: By “clinical information”, we mean all data needed to diagnose and treat
disease, such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac
imaging, nuclear medicine tests, and pulmonary function tests. We leave it to the provider's
clinical judgment as to identifying what clinical information is considered key clinical
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information for purposes of exchanging clinical information about a patient at a particular time
with other providers of care. The examples we provided in the proposed rule and the final rule
below are not intended to be exhaustive. ONC in their final rule provides a minimum set of
information that certified EHR technology must be able to exchange in order to be certified. A
provider’s determination of key clinical information could include some or all of this information
as well as information not included in the ONC final rule at 45 CFR 170.304(i) for EPs and 45
CFR 170.306(f) for eligible hospitals and CAHs.
Comment: Commenters requested clarification of the term “patient authorized entities.”
Response: By “patient authorized entities”, we mean any individual or organization to
which the patient has granted access to their clinical information. Examples would include an
insurance company that covers the patient, an entity facilitating health information exchange
among providers or a personal health record vendor identified by the patient. A patient would
have to affirmatively grant access to these entities.
Comment: Commenters requested clarification of the term “exchange.”
Response: We expect that this information, when exchanged electronically, would be
exchanged in structured electronic format when available (for example, drug and clinical lab
data). However, where the information is available only in unstructured electronic formats (for
example, free text and scanned images), we would allow the exchange of unstructured
information. We believe that the electronic exchange of information is most efficient when it is
exchanged from a provider’s certified EHR technology to another certified EHR technology
either directly or through an entity facilitating health information exchange using structured data
that can be automatically identified by the receiving system and integrated into the receiver’s
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records. However, we know that much information cannot currently be, and may never be,
transmitted in the way we just described.
Comment: Commenters requested clarification of the term “structured data.”
Response: This distinction between structured data and unstructured data applies to all
types of information. We have previously defined structured data in this section. To ensure that
certified EHR technology has a certain level of functionality, ONC at 45 CFR 170.304(i) for EPs
and 45 CFR 170.306(f) for eligible hospitals and CAHs specified certain types of information
that a certified EHR technology must be able to exchange to become certified. ONC also
provided standards to support this exchange. These standards do not preclude a vendor of EHR
technology from enabling its product to exchange additional types of information nor limit the
provider’s discretion (either in exchanging more or less) in deciding what information is key and
should be exchanged about a given patient at a given time.
Comment: Commenters expressed concern that the exchange of key clinical information
via certified EHR systems requires a unique or national patient identifier to ensure accurate
exchange.
Response: While such an identifier could facilitate an exchange, it need only be unique
to the parties involved in the exchange and need not be national in scope, nor is a specific unique
identifier necessary for successful exchanges. Many current health information exchanges have
had success identifying patients by a combination of several elements of information without a
separate independent identifier.
Comment: Commenters pointed out that the general term “allergies” is inconsistent with
other objectives of Stage 1 and with the capabilities mandated by certification under the ONC
final rule, which uses the term “medication allergies”.
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Response: As we have stated on several other objectives, we encourage all EPs, eligible
hospitals, and CAHs to work with their certified EHR technology designers to make capabilities
most relevant to their individual practices of care. However, we have maintained that at a
minimum the capabilities that are part of certification should be included so we modify the
example to change allergies to medication allergies to align it with other objectives and
certification.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(d)(14)(i) of our regulations to “Capability to exchange key
clinical information (for example, problem list, medication list, medication allergies, and
diagnostic test results), among providers of care and patient authorized entities electronically”
and for eligible hospitals and CAHs at §495.6(f)(13)(i) to “Capability to exchange key clinical
information (for example, discharge summary, procedures, problem list, medication list,
medication allergies, diagnostic test results), among providers of care and patient authorized
entities electronically”.
In response to our revised requirements for meeting meaningful use, we included this
objective in the core set. Section 1848 (o)(2)(A)(ii) of the Act specifically includes electronic
exchange of health information in meaningful use for eligible professionals.
NPRM EP/Eligible Hospital Measure - Performed at least one test of certified EHR
technology's capacity to electronically exchange key clinical information.
In the proposed rule, we identified this objective as reliant on the electronic exchange of
information. We said that we are aware that in most areas of the country, the infrastructure
necessary to support such exchange is still being developed. Therefore, for the Stage 1 criteria of
meaningful use we proposed that EPs and eligible hospitals test their ability to send such
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information at least once prior to the end of the EHR reporting period. We proposed that the
testing could occur prior to the beginning of the EHR reporting period. We also said that if
multiple EPs are using the same certified EHR technology in a shared physical setting, the
testing would only have to occur once for a given certified EHR technology, as we do not see
any value to running the same test multiple times just because multiple EPs use the same
certified EHR technology. Finally, we attempted to define an “exchange” as the clinical
information must be sent between different clinical entities with distinct certified EHR
technology and not between organizations that share a certified EHR. We received many
comments requesting further clarification on these concepts and we attempt to provide additional
information in the comment and response section below.
Comment: Commenters expressed concern that the receiving entities are not required to
have the same capabilities as meaningful users of certified EHR technology.
Response: The HITECH Act does not provide us the authority to require any entity
(medical provider or otherwise) to conform to certain standards and criteria unless they seek to
become a meaningful EHR user. The Act also limits the entities that are eligible to become
meaningful EHR users. In developing the associated measure for this objective, we have ensured
that eligible providers will be able to meet this objective as long as there is one other entity with
which they can test their capability. As electronic exchange is not constrained by distance, we
are confident that every provider seeking to test their system will be able to find another entity
with which to conduct such test.
Comment: Commenters asked whether the test needs to be “live” or if it could be a
“simulation.”
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Response: As specified in the proposed rule, this test must involve the actual submission
of information to another provider of care with distinct certified EHR technology or other system
capable of receiving the information.
Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.
Response: While the use of test patient information may increase the risk that the system
will not be testing to its full capability, given the privacy and security concerns surrounding the
transmission of actual patient information we do not require it for the purposes of a test.
Therefore, the use of test information about a fictional patient that would be identical in form to
what would be sent about an actual patient would satisfy this objective.
Comment: Commenters suggested deferring the measure to a later stage due to the lack
of a mature HIE infrastructure and/or to emulate the Health Information and Management
System Society (HIMSS) EMR Adoption Model.
Response: We agree that many areas of the country currently lack the infrastructure to
support the electronic exchange of information. As the goal of this meaningful use objective is
to ensure that certified EHR technology has the capability to electronically exchange key clinical
information, we only require a single test.
After consideration of the public comments received, we are finalizing the meaningful
use measure at §495.6(d)(14)(ii) and §495.6(f)(13)(ii) of our regulations as proposed.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(i) for EPs and 45 CFR 170.306(f) for eligible hospitals and CAHs.
The ability to calculate the measure is included in certified EHR technology. EPs, eligible
hospitals, and CAHs should attempt to identify one other entity with whom to conduct a test of
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the submission of electronic data. This test must include the transfer of either actual or
“dummy” data to the chosen other entity. The testing could occur prior to the beginning of the
EHR reporting period, but must occur prior to the end of the EHR reporting period and every
payment year would require its own, unique test as infrastructure for health information
exchange is expected to mature over time. Therefore, if an eligible hospital or CAH were to
become a meaningful EHR user in 2011 for their first payment year, they would have to conduct
another, unique test to become a meaningful EHR user in 2012 for their second payment year. If
multiple EPs are using the same certified EHR technology in a shared physical setting, the
testing would only have to occur once for a given certified EHR technology, as we do not see
any value to running the same test multiple times just because multiple EPs use the same
certified EHR technology. To be considered an “exchange” for this objective and measure the
clinical information must be sent between different legal entities with distinct certified EHR
technology or other system that can accept the information and not between organizations that
share certified EHR technology. CMS will accept a yes/no attestation to verify all of the above
for EPs, eligible hospitals, and CAHs.
As the measure already accounts for the possibility of a failed test and we are confident
that everyone will be identify an entity with which to conduct a test, we do not believe an
exception is required for EPs, eligible hospitals or CAHs.
NPRM EP/Eligible Hospital Objective: Perform medication reconciliation at relevant
encounters and each transition of care.
In the proposed rule, we described “medication reconciliation” as the process of
identifying the most accurate list of all medications that the patient is taking, including name,
dosage, frequency and route, by comparing the medical record to an external list of medications
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obtained from a patient, hospital or other provider. We maintain this description for the final
rule. We also described “relevant encounter” and “transition of care”; however, as we received
comments requested additional clarification of these terms we address them in the comment and
response section below.
Comment: Several commenters requested that this objective be deferred until it can be
conducted using the exchange of electronic information between certified EHR technology.
Other commenters believed that the process is not one for avoiding medication errors, but a
human workflow process supported by the EHR, and not an automated EHR process.
Response: We certainly look forward to a time when most medication reconciliation
occurs as an automated process within the EHR reconciling information that has been
exchanged. However, it is unlikely that an automated process within the EHR will fully supplant
the medication reconciliation conducted between the provider and the patient. In order for this
automated reconciliation process to occur and be useful, the relevant structured data exchanged
needs to be as accurate as possible. Requiring medication reconciliation as part of meaningful
use in Stage 1 lays the groundwork for future reliable electronic exchange. We therefore do not
believe this objective should be deferred to a later stage.
Comment: Commenters requested additional clarity of the term “relevant encounter.”
Only a few suggestions on such clarity were provided by commenters. Two examples of
commenters’ recommendations are “when a prescription is generated” and “a significant change
in the patient’s condition that resulted in change in medication regimen which could include
significant change in dosing of more than 1 medication, identification of a new medical
condition, decline in functional status or change in advanced directive.”
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Response: We finalize our proposal by defining “relevant encounter” as an encounter
during which the EP, eligible hospital or CAH performs a medication reconciliation due to new
medication or long gaps in time between patient encounters or for other reasons determined
appropriate by the EP, eligible hospital or CAH. Essentially an encounter is relevant if the EP,
eligible hospital, or CAH judges it to be so. This flexibility has implications for the measure that
were not fully considered in the proposed rule. We will discuss those below in connection with
our discussion of the associated measure.
Comment: Commenters requested additional clarity of the term “transition of care.” A
few suggestions were provided by commenters including expanding the description to include all
transfers to different settings within a hospital or revising the definition to “the movement of a
patient from one setting of care (hospital, ambulatory primary care practice, ambulatory,
specialty care practice, long-term care, home health, rehabilitation facility) to another”.
Response: In the proposed rule we clarified “transition of care” as the transfer of a
patient from one clinical setting (inpatient, outpatient, physician office, home health, rehab, longterm care facility, etc) to another or from one EP, eligible hospital, or CAH (as defined by CCN)
to another. We believe that different settings within one hospital using certified EHR technology
would have access to the same information so reconciliation would not be necessary. We modify
our clarification to account for some of the revisions provided. We clarify “transition of care” as
the movement of a patient from one setting of care (hospital, ambulatory primary care practice,
ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to
another. We also clarify that the receiving eligible hospital or EP would conduct the medication
reconciliation.
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Comment: Some commenters requested clarification on which EP, eligible hospital or
CAH would conduct the medication reconciliation. The one to whom the patient is transferred to
or the one who transfers the patient.
Response: When conducting medication reconciliation during a transfer of care, we
believe that it is the EP, eligible hospital or CAH that receives the patient into their care that
should conduct the medication reconciliation. It is for this provider that the information is most
crucial, as they will be making the future clinical judgments regarding the patient. Therefore, we
revise this objective and its associated measure to reflect this clarification.
Comment: Commenters requested a standard list be defined for the process including
prescription and non prescription medications, herbal products, dietary supplements, prescriber,
drug name, regimen and allergies.
Response: We believe the information included in the process of medication
reconciliation is appropriately determined by the provider and patient.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(e)(7)(i) and for eligible hospitals and CAHs at §495.6(g)(6)(i)
of our regulations to “The EP, eligible hospital or CAH who receives a patient from another
setting of care or provider of care or believes an encounter is relevant should perform medication
reconciliation”.
NPRM EP/Eligible Hospital Measure: Perform medication reconciliation for at least 80
percent of relevant encounters and transitions of care.
Comment: Commenters believed it was an unjustifiable burden to record, which
encounters were relevant and which were not given our flexible definition of "relevant
encounter".
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Response: We agree that the inclusion of relevant encounter creates a burden that one
commenter described as “non-value-added work”. We also believe that when the EP, eligible
hospital, or CAH identifies the encounter as relevant, it is unlikely that the EP, eligible hospital,
or CAH would then not carry out the medication reconciliation. For these reasons, we are
removing relevant encounters from the measure for this objective.
Comment: Commenters said the percent measurements should be replaced with a
numerical count or an attestation the objective has been met or the demonstration of the
capability by performing one test of certified EHR technology's capacity to present providers
with patient medication information that supports the reconciliation of medications at time of
admission and discharge. Other commenters stated the proposed 80 percent threshold was too
high.
Response: We are maintaining a percentage for the reasons discussed previously in this
section. However, we do reduce the threshold to over 50 percent as this objective meets the
criteria of relying solely on a capability included as part of certified EHR technology and while
not absolutely reliant on electronic exchange of information, it does involve the exchange of
information between providers and therefore we adopt a threshold of 50 percent (rather than
8 percent).
Comment: Commenters requested we align this objective with The Joint Commission
National Patient Safety Goal on medication reconciliation (Goal 8) in order to decrease
confusion, prevent the slowing of adoption of best practices and match current hospital
reconciliation processes.
Response: CMS understands the commenters’ concerns regarding possible confusion if
the meaningful use medication reconciliation requirement differs from The Joint Commission’s
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requirement for those facilities accredited by that organization. However, currently there is no
finalized Joint Commission standard as the Commission is currently in the process of reevaluating their National Patient Safety Goal 8 (Accurately and completely reconcile
medications across the continuum of care) given the difficulties that many organizations are
having in meeting the complex requirements. In the absence of a definitive Joint Commission
standard to take into consideration, this is not possible.
Comment: Some commenters expressed the desire to expand the scope of the measure to
include the clinical decision making and patient counseling and education by a pharmacist.
Response: We believe that is both beyond the scope of meaningful use as pharmacists
are not eligible professionals for the EHR incentive programs and that the provision of patient
counseling is more aligned with the objectives of clinical quality measures. Information from the
medication reconciliation could be used for the basis of clinical decision support rules, but is not
in and of itself a clinical decision.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(7)(ii) and for eligible hospitals and CAHs at §495.6(g)(6)(ii)
of our regulations to “The EP, eligible hospital or CAH performs medication reconciliation for
more than 50 percent of transitions of care in which they patient is transitioned into the care of
the EP or admitted to the eligible hospital’s or CAH’s inpatient or emergency department (POS
21 or 23)”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(j). The ability to calculate the measure is included in certified
EHR technology.
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As discussed previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, we only include in the
denominator transitions of care related to patients whose records are maintained using certified
EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of transitions of care during the EHR reporting period for which
the EP or eligible hospital’s or CAH’s inpatient or emergency department (POS 21 to 23) was
the receiving party of the transition.
•
Numerator: The number of transitions of care in the denominator where medication
reconciliation was performed.
•
Threshold: The resulting percentage must be more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this measure.
If an EP was not on the receiving end of any transition of care during the EHR reporting period
they would be excluded as previously discussed in this section under our discussion of whether
certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives given
established scopes of practices. We do not believe that any eligible hospital or CAH would be in
a situation where they would not need to know the precise medications their patients are taking.
NPRM EP/Eligible Hospital Objective: Provide summary care record for each transition of
care or referral.
In the proposed rule, we pointed out that this objective was not explicitly included in the
HIT Policy Committee's recommended objectives, but that they did include a measure for the
“percent of transitions in care for which summary care record is shared. We said that we believe
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that in order for a measure to be relevant it must correspond to an objective in the definition of
meaningful use. Therefore, we proposed to add this objective in order to be able to include the
recommended measure. Furthermore, we add referrals because the sharing of the patient care
summary from one provider to another communicates important information that the patient may
not have been able to provide, and can significantly improve the quality and safety of referral
care, and reduce unnecessary and redundant testing. We received support for this inclusion from
commenters and include this objective in the final rule for the reasons outlined in the proposed
rule. We did receive comments requesting clarifications around this objective and address them
in the comment and response section below.
Comment: We received several comments that requested clarification as to the purpose
of this objective.
Response: The purpose of this objective is to ensure a summary of care record is
provided to the receiving provider when a patient is transitioning to a new provider or has been
referred to another provider while still remaining under the care of the referring provider. If the
provider to whom the referral is made or to whom the patient is transitioned to has access to the
medical record maintained by the referring provider then the summary of care record would not
need to be provided. The most common example cited by commenters was a referral during
which patient remains an inpatient of the hospital. Finally, unlike with medication
reconciliation, where the receiving party of the transfer conducts the action, the transferring party
would provide the summary care record to the receiving party.
Comment: Commenters requested additional clarity of the term “transition of care”. A
few suggestions were provided by the commenters including expanding the description to
include all transfers to different settings within a hospital or revising the definition to “the
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movement of a patient from one setting of care (hospital, ambulatory primary care practice,
ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to
another”.
Response: In the proposed rule we clarified that the term transition of care means a
transfer of a patient from one clinical setting (inpatient, outpatient, physician office, home health,
rehab, long-term care facility, etc) to another or from one EP, eligible hospital, or CAH (as
defined by CMS Certification Number (CCN) to another. We believe that different settings
within a hospital using certified EHR technology would have access to the same information so
providing a clinical care summary would not be necessary. We further clarify transition of care
as the movement of a patient from one setting of care (hospital, ambulatory primary care
practice, ambulatory, specialty care practice, long-term care, home health, rehabilitation facility)
to another.
Comment: Some commenters requested clarification on which EP, eligible hospital or
CAH should provide the summary of care document; the one to whom the patient is transferred
or referred or the one who transfers or refers the patient.
Response: We believe that it is the EP, eligible hospital or CAH that transfers or refers
the patient to another setting of care or provider that should provide the summary of care
document. It is for this provider that has the most recent information on the patient that maybe
crucial to the provider to whom the patient is transferred or referred. Therefore, we revise this
objective and its associated measure to reflect this clarification.
Comment: Commenters asked for clarification on how the summary of care record
should be transferred.
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Response: The goal is to get the summary care record into the next provider’s
possession. While we highly encourage all EPs, eligible hospitals, and CAHs to explore ways to
accomplish the transfer using electronic exchange, we realize that this capability is still in the
development stages. Therefore, an EP, eligible hospital, or CAH could send an electronic or
paper copy of the summary care record directly to the next provider or could provide it to the
patient to deliver to the next provider, if the patient can reasonably expected to do so. Certified
EHR technology would be used to generate the summary of care record and to document that it
was provided to the patient or receiving provider.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(e)(8)(i) and for eligible hospitals and CAHs at §495.6(g)(7)(i) of
our regulations to “ The EP, eligible hospital or CAH who transitions their patient to another
setting of care or provider of care or refers their patient to another provider of care should
provide summary care record for each transition of care or referral”.
NPRM EP/Eligible Hospital Measure: Provide summary of care record for at least 80 percent
of transitions of care and referrals.
Comment: Commenters said that this should be replaced with a count and that the
threshold was too high.
Response: We are maintaining a percentage for the reasons discussed previously in this
section. However, we do reduce the threshold to over 50 percent as this objective meets the
criteria of relying solely on a capability included as part of certified EHR technology and while
not absolutely reliant on electronic exchange of information, it does involve the exchange of
information between providers and therefore we adopt a threshold of 50 percent (rather than 80
percent).
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Comment: There were concerns about the ability of certified EHR technology to
calculate this measure. As long as an EP, eligible hospital, or CAH records the order for a
referral or transfer as structured data and a record is made that the summary care record was
provided then certified EHR technology will be able to calculate this measure.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(8)(ii) and for eligible hospitals and CAHs at §495.6(g)(7)(ii)
of our regulations to “The EP, eligible hospital or CAH who transitions or refers their patient to
another setting of care or provider of care provides a summary of care record for more than
50 percent of transitions of care and referrals”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.304(i) for EPs and 45 CFR 170.306(f) for eligible hospitals and CAHs.
The ability to calculate the measure is included in certified EHR technology.
As discussed previously in this section under our discussion of the burden created by the
measures associated with the Stage 1 meaningful use objectives, we only include in the
denominator transitions of care and referrals related to patients whose records that are
maintained using certified EHR technology.
To calculate the percentage, CMS and ONC have worked together to define the following for
this objective:
•
Denominator: Number of transitions of care and referrals during the EHR reporting
period for which the EP or eligible hospital’s or CAH’s inpatient or emergency department (POS
21 to 23) was the transferring or referring provider.
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Numerator: The number of transitions of care and referrals in the denominator where a
summary of care record was provided.
•
Threshold: The percentage must be more than 50 percent in order for an EP, eligible
hospital, or CAH to meet this measure.
As addressed in other objectives and in comment response, if an EP does not transfer a
patient to another setting or refer a patient to another provider during the EHR reporting period
then they would have a situation of a null denominator as described would be excluded from this
requirement as described previously in this section under our discussion of whether certain EP,
eligible hospital or CAH can meet all Stage 1 meaningful use objectives given established scopes
of practices. We do not believe that any eligible hospital or CAH would be in a situation where
they would never transfer a patient to another care setting or make a referral to another provider.
The fourth health outcomes policy priority identified by the HIT Policy Committee is
improving population and public health. The HIT Policy Committee identified the following care
goal to address this priority:
● The patient's health care team communicates with public health agencies
The goal as recommended by the HIT Policy Committee is “communicate with public
health agencies.” In the proposed rule, we explained that we found this goal to be somewhat
ambiguous, as it does not specify who must communicate with public health agencies. We
propose to specify “the patient's health care team” as the individuals who would communicate
with public health agencies.
NPRM EP/Eligible Hospital Objective: Capability to submit electronic data to immunization
registries and actual submission where required and accepted.
In the proposed rule, we did not elaborate on this objective.
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Comment: Some commenters suggested out that not every EP, eligible hospital, or CAH
administers immunization. Therefore, as proposed, this objective and its associated measure
would require an EP, eligible hospital, or CAH to implement and test a capability that they
would not use.
Response: We acknowledge that this objective is not relevant to all EPs, eligible
hospitals or CAHs. Therefore, in this final rule, we clarify that this objective and its associated
measure apply only to EPs, eligible hospitals or CAHs that administer one or more
immunizations during the EHR reporting period.
Comment: Some commenters recommended revising the language of the immunization
objective to be consistent with the language of the syndromic surveillance objective by replacing
“where required and accepted” with “according to applicable law and practice.”
Response: First, we make a technical correction. The objective listed for EPs on page
1858 of the proposed rule listed this objective as “Capability to submit electronic data to
immunization registries and actual submission where possible and accepted.” The objective was
intended to be “Capability to submit electronic data to immunization registries and actual
submission where required and accepted” for EPs, eligible hospitals, and CAHs. It is written as
such in every other instance in the proposed rule including the regulation text. Second, in
response to the comment that “where required and accepted” be replaced with “according to
applicable law and practice”, we see little distinction between the two in terms of requirement as
applicable law and practice would be the things imposing a requirement. Therefore, we adopt
the proposed language, but modify the language slightly to “in accordance with applicable law
and practice”. We do note however, that applicable law and practice do not guarantee every
receiving entity will be able to accept it electronically. Our measure for meeting this objective is
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one test of electronic data submission and if the test is successful follow up submission to that
one entity. We do not seek to enforce through meaningful use every law and practice that may
require submission of immunization data. We also make another consistency change to the
objectives under the health care policy goal of improving population and public health. In this
objective, we describe the capability as submitting electronic data. In the other objectives under
this goal we describe the capability as providing electronic data. We believe that functionally
these terms are interchangeable, but to avoid any confusion we adopt the same term of “submit”
electronic data across all three objectives.
Comment: Some commenters suggested that the term “Immunization Information
Systems (IIS)” has replaced the term “registry” and is referred to as such by the Centers for
Disease Control (CDC).
Response: We modified the objective to account for both terms.
After consideration of the public comments received, we are modifying the meaningful use
objective for EPs at §495.6(e)(9)(i) and for eligible hospitals and CAHs at §495.6(g)(8)(i) of our
regulations to Capability to submit electronic data to immunization registries or Immunization
Information Systems and actual submission in accordance with to applicable law and practice.
NPRM EP/Eligible Hospital Measure: Performed at least one test of certified EHR
technology's capacity to submit electronic data to immunization registries (unless none of the
immunization registries to which the EP, eligible hospital, or CAH submits such information
have the capacity to receive the information electronically).
In the proposed rule, we identified this as an objective where more stringent requirements
may be established for EPs and hospitals under the Medicaid program in states where this
capability exists. This is just one example of a possible State proposed modification to
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meaningful use in the Medicaid EHR incentive program. This ability for the States is also
included in our final rule.
Comment: As with the objective of exchanging key clinical information, some
commenters asked whether the test needs to be “live” or if it could be a “simulation”. Some
commenters suggested that a simulation where the ability was tested without being transmitted to
another party should be sufficient. Others suggested that the test needs to include transmission
or difficulties in actual sending information might not be uncovered.
Response: As specified in the proposed rule, this test must involve the actual submission
of information to a registry or immunization information system, if one exists that will accept the
information.
Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.
Response: While the use of test patient information may increase the risk that the system
will not be testing to its full capability, given the privacy and security concerns surrounding the
transmission of actual patient information we do not require it for the purposes of a test.
Therefore, the use of test information about a fictional patient that would be identical in form to
what would be sent about an actual patient would satisfy this objective. However, we note that
this is one of the objectives that a State may modify in accordance with the discussion in
II.A.2.c. of the proposed rule. Therefore, more stringent requirements may be established for
EPs and eligible hospitals under the Medicaid program in states where this capability exists.
Comment: Commenters expressed concern about the burden of multiple requirements for
submission from federal, state, and local government agencies or non-governmental registries.
They also raised the issue of lack of standardization of means and form of submission.
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Response: Standards for content exchange and vocabulary are established in the ONC
final rule at 45 CFR 170.302(k). As meaningful use seeks to utilize certified EHR technology
for purposes of the test and subsequent submission (if test was successful) these are the standards
that should be utilized. While we encourage all providers and registries to work together to
develop efficient, electronic submission of immunization information to all registries where it
can be used to improve population and public health, for purposes of becoming a meaningful
EHR user, we only require a single test and follow up submission if that test is successful.
Comment: Commenters suggested deferring the measure to a later stage due to the lack
of a mature HIE infrastructure.
Response: We agree that many areas of the country currently lack the infrastructure to
support the electronic exchange of information. As meaningful use seeks to ensure certified
EHR technology has the capability to submit electronic data to registries, we only require a
single test if a receiving entity is available and follow up submission only if that test is
successful. If none of the immunization registries to which the EP, eligible hospital or CAH
submits information has the capacity to receive the information electronically, then this objective
would not apply.
Comment: Commenters requested clarification whether on a failed attempted test
satisfies the criteria of this measure and whether EPs in a group setting using identical certified
EHR technology would only need to conduct a single test, not one test per EP.
Response: A failed attempt would meet the measure. We highly encourage EPs, eligible
hospitals, and CAHs to work with their vendor and the receiving entity with whom they tested to
identify the source of the failure and develop remedies, but for Stage 1 of meaningful use a failed
attempt would meet the requirements. We had indicated in the proposed rule that only one test is
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required for EPs practicing in a group setting that shares the same certified EHR technology. We
maintain that proposal for the final rule.
Comment: Commenters recommended the inclusion of electronically reporting to other
types of registries in addition to immunization registries such as disease-specific registries such
as the Cystic Fibrosis Registry.
Response: While we encourage all providers and registries to work together to develop
efficient, electronic submission of information to all registries where it can be used to improve
population and public health, for purposes of becoming a meaningful EHR user, we only require
a single test utilizing immunization data and follow up submission if that test is successful.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(9)(ii) and for eligible hospitals and CAHs at §495.6(g)(8)(ii)
of our regulations to “Performed at least one test of certified EHR technology's capacity to
submit electronic data to immunization registries and follow up submission if the test is
successful (unless none of the immunization registries to which the EP, eligible hospital, or CAH
submits such information have the capacity to receive the information electronically)”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(k). The ability to calculate the measure is included in certified
EHR technology. We require that an EP, eligible hospital, or CAH determine if they have given
any immunizations during the EHR reporting period. Those that have not given any
immunizations during the EHR reporting period are excluded from this measure according to the
discussion of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use
objectives given established scopes of practices. If they have given immunizations during the
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reporting period, they should then attempt to locate a registry or IIS with whom to conduct a test
of the submission of electronic data. This test must include the transfer of either actual or
“dummy” data to the chosen registry or IIS. The testing could occur prior to the beginning of the
EHR reporting period, but must occur prior to the end of the EHR reporting period. EPs in a
group setting using identical certified EHR technology would only need to conduct a single test,
not one test per EP. If the test is successful, then the EP, eligible hospital, or CAH should
institute regular reporting to that entity in accordance with applicable law and practice. CMS
will accept a yes/no attestation to verify all of the above for EPs, eligible hospitals or CAHs that
have administered immunizations during the EHR reporting period.
NPRM Eligible Hospital Objective: Capability to provide electronic submission of reportable
(as required by state or local law) lab results to public health agencies and actual submission
where it can be received.
In the proposed rule, we did not elaborate on this objective.
Comment: A few commenters requested this objective be applied to EPs as long as the
EHR Certification requirements are met. A commenter remarked that electronic submission of
reportable lab results should not put an additional burden on the providers as the EHR would be
able to automate this process.
Response: We based the limitation on the recommendation of the HIT Policy Committee
who in turn went through a considerable public development process. We do not believe that
burden of reporting was the only limiting factor in keeping this objective from being applied to
EPs; therefore, we maintain our proposal to limit this objective to eligible hospitals and CAHs.
EPs usually send out lab test to other organizations on which reporting burdens may fall.
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Comment: Commenters requested that the actual transmission of the information be
required.
Response: In the discussion of the reporting immunization data objective, we discussed
at length the need to align the language for the three objectives included under the health care
policy priority of improve population and public health, which is one of the five priorities of the
Stage 1 definition of meaningful use. Our interpretation is that the three phrases result in the
same outcome, but introduce confusion due to the varied wordings. As commenters strongly
preferred the phrase “according to applicable law and practice”, we will so modify this objective.
We do note however that applicable law and practice does not guarantee every receiving entity
will be able to accept it electronically. Our measure for meeting this objective is one test of
electronic data submission and if the test is successful, a follow up submission to that one entity.
We do not seek to enforce through meaningful use every law and practice that may require
submission of lab results.
After consideration of the public comments received, we are modifying the meaningful use
objective for eligible hospitals and CAHs at §495.6(g)(9)(i) of our regulations to “Capability to
submit electronic data on reportable (as required by state or local law) lab results to public health
agencies and actual submission in accordance with applicable law and practice”.
NPRM Eligible Hospital Measure: Performed at least one test of certified EHR technology
capacity to provide electronic submission of reportable lab results to public health agencies
(unless none of the public health agencies to which eligible hospital submits such information
have the capacity to receive the information electronically).
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In the proposed rule, we identified this as an objective where more stringent requirements
may be established for eligible hospitals under the Medicaid program in states where this
capability exists. This is just one example of a possible State proposed modification to
Comment: Commenters asked whether the test needs to be “live” or if it could be a
“simulation”.
Response: As specified in the proposed rule, this test must involve the actual submission
of information to a public health agency, if one exists that will accept the information.
Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.
Response: While the use of test patient information may increase the risk that the system
will not be testing to its full capability, given the privacy and security concerns surrounding the
transmission of actual patient information we do not require it for the purposes of a test.
Therefore, the use of test information about a fictional patient that would be identical in form to
what would be sent about an actual patient would satisfy this objective. However, we note that
this is one of the objectives that a State may modify as discussed previously in this section.
Therefore, more stringent requirements may be established for EPs and eligible hospitals under
the Medicaid program in states where this capability exists.
Comment: Commenters requested that one national standard be established for reporting
lab results to public health agencies.
Response: Standards for content exchange and vocabulary are established in the ONC
final rule at 45 CFR 170.306(g). While we encourage all providers and public health agencies to
work together to develop efficient, electronic submission of reportable lab results to all public
health agencies, for purposes of becoming a meaningful EHR user, we only require a single test
and follow up submission if that test is successful.
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Comment: Commenters suggested deferring the measure to a later stage due to the lack
of a mature HIE infrastructure and lack of a clear standard for exchanging bio-surveillance data.
Response: We agree that many areas of the country currently lack the infrastructure to
support the electronic exchange of information. As meaningful use seeks to ensure certified
EHR technology has the capability to submit electronic data to public health agencies, we only
require a single test if a receiving entity is available and follow up submission only if that test is
successful.
After consideration of the public comments received, we are modifying the meaningful
use measure for eligible hospitals and CAHs at §495.6(g)(9)(ii) of our regulations to “Performed
at least one test of certified EHR technology’s capacity to provide electronic submission of
reportable lab results to public health agencies and follow-up submission if the test is successful
(unless none of the public health agencies to which eligible hospital or CAH submits such
information have the capacity to receive the information electronically)”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.306(g). The ability to calculate the measure is included in certified
EHR technology. Eligible hospitals and CAHs should attempt to identify one public health
agency with whom to conduct a test of the submission of electronic data. This test must include
the transfer of either actual or “dummy” data to the chosen public health agency. The testing
could occur prior to the beginning of the EHR reporting period, but must occur prior to the end
of the EHR reporting period. If the test is successful, then the eligible hospital or CAH should
institute regular reporting to that entity according to applicable law and practice. CMS will
accept a yes/no attestation to verify all of the above for eligible hospitals and CAHs.
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NPRM EP/Eligible Hospital Objective: Capability to provide electronic syndromic
surveillance data to public health agencies and actual transmission according to applicable law
and practice.
In the proposed rule, we did not elaborate on this objective.
Comment: Half of the commenters commenting on this objective recommended that the
objective be deferred to Stage 2 or 3 as the objective is considered expensive, complex and
imposes significant administrative burdens on EPs, eligible hospitals and CAHs unless the
certified EHR technologies support the automate, electronic capture of the requisite data.
Response: The measure for this objective accounts for the possibility that such electronic
exchange of syndromic data is not possible. Standards and certification for certified EHR
technologies are covered under the ONC final rule and do support the automatic identification of
the requisite data and its electronic capture. This greatly limits the cost, complexity and burden
of this objective.
Comment: Commenters requested that an actual transmission be required.
Response: In discussing the reporting immunization data objective, we focused on the
need to align the language for the three objectives contained in under the health care policy
priority of improving population and public health. Our interpretation is that the three phrases
result in the same outcome, but introduce confusion with the current language. We adopted the
language from this objective for the others. We do note however that applicable law and practice
does not guarantee every receiving entity will be able to accept it electronically. Our measure
for meeting this objective is one test of electronic data submission and if the test is successful,
then follow up submission to that one entity based on the reporting requirements of that entity.
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We do not seek to enforce through meaningful use every law and practice that may require
submission of lab results.
Comment: Some commenters requested a clarification of the term “public health
agencies.”
Response: A public health agency is an entity under the jurisdiction of the U.S.
Department of Health and Human Services, tribal organization, State level and/or city/county
level administration that serves a public health function.
Comment: Some commenters recommended that providers be required to satisfy either
electronic submission to immunization registries or electronic submission of syndromic
surveillance data to a public health agency, but not both.
Response: We disagree. We believe these are fundamentally different types of
information. Each may impose unique requirements in terms of ability to exchange information
on both the EP, eligible hospital, or CAH and the receiving entity. Therefore, a test for one does
not prove or disprove the ability to exchange information for the other.
After consideration of the public comments received, we are modifying the meaningful
use objective for EPs at §495.6(e)(10)(i) and eligible hospitals and CAHs at §495.6(g)(10(i) of
our regulations to “Capability to submit electronic syndromic surveillance data to public health
agencies and actual submission in accordance with applicable law and practice.”
NPRM EP/Eligible Hospital Measure: Performed at least one test of certified EHR
technology's capacity to provide electronic syndromic surveillance data to public health agencies
(unless none of the public health agencies to which an EP, eligible hospital, or CAH submits
such information have the capacity to receive the information electronically).
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In the proposed rule, we identified this as an objective where more stringent requirements
may be established for EPs and hospitals under the Medicaid program in states where this
capability exists. This is just one example of a possible State proposed modification to
meaningful use.
First, a technical correction, in the proposed rule we incorrectly stated that the capability
to send electronic data to immunization registries was included in the certification standards for
certified EHR technology. We intended for this data to be sent to public health agencies and
ONC in their final rule at 45 CFR 170.304(l) correctly stated this capability as such.
Comment: Commenters asked whether the test needs to be “live” or if it could be a
“simulation”.
Response: As specified in the proposed rule, this test must involve the actual submission
of information to a public health agency, if one exists that will accept the information.
Comment: Commenters asked whether the use of “test” or “dummy” data is permissible.
Response: While the use of test patient information may increase the risk that the system
will not be testing to its full capability, given the privacy and security concerns surrounding the
transmission of actual patient information we do not require it for the purposes of a test.
Therefore, the use of test information about a fictional patient that would be identical in form to
what would be sent about an actual patient would satisfy this objective. However, we note that
this is one of the objectives that a State may modify in accordance with the discussion in
II.A.2.c. of the proposed rule. Therefore, more stringent requirements may be established for
EPs and eligible hospitals under the Medicaid program in states where this capability exists.
Comment: A few commenters expressed confusion as to the required frequency of the
test.
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Response: As stated in the proposed rule, the required frequency of a test in Stage 1 for
EPs, eligible hospitals, and CAHs is at least once prior to the end of the EHR reporting period.
We further clarify that each payment year would require it own unique test.
Comment: Commenters requested that one national standard be established for reporting
syndromic surveillance data to public health agencies.
Response: Standards for content exchange and vocabulary are established in the ONC
final rule. While we encourage all providers and public health agencies to work together to
develop efficient, electronic submission of syndromic surveillance data to all public health
agencies, for purposes of becoming a meaningful EHR user, we only require a single test and
follow up submission if that test is successful.
Comment: Commenters suggested deferring the measure to a later stage due to the lack
of a mature HIE infrastructure.
Response: We agree that many areas of the country currently lack the infrastructure to
support the electronic exchange of information. As meaningful use seeks to ensure certified
EHR technology has the capability to submit electronic data to public entities, we only require a
single test if a receiving entity is available and follow up submission only if that test is
successful. We note that this measure only applies if there is a public health agency with the
capacity to receive this information.
Comment: Commenters requested clarification on whether a failed attempted test
satisfies the measure and whether EPs in a group setting using identical certified EHR
technology would only need to conduct a single test, not one test per EP.
Response: A failed attempt would meet the measure. We highly encourage EPs, eligible
hospitals, and CAHs to work with their vendor and the receiving entity with whom they tested to
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identify the source of the failure and develop remedies, but for Stage 1 of meaningful use a failed
attempt would meet the requirements. We had indicated in the proposed rule that only on test is
required for EPs practicing in a group setting that shares the same certified EHR technology. We
maintain that proposal for the final rule.
After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(e)(10)(ii) and eligible hospitals and CAHs at §495.6(g)(10)(ii) of
our regulations to “Performed at least one test of certified EHR technology's capacity to provide
electronic syndromic surveillance data to public health agencies and follow-up submission if the
test is successful (unless none of the public health agencies to which an EP, eligible hospital, or
CAH submits such information have the capacity to receive the information electronically)”.
We further specify that in order to meet this objective and measure, an EP, eligible
hospital, or CAH must use the capabilities Certified EHR Technology includes as specified and
standards at 45 CFR 170.302(l). The ability to calculate the measure is included in certified EHR
technology. EPs, eligible hospitals, and CAHs should attempt to identify one public health
agency with whom to conduct a test of the submission of electronic data. This test must include
the transfer of either actual or “dummy” data to the chosen public health agency. The testing
could occur prior to the beginning of the EHR reporting period, but must occur prior to the end
of the EHR reporting period. If the test is successful, then the EP, eligible hospital, or CAH
should institute regular reporting to that entity according to applicable law and practice. CMS
will accept a yes/no attestation to verify all of the above for eligible hospitals and CAHs.
If an EP does not collect any reportable syndromic information on their patients during
the EHR reporting period, then they are excluded from this measure according to the discussion
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of whether certain EP, eligible hospital or CAH can meet all Stage 1 meaningful use objectives
given established scopes of practices.
The fifth health outcomes policy priority is to ensure adequate privacy and security
protections for personal health information. The following care goals for meaningful use address
this priority:
● Ensure privacy and security protections for confidential information through operating
policies, procedures, and technologies and compliance with applicable law
● Provide transparency of data sharing to patient
NPRM EP/Eligible Hospital Objective: Protect electronic health information created or
maintained by the certified EHR technology through the implementation of appropriate technical
capabilities.
In the proposed rule, we discussed how we were relating the objectives presented by the
HIT Policy committee more tightly to the meaningful use of certified EHR technology as
opposed to the broader success of the EP, eligible hospital or CAH in ensuring privacy and
security. The primary reason we gave was that the proper vehicle for ensuring privacy and
security is the HIPAA Privacy and Security Act and that we sought with this objective to ensure
that certified EHR technology does not impede an EP’s, eligible hospital’s or CAH’s ability to
comply with HIPAA.
Comment: We received considerable support from many commenters who supported this
objective and measure as proposed.
Response: We appreciate the support of these commenters for our proposed objective
and measure.
Comment: Commenters requested clarification of appropriate technical capabilities.
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Response: The ONC final rule specifies certain capabilities that must be in certified EHR
technology. For the objective we simply mean that a technical capability would be appropriate if
it protected the electronic health information created or maintained by the certified EHR
technology. All of these capabilities could be part of the certified EHR technology or outside
systems and programs that support the privacy and security of certified EHR technology. We
could not develop an exhaustive list. Furthermore as we state in the proposed rule compliance
with HIPAA privacy and security rules is required for all covered entities, regardless of whether
or not they participate in the EHR incentive programs. Furthermore, compliance with the
HIPAA Privacy and Security Rules constitutes a wide range of activities, procedures and
infrastructure. We rephrased the objective to ensure that meaningful use of the certified EHR
technology supports compliance with the HIPAA Privacy and Security Rules and compliance
with fair sharing data practices outlined in the Nationwide Privacy and Security Framework
(http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848088_0_0_18/Nationwid
ePS_Framework-5.pdf), but do not believe meaningful use of certified EHR technology is the
appropriate regulatory tool to ensure such compliance with the HIPAA Privacy and Security
Rules.
Comment: Several commenters urged CMS not to finalized requirements for the fair data
sharing practices set forth in the Nationwide Privacy and Security Framework and to clarify the
policies to which CMS is referring.
Response: While we stated in the proposed rule we rephrased the objective to ensure
“compliance with fair sharing data practices outline in the Nationwide Privacy and Security
Framework,” we did not propose any practices or policies related to the Nationwide Privacy and
Security Framework and do not finalize any in this final rule.
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Comment: Several commenters requested the elimination of this objective as redundant
to HIPAA.
Response: We do not see meaningful use as an appropriate regulatory tool to impose
different, additional, and/or inconsistent privacy and security policy requirements from those
policies already required by HIPAA. With that said, we do feel it is crucial that EPs, eligible
hospitals, and CAHs evaluate the impact certified EHR technology has on their compliance with
HIPAA and the protection of health information in general. Therefore, we retain this objective
and measure for meaningful use in the final rule.
Comment: We received hundreds of comments that requested the cancelation of the
EHR incentive payment program due to the privacy and security risks imposed by the
implementation and use of certified EHR technology.
Response: We are required by the ARRA to implement the EHR incentive programs and
cannot cancel them. We seek to mitigate the risks to the security and privacy of patient
information by requiring EPs, eligible hospitals, and CAHs to conduct or review a security risk
analysis in accordance with the requirements under 45 CFR 164.308 (a)(1) and implement
security updates as necessary.
After consideration of the public comments received, we are finalizing the meaningful use
objective for EPs at §495.6(d)(15)(i) and eligible hospitals and CAHs at §495.6(f)(14)(i) of our
regulations as proposed.
We include this objective in the core set. We believe maintaining privacy and security is
crucial for every EP, eligible hospital or CAH that uses certified EHR technology and was
recommended by the HIT Policy Committee for inclusion in the core set.
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NPRM EP/Eligible Hospital Measure: Conduct or review a security risk analysis in accordance
with the requirements under 45 CFR 164.308 (a)(1) and implement security updates as
necessary.
In the proposed rule, we discussed the role of certified EHR technology in privacy and
security. We said that while certified EHR technology provides tools for protecting health
information, it is not a full protection solution. Processes and possibly tools outside the scope of
certified EHR technology are required. Therefore, for the Stage 1 criteria of meaningful use we
propose that EPs and eligible hospitals conduct or review a security risk analysis of certified
EHR technology and implement updates as necessary at least once prior to the end of the EHR
reporting period and attest to that conduct or review. The testing could occur prior to the
beginning of the EHR reporting period. This is to ensure that the certified EHR technology is
playing its role in the overall strategy of the EP or eligible hospital in protecting health
information. We have maintained this discussion for the final rule, but modified the measure to
account for requests discussed in the comment and response section below.
Comment: Some commenters requested clarification of the phrase “implement security
updates as necessary”.
Response: A security update would be required if any security deficiencies were
identified during the risk analysis. A security update could be updated software for certified
EHR technology to be implemented as soon as available, to changes in workflow processes, or
storage methods or any other necessary corrective action that needs to take place in order to
eliminate the security deficiency or deficiencies identified in the risk analysis. To provide better
clarity on this requirement, we are modifying the measure.
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After consideration of the public comments received, we are modifying the meaningful
use measure for EPs at §495.6(d)(15)(ii) and eligible hospitals and CAHs at §495.6(f)(14)(ii) of
our regulations “Conduct or review a security risk analysis per 45 CFR 164.308(a)(1) of the
certified EHR technology, and implement security updates and correct identified security
deficiencies as part of its risk management process”.
Table 2: Stage 1 Meaningful Use Objectives and Associated Measures Sorted by Core and
Menu Set
CORE SET
Health
Outcomes Policy
Priority
Improving
quality, safety,
efficiency, and
reducing health
disparities
Eligible Professionals
Stage 1 Objectives
Eligible Hospitals and CAHs
Use CPOE for medication
orders directly entered by any
licensed healthcare
professional who can enter
orders into the medical record
per state, local and
professional guidelines
Use CPOE for medication
orders directly entered by any
licensed healthcare professional
who can enter orders into the
medical record per state, local
and professional guidelines
Implement drug-drug and
drug-allergy interaction
checks
Implement drug-drug and drugallergy interaction checks
Generate and transmit
permissible prescriptions
electronically (eRx)
Record demographics
Record demographics
o
o
preferred language
gender
o
o
o
o
o
race
ethnicity
date of birth
o race
o ethnicity
o date of birth
o date and preliminary cause
of death in the event of
mortality in the eligible hospital
or CAH
preferred language
gender
Stage 1 Measures
More than 30% of unique
patients with at least one
medication in their
medication list seen by the
EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one medication order
entered using CPOE
The EP/eligible
hospital/CAH has enabled
this functionality for the
entire EHR reporting
period
More than 40% of all
permissible prescriptions
written by the EP are
transmitted electronically
using certified EHR
technology
More than 50% of all
unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have
demographics recorded as
structured data
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Maintain an up-to-date
problem list of current and
active diagnoses
Maintain an up-to-date problem
list of current and active
diagnoses
Maintain active medication
list
Maintain active medication list
Maintain active medication
allergy list
Maintain active medication
allergy list
Record and chart changes in
vital signs:
o Height
o Weight
o Blood pressure
o Calculate and display
BMI
o Plot and display
growth charts for
children 2-20 years,
including BMI
Record smoking status for
patients 13 years old or older
Record and chart changes in
vital signs:
o Height
o Weight
o Blood pressure
o Calculate and display
BMI
o Plot and display
growth charts for
children 2-20 years,
including BMI
Record smoking status for
patients 13 years old or older
More than 80% of all
unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one entry or an
indication that no
problems are known for
the patient recorded as
structured data
More than 80% of all
unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23)have at
least one entry (or an
indication that the patient
is not currently prescribed
any medication) recorded
as structured data
More than 80% of all
unique patients seen by
the EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have at
least one entry (or an
indication that the patient
has no known medication
allergies) recorded as
structured data
For more than 50% of all
unique patients age 2 and
over seen by the EP or
admitted to eligible
hospital’s or CAH’s
inpatient or emergency
department (POS 21 or
23), height, weight and
blood pressure are
recorded as structured data
More than 50% of all
unique patients 13 years
old or older seen by the
EP or admitted to the
eligible hospital’s or
CAH’s inpatient or
emergency department
(POS 21 or 23) have
smoking status recorded
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as structured data
Engage patients
and families in
their health care
Implement one clinical
decision support rule relevant
to specialty or high clinical
priority along with the ability
to track compliance that rule
Report ambulatory clinical
quality measures to CMS or
the States
Implement one clinical decision
support rule related to a high
priority hospital condition along
with the ability to track
compliance with that rule
Report hospital clinical quality
measures to CMS or the States
Provide patients with an
electronic copy of their health
information (including
diagnostic test results,
problem list, medication lists,
medication allergies), upon
request
Provide patients with an
electronic copy of their health
information (including
diagnostic test results, problem
list, medication lists, medication
allergies, discharge summary,
procedures), upon request
Provide patients with an
electronic copy of their
discharge instructions at time of
discharge, upon request
Provide clinical summaries for
patients for each office visit
Implement one clinical
decision support rule
For 2011, provide
aggregate numerator,
denominator, and
exclusions through
attestation as discussed in
section II(A)(3) of this
final rule
For 2012, electronically
submit the clinical quality
measures as discussed in
section II(A)(3) of this
final rule
More than 50% of all
patients of the EP or the
inpatient or emergency
departments of the eligible
hospital or CAH (POS 21
or 23) who request an
electronic copy of their
health information are
provided it within 3
business days
More than 50% of all
patients who are
discharged from an
eligible hospital or CAH’s
inpatient department or
emergency department
(POS 21 or 23) and who
request an electronic copy
of their discharge
instructions are provided it
Clinical summaries
provided to patients for
more than 50% of all
office visits within 3
business days
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Improve care
coordination
Capability to exchange key
clinical information (for
example, problem list,
medication list, medication
allergies, diagnostic test
results), among providers of
care and patient authorized
entities electronically
Capability to exchange key
clinical information (for
example, discharge summary,
procedures, problem list,
medication list, medication
allergies, diagnostic test
results), among providers of
care and patient authorized
entities electronically
Performed at least one test
of certified EHR
technology's capacity to
electronically exchange
key clinical information
Ensure adequate
privacy and
security
protections for
personal health
information
Protect electronic health
information created or
maintained by the certified
EHR technology through the
implementation of appropriate
technical capabilities
Protect electronic health
information created or
maintained by the certified
EHR technology through the
implementation of appropriate
technical capabilities
Conduct or review a
security risk analysis per
45 CFR 164.308 (a)(1)
and implement security
updates as necessary and
correct identified security
deficiencies as part of its
risk management process
MENU SET
Health Outcomes
Policy Priority
Improving quality,
safety, efficiency,
and reducing
health disparities
Stage 1 Objectives
Eligible Professionals
Implement drugformulary checks
Eligible Hospitals and
CAHs
Implement drug-formulary
checks
Record advance directives
for patients 65 years old or
older
Incorporate clinical labtest results into certified
EHR technology as
structured data
Incorporate clinical lab-test
results into certified EHR
technology as structured
data
Generate lists of patients
by specific conditions to
use for quality
improvement, reduction
of disparities, research
or outreach
Generate lists of patients by
specific conditions to use
for quality improvement,
reduction of disparities,
research or outreach
Stage 1 Measures
The EP/eligible hospital/CAH has
enabled this functionality and has
access to at least one internal or
external drug formulary for the
entire EHR reporting period
More than 50% of all unique
patients 65 years old or older
admitted to the eligible hospital’s or
CAH’s inpatient department (POS
21) have an indication of an
advance directive status recorded
More than 40% of all clinical lab
tests results ordered by the EP or by
an authorized provider of the
eligible hospital or CAH for
patients admitted to its inpatient or
emergency department (POS 21 or
23) during the EHR reporting
period whose results are either in a
positive/negative or numerical
format are incorporated in certified
EHR technology as structured data
Generate at least one report listing
patients of the EP, eligible hospital
or CAH with a specific condition
CMS-0033-F
Engage patients
and families in
their health care
Improve care
coordination
225
Send reminders to
patients per patient
preference for
preventive/ follow up
care
More than 20% of all unique
patients 65 years or older or 5 years
old or younger were sent an
appropriate reminder during the
EHR reporting period
Provide patients with
timely electronic access
to their health
information (including
lab results, problem list,
medication lists,
medication allergies)
within four business
days of the information
being available to the
EP
Use certified EHR
technology to identify
patient-specific
education resources and
provide those resources
to the patient if
appropriate
The EP, eligible hospital
or CAH who receives a
patient from another
setting of care or
provider of care or
believes an encounter is
relevant should perform
medication
reconciliation
The EP, eligible hospital
or CAH who transitions
their patient to another
setting of care or
provider of care or
refers their patient to
another provider of care
should provide summary
of care record for each
transition of care or
referral
More than 10% of all unique
patients seen by the EP are provided
timely (available to the patient
within four business days of being
updated in the certified EHR
technology) electronic access to
their health information subject to
the EP’s discretion to withhold
certain information
Use certified EHR
technology to identify
patient-specific education
resources and provide those
resources to the patient if
appropriate
The EP, eligible hospital or
CAH who receives a
patient from another setting
of care or provider of care
or believes an encounter is
relevant should perform
medication reconciliation
The EP, eligible hospital or
CAH who transitions their
patient to another setting of
care or provider of care or
refers their patient to
another provider of care
should provide summary of
care record for each
transition of care or referral
More than 10% of all unique
patients seen by the EP or admitted
to the eligible hospital’s or CAH’s
inpatient or emergency department
(POS 21 or 23) are provided
patient-specific education resources
The EP, eligible hospital or CAH
performs medication reconciliation
for more than 50% of transitions of
care in which the patient is
transitioned into the care of the EP
or admitted to the eligible hospital’s
or CAH’s inpatient or emergency
department (POS 21 or 23)
The EP, eligible hospital or CAH
who transitions or refers their
patient to another setting of care or
provider of care provides a
summary of care record for more
than 50% of transitions of care and
referrals
CMS-0033-F
Improve
population and
public health2
226
Capability to submit
electronic data to
immunization registries
or Immunization
Information Systems
and actual submission in
accordance with
applicable law and
practice
Capability to submit
electronic data to
immunization registries or
Immunization Information
Systems and actual
submission in accordance
with applicable law and
practice
Capability to submit
electronic data on
reportable (as required by
state or local law) lab
results to public health
agencies and actual
submission in accordance
with applicable law and
practice
Capability to submit
electronic syndromic
surveillance data to
public health agencies
and actual submission in
accordance with
applicable law and
practice
Capability to submit
electronic syndromic
surveillance data to public
health agencies and actual
submission in accordance
with applicable law and
practice
Performed at least one test of
certified EHR technology's capacity
to submit electronic data to
immunization registries and follow
up submission if the test is
successful (unless none of the
immunization registries to which
the EP, eligible hospital or CAH
submits such information have the
capacity to receive the information
electronically)
Performed at least one test of
certified EHR technology’s
capacity to provide electronic
submission of reportable lab results
to public health agencies and
follow-up submission if the test is
successful (unless none of the
public health agencies to which
eligible hospital or CAH submits
such information have the capacity
to receive the information
electronically)
Performed at least one test of
certified EHR technology's capacity
to provide electronic syndromic
surveillance data to public health
agencies and follow-up submission
if the test is successful (unless none
of the public health agencies to
which an EP, eligible hospital or
CAH submits such information
have the capacity to receive the
information electronically)
Table 3: Stage 1 Meaningful Use Objectives and Associated Measures Sorted by Method of
Measure Calculation
Measures with a Denominator of Unique Patients Regardless of Whether the Patient’s Records Are
Maintained Using Certified EHR Technology
Stage 1 Objectives
Stage 1 Measures
Eligible Professionals
Eligible Hospitals and CAHs
2
Unless an EP, eligible hospital or CAH has an exception for all of these objectives and measures they must complete at least
one as part of their demonstration of the menu set in order to be a meaningful EHR user.
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227
Maintain an up-to-date problem
list of current and active
diagnoses
Maintain an up-to-date problem
list of current and active
diagnoses
Maintain active medication list
Maintain active medication list
Maintain active medication
allergy list
Maintain active medication
allergy list
Record demographics
o Preferred language
o Gender
o Race
o Ethnicity
o Date of Birth
Record demographics
o Preferred language
o Gender
o Race
o Ethnicity
o Date of Birth
o Date and preliminary cause of
death in the event of
mortality in the eligible
hospital or CAH
Provide patients with timely
electronic access to their health
information (including lab results,
problem list, medication lists,
medication allergies) within four
business days of the information
being available to the EP
Use certified EHR technology to
identify patient-specific education
resources and provide those
resources to the patient if
appropriate
More than 80% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one entry or an indication
that no problems are known for the patient
recorded as structured data
More than 80% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or
23)have at least one entry (or an
indication that the patient is not currently
prescribed any medication) recorded as
structured data
More than 80% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one entry (or an indication
that the patient has no known medication
allergies) recorded as structured data
More than 50% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have demographics recorded as structured
data
More than 10% of all unique patients seen
by the EP are provided timely (available
to the patient within four business days of
being updated in the certified EHR
technology) electronic access to their
health information subject to the EP’s
discretion to withhold certain information
Use certified EHR technology to
identify patient-specific education
resources and provide those
resources to the patient if
appropriate
More than 10% of all unique patients seen
by the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23) are
provided patient-specific education
resources
Measures with a Denominator of Based on Counting Actions for Patients whose Records are Maintained
Using Certified EHR Technology
Stage 1 Objectives
Stage 1 Measures
Eligible Professionals
Eligible Hospitals and CAHs
CMS-0033-F
Use CPOE for medication orders
directly entered by any licensed
healthcare professional who can
enter orders into the medical
record per state, local and
professional guidelines
228
Use CPOE for medication orders
directly entered by any licensed
healthcare professional who can
enter orders into the medical
record per state, local and
professional guidelines
More than 30% of unique patients with at
least one medication in their medication
list seen by the EP or admitted to the
eligible hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one medication order entered
using CPOE
More than 40% of all permissible
prescriptions written by the EP are
transmitted electronically using certified
EHR technology
Record and chart changes in vital
signs:
o Height
o Weight
o Blood pressure
o Calculate and display
BMI
o Plot and display growth
charts for children 2-20
years, including BMI
Record smoking status for
patients 13 years old or older
For more than 50% of all unique patients
age 2 and over seen by the EP or admitted
to eligible hospital’s or CAH’s inpatient
or emergency department (POS 21 or 23),
height, weight and blood pressure are
recorded as structured data
Generate and transmit
permissible prescriptions
electronically (eRx)
Record and chart changes in vital
signs:
o Height
o Weight
o Blood pressure
o Calculate and display
BMI
o Plot and display growth
charts for children 2-20
years, including BMI
Record smoking status for
patients 13 years old or older
Record advance directives for
patients 65 years old or older
Incorporate clinical lab-test
results into certified EHR
technology as structured data
Incorporate clinical lab-test results
into certified EHR technology as
structured data
Provide patients with an
electronic copy of their health
information (including diagnostic
test results, problem list,
medication lists, medication
allergies), upon request
Provide patients with an
electronic copy of their health
information (including diagnostic
test results, problem list,
medication lists, medication
allergies, discharge summary,
procedures), upon request
More than 50% of all unique patients 13
years old or older seen by the EP or
admitted to the eligible hospital’s or
CAH’s inpatient or emergency department
(POS 21 or 23) have smoking status
recorded as structured data
More than 50% of all unique patients 65
years old or older admitted to the eligible
hospital have an indication of an advance
directive status recorded
More than 40% of all clinical lab tests
results ordered by the EP or by an
authorized provider of the eligible hospital
or CAH for patients admitted to its
inpatient or emergency department (POS
21 or 23) during the EHR reporting period
whose results are either in a
positive/negative or numerical format are
incorporated in certified EHR technology
as structured data
More than 50% of all patients of the EP or
the inpatient or emergency departments of
the eligible hospital or CAH (POS 21 or
23) who request an electronic copy of
their health information are provided it
within 3 business days
CMS-0033-F
229
Provide patients with an
electronic copy of their discharge
instructions at time of discharge,
upon request
More than 50% of all patients who are
discharged from an eligible hospital or
CAH’s inpatient department or emergency
department (POS 21 or 23) and who
request an electronic copy of their
discharge instructions are provided it
Provide clinical summaries for
patients for each office visit
Clinical summaries provided to patients
for more than 50% of all office visits
within 3 business days
Send reminders to patients per
patient preference for preventive/
follow up care
More than 20% of all unique patients 65
years or older or 5 years old or younger
were sent an appropriate reminder during
the EHR reporting period
The EP, eligible hospital or CAH
who receives a patient from
another setting of care or provider
of care or believes an encounter is
relevant should perform
medication reconciliation
The EP, eligible hospital or CAH
who receives a patient from
another setting of care or provider
of care or believes an encounter is
relevant should perform
medication reconciliation
The EP, eligible hospital or CAH The EP, eligible hospital or CAH
who transitions their patient to
who transitions their patient to
another setting of care or provider another setting of care or provider
of care or refers their patient to
of care or refers their patient to
another provider of care should
another provider of care should
provide summary of care record
provide summary of care record
for each transition of care or
for each transition of care or
referral
referral
Measures Requiring Only a Yes/No Attestation
Stage 1 Objectives
Eligible Professionals
Hospitals
Implement drug-drug and drugallergy interaction checks
Implement drug-drug and drugallergy interaction checks
Implement drug-formulary
checks
Implement drug-formulary checks
The EP, eligible hospital or CAH
performs medication reconciliation for
more than 50% of transitions of care in
which the patient is transitioned into the
care of the EP or admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
The EP, eligible hospital or CAH who
transitions or refers their patient to another
setting of care or provider of care provides
a summary of care record for more than
50% of transitions of care and referrals
Stage 1 Measures
The EP/eligible hospital/CAH has enabled
this functionality for the entire EHR
reporting period
The EP/eligible hospital/CAH has enabled
this functionality and has access to at least
one internal or external drug formulary for
the entire EHR reporting period
CMS-0033-F
230
Generate lists of patients by
specific conditions to use for
quality improvement, reduction
of disparities, research or
outreach
Generate lists of patients by
specific conditions to use for
quality improvement, reduction of
disparities, research or outreach
Generate at least one report listing patients
of the EP, eligible hospital or CAH with a
specific condition
Implement one clinical decision
support rule relevant to specialty
or high clinical priority along
with the ability to track
compliance that rule
Implement one clinical decision
support rule related to a high
priority hospital condition along
with the ability to track
compliance with that rule
Implement one clinical decision support
rule
Capability to exchange key
clinical information (for example,
problem list, medication list,
medication allergies, diagnostic
test results), among providers of
care and patient authorized
entities electronically
Capability to exchange key
clinical information (for example,
discharge summary, procedures,
problem list, medication list,
medication allergies, diagnostic
test results), among providers of
care and patient authorized
entities electronically
Capability to submit electronic
data to immunization registries or
Immunization Information
Systems and actual submission in
accordance with applicable law
and practice
Performed at least one test of certified
EHR technology's capacity to
electronically exchange key clinical
information
Capability to submit electronic
data to immunization registries or
Immunization Information
Systems and actual submission in
accordance with applicable law
and practice
Capability to submit electronic
data on reportable (as required by
state or local law) lab results to
public health agencies and actual
submission in accordance with
applicable law and practice
Capability to submit electronic
syndromic surveillance data to
public health agencies and actual
submission in accordance with
applicable law and practice
Capability to submit electronic
syndromic surveillance data to
public health agencies and actual
submission in accordance with
applicable law and practice
Performed at least one test of certified
EHR technology's capacity to submit
electronic data to immunization registries
and follow up submission if the test is
successful (unless none of the
immunization registries to which the EP,
eligible hospital or CAH submits such
information have the capacity to receive
the information electronically)
Performed at least one test of certified
EHR technology capacity’s to provide
electronic submission of reportable lab
results to public health agencies and
follow-up submission if the test is
successful (unless none of the public
health agencies to which eligible hospital
or CAH submits such information have
the capacity to receive the information
electronically)
Performed at least one test of certified
EHR technology's capacity to provide
electronic syndromic surveillance data to
public health agencies and follow-up
submission if the test is successful (unless
none of the public health agencies to
which an EP, eligible hospital or CAH
submits such information have the
capacity to receive the information
electronically)
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Protect electronic health
information created or maintained
by the certified EHR technology
through the implementation of
appropriate technical capabilities
231
Protect electronic health
information created or maintained
by the certified EHR technology
through the implementation of
appropriate technical capabilities
Conduct or review a security risk analysis
per 45 CFR 164.308 (a)(1) and implement
security updates as necessary and correct
identified security deficiencies as part of
its risk management process
3. Sections 4101(a) and 4102(a)(1) of the HITECH Act: Reporting on Clinical Quality
Measures Using EHRs by EPs, Eligible Hospitals, and CAHs3
a. General
As discussed in the meaningful use background in section II.A.2.a. there are three
elements of meaningful use. In this section, we discuss the third requirement: using certified
EHR technology, the EP, eligible hospital, or CAH submits to the Secretary, in a form and
manner specified by the Secretary, information for the EHR reporting period on clinical quality
measures and other measures specified by the Secretary. The submission of other measures is
discussed in section II.A.2.c of this final rule. The two other elements of meaningful use are
discussed in section II.A.2.d.1 of this final rule.
b. Requirements for the Submission of Clinical Quality Measures by EPs, Eligible Hospitals,
and CAHs
Sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act provide that the Secretary
may not require the electronic reporting of information on clinical quality measures unless the
Secretary has the capacity to accept the information electronically, which may be on a pilot
basis.
In the proposed rule, we stated that we do not anticipate that HHS will complete the
necessary steps for us to have the capacity to electronically accept data on clinical quality
3
For purposes of this final rule, the term “eligible hospital” for the Medicaid EHR incentive program is inclusive of
Critical Access Hospitals (CAHs) as defined in this final rule.
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measures from EHRs for the 2011 payment year. We believe that it is unlikely that by 2011
there will be adequate testing and demonstration of the ability to receive the required transmitted
information on a widespread basis. The capacity to accept information on clinical quality
measures also would depend upon the Secretary promulgating technical specifications for EHR
vendors with respect to the transmission of information on clinical quality measures sufficiently
in advance of the EHR reporting period for 2011, so that adequate time has been provided either
for such specifications to be certified, or for EHR vendors to code such specifications into
certified systems. Therefore, for 2011, we proposed that Medicare EPs, eligible hospitals, and
CAHs use an attestation methodology to submit summary information to us on clinical quality
measures as a condition of demonstrating meaningful use of certified EHR technology, rather
than electronic submission.
We proposed that from the Medicaid perspective, delaying the onset of clinical quality
measures electronic reporting until 2012 addresses concerns about States having the ready
infrastructure to receive and store clinical quality measures data before then. More importantly,
we recognized that since Medicaid providers are eligible to receive incentive payments for
adopting, implementing, or upgrading certified EHR technology, Medicaid providers may not be
focused on demonstrating meaningful use until 2012 or later.
We stated that we anticipate that for the 2012 payment year we will have completed the
necessary steps to have the capacity to receive electronically information on clinical quality
measures from EHRs, including the promulgation of technical specifications for EHR vendors to
use for obtaining certification of their systems. Therefore, for the Medicare EHR incentive
program beginning in CY 2012 we proposed that an EP using a certified EHR technology or
beginning in FY 2012 an eligible hospital or CAH using a certified EHR technology, as
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appropriate for clinical quality measures, must submit information on clinical quality measures
electronically, in addition to submitting the other measures described in section II.2.d.2, in order
for the EP, eligible hospital, or CAH to be a meaningful EHR user, regardless of whether CY
2012 is their first or second payment year. However, if the Secretary does not have the capacity
to accept the information on clinical quality measures electronically in 2012, consistent with
sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act, we will continue to rely on an
attestation methodology for reporting of clinical quality measures as a requirement for
demonstrating meaningful use of certified EHR technology for payment year 2012. We stated in
the proposed rule that should we not have the capacity to accept information on clinical quality
measures electronically in 2012, we would inform the public of this fact by publishing a notice in
the Federal Register and providing instructions on how this information should be submitted to
us.
We also are finalizing in this final rule that States must identify for us in their State
Medicaid HIT Plans how they plan to accept data from Medicaid providers who seek to
demonstrate meaningful use by reporting on clinical quality measures, either via attestation or
via electronic reporting, subject to our prior approval. If they initiate their program by accepting
attestations for clinical quality measures, they must also describe how they will inform providers
of their timeframe to accept submission of clinical quality measures electronically. We expect
that States will have the capacity to accept electronic reporting of clinical quality measures by
their second year implementing their Medicaid EHR incentive program.
For purposes of the requirements under sections 1848(o)(2)(A)(iii) and 1886 (n)(3)(iii) of
the Act, we defined “clinical quality measures” to consist of measures of processes, experience,
and/or outcomes of patient care, observations or treatment that relate to one or more quality aims
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for health care such as effective, safe, efficient, patient-centered, equitable, and timely care. We
noted that certain statutory limitations apply only to the reporting of clinical quality measures,
such as the requirement discussed in the previous paragraph prohibiting the Secretary from
requiring the electronic reporting of information on clinical quality measures unless the Secretary
has the capacity to accept the information electronically, as well as other statutory requirements
for clinical quality measures that are discussed below in section II.A.3.c.1 of this final rule.
These limitations apply solely to the submission of clinical quality measures, and do not apply to
other measures of meaningful EHR use. The clinical quality measures on which EPs, eligible
hospitals, or CAHs will be required to submit information using certified EHR technology, the
statutory requirements and other considerations that were used to select these measures, and the
reporting requirements are described below.
With respect to Medicaid EPs and eligible hospitals, we noted that section 1903(t)(6) of
the Act recognizes that the demonstration of meaningful use may also include the reporting of
clinical quality measures to the States. We proposed that in the interest of simplifying the
program and guarding against duplication of meaningful use criteria, the clinical quality
measures adopted for the Medicare EHR incentive program, would also apply to EPs and eligible
hospitals in the Medicaid EHR incentive program.
Despite the statutory limitation prohibiting the Secretary from requiring the electronic
submission of clinical quality measures in the Medicare EHR incentive program, if HHS does
not have the capacity to accept this information electronically, as previously discussed, the
Secretary has broad discretion to establish requirements for meaningful use of certified EHR
technology and for the demonstration of such use by EPs, eligible hospitals, and CAHs.
Although we proposed to require the electronic submission of information on clinical quality
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measures in 2012, we stated that we do not desire this to delay the use of certified EHR
technology by EPs, eligible hospitals, and CAHs to measure and improve clinical quality.
Specifically, we stated that using EHR functionalities that support measurement of clinical
quality is critical to a central goal of the HITECH Act, improving health care quality. Measuring
quality is a fundamental aspect of improving such quality, because it allows EPs, eligible
hospitals, and CAHs to receive quantitative information upon which they can then act in order to
improve quality.
Accordingly, although we did not propose under sections 1848(o)(2)(A)(iii) and
1886(n)(3)(A)(iii) of the Act to require that for 2011 EPs, eligible hospitals, and CAHs report
clinical quality measures to us or States electronically, we proposed to require as an additional
condition of demonstrating meaningful use of certified EHR technology under sections
1848(o)(2)(A)(i), 1886(n)(3)(A)(ii), and 1903(t)(6) of the Act that EPs and eligible hospitals use
certified EHR technology to capture the data elements and calculate the results for certain
clinical quality measures. Further, we proposed that EPs, eligible hospitals, and CAHs
demonstrate that they have satisfied this requirement during the EHR reporting period for 2011
through attestation. We also proposed to require that Medicare EPs, eligible hospitals, and
CAHs attest to the accuracy and completeness of the numerators and denominators for each of
the applicable measures. Finally, in accordance with our authority under sections
1848(o)(C)(i)(V) and 1886(n)(3)(C)(i)(V) of the Act, which grants us broad discretion to specify
the means through which EPs, eligible hospitals, and CAHs demonstrate compliance with the
meaningful use criteria, we proposed that EPs, eligible hospitals, and CAHs demonstrate their
use of certified EHR technology to capture the data elements and calculate the results for the
applicable clinical quality measures by reporting the results to us for all applicable patients. For
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the Medicaid incentive program, we proposed that States may accept provider attestations in the
same manner to demonstrate meaningful use in 2011. However, we indicated that we expect that
most Medicaid providers will qualify for the incentive payment by adopting, implementing, or
upgrading to certified EHR technology, and therefore will not need to attest to meaningful use of
certified EHR technology in 2011, for their first payment year.
We stated that we recognize that considerable work needs to be done by measure owners
and developers with respect to the clinical quality measures that we proposed. This includes
completing electronic specifications for measures, implementing such specifications into EHR
technology to capture and calculate the results, and implementing the systems, themselves. We
also recognized that some measures are further developed than others, as discussed in the
measures section (see 75 FR 1871) of the proposed rule. Nevertheless we stated our belief that
overall there is sufficient time to complete work on measures and measures specifications so as
to allow vendors and EPs, eligible hospitals, and CAHs to implement such systems. We stated
that it was our intention not to finalize those specific measures should the necessary work on
measure specifications not be completed for particular measures according to the timetable we
discuss below. As we discuss below, we finalize in this final rule only those clinical quality
measures for which clearly defined electronic specifications have been finalized by the date of
display of this final rule. Finalized clinical quality measures are listed in Table 6 for EPs and
Table 7 for eligible hospitals and CAHs. We also clarify that while States may not have the
capacity to accept electronic reporting of clinical quality measures in 2011 or their first year
implementing their Medicaid EHR incentive program, we expect that they will have such
capacity by their second implementation year. However, if they do not, as with the Federal
government, the State would continue to rely on an attestation methodology for reporting clinical
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quality measures as a requirement for demonstrating meaningful use of certified EHR
technology, subject to CMS prior approval via an updated State Medicaid HIT plan.
Comment: A few commenters requested that the definition of “clinical quality measures”
be expanded to include “appropriate clinical prevention.”
Response: We agree that appropriate clinical prevention is a pertinent topic for clinical
quality measures, but we do not believe the definition of clinical quality measures needs to
delineate every aspect of quality care included in the definition.
Comment: Several commenters said it will be difficult to develop the EHR capability to
capture, integrate and train staff regarding measure specifications if the clinical quality measures
are not posted with sufficient time to allow these activities. Other commenters said there is
insufficient time allowed for vendors to retool their products and complete development of the
reports and/or systems. Several commenters indicated that the clinical quality measures have not
been tested, and reliability and validity testing should be performed. Other commenters indicated
that standard, clearly defined electronic specifications do not exist and new specifications should
be pilot tested and published for stakeholder/public comment. A commenter requested that CMS
establish an explicit process for development and testing of evidence based electronically
specified measures (eMeasure), and ensure adequate time for field testing.
Response: In general we agree with the desirability of having electronic specifications
available, pilot tested, and published for stakeholder viewing sufficiently in advance so as to
allow adequate time for modifications if necessary and vendors to incorporate them into certified
EHR technology, and for EPs, eligible hospitals, and CAHs to integrate the measures into their
operations and train staff on the measures. In this case, however, there is a process for
certification of certified EHR technology which includes testing of the capability of the certified
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EHR. The final rule issued by ONC (found elsewhere in this issue of the Federal Register)
provides that certified EHR technology must have the ability to calculate clinical quality
measures as specified by us. We interpret this requirement to mean that certified EHR
technology must have the capability to calculate those clinical quality measures selected in this
final rule based on the specifications we select and post on the CMS website. In order to provide
sufficient time for vendors to retool their products and complete development of the necessary
reports and/or systems for calculation of the results for the required clinical quality measures,
and for certifying bodies to test and certify that EHR technologies adequately do so, we are
adopting only those electronic specifications that are posted on the CMS website as of the date of
display of this final rule. We believe testing that is part of the process for certification of EHR
technology will substitute for testing that might otherwise occur. Additionally, some of the
selected measures have undergone various amounts of testing already. For example, the
Emergency Department Throughput, Stroke and Venous Thromboembolism (VTE) measures
mentioned by the commenter were tested during the January 2010 Connectathon and
demonstrated at the Health Information and Management Systems Society (HIMSS) 2010
Interoperability Showcase which demonstrated the use of the measures by participating vendors.
However, we expect the EHR certification process to carry out the necessary testing to assure
that applicable certified EHR technology can calculate sufficient number of EP, eligible hospital
and CAH clinical quality measures required to qualify for the meaningful use incentive program.
In order to permit greater participation by EHR vendors, including specialty EHRs, the
certification program (see ONC final rule found elsewhere in this issue of the Federal Register)
will permit EHRs to be certified if they are able to calculate at a minimum three clinical quality
measures in addition to the six core and alternative core measures. In addition, the fact that EPs,
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eligible hospitals, and CAHs can adopt an EHR reporting period toward the end of FY/CY 2011,
we believe, will provide additional time for providers to implement and train staff on the
measures we adopt in this final rule.
c. Statutory Requirements and Other Considerations for the Selection of Clinical Quality
Measures for Electronic Submission by EPs, Eligible Hospitals, and CAHs
(1) Statutory Requirements for the Selection of Clinical Quality Measures for Electronic
Submission by EPs, Eligible Hospitals, and CAHs
Sections 1848(o)(2)(B)(i)(II) and 1886(n)(3)(B)(i) of the Act require that prior to any
clinical quality measure being selected, the Secretary will publish in the Federal Register such
measure and provide for a period of public comment on such measure. The proposed clinical
quality measures for EPs, eligible hospitals, and CAHs for 2011 and 2012 payment were listed in
Tables 3 through 21 of the proposed rule (see 75 FR 1874 through 1900).
In the proposed rule, we noted that for purposes of selecting clinical quality measures on
which EPs will be required to submit information using certified EHR technology, section
1848(o)(2)(B)(i)(I) of the Act, as added by section 4101 of the HITECH Act, states that the
Secretary shall provide preference to clinical quality measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) of the Act, as added by section
183 of the Medicare Improvement for Patients and Providers Act (MIPPA) of 2008. For
submission of clinical quality measures by eligible hospitals and CAHs, section
1886(n)(3)(B)(i)(I) of the Act, as added by section 4102(a) of the HITECH Act, requires the
Secretary to provide preference to those clinical quality measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) of the Act, as added by section
183 of the MIPPA, or clinical quality measures that have been selected for the purpose of
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applying section 1886(b)(3)(B)(viii) of the Act (that is, measures that have been selected for the
Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program).
On January 14, 2009, the U.S. Department of Health and Human Services awarded the
contract required under section 1890(a) of the Act to the National Quality Forum (NQF).
Therefore, we explained in the proposed rule that when selecting the clinical quality measures
EPs must report in order to demonstrate meaningful use of certified EHR technology in
accordance with section 1848(o)(2)(B)(i)(I) of the Act, we will give preference to the clinical
quality measures endorsed by the NQF, including NQF endorsed measures that have previously
been selected for the Physician Quality Reporting Initiative (PQRI) program. Similarly, we
stated that when selecting the clinical quality measures eligible hospitals and CAHs must report
in order to demonstrate meaningful use of certified EHR technology in accordance with section
1886(n)(3)(B)(i)(I) of the Act, we will give preference to the clinical quality measures selected
from those endorsed by the NQF or that have previously been selected for the RHQDAPU
program. In some instances we proposed measures for EPs, eligible hospitals, and CAHs that are
not currently NQF endorsed in an effort to include a broader set of clinical quality measures. In
the proposed rule, we noted that the HITECH Act does not require the use of NQF endorsed
measures, nor limit the measures to those included in PQRI or RHQDAPU. We stated that if we,
professional societies, or other stakeholders identify clinical quality measures which may be
appropriate for the EHR incentive programs, we will consider those measures even if they are
not endorsed by the NQF or have not been selected for the PQRI or RHQDAPU programs,
subject to the requirement to publish in the Federal Register such measure(s) for a period of
public comment.
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We proposed certain clinical quality measures for EPs, eligible hospitals, and CAHs, and
listed these measures in Tables 3 through 21 of the proposed rule (see 75 FR 1874-1900) for use
in the 2011 and 2012 payment years. We stated that no changes (that is, additions of clinical
quality measures) would be made after publication of the final rule, except through further
rulemaking. However, we stated that we may make administrative and/or technical
modifications or refinements, such as revisions to the clinical quality measures titles and code
additions, corrections, or revisions to the detailed specifications for the 2011 and 2012 payment
year measures. We stated that the 2011 specifications for user submission of clinical quality
measures would be available on our website when they are sufficiently developed or finalized.
Specifications for the EHR incentive programs must be obtained only from the specifications
documents for the EHR incentive program clinical quality measures.
Comment: Numerous comments were received regarding the criteria for selection of
clinical quality measures. Some commenters noted the importance of scientific and medical
evidence supporting the measure, as well as concerns regarding how the clinical quality
measures are maintained. Many other commenters indicated that all clinical quality measures
should be evidence-based and up-to-date with current medical standards. Several commenters
communicated support for using NQF; Hospital Quality Alliance (HQA); Ambulatory care
Quality Alliance (AQA); and the American Medical Association-Physician Consortium for
Performance Improvement (AMA-PCPI) clinical quality measures. Another commenter
suggested that measures that have a related U.S. Preventative Services Task Force (USPSTF)
recommendation should follow the USPSTF guidelines and the regulations should allow for
clinical quality measures to be updated as the evidence base changes. Another commenter
indicated CMS should ensure that all clinical quality measures are endorsed through a
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stakeholder consensus process. Commenters also questioned why some clinical quality measures
in the proposed rule do not have identifiers for example, NQF number and another commenter
indicated some of the clinical quality measures titles were different in the clinical quality
measure tables. Some commenters also stated that clinical quality measures should be phased in,
implementing the clinical quality measures by clinically related sets, and that all CMS proposed
clinical quality measures should be NQF endorsed.
Some commenters suggested that CMS should consult with other quality measure
stakeholders, such as, NQF, the Hospital Quality Alliance (HQA), and the National Committee
for Quality Assurance (NCQA), The Joint Commission (TJC), and Regional Health
Improvement Collaboratives to verify the validity, reliability, and appropriateness of proposed
clinical measures. In addition when developing, validating and recommending clinical quality
measures for the pediatric population, a commenter suggested CMS include consultation with the
Child Healthcare Corporation of America (CHCA) or the National Association of Children’s
Hospitals (NACHRI).
Response: The HITECH Act requires that we give preference to clinical quality
measures that are NQF endorsed. NQF is the only organization that we are aware of which is
in compliance with the requirements of National Technology Transfer and Advancement Act
(NTTAA), to endorse quality measures through voluntary consensus standards. However, the
HITECH Act does not require the exclusive use of NQF endorsed measures, nor limit the
measures to those produced by any particular developer or adopted or supported by any
particular organization, such as those suggested by the commenters. We gave preference to
NQF endorsed clinical quality measures in this final rule. However, we do not adopt a policy
that would restrict the Secretary’s discretion of beyond what is required by the statute.
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Measures listed in the proposed rule that did not have an NQF identifying number were not
NQF endorsed.
With respect to specific organizations, we have received broad input regarding clinical
quality measures including from many organizations mentioned by commenters and have
considered their comments in determining which clinical quality measures to finalize in this
final rule. We also note that, for NQF endorsed measures, the NQF provides a venue for public
and member input as a part of the endorsement process. With respect to commenters urging
consideration of whether the scientific and medical evidence support the measure, whether the
clinical quality measures are evidence-based and consistent with current medical standards, and
how the clinical quality measures are maintained, we note that these factors are part of the NQF
process, as well as standard measure development processes. We are committed to working
with national, State and local associations to identify or develop additional electronically
specified clinical quality measures, particularly for pediatric populations, for later stages of
meaningful use.
In selecting clinical quality measures for the Medicare EHR incentive program, the
Secretary is required to provide for notice in the Federal Register with public comment. This
provides broad public input which we fully consider. However, as we stated in the proposed
rule, we are finalizing the policy that technical specifications for clinical quality measures are
developed and finalized through the sub-regulatory process. Further, this requirement does not
pertain to the Medicaid EHR incentive program. We expect to develop a process in the future to
solicit public input on Medicaid-specific clinical quality measures for future stages of
meaningful use, if needed. However, because there are no such Medicaid-specific measures in
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this final rule, and all measures apply uniformly across both the Medicare and Medicaid EHR
incentive program, we have not developed such a process in this final rule.
After consideration of the public comments received, the HITECH Act requires that we
give preference to clinical quality measures that are NQF endorsed. However, it does not require
the exclusive use of NQF endorsed measures, nor limit the measures to those produced by any
particular developer nor be adopted by any particular organization. In this case, all clinical
quality measures we are finalizing are NQF endorsed and have current electronic specifications
as of the date of display of this final rule. Effective with the publication of this final rule, these
specifications are final for clinical quality measure reporting under the HITECH Act beginning
with 2011 and 2012. The detailed electronic specifications of the clinical quality measures for
EPs, eligible hospitals, and CAHs are displayed on the CMS website at
http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp#TopOfPage.
Sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act requires that in selecting
clinical quality measures, the Secretary shall seek to avoid redundant or duplicative reporting
otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the PQRI
program) and eligible reporting under section 1886(b)(3)(B)(viii) of the Act (RHQDAPU
program). For EPs, when the proposed rule was issued there was no statutory authority to
provide PQRI incentive payments for services furnished for 2011 or subsequent years. Since
then, the PQRI incentive payment for 2011 has been authorized. We acknowledge there is
overlap within the clinical quality measure reporting for EPs in the EHR incentive program with
the PQRI incentive program. However, the reporting periods in these two incentive programs
are different. Currently, the PQRI has a six and a twelve month reporting period. The reporting
period for the HITECH EHR incentive program for the first payment year is 90 days, which does
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not meet the PQRI reporting requirement of six or twelve month reporting period, as currently
provided. However, in the second payment year of the HITECH EHR incentive program the
reporting period is one year, and the PQRI reporting period, would be synchronous. The
requirement for qualification for PQRI is subject to a separate regulation. Although there may be
additional issues beyond the reporting periods, we anticipate efforts to avoid redundant and
duplicative reporting in PQRI of the same clinical quality measures as required in the EHR
incentive program. We envision a single reporting infrastructure for electronic submission in the
future, and will strive to align the EHR incentive program and PQRI as we develop the reporting
framework for clinical quality measures to avoid redundant or duplicative reporting. Further, we
also note that the Affordable Care Act (Pub. L. 111-148) requires that the Secretary develop a
plan to integrate the EHR incentive program and PQRI by January 1, 2012. In doing so we
expect to further address the issue of redundant and duplicative reporting. For eligible hospitals
and CAHs, for the EHR incentive program, we are finalizing one set of 15 clinical quality
measures for both Medicare and Medicaid. For Stage 1 (for clinical quality measures Stage 1 is
2011 and beginning in 2012), none of the finalized 15 clinical quality measures for eligible
hospitals and CAHs are currently included in the RHQDAPU program, and therefore there is no
issue of redundant and duplicative reporting based upon the HITECH Act. Nevertheless, clinical
quality measures in the EHR incentive program for eligible hospitals and CAHs were
electronically specified for use in the RHQDAPU program with the anticipation to place these
measures in RHQDAPU once we have completed and implemented the mechanism to accept
quality measures through electronic submission. For the future, we do not anticipate having one
set of clinical quality measures for the EHR incentive program and another set for RHQDAPU.
Rather, we anticipate a single set of hospital clinical quality measures, most of which we
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anticipate can be electronically specified. We note some of the RHQDAPU quality measures,
for example HCAHPS experience of care measures, do not lend themselves to EHR reporting.
Similarly, certain outcome quality measures, such as the current RQHDAPU readmission
measures, are based on claims rather than clinical data. In the future, we anticipate hospitals that
report RHQDAPU measures electronically would receive incentives from both the RHQDAPU
and EHR incentive program, in addition to properly reporting any required quality measures that
are not able to be derived from EHRs; this is however subject to future rulemaking. Further, in
the future, for hospitals that do not report electronically we anticipate that they may only qualify
for an incentive through the RHQDAPU program, and not through the EHR incentive program.
Again this is subject to future rulemaking. We envision a single reporting infrastructure for
electronic submission in the future, and will strive to align the hospital quality initiative
programs to seek to avoid redundant and duplicative reporting of quality measures for eligible
hospitals and CAHs.
Comment: Many commenters also suggested aligning clinical quality measure reporting
across federal agencies (for example, HRSA, CMS) as well as across programs, (for example,
PQRI, CHIP, Medicare and Medicaid) to avoid duplicative and redundant quality performance
reporting. Additionally, several commenters suggested that similar clinical quality measures
and/or quality data efforts included in the proposed rule are included in other clinical quality
recognition programs and EPs who successfully report in these programs via a certified EHR
should be deemed to have successfully reported in the EHR incentive program. Other
commenters suggested using the PQRI reporting process to satisfy the meaningful use
requirement under the EHR incentive program for EPs. Another commenter indicated that
clinical quality measures employed by this program and others will be valuable if EPs using
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EHRs have an in-depth understanding of how to leverage the technology and the data they
produce to improve care. A number of commenters requested that only clinical quality measures
chosen for use in the RHQDAPU program should be considered for implementation in the EHR
incentive program for eligible hospitals and CAHs that qualify for both incentives. Additionally,
the commenters stated they would like the process for avoiding duplicative reporting clearly
defined.
Response: The HITECH Act requires that the Secretary seek to avoid redundant and
duplicative reporting, with specific reference to PQRI for EPs and RHQDAPU for eligible
hospitals and CAHs. We have sought to avoid duplicative and redundant reporting in the
implementation of the HITECH Act as discussed elsewhere in our responses to comments in this
final rule. We will seek to align quality initiative programs in future rulemaking.
(2) Other Considerations for the Selection of Clinical Quality Measures for Electronic
Submission by EPs, Eligible Hospitals, and CAHs
In addition to the requirements under sections 1848(o)(2)(B)(i)(I) and 1886(n)(3)(B)(i)(I)
of the Act and the other statutory requirements described above, we also proposed applying the
following considerations to the selection of the clinical quality measures for electronic
submission under the Medicare and Medicaid EHR incentive programs:
• Clinical quality measures that are included in, facilitate alignment with, or allow
determination of satisfactory reporting in other Medicare (for example, PQRI or the RHQDAPU
program), Medicaid, and Children's Health Insurance Program (CHIP) program priorities.
• Clinical quality measures that are widely applicable to EPs and eligible hospitals based
on the services provided for the population of patients seen.
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• Clinical quality measures that promote CMS and HHS policy priorities related to
improved quality and efficiency of care for the Medicare and Medicaid populations that would
allow us to track improvement in care over time. These current and long term priority topics
include: prevention; management of chronic conditions; high cost and high volume conditions;
elimination of health disparities; healthcare-associated infections and other conditions; improved
care coordination; improved efficiency; improved patient and family experience of care;
improved end-of-life/palliative care; effective management of acute and chronic episodes of
care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use
of interoperable HIT.
• Clinical quality measures that address or relate to known gaps in the quality of care and
measures that through the PQRI program, performed at low or highly variable rates.
• Clinical quality measures that have been recommended for inclusion in the EHR
incentive by the HIT Policy Committee.
We noted in the proposed rule that the Children's Health Insurance Program
Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3) Title IV, section 401 requires the
Secretary to publish a core set of clinical quality measures for the pediatric population. We
stated that, to the extent possible, we would align the clinical quality measures selected under the
EHR incentive program with the measures selected under the CHIPRA core measure set.
Included in the proposed clinical quality measures were nine clinical quality measures pertaining
to pediatric providers. Four of these nine measures were on the list of CHIPRA initial core
measures that were recommended to the Secretary by the Subcommittee to AHRQ's National
Advisory Committee (SNAC). In our proposed rule, we noted that not all CHIPRA initial
measures recommended to the Secretary were applicable to EHR technology or to the EHR
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incentive payment program. For example, some of the measures are population-based, surveyderived, or not yet NQF endorsed. We stated that new or additional measures for the next
iteration of the CHIPRA core set would have EHR extractability as a priority.
Since the publication of the proposed rule, the CHIPRA core measure set has been
published in a final rule (see 74 FR 68846 through 68849). In this EHR incentive program final
rule, there are four clinical quality measures that are also in the published CHIPRA initial core
measure set. These clinical quality measures are shown below in Table 4:
Table 4: Clinical Quality Measures in the EHR Incentive Program Final Rule that are also
in the CHIPRA Initial Core Measure Set
Measure Number
NQF 0024
NQF 0033
NQF 0038
NQF 0002
PQRI 66
Clinical Quality Measure Title
Weight Assessment Counseling for Children and Adolescents
Chlamydia Screening for Women
Childhood Immunization Status
Appropriate Testing for Children with Pharyngitis
Due to the concurrent CHIPRA and ARRA HIT implementation activities, we believe
there is an exciting opportunity to align the two programs and strive to create efficiencies for
States and pediatric providers, where applicable. Similarly, the adult quality measures
requirements enacted in the ACA will provide another opportunity for CMS to align its quality
measures programs for consistency and to maximize use of electronic reporting. As these
programs move forward, we will continue to prioritize consistency in clinical quality measure
selection for providers when possible.
We solicited comments on the inclusion or exclusion of any clinical quality measure or
measures proposed for the 2011 and 2012 payment years, and to our approach in selecting
clinical quality measures.
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We stated in the proposed rule that we do not intend to use notice and comment
rulemaking as a means to update or modify clinical quality measure specifications. A clinical
quality measure that has completed the consensus process through NQF has a designated party
(usually, the measure developer/owner) who has accepted responsibility for maintenance of the
clinical quality measure. In general, it is the role of the clinical quality measure owner,
developer, or maintainer/steward to make basic changes to a clinical quality measure in terms of
the numerator, denominator, and exclusions. We proposed that the clinical quality measures
selected for the 2011 and 2012 payment year be supplemented by our technical specifications for
EHR submission. We proposed to post the complete clinical quality measures specifications
including technical specifications to our website and solicited comments on our approach.
We received various comments as to our proposed considerations for selection of clinical
quality measures for submission by EPs, eligible hospitals, and CAHs.
Comment: One commenter said that there needs to be longer than nine months for the
look back for capturing clinical quality measures data. Several commenters indicated that
baseline measurements that have used the clinical quality measure in the past have not been
performed. Commenters also recommended the linkage of clinical decision support to clinical
quality measures to strengthen quality improvement efforts. A commenter supported our
inclusion of measures that address both quality and resource use efficiency. Another commenter
indicated support for the clinical quality measures as represented in the proposed rule.
Response: The look back for capturing clinical quality measures is the period of time for
which data would be considered as applying to the measure calculation. The look back period
for a clinical quality measure and the method of documentation of prior information is defined
by the clinical quality measure specification. The clinical quality measures require reporting and
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not achievement on particular performance thresholds. We agree with the commenters regarding
the benefits of linking clinical decision support tools to the clinical quality measures, and
anticipate that as EHR technology evolves, many of the clinical quality measures will be
supported by clinical decision support tools. We also agree with the benefits of efficiency
measures and we expect that in future program years the scope and variety of measures that
address these factors will expand.
Comment: Commenters requested a definition for “Eligible Provider and NonQualifying Eligible Provider” with respect to the provider’s ability to meet meaningful use if
there are no appropriate clinical quality measures to report, the application of financial penalties
beginning in 2015, and the handling of exclusions. Another commenter stressed the need for
detailed information regarding what is included and excluded in the numerator and denominator
for each measure so as to ensure that certified EHR technology’s programmed analytics capture
all patients who meet the relevant criteria and to ensure that clinical quality measures are
properly evaluated. Others indicated that reporting measures electronically will reduce
administrative reporting costs. Other commenters supported the ability to report “N/A” for
clinical quality measures where an insufficient denominator exists. Other commenters urged that
CMS not include any clinical quality measures in Stage 1 of Meaningful Use because they
believe Stage 1 should focus on the initial implementation of certified EHR systems and its use
for patient care, and that EPs must gain experience with their certified EHR technology before
attesting to the accuracy and completeness of numerators, denominators and quality calculations
generated from these systems.
Response: While some commenters recommended we not include any clinical quality
measures in Stage 1 (2011 and beginning in 2012), as previously described for Stage 1 EPs are
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required to attest to the clinical quality measures calculated results (numerator, denominator, and
exclusions) as automatically calculated by the certified EHR technology. Given that the
statutory requirement for clinical quality measures is an element of meaningful use, we believe
that providing this information on clinical quality measures is appropriate for Stage 1 (2011 and
beginning in 2012). We would expect that the patient for whom a clinical quality measure does
not apply will not be included in the denominator of the clinical quality measure. If not
appropriate for a particular EP we would expect that either patients would not appear in the
denominator of the measure (a zero value) or an exclusion would apply. Therefore reporting
“N/A” is not necessary. Exclusion parameters–-that is, information on what is included and
excluded in the numerator and denominator for a clinical quality measure–are included in the
measure specifications. We agree that reporting measures electronically will reduce
administrative reporting costs, however as discussed in this final rule we will not require
electronic submission of clinical quality measures until 2012. Also discussed earlier in this final
rule, we believe collecting clinical quality measure data is an important part of meaningful use.
Comment: A commenter indicated that CMS should take ownership of each of the EP
clinical quality measures so that CMS can then adjudicate issues related to the clinical quality
measures, instead of referring the EP to the measure owner. One commenter believes that EPs
and their specialty societies should be the only owners of EP clinical quality measures.
Response: We are the owner/developer for certain clinical quality measures. More
commonly, we use the clinical quality measures developed and owned by others, who are then
responsible for the clinical quality measure specifications as endorsed by NQF. Numerous
measures have been developed over the years by various organizations and CMS, and therefore
we do not believe that specialty societies should be the only owners of EP clinical quality
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measures. The HITECH Act does not suggest or require that we should be the sole
owner/developer of clinical quality measures.
Comment: A commenter questioned whether clinical quality measures would be updated
during the bi-annual review process and how much lead time will be given.
Response: The measures for Stage1 (2011 and beginning in 2012) of meaningful use are
finalized in this final rule and will not change during that stage. Additionally, the electronic
specifications, as posted on the CMS website at the time of publication of this final rule, are
final. We intend to expand the clinical quality measures again for Stage 2 of meaningful use,
which we anticipate will first be effective for the 2013 payment year. As required by the
HITECH Act for the Medicare EHR incentive program, prior to selecting any new clinical
quality measure(s) for Stage 2 of meaningful use, we will publish notice of the proposed
measure(s) and request and consider public comments on the proposed measures. We note that
the Medicaid EHR incentive program does not have the same statutory requirement. If future
stages of meaningful use include clinical quality measures specific for Medicaid providers, we
will consider a process to receive public input on such measures.
Comment: One commenter suggested that only measures chosen for use in the pay-forreporting program should be considered for implementation in the EHR incentive program.
Response: We selected clinical quality measures that are broadly applicable for the 2011
and 2012 EHR incentive program. Many clinical quality measures used in other Medicare
pay-for-reporting programs are not applicable to all Medicaid eligible providers, such as
pediatricians, certified nurse-midwives, and children’s hospitals.
Comment: Commenters suggested alignment between measures with vocabulary
standards, in order to promote interoperability of clinical data. Stage 1 allows alternative
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vocabularies for problems, drugs, and procedures; and measures should only be included if
alternative specifications using all Stage 1 vocabularies are provided. Commenters
recommended incorporating HL7, LOINC, SNOMED, ICD-9, and ICD-10 for data exchange.
Response: Standards for certified EHRs, including vocabulary standards, are included in
ONC’s final rule (found elsewhere in this issue of the Federal Register).
Comment: Commenter recommended that in the beginning stages of implementation of
the EHR incentive programs, CMS should base its reporting initiatives on existing industry
models to prevent delays, consumer mistrust, and potential legal issues.
Response: We have conducted extensive reviews of industry standards, employed the
comments of industry experts and solicited public comments on all proposed processes.
Comment: Many commenters are concerned that there will not be adequate time to
communicate and implement the electronic specification for 2011 clinical quality measure
requirements. Additionally, one commenter expressed concern that the additional clinical
quality measures required for 2011 reporting will not be posted by CMS in time for careful
review and assessment, since currently there are only 15 measures electronically specified and
posted. Commenters requested clinical quality measures to be posted with implementation
guides for each quality reporting metric to ensure successful reporting.
Response: We have limited the requirements for clinical quality measure reporting for
eligible hospitals and CAHs to the 15 measures that were electronically specified and posted at
the time of publishing the proposed rule. All measures specifications for clinical quality
measures selected are final effective upon publication of the EHR incentive program final rule.
d. Clinical Quality Measures for EPs
For the 2011 and 2012 EHR reporting periods, based upon the considerations for
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selecting clinical quality measures discussed above, we proposed certain clinical quality
measures that were identified in the proposed rule (see 75 FR 1874-1889) for EPs. Tables 4
though 19 of the proposed rule divided the clinical quality measures identified in Table 3 into
core measures and specialty group measures (see 75 FR 1890 through 1895). The concept of
core measures and specialty group measures is discussed below.
We also stated that some measures were in a higher state of readiness than others, and
requested comment on each measure’s state of readiness for use in the EHR incentive programs.
For those measures where electronic specifications did not, at the time of the proposed rule,
exist, we solicited comment on how quickly electronic specifications could be developed, and
the period of time required from final posting of the electronic specifications for final measures
to ensure the effective implementation of the measures. We stated our intention to publish
electronic specifications for the proposed clinical quality measures on the CMS website as soon
as they become available from the measure developer(s). Electronic specifications may be
developed concurrently with the development of measures themselves and potentially with the
NQF endorsement processes. We stated that all of the proposed clinical quality measures
included in Table 3 (see 75 FR 1874-1889) meet one or more of the criteria for the selection of
clinical quality measures, discussed in the proposed rule. A large portion of these measures had
been through notice and comment rulemaking for PQRI, and nearly all PQRI clinical quality
measures are NQF endorsed. Additionally, they have broad applicability to the range of
Medicare designated specialties, and the services provided by EPs who render services to
Medicare and Medicaid beneficiaries and many others. Further, nine of the proposed 90 clinical
quality measures listed in Table 3 (see 75 FR 1874-1889) (PQRI numbers 1, 2, 3, 5, 7, 110, 111,
112, and 113) had preliminary specifications for electronic submission that had already been
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developed for the purpose of testing the submission of clinical quality data extracted from an
EHR for the PQRI program. The link to the preliminary electronic specifications for nine PQRI
clinical quality measures was provided: http://www.cms.hhs.gov/pqri.
We stated that in terms of CMS and HHS healthcare quality priorities, clinical quality
PQRI measures numbered 1, 2, 3, 5, and 7 address high priority chronic conditions, namely
diabetes, coronary artery disease, and heart disease. Clinical quality PQRI measures numbered
110, 111, 112, 113, 114, 115, and 128 support prevention which is a high CMS and HHS
priority. The PQRI clinical quality measure specifications for claims-based or registry-based
submission of these clinical quality measures for the most current PQRI program year can be
found on the PQRI section of the CMS website at
http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPage. A description of the
clinical quality measure, including the clinical quality measure's numerator and denominator, can
be found in the PQRI clinical quality measure specifications.
We pointed out that the PQRI clinical quality measures that were proposed largely align
with the recommendations of the HIT Standards Committee. However, in addition to proposed
clinical quality measures that are currently included in PQRI, we also proposed certain other
clinical quality measures that we stated are of high importance to the overall population. Those
clinical quality measures are Ischemic Vascular Disease (IVD): Use of Aspirin or another
Antithrombotic; IVD: Complete Lipid Profile; IVD: Low Density Lipoprotein (LDL-C) Control,
and Blood Pressure Management. Finally, we proposed an array of other measures which
address important aspects of clinical quality.
We stated our belief that the proposed clinical quality measures were broad enough to
allow for reporting for EPs and addressed high priority conditions. We recognized the
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importance of integrating the measures into certified EHR technologies for calculation of
measures results, and that not all measures would be feasible for 2011 and 2012. We invited
comment on the advisability of including the measures for payment years 2011 and 2012.
Although we recognized that there are many other important clinical quality measures of health
care provided by EPs, we anticipated expanding the set of clinical quality measures in future
years and listed a number of clinical quality measures for future consideration in section II.A.3.g
of the proposed rule preamble, on which we also invited comment.
Comment: Many of the proposed clinical quality measures received favorable comments
and support for inclusion in the final clinical quality measure set. A few examples of measures
that were supported for inclusion were measures related to prevention and screening, and
diabetes. It was stated by a commenter that the proposed rule includes some similar clinical
quality measures. For example, the commenter indicated NQF 0059 and NQF 0575 both deal
with hemoglobin A1c control. Others commented that some measures should be eliminated and
not utilized in the final set of clinical quality measures for EPs. For example, a few commented
that the following two measures should be eliminated, NQF 0052 and NQF 0513 were intended
to be implemented at the administrator site level using outpatient hospital claims and not at the
individual practitioner level. A number of commenters stated that the specifications for certain
clinical quality measures, for example, NQF 0022, NQF 0031, NQF 0032, NQF 0033, NQF
0034, and NQF 0061 were not consistent with current clinical practice guidelines. Another
commenter requested clarification for the specifications for NQF 0013 because blood pressures
are not routinely monitored for 2 month old patients. Many commenters provided suggestions
for other clinical quality measures not included in the proposed rule
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Response: We appreciate all of the suggestions from the commenters. We are unable to
add any clinical quality measures that were not identified in the proposed rule due to language in
sections 1848(o)(2)(B)(i)(II) and 1886(n)(3)(B)(i) of the Act requiring a period of public
comment for any finalized measures. This requirement does not pertain to the Medicaid EHR
incentive program, we expect to develop a process in the future to solicit public input on
Medicaid-specific clinical quality measures for future stages of meaningful use, if needed.
However, we will consider those additional clinical quality measures recommended by
commenters for future inclusion in the clinical quality measure sets.
In regard to suggested changes/revisions and/or elimination of the proposed clinical
quality measures, we considered these suggestions when finalizing clinical quality measures in
this final rule. In regard to this, we considered these suggestions when evaluating the clinical
quality measures for selection in this final rule. Of the clinical quality measures in the proposed
rule that we are not finalizing, we removed the measures that do not have electronic
specifications by the date of display of this final rule. Additionally, some of the proposed
clinical quality measures were recommended for deletion or modification, and therefore were
recommended to not be used in the final rule; this is delineated in other comments and responses
in this final rule. Further, we are only finalizing clinical quality measures that are electronically
specified the date of display of the final rule. The electronic specifications included in the final
set of clinical quality measures for EPs are posted to the CMS website at:
http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp#TopOfPage.
Comment: Numerous commenters were concerned about the burden (economic and
other) of reporting on the large number of clinical quality measures and the overall quality
reporting burden this will add to EPs. Some commenters stated that the use of numerators and
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denominators for some measures will require manual calculation on the part of the EPs since
there are no automated reports that can capture all of the information that must be tabulated. One
commenter stated that there are insufficient resources to calculate the denominators of the
required measures. Other commenters suggested using the PQRI requirements of reporting only
three measures, and others suggested reporting on significantly smaller number of measures.
Response: In response to the many comments received regarding the undue burden
associated with reporting on a large number of clinical quality measures, or measures that
involve a manual process, we have finalized only those clinical quality measures that can be
automatically calculated by a certified EHR technology. We further limited the measures to
those for which electronic specifications are currently available, which we posted as final by the
date of display of this final rule. This limitation significantly reduces the number of measures
EPs are required to report in 2011 and 2012, thus reducing the EPs’ reporting burden as well as
addressing commenters’ concerns about readiness. Although for 2011, Medicare EPs, eligible
hospitals, and CAHs will still need to manually report (attest) to the results automatically
calculated by their certified EHR technology, we believe that with the reduction in the number of
measures that the burden is reasonable. Additionally, this provides for the reporting of clinical
quality measures beyond simply the core clinical quality measures that EPs identify as suitable to
report.
Table 5, below, shows the proposed clinical quality measures for submission by Medicare
and Medicaid EPs for the 2011 and 2012 payment year as stated in the proposed rule (see 75 FR
1874-1889) for EPs, but that are not being finalized. Table 5 conveys the NQF measure number
and PQRI implementation number (that is, the number used in the PQRI program to identify the
measure as implemented in PQRI (for the 2010 PQRI measures list see
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https://www.cms.gov/PQRI/Downloads/2010_PQRI_MeasuresList_111309.pdf)), clinical
quality measure title and description, and clinical quality measure steward and contact
information. The measures listed below in Table 5 do not have electronic specifications finished
before the date of display of this final rule, thus we have eliminated these measures for this final
rule and will consider the addition of these measures in future rulemaking. Also several
measures listed below were only concepts at the time of publication of the proposed rule (that is,
Hysterectomy rates, Appropriate antibiotic use for ear infections, Statin after Myocardial
Infarction, 30 day Readmission Rate, 30 Readmission Rate following deliveries, and Use of CT
Scans). These concept measures were not developed or electronically specified clinical quality
measures, nor NQF endorsed; and there was not adequate time to consider these concepts for
development for this final rule. Therefore, the concepts listed below will be considered in future
rulemaking. Lastly, NQF 0026 has since been retired since publication of the proposed rule.
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TABLE 5: Proposed Clinical Quality Measures for Submission by Medicare or Medicaid EPs for
the 2011 and 2012 Payment Year; Included in the Proposed Rule (see 75 FR 1874 through 1889)
and Not in the Final Rule
NQF Measure
Number & PQRI
Implementation
Number
NQF 0246
PQRI 10
NQF 0270
PQRI 20
NQF 0268
PQRI 21
NQF 0271
PQRI 22
Clinical Quality Measure Title & Description
Title: Stroke and Stroke Rehabilitation:
Computed Tomography (CT) or Magnetic
Resonance Imaging (MRI) Reports
Description: Percentage of final reports for CT or
MRI studies of the brain performed within 24
hours of arrival to the hospital for patients aged 18
years and older with either a diagnosis of ischemic
stroke or transient ischemic attack (TIA) or
intracranial hemorrhage or at least one documented
symptom consistent with ischemic stroke or TIA or
intracranial hemorrhage that includes
documentation of the presence or absence or each
of the following: hemorrhage and mass lesion and
acute infarction.
Title: Perioperative Care: Timing of Antibiotic
Prophylaxis – Ordering Physician
Description: Percentage of surgical patients aged
18 years and older undergoing procedures with the
indications for prophylactic parenteral antibiotics,
who have an order for prophylactic antibiotic to be
given within one hour (if fluoroquinolone or
vancomycin, two hours), prior to the surgical
incision (or start of procedure when no incision is
required)
Title: Perioperative Care: Selection of
Prophylactic Antibiotic – First OR Second
Generation Cephalosporin
Description: Percentage of surgical patients aged
18 years and older undergoing procedures with the
indications for a first OR second generation
cephalosporin prophylactic antibiotic, who had an
order for cefazolin OR cefuroxime for
antimicrobial prophylaxis
Title: Perioperative Care: Discontinuation of
Prophylactic Antibiotics (Non-Cardiac Procedures)
Description: Percentage of non-cardiac surgical
patients aged 18 years and older undergoing
procedures with the indications for prophylactic
antibiotics AND who received a prophylactic
antibiotic, who have an order for discontinuation
of prophylactic antibiotics within 24 hours of
surgical end time
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
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NQF Measure
Number & PQRI
Implementation
Number
NQF 0239
PQRI 23
NQF 0241
PQRI 33
NQF 0102
PQRI 52
NQF 0069
PQRI 65
NQF 0323
PQRI 81
262
Clinical Quality Measure Title & Description
Title: Perioperative Care: Venous
Thromboembolism (VTE) Prophylaxis (When
Indicated in ALL Patients)
Description:Percentage of patients aged 18 years
and older undergoing procedures for which VTE
prophylaxis is indicated in all patients, who had an
order for Low Molecular Weight Heparin
(LMWH), Low-Dose Unfractionated Heparin
(LDUH), adjusted-dose warfarin, fondaparinux or
mechanical prophylaxis to be given within 24
hours prior to incision time or within 24 hours after
surgery end time
Title: Stroke and Stroke Rehabilitation:
Anticoagulant Therapy Prescribed for Atrial
Fibrillation at Discharge
Description: Percentage of patients aged 18 years
and older with a diagnosis of ischemic stroke or
transient ischemic attack (TIA) with documented
permanent, persistent, or paroxysmal atrial
fibrillation who were prescribed an anticoagulant
at discharge
Title: Chronic Obstructive Pulmonary Disease
(COPD): Bronchodilator Therapy
Description: Percentage of patients aged 18 years
and older with a diagnosis of COPD and who have
an FEV1/FVC less than 70% and have symptoms
who were prescribed an inhaled bronchodilator
Title: Treatment for Children with Upper
Respiratory Infection (URI): Avoidance of
Inappropriate Use
Description: Percentage of children aged 3
months through 18 years with a diagnosis of URI
who were not prescribed or dispensed an antibiotic
prescription on or within 3 days of the initial date
of service
Title: End Stage Renal Disease (ESRD): Plan of
Care for Inadequate Hemodialysis in ESRD
Patients
Description: Percentage of calendar months
during the 12-month reporting period in which
patients aged 18 years and older with a diagnosis
of ESRD receiving hemodialysis have a Kt/V ≥ 1.2
OR patients who have a Kt/V < 1.2 with a
documented plan of care for inadequate
hemodialysis
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI
Contact Information:
[email protected]
NCQA
Contact Information:
www.ncqa.org
AMA-PCPI
Contact Information:
[email protected]
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NQF Measure
Number & PQRI
Implementation
Number
NQF 0321
PQRI 82
NQF 0397
PQRI 86
NQF 0401
PQRI 89
NQF 0103
PQRI 106
NQF 0104
PQRI 107
NQF 0066
PQRI 118
263
Clinical Quality Measure Title & Description
Title: End Stage Renal Disease (ESRD): Plan of
Care for Inadequate Peritoneal Dialysis
Description: Percentage of patients aged 18 years
and older with a diagnosis of ESRD receiving
peritoneal dialysis who have a Kt/V ≥ 1.7 OR
patients who have a Kt/V < 1.7 with a documented
plan of care for inadequate peritoneal dialysis at
least three times (every 4 months) during the 12month reporting period
Title: Hepatitis C: Antiviral Treatment Prescribed
Description: Percentage of patients aged 18 years
and older with a diagnosis of chronic hepatitis C
who were prescribed peginterferon and ribavirin
therapy within the 12-month reporting period
Title: Hepatitis C: Counseling Regarding Risk of
Alcohol Consumption
Description: Percentage of patients aged 18 years
and older with a diagnosis of hepatitis C who were
counseled about the risks of alcohol use at least
once within the 12-month reporting period
Title: Major Depressive Disorder (MDD):
Diagnostic Evaluation
Description: Percentage of patients aged 18 years
and older with a new diagnosis or recurrent
episode of MDD who met the DSM-IV criteria
during the visit in which the new diagnosis or
recurrent episode was identified during the
measurement period
Title: Major Depressive Disorder (MDD): Suicide
Risk Assessment
Description: Percentage of patients aged 18 years
and older with a new diagnosis or recurrent
episode of MDD who had a suicide risk
assessment completed at each visit during the
measurement period
Title: Coronary Artery Disease (CAD):
Angiotensin-Converting Enzyme (ACE) Inhibitor
or Angiotensin Receptor Blocker (ARB) Therapy
for Patients with CAD and Diabetes and/or Left
Ventricular Systolic Dysfunction (LVSD)
Description: Percentage of patients aged 18
years and older with a diagnosis of CAD who also
have diabetes mellitus and/or LVSD (LVEF <
40%) who were prescribed ACE inhibitor or ARB
therapy
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
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NQF Measure
Number & PQRI
Implementation
Number
PQRI 121
Ambulatory Quality
Alliance (AQA)
adopted
PQRI 122
AQA adopted
PQRI 123
AQA adopted
NQF 0416
PQRI 127
NQF 0510
PQRI 145
NQF 0508
PQRI 146
264
Clinical Quality Measure Title & Description
Title: Chronic Kidney Disease (CKD):
Laboratory Testing (Calcium, Phosphorus, Intact
Parathyroid Hormone (iPTH) and Lipid Profile)
Description: Percentage of patients aged 18 years
and older with a diagnosis of advanced CKD
(stage 4 or 5, not receiving Renal Replacement
Therapy [RRT]), who had the following laboratory
testing ordered within 12 months: serum levels of
calcium, phosphorus and intact PTH, and lipid
profile
Title: Chronic Kidney Disease (CKD): Blood
Pressure Management
Description: Percentage of patient visits for
patients aged 18 years and older with a diagnosis
of advanced CKD (stage 4 or 5, not receiving
Renal Replacement Therapy [RRT]), with a blood
pressure < 130/80 mmHg OR blood pressure ≥
130/80 mmHg with a documented plan of care
Title: Chronic Kidney Disease (CKD): Plan of
Care – Elevated Hemoglobin for Patients
Receiving Erythropoiesis-Stimulating Agents
(ESA)
Description: Percentage of calendar months
during the 12-month reporting period in which
patients aged 18 years and older with a diagnosis
of advanced CKD (stage 4 or 5, not receiving
Renal Replacement Therapy [RRT]), receiving
ESA therapy, have a hemoglobin < 13 g/dL OR
patients whose hemoglobin is ≥ 13 g/dL and have a
documented plan of care
Title: Diabetes Mellitus: Diabetic Foot and Ankle
Care, Ulcer Prevention – Evaluation of Footwear
Description: Percentage of patients aged 18 years
and older with a diagnosis of diabetes mellitus who
were evaluated for proper footwear and sizing
Title: Radiology: Exposure Time Reported for
Procedures Using Fluoroscopy
Description: Percentage of final reports for
procedures using fluoroscopy that include
documentation of radiation exposure or exposure
time
Title: Radiology: Inappropriate Use of "Probably
Benign" Assessment Category in Mammography
Screening
Description: Percentage of final reports for
screening mammograms that are classified as
"probably benign"
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
American Podiatric
Medical Association
(APMA)
Contact Information:
http://www.apma.org/
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
CMS-0033-F
NQF Measure
Number & PQRI
Implementation
Number
NQF 0511
PQRI 147
PQRI 153
AQA adopted
NQF 0399
PQRI 183
NQF 0400
PQRI 184
PQRI 185
AQA adopted
NQF 0507
PQRI 195
265
Clinical Quality Measure Title & Description
Title: Nuclear Medicine: Correlation with Existing
Imaging Studies for All Patients Undergoing Bone
Scintigraphy
Description: Percentage of final reports for all
patients, regardless of age, undergoing bone
scintigraphy that include physician documentation
of correlation with existing relevant imaging
studies (for example,, x-ray, MRI, CT, etc.) that
were performed
Title: Chronic Kidney Disease (CKD): Referral
for Arteriovenous (AV) Fistula
Description: Percentage of patients aged 18 years
and older with the diagnosis of advanced CKD
(stage 4 or 5, not receiving Renal Replacement
Therapy [RRT]), who were referred for AV fistula
at least once during the 12-month reporting period
Title: Hepatitis C: Hepatitis A Vaccination in
Patients with HCV
Description: Percentage of patients aged 18 years
and older with a diagnosis of hepatitis C who
received at least one injection of hepatitis A
vaccine, or who have documented immunity to
hepatitis A
Title: Hepatitis C: Hepatitis B Vaccination in
Patients with HCV
Description: Percentage of patients aged 18 years
and older with a diagnosis of hepatitis C who
received at least one injection of hepatitis B
vaccine, or who have documented immunity to
hepatitis B
Title: Endoscopy & Polyp Surveillance:
Colonoscopy Interval for Patients with a History of
Adenomatous Polyps – Avoidance of Inappropriate
Use
Description: Percentage of patients aged 18 years
and older receiving a surveillance colonoscopy and
a history of colonic polyp(s) in a previous
colonoscopy, who had a follow-up interval of 3 or
more years since their last colonoscopy
documented in the colonoscopy report
Title: Stenosis Measurement in Carotid Imaging
Reports
Description: Percentage of final reports for
carotid imaging studies (neck MR angiography
[MRA], neck CT angiography [CTA], neck duplex
ultrasound, carotid angiogram) performed for
patients aged 18 years and older with the diagnosis
of ischemic stroke or transient ischemic attack
(TIA) that include direct or indirect reference to
measurements of distal internal carotid diameter as
the denominator for stenosis measurement
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
AMA-PCPI/NCQA
Contact Information:
[email protected]
www.ncqa.org
CMS-0033-F
NQF Measure
Number & PQRI
Implementation
Number
NQF 0022
NQF 0026
NQF 0060
NQF 0106
NQF 0107
266
Clinical Quality Measure Title & Description
Title: Drugs to be avoided in the elderly: a.
Patients who receive at least one drug to be
avoided, b. Patients who receive at least two
different drugs to be avoided.
Description: Percentage of patients ages 65 years
and older who received at least one drug to be
avoided in the elderly in the measurement year.
Percentage of patients 65 years of age and older
who received at least two different drugs to be
avoided in the elderly in the measurement year.
Title: Measure pair - a. Tobacco use prevention for
infants, children and adolescents, b. Tobacco use
cessation for infants, children and adolescents
Description: Percentage of patients' charts
showing either that there is no tobacco
use/exposure or (if a user) that the current use was
documented at the most recent clinic visit.
Percentage of patients with documented tobacco
use or exposure at the latest visit who also have
documentation that their cessation interest was
assessed or that they received advice to quit.
Title: Hemoglobin A1c test for pediatric patients
Description: Percentage of pediatric patients with
diabetes with a HBA1c test in a 12-month
measurement period.
Title: Diagnosis of attention deficit hyperactivity
disorder (ADHD) in primary care for school age
children and adolescents
Description: Percentage of patients newly
diagnosed with attention deficit hyperactivity
disorder (ADHD) whose medical record contains
documentation of Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition
(DSM-IV) or Diagnostic and Statistical Manual for
Primary Care (DSM-PC) criteria being addressed.
Title: Management of attention deficit
hyperactivity disorder (ADHD) in primary care for
school age children and adolescents
Description: Percentage of patients diagnosed
with attention deficit hyperactivity disorder
(ADHD) and on first-line medication whose
medical record contains documentation of a
follow-up visit twice a year.
Clinical Quality Measure
Steward & Contact
Information
NCQA
Contact Information:
www.ncqa.org
Institute for Clinical
Systems Improvement
(ICSI)
Contact Information:
http://www.icsi.org/
NCQA
Contact Information:
www.ncqa.org
ICSI
Contact Information:
http://www.icsi.org/
ICSI
Contact Information:
http://www.icsi.org/
CMS-0033-F
NQF Measure
Number & PQRI
Implementation
Number
NQF 0108
267
Clinical Quality Measure Title & Description
Title: ADHD: Follow-Up Care for Children
Prescribed Attention-Deficit/Hyperactivity
Disorder (ADHD) Medication.
Clinical Quality Measure
Steward & Contact
Information
NCQA
Contact Information:
www.ncqa.org
Description: a. Initiation Phase: Percentage of
children 6 – 12 years of age as of the Index
Prescription Episode Start Date with an
ambulatory prescription dispensed for and ADHD
medication and who had one follow-up visit with a
practitioner with prescribing authority during the
30-Day Initiation
NQF 0110
NQF 0299
NQF 0471
Phase b. Continuation and Maintenance (C&M)
Phase: Percentage of children 6 – 12 years of age
as of the Index Prescription Episode Start Date
with an ambulatory prescription dispensed for
ADHD medication who remained on the
medication for at least 210 days and who in
addition to the visit in the Initiation Phase had at
least two additional follow-up visits with a
practitioner within 270 days (9 months) after the
Initiation Phase ends.
Title: Bipolar Disorder and Major Depression:
Appraisal for alcohol or chemical substance use
Description: Percentage of patients with
depression or bipolar disorder with evidence of an
initial assessment that includes an appraisal for
alcohol or chemical substance use
Title: Surgical Site Infection Rate
Description: Percentage of surgical site infections
occurring within thirty days after the operative
procedure if no implant is left in place or with one
year if an implant is in place in patients who had
an NHSN operative procedure performed during a
specified time period and the infection appears to
be related to the operative procedure.
Title: Cesarean Rate for low-risk first birth women
(aka NTSV CS rate)
Description: Percentage of low-risk first birth
women (aka NTSV CS rate: nulliparous, term,
singleton, vertex) with a Cesarean rate that has the
most variation among practicioners, hospitals,
regions and states. Unlike other cesarean measures,
it focuses attention on the proportion of cesarean
births that is affected by elective medical practices
such as induction and early labor admission.
Furthermore, the success (or lack thereof) of
management of the first labor directly impacts the
remainder of the woman's reproductive life
(especially given the current high rate of repeat
cesarean births).
Center for Quality
Assessment and
Improvement in Mental
Health
Contact Information:
http://www.cqaimh.org/
Centers for Disease Control
and Prevention (CDC)
Contact Information:
http://www.cdc.gov/
California Maternal
Quality Care Collaborative
(CMQCC)
Contact Information:
http://cmqcc.org/
CMS-0033-F
NQF Measure
Number & PQRI
Implementation
Number
NQF 0513
NQF 0519
Not applicable
Not applicable
Not applicable
Not Applicable
Not Applicable
Not applicable
268
Clinical Quality Measure Title & Description
Title: Use of Contrast: Thorax CT
Description: Thorax CT – Use of combined
studies (with and without contrast)
Title: Diabetic Foot Care and Patient Education
Implemented
Description: Percent of diabetic patients for
whom physician-ordered monitoring for the
presence of skin lesions on the lower extremities
and patient education on proper foot care were
implemented during their episode of care
Title: Hysterectomy rates
Description:
Title: Appropriate antibiotic use for ear infections
Description:
Title: Statin after Myocardial Infarction
Description:
Title: 30 day Readmission Rate
Description:
Title: 30 Readmission Rate following deliveries
Description:
Title: Use of CT scans
Description: Number of repeat CT scans within 60
days
Clinical Quality Measure
Steward & Contact
Information
CMS
Contact Information:
http://www.cms.hhs.gov/
CMS
Contact Information:
http://www.cms.hhs.gov/
Comment: Some commenters requested that CMS implement feedback reports early in
the process that document whether EPs are successfully participating in the PQRI Program, the
EHR incentive program, and the e-prescribing program, and that the report communicate
whether the information received by CMS for these programs was successfully submitted and
received.
Response: As the PQRI and e-prescribing programs are beyond the scope of this rule, we
do not address suggestions that we implement feedback reports related to these programs. The
criteria to qualify for the EHR incentive payments are based on results automatically calculated
by EPs’ certified EHR technology, as attested by the EPs. As such, we believe that the EP will
be able to determine whether they have reported the required clinical quality measures to CMS
or the State, rendering it unnecessary that CMS or the State provide the EP with a feedback
CMS-0033-F
269
report. We expect the system through which EPs, must submit information would indicate
successful receipt beginning the first year of Stage 1.
Comment: A commenter indicated that the clinical quality measure that addresses
tobacco use and the measure that addresses smoking status apply to different age groups, and
stated that they should be consistent. A number of commenters recommended removing
smoking status as an objective from meaningful use section of this final rule, and only including
it in the clinical quality measures in order to avoid confusion.
Response: We are in agreement that the meaningful use objective and the clinical quality
measure address the same topic of smoking. The clinical quality measure requires measurement
of a clinical action performed by the EP to address the negative consequences of smoking,
whereas the meaningful use objective seeks to make sure smokers are identified. Additionally,
the age for recording smoking status for meaningful use is 13 years and older, and the population
addressed by the clinical quality measure is 18 years and older, thus they are different with
respect to intent of the objective/measure and the age population. For the clinical quality
measure, we are keeping the age range at 18 years and older because the measure is currently
NQF endorsed with these specifications. We will consider merging these in the future to
reconcile the age range.
Comment: Some commenters stated that reporting of ambulatory quality measures
should remain voluntary for EPs, based on the view that many process measures do not correlate
with outcomes and are not evidence based. A process measure focuses on a process which leads
to a certain outcome, meaning that a scientific basis exists for believing that the process, when
executed well, will increase the probability of achieving a desired outcome. A commenter stated
that EPs serving needy patients, minorities, and populations with lower socioeconomic levels
CMS-0033-F
270
will experience lower performance on many clinical quality measures, and therefore will be
deterred from participating in the EHR incentive program.
Response: The EHR incentive program is voluntary. Similar to other Medicare quality
measure reporting programs, EPs are not required to satisfy minimum clinical quality
performance levels in order to qualify for the EHR payment incentive, but rather merely report
on their ambulatory quality measure results. Thus, as currently structured, we do not believe the
requirement that EPs report clinical quality measures would deter EPs who serve minority
patients or patients of lower socioeconomic status or otherwise disadvantaged from participating
in the program.
After consideration of the public comments received, we are finalizing the basic
requirement that EPs submit results for clinical quality measures. This requirement applies to
both the 2011 and 2012 reporting periods (and will potentially continue to apply, until CMS
issues a subsequent final rule that supplants this final rule). We are limiting the clinical quality
measures to those for which electronic specifications are available (posted by CMS on the
website at the time of display of this final rule.) These measures are listed in Table 6 of this final
rule for EPs. They constitute the clinical quality measures “specified by CMS” for the purposes
of the ONC final rule (found elsewhere in this issue of the Federal Register) and are the
measures that certified EHRs are required to be able to calculate. Of these, nine EP measures
have preliminary electronic specifications for which we provided links for in the proposed rule.
The remaining 35 clinical quality measures for EPs were electronically specified more recently
and posted on the CMS website by the date of display of this final rule. We are finalizing only
those measures for which there are available electronic specifications as of the date of display of
this final rule. Although we are not finalizing all of 90 proposed clinical quality measures that
CMS-0033-F
271
were proposed for EPs in Table 3 (see 75 FR 1874-1889) of the proposed rule, because of lack of
electronic specifications, our intent is to include all of them in our proposed Stage 2
requirements, or to propose alternative measures following a transparent process that includes
appropriate consultation with stakeholders and other interested parties. In addition, we plan to
add new measures to fill gaps where measures were not previously proposed, such as in behavior
and mental health (e.g. depression and alcoholism). Certified EHR technology must be able to
calculate each measure numerators, denominators and exclusions for each of the clinical quality
measures finalized for the EHR incentive program. Table 6 conveys the applicable NQF
measure number and PQRI implementation number (that is, the number used in the PQRI
program to identify the measure as implemented in PQRI (for the 2010 PQRI measures list see
https://www.cms.gov/PQRI/Downloads/2010_PQRI_MeasuresList_111309.pdf)), title,
description, the owner/steward, and a link to existing electronic specifications. The NQF number
is an identifying number that is associated with the NQF endorsed measure number. All of the
clinical quality measures in Table 6 are NQF endorsed and have broad applicability to the range
of Medicare designated specialties, and the services provided by EPs who render services to
Medicare and Medicaid beneficiaries and many others. In terms of CMS and HHS healthcare
quality priorities, clinical quality PQRI measures numbered 1, 2, 3, 5, and 7 address high priority
chronic conditions, namely diabetes, coronary artery disease, and heart disease. Clinical quality
PQRI measures numbered 66, 110, 111, 112, 113, 114, 115, and 128 support screening and
prevention all of which is a high CMS and HHS priority.
272
Title: Diabetes: Blood Pressure Management
Description: Percentage of patients 18 - 75 years of age
with diabetes (type 1 or type 2) who had blood pressure
<140/90 mmHg.
Title: Heart Failure (HF): Angiotensin-Converting
Enzyme (ACE) Inhibitor or Angiotensin Receptor
Blocker (ARB) Therapy for Left Ventricular Systolic
Dysfunction (LVSD)
Description: Percentage of patients aged 18 years and
older with a diagnosis of heart failure and LVSD (LVEF
< 40%) who were prescribed ACE inhibitor or ARB
therapy.
NQF 0061
NQF 0081
4 *∗
[email protected]
American Medical
Association-sponsored
Physician Consortium for
Performance Improvement
(AMA-PCPI)
Contact Information:
www.ncqa.org
NCQA
Contact Information:
www.ncqa.org
NCQA
Contact Information:
www.ncqa.org
Clinical Quality Measure
Steward & Contact
Information
National Committee for
Quality Assurance (NCQA)
Contact Information:
http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
Electronic Measure
Specifications
Information
Core Clinical Quality
Measure
In the event that new clinical quality measures are not adopted by 2013, the clinical quality measures in this Table would continue to apply.
PQRI 5
PQRI 3
PQRI 2
Title: Diabetes: Low Density Lipoprotein (LDL)
Management and Control
Description: Percentage of patients 18-75 years of age
with diabetes (type 1 or type 2) who had LDL-C < 100
mg/dL).
Clinical Quality Measure Title & Description
Title: Diabetes: Hemoglobin A1c Poor Control
Description: Percentage of patients 18 - 75 years of age
with diabetes (type 1 or type 2) who had hemoglobin A1c
> 9.0%.
NQF 0064
PQRI 1
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0059
TABLE 6: Clinical Quality Measures for Submission by Medicare or Medicaid EPs for the 2011 and 2012 Payment Year4
CMS-0033-F
Title: Breast Cancer Screening
Description: Percentage of women 40-69 years of age
who had a mammogram to screen for breast cancer.
Title: Colorectal Cancer Screening
Description: Percentage of adults 50-75 years of age
who had appropriate screening for colorectal cancer.
NQF 0031
NQF 0034
PQRI 113
PQRI 112
PQRI 111
Title: Pneumonia Vaccination Status for Older Adults
Description: Percentage of patients 65 years of age and
older who have ever received a pneumococcal vaccine.
Clinical Quality Measure Title & Description
Title: Coronary Artery Disease (CAD): Beta-Blocker
Therapy for CAD Patients with Prior Myocardial
Infarction (MI)
Description: Percentage of patients aged 18 years and
older with a diagnosis of CAD and prior MI who were
prescribed beta-blocker therapy.
Title: Preventive Care and Screening: Influenza
Immunization for Patients 50 Years Old
Description: Percentage of patients aged 50 years and
older who received an influenza immunization during the
flu season (September through February).
NQF 0043
PQRI 110
NQF 0041
PQRI 7
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0070
CMS-0033-F
≥
www.ncqa.org
NCQA
Contact Information:
www.ncqa.org
NCQA
Contact Information:
www.ncqa.org
NCQA
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
273
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tyMeasures/03_Electronic
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Specifications.asp#TopOf
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http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
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http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
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http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
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Electronic Measure
Specifications
Information
Alternate Core
Core Clinical Quality
Measure
PQRI 12
NQF 0086
PQRI 9
NQF 0105
PQRI 8
NQF 0083
PQRI 6
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0067
CMS-0033-F
Title: Heart Failure (HF): Beta-Blocker Therapy for Left
Ventricular Systolic Dysfunction (LVSD)
Description: Percentage of patients aged 18 years and
older with a diagnosis of heart failure who also have
LVSD (LVEF < 40%) and who were prescribed betablocker therapy.
Title: Anti-depressant medication management: (a)
Effective Acute Phase Treatment,(b)Effective
Continuation Phase Treatment
Description: The percentage of patients 18 years of age
and older who were diagnosed with a new episode of
major depression, treated with antidepressant medication,
and who remained on an antidepressant medication
treatment.
Title: Primary Open Angle Glaucoma (POAG): Optic
Nerve Evaluation
Description: Percentage of patients aged 18 years and
older with a diagnosis of POAG who have been seen for
at least two office visits who have an optic nerve head
evaluation during one or more office visits within 12
months.
Clinical Quality Measure Title & Description
Title: Coronary Artery Disease (CAD): Oral Antiplatelet
Therapy Prescribed for Patients with CAD
Description: Percentage of patients aged 18 years and
older with a diagnosis of CAD who were prescribed oral
antiplatelet therapy.
[email protected]
AMA-PCPI
Contact Information:
NCQA
Contact Information:
www.ncqa.org
[email protected]
AMA-PCPI
Contact Information:
[email protected]
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
274
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tyMeasures/03_Electronic
Specifications.asp#TopOf
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tyMeasures/03_Electronic
Specifications.asp#TopOf
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http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
Page
Electronic Measure
Specifications
Information
Core Clinical Quality
Measure
PQRI 64
NQF 0001
PQRI 53
NQF 0047
PQRI 19
NQF 0089
PQRI 18
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0088
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Diabetic Retinopathy: Documentation of Presence
or Absence of Macular Edema and Level of Severity of
Retinopathy
Description: Percentage of patients aged 18 years and
older with a diagnosis of diabetic retinopathy who had a
dilated macular or fundus exam performed which
included documentation of the level of severity of
retinopathy and the presence or absence of macular
edema during one or more office visits within 12 months.
Title: Diabetic Retinopathy: Communication with the
Physician Managing Ongoing Diabetes Care
Description: Percentage of patients aged 18 years and
older with a diagnosis of diabetic retinopathy who had a
dilated macular or fundus exam performed with
documented communication to the physician who
manages the ongoing care of the patient with diabetes
mellitus regarding the findings of the macular or fundus
exam at least once within 12 months.
Title: Asthma Pharmacologic Therapy
Description: Percentage of patients aged 5 through 40
years with a diagnosis of mild, moderate, or severe
persistent asthma who were prescribed either the
preferred long-term control medication (inhaled
corticosteroid) or an acceptable alternative treatment.
Title: Asthma Assessment
Description: Percentage of patients aged 5 through 40
years with a diagnosis of asthma and who have been seen
for at least 2 office visits, who were evaluated during at
least one office visit within 12 months for the frequency
(numeric) of daytime and nocturnal asthma symptoms.
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
Clinical Quality Measure
Steward & Contact
Information
AMA-PCPI
Contact Information:
275
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Specifications.asp#TopOf
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tyMeasures/03_Electronic
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Electronic Measure
Specifications
Information
Core Clinical Quality
Measure
PQRI 102
NQF 0389
PQRI 72
NQF 0385
PQRI 71
NQF 0387
PQRI 66
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0002
CMS-0033-F
Title: Oncology Breast Cancer: Hormonal Therapy for
Stage IC-IIIC Estrogen Receptor/Progesterone Receptor
(ER/PR) Positive Breast Cancer
Description: Percentage of female patients aged 18
years and older with Stage IC through IIIC, ER or PR
positive breast cancer who were prescribed tamoxifen or
aromatase inhibitor (AI) during the 12-month reporting
period.
Title: Oncology Colon Cancer: Chemotherapy for Stage
III Colon Cancer Patients
Description: Percentage of patients aged 18 years and
older with Stage IIIA through IIIC colon cancer who are
referred for adjuvant chemotherapy, prescribed adjuvant
chemotherapy, or have previously received adjuvant
chemotherapy within the 12-month reporting period.
Title: Prostate Cancer: Avoidance of Overuse of Bone
Scan for Staging Low Risk Prostate Cancer Patients
Description: Percentage of patients, regardless of age,
with a diagnosis of prostate cancer at low risk of
recurrence receiving interstitial prostate brachytherapy,
OR external beam radiotherapy to the prostate, OR
radical prostatectomy, OR cryotherapy who did not have
a bone scan performed at any time since diagnosis of
prostate cancer.
Clinical Quality Measure Title & Description
Title: Appropriate Testing for Children with Pharyngitis
Description: Percentage of children 2-18 years of age
who were diagnosed with pharyngitis, dispensed an
antibiotic and received a group A streptococcus (strep)
test for the episode.
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
www.ncqa.org
Clinical Quality Measure
Steward & Contact
Information
NCQA
Contact Information:
276
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Specifications.asp#TopOf
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http://www.cms.gov/Quali
tyMeasures/03_Electronic
Specifications.asp#TopOf
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Electronic Measure
Specifications
Information
Core Clinical Quality
Measure
Title: Adult Weight Screening and Follow-Up
Description: Percentage of patients aged 18 years and
older with a calculated BMI in the past six months or
during the current visit documented in the medical record
AND if the most recent BMI is outside parameters, a
follow-up plan is documented.
NQF 0421
PQRI 128
PQRI 119
Title: Diabetes: Urine Screening
Description: Percentage of patients 18 - 75 years of age
with diabetes (type 1 or type 2) who had a nephropathy
screening test or evidence of nephropathy.
Clinical Quality Measure Title & Description
Title: Smoking and Tobacco Use Cessation, Medical
assistance: a. Advising Smokers and Tobacco Users to
Quit, b. Discussing Smoking and Tobacco Use Cessation
Medications, c. Discussing Smoking and Tobacco Use
Cessation Strategies
Description: Percentage of patients 18 years of age and
older who were current smokers or tobacco users, who
were seen by a practitioner during the measurement year
and who received advice to quit smoking or tobacco use
or whose practitioner recommended or discussed
smoking or tobacco use cessation medications, methods
or strategies.
Title: Diabetes: Eye Exam
Description: Percentage of patients 18 -75 years of age
with diabetes (type 1 or type 2) who had a retinal or
dilated eye exam or a negative retinal exam (no evidence
of retinopathy) by an eye care professional.
NQF 0062
PQRI 117
NQF 0055
PQRI 115
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0027
CMS-0033-F
www.usqualitymeasures.o
rg
CMS/Quality Insights of
Pennsylvania (QIP)
Contact Information:
www.ncqa.org
NCQA
Contact Information:
[email protected]
AMA-PCPI
Contact Information:
www.ncqa.org
Clinical Quality Measure
Steward & Contact
Information
NCQA
Contact Information:
277
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Specifications.asp#TopOf
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tyMeasures/03_Electronic
Specifications.asp#TopOf
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Electronic Measure
Specifications
Information
Core
Core Clinical Quality
Measure
PQRI 201
NQF 0073
PQRI 200
NQF 0084
PQRI 197
NQF 0074
PQRI 163
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0056
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Diabetes: Foot Exam
Description: The percentage of patients aged 18 - 75
years with diabetes (type 1 or type 2) who had a foot
exam (visual inspection, sensory exam with
monofilament, or pulse exam).
Title: Coronary Artery Disease (CAD): Drug Therapy
for Lowering LDL-Cholesterol
Description: Percentage of patients aged 18 years and
older with a diagnosis of CAD who were prescribed a
lipid-lowering therapy (based on current ACC/AHA
guidelines).
Title: Heart Failure (HF): Warfarin Therapy Patients
with Atrial Fibrillation
Description: Percentage of all patients aged 18 years
and older with a diagnosis of heart failure and
paroxysmal or chronic atrial fibrillation who were
prescribed warfarin therapy.
Title: Ischemic Vascular Disease (IVD): Blood Pressure
Management
Description: Percentage of patients 18 years of age and
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal coronary angioplasty
(PTCA) from January 1- November 1 of the year prior to
the measurement year, or who had a diagnosis of
ischemic vascular disease (IVD) during the measurement
year and the year prior to the measurement year and
whose recent blood pressure is in control (<140/90
mmHg).
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Electronic Measure
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Information
Core Clinical Quality
Measure
NQF 0013
NQF 0012
NQF 0004
PQRI 204
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0068
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Ischemic Vascular Disease (IVD): Use of Aspirin
or Another Antithrombotic
Description: Percentage of patients 18 years of age and
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal coronary angioplasty
(PTCA) from January 1-November 1 of the year prior to
the measurement year, or who had a diagnosis of
ischemic vascular disease (IVD) during the measurement
year and the year prior to the measurement year and who
had documentation of use of aspirin or another
antithrombotic during the measurement year.
Title: Initiation and Engagement of Alcohol and Other
Drug Dependence Treatment: (a) Initiation, (b)
Engagement
Description: The percentage of adolescent and adult
patients with a new episode of alcohol and other drug
(AOD) dependence who initiate treatment through an
inpatient AOD admission, outpatient visit, intensive
outpatient encounter or partial hospitalization within 14
days of the diagnosis and who initiated treatment and
who had two or more additional services with an AOD
diagnosis within 30 days of the initiation visit.
Title: Prenatal Care: Screening for Human
Immunodeficiency Virus (HIV)
Description: Percentage of patients, regardless of age,
who gave birth during a 12-month period who were
screened for HIV infection during the first or second
prenatal care visit.
Title: Hypertension: Blood Pressure Measurement
Description: Percentage of patient visits for patients
aged 18 years and older with a diagnosis of hypertension
who have been seen for at least 2 office visits, with blood
pressure (BP) recorded.
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Electronic Measure
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Information
Core
Core Clinical Quality
Measure
NQF 0032
NQF 0028
NQF 0024
NQF 0018
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0014
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Prenatal Care: Anti-D Immune Globulin
Description: Percentage of D (Rh) negative,
unsensitized patients, regardless of age, who gave birth
during a 12-month period who received anti-D immune
globulin at 26-30 weeks gestation.
Title: Controlling High Blood Pressure
Description: The percentage of patients 18-85 years of
age who had a diagnosis of hypertension and whose BP
was adequately controlled during the measurement year
Title: Weight Assessment and Counseling for Children
and Adolescents
Description: Percentage of patients 2 -17 years of age
who had an outpatient visit with a Primary Care
Physician (PCP) or OB/GYN and who had evidence of
BMI percentile documentation, counseling for nutrition
and counseling for physical activity during the
measurement year.
Title: Preventive Care and Screening Measure Pair: a.
Tobacco Use Assessment, b. Tobacco Cessation
Intervention
Description: Percentage of patients aged 18 years and
older who have been seen for at least 2 office visits who
were queried about tobacco use one or more times within
24 months b. Percentage of patients aged 18 years and
older identified as tobacco users within the past 24
months and have been seen for at least 2 office visits,
who received cessation intervention.
Title: Cervical Cancer Screening
Description: Percentage of women 21-64 years of age,
who received one or more Pap tests to screen for cervical
cancer
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Electronic Measure
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Information
Core
Alternate Core
Core Clinical Quality
Measure
NQF 0052
NQF 0038
NQF 0036
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0033
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Chlamydia Screening for Women
Description: Percentage of women 15- 24 years of age
who were identified as sexually active and who had at
least one test for chlamydia during the measurement
year.
Title: Use of Appropriate Medications for Asthma
Description: Percentage of patients 5 - 50 years of age
who were identified as having persistent asthma and were
appropriately prescribed medication during the
measurement year. Report three age stratifications (5-11
years, 12-50 years, and total).
Title: Childhood Immunization Status
Description: Percentage of children 2 years of age who
had four diphtheria, tetanus and acellular pertussis
(DTaP); three polio(IPV), one measles, ,mumps and
rubella (MMR); two H influenza type B (HiB); three
hepatitis B (Hep B); one chicken pox (VZV); four
pneumococcal conjugate (PCV); two hepatitis A (Hep
A); two or three rotavirus (RV); and two influenza (flu)
vaccines by their second birthday. The measure
calculates a rate for each vaccine and nine separate
combination rates.
Title: Low Back Pain: Use of Imaging Studies
Description: Percentage of patients with a primary
diagnosis of low back pain who did not have an imaging
study (plain x-ray, MRI, CT scan) within 28 days of
diagnosis.
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Electronic Measure
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Information
Alternate Core
Core Clinical Quality
Measure
NQF 0575
NQF Measure
Number &
PQRI
Implementation
Number
NQF 0075
CMS-0033-F
Clinical Quality Measure Title & Description
Title: Ischemic Vascular Disease (IVD): Complete
Lipid Panel and LDL Control
Description: Percentage of patients 18 years of age and
older who were discharged alive for acute myocardial
infarction (AMI), coronary artery bypass graft (CABG)
or percutaneous transluminal angioplasty (PTCA) from
January 1-November1 of the year prior to the
measurement year, or who had a diagnosis of ischemic
vascular disease (IVD) during the measurement year and
the year prior to the measurement year and who had a
complete lipid profile performed during the measurement
year and whose LDL-C<100 mg/dL.
Title: Diabetes: Hemoglobin A1c Control (<8.0%)
Description: The percentage of patients 18-75 years of
age with diabetes (type 1 or type 2) who had hemoglobin
A1c <8.0%.
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e. Clinical Quality Measures Reporting Criteria for EPs
For the 2011 and 2012 EHR reporting periods, to satisfy the requirements for reporting
on clinical quality measures for Medicare under section 1848(o)(2)(A)(i) and (iii) of the Act and
for Medicaid under section 1903(t)(6)(C) of the Act, we proposed to require that each EP submit
information on two measure groups: a core measures group (Table 4 of the proposed rule see
75 FR 1890), and the subset of clinical measures most appropriate given the EP’s specialty
(Tables 5 through 19 specialty group measures see 75 FR 1891 through 1895). For the core
measure group, we stated our belief that the clinical quality measures were sufficiently general in
application and of such importance to population health; we would require that all EPs treating
Medicare and Medicaid patients in the ambulatory setting report on all of the core measures as
applicable for their patients.
We proposed that with the inclusion of measures applicable to targeting children and
adolescents and the wide applicability of the measures like Blood Pressure Management, we
believed the proposed core set of clinical quality measures and specialty measures was broad
enough to enable reporting by all EPs. However, we encouraged commenters to identify the EPs
in question and propose specific remedies if the public believed that other EPs would not have
sufficient patients in the denominator of these core measures.
Comment: Several commenters requested clarification about the core measures group.
Many comments were received regarding the inclusion of a core measure set for EPs. Some
commenters favored the inclusion of one or more core measures (for example, preventive
care) and others indicated core measures were essential for improving the quality of care.
Conversely, numerous commenters suggested eliminating the core measure set for EPs. The
primary reason offered by commenters for excluding core measures was that these clinical
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quality measures were outside their scope of practice and/or not relevant to their specific patient
population. A commenter requested that the core set of clinical quality measures be better
defined and/or increased for each reporting period. Many commenters indicated the clinical
quality measures included in the core measure set are not appropriate to all EPs and specialists
(for example, EPs that do not have direct physical access to the patients such as teleradioloists,
EPs that do not routinely report blood pressure in patients with diagnosed hypertension, such as
dermatologists) and they would not be able to report on these clinical quality measures. Many
commenters supported reporting exclusions. A commenter recommended the use of PQRI
128/NQF 0421 Preventive Care and Screening: BMI Screening and Follow-up as a core clinical
quality measure. Other commenters indicated these clinical quality measures were important for
improving care and the core measure set should be expanded.
Response: After considering the comments, we agree there may be circumstances such
that the core clinical quality measures are not applicable for specific patient populations and/or a
specific EP’s scope of practice. In such circumstances we anticipate that the patients will not
appear in the denominator at all or will be excluded. We have defined the core measure set for
EPs in Table 7 of this final rule, and these core measures will be required for Stage 1. We
expanded the core measures set to include three alternate measures, as well as added PQRI
128/NQF0421 as a required core measure, based on commenters feedback. Although we require
all EPs to report the core measures, there is no requirement that the EP have any particular
number of patients in the denominator, which could be zero as calculated by the EHR. Therefore
we have changed the reporting criteria to require EPs to report on all three core measures (as
shown in Table 7, below), and three additional clinical quality measures selected from Table 6
(other than the core or alternate core measures listed in Table 6). The clinical quality measures
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included in this final rule reflect a subset of measures that were included in the proposed rule
(see 75 FR 1874 through 1889). The clinical quality measures included in Table 6 of this final
rule were selected from the Tables included in the proposed rule, based on having
electronic specifications fully developed by the date of display of this final rule.
Comment: Many commenters indicated that NQF 0022 Drugs to be avoided in the
elderly is an inappropriate clinical quality measure and should be removed. The rationale given
for removal is that the numerator (at least one prescription for any drug to be avoided in the
elderly in the measurement year or at least two different drugs to be avoided in the elderly in the
measurement year) tends to be very small. Others considered polypharmacy a more significant
problem in the elderly than avoidance of specific drugs. A number of commenters indicated this
clinical quality measure should include a list of the drugs to be avoided.
Response: We agree with the concerns expressed by the commenters and have removed
the measure NQF 0022. Additionally, electronic specifications are not available for this measure
by the date of display of this final rule making this measure impractical to use for Stage 1. We
will consider this measure in future rulemaking.
After consideration of the public comments received, we are finalizing the requirement
that all EPs must submit calculated results for three core measures using the certified EHR
technology. However, we are finalizing only two of the clinical quality measure that were
proposed as “core measures” in the proposed rule. The other core measures presented in Table 6
of this final rule were selected because they have broad applicability, support prevention, were
recommended by commenters, and have electronic specifications by the date of display of this
final rule. Insofar as a measure does not apply to patients treated by the EP, this will be reflected
in the calculation of the clinical quality measure either by the patient not being included in the
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denominator for the measure or the patient being excluded. Therefore, it is not necessary for
CMS to delineate for a particular specialty which measures may or not apply. We note that to
qualify as a meaningful EHR user, EPs need only report the required clinical quality measures;
they need not satisfy a minimum value for any of the numerator, denominator, or exclusions
fields for clinical quality measures. The value for any or all of those fields, as reported to CMS
or the States, may be zero if these are the results as displayed by the certified EHR technology.
Thus, the clinical quality measure requirement for 2011 and beginning in 2012 is a reporting
requirement and not a requirement to meet any particular performance standard for the clinical
quality measure, or to in all cases have patients that fall within the denominator of the measure.
The three core measures that EPs will be required to report are: [NQF 0013:
Hypertension: Blood Pressure Management; NQF 0028: Preventative Care and Screening
Measure Pair: a. Tobacco Use Assessment b. Tobacco Cessation Intervention; and
NQF0421/PQRI 128: Adult Weight Screening and Follow-up]. Insofar as the denominator for
one or more of the core measures is zero, EPs will be required to report results for up to three
alternate core measures [NQF 0041/PQRI 110: Preventative Care and Screening: Influenza
Immunization for Patients ≥50 Years Old; NQF 0024: Weight Assessment and Counseling for
Children and Adolescents; and NQF 0038: Childhood Immunization Status]. We believe this
final set of core clinical quality measures provides EPs a greater opportunity for successful
reporting. The EP will not be excluded from reporting any core or alternate clinical quality
measure because the measure does not apply to the EPs scope of practice or patient population.
The expectation is that the EHR will automatically report on each core clinical quality measure,
and when one or more of the core measures has a denominator of zero then the alternate core
measure(s) will be reported. If all six of the clinical quality measures in Table 7 have zeros for
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the denominators (this would imply that the EPs patient population is not addressed by these
measures), then the EP is still required to report on three additional clinical measures of their
choosing from Table 6 in this final rule. In regard to the three additional clinical quality
measures, if the EP reports zero values, then for the remaining clinical quality measures in Table
6 (other than the core and alternate core measures) the EP will have to attest that all of the other
clinical quality measures calculated by the certified EHR technology have a value of zero in the
denominator, if the EP is to be exempt from reporting any of the additional clinical quality
measures (other than the core and alternate core measures) in Table 6. Thus, EPs are not
penalized in the Stage 1 reporting years as long as they have adopted a certified EHR and that
EHR calculates and the EP submits the required information on the required clinical quality
measures, and other meaningful use requirements as defined in this final rule in section
II.A.2.d.1 of this final rule.
Table 7, below, shows the core measure groups for all EPs for Medicare and Medicaid to
report.
TABLE 7: Measure Group: Core for All EPs, Medicare and Medicaid
NQF Measure Number
& PQRI
Implementation
Number
Clinical Quality Measure Title
NQF 0013
Title: Hypertension: Blood Pressure Measurement
NQF 0028
Title: Preventive Care and Screening Measure Pair: a. Tobacco Use Assessment
b. Tobacco Cessation Intervention
NQF 0421
Title: Adult Weight Screening and Follow-up
PQRI 128
NQF 0024
NQF 0041
PQRI 110
Alternate Core Measures
Title: Weight Assessment and Counseling for Children and Adolescents
Title: Preventive Care and Screening: Influenza Immunization for Patients ≥ 50
Years Old
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NQF Measure Number
& PQRI
Implementation
Number
Clinical Quality Measure Title
NQF 0038
Title: Childhood Immunization Status
We proposed that EPs were to submit calculated results on at least one of the sets listed in
Tables 5 and 19 as specialty groups (see 75 FR 1891-1895). The specialty groups were
Cardiology, Pulmonary Diseases, Endocrinology, Oncology, Proceduralist/Surgery, Primary
Care Physicians, Pediatrics, Obstetrics and Gynecology, Neurology, Psychiatry, Ophthalmology,
Podiatry, Radiology, Gastroenterology, and Nephrology.
We recognized that clinical quality measures as specified by measures developers and as
endorsed by the NQF were not specific to particular specialties. Rather, the denominator of
clinical quality measures and the applicability of a measure is determined by the patient
population to whom the measure applies and the services rendered by the particular EP.
Nevertheless, we grouped the proposed measures according to the types of patients
commonly treated and services rendered by EPs of various specialties. We did this for purposes
similar to measures groups used in PQRI which, however, are based on clinical conditions, rather
than specialty types. We proposed that the general purpose of each specialty measures grouping
was to have standardized sets of measures, all of which must be reported by the EP for the selfselected specialty measures groups in order to meet the reporting requirements. We expected to
narrow down each set to a required subset of three-five measures based on the availability of
electronic measure specifications and comments received.
We also proposed to require for 2011 and 2012 that EPs would select a specialty
measures group, on which to report on all applicable cases for each of the measures in the
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specialty group. We also proposed that the same specialty measures group selected for the first
payment year would be required for reporting for the second payment year. We invited comment
on whether there were EPs who believed no specialty group would apply to them. In accordance
with public comments, we noted that we would specify in the final rule which EP specialties
would be exempt from selecting and reporting on a specialty measures group. As stated, we
proposed, EPs that are so-designated would be required to attest, to CMS or the States, to the
inapplicability of any of the specialty groups and would not be required to report information on
clinical quality measures from a specialty group for 2011 or 2012, though the EP would still be
required to report information on all of the clinical quality measures listed in the proposed core
measure set (see 75 FR 1890).
Comment: Several commenters asked if certain specialties, such as chiropractors,
audiologists, allergist and immunology, otolaryngologists, etc., could be exempt from having to
report all specific clinical quality specialty measures. Many of these EPs indicated the clinical
quality measures included in Table 3 were not relevant to their specific practice and/or patient
population. Other commenters requested that specialty groups be created for specialties not
included in the proposed rule measure groups, (for example, chiropractors, dentists,
dermatologists, infectious disease, pediatric oncology, neurosurgery, interventional radiology,
plastic & reconstructive surgery, physical therapists, occupational therapists, eye care specialists,
family planning, genetics, ear/nose/throat, and nutritionists providers, etc.). Other commenters
indicated that specialty clinical quality measures were specific to a subset of patients, but were
not broadly applicable to their specialty for treating other conditions within their specialty area.
Other commenters asked that CMS reconsider allowing EPs to attest only and be exempt from
reporting if no applicable clinical quality measures specialty group exists for them. Another
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commenter indicated support of specific measure sets for different clinical specialties. Many
commenters supported the elimination of specialty groups altogether as a mandatory set and
instead supported the reporting of a fixed number of relevant clinically quality measures
regardless of the specialty group. A commenter asked for a definition of “specialist” which is
not included in the proposed rule. Several commenters expressed concern about the large
number of clinical quality measures in certain measure groups versus other measure groups (for
example, the primary care, pediatric and ob/gyn measure groups) as well as the applicability of
clinical quality measures assigned to primary care EPs when they do not manage conditions that
are typically referred to a specialist for example, ischemic vascular disease. A commenter
requested clarification and suggestions on how to select a clinical quality measure group.
Several commenters wanted clarification on the proposed EP Specialty Measures Tables (see
75 FR 1874), and whether the EPs are accountable for only the clinical quality measures for their
specialty. One comment indicated agreement with CMS regarding requiring EPs to report on the
same specialty measure groups for 2011 and 2012 and another commenter indicated that CMS
should not delay reporting of clinical quality measures as early adopters of EHRs will be ready to
report. A few commenters suggested adding NQF 0033 Chlamydia screening in women to all
other appropriate specialty clinical quality measure groups. A commenter indicated that PQRI
#112, 113, and NQF 0032 should be removed from the oncology clinical quality specialty
measure group as oncologists do not perform routine cancer screenings.
Response: We are appreciative of the detail provided by commenters to the potential
inapplicability of the proposed specialty measures groups to various practitioner types or to the
inapplicability of certain measures within groups to the specialties designated. Our primary
purpose, similar to the core measures, was to encourage a certain consistency in reporting of
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clinical quality measures by EPs. However, after consideration of the comments we do not
believe that the proposed specialty measures groups are sufficient to have a robust set of
specialty measures groups. Further, given the lack of electronic specifications or final
development of many of these measures, requiring specialty measures groups becomes even
more impractical. We expect that electronic specifications will be developed for measures which
would allow for a broadly applicable set of specialty measures groups in the future.
After consideration of the public comments received, we removed the requirement for
EPs to report on specialty measures groups as proposed. We intend to reintroduce the proposed
rule’s specialty group reporting requirement in Stage 2 with at least as many clinical quality
measures by specialty as we proposed for Stage 1 in the proposed rule. We expect to use a
transparent process for clinical quality measure development that includes appropriate
consultation with specialty groups and other interested parties, and we expect that electronic
specifications will be developed for all of the measures that we originally proposed for Stage 1 or
alternative related measures, which would allow for a broadly applicable set of specialty
measures groups and promote consistency in reporting of clinical quality measures by EPs.
Also, in consideration of public comments received, we are finalizing the requirement (in
addition to the core measure requirement) that EPs must report on three measures to be selected
by the EP from the set of 38 measures as shown in Table 6, above. As stated previously, in
regard to the three additional clinical quality measures, if the EP reports zero values, then for the
remaining clinical quality measures in Table 6 (other than the core and alternate core measures)
the EP will have to attest that all of the other clinical quality measures calculated by the certified
EHR technology have a value of zero in the denominator. In sum, EPs must report on six total
measures, three core measures (substituting alternate core measures where necessary) and three
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additional measures (other than the core and alternate core measures) selected from Table 6.
We also proposed that although we do not require clinical quality measure reporting
electronically until 2012, we would require clinical quality reporting through attestation in the
2011 payment year. We solicited comment on whether it may be more appropriate to defer some
or all clinical quality reporting until the 2012 payment year. If reporting on some but not all
measures in 2011 was feasible, we solicited comment on which key measures should be chosen
for 2011 and which should be deferred until 2012 and why. We discuss comments received
regarding the reporting method for clinical quality measures in section II.A.3.h. of this final rule.
f. Clinical Quality Measures for Electronic Submission by Eligible Hospitals and CAHs
Our proposed rule would have required eligible hospitals and CAHs to report summary
data to CMS on the set of clinical quality measures identified in Table 20 and 21 of the proposed
rule (see 75 FR 1896-1899), with eligible hospitals attesting to the measures in 2011 and
electronically submitting these measures to CMS using certified EHR technology beginning in
2012. For hospitals eligible for only the Medicaid EHR incentive program, we proposed that
reporting would be to the States. In the proposed rule, for eligible hospitals under both
programs, we proposed that they would have to also report on the clinical quality measures
identified in Table 21 of the proposed rule to meet the requirements for the reporting of clinical
quality measures for the Medicaid program incentive (see 75 FR 1896 through 1900). Tables 20
and 21 of the proposed rule (see 75 FR 1896 through 1900) conveyed the clinical quality
measure's title, number, owner/developer and contact information, and a link to existing
electronic specifications where applicable.
We included in the proposed hospital measures set several clinical quality measures
which have undergone development of electronic specifications. These clinical quality measures
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have been developed for future RHQDAPU consideration. The electronic specifications were
developed through an interagency agreement between CMS and ONC to develop interoperable
standards for EHR electronic submission of the Emergency Department Throughput, Stroke, and
Venous Thromboembolism clinical quality measures on Table 20 of the proposed rule (see
75 FR 1896 through 1899). We also proposed to test the submission of these clinical quality
measures in Medicare (see 75 FR 43893). The specifications for the RHQDAPU clinical quality
measures for eligible hospitals and CAHs that are being used for testing EHR-based submission
of these clinical quality measures can be found at
http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906 (A
description of the clinical quality measure, including the clinical quality measure's numerator and
denominator, can be found here as well.) Other measures we proposed derived from the
RHQDAPU program or were measures we considered important for measuring or preventing
adverse outcomes. In addition to risk standardized readmission clinical quality measures, we
proposed that non-risk-adjusted readmission rates also be reported. For the proposed rule, we
also considered HIT Standards Committee recommendations, including the Committee’s
recommendation to include a measure on Atrial Fibrillation Receiving Anticoagulation Therapy
which was included on Table 20 of the proposed rule Our proposed rule noted that we did not
propose one measure recommended by the HIT Standards Committee: surgery patients who
received Venous Thromboembolism prophylaxis within 24 hours period to surgery to 24 hours
after surgery end time. We noted that the measure is a current clinical quality measure collected
in the RHQDAPU program through chart abstraction for all applicable patients (SCIP-VTE-2),
and that the VTE-2 clinical quality measure in Table 20 of the proposed rule (see 75 FR 1896
through 1899) was a parallel clinical quality measure to SCIP-VTE-2. SCIP-VTE-2 includes
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surgical and non-surgical patients, and can be more easily implemented for the EHR incentive
program because electronic specifications had been completed. We added SCIP-VTE-2 for
future consideration.
Comment: Many commenters recommended reducing the number of eligible hospital
clinical quality measures and indicated that such a large number of measures would pose a
significant financial and administrative burden on hospitals. Commenters suggested a variety of
solutions which include: eliminating duplication between clinical quality measures and
meaningful use objectives and associated measures, reducing the number of clinical quality
measures for reporting and allowing organizations to select a limited number of clinical quality
measures on which they would like to report.
We received comments supporting many of the measures in the proposed rule including
Venous Thromboembolism, Emergency Department, Stroke, RHQDAPU, and measures that are
evidence-based that could improve the quality of care. Others recommended additional clinical
quality measures, changes to the specifications for clinical quality measures or the elimination of
certain clinical quality measures such as risk adjusted re-admission measures or measures not
applicable to CAHs. Many commenters supported the process through which the electronic
specifications were developed for the Emergency Department Throughput, Stroke and Venous
Thromboembolism measures while also pointing out the length of time necessary to adequately
develop electronic specifications and test the clinical quality measures. Many commented that
the remaining measures had not been electronically specified or had otherwise not completed
development and would not be ready in time for the 2011-2012 implementation. Others stated
their concerns about duplicate reporting systems and the belief that the HITECH Act reporting
requirements should be based on the RHQDAPU program, similar to the conceptual framework
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of hospitals value-based purchasing plan. Others pointed to measures that are already currently
reported in RHQDAPU and the statutory provision that clinical quality measure reporting
required for the HITECH Act should seek to avoid duplicative and redundant reporting of
measures reported under RHQDAPU.
Response: We are appreciative of the comments supporting many of the clinical quality
measure sets and the process utilized for electronically specifying the Emergency Department
Throughput, Stroke, and Venous Thromboembolism sets. As we have discussed for the EP
measures, we agree that we should limit the required clinical quality measures to those measures
for where there are electronic specifications as of the date of display of this final rule. This will
allow EHR vendors sufficient time to ensure that certified EHR technology will be able to
electronically calculate the measures. Therefore, we are not finalizing those clinical quality
measures that either have not been fully developed, are currently only specified for claims based
calculation, or for which there are not fully developed electronic specifications as of the date of
display of this final rule. Accordingly, we are only finalizing the 15 measures listed in Table 10
of this final rule. We note that none of these measures are duplicate measures which are
currently required for reporting in the RHQDAPU program. We therefore do not need to address
the issue of duplicate or redundant reporting. We will consider adding, changing, developing,
and eliminating duplicative clinical quality measures and meaningful use objectives/associated
measures in future rulemaking.
Table 8, shows the proposed clinical quality measures for submission by Medicare and
Medicaid Eligible Hospitals for the 2011 and 2012 payment year as stated in the proposed rule
(see 75 FR 1896-1899) for EPs, but that are not being finalized. Table 9, shows the proposed
alternative Medicaid clinical quality measures for Medicaid eligible hospitals in the proposed
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rule (see 75 FR 1899-1900). Tables 8 and 9 convey the NQF measure number, clinical quality
measure title and description, and clinical quality measure steward and contact information. The
measures listed below in Tables 8 and 9 do not have electronic specifications finished before the
date of display of this final rule, thus we have eliminated these measures for this final rule and
will consider the addition of these measures in future rulemaking. Also several measures listed
below were only concepts at the time of publication of the proposed rule (that is, Hospital
Specific 30 day Rate following AMI admission, Hospital Specific 30 day Rate following Heart
Failure admission, Hospital Specific 30 day Rate following Pneumonia admission, and
All-Cause Readmission Index). These concept measures were not developed or electronically
specified clinical quality measures, nor NQF endorsed; and there was not adequate time to
consider these concepts for development for this final rule. Therefore, the concepts listed below
will be considered in future rulemaking.
TABLE 8: Proposed Clinical Quality Measures for Submission by Medicare or Medicaid
Eligible Hospitals for the 2011 and 2012 Payment Year; Included in the Proposed Rule (see
75 FR 1896 through 1899) and Not in the Final Rule
Measure
Number
Identifier
Emergency
Department
(ED)-3
NQF 0496
RHQDAPU
AMI-8a
NQF 0163
Measure Title, Description & Measure Developer
Title: Emergency Department Throughput – discharged patients
Median Time from ED Arrival to ED Departure for Discharged ED
Patients
Description: Median Time from ED arrival to time of departure from the
ED for patients discharged from the ED
Measure Developer: CMS/OFMQ
Title: Primary PCI Received Within 90 Minutes of Hospital Arrival
Description: Acute myocardial infarction (AMI) patients with STsegment elevation or LBBB on the ECG closest to arrival time receiving
primary PCI during the hospital stay with a time from hospital arrival to
PCI of 90 minutes or less
Measure Developer: CMS/OFMQ
CMS-0033-F
Measure
Number
Identifier
RHQDAPU
PN-3b
NQF 0148
RHQDAPU
AMI-2
NQF 0142
RHQDAPU
AMI-3
NQF 0137
RHQDAPU
AMI-5
NQF 0160
RHQDAPU
AMI-READ
297
Measure Title, Description & Measure Developer
Title: Blood Cultures Performed in the Emergency Department Prior to
Initial Antibiotic Received in Hospital
Description: Pneumonia patients whose initial emergency room blood
culture specimen was collected prior to first hospital dose of antibiotics.
This measure focuses on the treatment provided to Emergency
Department patients prior to admission orders.
Measure Developer: CMS/OFMQ
Title: Aspirin Prescribed at Discharge
Description: Acute myocardial infarction (AMI) patients who are
prescribed aspirin at hospital discharge
Measure Developer: CMS/OFMQ
Title: Angiotensin Converting Enzyme Inhibitor(ACEI) or Angiotensin
Receptor Blocker (ARB) for Left Ventricular Systolic
Dysfunction (LVSD)
Description: Acute myocardial infarction (AMI) patients with left
ventricular systolic dysfunction (LVSD) who are prescribed an ACEI or
ARB at hospital discharge. For purposes of this measure, LVSD is defined
as chart documentation of a left ventricular ejection fraction (LVEF) less
than 40% or a narrative description of left ventricular systolic (LVS)
function consistent with moderate or severe systolic dysfunction.
Measure Developer: CMS/OFMQ
Title: Beta-Blocker Prescribed at Discharge
Description: Acute myocardial infarction (AMI) patients who are
prescribed a betablocker at hospital discharge
Measure Developer: CMS/OFMQ
Title &Description: Hospital Specific 30 day Risk-Standardized
Readmission Rate following AMI admission
NQF 0505
Not
applicable
RHQDAPU
HF-READ
Measure Developer: CMS
Title: Hospital Specific 30 day Rate following AMI admission
NQF 0330
Not
applicable
RHQDAPU
PNE-READ
Measure Developer: CMS/OFMQ
Title: Hospital Specific 30 day Rate following Heart Failure admission
NQF 0506
Not
applicable
Title &Description: Hospital Specific 30 day Risk-Standardized
Readmission Rate following Heart Failure admission
Title &Description: Hospital Specific 30 day Risk-Standardized
Readmission Rate following Pneumonia admission
Measure Developer: CMS
Title: Hospital Specific 30 day Rate following Pneumonia admission
CMS-0033-F
Measure
Number
Identifier
NQF 0528
NQF 0302
NQF 0298
NQF 0140
NQF 0138
298
Measure Title, Description & Measure Developer
Title: Infection SCIP Inf-2 Prophylactic antibiotics consistent with
current recommendations
Description: Surgical patients who received prophylactic antibiotics
consistent with current guidelines (specific to each type of surgical
procedure).
Measure Developer : CMS/OFMQ
Title: Ventilator Bundle
Description: Percentage of intensive care unit patients on mechanical
ventilation at time of survey for whom all four elements of the ventilator
bundle are documented and in place. The ventilator bundle elements are:
•Head of bed (HOB) elevation 30 degrees or greater (unless medically
contraindicated); noted on 2 different shifts within a 24 hour period •Daily
"sedation interruption" and daily assessment of readiness to extubate;
process includes interrupting sedation until patient follow commands and
patient is assessed for discontinuation of mechanical ventilation;
Parameters of discontinuation include: resolution of reason for intubation;
inspired oxygen content roughly 40%; assessment of patients ability to
defend airway after extubation due to heavy sedation; minute ventilation
less than equal to 15 liters/minute; and respiratory rate/tidal volume less
than or equal to 105/min/L(RR/TV< 105)•SUD (peptic ulcer disease)
prophylaxis•DVT (deep venous thrombosis) prophylaxis
Measure Developer: IHI
Title: Central Line Bundle Compliance
Description: Percentage of intensive care patients with central lines for
whom all elements of the central line bundle are documented and in place.
The central line bundle elements include:•Hand hygiene , •Maximal
barrier precautions upon insertion •Chlorhexidine skin antisepsis •Optimal
catheter site selection, with subclavian vein as the preferred site for nontunneled catheters in patients 18 years and older •Daily review of line
necessity with prompt removal of unnecessary lines
Measure Developer: IHI
Title: Ventilator-associated pneumonia for ICU and high-risk nursery
(HRN) patients
Description: Percentage of ICU and HRN patients who over a certain
amount of days have ventilator-associated pneumonia
Measure Developer: CDC
Title: Urinary catheter-associated urinary tract infection for intensive care
unit (ICU) patients
Description: Percentage of intensive care unit patients with urinary
catheter-associated urinary tract infections
Measure Developer: CDC
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Measure
Number
Identifier
NQF 0139
NQF 0329
Not
applicable
Measure Title, Description & Measure Developer
Title: Central line catheter-associated blood stream infection rate for ICU
and high-risk nursery (HRN) patients
Description: Percentage of ICU and high-risk nursery patients, who over
a certain amount of days acquired a central line catheter-associated blood
stream infections over a specified amount of line-days
Measure Developer: CDC
Title: All-Cause Readmission Index (risk adjusted)
Description: Overall inpatient 30-day hospital readmission rate.
Measure Developer: United Health Group
Title: All-Cause Readmission Index
Description: Overall inpatient 30-day hospital readmission rate.
TABLE 9: Proposed Alternative Medicaid Clinical Quality Measures for Medicaid
Eligible Hospitals; Included in the Proposed Rule (see 75 FR 1899-1900) and Not in the
Final Rule
NQF
Measure
Number
0341
0348
0362
0151
0147
Measure Title, Description & Measure Developer
Title: PICU Pain Assessment on Admission
Description: Percentage of PICU patients receiving:
a. Pain assessment on admission
b. Periodic pain assessment.
Measure Developer: Vermont Oxford Network
Title: Iotrogenic pneumothorax in non-neonates (pediatric up to 17 years of
age)
Description: Percent of medical and surgical discharges, age under 18 years,
with ICD-9-CM-CM code of iatrogenic pneumothorax in any secondary
diagnosis field.
Measure Developer: AHRQ
Title: Foreign body left after procedure, age under 18 years
Description: Discharges with foreign body accidentally left in during
procedure per 1,000 discharges
Measure Developer: AHRQ
Title: Pneumonia Care PNE-5c Antibiotic
Description: Percentage of pneumonia patients 18 years of age and older who
receive their first dose of antibiotics within 6 hours after arrival at the hospital
Measure Developer: CMS/OFMQ
Title: Pneumonia Care PN-6 Antibiotic selection
Description: Percentage of pneumonia patients 18 years of age or older selected
for initial receipts of antibiotics for community-acquired pneumonia (CAP).
Measure Developer: CMS/OFMQ
CMS-0033-F
NQF
Measure
Number
0356
0527
0529
300
Measure Title, Description & Measure Developer
Title: Pneumonia Care PN-3a Blood culture
Description: Percent of pneumonia patients, age 18 years or older, transferred
or admitted to the ICU within 24 hours of hospital arrival who had blood
cultures performed within 24 hours prior to or 24 hours after arrival at the
hospital.
Measure Developer: CMS/OFMQ
Title: Infection SCIP Inf-1 Prophylactic antibiotic received within 1 hour prior
to surgical incision
Description: Surgical patients with prophylactic antibiotics initiated within one
hour prior to surgical incision. Patients who received vancomycin or a
fluoroquinolone for prophylactic antibiotics should have the antibiotics initiated
within two hours prior to surgical incision. Due to the longer infusion time
required for vancomycin or a fluoroquinolone, it is acceptable to start these
antibiotics within two hours prior to incision time.
Measure Developer: CMS/OFMQ
Title: Infection SCIP Inf-3 Prophylactic antibiotics discontinued within 24
hours after surgery end time
Description: Surgical patients whose prophylactic antibiotics were discontinued
within 24 hours after Anesthesia End Time.
Measure Developer: CMS/OFMQ
Comment: Commenters stated that current health information technology is not capable
of electronically collecting or reporting on clinical quality measures. Commenters also stated we
should not require reporting on clinical quality measures that cannot easily be derived from
EHRs. Other commenters believed the timeline was unreasonable to obtain the functionality
required in the EHR system to report on these clinical quality measures and were concerned that
there were no vocabulary standards.
Response: We agree with the comment that eligible hospitals should only be required to
submit information that can be automatically obtained from certified EHR technology. As we
discussed elsewhere, ONC’s final rule (found elsewhere in this issue of the Federal Register)
requires that certified EHR technology must be able to calculate clinical quality measures
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specified by us in this final rule. Standards for certified EHRs, including vocabulary standards,
are included in ONC’s final rule (found elsewhere in this issue of the Federal Register).
Comment: Commenters recommended that CMS conduct a pilot test of the NQF
endorsed HITSP electronic specifications of measures in the proposed rule for Stage 1 prior to
their adoption. Commenters requested CMS publish results of the pilot and use this information
to inform the setting of Stage 2 and 3 objectives and clinical quality measures. Commenters also
requested allowing adequate time for implementation after the pilot test before such measures are
considered for certification, and 24 months before requiring them for meaningful use. One
commenter stated that the Emergency Department Throughput, Stroke, and Venous
Thromboembolism have not yet been thoroughly tested for automated reporting and data element
capture. Additional commenters recommended that the measures selected for the eligible
hospitals incentive program should be comprehensively standardized and tested in the field to
ensure that they are thoroughly specified, clinically valid when the data are collected through the
eligible hospitals system, feasible to collect, and are regularly updated and maintained with a
well established process.
Response: We agree with the commenters that it is important to allow adequate time for
pilot testing and implementation before clinical quality measures should be considered for
certification, as well as requiring these measures for meaningful use. Emergency Department 1,
Emergency Department 2, and Stroke 3, clinical quality measures for eligible hospitals and
CAHs that are included in this final rule, were tested during the January 2010 Connectathon and
demonstrated at the HIMSS 2010 Interoperability Showcase. Additionally, as part of the process
of certification of EHR technology it is expected that certifying bodies will test the ability of
EHR technology to calculate the clinical quality measures finalized in this final rule.
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After consideration of the public comments received, eligible hospitals and CAHs will be
required to report on each of the 15 clinical quality measures, as shown in Table 10. Requiring
eligible hospitals and CAHs to report on each of the 15 clinical quality measures in the EHR
incentive program is consistent with the RHQDAPU program, which requires reporting on all
applicable quality measures. Eligible hospitals and CAHs will report numerators, denominators,
and exclusions, even if one or more values as displayed by their certified EHR is zero. We note
that to qualify as a meaningful EHR user, eligible hospitals and CAHs need only report the
required clinical quality measures; they need not satisfy a minimum value for any of the
numerator, denominator, or exclusions fields for clinical quality measures. The value for any or
all of those fields, as reported to CMS or the States, may be zero if these are the results as
displayed by the certified EHR technology. Thus, the clinical quality measure requirement for
2011 and beginning with 2012 is a reporting requirement and not a requirement to meet any
particular performance standard for the clinical quality measure, or to in all cases have patients
that fall within the denominator of the measure. Further, the criteria to qualify for the EHR
incentive payments are based on results automatically calculated by eligible hospitals or CAHs
certified EHR technology, as attested by the eligible hospital or CAH. As such, we believe that
the eligible hospitals or CAHs will be able to determine whether they have reported the required
clinical quality measures to CMS or the State, rendering it unnecessary that CMS or the State
provide the eligible hospital or CAH with a feedback report, which provides information to
eligible hospitals and CAHs as to whether they have reported their required clinical quality
measures. We expect successful receipt of Medicare eligible hospitals and CAHs’ information,
beginning the first year of Stage 1.
We are finalizing Table 10, which conveys the clinical quality measure's title, number,
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owner/steward and contact information, and a link to existing electronic specifications.
TABLE 10: Clinical Quality Measures for Submission by Eligible Hospitals and CAHs for
Payment Year 2011-20125
Measure Number
Identifier
Emergency
Department (ED)-1
NQF 0495
ED-2
NQF 0497
Stroke-2
NQF 0435
Stroke-3
NQF 0436
Stroke-4
NQF 0437
5*
Measure Title, Description & Measure Steward
Title: Emergency Department Throughput – admitted
patients Median time from ED arrival to ED departure for
admitted patients
Description: Median time from emergency department
arrival to time of departure from the emergency room for
patients admitted to the facility from the emergency
department
Measure Developer: CMS/Oklahoma Foundation for
Medical Quality (OFMQ)
Title: Emergency Department Throughput – admitted
patients
Admission decision time to ED departure time for admitted
patients
Description: Median time from admit decision time to time
of departure from the emergency department of emergency
department patients admitted to inpatient status
Measure Developer: CMS/OFMQ
Title: Ischemic stroke – Discharge on anti-thrombotics
Description: Ischemic stroke patients prescribed antithromboti
therapy at hospital discharge
Measure Developer: The Joint Commission
Title: Ischemic stroke – Anticoagulation for A-fib/flutter
Description: Ischemic stroke patients with atrial
fibrillation/flutter who are prescribed anticoagulation therapy
at hospital discharge.
Measure Developer: The Joint Commission
Title: Ischemic stroke – Thrombolytic therapy for patients
arriving within 2 hours of symptom onset
Description: Acute ischemic stroke patients who arrive at
this hospital within 2 hours of time last known well and for
whom IV t-PA was initiated at this hospital within 3 hours of
time last known well.
Measure Developer: The Joint Commission
Electronic Measure
Specifications
Information
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
In the event that new clinical quality measures are not adopted by 2013, the clinical quality measures in this Table
would continue to apply.
CMS-0033-F
Measure Number
Identifier
Stroke-5
NQF 0438
Stroke-6
NQF 0439
Stroke-8
NQF 0440
Stroke-10
NQF 0441
Venous
Thromboembolism
(VTE)-1
NQF 0371
VTE-2
NQF 0372
304
Measure Title, Description & Measure Steward
Title: Ischemic or hemorrhagic stroke – Antithrombotic
therapy by day 2
Description: Ischemic stroke patients administered
antithrombotic therapy by the end of hospital day 2.
Measure Developer: The Joint Commission
Title: Ischemic stroke – Discharge on statins
Description: Ischemic stroke patients with LDL ≥ 100
mg/dL, or LDL not measured, or, who were on a lipidlowering medication prior to hospital arrival are prescribed
statin medication at hospital discharge.
Measure Developer: The Joint Commission
Title: Ischemic or hemorrhagic stroke – Stroke education
Description: Ischemic or hemorrhagic stroke patients or
their caregivers who were given educational materials during
the hospital stay addressing all of the following: activation of
emergency medical system, need for follow-up after
discharge, medications prescribed at discharge, risk factors
for stroke, and warning signs and symptoms of stroke.
Measure Developer: The Joint Commission
Title: Ischemic or hemorrhagic stroke – Rehabilitation
assessment
Description: Ischemic or hemorrhagic stroke patients who
were assessed for rehabilitation services.
Measure Developer: The Joint Commission
Title: VTE prophylaxis within 24 hours of arrival
Description: This measure assesses the number of patients
who received VTE prophylaxis or have documentation why
no VTE prophylaxis was given the day of or the day after
hospital admission or surgery end date for surgeries that start
the day of or the day after hospital admission.
Measure Developer: The Joint Commission
Title: Intensive Care Unit VTE prophylaxis
Description: This measure assesses the number of patients
who received VTE prophylaxis or have documentation why
no VTE prophylaxis was given the day of or the day after the
initial admission (or transfer) to the Intensive Care Unit
(ICU) or surgery end date for surgeries that start the day of or
the day after ICU admission (or transfer).
Measure Developer: The Joint Commission
Electronic Measure
Specifications
Information
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
CMS-0033-F
Measure Number
Identifier
VTE-3
NQF 0373
VTE-4
NQF 0374
VTE-5
NQF 0375
VTE-6
NQF 0376
305
Measure Title, Description & Measure Steward
Title: Anticoagulation overlap therapy
Description: This measure assesses the number of patients
diagnosed with confirmed VTE who received an overlap of
parenteral (intravenous [IV] or subcutaneous [subcu])
anticoagulation and warfarin therapy. For patients who
received less than five days of overlap therapy, they must be
discharged on both medications. Overlap therapy must be
administered for at least five days with an international
normalized ratio (INR) ≥ 2 prior to discontinuation of the
parenteral anticoagulation therapy or the patient must be
discharged on both medications.
Measure Developer: The Joint Commission
Title: Platelet monitoring on unfractionated heparin
Description: This measure assesses the number of patients
diagnosed with confirmed VTE who received intravenous
(IV) UFH therapy dosages AND had their platelet counts
monitored using defined parameters such as a nomogram or
protocol.
Measure Developer: The Joint Commission
Title: VTE discharge instructions
Description: This measure assesses the number of patients
diagnosed with confirmed VTE that are discharged to home,
to home with home health, home hospice or
discharged/transferred to court/law enforcement on warfarin
with written discharge instructions that address all four
criteria: compliance issues, dietary advice, follow-up
monitoring, and information about the potential for adverse
drug reactions/interactions.
Measure Developer: The Joint Commission
Title: Incidence of potentially preventable VTE
Description: This measure assesses the number of patients
diagnosed with confirmed VTE during hospitalization (not
present on arrival) who did not receive VTE prophylaxis
between hospital admission and the day before the VTE
diagnostic testing order date.
Measure Developer: The Joint Commission
Electronic Measure
Specifications
Information
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
http://www.cms.gov/Q
ualityMeasures/03_El
ectronicSpecifications.
asp#TopOfPage
We proposed that to satisfy the requirements of reporting on clinical quality measures
under sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act for the 2011 - 2012 payment year,
we would require eligible hospitals and CAHs to report on all EHR incentive clinical quality
CMS-0033-F
306
measures for which they have applicable cases, without regard to payer. We proposed that
Medicare eligible hospitals and CAHs, who are also participating in the Medicaid EHR incentive
program, will also be required to report on all Medicaid clinical quality measures for which the
eligible hospital has applicable cases. We also proposed that to demonstrate an eligible hospital
or CAH is a meaningful EHR user, the eligible hospital or CAH would be required to
electronically submit information on each clinical quality measures for each patient to whom the
clinical quality measure applies, regardless of payer, discharged from the hospital during the
EHR reporting period and for whom the clinical quality measure is applicable. Although as
proposed, we did not require clinical quality reporting electronically until 2012, we would begin
clinical quality reporting though attestation in the 2011 payment year. We solicited comment on
whether it may be more appropriate to defer some or all clinical quality reporting until the 2012
payment year. If reporting on some but not all measures in 2011 was feasible, we solicited
comment on which key measures should be chosen for 2011 and which should be deferred until
2012 and why. Comment:We received numerous comments strongly opposed to requiring the reporting
of clinical quality measures by eligible hospitals prior to 2013, although some comments favored
the reporting in 2011 and 2012. Comments in favor pointed to the importance of quality
measurement to achieving improvement in healthcare quality. Those opposed to the reporting of
clinical quality measures in 2011 and 2012 cited concerns as to the readiness of EHR technology
for automated calculation and reporting of clinical quality measures as well as financial and
administrative burden. Many commenters stated that measures should be fully automated and
tested prior to implementation, and recommended the process for Emergency Department
Throughput, Stroke, and Venous Thromboembolism measures where CMS developed the
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specifications and has in place a plan to test the submission of such measures for RHQDAPU.
Commenters stated their expectation that the testing process would reveal important insights as
to potential challenges of electronic submission. Numerous commenters opposed measures
already in RHQDAPU and not able to be calculated by the EHR technology. Many commenters
stated that electronic data submission should be developed through the RHQDAPU program
rather than have a separate quality measure reporting program, such as the EHR incentive
program. Further, commenters stated that RHQDAPU should provide the foundation for
migration to electronic reporting. Numerous commenters were opposed to having a temporary
data collection and reporting process through attestation that would need to be updated or
replaced once CMS has the appropriate infrastructure in place. Many commenters stated that
requiring hospitals to report summary data through attestation, without the ability for CMS to
receive the summary data electronically, creates a dual reporting burden for measures currently
in RHQDAPU. Many commenters stated concerns as to the timing of the certification process
for EHRs since having a certified EHR is an essential element for quality incentives. Numerous
commenters pointed out that only 15 of the proposed measures have electronic specifications
currently available.
Response: We are sensitive to and appreciate the many comments urging us not to require
the submission of clinical quality measures, through attestation or electronic submission, prior to
2013, based on lack of readiness of many of the proposed measures, fully automating and testing
prior to implementation, burden, and the potential duplication of quality measures reporting
requirements under the RHQDAPU and the EHR incentive payment programs. Having carefully
considered these comments, we have sought to address them while still retaining the important
goal of beginning the process of using the capacity of EHRs to promote improved quality of care
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in hospitals by providing calculated results of clinical quality measures. In terms of readiness,
we are limiting the clinical quality measures to those measures having existing electronic
specifications as of the date of display of this final rule. Additionally, as recommended by
commenters, we will only require hospitals to submit that information that can be automatically
calculated by their certified EHR technology. Thus we will require no separate data collection
by the hospital, but require submission solely of that information that can be generated
automatically by the certified EHR technology; that is, we only adopt those clinical quality
measures where the certified EHR technology can calculate the results. Further, we are not
adopting any measures which are already being collected and submitted in the RHQDAPU
program. Therefore, we are imposing no duplicate reporting requirement on hospitals who
participate in RHQDAPU. Through future rulemaking we will seek to align the EHR incentive
program with RHQDAPU.
Comment: Some commenters stated that CMS contradicts itself, where the proposed rule
states that Medicare eligible hospitals who are also participating in Medicaid EHR incentive
program will need to report on all of the Medicaid clinical quality measures and where it says
that Table 21 is an alternative set of clinical quality measures if the hospital does not have any
patients in the denominators of the measures in Table 20. Many commenters requested
clarification of the Medicare and Medicaid reporting.
Response: We agree that the description of the eligible hospital and CAH reporting
requirements was unclear. To clarify, our proposal was that if a hospital could submit
information on clinical quality measures sufficient to meet the requirements for Medicare that
would also be sufficient for Medicaid. However, hospitals for which the Medicare measures did
not reflect their patient populations could satisfy the Medicaid requirements by reporting the
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alternate Medicaid clinical quality measures. Reporting the alternate Medicaid measures would
only qualify for the Medicaid program and would not qualify eligible hospitals as to the
Medicare incentive program. In this final rule, this clarification is moot, however, because we
removed the alternate Medicaid list of clinical quality measures listed in Table 21 (see
75 FR 1896 through 1900) of the proposed rule for eligible hospitals. This was based on the lack
of electronic specifications for these measures available at the time of display of this final rule.
Hospitals that report information on all 15 of the clinical quality measures, as applicable to their
patient population, will qualify for both the Medicare and the Medicaid submission requirements
for clinical quality measures. We recognize that many of the measures in the Medicare list
would likely not apply to certain hospitals, such as children’s hospitals. However, an eligible
hospital would meet the clinical quality measure requirement by reporting values for the 15
clinical quality measures, including, values of zero for the denominator, if accurate. Some value
is required for each of the 15 clinical quality measures for eligible hospitals and CAHs.
Therefore, for example, a children’s hospital would enter zero for the denominator for any of the
15 measures for which they do not have any patients as described in the measure.
After consideration of public comments received, we are finalizing 15 clinical quality
measures that eligible hospitals and CAHs will be required to report for Stage 1 (2011 and
beginning 2012), as applicable to their patient population. Those 15 clinical quality measures for
eligible hospitals and CAHs can be found in Table 10 of this final rule.
g. Potential Measures for EPs, Eligible Hospitals, and CAHs in Stage 2 and Subsequent Years
We stated our expectation that the number of clinical quality measures for which EPs,
eligible hospitals, and CAHs would be able to electronically submit information would rapidly
expand in 2013 and beyond.
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We plan to consider measures from the 2010 PQRI program. These clinical quality
measures can be found at
http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp
For future considerations of clinical quality measures for Stage 2 of meaningful use and beyond
for eligible hospitals and CAHs, we also plan to consider other clinical quality measures from the
RHQDAPU program which are identified in the FY 2010 IPPS final rule (75 FR 43868-43882).
We invited comments on inclusion of clinical quality measures for the 2013 and beyond for the
HITECH Act Medicare and Medicaid incentive program. We note that as with the other
meaningful use objectives and measures, in the event that we have not promulgated clinical
quality measures for the 2013 payment year, the measures for Stage 1 (beginning in 2011) would
continue in effect.
For the Stage 2 of meaningful use, we indicated in the proposed rule that we are
considering expanding the Medicaid EHR incentive program’s clinical quality measure set for
EPs and eligible hospitals to include clinical quality measures that address the following clinical
areas, to address quality of care for additional patient populations, and facilitate alignment with
Medicaid and CHIP programs:
• Additional pediatrics measures (such as completed growth charts, electronic
prescriptions with weight-based dosing support and documentation of newborn screening).
• Long-term care measures.
• Additional obstetrics measures.
• Dental care/oral health measures.
• Additional behavioral/mental health and substance abuse measures.
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The above list does not constitute a comprehensive list of all clinical quality measures that may
be considered. We stated that specific measures for Stage 2 of meaningful use and beyond may
be addressed by CMS in future notice and comment rulemaking. To assist us in identifying
potential clinical quality measures for future consideration for Stage 2 of meaningful use and
beyond, we solicited comments on the potential topics and/or clinical quality measures listed
above as well as suggestions for additional clinical quality measure topics and/or specific clinical
quality measures.
The following is a summary of comments received regarding the request for public
comment on potential measures for EPs, eligible hospitals, and CAHs for Stage 2 of meaningful
use and subsequent stages, and our responses.
Comment: A commenter suggested using newly adopted NQF Level 3 measures that
incorporate common electronic administrative and clinical data that represent a better measure of
the patient’s condition. A commenter suggested adding long term care and post acute care
measures in the next stage of meaningful use. A few commenters suggested future clinical
quality measures be coordinated with Healthy People 2020. Another comment regarding
measures included a request for medication measures that evaluate provider intervention. Other
commenters indicated CMS should provide a more structured process for the adoption of clinical
quality measures such that specialty EPs would have greater input into and ownership of the
process. A commenter requested consideration that future clinical quality measures address both
quality and resource use efficiency (for example potentially preventable Emergency Department
visits and hospitalizations and inappropriate use of imaging MRI for acute low back pain). A
commenter requested future clinical quality measures for the following areas: reduce hospital
readmissions and to improve medication management, specifically safe and efficient
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management of heart disease, diabetes, asthma, mental health conditions and hospital
procedures. A commenter requested clinical quality measures that will aid in increasing
improved patient safety and reduce disparities. A commenter also recommended developing
new clinical quality outcomes measures to address overuse and efficiency, care coordination, and
patient safety. Some commenters requested the inclusion of HIV testing and reporting for
preventive service quality measures. Some commenters stated that this would help to facilitate
continued efforts to promote and implement the 2006 CDC Revised Recommendation on HIV
testing, especially to non-HIV medical specialties. Some commenters recommended measure
development in the areas of community mental health, home health, renal dialysis centers, long
term care, post acute care, and nursing homes. A commenter recommended including 3 month
treatment of pulmonary emboli (NQF 0593) and deep vein thrombosis (NQF 0434) for the next
stage of meaningful use and beyond. A commenter requested including health disparity data in
all clinical quality measure analyses. Some commenters also recommended future clinical
quality measure development in the following areas: diabetes, heart disease, asthma, disease
screening, chronic disease management, patient safety, nursing sensitive measures, atrial
fibrillation, and ethnic disparities. Commenters requested expanding pediatric measures to
provide expanded focus on childhood diseases that require hospitalization such as asthma,
developmental issues and weight-based medication dosage safety issues. Additional commenters
requested measures for blood test for lead levels for children up to 1 year of age and between 1
and 2 years of age, co-morbid conditions and dental utilization. A commenter recommended that
only one EP should be accountable for the quality intervention and clinical quality measure such
as NQF 0323 Title: End Stage Renal Disease (ESRD): Plan of Care for Inadequate
Hemodialysis in ESRD Patient. The commenter indicated that this type of measure could
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involve more than one provider, for example, nephrologist and a dialysis facility. Because
provider clinical practices may vary, practice variations may independently influence patient
outcomes. Some commenters suggested future development of measures foster greater use of the
clinical information available in EHRs to improve clinical processes and evaluate patient
outcomes and suggested use of outcomes measures instead of process measures. Furthermore,
commenters support the inclusion of outcomes measures rather than process measures and
composite versus individual measures. Several commenters indicated support for the preventive
care measures included in the proposed rule and suggested expanding the set of preventive care
measures to include HIV and STD screening and eye care specialty measures. A commenter
requested CMS provide information about their strategic plan for future Medicare clinical quality
measurement selection, how they will improve care delivery, proposed stages of reporting, goals
and metrics.
Response: We are appreciative of the many suggestions and acknowledge the breadth of
interest in certified EHR technology being the vehicle for clinical quality measures reporting.
We expect to consider these suggestions for future measure selection in the Medicare and
Medicaid EHR incentive payment programs.
Comment: We received various comments pertaining to future clinical quality measures
applicable principally to the Medicaid population. One commenter urged CMS to include
clinical quality measures specific to newborn screening in Stage 1 of meaningful use for
pediatric providers.
Response: We agree that newborn screening, both as a clinical quality measure, and from
a data standards perspective, is a prime candidate for inclusion in the Stage 2 definition of
meaningful use. We affirm our proposed statement about our commitment to work with the
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measure development community to fill noted gaps. We are appreciative of the many
suggestions. We expect to consider these suggestions for immunizations, prenatal screening,
infectious disease, etc. in measure selection in future rulemaking.
Comment: A commenter indicated CMS should make explicit the health goals and
targets for the HITECH Act investments that are already implied by the proposed clinical
measures. Making them explicit allows CMS to set national targets.
Response: In general, the goal with respect to clinical quality measures is to improve
healthcare quality as measured by the clinical quality measures. We believe that specific
quantitative targets are impractical at this stage given lack of established base level notes and no
prior clinical quality measure reporting via certified EHR technology.
Comment: Several commenters asked how CMS plans to develop further measure
specifications for clinical quality measures. Another commenter asked for an electronic source
for ICD-9 and CPT codes defining the specific conditions or diagnoses or treatments in order to
maintain an up-to-date capability.
Response: For many clinical quality measures, clearly defined electronic specifications
are not yet available. In general, CMS relies on the measures’ stewards to both develop
measures and to provide the specifications. Nevertheless, we recognize that many existing
measures, some of which are owned and maintained by us or its contractors, do not currently
have electronic specifications. We are aware of work currently taking place to fill this gap. We
expect to actively work in a collaborative way with measures developers and stewards to help
assure the development of electronic specifications for clinical quality measures, but we also
expect to engage a contractor to perform work developing electronic specifications which may or
may not involve measure developers and stewards. As for CPT codes, these are copyrighted by
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and are available from the American Medical Association. The National Center for Health
Statistics (NCHS) and CMS are the U.S. governmental agencies responsible for overseeing all
changes and modifications to the ICD-9 codes.
Comment: Some commenters suggested specific new clinical quality measures which are
listed below in Table 11. Several commenters suggested new or revised clinical quality
measures or the use of existing measures from other programs.
Table 11: EP Proposed New Clinical Quality Measures
Measure Number
PQRI 27
PQRI 30
PQRI 76
PQRI 124
PQRI 126
PQRI 128
PQRI 130
PQRI 131
PQRI 148
PQRI 149
PQRI 150
PQRI 151
PQRI 154
PQRI 155
PQRI 159
PQRI 160
PQRI 161
PQRI 162
Clinical Quality Measure Title and/or
Description
Diabetes Mellitus: Diabetic foot and ankle care,
ulcer prevention evaluation of footwear;
preventive care and screening
Timely administration of prophylactic parenteral
antibiotics
Prevention of catheter related bloodstream
infections CBSI
HIT: Adoption/use of medical records
Diabetes Mellitus: Diabetic foot and ankle care,
peripheral neuropathy neurological evaluation
BMI Screening and follow-up
Documentation and Verification of Current
Medications in the Medical Record
Pain Assessment Prior to Initiation of Patient
Treatment
Back Pain: Initial Visit
Back Pain: Physical Exam
Back Pain: Advice for Normal Activities
Back Pain: Advice Against Bed Rest
Falls: Plan of care
Falls: Risk Assessment
HIV/AIDS: CD4 + Cell Count or CD4 +
Percentage
HIV/AIDS: Pneumocystis jirovecii Pneumonia
Prophylaxis
HIV/AIDS: Adolescent and Adult Patients with
HIV/AUDS who are Prescribed Potent
Antiretroviral Therapy
HIV/AIDS: HIV RNA Control After 6 Months of
Potent Antiretroviral Therapy
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Measure Number
PQRI 193
PQRI 205
PQRI 206
PQRI 207
PQRI 208
NQF 0021
NQF 0039
NQF 0058
NQF 0071
NQF 0082
NQF 0111
NQF 0116
NQF 0117
NQF 0118
NQF 0278
NQF 0477
NQF 0309
NQF 0602
NQF 0613
NQF 0632
NQF EC-20-08
NQF EC-203-08
NQF EC-227-08
NQF EC-231-08
NQF EC-232-08
NQF EC-238-08
NQF EC-252-08
316
Clinical Quality Measure Title and/or
Description
Perioperative temperature management
HIV/AIDS: STDs, Chlamydia and Gonorrhea
Screenings
HIV/AIDS: Screening for High Risk Sexual
Behaviors
HIV/AIDS: Screening for Injection Drug Use
HIV/AIDS: STDs Syphilis Screening
Therapeutic Monitoring: Annual monitoring for
patients on persistent medications
Flu Shots for Adults Ages 50-64
Inappropriate antibiotic treatment for adults with
acute bronchitis
Acute Myocardial Infarction: Persistence of BetaBlocker Treatment After a Heart Attack
Heart Failure: Patient Education
Bipolar Disorder: Appraisal for risk of suicide
CABG: Anti-Platelet Medication at Discharge
CABG: Beta Blockage at Discharge
CABG: Anti-Lipid Treatment at Discharge
Low Birth Weight
Rate of Very Low Birth Weight Deliveries
LBP: Appropriate Use of Epidural Steroid
Injections
Migraine: Adults with frequent use of acute
medications that also received prophylactic
medications
MI: Use of beta blocker therapy
Primary prevention of cardiovascular events in
diabetics (older than 40 yrs): Use of Aspirin or
Antiplatelet Therapy
Warfarin – INR Monitoring
Hyperlipidemia (Primary Prevention) – Lifestyle
changes and/or lipid lowering therapy
High Risk for Pneumococcal Disease –
Pneumococcal vaccination.
Diabetes with LDL greater than 100 – Use of
lipid lowering agent
Diabetes with Hypertension or Proteinuria – Use
of an ACE Inhibitor or ARB.
Non-diabetic Nephropathy
Chronic Kidney Disease with LDL greater than
130
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Measure Number
NQF EC-256-08
NQF EC-262-08
NQF EC-272-08
NQF EC-274-08
NQF EC-281-08
NQF EC-285-08
NQF EC-288-08
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
NA
N/A
N/A
317
Clinical Quality Measure Title and/or
Description
Male Smokers or Family History of AAA
Screening for AAA
Diabetes and elevated HbA1c – Use of diabetes
medications
Secondary Prevention of Cardiovascular Events –
Use of Aspirin or anti-platelet therapy
Primary prevention of cardiovascular events in
diabetics older than 40 yrs – Use of aspirin or anti
platelet therapy
Osteopenia and Chronic Steroid Use – Treatment
to prevent Osteoporosis
Chronic Liver Disease – Hepatitis A vaccination
Atherosclerotic Disease and LDL greater than
100-use of a Lipid Lowering Agent
Family Planning - Percent of sexually active
clients at risk for unintended pregnancy –
screened at least once annually for use of
contraceptive method at last intercourse.
Percent of patients for which EP retrieves and acts
on prescription refill data obtained through the eRx system
Percent of patients for which a generic drug has
been prescribed
Provider follow-up on growth chart information
where clinically indicated
Inappropriate Use of Antibiotics in Bronchitis
Chronic Disease Self Management Goal: Percent
of Asthmatics, Diabetics, Diagnosed
Hypertension, or Other CVD-Related Illness with
a Self-Management Goal/Readiness Plan ( 4
possible measures)
Good glycemic control: A1C < 7
Elective Preterm Induction Rate
Diabetes Mellitus A1C Frequency: Percent of
patients with Diabetes Mellitus with two A1C
measures in most recent 12 month period
Pediatric Type I Diabetes Mellitus Diabetic
Retinopathy
Performing a complete lipid panel to assess CVD
risk
Adolescent Preventive Care
Child Preventive Care
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Measure Number
N/A
N/A
N/A
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Clinical Quality Measure Title and/or
Description
Preventive Screening Lipid Disorders: Percent of
male patients over age 35 who have been
screened for lipid disorders, percent of females
over age 45 screened if they have risk factors for
CAD
Preventive Care & Screening: Screening for
Diabetes
Cervical Cancer Prevention: Percent of female
patients age 9-26 yrs who received three doses of
HPV vaccine
Asthma Action Plan: Percent of asthma patients
with a documented asthma action plan that has
been developed or updated within the past 6
months.
Asthma Assessment of Percent of asthma patients
who have a documented level of control at last
asthma visit
Asthma Assessment/Spirometry -Percent of
asthma patients ages 5 and older who received
spirometry in the past 12 months.
Asthma Assessment of Severity: Percent of
Patients who have a Documented Level of
Asthma Severity for the Last Asthma Visit
N/A
N/A
N/A
N/A
Response: Many of the proposed clinical quality measures are in the existing PQRI
program or are NQF endorsed. Others are not. We are appreciative of these many specific
suggestions and will retain the comments for future consideration. Prior to including measures
in the Medicare EHR incentive payment program, as required by the HITECH Act, we will
publish the measures in the Federal Register and provide an opportunity for public comment.
We will examine all options for soliciting public comment on future Medicaid-specific clinical
quality measures, as the Federal Register notice requirement does not apply to the Medicaid
EHR incentive program.
Comment: Some commenters suggested the following new topics for clinical quality
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measure development for our program:
Table 12: EP Proposed New Topics
Measure Number
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Proposed Clinical Quality Measure Topics
Measures dealing with overuse e.g, antibiotics and epidural
injections and unwarranted procedures-spine surgery, PTCA,
hysterectomy, CT, polypharmacy
History regarding new or changing moles
Counseling on monthly skin self exam
Melanoma patients entered into recall system
Newborn Screening
Preventing Eye Disease
Epilepsy
Health Disparities
Long Term Care
Mental Health
Substance Abuse
School Health Services for Children
Newborn Hearing and Bloodspot Screening
Children at Risk for Developmental Disabilities
Children with Chronic Disabling Conditions
Child Health-Related Quality of Life
Child Specific Health Outcomes
Lead Poisoning Screening for Children
Hepatitis A (childhood immunization)
Hepatitis B and hepatitis immune globulin (for newborns of
mothers with chronic hepatitis)
Functional Status
Use of epidural injections
Healthy Weight/Reduction in Obesity
Population-level lipid test results
Population-level Blood pressure results
Population-level Aspirin therapy
Pharmacologic Prescription for Tobacco Cessation
Alcohol/Drug Misuse
Family History for Chronic Diseases
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Measure Number
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
75, 610, 120, 355, 560,
79,
684, 132, 566, 356
N/A
N/A
N/A
N/A
N/A
N/A
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Proposed Clinical Quality Measure Topics
Sexually activity status (13+) to trigger screening for STDs
Screening pregnant women for STDs
Screening for infectious disease risk factors
Vaccine Reminders
STD HIV Screening
Central Line Placement-Related Pneumothorax for Pediatric
Population
Acute Otitis Externa-Topical Therapy, Pain assessment, and
systemic antimicrobial therapy
Otitis media with effusion (OME)- diagnostic evaluation of
tympanic membrane mobility
NQF Care Coordination Measures
Additional new pediatric measures
Radiation dose
Dental measures/Oral Health
HRSA Clinical Measures for Health Center Grantee
Performance Reviews
Patient centered quality measures
Outcomes Measures
Outpatient Measure core set (NQA/AQA/HQA)
Nutrition-related measures
Efficiency Measures
Patient Engagement Measures
Decision Support Measures
New Radiation Oncology measures
Tobacco Use Assessment
Tobacco Use Treatment
Tobacco Use Treatment at Discharge
Tobacco Use Follow-up
Preventive Screening: Tobacco Use
Preventive Screening: Falls in Older Adults
Preventive Counseling: Breastfeeding
Preventive Counseling: Use of Folic Acid
HRSA/BPHC Measures
CDS alert responses
Population health measures
Identifying patients with paroxysmal atrial fibrillation
Group practice measures
Genetic Measures
Ear, nose, throat measures
Home health
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Measure Number
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
321
Proposed Clinical Quality Measure Topics
ESRD Center measures
Adherence related measures by therapeutic class
Medication dosing for certain disease states such as diabetes
Suboptimal treatment regimens for chronic disease such as
diabetes and asthma
Absence of control therapy in persistent asthma patients
HEDIS high risk medication use in the elderly measures
TB Screening
Patient self report satisfaction
Prescribing and monitoring of psychotropic medications for
children and adolescents with psychiatric illness
Measure for treatment of ADD and other mood disorders
Measure immunizations for adolescents including TDaP,
HPV, and meningococcal.
Hepatitis B/immune globulin to newborns to mothers who
have chronic hepatitis B infection as recommended by CDC
Underutilization of medication measures
Improve active engagement of patients in their care
Improved care coordination and reduce gaps in care
Response: We appreciate the suggested measure topics submitted by commenters for
potential new clinical quality measures. Any future clinical quality measures developed will be
in consideration of the clinical practices particular to EPs and eligible hospitals. We have
captured these recommendations and will have them available for consideration in future years.
h. Reporting Method for Clinical Quality Measures for 2011 and Beginning with the 2012
Payment Year
(1) Reporting Method for 2011 Payment Year
As we previously discussed, we proposed to use attestation as a means for EPs, eligible
hospitals and CAHs, for purposes of the Medicare incentive program, to demonstrate the
meaningful use requirement for the calculation and submission of clinical quality measure results
to CMS.
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Specifically, for 2011, we proposed to require that Medicare EPs and hospitals attest to
the use of certified EHR technology to capture the data elements and calculate the results for the
applicable clinical quality measures. State Medicaid HIT Plans submitted to CMS will address
how States will verify use of certified EHR technology to capture and calculate clinical quality
measures by Medicaid EPs and eligible hospitals.
Further, we proposed to require that Medicare EPs, eligible hospitals, and CAHs attest to
the accuracy and completeness of the numerators, denominators, and exclusions submitted for
each of the applicable measures, and report the results to CMS for all applicable patients. We
expect that States will follow a similar strategy as Medicare for the Medicaid EHR incentive
program.
We proposed that attestation will utilize the same system for other attestation for
meaningful use objectives, and proposed we would require for Medicare EPs that they attest to
the following:
• The information submitted with respect to clinical quality measures was generated as
output of an identified certified EHR technology.
• The information submitted is accurate to the best of the knowledge and belief of the
EP.
• The information submitted includes information on all patients to whom the clinical
quality measure applies.
• The NPI and TIN of the EP submitting the information, and the specialty group of
clinical quality measures that are being submitted.
• For an EP who is exempt from reporting each of the core measures, an attestation that
one or more of the core measures do not apply to the scope of practice of the EP.
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• For an EP who is exempt from reporting on a specialty group, an attestation that none
of the specialty groups applies to the scope of practice of the EP.
• For an EP who does report on a specialty group, but is exempt from reporting on each
of the clinical quality measures in the group, an attestation that the clinical quality measures not
reported do not apply to any patients treated by the EP.
• The numerators, denominators, and exclusions for each clinical quality measure result
reported, providing separate information for each clinical quality measure including the
numerators, denominators, and exclusions for all patients irrespective of third party payer or lack
thereof; for Medicare FFS patients; for Medicare Advantage patients; and for Medicaid patients.
• The beginning and end dates for which the numerators, denominators, and exclusions
apply.
Again, State Medicaid Agencies will determine the required elements for provider attestations
for clinical quality measure reporting, subject to CMS prior approval via the State Medicaid HIT
Plan.
For eligible hospitals, we proposed to require that they attest to the following:
• The information submitted with respect to clinical quality measures was generated as
output from an identified certified EHR technology.
• The information submitted to the knowledge and belief of the official submitting on
behalf of the eligible hospital.
• The information submitted includes information on all patients to whom the measure
applies.
• The identifying information for the eligible hospital.
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• For eligible hospitals that do not report one or more measures an attestation that the
clinical quality measures not reported do not apply to any patients treated by the eligible hospital
during the reporting period.
• The numerators, denominators, and exclusions for each clinical quality measure result
reported, providing separate information for each clinical quality measure including the
numerators, denominators, and exclusions for all patients irrespective of third party payer or lack
thereof; for Medicare FFS patients; for Medicare Advantage patients; and for Medicaid patients.
• The beginning and end dates for which the numerators, denominators, and exclusions
apply.
The following is a summary of comments received regarding the proposed reporting
method for clinical quality measures for the 2011 payment year, and our responses.
Comment: The majority of commenters were against requiring attestation for 2011,
rather than suggesting modification of the specific attestation requirements. Others commented
that reporting should not be delayed to realize quality improvements and better health outcomes
for patients as soon as possible. Many commenters suggested deferral of clinical quality
measures submission until CMS can electronically accept data. Commenters indicated that this is
consistent with allowing delayed reporting by Medicaid providers until 2012 or beyond. A
number of commenters suggested that attestation should be confined to attesting that the EP’s
had reviewed or selected relevant clinical quality measures.
Response: While we received many comments to delay attestation past 2011, we are
finalizing our proposed requirement for EPs and eligible hospitals to attest to the numerators,
denominators, and exclusions in their first payment year for the required clinical quality
measures as described in section II.A.3.d through f of this final rule. Medicaid providers do not
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have “delayed reporting of clinical quality measures.” The statute and this final rule allow
Medicaid providers the option of receiving the EHR Incentive Payment for having adopted,
implemented or upgraded to certified EHR technology, in lieu of meeting the meaningful use bar
in their first participation year. We expect that most Medicaid providers would choose to adopt,
implement or upgrade to certified EHR technology, rather than demonstrating they are
meaningful EHR users in their first participation year.
Comment: Some commenters also suggested EPs should only have to attest that the EP
is entering the required data elements for clinical quality measure reporting where those fields
exist in the certified EHR technology and provide feedback to the vendor where structured data
fields are not available. Other commenters indicated the burden of adding numerous new data
elements is high and labor intensive.
Response: We considered the suggestion of only requiring attestation of documentation
of clinical encounters. While we agree that this could be considered “information on clinical
quality measures,” however, we do not believe that such information is needed when including
the submission of information on clinical quality measures, which is a required element of
meaningful use. We also believe that submission of such information would be of limited value.
We believe that by limiting the clinical quality measure submission requirement to those results
calculated by certified EHR technology, we have limited the potential burden.
After consideration of the public comments received, we are requiring EPs, eligible
hospitals, and CAHs to attest to the numerator, denominator, and exclusions for the payment
year 2011 at §495.8. We are finalizing the following requirements for EPs in this final rule for
reporting clinical quality measures:
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• The information submitted with respect to clinical quality measures was generated as
output of an identified certified electronic health record.
• The information submitted is accurate to the best of the knowledge and belief of the
EP.
• The information submitted includes information on all patients to whom the clinical
quality measure applies for all patients included in the certified EHR technology.
• The NPI and TIN of the EP submitting the information at §495.10.
• The numerators, denominators, and exclusions for each clinical quality measure result
reported, providing separate information for each clinical quality measure including the
numerators, denominators, and exclusions for all applicable patients contained in the certified
EHR technology irrespective of third party payer or lack thereof.
• The beginning and end dates for which the numerators, denominators, and exclusions
apply (the Medicare EHR reporting period in payment year 1 is 90 days as stated at §495.4, and
for payment year 2 is the beginning and end date of the reporting period as stated at §495.4. For
Medicaid providers, as there is no EHR reporting period for adopting, implementing or
upgrading for their first payment year, it is in their second payment year/first year of
demonstrating meaningful use that they have a 90-day EHR reporting period. Therefore, it is
their 2nd year of demonstrating meaningful use that has a 12 months EHR reporting period.
For eligible hospitals and CAHs, we are finalizing the following requirements in this final rule:
• The information submitted with respect to clinical quality measures was generated as
output from an identified certified EHR technology.
• The information submitted is accurate to the best of the knowledge and belief of the
official submitting on behalf of the eligible hospital or CAHs.
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• The information submitted includes information on all patients to whom the measure
applies for all patients included in the certified EHR technology.
• The identifying information for the eligible hospital and CAH at §495.10.
• The numerators, denominators, and exclusions for each clinical quality measure result
reported, providing separate information for each clinical quality measure including the
numerators, denominators, and exclusions for all applicable patients contained in the certified
EHR technology irrespective of third party payer or lack thereof.
• The beginning and end dates for which the numerators, denominators, and exclusions
apply (the Medicare EHR reporting period in payment year 1 is 90 days as stated at §495.4, and
for payment year 2 is the beginning and end date of the reporting period as stated at §495.4. For
Medicaid providers, as there is no EHR reporting period for adopting, implementing or
upgrading for their first payment year, it is in their second payment year/first year of
demonstrating meaningful use that they have a 90-day EHR reporting period. Therefore, it is
their 2nd year of demonstrating meaningful use that has a 12 month EHR reporting period.
States must implement the same meaningful use requirements, including clinical quality
measures, with the exceptions described in section II.A. of this final rule. Therefore, Medicaid
EPs and eligible hospitals must submit the same required information described above for
clinical quality measures. States will propose in their State Medicaid HIT Plans how they will
accept provider attestations in the first year they implement their Medicaid EHR incentive
program, and how they will accept electronic reporting of clinical quality measures from
providers’ certified EHR technology in their second and subsequent implementation years.
(2) Reporting Method Beginning In 2012
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In our proposed rule, we proposed that for the 2012 payment year, the reporting method
for clinical quality measures would be the electronic submission to CMS of summary
information, (that is, information that is not personally identifiable) on the clinical quality
measures selected by the Secretary using certified EHR technology. For Medicaid, we proposed
that EPs and hospitals eligible only for the Medicaid EHR incentive program must report their
clinical quality measures data to States. We proposed that States would propose to CMS how
they plan to accept and validate Medicaid providers' clinical quality measures data in their State
Medicaid HIT Plans, subject to CMS review and approval.
As we did for payment year 2011, for 2012, we also proposed reporting on all cases to
which a clinical quality measures applies in order to accurately assess the quality of care
rendered by the particular EP, eligible hospital, or CAH generally. Otherwise it would only be
possible to evaluate the care being rendered for a portion of patients and lessen the ability to
improve quality generally. We solicited comments on the impact of requiring the submission of
clinical quality measures data on all patients, not just Medicare and Medicaid beneficiaries.
The following is a summary of comments received regarding the proposed reporting
method beginning in 2012 in regard to the collection of aggregate level data on all patients.
Comment: Several commenters noted that it appears that EPs are supposed to submit
clinical quality measures electronically to the States in 2012. The commenters noted that several
States have aging Medicaid Management Information Systems that may not be capable of
accepting this data/information. The commenters requested clarification about whether CMS
expects the States to utilize and report this data immediately.
Response: To clarify, States may propose to CMS in their State Medicaid HIT Plans (See
Section 495.332) the means by which they want to receive providers’ clinical quality measures,
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starting with States’ second implementation year of their Medicaid EHR incentive program.
States are not obliged to receive this data using their MMIS but can consider other options such
as but not limited to: an external data warehouse, registries or health information exchanges that
include data repositories.
Comment: A commenter asked that we state the authority which provides us the ability
to require EPs and hospitals to report on non-Medicare and Medicaid patients.
Response: Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act broadly state
that as a condition of demonstrating meaningful use of certified EHR technology, an EP, CAH or
eligible hospital must “submit information” for the EHR reporting period on the clinical quality
or other measures selected by the Secretary “in a form and manner specified by the Secretary.”
Likewise, section 1903(t)(6) of the Act states that demonstrating meaningful use may include
clinical quality reporting to the States, and may be based upon the methodologies that are used in
sections 1848(o) and 1886(n). This language does not limit us to collecting only that information
pertaining to Medicare and Medicaid beneficiaries. Therefore, we believe that we have the
authority to collect summarized clinical quality measures selected by the Secretary, with respect
to all patients to whom the clinical quality measure applies, treated by the EP, eligible hospital,
or CAH. We believe that the quality of care of our EP, eligible hospitals, and CAHs, as well as
the ability to demonstrate the meaningful use of certified EHR technology, is best reflected by
the care rendered to all patients, not just Medicare or Medicaid beneficiaries.
Comment: Some commenters recommended patient level data for clinical quality
measure reporting while others supported CMS’ requirement to submit summary level data for
EPs and hospitals. There were several commenters that indicated support for reporting clinical
quality measure data on all patients rather than just on Medicare and Medicaid patients. Another
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commenter stated that CMS should not require hospitals to submit patient level data and that the
data should be at the aggregated level for all payment years. Another commenter stated that it is
well proven in other disciplines that aggregated clinical data on quality measures can drive
improvements in outcomes. Another commenter recommended patient level data that would be
useful to State health programs and link information to managed care organizations.
Response: We agree with the commenters that stated that reporting clinical quality
measure data for all patients provides a more comprehensive measure of quality. We
acknowledge that there are potential advantages to patient level data in measuring quality such as
those stated by the commenter. However, for Stage 1 we have elected to require aggregate level
data since the EHR standards as adopted by ONC’s final rule (found elsewhere in this issue of
the Federal Register) do not provide standards for the submission of patient level data.
Comment: The commenter requested that CMS should have a process in place to support
end-users with on-going help desk support.
Response: We agree with the suggestion for the implementation of a help desk to
respond to questions related to the various CMS related questions after implementation of the
proposed rule. Information about how we will provide assistance to providers will occur outside
this final rule.
Comment: A few commenters asked for clarification regarding the Stage 1 audit process
to ensure accuracy for the reporting of clinical quality measures (for example, numerator,
denominator, and exception data).
Response: EPs, eligible hospitals, and CAHs are required for 2011 to attest to results as
automatically calculated by certified EHR technology. Beginning with 2012, such information
will be submitted electronically with respect to these requirements; we expect our audit strategy
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would be based on verifying that the results submitted accord with how they were calculated by
the certified EHR technology.
Comment: We received comments requesting that CMS require that eligible providers
report their clinical quality measures data to not only States and CMS, but also to Regional
Health Improvement Collaboratives, where such programs exist. The commenters believed that
this represents an alternative means for data submission rather than attestation and would allow
States and CMS to test this alternative in 2011 or 2012. A commenter requested that CMS
interpret the statutory requirement (Sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii)) to avoid
redundant or duplicative reporting of quality measures to include not just other CMS reporting
efforts but also to avoid duplicative and redundant reporting with State and/or regional quality
measurement and reporting efforts. They therefore requested that for Medicaid, CMS require
EPs and hospitals report their clinical quality measures to not only States/CMS but also to
Regional Health Improvement Collaboratives, where such programs exist.
Response: Clinical quality measures need to be reported to CMS for the Medicare
program. For 2011, we intend to provide a web based tool for attestation. Beginning with 2012
for Medicare, we will provide one or more alternative options for electronic submission which
may include intermediaries. For Medicaid, information will go to the States as directed by the
States. We believe it would go well beyond the purview of this provision to require additional
reporting other than to CMS or the States. To clarify the issue raised by the commenter, sections
1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) are tied to the Secretary and Federally-required quality
measures reporting programs. However, CMS agrees that State and regional redundancies could
be very problematic. We therefore clarify our proposed policy. States must include in their State
Medicaid HIT Plans an environmental scan of existing HIT and quality measure reporting
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activities related to Medicaid. We expect States to include details in their SMHP about how
these other on-going efforts can be leveraged and supported under HITECH; and how HITECH
will not result in duplicative and/or burdensome reporting requirements on the same providers or
organizations.
In the proposed rule, we proposed that Medicare EPs, eligible hospitals, and CAHs would
be required to report the required clinical quality measures information electronically using
certified EHR technology via one of three methods. The primary method we proposed would
require the EP, eligible hospital, or CAH to log into a CMS-designated portal. Once the EP,
eligible hospital, or CAH has logged into the portal, they would be required to submit, through
an upload process, data payload based on specified structures, such as Clinical Data Architecture
(CDA), and accompanying templates produced as output from their certified EHR technology.
As an alternative to this data submission method, we proposed to permit Medicare EPs,
eligible hospitals, and CAHs to submit the required clinical quality measures data using certified
EHR technology through Health Information Exchange (HIE)/Health Information Organization
(HIO). This alternative data submission method would be dependent on the Secretary's ability to
collect data through a HIE/HIO network and would require the EP, eligible hospital, or CAH
who chooses to submit data via an HIE/HIO network to be a participating member of the
HIE/HIO network. Medicare EPs, eligible hospitals, and CAHs would be required to submit
their data payload based on specified structures or profiles, such as Clinical Data Architecture
(CDA), and accompanying templates. The EPs, eligible hospitals, or CAHs data payload would
be an output from their respective certified EHR technologies, in the form and manner specified
from their HIE/HIO adopted architecture into the CMS HIE/HIO adopted architecture.
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As another potential alternative, we proposed to accept submission through registries
dependent upon the development of the necessary capacity and infrastructure to do so using
certified EHRs.
We stated in the proposed rule that we intended to post the technical requirements for
portal submission and the alternative HIE/HIO submission, the HIE/HIO participating member
definition, and other specifications for submission on our web site for Medicare EPs on or before
July 1, 2011 and for Medicare eligible hospitals and CAHs on or before April 1, 2011 for EHR
adoption and incorporation and to accommodate EHR vendors.
The following is a summary of comments received regarding the proposed reporting
method for clinical quality measures beginning with the 2012 payment year, and our responses.
Comment: A commenter recommended that CMS test a range of reporting options for
clinical quality measures to establish uniform and reliable rates of data transmission. Several
commenters supported the three data submission methodologies listed in the proposed rule to
allow flexibility in the quality reporting mechanisms. Many commenters requested reporting via
registries.
Response: We agree with the desirability of considering the three transmission
methodologies listed in the proposed rule. The submission through a portal is the only
mechanism that is feasible and practical for 2012 electronic clinical quality measure submission.
We plan to test HIE/HIO and registry submission for future possible implementation through
HITECH.
Comment: A commenter requested clarification as to when CMS would no longer accept
data for 2012 for Medicare EPs.
Response: The specific technical mechanism for attestation and electronic submission
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will be posted on the CMS website, and through various educational products in development.
We anticipate that the last date for attestation or electronic submission will be two-three months
after the close of the applicable EHR reporting period for EPs, eligible hospitals, and CAHs
respectively.
Comment: Several commenters requested that CMS continue programs that incentivize
advanced patient care for providers who are not eligible for the EHR incentive program and/or
who do not become meaningful users of certified EHR technology.
Response: CMS clarifies, based upon the comments, that our efforts to avoid duplicative
quality reporting requirements do not necessarily mean the discontinuation of other quality
reporting programs. CMS and State Medicaid agencies support several quality reporting
programs that are legislatively mandated or approach quality measurement in ways that are not
exclusively tied to HIT, or that, are voluntary and/or address emerging or developing quality
measure focus areas. We are committed to determining where the EHR incentive program’s
quality measure reporting can support other quality objectives, where it cannot and how to best
align our overall quality measurement efforts across programs.
Comment: Many commenters requested deferring quality measure reporting until 2012
and/or 2013, at which time all measures will be electronically specified and tested. Commenters
believed that this was especially important for new clinical quality measures such as Emergency
Department Throughput and Stroke, and recommended gradually phasing in or gradually
increasing the number of reportable measures and measure sets over time to allow for sufficient
testing and harmonization between programs. Some commenters suggested that for Stage 1,
eligible hospitals should be required to report only on the 15 measures that have been
electronically specified and those that are appropriate for that organization. One commenter
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requested clinical quality measure reporting should be optional. Also, commenters requested for
2011 and 2012 that hospitals continue to report clinical quality measures through the current payfor-reporting (RHQDAPU and HOP QDRP) programs or on clinical quality measures that
coincide with HEDIS reporting measures including HOS and CAHPS, using the existing
approaches, while quality measurement specialists and vendors create valid, reliable, and fieldtested e-measures for deployment in the eligible hospitals for 2013. Finally, commenters stated
that the proposed timeline may negatively impact credibility of data produced and have
potentially negative impact on patient safety.
Response: With respect to comments received regarding the timeline for implementation
of the EHR incentive program, we are only finalizing clinical quality measures that are
electronically specified by the date of display of this final rule. For eligible hospitals and CAHs,
we are finalizing 15 clinical quality measures as listed in Table 10 of this final rule that will be
required to report for 2011 and 2012, as applicable to their patient population. Although we
understand the suggestion that reporting through RHQDAPU should suffice for the HITECH
Act, the difficulty is that HITECH specifically requires that EPs, eligible hospitals, and CAHs
use “certified EHR technology” in connection with the submission of clinical quality measures.
Thus the HITECH Act introduces a requirement that at least some clinical quality measures be
submitted in connection with the use of certified EHR technology, whereas RHQDAPU has no
such requirement. We have limited the measures to those that have been electronically specified
and that are able to be automatically calculated by the certified EHR technology. These results
will be reported by EPs, eligible hospitals, and CAHs. We will seek to align the EHR incentive
program and quality reporting programs in future rulemaking.
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Comment: A number of commenters urged CMS not to require submission of clinical
quality measures data beyond what a certified EHR can produce. Specifically, commenters stated
that no clinical quality measures required for submission in Stage 1 should require a manual
chart review. Some commenters also requested allowing submission of clinical quality measures
through other EHRs that are not certified.
Response: We have adopted the suggested approach for 2011 and 2012 that limits the
required information on clinical quality measures results to that which can be automatically
calculated by the certified EHR technology. As to non-certified EHR technology, the HITECH
Act incentive program specifically requires the meaningful use of certified EHR technology.
Comment: Several commenters stated that currently the data required to be used in the
calculation of clinical quality measures are obtained from EHR discrete fields, free text and
paper records. Commenters recommended a uniform reporting structure. Commenters
questioned if they would be submitting raw data, numerators and denominators only, if there will
be an intermediary file that will allow manual edits to the file prior to submission, and if not will
validity be based entirely on discrete electronic data. Commenters asked if sampling will be
permitted or if hospitals will be required to report on entire populations. Commenters supported
the value of reporting clinical quality measures for all patients, not just Medicare and Medicaid
patients, in order to see the whole picture of the patient population which will enhance quality
improvement.
Response: As discussed elsewhere, the submission requirement is limited to calculated
results of clinical quality measures from certified EHR technology, as specified in this final rule,
and as is consistent with the ONC final rule (see 75 FR 2014) which requires certified EHR
technology to be able to calculate clinical quality measures as specified by CMS.
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Comment: Several commenters suggested the clinical quality measures requiring
medication administration data be delayed for reporting because they require advanced features
of EHR systems with implementation of the features, in particular Electronic Medication
Administration Record (eMAR).
Response: The Department has adopted certification criteria for EHR Modules and
Complete EHRs, as identified in the Health Information Technology: Initial Set of Standards,
Implementation Specifications, and Certification Criteria for Electronic Health Record
Technology; Interim Final Rule (75 FR 2014). It has also proposed temporary and permanent
certification programs for testing and certifying health information technology in a
March 10, 2010 proposed rule (75 FR 11328). The certification of EHRs will assure
functionality of the information system to obtain clinical quality data from the EHR.
After consideration of the public comments received, starting in payment year 2012, in
addition to meeting requirements for measures on meaningful EHR use and other requirements,
Medicare EPs, eligible hospitals, and CAHs will be required to electronically submit clinical
quality measures results (numerators, denominators, exclusions) as calculated by certified EHR
technology at §495.8. Medicaid EPs will be required to do so in the State’s second
implementation year for their Medicaid EHR incentive program. The clinical quality measures
will be for all patients, regardless of payer, and will be for the period of the EHR reporting
period. Medicare EPs, eligible hospitals, and CAHs will be required to report the required
clinical quality measures information electronically using certified EHR technology via one of
three methods. The primary method will require the EP, eligible hospital, or CAH to log into a
CMS-designated portal. Once the EP, eligible hospital, or CAH has logged into the portal, they
will be required to submit, through an upload process, data payload based on specified structures,
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such as Clinical Data Architecture (CDA), and accompanying templates produced as output from
their certified EHR technology.
As an alternative to this data submission method, contingent on feasibility, we will permit
Medicare EPs, eligible hospitals, and CAHs to submit the required clinical quality measures data
using certified EHR technology through a Health Information Exchange (HIE)/Health
Information Organization (HIO). This alternative data submission method will be dependent on
the Secretary's ability to collect data through a HIE/HIO network and would require the EP,
eligible hospital, or CAH who chooses to submit data via an HIE/HIO network to be a
participating member of the HIE/HIO network. Medicare EPs, eligible hospitals, and CAHs
would be required to submit their data payload based on specified structures or profiles. The
EPs, eligible hospitals, or CAHs data payload should be an output from their respective certified
EHR technologies, in the form and manner specified from their HIE/HIO adopted architecture
into the CMS HIE/HIO adopted architecture.
As another alternative, we will also accept submission through registries dependent upon
the development of the necessary capacity and infrastructure to do so using certified EHRs.
Finally, qualifying Medicare Advantage organizations for their eligible Medicare Advantage
EPs, as well as, Medicare Advantage-affiliated eligible hospitals and CAHs will continue to
submit HEDIS, HOS and CAHPS data instead of the clinical quality measures results under this
final rule in section II.C.6.
We will post the technical requirements for portal submission and the alternative
HIE/HIO submission, the HIE/HIO participating member definition, and other specifications for
submission on our website for Medicare EPs on or before July 1, 2011 and for Medicare eligible
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hospitals and CAHs on or before April 1, 2011 for EHR adoption and to accommodate EHR
vendors.
State Medicaid Agencies must follow the same requirements for meaningful use,
including clinical quality measures, for example, across all payers and for the entire EHR
reporting period for EPs and eligible hospitals. We expect that States will be able to accept the
electronic reporting of clinical quality measures by their second year of implementing the EHR
incentive program. States will include in their State Medicaid HIT Plan a description of how
Medicaid providers will be able to electronically report clinical quality measures, subject to CMS
prior approval.
i. Alternative Reporting Methods for Clinical Quality Measures
We proposed several alternative reporting methods to create a dataset of providersubmitted summary data. One such alternative we proposed is the development of a distributed
network of EHRs where health information is retained locally in individual EP, eligible hospital,
and CAH EHRs and only summary reports are submitted to CMS. Another alternative we
proposed is the creation of databases of patient-level EHR data stored at the state or regional
level.
The following is a summary of comments received regarding the proposed alternative
reporting methods for clinical quality measures and our responses.
Comment: A commenter recommends aggregate reporting necessary for clinical quality
measures to be able to be completed in secondary systems such as data warehouses.
Response: For Medicare, we require that the data source be from certified EHR
technology. EPs, eligible hospitals and CAHs may use intermediaries (data warehouses) to
submit the EHR-generated clinical quality measure if available, assuming all requirements are
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States may seek CMS prior approval via their State Medicaid HIT Plans for how they
expect Medicaid providers to report the required meaningful use data, including clinical quality
measures. For example, States may propose that the data, while it originates in the providers’
certified EHR technology, may be reported using a health information exchange organization or
registry as an intermediary.
Comment: A few commenters communicated that the calculation and submission of
quality measures may depend on the use of health information technology systems beyond those
used by the EP such as data warehouses or registries that have to manipulate the data received.
They indicated the final rule should not exclude the use of additional non-certified EHR
technology to assist EPs in satisfying the quality reporting requirements provided the EP uses
certified EHR technology to capture the data and to calculate the results.
Response: Certified EHR technology will be required to calculate the clinical quality
measure results for the CMS specified measures we finalize in this final rule and transmit under
the PQRI Registry XML specification, as provided in the ONC final rule (found elsewhere in this
issue of the Federal Register).
Comment: Several commenters recommended inclusion of QRDA with PQRI XML for
reporting, thus allowing vendors the ability to bypass PQRI XML if they plan to ultimately
implement QRDA. There is also concern that switching to QRDA from XML will require
duplicative investments. They recommended attestation for 2011 and 2012 as well as allowing
use of QRDA in 2012.
Response: Electronic specifications will need to utilize standards that the certified EHR
can support. ONC’s final rule (found elsewhere in this issue of the Federal Register) limits this
to PQRI Registry XML specifications. There is no current requirement that a certified EHR be
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able to produce QRDA.
j. Reporting Period for Reporting of Clinical Quality Measures
Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act state that to demonstrate
meaningful use of certified EHR technology for an EHR reporting period, an EP, eligible
hospital, and CAH must submit information “for such period” on the clinical quality measures
and other measures selected by the Secretary. Therefore we proposed that the reporting period
for the clinical quality measures selected by the Secretary be the EHR reporting period.
Another alternative we proposed was a fixed reporting period of four quarterly reporting
periods, or two six -month reporting periods. In terms of practice and precedent for other
Medicare clinical quality measure reporting programs, all of these programs submit data to us at
specific reporting intervals.
The following is a summary of comments received regarding the proposed EHR reporting
period for EPs, eligible hospitals, and CAHs.
Comment: Some commenters asked for clarification on whether the EP must
continuously report during the “entire payment year” or whether the reporting period for clinical
quality measures covers 12 month period. Other commenters questioned the timing of the
requirements associated with the measures—whether the specifications for Stage 1 payment year
1 apply to EPs regardless of when the EPs become first eligible or whether the clinical quality
measure specifications follow the calendar year.
Response: The EP only needs to report clinical quality measures once a year, as
described at §495.4. For Medicare EPs, eligible hospitals and CAHs, the EHR reporting period
is 90 days for their first payment year. For Medicaid eligible providers, their first payment year
in which they demonstrate meaningful use (which may be their second payment year, if they
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adopted, implemented or upgraded in their first payment year) also has a 90-day EHR reporting
period. For Medicare EPs, eligible hospitals and CAHs, in their second payment year, the
reporting period is 12 months. For Medicaid EPs and eligible hospitals, in their second payment
year of demonstrating meaningful use, they also have a 12-month EHR reporting period. Related
to the timing of the requirements, the final clinical quality measure specifications for 2011 and
2012 will be posted at the time of display of this final rule.
Comment: Some commenters requested clarification of the process for reporting in the
entire payment year. A commenter requested clarification regarding whether the EP must
continuously report during the entire payment year or whether the reporting period for clinical
quality measures covers an entire 12 month period. Some commenters pointed out that reporting
capability may not be available every day of the year due to information system availability.
Response: Technical requirements for electronic reporting will be posted on the CMS
website prior to the reporting period. The reporting period refers to parameters of the data
captured in the EHR or the services documented in the EHR, not the time when the submission
of information regarding clinical quality measures is made. States will dictate for Medicaid EPs
and eligible hospitals the timing of submission of their clinical quality measures data via
electronic reporting. Submission could be as infrequent as once a year after the close of the
reporting period. The reporting period beyond 2011 and 2012 for clinical quality measures will
be determined in future rulemaking.
4. Demonstration of Meaningful Use
Section 1848(o)(3)(C) of the Act, as added by section 4101(a) of the HITECH Act,
requires that as a condition of eligibility for the incentive payment, an EP must demonstrate
meaningful use of certified EHR technology (other than the reporting on clinical quality and
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other measures) as discussed in section II.A.3 of this final rule in the manner specified by the
Secretary, which may include the following: an attestation, the submission of claims with
appropriate coding, a survey response, reporting of clinical quality or other measures, or other
means. Similarly, section 1886(n)(3)(c) of the Act, as added by section 4102(a) of the HITECH
Act, requires that hospitals seeking the incentive payment demonstrate meaningful use of
certified EHR technology in the manner specified by the Secretary. Section 1903(t)(6)(C)(i)(II)
of the Act, as added by section 4201(a)(2) under the HITECH Act, states that a Medicaid EP or
eligible hospital must demonstrate meaningful use through a “means that is approved by the
State and acceptable to the Secretary.” In addition, pursuant to section 1903(t)(9) of the Act, a
State must demonstrate to the satisfaction of the Secretary that the State is conducting adequate
oversight, including the routine tracking of meaningful use attestations and reporting
mechanisms.
a. Common Methods of Demonstration in Medicare and Medicaid
As proposed, in the final rule, we are adopting a common method for demonstrating
meaningful use in both the Medicare and Medicaid EHR incentive programs, for the same
reasons we have a uniform definition of meaningful use. The demonstration methods we adopt
for Medicare would automatically be available to the States for use in their Medicaid programs.
The Medicare methods are segmented into two parts, as discussed in section II.4.b of this final
rule. States seeking to modify or propose alternative demonstration methods must submit the
proposed methods for prior CMS approval. This process is discussed more fully in section
II.D.7.b.2.c. of this final rule.
b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use
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Our final regulations, at §495.8, will require that for CY 2011, EPs demonstrate that they
satisfy each of the fifteen objectives and their associated measures of the core set listed at
§495.6(d) and five of the objectives and their associated measures from the menu set listed at
§495.6(e) unless excluded as described in §495.6(a)(2). (An exclusion will reduce the number of
objectives/measures the EP must satisfy by the number that is equal to the EP’s exclusions. For
example, an EP that can exclude two menu objectives/measures is required to satisfy only three
of the objectives and associated measures from the menu set. Similarly, an exclusion will reduce
the number of core objectives/measures that apply). We permit only those exclusions that are
specifically indicated in the description of each objective and its associated measure (§495.6(d)
for the core set and §495.6(e) for the menu set). If an exclusion exists and the EP meets the
criteria for it, the EP would report to CMS or the States that fact rather than demonstrating that
they satisfy the objective and associated measure. At §495.8, we will require that for FY 2011,
eligible hospitals and CAHs demonstrate that they satisfy each of the fourteen objectives and
their associated measures of the core set listed at §495.6(f) and five of objectives and their
associated measures from the menu set listed at §495.6(g) unless excluded as described in
§495.6(b)(2). As with EPs, all exclusions are specifically indicated, in the description of the
objective and associated measures (§495.6(f) for the core set and §495.6(g) for the menu set) and
an exclusion will reduce the number of objectives and associated measures an eligible hospital or
CAH must satisfy (see above example for EPs). If an exclusion exists and the hospital meets the
criteria for it, the eligible hospital or CAH would report to CMS or the States that fact rather than
demonstrating that they satisfy the objective and associated measure. Finally, as specified in
495.316(d), for those participating in the Medicaid EHR incentive program, the State may alter
the requirements for demonstrating that an EP or eligible hospital is a meaningful user, with
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regard to four specific objectives and measures. For these objectives and measures, the State
may also choose to make a menu-set objective a core objective. Such State additions could
increase the core or menu set objectives and measures that must be satisfied.
For payment years beginning in CY 2012 and subsequent years, our final regulations, at
§495.8, will require that for Stage 1 of meaningful use, EPs demonstrate that they satisfy each of
the 15 objectives and their associated measures of the core set listed at §495.6(d), except
§495.6(d)(4) “Report ambulatory quality measures to CMS or, in the case of Medicaid EPs, the
states” and 5 of the objectives and their associated measures from the menu set listed at
§495.6(e) unless excluded as described in §495.6(a)(2). The form and mechanism for excluding
an objective and its associated measure is the same for CY2012 and subsequent years as it is for
CY2011. The ability for States to add certain requirements is the same for CY 2012 and
subsequent years as it is for CY 2011. The EP must demonstrate that they satisfy the objective
“Submitting quality measure to CMS or the States” through electronic reporting of clinical
quality measures to CMS or the States, as specified in section II.A.3 of this final rule. For
payment years beginning in FY2012 and subsequent years, our final regulations, at §495.8, will
require that eligible hospitals and CAHs demonstrate that they satisfy each of the fourteen
objectives and their associated measures of the core set listed at §495.6(f), except §495.6(f)(3)
“Report hospital quality measures to CMS or, in the case of Medicaid EPs, the states” and five of
the objectives and associated measures from the menu set listed at §495.6(g) unless excluded as
described in §495.6(b)(2). The form and mechanism for excluded an objective and its associated
measure is the same for FY2012 and subsequent years as it is for FY2011. The ability for States
to add certain requirements also is the same for FY 2012 and subsequent years as it is for FY
2011. The eligible hospital or CAH must demonstrate that they satisfy the objective “Submitting
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quality measure to CMS or the States” through electronic reporting of clinical quality measures
to CMS or the States, as specified in section II.A.3 of this final rule.
Except for the clinical quality measures (for which we require electronic reporting in CY
or FY 2012 and subsequent years as discussed above), satisfaction of meaningful use objectives
and associated measures may be demonstrated through attestation. Specifically, we will require
that EPs, eligible hospitals and CAHs attest through a secure mechanism, such as through claims
based reporting or an online portal. For the Medicare FFS and MA EHR incentive programs,
CMS will issue additional guidance on this mechanism. For the Medicaid EHR incentive
program, the States will include additional information in the State Medicaid HIT plans they
submit to CMS to implement the program. We will require that an EP, eligible hospital or CAH
would, through a one-time attestation following the completion of the EHR reporting period for a
given payment year, identify the certified EHR technology they are utilizing and the results of
their performance on all the measures associated with the reported objectives of meaningful use.
We would require attestation through a secure mechanism because we do not believe that HIT
will advance enough from its current state to allow for more automated and/or documented
options of demonstrating meaningful use. As HIT matures we expect to base demonstration
more on automated reporting by certified EHR technologies, such as the direct electronic
reporting of measures both clinical and non clinical and documented participation in HIE. The
first example is to the move from attestation for clinical quality measures to direct reporting in
2012 and subsequent years for EPs, eligible hospitals and CAHs. As HIT advances we expect to
move more of the objectives away from being demonstrated through attestation. However, given
the current state of HIT, we believe that imposing such demonstration requirements for 2011
would pose significant barriers to participation in the EHR incentive programs.
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We believe that the means by which EPs, eligible hospitals and CAHs demonstrate
meaningful use should work for all provider types. We also believe that uniform means of
demonstration for EPs, eligible hospitals and CAHs are preferred and that a greater burden
should not be placed on one or the other. In addition, we do not believe that demonstration of
meaningful use could require use of certified EHR technology beyond the capabilities certified
according to the ONC FR.
In addition to requiring electronic reporting of clinical quality measures beginning in
2012 in Medicare and Medicaid, we also leave open the possibility for CMS and/or the States to
test options to utilize existing and emerging HIT products and infrastructure capabilities to
satisfy other objectives of the meaningful use definition. The optional testing could involve the
use of registries or the direct electronic reporting of some measures associated with the
objectives of the meaningful use definition. We do not require any EP, eligible hospital or CAH
to participate in this testing in either 2011 or 2012 in order to receive an incentive payment. The
state of electronic exchange varies widely across the country and is dependent on numerous
Federal, State, local, non-profit and for-profit initiatives. Given this high state of flux, CMS
and/or the States would have to issue considerable updated guidance to EPs, eligible hospitals
and CAHs who wish to join in our efforts to explore the electronic exchange of information.
Any testing should be based on the principle of electronic exchange of information from certified
EHR technology either directly to the States or through an intermediary. For purposes of the
programs in this final rule it would be counterproductive for an intermediary to collect
information through paper abstraction.
We will issue further instructions on the specifics for submitting attestation through
established outreach venues.
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Comment: Several commenters submitted comments regarding the methods of
demonstration for clinical quality measures.
Response: We summarize and respond to those comments in section II.A.3 of this final
rule.
Comment: A few commenters submitted comments regarding section 1848(o)(2)(A) of
the Act, which provides discretion to the Secretary to provide for the use of alternative means for
meeting the requirements of meaningful use in the case of an eligible professional furnishing
covered professional services in a group practice. Some of these commenters suggested that
CMS provide such an alternative means in the final rule, while other suggested we consider
doing so in future rulemaking.
Response: We did not propose any alternative means in the proposed rule. Given the per
EP basis for most of the objectives and their associated measures, we did not believe group
reporting would provide an accurate reflection of meaningful use. In addition, as the incentives
payments are calculated on a per EP basis it is unclear to us how variance of meaningful use
among EPs within the group should be treated. We believe the possible reduction in burden of
attesting once per group versus once per EP is outweighed by the less accurate reporting,
increased possibility of duplicate payments and decreased transparency. We note that many of
the measures rely on data which could easily be stored at a group level such as a patient’s
demographics or medication lists and any EP with access to that information about a patient in
their certified EHR technology and who sees that same patient in the EHR reporting period
would receive credit for that patient in their numerator and denominator. Other aspects such as
the enabling of drug-drug, drug-allergy checks, using CPOE and eRx could vary widely from EP
to EP within the same group. We would also be concerned with EPs in multi-specialty group
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practices some of whom might be eligible for an exclusion, while others would not be. As
requested by commenters we will continue to review this option in future rulemaking, but for this
final rule we do not include the option to demonstrate meaningful use at a group level.
While we did not make changes to the demonstration of meaningful use requirements
based on the comments above, we did make modifications to other aspects of the Stage 1
definition of meaningful use that required the descriptions of how many and which objectives
and their associated measure EPs, eligible hospitals and CAHs to be altered accordingly. These
changes are to the first paragraph of this section (II.4.b).
5. Data Collection for Online Posting, Program Coordination, and Accurate Payments
As described below, the HITECH Act requires the Secretary to post online the names of
Medicare EPs and eligible hospitals and CAHs who are meaningful EHR users for the relevant
payment year. Section 1903(t)(2) of the Act also requires us to ensure that EPs do not receive an
EHR incentive payment under both Medicare and Medicaid. To fulfill these mandates, we must
collect several data elements from EPs and eligible hospitals. Beyond these two direct HITECH
Act requirements, CMS and the States also require certain data in order to accurately calculate
and distribute the incentive payments.
a. Online Posting
In the proposed rule, we said that section 1848(o)(3)(D) of the Act requires the Secretary
to list in an easily understandable format the names, business addresses, and business phone .
numbers of the Medicare EPs and, as determined appropriate by the Secretary, of group practices
receiving incentive payments for being meaningful EHR users under the Medicare FFS program
on our internet web site. We will not post information on group practices because we will not
base incentive payments at the group practice level. Section 1886(n)(4)(B) of the Act, as added
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by section 4102(c) of the HITECH Act, requires the Secretary to list in an easily understandable
format the names and other relevant data, as she determines appropriate, of eligible hospitals and
CAHs who are meaningful EHR users under the Medicare FFS program, on our internet web
site. Eligible hospitals and CAHs will have the opportunity to review the list before the list is
publicly posted. Sections 1853(m)(5) and 1853(l)(7) of the Act, as added by sections 4101(c)
and 4102(c) of the HITECH Act, require the Secretary to post the same information for EPs and
eligible hospitals in the MA program as would be required if they were in the Medicare FFS
program. Additionally, the Secretary must post the names of the qualifying MA organizations
receiving the incentive payment or payments. We would collect the information necessary to
post the name, business address and business phone numbers of all EPs, eligible hospitals and
CAHs participating in the Medicare FFS and MA EHR incentive programs, and to post this
information on our web site. The HITECH Act did not require Medicaid EPs and eligible
hospitals to be identified online so we will not do so.
We did not receive any comments and we are finalizing these provisions as proposed.
b. Program Election Between Medicare FFS/MA and Medicaid for EPs
In the proposed rule, we said section 1903(t)(2) of the Act prohibits an EP from receiving
incentive payments under the Medicaid program unless the EP has waived any rights to incentive
payments under the Medicare FFS or MA programs. Furthermore, section 1903(t)(7) of the Act
requires the Secretary to assure no duplication of funding with respect to the Medicaid program,
and the physician and MA incentive payments under sections 1848(o) and 1853(l) of the Act
This waiver and non-duplication requirement applies only to EPs meeting both the Medicare
FFS/MA and Medicaid EHR incentive programs eligibility criteria, and does not apply to
hospitals (which, if eligible, could receive incentive payments from both Medicare and Medicaid
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simultaneously). Section 495.10 allows an EP meeting the eligibility criteria for both the
Medicare FFS/MA and Medicaid programs to participate in either program. We would also
allow an EP to change his or her election once during the life of the EHR incentive programs
after making the initial election, for payment years 2014 and before. We believe this one-time
election rule allows an EP whose patient volume no longer makes him or her eligible for the
Medicaid program to nevertheless continue to receive incentive payments that would encourage
the meaningful use of certified EHR technology. For example, an EP who moves to a different
practice or geographically relocates practices may reduce his or her Medicaid patient volume,
and therefore become ineligible for the Medicaid incentive payments. Allowing this EP to
continue to receive incentive payments under Medicare (if eligible) continues the availability to
the EP of the incentive for meaningfully using EHR technology, and would allow EPs a certain
amount of flexibility in their operations. While allowing this flexibility creates administrative
complexity, we believe a significant number of EPs could have their participation in the EHR
incentive programs endangered due to changing circumstances unrelated to the EHR incentive
programs.
In the proposed rule, we proposed at 495.10(e)(5), that an EP switching program is
“placed in the payment year the EP would have been in, had the EP not switched programs.” For
example, if an EP decides to switch after receiving his or her Medicare FFS incentive payment
for their second payment year, then the EP would be in its third payment year for purposes of the
Medicaid incentive payments. For the final rule, we are clarifying that the EP is “placed in the
payment year the EP would have been in had the EP begun in and remained in the program to
which he or she has switched.” We have modified 495.10(e)(5) accordingly.
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We believe this clarification is necessary in order to address comments we received on
non-consecutive payments. As outlined in II.A.1.c and d of this final rule, the definition of first,
second, third, fourth, fifth, and sixth payment year differs across the Medicare and Medicaid
programs. Section 1848(o)(1)(E)(ii) of the Act requires that the second Medicare payment year
be successive to the first payment year and immediately follow it. Similarly, the third payment
year must immediately follow the second, and so on. Thus, as explained in II.A.1.c., “if a
Medicare EP receives an incentive in CY2011, but does not successfully demonstrate meaningful
use or otherwise fails to qualify for the incentive in CY2012, CY2012 still counts as one of the
EP's five payment years and they would only be able to receive an incentive under the Medicare
EHR incentive program for three more years.” The same rule, however, does not apply to the
Medicaid EHR incentive program. For that program, EP payments may generally be nonconsecutive. If an EP does not receive an incentive payment for a given CY or FY then that year
would not constitute a payment year. For example, if a Medicaid EP receives incentives in
CY2011 and CY2012, but fails to qualify for an incentive in CY 2013, they would still be
potentially eligible to receive incentives for an additional four payment years.
The rules on consecutive payment, discussed above, govern how an EP should be treated
after switching from the Medicaid to the Medicare EHR incentive program, or vice versa. As
stated above, we believe that an EP that switches from the Medicaid to the Medicare program
should be treated in the same manner as if such EP had started in the Medicare program.
Payment years that are skipped in the Medicaid EHR incentive program thus become payment
years that count against the EP’s five years of payment in Medicare. For example, an EP that
receives nonconsecutive payment under Medicaid for CYs 2011 and 2013 (but skips CY 2012),
and then switches to the Medicare program in CY 2014, is in the fourth payment year in 2014,
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and is limited to that payment year’s limit on incentive payments. Such an EP may receive only
one more year of incentive payments under the Medicare EHR incentive program. We believe
this rule is equitable, given that, had the EP started in the Medicare program, the EP would not
have been able to benefit from non-consecutive payments available under the Medicaid EHR
incentive program. We see no reason why EPs that switch from the Medicaid to the Medicare
program should be treated differently from those who initially began in the Medicare program,
and believe that any other rule might encourage gaming on the part of eligible professionals.
By the same token, an EP that switches from the Medicare to the Medicaid EHR
incentive program will not be penalized for non-consecutive payment years accrued while in the
Medicare program. For example, an EP that receives nonconsecutive payment under Medicare
for CYs 2011 and 2013 (but skips CY 2012), and then switches to the Medicaid program in CY
2014, is in the third year of payment in 2014, and is potentially eligible to receive three
additional years of payment under Medicaid (after 2014), for a total of six years of payment.
Similar to our rationale described in the paragraph above, we do not believe an EP that switches
to the Medicaid program should be treated differently from the EP that initially begins in the
Medicaid program, as once the EP switches to the Medicaid program, there is no statutory
requirement that the payment year ordering be consecutive.
We believe it is self-evident that an EP switching to a new program is subject to the
requirements of such new program. Thus, for example, an EP switching from Medicaid to
Medicare might be subject to a higher stage of meaningful use upon moving to the Medicare
program. The EP also would be subject to fewer years of payment and to the requirement that no
incentive payments may be made after 2016.
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Finally, even after lining up the payment years, it is possible for an EP to exceed the
payment cap under Medicaid by switching programs at the right time. We do not believe that the
Congress intended for the payment caps to be exceeded under any circumstance, and therefore
proposed that no EP should receive more than the maximum incentive available to them under
Medicaid, which is the higher of the two caps. The last year incentive payment would be
reduced if awarding the EP the full amount would exceed the overall maximum available under
Medicaid. This is possible if an EP receives their first two payment years from Medicare and
then the last four from Medicaid, as the cap would be exceeded by $250. If the EP receives the
HPSA bonus available under the Medicare FFS EHR incentive program, this amount could be as
much as $4,450. An EP who switches from Medicaid to Medicare could potentially exceed the
Medicare threshold in a number of circumstances; however, since they will not be allowed to
exceed the Medicaid threshold under any circumstance, we would pay the incentive for which
they are eligible for a given payment year in whichever program they are in for that payment
year until they exceed the Medicaid threshold. No incentive payments will be made to any EP
that would allow the EP to exceed the Medicaid threshold. We anticipate that this would result
in a prorated final year incentive payment. Finally, we proposed that the last year for making an
incentive payment program switch would be CY 2014. In making this proposal, we considered
that it is both the last year an EP can enroll in the Medicare EHR incentive program, and also the
last year before the payment adjustments under Medicare can begin.
Comment: We received comments requesting clarification on when an EP could make
their one switch.
Response: As described in our example, the EP could make their one switch anytime
after the receipt of an incentive payment under either the Medicare or Medicaid program. Since
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this policy would also apply to other program changes (for example, changing from one State to
another, or updating registration data elements), we want to clarify when program registration
changes can take place. An EP, eligible hospital or CAH sets into motion receipt of the incentive
payment when they attempt to demonstrate meaningful use or demonstrate to the State efforts to
adopt, implement, or upgrade to certified EHR technology. Therefore, prior to their first
successful attempt to demonstrate meaningful use or demonstrate to the State efforts to adopt,
implement, or upgrade to certified EHR technology, the EP could change their registration in
either the Medicare or Medicaid EHR incentive program as many times as they wish.
Furthermore, EPs and hospitals selecting the Medicaid incentive program may also switch freely
prior to payment as described here. However, there may only be one payment from one State in
any one payment year.
After consideration of the public comment received, we are modifying the provision at
§495.10(e)(2) to “(2) After receiving at least one EHR incentive payment, may switch between
the two EHR incentive programs only one time , and only for a payment year before 2015”. This
modification better reflects our clarification in response to the comment received on the ability to
switch between programs. For the final rule, we have made a few other technical changes to
§495.10, in addition to the changes made to §495.10(e)(2) and (e)(5).
c. Data to be Collected
In addition to information regarding the demonstration of meaningful use, in §495.10 of
this final rule we would collect the following administrative data for the Medicare and Medicaid
EHR incentive programs to fulfill our requirements of online posting, avoidance of duplication
of incentive payments, and to ensure accurate and timely incentive payments:
● Name, NPI, business address, and business phone of each EP or eligible hospital.
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● Taxpayer Identification Number (TIN) to which the EP or eligible hospital wants the
incentive payment made. For Medicaid EPs this must be consistent with assignment rules at
§495.10.
● For EPs, whether they elect to participate in the Medicare EHR incentive programs or
the Medicaid EHR incentive program.
● For eligible hospitals and CAHs, their CCN.
To coordinate with the States to avoid duplication of payments, we would make available
to the States through a single National Level Repository (NLR) the following additional data:
● Whether an EP or eligible hospital is a meaningful EHR user, and
● The remittance date and amount of any incentive payments made to an EP or eligible
hospital.
● Other information as specified by CMS.
CMS, our contractors, and the States will have access to these data elements through the
NLR maintained by CMS. The States will have to provide information to us on whether EPs or
eligible hospitals are eligible for the Medicaid incentive program, whether EPs or eligible
hospitals participating in the Medicaid program are meaningful EHR users, and when any
Medicaid incentive payments are made and the amount of the payment. We will put in place
processes for an EP or eligible hospital to change their information, including the one-time
switch in EHR incentive program election by EPs.
Comment: We received comments that some EPs do not use TINs, but rather the EPs
social security number (SSN).
Response: In these cases the EP would submit a TIN, which is their SSN. An
incorporated EP would have a TIN for the corporation that would be an EIN. The EP’s own TIN
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remains his/her SSN.
Comment: Some commenters requested clarification on whether the business address is
the physical location or the mailing address.
Response: We believe that the HITECH Act required reporting of this information to
assist the public in identifying meaningful EHR users. We believe the practice location address
serves this purpose better than the mailing address. However we will allow EPs to enter
alternate address for posting purposes but will not allow that address to be a post office box.
Comment: Commenters suggested that States would be allowed to determine the
requirements associated with Medicaid provider TIN assignments.
Response: We discuss the requirements associated with TIN assignment in 495.10(f) and
in the requirements associated with SMHPs in this preamble at section 495.332 SMHPs. States
are responsible for making sure the providers are providing an acceptable TIN, consistent with
the regulations at 495.10(f), which states that providers may only assign to certain TINs.
We clarified 495.10(f), to reflect this and other changes.
Comment: CMS received numerous comments about the schedule for and State’s role in
the national single repository where CMS will collect data elements on all registrants.
Response: The technological requirements and systems interfaces are outside this
regulation and we look forward to providing additional guidance.
Comment: Some commenters recommended a shorter record retention period that the ten
years proposed. Commenters recommended periods ranging from three to eight years. The
reasons given for a shorter time period were the cost of record retention, no perceived need for a
retention period longer than the incentive period, rapid changes in EHR technology and
consistency with other unspecified retention requirements.
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Response: After reviewing the comments, we agree with commenters that ten years in
longer than necessary to ensure the integrity of the program. In considering a shorter retention
period, we believe that there may be cause to look over the entire incentive period. As a
Medicaid EP would be eligible for incentives over a six year period if they successfully receive
an incentive each year and that is the longest such period available to any participant in the
Medicare and Medicaid EHR incentive programs, we adopt a new retention period of six years
for this final rule.
Comment: We received a comment suggesting that Medicare adopt an appeals process
similar to the one proposed for Medicaid.
Response: We expect to address Medicare appeals in future guidance.
6. Hospital-based Eligible Professionals
Section 1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of the HITECH Act,
states that hospital-based EPs are not eligible for the Medicare incentive payments. Similarly,
the majority of hospital-based EPs will not be eligible for Medicaid incentive payments under
1903(t)(2)(A) of the Act (the only exception to this rule is for those practicing predominantly in
an FQHC or RHC). Sections 4101(a) and 4201(a) of the HITECH Act originally defined the
term “hospital-based eligible professional” to mean an EP, such as a pathologist,
anesthesiologist, or emergency physician, who furnishes substantially all of his or her Medicarecovered professional services during the relevant EHR reporting period in a hospital setting
(whether inpatient or outpatient) through the use of the facilities and equipment of the hospital,
including the hospital's qualified EHRs. Following publication of our proposed rule, Congress
modified the definition of hospital-based EPs. More specifically, on April 15, 2010, President
Obama signed into law the Continuing Extension Act of 2010 (Pub.L. 111-157) which, in
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Section 5, made the following changes to the Social Security Act as it applies to both the
Medicare and Medicare EHR incentives for EPs:
(1) Medicare- Section 1848(o)(1)(C)(ii) of the Social Security Act (42 U.S.C.
1395w-4(o)(1)(C)(ii)) is amended by striking `setting (whether inpatient or outpatient)' and
inserting `inpatient or emergency room setting'.
(2) Medicaid- Section 1903(t)(3)(D) of the Social Security Act (42 U.S.C.
1396b(t)(3)(D)) is amended by striking `setting (whether inpatient or outpatient)' and inserting
`inpatient or emergency room setting'.
These amendments were effective as if included in the enactment of the HITECH Act.
The above sections indicate that the determination of whether an EP is a hospital-based
EP shall be made on the basis of the site of service, as defined by the Secretary, and without
regard to any employment or billing arrangement between the EP and any other provider. For
example, the hospital-based determination for an EP would not be affected by whether the EP is
an employee of the hospital, under a contractual relationship with the hospital, or with respect to
whether he or she has made a reassignment to the hospital for Part B billing purposes.
In addition, as discussed below, section 1848(a)(7)(D) of the Act, as added by section
4101(b) of the HITECH Act, exempts hospital-based EPs from the downward payment
adjustment applied under section 1848(a)(7)(A)(i) of the Act to covered professional services
provided during a payment year by EPs who are not meaningful EHR users for the relevant
payment year beginning in 2015.
Based on section 4101(a) of the HITECH Act (and prior to the amendments in the
Continuing Extension Act of 2010), we proposed that an EP would be a hospital based EP and
therefore ineligible to receive a Medicare or Medicaid EHR incentive payment if more than 90
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percent of their services are provided in the following place of service (POS) codes for HIPAA
standard transactions: 21—Inpatient Hospital, 22 – Outpatient Hospital, 23 – Emergency Room.
In addition, because of concerns that some primary care EPs who provide services to
Medicare and Medicaid beneficiaries would be ineligible for the incentive payments under this
proposed definition, in the proposed rule, we asked for comments on whether we should use
another method for defining hospital-based EPs. We estimated that under this proposal, 12–13
percent of family practitioners under Medicare would be considered hospital-based. We did not
have corresponding data for Medicaid EPs.
Comment: Many congressional representatives, hospital associations, individual
providers and other commenters indicated that they believed that the proposal would
inappropriately exclude from receiving EHR incentive payments EPs practicing in ambulatory
settings such as those that practice in hospital provider-based departments (referred to by most
commenters as “outpatient centers and clinics”). They indicated these centers and clinics
provide services similar to services furnished by EPs in private offices. Many suggested that this
definition may inhibit hospital investments in their outpatient primary care sites. Commenters
believe the absence of any EP incentive payment in these settings may discourage hospitals from
adopting EHR in ambulatory settings, particularly if doing so requires the purchase of an
ambulatory-based EHR system (or an ambulatory component to be added to the hospital’s EHR
system.) This is because the hospital's total incentive payment is based on total inpatient
services. A hospital with a large outpatient department will not receive a higher incentive
payment as a result of their outpatient services. These commenters indicated that ambulatory
care EHRs are very different from inpatient EHRs because of the inherent differences between
the types of care provided in each setting. Commenters differed somewhat to the extent that they
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provided specific alternatives. Some commenters went so far as to suggest that all EPs should be
eligible to receive EHR incentive payments, regardless of where they practice.
Response: The changes to the hospital-based definition that are included in the
Continuing Extension Act of 2010 (Pub. L. 111-157) discussed above address commenters
concerns about ambulatory settings. These changes have been incorporated into the final rule.
An EP will be a hospital based EP and therefore ineligible to receive a Medicare (or Medicaid)
EHR incentive payment if more than 90 percent of their Medicare (or Medicaid) services are
provided in the following two place of service (POS) codes for HIPAA standard transactions:
21—Inpatient Hospital, 23 – Emergency Room.
Comment: Some commenters argued that the proposed rule failed to make a critical
distinction between hospital-based EPs who primarily use an EHR paid for and maintained by
the hospital and those that did not. Some commenters suggested that an EP should be eligible for
an EHR incentive payment if he or she had contributed 15 percent or more toward the cost of
acquiring or maintaining the certified EHR. Some commenters requested that CMS change the
definition of a hospital-based EP to read: “An EP who furnishes 90 percent or more of his or her
covered professional services in the CY preceding the payment year in a hospital setting and
primarily through the use of the qualified electronic health records of the hospital.” The
commenters believed that Congress’s intent was to exclude only those EPs using qualified EHRs
of the hospital, and that their approach would allow separate EHR incentive payments for EPs
who have developed cutting-edge, patient centered EHR modules, thereby allowing for a clinical
specificity not currently available in more generalized, hospital-wide EHR systems.
Commenters stated that these EHR technologies are currently used in hospital settings and
interoperate with hospital systems, but are paid for and primarily maintained by physician groups
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who see patients in hospital settings. The commenters indicate that these physician groups
continue to invest in their EHRs through improvements, ongoing maintenance, and support staff
employed to ensure optimal use of such technology. The commenters indicated that many early
health IT champions, including hospital-based anesthesiologists, radiologists, pathologists,
hospitalists, emergency medicine physicians, and neonatal physicians would be negatively
affected by the proposal. These comments would apply to EP services provided in all hospital
settings, including inpatient, outpatient, and emergency rooms.
Response: The statute, as now amended, indicates that hospital-based EPs are those who
furnish substantially all their services in an inpatient or emergency room setting, such as a
pathologist, anesthesiologist, or emergency physician, and who do so using the facility and
equipment, including qualified electronic health care records, of the hospital. While commenters
focused on the statutory language: “…including qualified electronic health care records of the
hospital”, they did not address the broader meaning of the section which also includes the
requirement that hospital-based EPs are those who furnish services “using the facility and
equipment”, including qualified electronic health care records of the hospital. We believe both
phrases together are intended to provide an explanation of why hospital-based EPs are to be
excluded from receiving EHR incentive payments (that is, that they would typically use the
facilities and equipment, including the EHR, of the hospital and that therefore it would represent
double payment if both hospitals and hospital-based EPs were to be paid incentives). We do not
believe that the intent of this language was to require CMS to evaluate each EP as to whether
they are using the EHR of the hospital. Further, the commenters did not address the significance
of the next sentence of the statute, which clearly indicates that: “The determination of whether an
eligible professional is a hospital-based eligible professional shall be made on the basis of the
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site of service…”. Since Congress directed that site of service must be the determinant of
whether an EP is hospital-based, we could not use individualized determinations of whether an
EP is using the EHR of the hospital to deliver his or her services. Also, the subsequent
legislation in the Continuing Extension Act of 2010 is consistent with the interpretation that the
determination of whether an EP is hospital-based is based on the place where the EP furnishes
services, as that subsequent legislation further limited hospital-based to those EPs providing
substantially all services in the emergency room or inpatient hospital settings. Furthermore, our
final policy is that eligible hospitals must demonstrate meaningful use based upon all applicable
cases in the inpatient (21) and emergency department (23) site of service codes. Therefore, there
would be duplication in measuring meaningful use for the purposes of making EHR incentive
payments in the scenario proposed by these commenters.
The HITECH Act does not define the term ‘hospital” for purposes of establishing a
definition of hospital-based EPs for Medicare and Medicaid. However, section 1861(e) of the
Act defines the term a “'hospital” to mean an institution that “is primarily engaged in providing,
by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic
services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B)
rehabilitation services for the rehabilitation of injured, disabled, or sick persons.” Therefore,
clearly EPs that practice primarily in inpatient hospital settings, as referenced in section 1861(e)
of the Act, would be considered hospital-based EPs.
We will consider the use of place of service (POS) codes on physician claims to
determine whether an EP furnishes substantially all of their professional services in a hospital
setting and is, therefore, hospital-based. This code set is required for use in the implementation
guide adopted as the national standard for electronic transmission of professional health care
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claims under the provisions of the Health Insurance Portability and Accountability Act of 1996
(HIPAA). HIPAA directed the Secretary of HHS to adopt national standards for electronic
transactions. These standard transactions require all health plans and providers to use standard
code sets to populate data elements in each transaction. The Transaction and Code Set Rule (65
FR 50312) adopted the ASC X12N-837 Health Care Claim: Professional, volumes 1 and 2,
version 4010, as the standard for electronic submission of professional claims. This standard
names the POS code set currently maintained by CMS as the code set to be used for describing
sites of service in such claims and is available at
http://www4.cms.gov/PlaceofServiceCodes/Downloads/posdatabase110509.pdf
From this code set, we would consider the use of the following POS codes to determine
whether an EP is a hospital-based eligible professional for Medicare:
• 21—Inpatient Hospital – is a facility, other than psychiatric, which primarily provides
diagnostic, therapeutic (both surgical and nonsurgical), and rehabilitation services by, or under,
the supervision of physicians, to patients admitted for a variety of medical conditions.
• 23 – Emergency Room, Hospital – is a portion of a hospital where emergency
diagnosis and treatment of illness or injury is provided
Comment: Most commenters were supportive of the proposal to define “substantially
all” of his or her covered professional services in a hospital setting as EPs who furnish at least 90
percent of his/her services in a hospital setting. However, some commenters expressed concerns
that this threshold will be too high starting in 2015 when the time comes to determine which EPs
should be subject to penalties for failure to become meaningful users of certified EHR
technology. A few commenters misunderstood the proposal and requested that a hospital-based
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EP be defined as one who provides at least 90 percent of his or her services, defined as
encounters and not as charges.
Response: The statutory definition of hospital-based EP provides that to be considered a
hospital-based EP, the EP must provide “substantially all” of his or her covered professional
services in a hospital setting. Therefore, we must identify the minimum percentage of an EP's
covered professional services that must be provided in a hospital setting in order for the EP to be
considered as providing “substantially all” of his or her covered professional services in a
hospital setting. Consistent with the statute, we proposed to make this determination on the basis
of services performed by each EP, not the charges for each EP. We are finalizing the proposed
definition of “substantially all” as furnishing at least 90 percent of services in a hospital setting.
We believe a 90 percent threshold certainly would qualify as “substantial.”
Comment: Representatives of surgeons asked that CMS make an accommodation to the
hospital-based definition to account for services paid under a global fee.
Response: The determination of whether or not an EP is hospital-based is determined
individually for each EP. A global fee is a single payment for a bundle of services, some of
which could be performed in a hospital such as major surgery or hospital visits, whereas some
could be performed in an office such as follow-up visits, CMS does not have data, for the place
of service for services performed by individual EPs when the services are paid as part of a global
fee. We considered possibilities for using national level estimates for individual services
typically performed under global fees as proxies for services provided by individual EPs.
However, this would add significant additional operational complexity to the determination of
hospital-based status and we have not pursued this approach.
Comment: Some commenters requested that CMS establish a process by which EPs
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could know in advance of a payment year whether CMS considered them as being hospital-based
and therefore ineligible for an incentive payment.
Response: To the extent practical, we intend on establishing a process whereby the EP
would know his/her hospital-based status during the registration period. We plan to provide
information to EPs regarding their hospital-based status as early as possible (that is, no later than
early in each payment year). As indicated in the proposed rule, we will make a determination for
Medicare incentive payment purposes, as to whether or not an EP is hospital-based by annually
analyzing an EP's claims history from the prior year. In the proposed rule we indicated that we
would use claims data from the prior calendar year to make hospital-based determinations for
EPs. However, in order to provide information regarding the hospital-based status of each EP at
the beginning of each payment year, we will need to use claims data from an earlier period.
Therefore, we will use claims data from the prior fiscal year (October through September).
Under this approach, the hospital-based status of each EP would be reassessed each year, using
claims data from the fiscal year preceding the payment year. The hospital-based status will be
available for viewing beginning in January of each payment year. For Medicaid purposes, State
Medicaid agencies will make the determination about whether or not an EP is hospital-based by
analyzing an EP's Medicaid claims data, or in the case of EPs who deliver care via Medicaid
managed care programs, by analyzing either encounter data or other equivalent data sources, at
the State's option. For purposes of making this determination, States would be permitted to use
data either from the prior fiscal or calendar year.
After consideration of the public comments received, we are revising the definition of
hospital based EPs in this final rule. An EP will be defined as being hospital-based and therefore
ineligible to receive an EHR incentive payment under either Medicare or Medicaid, regardless of
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the type of service provided, if more than 90 percent of their services are identified as being
provided in places of service classified under two place of service codes 21 (Inpatient Hospital)
or 23 Emergency Room, Hospital. We plan to reassess the hospital-based status of each EP for
Medicare purposes each year, using claims data from the fiscal year immediately preceding the
payment year. Based on preliminary claims data from the first 9 months of 2009, CMS currently
estimates that, under this final definition of hospital-based EPs, about 14 percent of Medicare
EPs (physicians) would be considered hospital-based and thus not eligible to receive any
incentive payments. We do not have any data on Medicaid practitioners.
7. Interaction with Other Programs
In the proposed rule, we described how the HITECH Act addresses interactions between
the Medicare EHR incentive program and the E-prescribing Incentive Program authorized by
MIPPA. Under section 1848(m)(2)(D) of the Act, as added by section 4101(f)(2)(B) of the
HITECH Act, if a Medicare FFS or MA EP receives an incentive payment from the Medicare
EHR incentive program, the EP (or group practice) is not eligible to also receive the incentive
payment under the E-prescribing Incentive Program created by MIPPA. Given the payment
timelines in this final rule for the Medicare EHR incentive program and the existing payment
timeline for the E-prescribing Incentive Program, we will know whether an EP received a
Medicare EHR incentive payment before the e-prescribing Incentive Program payment is
calculated. Thus we will exclude those EPs (or group practices) who accept a Medicare EHR
incentive payment for a given year from being eligible for the e-prescribing Incentive Program
payment for that same year. EPs receiving a Medicaid EHR incentive payment would remain
eligible for the Medicare MIPAA E-Prescribing Incentive Program payment.
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As the HITECH Act does not specify any other restrictions on participation in other
programs and participation in the Medicare and Medicaid EHR incentive programs, we do not
propose any other restrictions. There may be opportunities to avoid duplication of reporting
requirements among our various programs. In section II.A.3. of this final rule, we discuss how
we will avoid duplication of reporting requirements for clinical quality measures.
Comment: Some commenters requested more information on efforts to avoid duplication
of requirements and highly encouraged CMS to do everything it could in this regard.
Response: We address comments on the avoidance of duplication of requirements in
several other areas of this rule where more specifics can be provided.
Comment: Commenters generally supported our proposal to only apply the limitation of
participation in multiple programs to the limitation outlined in the HITECH Act.
Response: We continue to believe that providers should be able to participate in every
program for which they are statutorily eligible and therefore are maintaining our proposal to only
limit Medicare EPs from receiving either the Medicare EHR incentive payment or the Medicare
E-Prescribing incentive payment.
B. Medicare Fee-for Service Incentives
1. Incentive Payments for Eligible Professionals (EP)
Section 1848(o)(1)(A) of the Act, as amended by section 4101(a) of the HITECH Act,
provides for incentive payments to EPs who are meaningful users of certified EHR technology
during the relevant EHR reporting periods. Section 1848(o)(1)(A)(i) of the Act provides that
EPs who are meaningful EHR users during the relevant EHR reporting period are entitled to an
incentive payment amount, subject to an annual limit, equal to 75 percent of the Secretary's
estimate of the Medicare allowed charges for covered professional services furnished by the EP
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during the relevant payment year. Under section 1848(o)(1)(B)(ii)(VI) of the Act, an EP is
entitled to an incentive payment for up to 5 years. In addition, in accordance with section
1848(o)(1)(A)(ii) of the Act, there shall be no incentive payments made with respect to a year
after 2016. The incentive payments would be disbursed from the Federal Supplementary
Medical Insurance Trust Fund, as provided for under section 1848(o)(1)(A)(i) of the Act. As
noted in section II.A. of this final rule, EPs who qualify for both the Medicare and Medicaid
incentive payments must elect to receive payments from one program or the other.
a. Definitions
In accordance with section 1848(o)(5)(C) of the Act, we will add a definition of the term
"eligible professional" in our regulations at §495.100 to mean a physician as defined under
section 1861(r) of the Act. Section 1861(r) of the Act defines the term "physician" to mean the
following five types of professionals, each of which must be legally authorized to practice their
profession under state law: a doctor of medicine or osteopathy, a doctor of dental surgery or
dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. As
discussed in section II.B.1.a of this final rule, in accordance with section 1848(o)(1)(C) of the
Act, hospital-based EPs are not eligible for an incentive payment.
Section 1848(o)(5)(A) of the Act defines covered professional services as having the
same meaning as in section 1848(k)(3) of the Act, that is, services furnished by an eligible
professional for which payment is made under, or is based on, the Medicare physician fee
schedule.
In accordance with section 1848(a)(1) of the Act, the Medicare allowed charge for
covered professional services is the lesser of the actual charge or the Medicare physician fee
schedule amount established in section 1848 the Act. As specified under section
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1848(o)(1)(A)(i) of the Act, the Secretary's estimate of allowed charges is based on claims
submitted to Medicare no later than 2 months following the end of the relevant payment year.
We proposed to codify these specifications and definitions in our regulations at 495.102.
Comment: The commenters who expressed concerns about the EP definition under the
Medicare program had one overall theme. It is that the definition is too narrow and that it should
be more inclusive of other health professionals in order to serve the goals of the HITECH Act.
The commenters stated that they believe that the intent of the electronic health records (EHR)
legislation is to encompass a wide range of health professionals to incorporate efficient and
effective EHR technology. Specifically, these commenters stated that the Medicare EP
definition should be expanded to include nonphysician practitioners and health professionals
such as physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs),
certified nurse- midwives (CNMs), clinical psychologists (CPs), clinical social workers (CSWs),
certified registered nurse anesthetists (CRNAs), registered nurses (RNs), occupational therapists
(OTs), and credentialed pedorthists who make shoes for diabetic patients. Additionally, we
received a comment that the Medicare EP definition should recognize health professionals who
provide health support services as members of an interdisciplinary health care team such as a
team consisting of diabetes nurse educators, NPs, pharmacists, PAs, dieticians, and case
managers.
Representatives of rural health clinics (RHCs), Federally qualified health centers
(FQHCs), ambulatory surgical centers (ASCs), outpatient clinics and dialysis facilities
commented that their providers should also be included under the Medicare EP definition to
qualify for Medicare incentive payments. These providers believe that they are a key set of
contributors that will implement and meaningfully utilize electronic health care record program
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modules that directly benefit their patient populations. Alternatively, one of these commenters
recommended that provider eligibility should be determined by type of service provided rather
than by location of service and should include non-physician clinicians and providers.
The sub-theme of the comments that we received on the Medicare EP definition is that the
definition of an "eligible provider" that qualifies for EHR incentive payments should be a
common definition for the Medicare and Medicaid programs. The commenters believe that a
uniform definition of an EP would be more administratively efficacious for the Medicare and
Medicaid programs considering that EPs are permitted to switch participation between the
Medicare and Medicaid incentive programs one-time after the initial payment year.
An organization representing pathologists expressed concern that the Medicare EP
definition, as currently drafted would subject certain pathologists to payment incentive penalties
for not being meaningful EHR users if the pathologists performed less than 90 percent of their
professional services in any inpatient or outpatient setting in the prior year. All EPs have to
report on all Core Measures and a subset of clinical measures that pathologists could not meet in
their day-to-day practice given the nature of pathology’s scope of practice. Accordingly, this
organization recommended that CMS ensure that pathologists who are currently defined as
Medicare EPs be considered as "non-qualifying" EPs, that are exempt from future meaningful
user penalties.
Response: While we appreciate the comments that we received on the Medicare EP
definition, we are unable to expand or alter this statutory definition or consolidate it with the
Medicaid program EP definition as suggested by the commenters. Under the EHR incentive
payment program, the law provided a separate Medicare EP definition rather than giving the
Secretary authority or discretion to determine who is a Medicare EP or, who is an EP for both the
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Medicare and Medicaid programs.
Comment: A commenter requested clarification of the method used for determining
Medicare incentives for EPs practicing in a rural health clinic.
Response: The amount of the EHR incentive payment is based on the estimated allowed
charges for all covered professional services furnished by an EP during the payment year, subject
to the maximum payment amount for the payment year for the EP. For EPs that practice in an
RHC, EHR incentive payments are based on the amount of covered professional services that are
not part of the RHC package of services and are billed by the EP through the physician fee
schedule.
Comment: A commenter suggested that the definition of allowable charges be amended
to include the RHC schedule of services, or allow providers who use UB92 and HCFA 1500
forms to be eligible for the EHR incentive payment.
Response: The allowed charge is the amount that Medicare determines to be reasonable
payment for a provider or service under Part B, including coinsurance and deductibles. RHC
services furnished by an EP are not considered covered professional services for purposes of the
Medicare EHR because they are not billed or paid under the physician fee schedule.
After consideration of the public comments received on the term, "eligible professional"
for the Medicare program, we are adopting the Medicare EP definition in our regulations at
§495.100 that state that a Medicare EP is a physician as defined under §1861(r) of the Social
Security Act. That is, a Medicare EP is a doctor of medicine or osteopathy, a doctor of dental
surgery or dental medicine, a doctor of podiatric medicine, a doctor of optometry, or a
chiropractor and a doctor who is legally authorized to practice their profession under State law.
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b. Incentive Payment Limits
Section 1848(o)(1)(B)(i) of the Act sets forth the annual limits on the EHR-related
incentive payments to EPs. Specifically, section 1848(o)(1)(B) of the Act provides that the
incentive payment for an EP for a given payment year shall not exceed the following amounts:
• For the EP's first payment year, for such professional, $15,000 (or, $18,000 if the EP's
first payment year is 2011 or 2012).
• For the EP's second payment year, $12,000.
• For the EP's third payment year, $8,000.
• For the EP's fourth payment year, $4,000.
• For the EP's fifth payment year, $2,000.
• For any succeeding year, $0.
Under section 1848(o)(1)(B)(iv) of the Act, for EPs who predominantly furnish services in a
geographic HPSA (as designated by the Secretary under section 332(a)(1)(A) of the Public
Health Service (PHS) Act), the incentive payment limitation amounts for each payment year are
increased by 10 percent. Section 1848(o)(1)(B)(iii) of the Act also provides for a phased
reduction in payment limits for EPs who first demonstrate meaningful use of certified EHR
technology after 2013. Specifically, if the EP's first payment year is after 2013, then the annual
limit on the incentive payment equals the annual limit applicable to an EP whose first payment
year is 2013. Accordingly, if the EP's first payment year is 2014, the EP's maximum incentive
payment will be $12,000 in 2014, $8,000 in 2015, and $4,000 in 2016. Section 1848(o)(1)(B)(v)
of the Act provides that if the EP's first payment year is after 2014, then the applicable incentive
payment limit for such year and any subsequent year shall be $0. In other words, an EP who
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does not qualify to receive an EHR-related incentive payment prior to 2015 will not receive any
of these incentive payments.
Comment: One commenter believes that the methodology for determining the incentive
payments under the incentive program does not offer each EP an equal incentive, despite being
held to the same standards of adoption and implementation.
Response: We are uncertain why the commenter believes that the methodology for
determining the incentive payments under the incentive program does not offer each EP an equal
incentive to adopt EHR technology. However, the payment methodology in the statute for EPs
(as well as the methodologies for hospitals and CAHs) is quite prescriptive, and offers no
discretion for us to adopt revisions designed to enhance incentives for adoption. For EPs, the
HITECH Act defines the incentive payment amount as, "an amount equal to 75 percent of the
Secretary’s estimate…of the allowed charges under this part of all such covered professional
services furnished by the eligible professional during such year."
c. Increase in Incentive Payment for EPs who Predominantly Furnish Services in a Geographic
Health Professional Shortage Area (HPSA)
Section 1848(o)(1)(B)(iv) of the Act provides that the amount of the annual incentive
payment limit for each payment year be increased by 10 percent for EPs who predominantly
furnish services in an area that is designated by the Secretary (under section 332(a)(1)(A) of the
PHS Act) as a geographic health professional shortage area (HPSA). This section of the PHS
Act refers to geographic HPSAs, which are areas that have been designated by the Secretary as
having a shortage of health professionals, based on the population-to-provider ratio and other
factors. HPSAs are located in every State, and in both rural and urban areas.
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Geographic HPSAs are defined in 42 CFR Part 5 and include primary medical care,
dental, and mental health HPSAs. In accordance with the statute, we will increase the limits per
payment year by 10 percent for EHR-related incentive payments to EPs who predominantly
furnish covered professional services in a geographic primary medical care, dental, or mental
health HPSA.
We proposed that for an EP to be considered as "predominantly" furnishing covered
professional services in a geographic HPSA, more than 50 percent of the EP's covered
professional services must be furnished in a geographic HPSA. We stated that using "more than
50 percent" as the criterion to define "predominantly" is consistent with how the term is defined
in general parlance as well as how the definition is used for purposes of other aspects of the
Medicare program. Our data indicates that most physicians furnishing services in a HPSA
furnish 100 percent of their covered services in a HPSA, and only very few furnish services in
both HPSA and non-HPSA areas.
To determine whether an EP has furnished more than 50 percent of his/her covered
professional services in a geographic HPSA, we proposed to utilize frequency of services
provided over a 1-year period from January 1 to December 31, rather than basing it on the
percentage of allowed charges. We proposed to make the incentive payment to the EP based on
an EP's estimated allowed charges for the relevant payment year.
We proposed that once we compile a full year of data, we would determine eligibility for
the EHR HPSA payment limit increase for the payment year based on whether the EP provided
more than 50 percent of his/her services in a geographic HPSA during the payment year. The
determination would be made based on claims submitted not later than 2 months after the end of
the year. If we determine that the EP provided more than 50 percent of his/her services in a
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geographic HPSA and is therefore eligible for the EHR HPSA payment limit increase, we would
then make an additional lump sum payment to reflect that increased limit amount based on the
estimated allowable charges for that EP for the prior year. The additional amount would be paid
no later than 120 days after the end of the prior year for which the EP was eligible for the 10
percent EHR HPSA payment limit increase.
Most physicians furnishing services in a HPSA furnish 100 percent of their covered
services in a HPSA. Section 1848(o)(1)(B)(iv) of the Act also authorizes us to apply the
provisions of sections 1833(m) and (u) of the Act in implementing this 10 percent EHR HPSA
payment limit increase, as the Secretary determines appropriate. Section 1833(m) of the Act
establishes the HPSA bonus program, which provides a 10 percent bonus to physicians who
furnish Medicare covered professional services in a geographic HPSA.
Section 1833(m)(1) of the Act provides that physicians who furnish covered professional
services in a year in an area that is designated as a geographic HPSA prior to the beginning of
the year are eligible to receive the HPSA bonus for services furnished during the current year.
We have interpreted this to mean that bonus payments should continue throughout the current
year, even if the area loses its designation as a geographic HPSA during the current year.
Physicians furnishing Medicare-covered professional services in an area that is not designated as
a geographic HPSA by December 31 of the prior year are not eligible to receive the HPSA bonus
for the current year, even if the area is subsequently designated as a geographic HPSA during the
current year. We will apply these same rules for the 10 percent EHR HPSA payment limit
increase provided under section 1848(o)(1)(B)(iv) of the Act.
Section 1833(m)(2) of the Act also provides that geographic HPSAs that consist of an
entire county be identified and the bonus paid automatically. We publish a list annually of the
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zip codes that are in these areas on our website at
http://www.cms.hhs.gov/HPSAPSAPhysicianBonuses/01_Overview.asp#TopOfPage.
Physicians furnishing Medicare-covered professional services in a zip code that is on this list
automatically receive the HPSA bonus payment. Physicians furnishing Medicare covered
professional services in a zip code that is not on this list but that was designated as a geographic
HPSA as of December 31 of the prior year must use a modifier when submitting a Medicare
claim in order to receive the HPSA bonus.
Comment: We received a comment stating that many EPs who work in a HPSA do so
only on a part- time basis and that most would not qualify for the 10 percent increase in the
payment limit based on the proposed threshold of furnishing more than 50 percent of his/her
covered professional services in a geographic HPSA. The commenter suggested that an EP
should be able to qualify for the ten percent increase in the payment limit if at least 25 percent of
his/her covered services during an EHR reporting period are furnished in a HPSA.
Response: The statute states that the annual payment limit be increased by ten percent
for EPs who predominantly furnish services in a geographic HPSA. We continue to believe that
"more than fifty percent" correctly reflects the meaning of the word "predominantly" as used in
this statute. As noted above, our data also indicate that most physicians furnish all of their
services either in a HPSA or outside of a HPSA, and only very few furnish services in both
HPSA and non-HPSA areas.
Comment: Several commenters requested that Federally Qualified Health Centers
(FQHCs) be eligible to receive the ten percent increase in the payment limit for EPs who
predominantly furnish services in a HPSA since the FQHC is a legal entity that bills Medicare
and receives payment for services provided by physicians.
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Response: The 10 percent increase in the payment limit applies to EPs who
predominantly furnish services in a geographic HPSA. FQHCs and RHCs are not eligible for the
ten percent increase in the payment limit because they do not meet the definition of EP as
specified in section 1848(o)(5)(C) of the Act. Please see others sections of the regulation that
discuss the criteria to be considered an EP. Additionally, we wish to restate that FQHCs are not
entitled to any Medicare or Medicaid incentive payments under this program.
Comment: A commenter suggested that "predominantly" be defined as the location
where the EP provides the most services, so that an EP who sees patients in more than two
locations could receive the increase in the payment limit if he/she provided more care in the
HPSA location than any other location. The commenter also suggested that if this is too difficult
to administer, we should accept an attestation from the EP.
Response: We are aware that many physicians, especially in rural areas, furnish services
in more than one location, and appreciate the commenter’s interest in making the HPSA payment
limit increase available to these EPs. If we were to accept this recommendation, then an EP who
worked in three locations at forty percent, thirty percent, and thirty percent time respectively,
would be eligible for the HPSA payment limit increase if the first location was in a geographic
HPSA. If the EP worked in four locations at thirty percent, twenty-five percent, twenty five
percent, and twenty percent time respectively, he/she would be eligible for the HPSA payment
limit increase if the first location was in a geographic HPSA. We considered this suggestion and
concluded that lowering the threshold for services furnished in a HPSA would be inconsistent
with the intent of the HPSA payment limit increase, which is to provide an incentive to promote
the use of EHR by EPs who practice predominantly in HPSAs. Also, if an EP who worked in
more than two locations and furnished services in a HPSA only thirty or forty percent of his/her
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time was eligible for the HPSA payment limit increase, this would be unfair to an EP who
worked in two locations and spent forty-five percent of his/her time in a HPSA and fifty-five
percent time in a non-HPSA, because this EP would not be eligible for the HPSA payment limit
increase even though he/she spent more total time in a HPSA.
Comment: A commenter stated that the proposed HPSA payment limit increase was
being applied inconsistently because an EP would still get the payment limit increase if the
designation was removed mid-year, and would not get the payment limit increase if the
designation was added mid-year.
Response: Section 1848(o)(1)(B)(iv) of the Act authorizes us to apply the provisions of
the HPSA bonus program to the implementation of the EHR HPSA payment limit increase. The
HPSA bonus is paid to physicians who furnish Medicare-covered professional services in an area
that is designated as a geographic HPSA as of December 31 of the prior year. They are
authorized to receive the HPSA bonus throughout the current year, even if the area loses its
designation as a geographic HPSA during the current year. Physicians furnishing Medicarecovered professional services in an area that is not designated as a geographic HPSA as of
December 31 of the prior year are not eligible to receive the HPSA bonus for the current year,
even if the area is subsequently designated as a geographic HPSA during the current year. We
proposed to use the same methodology for the HPSA EHR program, and believe that this is
consistent with the statute.
After consideration of the public comments received, we are finalizing these provisions
as proposed.
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d. Form and Timing of Payment
Section 1848(o)(1)(D)(i) of the Act, as amended by section 4101(a) of the HITECH Act,
provides that the incentive payments may be disbursed as a single consolidated payment or in
periodic installments as the Secretary may specify. We proposed to make a single, consolidated,
annual incentive payment to EPs. Payments would be made on a rolling basis, as soon as we
ascertained that an EP had demonstrated meaningful use for the applicable reporting period (that
is, 90 days for the first year or a calendar year for subsequent years), and reached the threshold
for maximum payment.
Section 1848(o)(1)(A) of the Act provides that "with respect to covered professional
services provided by an eligible professional," the incentive payment "shall be paid to the
eligible professional (or to an employer or facility in the cases described in clause (A) of section
1842(b)(6))." Section 1842(b)(6)(A) of the Act allows for reassignment to an employer or entity
with which the physician has a valid contractual arrangement allowing the entity to bill for the
physician's services. Therefore, we proposed that EPs would be allowed to reassign their
incentive payment to their employer or an entity which they have a valid employment agreement
or contract providing for such reassignment, consistent with all rules governing reassignments.
We proposed to preclude an EP from reassigning the incentive payment to more than one
employer or entity. To implement this requirement, we proposed to use the EP's Medicare
enrollment information to determine whether an EP belongs to more than one practice (that is,
whether the EP's National Provider Identifier (NPI) is associated with more than one practice).
In cases where the EP was associated with more than one practice, we proposed that EPs would
select one tax identification number to receive any applicable EHR incentive payment.
As mentioned above, we proposed that payments would be made on a rolling basis, as
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soon as we ascertain that an EP has demonstrated meaningful use for the applicable reporting
period (that is, 90 days for the first year or a calendar year for subsequent years), and reached the
threshold for maximum payment. We proposed to add a new part 495.10 (e) and (f) to permit
reassignment of the incentive payment with certain limitations. The following is a summary of
the comments we received and our responses.
Comment: Several commenters, including one representing Rural Health Clinics,
requested clarification of the statement in the proposed rule (75 FR 1910) that an eligible
professional (EP) is allowed to reassign his/her EHR incentive payment to an employer or other
entity to which the EP has reassigned his/her payments for Medicare covered services. The
commenters believe that the HITECH Act requires in such cases that any Medicare EHR
incentive for which the EP qualifies must be paid to such employer or other entity. The
commenters reference the phrases from the HITECH Act, "shall be paid" to an eligible
professional (or to an employer or facility in cases described in the reassignment provisions of
the Social Security Act). In addition, the commenters referenced the phrase regarding the
transfer of an EP’s Medicaid EHR incentive which states that "such incentives are paid directly
to such provider (or to an employer or facility to which such provider has assigned payments)".
The commenters interpret these phrases to mean that an EP’s EHR incentive payments (both
Medicare and Medicaid) must be paid to an employer or other entity to which the EP has
reassigned payments for his/her services.
Response: We do not agree with the commenters’ conclusions regarding to whom the
payments must be made. As we stated in the proposed rule, Section 1842(b)(6) of the Act
allows, but does not require reassignment to an employer or entity with which the physician has
a valid contractual arrangement allowing the employer or entity to bill for the physician’s
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services. The HITECH Act provisions cited by the commenter similarly do not require that the
EHR incentive payment be made pursuant to a reassignment, but provide that the payment may
be made directly to the EP or to the employer or other entity. A physician reassigns payment
based on the scope of his or her employment or contractual arrangement. Based upon our
interpretation of the applicable provisions, we are finalizing our proposal at §495.10(f) to permit
EPs to reassign their incentive payments to their employer or to an entity with which they have a
contractual arrangement, consistent with all rules governing reassignments including part 424,
subpart F.
We are taking this opportunity to remind the public that if the EP wishes to reassign his
or her incentive payment to the employer or entity with which the EP has a contractual
arrangement, the parties should review their existing contract(s) to determine whether the
contract(s) currently provides for reassignment of the incentive payment or if the contract(s)
needs to be revised. Reassignment of the incentive payment must be consistent with applicable
Medicare laws, rules, and regulations, including, without limitation, those related to fraud, waste,
and abuse. For Medicaid, a discussion of reassignment of the incentive payment is found in
section II.D.3.e of this final rule "Entities Promoting the Adoption of Certified EHR
technology."
Comment: Several commenters stated that the rationale and objectives of the HITECH
Act provisions regarding transfer of the EP’s EHR incentives are merely to align EHR incentives
and EHR costs. Therefore, they believe that the HITECH Act provisions support their view that
Congressional intent was to prevent windfall EHR incentives to EPs who incur no EHR-related
costs. The commenters also asserted that CMS’s failure to address this issue will require entities
that employ or contract with EPs to enter into negotiations and a separate agreement transferring
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the EP’s EHR incentive payments to the employer or other entity.
Response: We do not agree with the commenters’ statement that the Congress intended
to prevent windfall EHR incentives to EPs who incur no EHR-related costs. Title IV, Division B
of the HITECH Act establishes incentive payments under the Medicare and Medicaid programs
for certain professionals and hospitals that meaningfully use certified EHR technology. The
provisions are not focused solely upon the costs associated with the EHR technology. Rather, as
we stated in the proposed rule (75 FR 1849), it focuses upon the adoption, implementation,
upgrade, or meaningful use of the technology.
However, we do agree that some entities may have to review and/or negotiate current
contractual arrangements to address the transfer of the incentive payments. The first payment
year for the incentive payment is CY 2011, which we believe should afford parties sufficient
time to reach a new agreement. For Medicaid, a discussion of reassignment of the incentive
payment is found in section II.D.3.e of this final rule "Entities Promoting the Adoption of
Certified EHR technology."
Comment: Several commenters supported our proposal that if an EP has reassigned his
or her payments for services to more than one employer or entity, that only one of those
employers or entities should receive the EP’s EHR incentive payments for a particular EHR
Reporting Period (75 FR 1910). The commenters do not believe that EPs should decide which
employer or entity should receive his or her EHR incentive payment. Rather, the commenters
stated that such payments should automatically be paid to the employer or entity that has
received for the reporting period the largest percentage of the EP’s Medicare or Medicaid
payments for services.
Response: We are not persuaded to adopt the commenters' suggestion. We believe that
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the suggestion by the commenters would create administrative complexities for both CMS and
EPs with little benefit. Many of these obstacles would be similar to those described in the
proposed rule when discussing the possibility of making proportional EHR incentive payments
(75 FR 1911). Therefore, we are finalizing our proposal to revise §495.10(e) to preclude an EP
from reassigning the incentive payment to more than one employer or entity. In cases where the
EP is associated with more than one practice, EPs must select one TIN to receive any applicable
EHR incentive payment.
Comment: The commenters also state that if an EP has incurred out-of-pocket costs in
connection with an EHR provided by an employer or other entity to which the EP has reassigned
payments for his or her services, the EP should be permitted to keep an amount of his or her
EHR incentives equal to the amount of such costs incurred.
Response: The statute does not address this issue. It simply provides that the incentive
payments are to be made directly to the EP or to an employer or other entity to which the EP has
reassigned the incentive payment. Reassignment of the incentive payment must be consistent
with applicable Medicare laws, rules, and regulations, including, without limitation, those related
to fraud, waste, and abuse. We believe that any cost-sharing or subsequent distribution of the
incentive payment, such as in the manner described by the commenter, should be resolved
between the parties.
Comment: Several commenters urged CMS to clarify that any reassignment of the EP’s
EHR incentive payment should not constitute a financial arrangement within the meaning of the
physician self-referral law, or remuneration within the meaning of the federal anti-kickback
statute.
Response: The physician self-referral law prohibits a physician from making a referral
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for designated health services to an entity with which the physician or a member of the
physician’s immediate family has a financial relationship, unless an exception applies. For
purposes of the physician self-referral law, a financial arrangement includes ownership or
investment interests and compensation arrangements. The statute defines a "compensation
arrangement" to mean any arrangement involving remuneration, direct or indirect, overt or
covert, in cash or in kind. A reassignment of an EP’s EHR payment would constitute
remuneration, and we note that reassignment generally occurs in the context of an existing
compensation arrangement (for example, employment). There are many potentially applicable
exceptions for compensation arrangements that involve a physician’s reassignment of Medicare
payments.
Similarly, with respect to the anti-kickback statute, absent compliance with a safe harbor,
a determination of whether a reassignment constitutes prohibited remuneration would be made
on a case-by-case basis and we therefore decline to issue any statement regarding the application
of the anti-kickback statute to a reassignment. For additional information regarding the
anti-kickback statute, please refer to the OIG’s website at http://oig.hhs.gov.
Comment: One commenter representing American Indian and Alaska Native health
providers urged CMS to require that the HITECH/EHR Meaningful Use provider incentive
payments be reassigned to the Tribal outpatient clinics, because the Tribal clinics developed the
infrastructure not the EPs themselves, and purchased electronic medical record systems to
complement the current Registration Patient Management Systems (RPMS) of the Indian Health
Service. In addition, the commenter noted that many tribal outpatient clinics have employment
contracts with their EPs. Thus, the commenters urged CMS to require that incentive EHR
payments should be included in employment contracts to help protect the EP as employee and
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the Tribe as the employer.
Response: As stated above, section 1848(o)(1)(A) of the Act provides that the EP’s
incentive payment shall be paid to the eligible professional (or to an employer or other entity
with which the physician has a valid contractual arrangement allowing the employer or other
entity to bill for the physician's services). We recognize that some tribes purchased EHR
systems based upon criteria established by the Indian Health Service. However, after careful
consideration, we believe that the same standards concerning the incentive payments should
apply. The EP and the Tribal outpatient clinic should jointly resolve whether the EP's EHR
incentive payment will be reassigned to the Tribal outpatient clinic or made directly to the EP.
Similarly, any decision by the Tribal outpatient clinic concerning whether to include language in
its employment contract (or in the alternative, whether any pre-existing contract already requires
reassignment of the payment), is a matter of contract interpretation that should be resolved by the
parties themselves. This discussion is also addressed in the Medicaid section of this rule at
II.D.4.a.3.
Comment: One commenter expressed concern about the potential tax consequences
associated with an EP’s reassignment of the EHR incentive payment by an independent
contractor to a larger organization. The commenter recommended that a 1099 independent
contractor should consult with his/her tax advisor before agreeing to reassign incentive payments
and to ensure that the election to reassign is made before payment is sent from CMS or the State
Medicaid Agency.
Response: The commenter's recommendation falls outside the scope of our authority.
This is a matter for the 1099 independent contractor EP to consider.
Comment: Many national and state medical associations expressed concern regarding the
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proposed requirement that the EP must identify a Tax Identification Number (TIN) to which the
EP’s incentive payment should be made. They assert that this will not work for physicians who
do not have a TIN, and are enrolled in Medicare or Medicaid through their Social Security
Number (SSN). Therefore, the commenters recommend that CMS accept the SSN in lieu of the
TIN, so that all eligible physicians are able to participate in the Medicare and Medicaid EHR
incentive programs.
Response: We recognize that many physicians are enrolled in Medicare or Medicaid
through their Social Security Number (SSN). Therefore, we are revising our proposal at §495.10
that an EP must submit, in a manner specified by CMS, the Taxpayer Identification Number
(TIN) to which the EP’s incentive payment should be made. In finalized §495.10(c), we provide
that the TIN may be the EP's Social Security Number (SSN) to which the EP’s incentive
payment should be made. We note that if the physician is part of a group with more than one
owner or organization that is incorporated, they would have a TIN for the corporation that is not
the EP’s SSN.
Comment: Some commenters recommended that the employer or entity to which an EP
reassigns payment for covered services, should be deemed authorized to provide, on the EP’s
behalf, any documentation necessary for the EP to qualify for EHR incentive payments.
Response: We believe that this should be resolved by the parties themselves. There is
nothing in the statute that requires an EP’s employer or other entity to which an EP reassigns
payment to provide any necessary documentation for an EP to qualify for EHR incentive
payments. Rather, the finalized regulatory provision at §495.8 provides that an EP must
demonstrate that he or she satisfies each of the applicable objectives and associated measures
under §495.6. If the parties wish to have the necessary documentation furnished by the employer
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or entity, they should resolve this pursuant to an employment or contractual agreement.
We are finalizing our proposal because we believe that making a single, consolidated payment
would be the least administratively burdensome for both CMS and EPs. In addition, we believe
a single, consolidated payment would reduce the possibility of fraud and duplicate payments.
Several of these issues related to reassignment of payment are also addressed in the Medicaid
section. See II.D.3.e.
e. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs who are not
Meaningful Users of Certified EHR Technology
Section 1848(a)(7) of the Act, as amended by section 4101(b) of the HITECH Act,
provides for payment adjustments effective for CY 2015 and subsequent years for EPs who are
not meaningful EHR users during the relevant EHR reporting period for the year. In general,
beginning in 2015, if an EP is not a meaningful EHR user for any EHR reporting period for the
year, then the Medicare physician fee schedule amount for covered professional services
furnished by the EP during the year (including the fee schedule amount for purposes of
determining a payment based on the fee schedule amount) is adjusted to equal the "applicable
percent" of the fee schedule amount (defined below) that would otherwise apply. The HITECH
Act includes a significant hardship exception, discussed below, which, if applicable, could
exempt certain EPs from this payment adjustment. The payment adjustments do not apply to
hospital-based EPs.
The term "applicable percent" means: "(I) for 2015, 99 percent (or, in the case of an EP
who was subject to the application of the payment adjustment if the EP is not a successful
electronic prescriber under section 1848(a)(5) for 2014, 98 percent); (II) for 2016, 98 percent;
and (III) for 2017 and each subsequent year, 97 percent."
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In addition, section 1848(a)(7)(iii) of the Act provides that if for 2018 and subsequent
years the Secretary finds that the proportion of EPs who are meaningful EHR users is less than
75 percent, the applicable percent shall be decreased by 1 percentage point from the applicable
percent in the preceding year, but in no case shall the applicable percent be less than 95 percent.
Significant Hardship Exception—section 1848(a)(7)(B) of the Act provides that the Secretary
may, on a case-by-case basis, exempt an EP who is not a meaningful EHR user for the year from
the application of the payment adjustment if the Secretary determines that compliance with the
requirements for being a meaningful EHR user would result in a significant hardship, such as in
the case of an EP who practices in a rural area without sufficient Internet access. The exemption
is subject to annual renewal, but in no case may an EP be granted a hardship exemption for more
than 5 years.
Comment: Some commenters believed that when an EP’s performance leads to a negative
financial impact under Medicare payment policy, it would be unfair and overly punitive for them
to face a separate and potentially more significant financial impact – whether through a denial of
funding and/or ARRA’s penalties. Further, some commenters indicated that they interpreted
these requirements to mean that Medicaid participants would or would not experience
fee-schedule adjustments if they are not meaningful users by the end of 2014.
Response: We will reduce payments as specified under the statute. Under sections
4101(b) and (c) of the HITECH Act, we are required to pay EPs less than 100 percent of the fee
schedule and to make downward adjustments to MA-affiliated EPs for their professional services
if they are not meaningful users of certified EHR beginning in CY 2015. Under sections
4102(a), (a)(2), and (c) of the HITECH Act, we are authorized to pay eligible hospitals a reduced
annual payment update, provide downward payment adjustment to CAHs for cost reporting
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periods, and provide downward payment adjustment to MA-affiliated hospitals respectively, if
they are not meaningful users of certified EHR technology beginning in FY 2015. The Medicare
fee schedule adjustments will impact any EP or subsection(d) hospital that is not a meaningful
user by the end of 2014. The adjustments are not authorized under Medicaid, but the adjustments
will still apply to Medicaid EPs who are also Medicare EPs and also to Medicaid acute care
hospitals that are also subsection(d) hospitals.
We are finalizing these provisions as proposed.
2. Incentive Payments for Hospitals
a. Definition of Eligible Hospital for Medicare
Section 1886(n) of the Act, as amended by section 4102(a)(1) of the HITECH Act,
provides for incentive payments, beginning in FY 2011 (that is, October 1, 2010 through
September 30, 2011) for eligible hospitals that are meaningful users of certified EHR technology
during the EHR reporting period for the payment year. In the proposed rule, we proposed a new
§495.104 to implement this provision. As we noted in the proposed rule, section 1886(n)(6)(B)
of the Act defines "eligible hospitals" for purposes of the incentive payments provision, as
"subsection (d) hospitals," referring to the definition of that term in section 1886(d)(1)(B) of the
Act. Section 1886(d)(1)(B) of the Act generally defines a "subsection (d) hospital" as a "hospital
located in one of the fifty States or the District of Columbia." The term therefore does not
include hospitals located in the territories or hospitals located in Puerto Rico. Section
1886(d)(9)(A) of the Act separately defines a "subsection (d) Puerto Rico hospital" as a hospital
that is located in Puerto Rico and that "would be a subsection (d) hospital if it were located in
one of the 50 states." Therefore, because section 4102(a)(1) of the HITECH Act does not refer
to "subsection (d) Puerto Rico hospitals," we proposed that incentive payments for meaningful
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users of certified EHR technology would not available under this provision to hospitals located
in Puerto Rico. The provision does apply to inpatient, acute care hospitals located in the State of
Maryland. These hospitals are not currently paid under the IPPS in accordance with a special
waiver provided by section 1814(b)(3) of the Act. Despite this waiver, the Maryland hospitals
continue to meet the definition of a "subsection (d) hospital" because they are hospitals located in
the 50 states. Therefore we proposed that incentive payments for meaningful users of certified
EHR technology would be available under this provision to acute care hospitals located in the
State of Maryland. The statutory definition of a subsection (d) hospital also does not apply to
hospitals and hospital units excluded from the IPPS under section 1886(d)(1)(B) of the Act, such
as psychiatric, rehabilitation, long term care, children's, and cancer hospitals. We also proposed
that, for purposes of this provision, we would provide incentive payments to hospitals as they are
distinguished by provider number in hospital cost reports. We proposed that incentive payments
for eligible hospitals would be calculated based on the provider number used for cost reporting
purposes, which is the CMS Certification Number (CCN) of the main provider (also referred to
as OSCAR number). Payments to eligible hospitals are made to each provider of record. The
criteria for being a meaningful EHR user, and the manner for demonstrating meaningful use, are
discussed in section B.2. of this final rule.
Comment: We received numerous comments on our proposal to identify all individual
hospitals eligible for incentive payments based on the provider number used for cost reporting
purposes (the CCN of the main provider). These commenters, including national and regional
hospital associations, hospital systems, and hospitals with multiple campuses, objected to the
proposed policy on various grounds. Many of these commenters pointed out that there is no
standard policy that defines the specific types of facilities to which a single CCN applies. As a
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result, a single CCN could encompass multiple hospitals within a hospital system in some cases,
while in other cases multiple hospitals within a system could have separate CCNs. These
commenters therefore maintained that our proposed policy would unjustifiably lead to disparate
treatment of hospital systems based solely on whether the system had one or more provider
numbers. Commenters also maintained that, because the Medicare and Medicaid payment
incentives are calculated using a per-hospital base amount, plus a capped per-discharge amount
per hospital, identifying individual hospitals solely by CCN would result in distributing
payments in a manner that does not foster widespread EHR adoption and use. The for this
argument regarding limited EHR adoption and use is that multi-campus systems with a single
CCN would receive only one base payment, and would be more likely to reach the discharge cap.
Some commenters also argued that linking incentive payments only to a single CCN would not
accurately reflect the pattern of costs required for deploying EHR systems across all sites in a
hospital system. For example, even hospital sites that are part of the same system often require
significant variations in their EHR systems, accommodating local policies and processes, as well
as different legacy systems, physician preferences, clinical protocols, and other variables. Some
commenters cited as a precedent our policy with regard to hospitals with one CCN, but multiple
sites spanning more than one wage index region. CMS has instructed such hospitals to report
wage data for each site separately on the cost report, and pays for discharges under the wage
index that applies where the service is provided, that is , under a different wage index for each
site.
These commenters recommended various approaches to recognizing and verifying the
status of separate hospitals under one CCN number. Many of them recommended that we adopt
a "multi-pronged approach that allows a "hospital" to be defined in ways that acknowledge the
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varied organizational structures of multi-hospital systems, including by a distinct CCN, a distinct
emergency department, or a distinct hospital license." Commenters recommended that we
indentify and verify the distinct hospitals within hospital systems either by revising the cost
report or by developing an attestation process similar to the process employed under §413.65 of
the regulations to verify provider-based status. Commenters also recommended that we either
collect the data necessary for determining payment amounts (for example, discharge counts)
directly from each hospital within a system with a single provider number, or develop a method
of allocating discharges, bed days, and other relevant data among the hospital campuses
represented in a hospital cost report under a single CCN.
Finally, a number of the commenters advocating a different approach contended that our
proposed policy ran counter to the intent of the EHR incentive provision, which is to promote
broader adoption of EHR systems. These commenters argued in various ways that recognizing
each campus of a multi-campus hospital for separate payment was most consistent with the
statute because it would provide a greater overall level of funding for EHR efforts, especially to
hospital systems that have elected to enroll multiple campuses under a single Medicare provider
agreement, and thus support diffusion of EHR systems more broadly. One of these commenters
did, however, acknowledge that "in most circumstances the term 'subsection(d) hospital' under
the Medicare Program includes all of a hospital system's inpatient facilities that operate under a
single provider number," before going on to argue that CMS has both the authority and the
obligation under the HITECH Act to diffuse EHR incentive payment more broadly by treating
each facility under a hospital system as a separate hospital, regardless of whether any of the
facilities share a single provider number.
Response: We appreciate the commenters’ concerns, but we continue to believe that our
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proposal represents the best policy approach in determining what constitutes an "eligible
hospital." In the absence of clear direction from the statute to the contrary, we believe that the
most appropriate policy is to interpret the terms in subsection (d) “acute care hospital" and
"children’s hospital" in the light of existing Medicare and Medicaid program policies and
precedents. It is quite true, as a number of the commenters noted, that hospital systems have
considerable latitude (although not unlimited) in choosing whether to obtain one CCN for all
their facilities, or to obtain separate CCNs for some or all of their facilities. However, once a
hospital has sought and obtained a single CCN for two or more facilities, that hospital has chosen
to represent itself to CMS as a single hospital, including for purposes of payment, cost reporting,
and satisfying the conditions of participation. Such systems submit unified cost reports
integrating data (including charges, discharges, bed days, and other relevant data) from every
facility under the single CCN. For purposes of DSH and IME payments under the IPPS, both
eligibility for payment and the applicable payment amounts are determined on the basis of this
integrated data. Most significantly, the Medicare conditions of participation require that a
system with a single CCN establish and maintain a single governing structure, medical staff,
nursing staff, and record services. Section 482.2 states that a "hospital must have an organized
medical staff that operates under by-laws approved by the governing body." Section 482.21(e)
states that the governing body must ensure, among other matters, that "the hospital-wide quality
assessment and performance improvement efforts address priorities for improved quality of
care." In addition, §482.24 states that the hospital must have "a medical record service that has
administrative for medical records.". For these reasons, we believe that recognition of the
decision made by each hospital or hospital to represent and organize itself as a single entity
under one CCN, or as two or more distinct entities under separate CCNs is a strength, rather than
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a weakness, of our proposed policy. Each institution that has exercised available latitude to
obtain one CCN for all their facilities not only represents itself as a single hospital, but also
agrees to conduct itself in significant ways as a single hospital.
We also do not agree with those commenters who argue that our policy of applying
different wage indexes to the campuses comprising a hospital system operating under a single
CCN warrants our treating each campus as a separate eligible hospital for purposes of the EHR
incentive payment program. Our policy for these few cases when a multi-campus hospital spans
two or more wage index areas does not amount to recognizing that each campus is a separate
hospital for payment purposes, but rather to accounting for the fact that, in these few cases, one
hospital is located in two wage index areas. In these cases, it is appropriate to pay, and to
account for wages, on the basis of where each discharge occurs rather than on the basis of where,
for example, the main campus of a hospital may be located.
With regard to the disparate treatment argument advanced by a number of commenters,
we acknowledge that, under our proposed policy, a single hospital system with two campuses
will receive (all other things being equal) lower incentive payments than the combined incentive
payments of two-single-campus hospitals with the same number of discharges. However, an
equivalent disparate treatment situation would arise under the policy advocated by these
commenters. Under the policy of recognizing each campus of a multi-campus system as a
separate hospital, a single-campus hospital would received lower incentive payments than a
multi-campus hospital with the same number of discharges, despite the fact that both hospitals
have a single CCN and are recognized for administrative and financial purposes, and for
purposes of the conditions of participation, as a single hospital.
Example: Hospital A is a multicampus hospital with 30,000 discharges and a Medicare
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share of 50 percent. Hospital A’s discharges are evenly split between its two campuses.
Hospital B is a single campus hospital with 30,000 discharges and a Medicare share of 50
percent. During the first year of the transition, each campus of Hospital A would receive a
separate incentive payment determined on the following manner:
($2,000,000 base amount + [(15,000 – 1,149) x $200] discharge-related amount) x .5 Medicare
share x 1.0 transition factor = ($2,000,000 + $2,770,200) x .5 x 1.0 = $2,385,100
Hospital A’s total payment would therefore be $4,770,200. In contrast, Hospital B would
receive a single payment determined in the following manner:
($2,000,000 base amount + [(23,000 – 1,149) x $200] discharge-related amount) x .5 Medicare
share x 1.0 transition factor = ($2,000,000 + $4,370,200) x .5 x 1.0 = $3,185,100.
Hospital B would thus receive a payment that is $1,585,100 smaller than Hospital A’s total
payment for the same number of discharges.
The change in policy recommended by these commenters will therefore replace one
equity issue with another. We see no reason to privilege one of these arguments over the other,
and therefore we believe that the decision on a final policy ought to turn on the other
considerations that we discuss.
Finally, we cannot agree with the commenters that determining the appropriate policy on
this question should turn on which alternative produces the greatest overall level of spending on
EHR systems. Many decisions could result in lower potential payments to some or all potential
meaningful users of EHR payments. Congress deliberately chose to limit incentive payments
based on the statutory formula (using the current statutory and regulatory definition of
"subsection (d) hospital"), and further limited the amount of incentive payments available to
large hospitals by not increasing incentive payments above 23,000 discharges.
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After consideration of the public comments received, we are finalizing our policy as
proposed. For purposes of this provision, we will provide incentive payments to hospitals as
they are distinguished by provider number in hospital cost reports. Incentive payments for
eligible hospitals will be calculated based on the provider number used for cost reporting
purposes, which is the CMS Certification Number (CCN) of the main provider (also referred to
as OSCAR number). Payments to eligible hospitals will be made to each provider of record.
b. Incentive Payment Calculation for Eligible Hospitals: Initial Amount
Section 1886(n)(2) of the Act, as amended by 4102(a) of the HITECH Act, describes the
methodology for determining the incentive payment amount for eligible hospitals that are
meaningful users of certified EHR technology during the EHR reporting period for a payment
year. In general, that section requires the incentive payment for each payment year to be
calculated as the product of: (1) an initial amount; (2) the Medicare share; and (3) a transition
factor applicable to that payment year.
As amended by section 4201(a) of the HITECH Act, section 1886(n)(2)(A)(i) of the Act
defines the initial amount as the sum of a "base amount," as defined in section 1886(n)(2)(B) of
the Act, and a "discharge related amount," as defined in section 1886(n)(2)(C) of the Act. The
base amount is $2,000,000, as defined in section 1886(n)(2)(B) of the Act. The term "discharge
related amount" is defined in section 1886(n)(2)(C) of the Act as "the sum of the amount,
estimated based upon total discharges for the eligible hospital (regardless of any source of
payment) for the period, for each discharge up to the 23,000th discharge as follows:
(i) for the first through the 1,149th discharge, $0.
(ii) for the 1,150th through the 23,000th discharge, $200.
(iii) for any discharge greater than the 23,000th, $0.
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In addition to the base amount, the discharge related amount provides an additional $200
for each hospital discharge during a payment year, beginning with a hospital's 1,150th discharge
of the payment year, and ending with a hospital's 23,000th discharge of the payment year. No
additional payment is made for discharges prior to the 1,150th discharge, or for those discharges
subsequent to the 23,000th discharge. We proposed to implement the "initial amount’ within the
formula as that term is defined in the statute.
Comment: Several commenters requested that we identify the sources of the discharge
data we plan to employ for purposes of determining the discharge related amount. These
commenters also requested confirmation of their understanding that no type of discharge,
regardless of source of payment, would be excluded from the discharge count for this purpose.
Commenters specifically cited nursery discharges and discharges from non-PPS areas of a
hospital as examples of discharges that should not be excluded under the statutory language,
which they believe requires the inclusion of all patient discharges regardless of type of patient
within the inpatient areas of the hospital.
Response: We cannot agree with the commenters that the statutory language includes all
patient discharges within the inpatient areas of the hospital. Rather, the statutory language
clearly restricts the discharges to be counted for purposes of determining the discharge-related
amount to discharges from the acute care portion of the hospital. As we discussed in the
proposed rule, the term "discharge related amount" is defined in section 1886(n)(2)(C) of the Act
as "the sum of the amount, estimated based upon total discharges for the eligible hospital
(regardless of any source of payment) for the period, for each discharge up to the 23,000th
discharge as follows:
(i) for the first through the 1,149th discharge, $0.
(ii) for the 1,150th through the 23,000th discharge, $200.
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(iii) for any discharge greater than the 23,000th, $0."
The phrase "total discharges for the eligible hospital (regardless of any source of
payment)" limits the count of discharges to the acute care inpatient discharges. This is because
of the reference to "eligible hospital." "Eligible hospital" is defined in section 1886(n)(6)(B) of
the Act for purposes of the incentive payments provision, as "a subsection (d) hospital,"
referring in turn to the definition of that term in section 1886(d)(1)(B) of the Act. Section
1886(d)(1)(B) of the Act generally defines a "subsection (d) hospital" as a "hospital located in
one of the fifty States or the District of Columbia," excluding hospitals that are not paid under
the IPPS in accordance with section 1886(d)(1)(B) of the Act, such as psychiatric, rehabilitation,
long term care, children's, and cancer hospitals. However, 1886(d)(1)(B) also specifies that the
"term ‘subsection (d) hospital… does not include a psychiatric or rehabilitation unit of the
hospital which is a distinct part of the hospital (as defined by the Secretary)." Therefore, the
term "eligible hospital" for purposes of the incentive payments provision does not extend to the
excluded units of the hospital. The term does, of course, include the inpatient portion of the
hospital that receives payment for Medicare purposes under the inpatient PPS. The phrase
"regardless of any source of payment," however, indicates that the count of "total discharges" for
this purpose should include not only patients for whom Medicare is the source of payment, but
also patients for whom payment is received from Medicaid or any other source of payment.
Accordingly, in the revised cost report form that is currently pending and which will be finalized
in time for the 2011 payment year, CMS Form 2552-10, Hospital and Hospital Health Care
Complex Cost Report, we have included a cell for entry of "Total hospital discharges as defined
in section 4102 of AARA," in the new Worksheet E-1, Part II, "Calculation of Reimbursement
for Settlement for HIT." This new cell is derived from "line 14, from "Worksheet S-3, Part I
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column 15." In turn, this cell from Worksheet S-3, Part I, column 15 incorporate all discharges
from the inpatient, acute care portion of the hospital, regardless of payment source. In this final
rule, we have also revised the definition of "eligible hospital" in §495.100 of the regulations, as
well as the specification of "initial amount" in §495.104(c)(3) of the regulations, in order to
clarify this point.
Section 1886(n)(2)(C) of the Act, as amended by section 4102(a) of the HITECH Act,
specifies that a "12-month period selected by the Secretary" may be employed for purposes of
determining the discharge related amount. While the statute specifies that the payment year is
determined based on a Federal fiscal year (FY), section 1886(n)(2)(C) of the Act provides the
Secretary with authority to determine the discharge related amount on the basis of discharge data
from a relevant hospital cost reporting period, for use in determining the incentive payment
during a FY. FYs begin on October 1 of each calendar year, and end on September 30 of the
subsequent calendar year. Hospital cost reporting periods can begin with any month of a
calendar year, and end on the last day of the 12th subsequent month. We proposed, for purposes
of administrative simplicity and timeliness, for each eligible hospital during each incentive
payment year, to use data on the hospital discharges from the hospital fiscal year that ends during
the FY that is prior to the FY that serves as the payment year as the basis for making preliminary
incentive payments. Similarly, we proposed that final payments would be determined at the time
of settling the cost report for the hospital fiscal year that ends during the payment year, and
settled on the basis of the hospital discharge data from that cost reporting period.
Example of proposal: FY 2011 begins on October 1, 2010 and ends on
September 30, 2011. For an eligible hospital with a cost reporting period running from
July 1, 2009 through June 30, 2010, we would employ the relevant data from the hospital's cost
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reporting period ending June 30, 2010 in order to determine the incentive payment for the
hospital during FY 2011. This timeline would allow us to have the relevant data available for
determining payments in a timely manner for the first and subsequent payment years. This
timeline would also render it unnecessary to develop a cumbersome process to extract and
employ discharge data across more than one hospital cost reporting period in order to determine
the discharge related amount for a FY-based payment period. However, final payments would
be based on hospital discharge data from the cost report ending June 30, 2011, and determined at
the time of settlement for that cost reporting period.
Commenters raised several issues with regard to our proposals regarding the timing of the
cost reports to be used for purposes of determining preliminary and final incentive payments.
Each of these issues embraces the use of several data elements, including discharge counts, bed
days, and other factors employed in the payment calculations. For purposes of simplicity, we
will address these issues in general terms in this section. As we will note at several junctures
below, this discussions of these issues, however, are applicable to the cost report data for other
elements of the computation.
Comment: Several commenters called our attention to timing issues with regard to the
cost reporting periods that we proposed to use for purposes of determining preliminary and final
incentive payments. These commenters noted that, if we finalize our proposal to use data from
the hospital fiscal year that ends during the FY prior to the FY that serves as the payment year as
the basis for making preliminary incentive payments, hospitals with cost reporting periods on the
October-to-September cycle would face a delay of two months or longer after potentially
qualifying as a meaningful user before receiving a preliminary incentive payment. Specifically,
for hospitals on this cycle, the cost report that would be used for determining interim payments
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for the first payment year (the October 1, 2009 through September 30, 2010 cost report) would
not be due until February 28, 2011, two months after the hospital may have been able to qualify
as a meaningful user (January 1, 2011). For hospitals on the September-to-August cycle, the
delay could be one month. The commenters pointed out that over one-fifth of subsection(d)
hospitals have cost reporting periods beginning on September 1 or October 1. The commenters
therefore recommended that we employ discharge and other data from a hospital’s most recently
filed cost report as the basis for determining the hospital's preliminary incentive payment once
the hospital has qualified as a meaningful user.
Response: We agree with these commenters, and in this final rule we are therefore
adopting the policy that we employ discharge and other data from a hospital’s most recently filed
12-month (see discussion below) cost report as the basis for determining the hospital's
preliminary incentive payment once the hospital has qualified as a meaningful user. However,
the precise timing of payments, especially during the first payment year, may be affected by
other factors such as the timeline for implementing the requisite systems to calculate and
disburse the payments. We are adopting the policy recommended by the commenters in order to
avoid any unnecessary delays in making interim payments due merely to the timing of cost
reporting periods.
Example: FY 2011 begins on October 1, 2010 and ends on September 30, 2011. For an
eligible hospital with a cost reporting period on the October-to-September cycle, we would
employ the relevant data from the hospital's most recently submitted cost reporting period in
order to determine the incentive payment for the hospital during FY 2011. If the hospital
qualifies for incentive payments on January 1, 2011, this would probably be the cost report for
the period running from October 1, 2008 through September 30, 2009. However, we would also
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employ the October 1, 2009 through September 30, 2010 cost report, if that cost report is
submitted before the point when preliminary incentive payments can be calculated.
Comment: A number of commenters also raised concerns about our proposal to
determine final incentive payments at the time of settling the cost report for the hospital fiscal
year that ends during the payment year, and to be settled on the basis of the hospital discharge
and other data from that cost reporting period. These commenters pointed out that that the
pending CMS Form 2552-10, will not be effective in time for all hospitals and CAHs to
complete the new S-10 worksheet, Hospital Uncompensated Care and Indigent Care Data,
reporting charity care for their cost reporting period ending during the payment year. The
effective date of the new cost report will be for cost reporting periods beginning on or after
May 1, 2010 (as opposed to February 1, 2010 date anticipated in the proposed rule). For
purposes of our proposal for determining final incentive payments, including the Medicare
share/charity calculation, the first cost reporting period for which the new cost report will be
available is the period running from May 1, 2010 through April 30, 2011. This means that, for
cost reporting periods ending in FY 2011 before April 30, hospitals will not be able to complete
the new S-10 worksheet to report charity care charges. Therefore, these commenters
recommended that we revise our proposed policy, so that final incentive payments will be
determined at the time of settlement for the cost reporting period beginning in the payment year.
In this way all hospitals, regardless of their cost reporting cycle, will have adequate time to
submit the revised cost reports in time for determining final incentive payments.
Response: We agree with these commenters, and in this final rule we are therefore
adopting the policy that we determine final incentive payments at the time of settling the
12-month (see discussion below) cost report for the hospital fiscal year that begins after the
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beginning of the payment year, and to be settled on the basis of the hospital discharge and other
data from that cost reporting period.
Example: FY 2011 begins on October 1, 2010 and ends on September 30, 2011. For an
eligible hospital with a cost reporting period running from July 1 through June 30, we would
employ the relevant data from the hospital's cost reporting period ending June 30, 2009 in order
to determine the preliminary incentive payment for the hospital during FY 2011 (or June 30,
2010, if that cost report was filed prior to the calculation). However, final payments would be
based on hospital discharge data from the cost report beginning on July 1, 2011 and ending
June 30, 2012, and determined at the time of settlement for that cost reporting period.
Comment: Several commenters requested that we explain how the occurrence of nonstandard cost reporting periods will be taken into account in determining the appropriate cost
reporting periods to employ for determining preliminary and final EHR incentive payments.
Non-standard cost reporting periods run for periods shorter than the standard 12-month cost
reporting periods (for example, 3 months, 6 months), and are typically employed to
accommodate the circumstances of hospitals in several distinct situations, such as newly
constructed hospitals, changes of ownership, and reorganization of a single multicampus hospital
into multiple separate providers. In these cases, one non-standard cost reporting period may be
employed before the hospital resumes (or begins) cost reporting on a 12-month cycle. One
commenter recommended that we account for these situations by adopting three changes to our
proposed regulations:
• For purposes of determining preliminary incentive payments, employ the most recently
submitted 12-month cost reporting period that ends in the year prior to the payment year, in order
to account for those situations in which the most recent cost reporting period ending prior to the
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payment year is a non-standard period.
• For purposes of determining final incentive payments, employ the first 12-month cost
reporting period that begins after the start of the payment year, in order to account for those
situations in which the cost reporting period ending during the payment year is a non-standard
period.
• Provide that a hospital may address the CMS regional office responsible for its
payment area for determination of the appropriate cost reporting period to employ for calculating
preliminary or final incentive payment in cases that are not anticipated by the rules adopted in
the final regulation.
Response: We acknowledge that we failed to address the circumstances of non-standard
cost reporting periods in the proposed rule, and we agree with the commenters that it is only
appropriate to do so. Non-standard cost reporting periods are not likely to be truly representative
of a hospital’s experience, even if methods were to be adopted for extrapolating data over a
normal 12-month cost reporting period. This is because these periods are often quite short (for
example, 3 months), which makes it questionable to extrapolate the data over a full cost
reporting period. In addition, these abbreviated periods often capture the experience of a hospital
during a period of transition (for example, change of ownership), which often renders the data
highly unrepresentative. We also agree with the logic of the policy revisions proposed by the
commenter cited above, subject only to the necessity of adapting the recommendations slightly to
the revisions, as discussed above, we are also adopting to our proposals for identifying the cost
reporting periods to be employed in determining preliminary and final EHR incentive payments.
After consideration of the public comments we receive with regard to the use of cost
reporting periods for preliminary and final incentive payment determinations, we are adopting
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the following policies in this final rule:
• For purposes of determining preliminary incentive payments, we will employ
discharge and other relevant data from a hospital’s most recently submitted 12-month cost report
once the hospital has qualified as a meaningful user.
• For purposes of determining final incentive payments, we will employ the first
12-month cost reporting period that begins after the start of the payment year, in order to settle
payments on the basis of the hospital discharge and other data from that cost reporting period.
In this final rule, we are revising section 495.104(c)(2) of the regulations accordingly. We are
not adopting the recommendation to allow the CMS regional offices to make a determination
about the appropriate cost reporting period in situations not anticipated by these rules because we
believe that these two rules cover all possible situations. For example, even in complicated cases
involving non-standard cost reporting periods, the cost reporting period for a hospital adjusts to a
standard 12-month cycle within a brief period.
c. Incentive Payment Calculation for Eligible Hospitals: Medicare Share
As previously discussed, the initial amount must be multiplied by the eligible hospital's
Medicare share and an applicable transition factor to determine the incentive payment to an
eligible hospital for a payment year. As added by section 4102(a) of the HITECH Act, section
1886(n)(2)(D) of the Act defines the Medicare share for purposes of calculating incentive
payments as a fraction based on estimated Medicare FFS and managed care inpatient bed days,
divided by estimated total inpatient bed-days, modified by charges for charity care. This section
specifies that the Medicare share fraction is determined for the incentive payment year "for an
eligible hospital for a period selected by the Secretary." As in the case of the discharge data
discussed above, this clause provides the Secretary with authority to determine the eligible
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hospital’s Medicare share fraction on the basis of data from a relevant hospital cost reporting
period, for use in determining the incentive payment during a FY. For purposes of
administrative simplicity and timeliness equivalent to those discussed above with regard to
discharge data, we proposed, for each eligible hospital during each payment year, to employ data
on the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient
bed-days, and charges for charity care from the hospital FY that ends during the FY prior to the
FY that serves as the payment year as the basis for preliminary payment. We also proposed that
final payment would be made on the basis of the data from the hospital fiscal year that ends
during the FY that serves as the payment year at the time of the settlement of the cost report for
the latter period.
As a result of the changes we are making to these proposed policies in response to the
comments discussed in the previous section, in this final rule we are adopting the following
policies for employing data on the eligible hospital's Medicare fee-for-service and managed care
inpatient bed days, total inpatient bed-days, and charges for charity care from the hospital in
making preliminary and final EHR incentive payment determinations:
• For purposes of determining preliminary incentive payments, we will employ data on
the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient
bed-days, and charges for charity care from a hospital’s most recently submitted 12-month cost
report once the hospital has qualified as a meaningful user.
• For purposes of determining final incentive payments, we will employ the first
12-month cost reporting period that begins after the start of the payment year, in order to settle
payments on basis of the hospital's Medicare fee-for-service and managed care inpatient bed
days, total inpatient bed-days, and charges for charity care data from that cost reporting period.
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Section 1886(n)(2)(D) of the Act, as amended by section 4102 of the HITECH Act,
defines the numerator and denominator of the Medicare share fraction for an eligible hospital in
terms of estimated Medicare FFS and managed care inpatient bed-days, estimated total inpatient
bed-days, and charges for charity care. Specifically, section 1886(n)(2)(D)(i) of the Act defines
the numerator of the Medicare share fraction as the sum of-• The estimated number of inpatient-bed-days (as established by the Secretary) which
are attributable to individuals with respect to whom payment may be made under part A; and
• The estimated number of inpatient-bed-days (as so established) that are attributable to
individuals who are enrolled with a MA organization under Part C.
We proposed to determine the numbers of Medicare Part A and Part C inpatient-bed-days
using the same data sources and methods for counting those days that we employ in determining
Medicare's share for purposes of making payments for direct graduate medical education costs,
as provided under section 1886(h) of the Act and §413.75 of our regulations. Specifically, we
proposed to derive "the estimated number of inpatient-bed-days… attributable to individuals
with respect to whom payment may be made under part A" from lines 1, 6 through 9, 10, and 14
in column 4 on Worksheet S-3, Part I of CMS Form 2552-96, Hospital and Hospital Health Care
Complex Cost Report. We stated that the data entered on these lines in the cost report include all
patient days attributable to Medicare inpatients, excluding those in units not paid under the IPPS
and excluding nursery days.
Comment: A number of commenters pointed out an apparent contradiction between the
cost report sources from which we proposed to derive the "the estimated number of
inpatient-bed-days… attributable to individuals with respect to whom payment may be made
under part A" (lines 1, 6 through 9, 10, and 14 in column 4 on Worksheet S-3, Part I of CMS
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Form 2552-96,), and our statement that "the data entered on these lines in the cost report include
all patient days attributable to Medicare inpatients, excluding those in units not paid under the
IPPS and excluding nursery days." These commenters supported our proposal to employ the
data from those lines of the cost report, on the grounds that these cost report lines "adequately
capture the necessary data. However, as the commenters pointed out, the data on the identified
lines do include patient days in units not paid under the inpatient PPS. These commenters also
contended that the relevant statutory language ("inpatient-bed-days… attributable to individuals
with respect to whom payment may be made under part A"; emphasis supplied) would seem to
include patient days in units not paid under the inpatient PPS.
Response: We agree with the commenters that our citation of the specific cost report
sources from which we proposed to derive the "the estimated number of inpatient-bed-days…
attributable to individuals with respect to whom payment may be made under part A" was not
consistent with our statement the data entered on these lines in the cost report include "all patient
days attributable to Medicare inpatients, excluding those in units not paid under the IPPS and
excluding nursery days." In this case, our error was in the specific cost report lines that we cited,
rather than in our statement that the relevant statutory language ("inpatient-bed-days…
attributable to individuals with respect to whom payment may be made under part A") includes
"all patient days attributable to Medicare inpatients, excluding those in units not paid under the
IPPS and excluding nursery days." As in the case which we discussed above with regard to
counting "total discharges," the relevant statutory language directs that the numerator and
denominator of the Medicare share fraction incorporate inpatient bed-day counts for the eligible
hospital, and, as discussed in our section on total discharges, "eligible hospital" is defined with
reference to section 1886(d)(1)(B) of the Act, which specifically excludes from the definition
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psychiatric or rehabilitation units that are a distinct part of the hospital. Specifically, the
"Medicare share" is to be "specified… for an eligible hospital." The numerator of the Medicare
share fraction is further defined as "the sum (…with respect to the eligible hospital) of-"(I) the estimated number of inpatient-bed-days (as established by the Secretary) which
are attributable to individuals with respect to whom payment may be made under part A; and
"(II) the estimated number of inpatient-bed-days (as so established) which are attributable
to individuals who are enrolled with a Medicare Advantage organization under part C."
Finally, the denominator of the Medicare share fraction includes "the estimated total
number of inpatient-bed-days with respect to the eligible hospital." Therefore, the
inpatient-bed-day counts included in the Medicare share fraction for purposes of the incentive
payments provision do not extend to inpatient-bed-days in excluded units of the hospital, but
only to inpatient-bed-days in the acute care portion of the hospital that receives Medicare
payment under the inpatient PPS. In this final rule, we are revising section 495.104(c)(4) of the
regulations in order to clarify this point.
Since the publication of the proposed rule, we have adopted various changes to the
Medicare cost report, including changes designed to accommodate the appropriate computation
and final settlement of EHR incentive payments for qualifying hospitals. These changes are
included in the pending cost report form, CMS Form 2552-10. In this revised form, the relevant
Medicare inpatient days are entered in line 2 of the new Worksheet E-1, Part II, "Calculation of
Reimbursement for Settlement for HIT." This new line is defined as the sum of lines 1 and 8
through 12, from Worksheet S-3, Part I, column 6 of CMS Form 2552-10. These lines include
all patient days attributable to Medicare inpatients, excluding those in units not paid under the
IPPS, and excluding nursery days.
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Comment: Several commenters also contended that our proposed exclusion of nursery
days from the determination of "inpatient-bed-days… attributable to individuals with respect to
whom payment may be made under part A" is inappropriate. These commenters maintained that
the statutory language is broad enough to include all inpatient days associated with Medicare
eligible individuals without restriction based on the type of Part A patient.
Response: In excluding nursery days from the count of Medicare inpatient bed days, we
are following the precedent of not counting such days for purposes of the direct medical
education, indirect medical education, and disproportionate share adjustments under the
Medicare IPPS. As in the case of the term "subsection (d)" hospital, we believe that, in the
absence of clear direction from the statute to the contrary, the most appropriate policy is to
interpret terms such as "inpatient bed-days" in the light of existing Medicare program policies
and precedents. Under our policies for the direct medical education, indirect medical education
and disproportionate share adjustments, a bed must be permanently maintained for lodging
inpatients in order to be included in available inpatient bed and inpatient bed day counts. We
exclude the days provided to newborns (except for those in intensive care units of the hospital)
because healthy new born infants are not provided with an acute level of hospital care. (This is
not the case with newborns assigned to intensive care units, who are included in the counts for
those units.) For these reasons, nursery days are explicitly excluded from;
• The counts of Medicare inpatient hospital days and total inpatient hospital days for
purposes of direct graduate medical education payments under section 413.75(b) of the
regulations, where the definition of Medicare patient load reads: "inpatient days in any distinct
part of the hospital are included and nursery days are excluded."
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• The counts of bed days for purposes of the Medicare indirect graduate medical education
adjustment under section 412.105(b): the "count of available bed days excludes bed days
associated with… (5) Beds or bassinets in the healthy newborn nursery…."
• The count of beds for purposes of the Medicare DSH adjustment under section
412.106(a)(i) of the regulations: "The number of beds in a hospital is determined in accordance
with §412.105(b)."
We note that, in addition to excluding nursery days from the numerator of the Medicare
share fraction, these days are excluded for the same reasons from the count of total inpatient bed
days in the denominator of the Medicare share fraction. We therefore do not believe that
excluding these days would result in disadvantage to hospitals in determining their Medicare
share fractions for purposes of calculating EHR incentive payments. (See our discussion of the
cost report data employed to determine total inpatient bed days in the denominator of the
Medicare share fraction, below.)
Comment: Other commenters maintained that swing bed days should also be included in
the determination of "inpatient bed-days… attributable to individuals with respect to whom
payment may be made under part A."
Response: Once again, as in the case of the term "subsection(d)" hospital, we believe
that, in the absence of clear direction from the statute to the contrary, the most appropriate policy
is to interpret terms such as "inpatient bed-days" in the light of existing Medicare program
policies and precedents. We are therefore also following the precedent of Medicare payment
adjustments in excluding certain swing bed days from the count of Medicare inpatient days. As
in these cases, swing bed days are excluded when the swing bed is used to furnish SNF care,
because only the days used for inpatient hospital care will be included in the count of "inpatient
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bed-days… attributable to individuals with respect to whom payment may be made under part
A." Otherwise, we would be including non-inpatient bed-days in the count.
Comment: One commenter objected that, for purposes of the Medicare inpatient day
count in the Medicare share, we appeared to be proposing to use only paid Medicare days. This
commenter argued that all eligible Medicare days should be counted in order to reflect a
hospital’s true Medicare utilization. The commenter also maintained that the statute’s reference
to days "attributable to individuals with respect to whom payment may be made under part A"
requires inclusion of all days when a beneficiary was eligible for Medicare, on the grounds that
this language "does not require actual payment by Medicare." The commenter further noted that
the other factor in the numerator of the Medicare share fraction requires inclusion of all patient
days associated with individuals enrolled in a Part C Medicare Advantage plan, and maintained
that there "would be no rational basis for Congress to include all enrolled Part C days, quite
clearly regardless of whether they are paid, but to limit part A days to those paid by Medicare.’
Response: We assume that, by the term "unpaid" Medicare days, the commenter is
referring to days provided to Medicare entitled beneficiaries for which the services are
non-covered, such as the cases in which a beneficiary has exhausted coverage of inpatient
hospital services, or in which the services are not covered under a national or local coverage
determination. We do not agree with the commenter that these days ought to be included in the
count of "inpatient-bed-days… attributable to individuals with respect to whom payment may be
made under part A." Indeed, we believe that the best reading of this statutory language suggests
the opposite of what the commenter maintains: in cases of non-covered days, payment may not
be made under Part A, and therefore these days should not be included in a count of days
"attributable to individuals with respect to whom payment may be made under part A." We
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agree with the commenter that the language for the other factor in the numerator of the Medicare
share fraction ("inpatient-bed-days attributable… to individuals who are enrolled with a MA
organization under Part C") is more inclusive. However, we must assume that the difference in
the statutory language is meaningful. Therefore, we are finalizing our proposal not to include
days provided to Medicare entitled beneficiaries for which the services are non-covered in the
count of Medicare inpatient days. It is important to note that we do include such "non-paid" days
for purposes of other Medicare payment provisions, where it is appropriate to do so under the
governing statutory provisions. For example, for purposes of the Medicare DSH adjustment the
relevant statutory language requires inclusion of days associated with individuals who are
"entitled" to benefits under Medicare Part A, rather than days for which "payment may be made
under part A."
After consideration of these comments, we are finalizing our proposals with regard to the
data to be used to determine the "inpatient bed-days… attributable to individuals with respect to
whom payment may be made under part A" in the numerator of the Medicare share fraction.
Accordingly, we will derive this information from Worksheet E-1, Part II, line 2 of the pending
Medicare cost report, Form CMS-2552-10, which is defined as the sum of lines 1 and 8 through
12 in column 6, Worksheet S-3, Part I of the pending cost report. As we have just discussed, we
are revising the cost report data sources from which we are deriving this information in order to
be consistent with the statutory requirement. We are also revising §495.104(c)(4)(ii)(A)(2) of
the regulations to clarify this point.
Comment: One commenter inquired about the status of inpatient-bed-days attributable to
individuals enrolled in the 1876 Medicare cost plan operating under "billing option 2," under
which the section 1876 cost contractor pays hospitals for Part A benefits, and then claims
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reimbursement from CMS. The cost-contractor pays Part A benefits for its 36,000 enrolled
Medicare beneficiaries to contracted hospitals in one State. The commenter maintained that a
reasonable interpretation of the statutory language suggests that the inpatient bed days for these
beneficiaries should be counted in the numerator of the Medicare share fraction. The commenter
requested clarification concerning the inclusion of these days in the data sources we proposed to
employ, or the development of an appropriate remedy in order ensure that they are counted.
Another commenter noted that Worksheet S-3, Part I, column 4, line 2 in of the Medicare cost
report, CMS 2552-96, has historically been completed primarily by teaching hospitals, based on
patient days reported on Provider Statistical and Reimbursement (PS&R) Report Type 118. The
commenter further stated that there have been many situations in which non-teaching hospitals
reporting days on this cost report line have the days removed by the Medicare fiscal intermediary
or Medicare administrative contractor (MAC), as PS&R Report Type 118 contains no patient day
data for non-teaching hospitals. The commenter recommended that we clarify our plans with
regard to PS&R Report Type 118 and allow the form to populate with accurate data for all
hospitals submitting no-pay bills for Medicare beneficiaries who are enrolled in Medicare
Advantage (MA) plans and who receive Medicare-covered hospital services. The commenter
further noted that, at this time, CAHs and IPPS hospitals that do not receive the DSH adjustment
are not required to submit no-pay bills for Medicare Advantage patients.
Response: We agree with the commenters that all these days should be counted in the
numerator of the Medicare share fraction. With respect to MA plan enrollees, these patients are
already included in the "estimated number of inpatient-bed-days attributable… to individuals
who are enrolled with a MA organization under Part C." In order for the data on the inpatient
days attributable to individuals enrolled in MA plans to be included on the Medicare cost report,
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the hospital must submit a "no-pay" bill to the Medicare contractor. We have issued instructions
clarifying that hospitals must submit no-pay bills for inpatient days attributable to individuals
enrolled in MA plans. Specifically, CR 5647, dated July 20, 2007, required all hospitals paid
under the inpatient prospective payment system (IPPS), inpatient rehabilitation facility
prospective payment system (IRF PPS), and long term care hospital prospective payment system
(LTCH PPS) to submit informational only Medicare Advantage claims. Furthermore, CR 6821,
dated May 5, 2010, provided that applicable IPPS, IRF PPS and LTC hospitals will be given one
final opportunity to comply with the requirement to submit FY 2007 informational only claims.
In addition, these hospitals are required to attest in writing to their Medicare contractor that they
have either submitted all of their Medicare Advantage claims for FY 2007 or that they have no
Medicare Advantage claims for that fiscal year.
After consideration of the comments, we are
finalizing our proposals for determining the "inpatient bed-days …attributable to individuals
with respect to whom payment may be made under part A" and the "estimated number of
inpatient-bed-days attributable… to individuals who are enrolled with a MA organization under
Part C." However, we are modifying the language of §495.104(c)(4)(ii)(A)(1) regarding the
counting of inpatient days bed-days attributable to individuals with respect to whom payment
may be under part A to clarify that this count includes days attributable to enrollees under section
1876 cost contracts where payments for Part A benefits are made by the section 1876 contractor.
We intend to derive this information from Worksheet E-1, Part II, line 3 of the pending Medicare
cost report, Form CMS-2552-10, which is derived from line 2 in column 6, Worksheet S-3, Part I
of the pending cost report. This data source on the revised Medicare cost report is the equivalent
of the source we cited in the proposed rule.
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Section 1886(n)(2)(D)(ii) of the Act defines the denominator of the Medicare share
fraction as the product of-• The estimated total number of inpatient-bed-days with respect to the eligible hospital
during such period; and
• The estimated total amount of the eligible hospital's charges during such period, not
including any charges that are attributable to charity care (as such term is used for purposes of
hospital cost reporting under Title XVIII), divided by the estimated total amount of the hospital’s
charges during such period.
As in the case of Medicare Part A and Part C inpatient-bed days, for purposes of
determining total inpatient-bed days in the denominator of the Medicare share fraction, we
proposed to use the same data sources, and the same methods, that we employ in determining
Medicare's share for purposes of making payments for direct graduate medical education costs.
Specifically, we proposed to derive the relevant data from lines 1, 6 through 9, 10, and 14 in
column 6 on Worksheet S-3, Part I of the Medicare cost report. We noted that the data entered
on these lines in the cost report include all patient days attributable to inpatients, excluding those
in units not paid under the IPPS.
Comment: Several commenters noted, regarding our proposal concerning Medicare
inpatient days in the denominator of the Medicare share fraction, an apparent contradiction
between the cost report sources from which we proposed to derive "estimated total number of
inpatient-bed-days with respect to the eligible hospital during such period"" (lines 1, 6 through 9,
10, and 14 in column 6 on Worksheet S-3, Part I), and our statement that "the data entered on
these lines in the cost report include all patient days attributable to inpatients, excluding those in
units not paid under the IPPS ." These commenters supported our proposal to employ the data
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from those lines of the cost report, on the grounds that these cost report lines adequately capture
the necessary data. However, as the commenters pointed out, the data on the identified lines do
include patient days in units not paid under the inpatient PPS. And these commenters contended
that the relevant statutory language ("the estimated total number of inpatient-bed-days with
respect to the eligible hospital during such period") would seem to include patient days in units
excluded from the inpatient PPS.
Response: As in the case of the equivalent issue with regard to Medicare inpatient bed
days, we agree with the commenters that our citation of the specific cost report sources from
which we proposed to derive the "the estimated total number of inpatient-bed-days with respect
to the eligible hospital during such period" was not consistent with our statement that the data
entered on these lines in the cost "include all patient days attributable to inpatients, excluding
those in units not paid under the IPPS." And as in the case of Medicare inpatient-bed-days, our
error was in the specific cost report lines that we cited, rather than in our statement that the
relevant statutory language ("the estimated total number of inpatient-bed-days with respect to the
eligible hospital") includes "all patient days attributable to inpatients, excluding those in units not
paid under the IPPS.", As we have discussed in connection with counting discharges and
Medicare inpatient-bed-days, the relevant statutory language directs that the denominator of the
Medicare share fraction incorporate inpatient bed-day counts for the eligible hospital. Therefore,
the inpatient-bed-day counts included in the Medicare share fraction for purposes of the
incentive payments provision do not extend to inpatient-bed-days in excluded units of the
hospital, but only to inpatient-bed-days in the acute care portion of the hospital that receives
payment for Medicare purposes under the inpatient PPS.
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We are finalizing our proposal for determining the count of total inpatient-bed days in the
denominator of the Medicare share fraction as including all patient days attributable to inpatients,
excluding those in units not paid under the IPPS. Accordingly, we will derive this information
from Worksheet E-1, Part II, line 4 of the pending Medicare cost report, Form CMS-2552--10,
which is defined as the sum of lines 1and 8 through 12, in column 8, Worksheet S-3, Part I of the
pending cost report. As we have just discussed, we are revising the cost report data sources from
which we are deriving this information in order to be consistent with the statutory requirement.
In this final rule, we are also revising §495.104(c)(4)(ii)(B)(1) to clarify this point.
As we noted above, the denominator of the Medicare share fraction also includes the
"estimated total amount of the eligible hospital's charges during such period, not including any
charges that are attributable to charity care (as such term is used for purposes of hospital cost
reporting under Title XVIII), divided by the estimated total amount of the hospital’s charges
during such period." We discuss the data sources and methods for calculating the charges and
charity care portions of this formula in the next section.
d. Incentive Payment Calculation for Eligible Hospitals: Charity Care and Charges
In determining the denominator of the Medicare share fraction, we also must determine
any charges that are attributable to charity care furnished by an eligible hospital or CAH. The
exclusion of charges attributable to charity care has the effect of decreasing the denominator of
the Medicare share fraction as the proportion of charity care (charity care charge ratio) provided
by a hospital increases. This is because the ratio of estimated total hospital charges, not
including charges attributable to charity care, to estimated total hospital charges during a period
decreases, relatively speaking, as a hospital provides a greater proportion of charity care. The
effect of a greater charity care factor on the denominator of the Medicare share fraction is
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therefore to decrease the denominator (as the total number of inpatient-bed days is multiplied by
a relatively lower charity care charge ratio), as a hospital provides a greater proportion of charity
care. A smaller denominator increases the Medicare share factor, providing for higher incentive
payments, to a hospital that provides a greater proportion of charity care. Conversely, as a
hospital provides a lower proportion of charity care, the ratio of estimated total hospital charges,
not including charges attributable to charity care, to estimated total hospital charges during a
period increases.
For the purposes of this final rule, we define charity care as part of uncompensated and
indigent care described for Medicare cost reporting purposes in the Medicare cost report
instructions at section 4012 of the Provider Reimbursement Manual (PRM), Part 2; Worksheet
S-10; Hospital Uncompensated and Indigent Care Data. Subsection (d) hospitals and CAHs are
required to complete the Worksheet S-10.
As part of the Form CMS-2552-10 described above, the revised Worksheet S-10
instructions define uncompensated care as follows: ". . . charity care and bad debt which
includes non-Medicare bad debt and non-reimbursable Medicare bad debt. Uncompensated care
does not include courtesy allowances or discounts given to patients." These instructions further
define charity care to include health services for which a hospital demonstrates that the patient is
unable to pay. Charity care results from a hospital's policy to provide all or a portion of services
free of charge to patients who meet certain financial criteria. For Medicare purposes, charity
care is not reimbursable, and unpaid amounts associated with charity care are not considered as
an allowable Medicare bad debt. Therefore, we proposed to use the charity care charges that are
reported on line 19 of the revised Worksheet S-10 in the computation of the Medicare share of
the incentive payments. Line number 19 of the revised Worksheet S-10, as proposed, has
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changed to line number 20 based on the pending OMB approved final Form CMS-2552-10.
Only the line number has changed as the instructions are the same for line 19 as proposed and for
line 20 in the pending final OMB approved Worksheet S-10. Thus, the charity care charges used
to calculate the final Medicare share is reported on line 20 of the pending final OMB approved
Worksheet S-10.
Under section 1886(n)(2)(D) of the Act, if the Secretary determines that data are not
available on charity care necessary to calculate the portion of the formula specified in clause
(ii)(II) of section 1886(n)(2)(D) of the Act, the Secretary shall use data on uncompensated care
and may adjust such data so as to be an appropriate proxy for charity care including a downward
adjustment to eliminate bad debt data from uncompensated care data. In the absence of the data
necessary for the Secretary to compute the amount described in clause (ii)(II) of section
1886(n)(2)(D) of the Act, the amount under such clause shall be deemed to be 1.
We believe that the charity care charges reported on line 20 of the pending final OMB
approved Worksheet S-10 represent the most accurate measure of charity care charges as part of
the hospital's overall reporting of uncompensated and indigent care for Medicare purposes.
Therefore, since eligible hospitals and CAHs are required to complete the Worksheet S-10, if a
hospital has not properly reported any charity care charges on line20, we may question the
accuracy of the charges used for computing the final Medicare share of the incentive payments.
With appropriate resources, we believe the charity care data can be obtained by the MAC. This
data would be used to determine if the hospital's charity care criteria are appropriate, if a hospital
should have reported charity care charges, and if the reported charges are proper. If we
determine, as based on the determination of the MAC, that the hospital did not properly report
charity care charges on line 20 of the pending final OMB approved Worksheet S-10, then we
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proposed to deem the portion of the denominator described in section 1886(n)(2)(D)(ii)(II) of
the Act to be 1.
In the proposed rule, we specifically solicited public comments on the charity care
financial criteria established by each hospital and reviewed by the MACs, the collection of
charity care data on the Worksheet S-10, and whether proxies for charity care may be developed
with other data available to us.
Comment: Some commenters requested that CMS clarify the definition of charity care.
One commenter believed the CMS incorrectly indicated that Medicare does not reimburse for
charity care. The commenter believed this statement is inconsistent with section 312 of the
Provider reimbursement Manual (PRM).
Response: Section 1886(n)(2)(D)(ii)(II) of the Act defines charity care charges to
compute the Medicare share as such term is used for purposes of hospital cost reporting under
Medicare. Thus, we are adopting our proposed definition of charity care as part of
uncompensated and indigent care described for Medicare cost reporting purposes in the Medicare
cost report instructions as described above.
In addition, we believe that our statement is correct in that Medicare does not pay for
charity care in accordance with the regulations and manual instructions. Specifically, section
413.89(b)(1) of the Medicare regulations defines bad debts as amounts considered to be
uncollectible from accounts and notes receivable that were created or acquired in providing
services. "Accounts receivable" and "notes receivable" are designations for claims arising from
the furnishing of services, and are collectible in money in the relatively near future. Section
413.89(b)(2) of the Medicare regulations defines charity allowances as reductions in charges
made by the provider of services because of the indigence or medical indigence of the patient.
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Cost of free care (uncompensated services) furnished under a Hill-Burton obligation are
considered as charity allowances. Furthermore, section 413.89(g) states that charity allowances
have no relationship to beneficiaries of the Medicare program and are not allowable costs. These
charity allowances include the costs of uncompensated services furnished under a Hill-Burton
obligation.
Also, section 312 of the PRM states that, for Medicare bad debt purposes, a nonMedicaid beneficiary may be considered indigent or medically indigent and that once indigence
is determined and the provider concludes that no improvements in the beneficiary’s financial
condition exist, the debt may be deemed uncollectible without applying the collection
requirements of section 310 of the PRM. We believe that the instructions at section 312 of the
PRM specify bad debt amounts that may be allowable under section 413.89 of the regulations
and, thus, these instructions are not related to charity care amounts that are not allowable for
Medicare.
After consideration of the public comments received, we are finalizing the definition of
charity care these provisions as proposed.
Comment: We received some comments asking if CMS will adopt standards to
determine if a hospital’s charity care policy is sufficient to qualify for the inclusion of charges in
the formula for EHR and whether that same policy would suffice to meet the criteria to
determine the eligibility for Medicare bad debt.
Response: Currently for bad debt purposes, section 312 of the PRM requires the provider
to perform asset/income tests of patient resources for non-Medicaid beneficiaries. These tests
will be used to determine if the beneficiary meets the provider’s indigent policy to qualify an
unpaid deductible and/or coinsurance amount as a Medicare bad debt. The provider is
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responsible for developing its indigent policy. Currently, the Medicare contractor will determine
if the indigent policies are appropriate for determining allowable Medicare bad debt under
section 312 of the PRM and §413.89 of the regulations. We believe that the Medicare contractor
will continue to determine if the provider's indigent policy for bad debt purposes is appropriate
and can determine if the same policy would be sufficient to use for charity care purposes.
Comment: We received many comments on the use of charity care charge data from line
19 of the revised worksheet S-10, as proposed. Commenters urge CMS to calculate charity care
costs by starting with the amount of charges a hospital has written off. Commenters noted that
this modification would help streamline and unify charity care reporting across the Federal
government (based on the way Internal Revenue Service (IRS)) requires charity care to be
reported) ensure consistency of reporting, and avoid significantly increasing hospitals’
administrative burden.
Response: As described above, we use charity care charges from line 20 of the pending
final OMB approved worksheet S-10 that captures "total initial payment obligations of the
patients who are given full or partial discounts, based on the hospital’s charity care criteria
(measured a full charge), for care delivered during the cost reporting period for the entire
facility." Similar comments received on our proposed rule were also received on the Agency
Information Collection Activities: Proposed Collection: Comment Request published in the
July 2, 2009 Federal Register (74 FR 31738).CMS issued a revised package, Agency
Information Collection Activities: Submission for OMB Review: Comment Request, in the
April 30, 2010 Federal Register (75 FR 22810). The comment period for the submission for
OMB review ended June 1, 2010. OMB will review the comments received and issue an
approved Form CMS 2552 10. The OMB approved Form CMS-2552-10 will be effective for
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cost reporting periods beginning on or after May 1, 2010.
Comment: Some commenters noted that the Hospital Uncompensated Care and Indigent
Care Worksheet S-10 that CMS proposed to revise in the July 2, 2009 Federal Register
(74FR 31738) would not be timely (based on the anticipated effective date for cost reporting
periods beginning on or after February 1, 2010 as stated in the proposed rule), and therefore,
hospitals with cost reporting periods beginning on November 1, 2009, December 1, 2009 or
January 1, 2010 would not have the opportunity to report charity care data for the first year of
the incentive payment. Commenters further highlighted their concern for available data
necessary to be included in interim payments and for final payments for periods that end
December 31, 2010. Commenters urged CMS to develop an interim mechanism for hospitals
to report the necessary information so that no hospital receives a charity care adjustment of "1"
merely because of its cost reporting cycle. Some commenters suggested that CMS use other
charity care data. Some commenters suggested that CMS use the current version of the Medicare
cost report, Form CMS-2552-96, to determine interim incentive payments.
Response: To calculate the Medicare share, which includes the charges for charity care,
we proposed in the proposed rule to employ data from the hospitals fiscal year that ends during
the FY prior to the FY that serves as the payment year as the basis for preliminary payment. We
further stated that final payment would be made on the basis of the data from the hospital fiscal
year that ends during the FY that serves as the payment year. After consideration of the public
comments received, we are revising the provision that for purposes of determining preliminary
incentive payments, we will employ data on the hospital’s/CAH's Medicare fee-for-service and
managed care inpatient bed days, total inpatient bed-days, and charges for charity care from a
hospital’s/CAH’s most recently submitted 12-month cost report once the hospital has qualified as
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a meaningful user. For purposes of determining final incentive payments, we will employ the
first 12-month cost reporting period that begins after the start of the payment year, in order to
settle payments on the basis of the hospital’s/CAH's Medicare fee-for-service and managed care
inpatient bed days, total inpatient bed-days, and charges for charity care data from that cost
reporting period.
In addition, as described in the proposed rule, hospitals have been required to fill out the
worksheet S-10 of the Form CMS 2552-96 since the BBRA of 1999 was enacted. We recognize
that the charity care data from the 2552-96 worksheet S-10 may have some limitations because,
in some cases, providers failed to complete the worksheet either partially or in its entirety.
Furthermore, in the past CMS did not review the worksheet S-10 because the data had no
Medicare payment implications. Thus, in the absence of availability of charity care data from
the OMB approved Form CMS 2552-10, a hospital for the purposes of calculating the charity
care charges in the interim may use the information from the 2552-96 worksheet S-10; line 22
until the revised worksheet is available. We believe that the Medicare contractor can make a
determination if the charity care charges from the 2552-96 are appropriate, and if so, use such
charges in determining the preliminary incentive payment amount for hospitals, as described
above. Since CAHs were not required to fill out the 2552-96 worksheet S-10, charity care
charges may not be available to determine preliminary incentive payments until the revised
worksheet is available. However, using data from the first 12-month cost reporting period that
begins after the start of the payment year, as described above, hospitals and CAHs will calculate
the final incentive payment amount with data from the pending Form CMS-2552-10 Medicare
cost report that is effective for cost reporting periods beginning on or after May 1,2010.
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Comment: Several commenters pointed out that we had failed to identify the source of
the data for "estimated total amount of the eligible hospital's charges" in the proposed rule.
Some of these commenters recommended that we employ Worksheet C, Column 8, line 103 for
this purpose.
Response: We did neglect to identify the source of the data for "estimated total amount
of the eligible hospital's charges" in the proposed rule. In the final rule, we are providing that,
for this purpose, we will employ the data from Worksheet E-1, Part II, line 5 of the revised
Medicare cost report, Form CMS-2552-10, which in turn derives this information from line 200
in column 8, Worksheet C, Part I of the pending cost report. We note that line 200 in column 8,
Worksheet C, Part I of the revised cost report is the equivalent of 101, Column 8, Worksheet C
of the current cost report. We are employing the equivalent of line 101, rather than the
equivalent of line 103, as recommended by the commenters, because line 101 (current line 200)
includes the charges for observation, and accordingly reflects the "total amount of the eligible
hospital's charges" more truly than line 103, which excludes those charges.
e. Incentive Payment Calculation for Eligible Hospitals: Transition Factor
As we have previously discussed, the initial amount must be multiplied not only by the
Medicare share fraction, but also by an applicable transition factor in order to determine the
incentive payment to an eligible hospital for an incentive payment year. Section 1886(n)(2)(E)(i)
of the Act designates that the applicable transition factor equals one (1) for the first payment
year, three-fourths for the second payment year, one-half for the third payment year, one-fourth
for the fourth payment year, and zero thereafter. However, section 1886(n)(2)(E)(ii) of the Act
provides that if "the first payment year for an eligible hospital is after 2013, then the transition
factor specified in this subparagraph for a payment year for such hospital is the same as the
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amount specified in clause (i) for such payment year for an eligible hospital for which the first
payment year is 2013." Accordingly, if a hospital's first payment year is FY 2014, then the
applicable transition factor equals three-fourths (¾) for the first payment year (FY 2014), onehalf (½) for the second payment year (FY 2015), one-fourth (¼) for the third payment year (FY
2015), and zero thereafter. If a hospital's first payment year is FY 2015, then the applicable
transition factor equals (½) for the first payment year (FY 2015), (¼) for the second payment
year (FY 2016), and zero thereafter. As discussed in more detail below, under section
1886(n)(2)(E)(ii) of the Act, the transition factor for a hospital for which the first payment year is
after 2015 equals zero for all years. In other words, 2015 is the last year for which eligible
hospitals may begin participation in the Medicare EHR Incentive Program.
Figure 1--Incentive Payment Calculation for Subsection D Hospitals
Incentive Amount = [Initial Amount] x [Medicare Share] x [Transition Factor]
Initial Amount = $2,000,000 + [$200 per discharge for the 1,150th – 23,000th discharge]
Medicare Share = Medicare/(Total*Charity Care) = [M/(T*C)]
M = [# of Inpatient Bed Days for Part A Beneficiaries] + [# of Inpatient Bed Days for
MA Beneficiaries]
T = [# of Total Inpatient Bed Days]
C = [Total Charges – Charges for Charity Care*]/[Total Charges]
*If data on charity care is not available, then the Secretary would use data on uncompensated
care as a proxy. If the proxy data is not also available, then "C" would be equal to 1.
Table13: Transition Factor
Consecutive Payment Year
1
2
3
4
Transition Factor
1
¾
½
¼
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f. Duration and Timing of Incentive Payments
Section 1886(n)(2)(E)(i) of the Act establishes that an eligible hospital that is a
meaningful user of certified EHR technology could receive up to 4 years of financial incentive
payments. The transition factor phases down the incentive payments over the 4-year period.
Therefore, an eligible hospital that is a meaningful user of certified EHR technology during the
relevant EHR reporting period, in payment year FY 2011, could receive incentive payments
beginning with FY 2011 (transition factor equals 1), and for FY 2012 (transition factor
equals ¾ ), 2013 (transition factor equals ½ ), and 2014 (transition factor equals ¼ ) if they
continue to be a meaningful user of certified EHR technology during the relevant EHR reporting
periods.
Section 1886(n)(2)(E)(ii) of the Act establishes the range of time during which a hospital
may begin to receive incentive payments, and the applicable transition periods for hospitals that
are permitted to begin receiving incentive payments after FY 2011. Specifically, that section
provides that if the "first payment year for an eligible hospital is after 2015, the transition factor .
. . for such hospital and for such year and subsequent year shall be 0." This clause in effect
provides that no incentive payments will be available to a hospital that would begin to receive
such payments after FY 2015. In other words, FY 2015 is the last FY in which a hospital can
begin to receive incentive payments. Taken together, sections 1886(n)(2)(G)(i) and
1886(n)(2)(E)(ii) of the Act allow hospitals to begin receiving incentive payments during FYs
2011 through 2015. Section 1886(n)(2)(E)(ii) of the Act also establishes the transition periods
and factors that will be in effect for hospitals that begin to receive transition payments during FY
2014 and 2015. As discussed previously, that section states that if "the first payment year for an
eligible hospital is after 2013, then the transition factor specified in this subparagraph for a
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payment year for such hospital is the same as the amount specified in clause (i) for such payment
year for an eligible hospital for which the first payment year is 2013." Section 1886(n)(2)(E)(ii)
of the Act also establishes the transition periods that will be in effect for hospitals that begin to
receive transition payments during FYs 2014 through 2015. That section states that if "the first
payment year for an eligible hospital is after 2013, then the transition factor specified in this
subparagraph for a payment year for such hospital is the same as the amount specified in clause
(i) for such payment year for an eligible hospital for which the first payment year is 2013." By
implication, this clause establishes that, for hospitals that begin to receive incentive payments in
FYs 2012 and 2013, the transition periods are equivalent to those for hospitals that begin to
receive such payments in FY 2011. An eligible hospital that is a meaningful user of certified
EHR technology could receive incentive payments beginning with FY 2012 (transition factor
equals 1), and for FY 2013 (transition factor equals ¾ ), FY 2014 (transition factor equals ½ ),
and FY 2015 (transition factor equals ¼ ). Similarly, an eligible hospital that is a meaningful
EHR user could receive incentive payments beginning with FY 2013 (transition factor equals 1),
and for FYs 2014 (transition factor equals ¾), 2015 (transition factor equals ½), and 2016
(transition factor equals ¼).
However, this section also specifically provides that the transition factor is modified for
those eligible hospitals that first become meaningful users of certified EHR technology
beginning in 2014 or 2015. Such hospitals would receive payments as if they became
meaningful EHR users beginning in 2013. In other words, if a hospital were to begin to
demonstrate meaningful use of EHR certified technology in 2014, the transition factor used for
that year (2014) would be ¾ instead of 1, ½ for the second year (2015), ¼ for the third year
(2016), and zero thereafter. Similarly, if a hospital were to begin meaningful use of certified
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EHR technology in 2015, the transition factor used for that year would be ½ instead of 1, ¼ for
the second year (2016), and zero thereafter.
Table 25 shows the possible years an eligible hospital could receive an incentive payment
and the transition factor applicable to each year.
TABLE 14: Transition Factor for Medicare FFS Eligible Hospitals
Fiscal Year
2011
2012
2013
2014
2015
2016
Fiscal Year that Eligible Hospital First Receives the
Incentive Payment
2011
2012
2013
2014
2015
1.00
--------------------0.75
1.00
---------------0.50
0.75
1.00
----------0.25
0.50
0.75
0.75
----------0.25
0.50
0.50
0.50
----------0.25
0.25
0.25
Comment: Several commenters pointed out an apparent inconsistency in the regulation
text that we proposed to implement the transition period and applicable transition factors for
EHR incentive payments. Specifically, the commenters noted that proposed section
495.104(b)(5) states that hospitals "whose first payment year is FY 2015 may receive such
payments for FY 2015 through 2017"(emphasis supplied), while proposed section 495.104(c)(5)
states that the transition factors for hospitals "whose first payment year is FY 2015" are:
(A) ½ for FY 2015; and
(B) ¼ for FY 2016. (Emphasis supplied.)
Response: These commenters are correct. Our proposed section 495.104(b)(5) contained
a typographical error. In order to be consistent with the clear requirements of the statute, section
495.104(b)(5) should have stated that hospitals "whose first payment year is FY 2015 may
receive such payments for FY 2015 through 2016." In this final rule, we are revising section
495.104(b)(5) of the final regulations accordingly.
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g. Incentive Payment Adjustment Effective in FY 2015 and Subsequent Years for Eligible
Hospitals who are not Meaningful EHR Users
In addition to providing for incentive payments for meaningful use of EHRs during a
transition period, section 1886(b)(3)(B) of the Act, as amended by section 4102(b)(1) of the
HITECH Act, provides for an adjustment to the market basket update to the IPPS payment rate
for those eligible hospitals that are not meaningful EHR users for the EHR reporting period for a
payment year, beginning in FY 2015 . Specifically, section 1886(b)(3)(B) of the Act provides
that, "for FY 2015 and each subsequent FY," an eligible hospital that is not "a meaningful EHR
user… for an EHR reporting period" will receive a reduced update to the IPPS standardized
amount. This reduction will apply to "three-quarters of the percentage increase otherwise
applicable." For FY 2015 and each subsequent FY, the reduction to three-quarters of the
applicable update for an eligible hospital that is not a meaningful EHR user will be "33 1/3
percent for FY 2015, 66 2/3 percent for FY 2016, and 100 percent for FY 2017 and each
subsequent FY." In other words, the Secretary is required to subject eligible hospitals who are
not meaningful users to ¼, ½, and ¾ reductions of their market basket updates in FY 2015, FY
2016, and FY 2017 and subsequent years respectively. Section 4102(b)(1)(B) of the HITECH
Act also provides that such "reduction shall apply only with respect to the FY involved and the
Secretary shall not take into account such reduction in computing the applicable percentage
increase … for a subsequent FY." This provision establishes a continuing incentive for hospitals
to become meaningful EHR users, because a hospital that does become a meaningful EHR user
in any year after the effective date of the update reduction will receive the same, fully updated
standardized amount for that year, and subsequent years, as those hospitals that were already
meaningful EHR users at the time when the update reduction went into effect (although hospitals
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would remain subject to a separate reduction for failure to report quality data under RHQDAPU).
In order to conform with this new update reduction, section 4102(b)(1)(A) of the HITECH Act
revises section 1886(b)(3)(B)(viii)(1) of the Act to provide that, beginning with FY 2015, the
reduction to the IPPS applicable percentage increase for failure to submit data on quality
measures to the Secretary shall be one-quarter of the applicable market basket update. In this
way, even the combined reductions for EHR use and quality data reporting will not produce an
update of less than zero for a hospital in a given FY as long as the hospital market basket
remains a positive number.
In the proposed rule, we noted that specific proposals to implement these payment
adjustments for subsection (d) hospitals that are not meaningful EHR users were not being made
at that time, but would be subject to future rule-making prior to the 2015 implementation date.
We invited comments on these payment adjustments, and stated any comments received would
be considered in developing future proposals to implement these provisions.
We received a few comments on this provision.
3. Incentive Payments for Critical Access Hospitals (CAHs)
Section 1814(l)(3)(A) of the Act, as amended by section 4102(a)(2) of the HITECH Act,
also provides for incentive payments for CAHs that are meaningful users of certified EHR
technology during an EHR reporting period for a cost reporting period beginning during a
payment year after FY 2010 but before FY 2016. The criteria for being a meaningful EHR user,
and the manner for demonstrating meaningful use, are discussed in section II.A.2. of this final
rule.
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a. Definition of CAHs for Medicare
Section 1861(mm)(1) of the Act defines a CAH as a facility that has been certified as a
critical access hospital under section 1820(c). CAHs are reimbursed for services furnished to
Medicare beneficiaries under section 1814(l) of the Act for inpatient services and section
1834(g) of the Act for outpatient services. Incentive payments for CAHs under section
1814(l)(3)(A) of the Act will be calculated based on the provider number used for cost reporting
purposes, which is the CCN of the main provider. The process for making incentive payments to
CAHs is discussed in section II.B.4.c. of this final rule.
Comment: We received many comments on the use of the CCN to identify CAHs. Most
comments were similar to those received on the use of the CCN for determining incentive
payments to eligible hospitals.
Response: We responded to the comments for eligible hospitals elsewhere in this final
rule. Our responses to comments received on using the CCN to identify CAHs are the same as
the responses for eligible hospital.
After consideration of the public comments received, we are finalizing our policy as
proposed. For purposes of this provision, we will provide incentive payments to qualifying
CAHs as they are distinguished by the provider number in the CAH’s cost reports. Incentive
payments for qualifying CAHs will be calculated based on the provider number used for cost
reporting purposes, which is the CCN of the main provider (also referred to as OSCAR number).
Payments to qualifying CAHs will be made to each provider of record.
b. Current Medicare Payment of Reasonable Cost for CAHs
For Medicare purposes, CAHs are paid for most inpatient and outpatient services to
Medicare beneficiaries on the basis of reasonable cost under section 1814(l) and section 1834(g)
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of the Act, respectively. Thus, CAHs are not subject to the IPPS and Hospital Outpatient
Prospective Payment System (OPPS).
Section 1861(v)(1)(A) of the Act is the statutory basis for reasonable cost reimbursement
in Medicare. Under the reasonable cost reimbursement methodology, payments to providers are
based on the reasonable cost of furnishing Medicare-covered services to beneficiaries.
Reasonable cost includes all necessary and proper costs in furnishing the services, subject to the
principles of reasonable cost reimbursement relating to certain specific items of revenue and
cost. Reasonable cost takes into account both direct and indirect costs of providers of services,
including normal standby costs. The objective of the reasonable cost methodology is to ensure
that the costs for individuals covered by the program are not borne by others not so covered, and
the costs for individuals not so covered are not borne by the program. The reasonable costs of
services and the items to be included are determined in accordance with the regulations at 42
CFR part 413, manual guidance, and other CMS instructions.
Currently, under section 1814(l)(1) of the Act and §413.70(a) of the regulations, effective
for cost reporting periods beginning on or after January 1, 2004, payment for inpatient services
of a CAH, other than services of a distinct part unit of a CAH, is 101 percent of the reasonable
costs of the CAH in providing CAH services to its inpatients, as determined in accordance with
section 1861(v)(1)(A) of the Act and with the applicable principles of cost reimbursement in
Parts 413 and 415 of the regulations. However, payment for inpatient CAH services is not
subject to the reasonable cost principles of the lesser of cost or charges, the reasonable
compensation equivalent limits for physician services to providers, the ceilings on hospital
operating costs, or the payment window provisions for preadmission services, specified in
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§412.2(c)(5) and §413.40(c)(2). Section 1834(g) of the Act and §413.70(b) of the regulations
describe the payment methodology for outpatient services furnished by a CAH.
Currently, reasonable cost reimbursement for CAHs includes payment for depreciation of
depreciable assets used in providing covered services to beneficiaries, as described under Part
413 subpart G of our regulations and §104 of the Medicare Provider Reimbursement Manual
(PRM). In general, the depreciation expense of an asset, representing a portion of the
depreciable asset's costs which is allocable to a period of operation, is determined by distributing
the acquisition costs of the depreciable asset, less any salvage costs, over the estimated useful
life of the asset.
c. Changes made by the HITECH Act
Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended section 1814(l) of the
Act, which governs payment for inpatient CAH services. The HITECH Act did not amend
section 1834(g) of the Act, which governs payment for outpatient CAH services.
Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended section 1814(l) of the
Act by adding new paragraphs (3), (4), and (5) as follows:
Section 1814(l)(3)(A) of the Act provides the following:
The following rules shall apply in determining payment and
reasonable costs . . . for a critical access hospital that would be a
meaningful EHR user (as would be determined under paragraph
(3) of section 1886(n)) for an EHR reporting period for a cost
reporting period beginning during a payment year if such critical
access hospital was treated as an eligible hospital under such
section:
(i) The Secretary shall compute reasonable costs by
expensing such costs in a single payment year and not depreciating
these costs over a period of years (and shall include as costs with
respect to cost reporting periods beginning during a payment year
costs from previous cost reporting periods to the extent they have
not been fully depreciated as of the period involved).
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(ii) There shall be substituted for the Medicare share that
would otherwise be applied [to CAHs under section 1814(l)(1),] a
percent (not to exceed 100 percent) equal to the sum of—
(I) the Medicare share (as would be specified under
paragraph (2)(D) of section 1886(n)) for such critical access
hospital if such critical access hospital was treated as an eligible
hospital under such section; and
(II) 20 percentage points.
Section 1814(l)(3)(B) of the Act provides that the incentive payment for CAHs
will be paid “through a prompt interim payment (subject to reconciliation) after
submission and review of such information (as specified by the Secretary) necessary to
make such payment.” The provision also states that “[i]n no case may payment under
this paragraph be made with respect to a cost reporting period beginning during a
payment year after 2015 and in no case may a critical access hospital receive payment
under this paragraph with respect to more than 4 consecutive payment years.”
Section 1814(l)(3)(C) of the Act provides that the reasonable costs for which a CAH may
receive an incentive payment are costs for the purchase of certified EHR technology to which
purchase depreciation (excluding interest) would otherwise apply under section 1814(l)(1) of the
Act.
Section 1814(l)(4)(A) of the Act provides for an adjustment, subject to the hardship
exemption in section 1814(l)(4)(C) of the Act, to a CAH's reimbursement at 101 percent of its
reasonable costs if the CAH has not met the meaningful EHR user definition for an EHR
reporting period that begins in FY 2015 or a subsequent fiscal year. Section 1814(l)(4)(B) of the
Act specifies that if a CAH is not a meaningful EHR user during the cost reporting period
beginning in FY 2015, its reimbursement will be reduced from 101 percent of its reasonable
costs to 100.66 percent. For FY 2016, the percentage of reimbursement for a CAH that is not a
meaningful EHR user is reduced to 100.33 percent of its reasonable costs. For FY 2017 and
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each subsequent FY, the percentage of reimbursement is reduced to 100 percent of reasonable
costs. Section 1814(l)(4)(C) of the Act states that, as provided for eligible subsection (d)
hospitals, the Secretary may, on a case-by-case basis, exempt a CAH from this adjustment if the
Secretary determines, subject to annual renewal, that requiring the CAH to be a meaningful EHR
user during a cost reporting period beginning in FY 2015 or a subsequent fiscal year would result
in a significant hardship, such as in the case of a CAH in a rural area without sufficient Internet
access. However, in no case may a CAH be granted an exemption under this provision for more
than 5 years.
Section 1814(l)(5) provides that there shall be no administrative or judicial review under
sections 1869 or 1878 of the Act, or otherwise, of: (1) the methodology and standards for
determining the amount of payment under section 1814(l)(3) of the Act and payment adjustments
under section 1814(l)(4) of the Act; (2) the methodology and standards for determining a CAH to
be a meaningful EHR user; (3) the methodology and standards for determining if the hardship
exemption applies to a CAH; (4) the specification of EHR reporting periods; and (5) the
identification of reasonable costs used to compute CAH incentive payments.
d. Incentive Payment Calculation for CAHs
Consistent with section 1814(l)(3)(A) of the Act, we proposed to amend §413.70(a) to
add a new paragraph (5) to provide for an incentive payment to a qualifying CAH for the
reasonable costs incurred for the purchase of certified EHR technology in a cost reporting period
beginning during a payment year after FY 2010 but before FY 2016. We proposed to include a
cross-reference to §495.106 which defines the terms associated with the CAH incentive payment,
including the definition of a “qualifying CAH” that is eligible to receive the CAH incentive
payment, and the methodology for determining the amount of that incentive payment. In
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addition, we proposed to amend §413.70(a) to add a new paragraph (6) to provide for the
adjustment of a CAH's reasonable costs of providing inpatient services starting in FY 2015 if the
CAH is not a qualifying CAH.
In computing the CAH incentive payment and applying the adjustments to a CAH's
payment if the CAH is not a qualifying CAH, we proposed to apply the definitions of certified
EHR technology, EHR reporting period, meaningful EHR user and qualified EHR in §495.4 that
are discussed elsewhere in this final rule.
In §495.106(a), we proposed to define a qualifying CAH as a CAH that would meet the
meaningful EHR user definition for eligible hospitals in §495.4, which is discussed in section II
A.1. of this final rule if it were an eligible hospital. Also in §495.106(a), for the purposes of
computing the CAH incentive payment, we proposed that the reasonable costs for the purchase
of certified EHR technology mean the reasonable acquisition costs, excluding any depreciation
and interest expenses associated with the acquisition, incurred for the purchase of depreciable
assets as described at part 413 subpart G, such as computers and associated hardware and
software, necessary to administer certified EHR technology as defined in §495.4 of this final
rule. We also proposed to define payment year for CAHs to mean a fiscal year beginning after
FY 2010 but before FY 2016.
Under proposed §495.106(b), we specified that a qualifying CAH must receive an
incentive payment for its reasonable costs incurred for the purchase of certified EHR technology.
The CAH incentive payment will be for a cost reporting period that begins during a payment
year after FY 2010 but before FY 2016.
Consistent with section 1814(l)(3)(A) of the Act, we proposed under §495.106(c) that the
payment methodology for computing the incentive payment for a qualifying CAH for a cost
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reporting period during a payment year would be equal to the product of-- (1) the reasonable
costs incurred for the purchase of certified EHR technology in that cost reporting period and any
similarly incurred costs from previous cost reporting periods to the extent they have not been
fully depreciated as of the cost reporting period involved and (2) the CAH's Medicare share
which equals the Medicare share as computed for eligible hospitals including the adjustment for
charity care (described in sections II.A.2.b. and A.3. of this final rule) plus 20 percentage points.
However, in no case will the resulting Medicare share for a CAH exceed 100 percent. This
payment methodology will be used in place of payment at 101 percent of reasonable costs
typically applied under section 1814(l)(1) of the Act and §413.70(a)(1) of the regulations.
For example, a CAH first requests an incentive payment for its cost reporting period
beginning on January 1, 2012 which is in FY 2012. The CAH incurred reasonable costs of
$500,000 for the purchase of certified EHR technology in its previous cost reporting period
beginning on January 1, 2011. This CAH is a meaningful user of certified EHR technology
during the relevant EHR reporting period and thus qualifies for an incentive payment for
FY 2012. (For illustrative purposes this example assumes no salvage value of the assets
acquired.) The CAH depreciated $100,000 of the costs of these items in the cost reporting period
beginning on January 1, 2011. As a result, the amount used to compute the incentive payment
will be the remaining $400,000 of undepreciated costs. The CAH's Medicare share is 90 percent
(its Medicare share of 70 percent using the methodology described in section II.A.2.b. of this
final rule plus 20 percentage points). Therefore, the CAH's incentive payment for FY 2012 is
$360,000 ($400,000 times 90 percent). This CAH's first payment year is FY 2012, and it can
receive incentive payments through 4 consecutive payment years which, in this example, would
be FYs 2012 through 2015.
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If, in the above example, the CAH also incurred reasonable costs of $300,000 for the
purchase of certified EHR technology in its cost reporting period beginning in FY 2012 that will
not be depreciated, then the incentive payment for FY 2012 is $630,000 ($700,000 ($400,000 in
FY 2011 plus $300,000 in FY 2012) times 90 percent).
(The preceding examples are offered for illustrative purposes only and are not intended to
encompass all possible computations of the CAH incentive payment.)
Under proposed §495.106(d)(1), the amount of the incentive payment made to a
qualifying CAH under this section represents the expensing and payment of the reasonable costs
of certified EHR technology computed as described above in a single payment year and, as
specified in §413.70(a)(5), such payment is made in lieu of any payment that would have been
made under §413.70(a)(1) for the reasonable costs of the purchase of certified EHR technology
including depreciation and interest expenses associated with the acquisition. The Medicare
contractor will review the CAH's current year and each subsequent year's cost report to ensure
that the assets associated with the acquisition of certified EHR technology are expensed in a
single period and that depreciation and interest expenses associated with the acquisition are not
allowed.
Under proposed §495.106(d)(2), the amount of the incentive payment made to a
qualifying CAH under this section would be paid through a prompt interim payment for the
applicable payment year after -- (1) the CAH submits the necessary documentation, as specified
by CMS or its Medicare contractor, to support the computation of the incentive payment amount;
and (2) CMS or its Medicare contractor reviews such documentation and determines the interim
amount of the incentive payment.
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Under proposed §495.106(d)(3), the interim incentive payment would be subject to a
reconciliation process as specified by CMS and the final incentive payment as determined by
CMS or its Medicare contractor would be considered payment in full for the reasonable costs
incurred for the purchase of certified EHR technology in a payment year.
Under §495.106(d)(4), we proposed that an incentive payment may be made with respect
to a cost reporting period beginning during a payment year beginning with FY 2011 (October 1,
2010 through September 30, 2011) through FY 2015 (October 1, 2014 through
September 30, 2015), but in no case may a CAH receive an incentive payment with respect to
more than four consecutive payment years. Therefore, a CAH, that is a meaningful EHR user,
may begin receiving an incentive payment for its cost reporting period beginning in FY 2011 for
the incurred reasonable costs for the purchase of certified EHR technology during that cost
reporting period and in previous cost reporting periods to the extent that the item or items have
not been fully depreciated. These incentive payments will continue for no more than 4
consecutive payment years and will not be made for a cost reporting period beginning during a
payment year after 2015. As discussed above and in section II.B.4. of this final rule, the CAH
must submit supporting documentation for its incurred costs of purchasing certified EHR
technology to its Medicare contractor (Fiscal Intermediary (FI)/MAC).
CAHs cannot receive an incentive payment for a cost reporting period that begins in a
payment year after FY 2015. If the first payment year for a CAH is FY 2013 then the fourth
consecutive payment year would be 2016. However, the CAH cannot be paid an incentive
payment for FYs 2016 and beyond. For FY 2016 and beyond, payment to CAHs for the
purchase of additional EHR technology will be made under §413.70(a)(1) in accordance with the
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reasonable cost principles, as described above, which would include the depreciation and interest
cost associated with such purchase.
Comment: We received many comments requesting CMS to provide a list of those
depreciable items that would be used to determine the CAH incentive payment under this
provision. The commenters were concerned that certain expenses, such as staff training,
associated with an EHR system may not be included in the CAH’s incentive payment. We also
received comments requesting a further explanation of what documentation will be required to
support the reasonable costs incurred by the CAH.
Response: Section 1814(l)(3)(C) of the Act, as amended by the HITECH Act, provides
that the costs for which a CAH may receive an incentive payment are reasonable costs for the
purchase of certified EHR technology to which purchase depreciation (excluding interest)
would otherwise apply under section 1814(l)(1) of the Act. Furthermore, section 1814(l)(3)(A)
of the Act, as amended by the HITECH Act, mandates that the Secretary shall compute
reasonable costs for the purchase of certified EHR technology by expensing such costs in a
single payment year and not depreciating these costs over a period of years (and shall include
as costs with respect to cost reporting periods beginning during a payment year costs from
previous cost reporting periods to the extent they have not been fully depreciated as of the
period involved). As described in the proposed rule, for the purposes of computing the CAH
incentive payment, we proposed that the reasonable costs for the purchase of certified EHR
technology mean the reasonable acquisition costs, excluding any depreciation and interest
expenses associated with the acquisition, incurred for the purchase of depreciable assets as
described at part 413 subpart G, such as computers and associated hardware and software,
necessary to administer certified EHR technology as defined in §495.4 of this final rule.
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CAHs will incur both depreciable and non-depreciable reasonable costs in a payment
year that are associated with implementing and maintaining certified EHR technology.
According to the statute, only the reasonable costs for the purchase of certified EHR
technology to which purchase depreciation (excluding interest) would otherwise apply are to
be included in the CAH incentive payment. Thus, CAHs will not have to depreciate these
reasonable costs over the useful life of the EHR asset purchased as such costs will be expensed
in a single payment year. Any non-depreciable reasonable costs incurred in that same single
payment year that are associated with an EHR system may be paid for under the current
Medicare reasonable cost payment system at 101 percent.
Currently, the CAH’s Medicare contractor determines if an item purchased is a
depreciable asset under Medicare principles or other accounting standards. The Medicare
contractor also determines the CAH’s reasonable cost for acquiring depreciable assets. For the
purposes of computing the CAH incentive payment, we are not changing the Medicare
contractor’s current responsibilities described above. We, therefore, suggest that CAHs
communicate with their Medicare contractors to determine the necessary documentation to
support their reasonable costs incurred for the purchase of certified EHR technology and to
determine if the items that they purchase are depreciable assets under Medicare principles or
other accounting standards.
Comment: We received some comments requesting clarification of how the incentive
payments will be computed if an eligible CAH converts to or from an eligible “subsection d”
hospital.
Response: If during a payment year an eligible CAH is converted to or from a
“subsection d” hospital, the CAH may receive an incentive payment as long as it incurred the
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reasonable costs of purchasing certified EHR technology in a payment year (or in a previous cost
reporting period) when it was a CAH and as long as the affected providers meet the meaningful
use criteria described elsewhere in this final rule. When a conversion takes place, the affected
CAH and “subsection d” hospital are each required to file a Medicare cost report under section
413.24 of the regulations. For instance, if in month 6 of a cost reporting period that begins
January 1, 2011 and ends December 31, 2011, a “subsection d” hospital converts to a CAH, the
“subsection d” hospital will file a terminating 6 month cost report (January 1, 2011 to June 30,
2011). If the CAH retains the same year end of December 31, 2011, the CAH will file a 6 month
cost report from July 1, 2011 to December 31, 2011. In this instance, the CAH’s 6 month cost
report would be used to determine if it incurred reasonable costs for the purchase of certified
EHR technology that may qualify for a CAH incentive payment during that period. The
“subsection d” hospital’s 6 month terminating cost report would be used to determine the
possible amount of any incentive payment for that eligible hospital.
After consideration of the public comments received, with the exception of a few minor,
technical and conforming changes, we are finalizing the applicable provisions as proposed.
Comment: We received many comments regarding the use of data from the revised
Medicare cost report (Form CMS-2552-10) described in the proposed rule to compute the
Medicare share portion of the CAH incentive payment. Commenters were also concerned that
certain cost report data may not be available at the time of computing a CAH’s incentive
payment.
Response: As discussed elsewhere in this final rule, we are addressing concerns with
data from the revised cost report in a final collection that is currently in the Paperwork Reduction
Act clearance process. In addition, we address the timing issues with the revised cost report data
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elsewhere in this final rule.
e. Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years for CAHs that are
not Meaningful EHR Users
Section 4102(b)(2) of the HITECH Act amends section 1814(l) to include an adjustment
to a CAH's reimbursement at 101 percent of its reasonable costs if the CAH has not met the
meaningful EHR user definition for an EHR reporting period that begins in FY 2015, FY 2016,
FY 2017, and each subsequent FY thereafter. Consistent with this provision, we proposed that
under §495.106(e) and §413.70(a)(6), if a CAH has not demonstrated meaningful use of certified
EHR technology for FY 2015, its reimbursement would be reduced from 101 percent of its
reasonable costs to 100.66 percent. For FY 2016, its reimbursement would be reduced to
100.33 percent of its reasonable costs. For FY 2017 and each subsequent FY, its reimbursement
would be reduced to 100 percent of reasonable costs.
However, as provided for eligible hospitals, a CAH may, on a case-by-case basis, be
exempted from this adjustment if CMS or its Medicare contractor determines, on an annual basis,
that requiring the CAH to be a meaningful EHR user would result in a significant hardship, such
as in the case of a CAH in a rural area without sufficient Internet access. However, in no case
may a CAH be granted an exemption under this provision for more than 5 years.
Comment: We received some comments requesting further clarification of how CMS
will be determining whether a significant hardship exists to warrant an exemption.
Response: We received a few comments on this provision which is not effective until
FY 2015. We will take these comments into account when we develop proposals for
implementing this provision at a later date.
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After consideration of the public comments received, we are finalizing sections
495.106(e) as proposed. We have renumbered proposed section 413.70(a)(6)(iv) as 413.70(a)(7),
but are otherwise finalizing section 413.70(a)(6) as proposed.
Section 1814(l)(5) of the Act exempts the determinations made under paragraphs (l)(3)
and (l)(4) from administrative and judicial review. Accordingly, under §413.70(a)(6)(iv) and
§495.106(f), we proposed that there shall be no administrative or judicial review under sections
1869 or 1878 of the Act, or otherwise, of the following:
• The methodology and standards for determining the amount of payment under section
1814(l)(3) of the Act and payment adjustments under section 1814(l)(4) of the Act for CAHs,
including selection of periods under section 1886(n)(2) of the Act for determining, and making
estimates or using proxies of, inpatient-bed-days, hospital charges, charity charges, and the
Medicare share under subparagraph (D) of section 1886(n)(2) of the Act;
• The methodology and standards for determining a CAH to be a meaningful EHR user
under section 1886(n)(3) of the Act as would apply if the CAH was treated as an eligible hospital
under section 1886(n) of the Act;
• The methodology and standards for determining if the hardship exemption under
section 1814(l)(4)(C) of the Act applies to a CAH;
• The specification of EHR reporting periods under section 1886(n)(6)(B) of the Act as
applied under section 1814(l)(3) and (4) of the Act for CAHs; and
• The identification of reasonable costs used to compute the CAH incentive payment
under section 1814(l)(3)(C) of the Act.
Comment: We received some comments requesting clarification of whether CAHs will
be able to appeal their incentive payment amounts.
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Response: We believe that the limitation of administrative and judicial review does not
apply to the amount of the CAH incentive payment. The CAH may appeal the statistical and
financial amounts from the Medicare cost report used to determine the CAH incentive payment.
The CAH would utilize the current provider appeal process pursuant to section 1878 of the Act.
Accordingly, after consideration of the public comments received, we are finalizing
§495.106(f) as proposed. We have renumbered proposed §413.70(a)(6)(iv) as §413.70(a)(7), but
are otherwise finalizing the provision as proposed.
4. Process for Making Incentive Payments Under the Medicare FFS Program
As previously discussed in section II.B.1. and 2. of this final rule and sections 1848(o)(1)
and 1886(n)(1) of the Act, the statute provides for incentive payments to eligible professionals,
eligible hospitals, and CAHS who are meaningful users of certified EHR technology as early as
FY 2011 for qualifying eligible hospitals and CAHs and CY 2011 for qualifying EPs. The
statute does not specify the process for making these payments to qualifying EPs and qualifying
eligible hospitals and CAHs participating in the FFS Medicare incentive payment program, but
instead leaves the payment process to the Secretary's discretion.
We proposed that FIs, carriers, and MACs, as appropriate, would be responsible for
determining the incentive payment amounts for qualifying EPs and qualifying eligible hospitals
and CAHs in accordance with the methodology set forth in section II.B.1.b. and B.2.b. of this
final rule based on the previously discussed meaningful use criteria, disbursing the incentive
payments to qualifying EPs and qualifying eligible hospitals and CAHs, and resolving any
reconciliation issues.
a. Incentive Payments to EPs
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We proposed that the carriers/MACs calculate incentive payment amounts for qualifying
EPs, where incentive payments would be disbursed on a rolling basis, as soon as they ascertained
that an EP demonstrated meaningful use for the applicable reporting period (that is, 90 days for
the first year or a calendar year for subsequent years), and reached the threshold for maximum
payment. In accordance with section 1848(l)(3)(B) of the Act, we proposed that if a qualifying
EP is not eligible for the maximum incentive payment amount for the payment year and if the
qualifying EP was also a qualifying MA EP, the qualifying MA organization with which the EP
is affiliated would receive the incentive payment for the EP through the MA EHR incentive
program. If the qualifying EP either does not also qualify as a MA EP or he or she qualifies as a
MA EP but is not eligible for the maximum incentive payment for the payment year, we
proposed that the carriers/MAC would calculate the amount of the qualifying EP's incentive
payment and disburse the incentive payment to the qualifying EP in the year following the
payment year. The proposed rule also outlined that incentive payments would not be issued to
qualifying EPs if an incentive payment was already made under the Medicaid program for the
relevant payment year, and as required by section 1848(m)(2) of the Act as amended by section
4101(f) of the HITECH Act, qualifying EPs who received incentive payments from the Medicare
EHR incentive payment program would not be eligible to receive an e-prescribing incentive
payment. Additionally, we proposed that the incentive payments would be tracked at the
qualifying EP's TIN level, and disbursed to the TIN that the qualifying EP indicated during the
registration process; qualifying EPs who do not have individual TINs (that is, a qualifying EP
who works solely in a group practice) would be paid at the group practice level's TIN. We
proposed that qualifying EPs select one TIN for disbursement of their Medicare EHR incentive
payment. Of course, after the payment is disbursed to their designated TIN, qualifying EPs may
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decide to allocate their incentive payment among the multiple practices in which they furnish
covered professional services subject to applicable laws, regulations and rules, including, without
limitation, those related to fraud, waste, and abuse.
To be clear, we note that financial relationships, including those arising from the
reallocation/reassignment of incentive payments, between physicians and their employers/other
entities may implicate certain fraud, waste, and abuse laws, regulations, and rules. Therefore, we
proposed to include specific safeguards to limit the risk that the allocation/reassignment of
incentive payments could raise under those and other applicable laws, regulations and rules.
Section II.B.1.d. above finalizes our proposal at §495.10(f) to permit EPs to reassign their
incentive payments to their employer or to an entity with which they have a contractual
arrangement, consistent with all rules governing reassignments including part 424, subpart F.
Comment: Several commenters expressed concern that the proposed rule contained
limited information on how the incentive program for Medicare EPs will be operationalized.
They requested additional information on the expected timeframe and process for payments.
Response: The HITECH Act requires that EHR incentive program payments be
separately tracked and monitored because these funds cannot be commingled with other
Medicare funds. Therefore, to facilitate funds control, payments will be made through a single
payment contractor rather than through the carriers/MACs as was originally proposed.
Additionally, the Integrated Data Repository (IDR), rather than the carriers/MACs will be
accumulating the allowed charges for each qualified EP’s NPI. Payments would be made on a
rolling basis, as soon as we ascertain that an EP has successfully demonstrated meaningful use
for the applicable reporting period (that is, 90 days for the first year or a calendar year for
subsequent years) and the EP’s allowed charges has reached the threshold that qualifies an EP
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for maximum incentive payment, for the relevant payment year. Once this determination has
been made, the National Level Repository (NLR) will calculate the EP’s incentive payment. The
payment will then be made by the single payment contractor. We anticipate that it will take
anywhere from 15 to 46 days from the time an EP successfully attests to being a meaningful user
to the time an incentive payment is made, and that for FY 2011, incentive payments will be made
to EPs who successfully demonstrate that they were meaningful EHR users for the EHR
reporting period (that is, 90 days) as early as May 2011. As proposed, we will pay a qualifying
EP a single consolidated incentive payment for a payment year, rather than make periodic
installment payments. In order to accommodate different attestation dates throughout the first
year for EPs, our payment cycle is on a monthly basis as previously described; however,
qualifying EPs will receive one single payment per year. In other words, CMS will issue
payments as soon as possible after a qualifying EP attested to meaningfully using a certified
EHR system, hence the monthly payment cycle; however, an EP will only receive one incentive
payment for each year he/she qualifies. For qualifying EPs whose allowed charges for the
payment year do not reach the maximum thresholds, the single payment contractor will disburse
an incentive payment in the following year.
Comment: One commenter recommended CMS make semi-annual incentive payments
for the second and subsequent payment years to ensure physician practices have cash flow to
deploy certified EHR systems and train employees how to use the systems.
Response: When the EHR reporting period is a full year, no EPs will have successfully
demonstrated that they are meaningful users at the mid-year mark. Therefore, as previously
described, qualifying Medicare EPs will receive a single payment per year, issued on a monthly
payment cycle. We intend to finalize this provision as proposed; there will be a single successful
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attestation per year and a single payment following the attestation for qualifying EPs.
Comment: One commenter questioned whether the scopes of work for the
MACs/Medicare Carriers would be revised to reflect the additional work that this program will
entail.
Response: As previously discussed in the first comment and response, the IDR, rather
than the MACs/Medicare Carriers, will accumulate the EPs allowed charges. The MAC/Carrier
work related the Medicare EHR incentive program will be within their current scope of work and
will be handled through the normal change request process.
Comment: One commenter believes an EP’s program selection (Medicare or Medicaid),
is tied to the TIN where the EP assigns incentive payments. The commenter recommended CMS
permit additional changes in program selection if EPs change their TIN. The commenter
believes allowing only one program change in the life of the program is too restricting given that
patient mix might change due to a practice being purchased by another TIN or an EP becoming a
part-time employee of another TIN.
Response: Section II.A.5.b. of this final rule outlines our policy decision around
changing program selections.
After consideration of the public comments received, we are finalizing our policy as proposed.
For purposes of this provision, payments will be made through a single payment contractor with
the IDR accumulating the allowed charges for each qualified EP’s NPI. Payments will be made
on a rolling basis, as soon as we ascertain that an EP has successfully demonstrated meaningful
use for the applicable reporting period (that is, 90 days for the first year or a calendar year for
subsequent years), and reached the threshold for maximum payment then the NLR will calculate
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the incentive payment. We estimate it will take anywhere from 15 to 46 days from the time an
EP successfully attests to being a meaningful user to the time an incentive payment is made.
b. Incentive Payments to Eligible Hospitals
We proposed that the FIs/MACs would calculate incentive payments for qualifying
eligible hospitals, and would disburse such payments on an interim basis once the hospital has
demonstrated it is a meaningful EHR user for the EHR reporting period for the payment year.
As discussed above in section B.2.b. of the final rule, the formula for calculating a qualifying
eligible hospital's incentive payment requires the following data: (1) an initial amount; (2) the
Medicare share; and (3) a transition factor applicable to that payment year. We proposed that
FIs/MACs would use the prior-year cost report, Provider Statistical and Reimbursement (PS&R)
System data, and other estimates to calculate the interim incentive payment. As discussed in
section II.B.2.c. of this final rule, beginning in 2010, cost reports will capture charity care data
which will be used in calculating the Medicare share of the payment. We proposed that the
MACs/FIs calculate a qualifying hospital's final incentive payment using data from the cost
report for the hospital's fiscal year that ends during the FY prior to the FY that serves as the
payment year. We also proposed that the FIs/MACs calculate the final incentive payment using
actual cost report data report for the hospital's fiscal year that ends during the FY prior to the
fiscal year that serves as the payment year, and would reconcile the incentive payment as
necessary at settlement of the cost report. Additionally, incentive payments for qualifying
eligible hospitals would be calculated based on the provider number used for cost reporting
purposes, which is the CCN of the main provider. Therefore, incentive payments for qualifying
hospitals would be disbursed to the CCN rather than the TIN.
Comment: Several commenters expressed concern that the proposed rule contained
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limited information on how the incentive program for hospitals will be operationalized. They
requested additional information on the expected timeframe and process for payments as wells as
requesting clarification that the incentive payments would be distributed as a "lump sum
payment". One commenter requested CMS disburse one lump sum payment at the start of each
eligible year for those hospitals that meet all of the meaningful use requirements.
Response: Hospital EHR incentive payments will be calculated by the FIs/MACs;
however, to facilitate funds control, payments will be made through a single payment contractor.
We will direct the payment contractor to issue to qualifying hospitals, that is those hospitals who
successfully demonstrate that they are meaningful EHR users, a single initial payment for the
year. We anticipate that payments will be made to qualifying Medicare hospitals beginning in
May 2011. No payment will be made prior to an eligible Medicare hospital successfully
demonstrating that it was a meaningful EHR user during the EHR period for the relevant
payment year. For purposes of determining interim incentive payments, we will employ data on
the hospital's Medicare fee-for-service and managed care inpatient bed days, total inpatient beddays, and charges for charity care from a hospital’s most recently submitted 12-month cost report
once the hospital has qualified as a meaningful user. For purposes of determining final incentive
payments, we will employ the first 12-month cost reporting period that begins after the start of
the payment year, in order to settle payments on the basis of the hospital's Medicare
fee-for-service and managed care inpatient bed days, total inpatient bed-days, and charges for
charity care data from that cost reporting period.
Comment: One commenter requested that CMS allow hospitals to make an interim
attestation 90 days after the start of the second and subsequent payment years. They suggested
the interim attestation would note that they are in compliance with the meaningful use rules and
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intend to remain in compliance. They requested that CMS instruct the contractor to issue interim
EHR payments after receipt of such attestation. The commenter believes this would cut down on
the time frame of 21 months between their first and second hospital interim payments.
Response: The reporting period requirements for a hospital’s second and subsequent
years are 365 days. Due to the year-long reporting period, we do not believe we can allow for an
interim attestation that the provider is a meaningful EHR user. Under our definitions at §495.4, a
provider is not a meaningful EHR user unless it has "for an EHR reporting period for a payment
year," demonstrated meaningful use "in accordance with §495.8 by meeting the applicable
objectives and associated measures under §495.6." Thus, we could not determine that the
provider is a meaningful user at an interim point in time, and there would be no basis for
providing the interim payment.
Comment: One commenter expressed confusion over the term "demonstration period"
and questioned if a hospital had to complete the full demonstration period before payments
would be made.
Response: We assume the commenter means EHR "reporting period" when using the
phrase, "demonstration period." A hospital must demonstrate that it met the requirements for
meaningful use for the full EHR reporting period for the relevant payment year before we will
direct the payment contractor to issue an incentive payment to the hospital for the payment year.
A hospital therefore must complete the full EHR reporting period before demonstrating that it
was a meaningful EHR user and before any payments would be made.
Comment: Several commenters recommended that CMS’ payment process for eligible
hospitals be consistent with its payment process for EPs, and that hospital’s initial incentive
payment thus be distributed no later than two months after the hospital successfully demonstrates
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meaningful use. The same commenters requested CMS specify that the final incentive payment
be issued no later than two months after the hospital submits its cost report from the FY that ends
during the payment year.
Response: We anticipate that for FY 2011, interim incentive payments will be made to
eligible hospitals that successfully demonstrate that they were meaningful EHR users for the
EHR reporting period for FY 2011 (that is , 90 days) as early as May 2011. The exact timing of
when a qualifying eligible hospital receives its interim incentive payment will depend on when
the hospital successfully demonstrates that it was a meaningful EHR user; the sooner a hospital
successfully demonstrate that is was a meaningful EHR user during the EHR reporting period for
the payment year, the sooner it will receive its interim incentive payment. For a Medicare
hospital’s second and subsequent participation years, after a hospital successfully demonstrates
that it was a meaningful EHR user during the EHR reporting period (that is, the federal fiscal
year) for the payment year, the hospital will receive the interim incentive payment in the
following year; the initial incentive payments will be made on a monthly payment cycle
beginning shortly after the hospital is determined to be a meaningful user. To the commenters’
point of requesting that we be consistent with the approach to paying EPs, there seems to be
confusion around what was proposed as to the timing and distribution of the EP’s incentive
payment. The proposal for the EP’s incentive payment was that EP’s accumulated allowed
charges would be based on claims submitted not later than two months after the end of the
payment year. The incentive payment for a qualifying EP’s second and subsequent payment
years was always to be disbursed in the year following the payment year. We did not propose
paying an EP within two months of being deemed a meaningful user.
Comment: Several commenters questioned how CMS would treat a hospital that
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qualified for an incentive payment one year, but did not qualify the next or subsequent years;
what is the impact on the stream of incentive payments to the hospital?
Response: An eligible hospital’s first payment year is the first year they successfully
demonstrate that they were a meaningful EHR user for the EHR reporting period for the payment
year. Section 1886(n)(2)(G) of the Act defines the second through fifth payment years for a
hospital as each successive year immediately following the first payment year for such hospital.
An eligible hospital's second payment year, then, is the year following its first payment year,
regardless of whether the eligible hospital qualifies for an incentive payment in the year
following its first payment year. Similarly, an eligible hospital's third, fourth, and fifth payment
year are the third, fourth, and fifth years, respectively, following the hospital's first payment year,
even if the hospital does not receive an incentive payment for one or more of those years.
Comment: Several commenters requested that CMS clarify that EHR incentive payments
for which a hospital qualifies or receives under the EHR incentive program (whether directly or
pursuant to an assignment, reassignment or other transfer) shall not affect or be taken into
account in the calculation or other payments made to the eligible hospital under Medicare,
Medicaid, or any other state or federal healthcare program, such as disproportionate share
payments, graduate medical education and indirect medical education payments, and payments
for un-compensated care payments.
Response: EHR incentive payments will have no bearing on the hospital’s Medicare
disproportionate share, indirect medical education or direct graduate medical education
payments. This discussion is also addressed in the Medicaid section at II.D.4.b.
After consideration of the public comments received, we are finalizing our policy as
proposed. For purposes of this provision, Hospital incentive payments will be calculated by the
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FIs/MACs; however, to facilitate funds control, payments will be made through a single payment
contractor. We will direct the payment contractor to issue to qualifying hospitals a single initial
payment per year, and expect initial payment may begin as early as May 2011, for those who
demonstrate they are meaningful EHR users at the earliest date possible. We estimate it will take
anywhere from 15 to 46 days from the time a hospital successfully attests to being a meaningful
user to the time an incentive payment is made.
c. Incentive Payments to CAHs
In the proposed rule, CMS proposed that because CAHs are paid on a cost reimbursement
basis once a CAH incurs actual EHR costs, it could submit supporting documentation to the
FI/MAC for review. The FIs/MACs would determine an incentive payment amount, as
discussed in section II.A.3 of the proposed rule by substituting for the Medicare share amount
that would otherwise be applied under the formula used for computing payments for eligible
hospitals, a percent (not to exceed 100 percent) equal to the sum of-- (1) the Medicare share for
such CAH, and (2) 20 percentage points.
As discussed in the proposed rule, the FIs/MACs would reconcile the cost report and
ensure the EHR expenses are adjusted on the cost report to avoid duplicate payments. Incentive
payments for qualifying CAHs would be calculated based on the provider number used for cost
reporting purposes, which is the CCN number of the main provider. Therefore, incentive
payments for qualifying CAHs would be based on the CCN rather than the TIN.
Comment: Several commenters expressed concern that the proposed rule contained
limited information on how the incentive program would be operationalized for CAHs. They
requested additional information on the expected timeframe and process for payments to CAHs.
Response: To facilitate funds control, payments will be made through a single payment
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contractor. In order to receive a HITECH incentive payment, a CAH will have to attest that it is
a meaningful user, and submit documentation to its FI/MAC to support the costs incurred for its
HIT system. Once the FI/MAC reviews the documentation and the allowable amount is
determined, we will direct the payment contractor to release to the CAH a single incentive
payment in the next HITECH payment cycle. Payment cycles will begin in May 2011.
Comment: Several commenters requested more information on the timing of the
distribution of payments to CAHs once the necessary documentation has been submitted and that
recommended CMS be consistent with its proposal on incentive payments for EPs and specify
that the CAH’s initial incentive payment will be distributed no later than two months after it
submits the necessary documentation. The same commenters requested that CMS specify that
the final incentive payment be issued no later than two months after the CAH submits its cost
report.
Response: CAHs will receive a single initial incentive payment per year with the initial
payments beginning in May 2011. Once the FIs/MACs review the documentation and the
allowable amount is determined, we will direct the payment contractor to release a single
incentive payment in the next incentive payment cycle to qualifying CAHs. We anticipate the
initial payments will generally be made within two months of the determination of the allowable
amount. The final payment will be calculated on the cost report, and the process to settle the cost
report will not be modified for these incentive payments. It will continue to follow the normal
final settlement process. For the CAHs’ second and subsequent participation years, CAHs will
also receive a single initial incentive payment per year and a final incentive payment as
described above. With respect to the commenters’ request that we be consistent with the
proposed approach to paying EPs, there seems to be confusion around what was proposed as to
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the timing and distribution of incentive payments to EPs. The proposal for EP incentive
payments was that an EP’s accumulated allowed charges would be based on claims submitted
not later than two months after the end of the payment year. The incentive payment for a
qualifying EP’s second and subsequent payment years was always to be disbursed in the year
following the payment year. We did not propose to make incentive payments to an EP within
two months of the EP being deemed a meaningful user.
Comment: Several commenters questioned what is considered "necessary
documentation" for CAHs to submit in order to receive Medicare CAH incentive payments. The
same commenters requested CMS propose and obtain comments on "necessary documentation"
and finalize a rule before FY 2011.
Response: The documentation submitted should include information reflecting what was
purchased, and support the costs incurred. Such documentation may include invoices, receipts,
or other comparable materials.
Comment: One commenter recommended CMS (not the MACs/FIs) should make all
determinations regarding CAHs.
Response: The documentation review process for Medicare CAH incentive payments is
similar to processes currently performed by FIs/MACs. Also, the data needed to calculate the
Medicare Share is on the cost reports, which are submitted to the FIs/MACs. Accordingly, we
believe it would be most appropriate for the payment determinations be made by the FIs/MACs,
and not by CMS.
After consideration of the public comments received, we are finalizing our policy as
proposed. For purposes of this provision, CAH payments will be calculated by the FIs/MACs;
however, as discussed above, to facilitate funds control, payments will be made through a single
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payment contractor. Once the FIs/MACs review the documentation and the allowable amount is
determined, we will direct the payment contractor to release to the CAH a single incentive
payment in the next HITECH payment cycle. Payment cycles will begin in May 2011.
d. Payment Accounting under Medicare
We will conduct selected compliance reviews of EPs, eligible hospitals, and qualified
CAHs who register for the incentive programs and of recipients of incentive payments for the
meaningful use of certified EHR technology. The reviews will validate provider eligibility
through their meaningful use attestations including verification of meaningful use and would also
review components of the payment formulas.
We will identify and recoup overpayments made under the incentive payment programs
that result from incorrect or fraudulent attestations, quality measures, cost data, patient data, or
any other submission required to establish eligibility or to qualify for a payment. The
overpayment will be recouped by CMS or its agents from the EP, eligible hospital, MA
organization, CAH, other entities to whom the right to payment has been assigned/reassigned, or,
in the case of Medicaid, from the State Medicaid agencies.
Medicare FFS EPs and eligible
hospitals will need to maintain evidence of qualification to receive incentive payments for
10 years after the date they register for the incentive program.
5. Preclusion of Administrative and Judicial Review
We did not discuss preclusion of administrative and judicial review in our proposed rule.
We are now including a discussion, in order to make the public aware of the preclusion. Also,
the sections of this final rule discussing payments to Medicare Advantage (MA) organizations
and CAHs both include a description of the preclusion, as well as accompanying regulation text.
Therefore, while we believe statutory provisions on preclusion of review are self-implementing,
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below, we include a discussion of the preclusion of review that applies to EPs and eligible
hospitals. We have also added regulation text to maintain consistency with the CAH and MA
organization provisions.
For EPs, section 1848(o)(3)(C) of the Act prohibits administrative or judicial review
under section 1869, section 1878, or otherwise, of all of the following:
• The methodology and standards for determining EP incentive payment amounts.
• The methodology and standards for determining the payment adjustments that apply to
EPs beginning with 2015.
• The methodology and standards for determining whether an EP is a meaningful EHR
user, including: (1) the selection of clinical quality measures; and (2) the means of demonstrating
meaningful EHR use.
• The methodology and standards for determining the hardship exception to the payment
adjustments.
• The methodology and standards for determining whether an EP is hospital-based.
• The specification of the EHR reporting period, as well as whether payment will be
made only once, in a single consolidated payment, or in periodic installments.
For eligible hospitals, section 1886(n)(4)(A) of the Act similarly prohibits administrative
or judicial review under section 1869, section 1878, or otherwise, of the following:
• The methodology and standards for determining the incentive payment amounts made
to eligible hospitals, including: (1) the estimates or proxies for determining discharges, inpatientbed-days, hospital charges, charity charges, and Medicare share; and (2) the period used to
determine such estimate or proxy.
• The methodology and standards for determining the payment adjustments that apply to
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eligible hospitals beginning with FY 2015.
• The methodology and standards for determining whether an eligible hospital is a
meaningful EHR user, including: (1) the selection of clinical quality measures; and (2) the means
of demonstrating meaningful EHR use.
• The methodology and standards for determining the hardship exception to the payment
adjustments.
• The specification of the EHR reporting period, as well as whether payment will be
made only once, in a single consolidated payment, or in periodic installments.
We note that the above listing may summarize or abbreviate portions of the statute. For precise
language on the preclusion of judicial review, readers should always refer to the statute.
C. Medicare Advantage (MA) Organization Incentive Payments
1. Definitions
a. Qualifying MA Organization
Section 1853(l)(1) of the Act, as added by section 4101(c) of the HITECH Act, provides
for incentive payments to qualifying MA organizations for certain of their affiliated EPs who are
meaningful users of certified EHR technology during the relevant EHR reporting period for a
payment year. Section 1853(l)(5) of the Act defines the term “qualifying MA organization” as
an MA organization that is organized as a health maintenance organization (HMO) as defined in
section 2791(b)(3) of the PHS Act. Section 2791(b)(3) of the PHS Act in turn defines a health
maintenance organization as a federally qualified HMO, an organization recognized as an HMO
under State law, or a similar organization regulated for solvency under State law in the same
manner and to the same extent as an HMO. Since there are few federally qualified HMOs, we
expect MA organizations to primarily qualify for incentive payments as State-licensed HMOs, or
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as organizations regulated for solvency under State law in the same manner and to the same
extent as HMOs.
In §495.200 we proposed to define “qualifying MA organization.” Specifically, in
§495.202(a)(2), we proposed to deem MA organizations offering MA HMO plans that are not
federally-qualified HMOs to meet the definition of HMO in section 2791(b)(3) of the PHS Act,
as HMOs recognized under State law, or as entities subject to State solvency rules in the same
manner as HMOs. We believe this is reasonable because under the MA application process,
State regulators are required to certify that MA organizations operating in their State are
authorized to offer the type of MA plan they proposed to offer, and meet solvency standards that
are adequate for these purposes. For each MA organization offering MA HMO plans, the State
has thus recognized that the organization is able to assume risk as an HMO. Therefore, we have
determined that absent evidence to the contrary, an MA organization offering HMO plans is
recognized by the State as a health maintenance organization, or that it is subject to State
solvency standards in the same manner and to the same extent as an HMO and therefore provides
sufficient assurance that the section 2791(b)(3) of the PHS Act definition is met.
In §495.202(a)(3), for MA organizations that offer other coordinated care MA plans
(Preferred Provider Organization (PPO) plans, Provider Sponsored Organization (PSO) plans,
and Regional Preferred Provider Organization (RPPO) plans) and for other MA organizations
offering other MA plan types (private fee-for-service (PFFS) plans, Medical Savings Account
(MSA) plans), we proposed that the sponsoring MA organization would be required to attest that
the MA organization is recognized under State law as an HMO, or that it is a similar organization
regulated under State law for solvency in the same manner and to the same extent as an HMO
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before we would make a determination that the MA organization is a qualifying MA
organization for purposes of incentive payments.
Although we did not receive any comments on these provisions and are finalizing them as
proposed, there is one exception. In order to bring 422.202(a) into conformance with the change
we are making to 422.202(b)(1), we are changing the date by which MAOs are required to
identify themselves to us from the bidding deadline in June 2010 (for plan year 2011) to the
bidding deadline in June 2011 (for plan year 2012).
b. Qualifying MA Eligible Professional (EP)
A qualifying MA organization may receive an incentive payment only for those EPs
described under section 1853(l)(2) of the Act, as added by section 4101(c) of the HITECH Act.
Section 1853(l)(2) of the Act provides that MA EPs must be “eligible professionals” as defined
under section 1848(o) of the Act as added by section 4101(a) of the HITECH Act, and must
either-• Be employed by the qualifying MA organization; or
• Be employed by, or be a partner of, an entity that through contract with the qualifying
MA organization furnishes at least 80 percent of the entity's Medicare patient care services to
enrollees of the qualifying MA organization.
Further, the EP must furnish at least 80 percent of his or her professional services covered under
Title XVIII (Medicare) to enrollees of the qualifying MA organization and must furnish, on
average, at least 20 hours per week of patient care services.
As discussed in section II.A.1. of this final rule, an EP is defined as a physician (under
section 1861(r) of the Act).
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We said we interpreted “employed by” to mean that the EP is considered an employee of
a qualifying MA organization or qualifying entity under the usual common law rules applicable
in determining the employer-employee relationship under section 3121(d)(2) of the Internal
Revenue Code of 1986.
We said we interpreted “to be a partner of” to mean that the qualifying MA EP has an
ownership stake in the entity. Under this interpretation, a professional that contracts with an
entity, but who has no ownership stake in the entity, would not be considered a qualifying MA
EP.
We said we interpreted “furnishing at least 80 percent” of the entity's “patient care
services” to enrollees of the organization to mean at least 80 percent of the qualifying entity’s
total Medicare revenue in a year (that is, total revenue from Medicare FFS as well as from all
MA organizations) must be from a single qualifying MA organization.
We proposed to interpret the requirement that a qualifying MA EP furnish at least 80
percent of their professional services covered under Title XVIII to enrollees of the organization
to mean that at least 80 percent of the professional's total Medicare revenue in a year (that is,
total revenue from Medicare FFS as well as from all MA organizations) must be from a single
qualifying MA organization. We said we believed that in establishing the rule that qualifying
MA EPs need to furnish at least 80 percent of their Title XVIII covered services “to enrollees of
the organization,” the statute limits payment related to any specific qualifying MA EP to a single
qualifying MA organization. Thus, if a qualifying MA EP provided an average of 20 hours per
week of patient care services to two distinct qualifying MA organizations, we said we would pay
the qualifying MA organization for the MA EP only if such a qualifying EP provided at least 80
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percent of his or her professional services covered under Title XVIII to enrollees of that
organization.
For purposes of determining whether a qualifying MA EP furnishes, on average, at least
20 hours per week of patient care services, we interpreted the requirement to include both
Medicare and non-Medicare patient care services. Moreover, we proposed that the relevant time
period for determining whether an MA EP furnishes at least 20 hours per week of patient care
services should be the EHR reporting period. (We discuss the definition of EHR reporting
period in section II.A. 1. e. of this final rule.) Therefore, we said that over the EHR reporting
period, the qualifying MA EP must provide on average 20 hours per week of patient care
services. Finally, we interpreted “patient care services” to mean services that would be
considered “covered professional services” under sections 1848(o)(5)(A) and (k)(3) of the Act.
That is, health care services for which payment would be made under, or for which payment
would be based on, the fee schedule established under Medicare Part B if they were furnished by
an eligible professional to a Medicare beneficiary.
We considered various methods of determining when at least 20 hour per week, on
average, of patient care services would be considered to be provided by MA EPs. We considered
methods such as defining a dollar or service threshold, or the number of hours of direct patient
care services actually provided. After due consideration we proposed to require qualifying MA
organizations to attest to the fact that MA EPs for whom they are requesting EHR incentive
payments have provided, on average, 20 hours of patient care services during the EHR reporting
period.
Comment: A few commenters referenced the Report to Congress required by section
4101(d) of the HITECH Act. The commenters suggested ways in which we could combine
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original FFS Medicare claims-payment data and MA services provided by EPs in order to arrive
at a single, combined EHR payment. One commenter asked whether payments to a provider
from a Medicare Advantage plan can contribute to the volume of Allowed Charges for the
purpose of calculating maximum Meaningful Use rewards, saying that he believed that they
should. Another commenter said that a substantial percentage of senior citizens receive their
care from EPs providing services by way of Medicare Advantage plans. The commenter
continued that current proposed rules provide incentive payment only to EPs in whose practices
80 percent or more of total services are to Medicare Advantage patients. The commenter
concluded that this would exclude many EPs treating our most vulnerable citizens from the
opportunity to meaningfully adopt EHRs in their practices and that the 80 percent [MA] practice
requirement should be eliminated. Other commenters argued that the regulation was unclear
regarding an exclusion of covered professional services of an EP not employed by an MAO
when determining their participation or level of payment because those services are provided to
MA beneficiaries. The commenter believed that the Secretary should provide a mechanism,
whereby EPs can supplement their record to the appropriate carrier/MAC with their MA charges.
Response: We do not have statutory authority to combine payments across the FFS and
MA EHR incentive payment programs. The statutory provision at section 1853(l)(3)(B) of the
Act, as added by section 4101 of the HITECH, entitled “Avoiding Duplication of Payments,”
specifically prohibits us from making payments to EPs for both FFS and MA services.
Additionally, had Congress wanted CMS to combine FFS and MA charges it could have
included a provision similar to the provision in section 1886(n)(2)(D)(i) of the Act, as added by
section 4102(a) of the HITECH Act, where FFS and MA inpatient-bed-days are added together
to derive the numerator of the Medicare share fraction. We do not have the authority to
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eliminate the requirement that an EP provide 80 percent of Medicare services to enrollees of an
MA organization, as that requirement is set forth in section 1853(l)(2)(A)(i)(II) of the Act, as
added by the HITECH Act, which is clear in requiring that an MA EP provide “80 percent of ...
professional services ... covered under this title to enrollees of the [MA] organization.”
Comment: One commenter recommended that CMS retain its proposal regarding how
the 80 percent and the 20 hours per week criteria will be met by MA EPs. Another commenter
said that many EPs in Puerto Rico would not qualify for incentives under this test. The
commenter said that the single MA organization requirement of 80 percent revenue and 20 hours
per week for MA EPs would not be met due to the competition and market changes from year to
year. The commenter suggested eliminating the single MA organization requirement. Instead,
the commenter said we should change the standards to consider all enrollees of all MA
organizations to which an EP furnishes services. The commenter continued by saying that if the
requirements are not modified to accept multiple MA organizations, the commenter anticipated
several unintended consequences in the Puerto Rico market. First, the commenter said, it would
be impossible for providers to meet the single MA organization requirement of 80 percent
revenue and 20 hours per week, and therefore, the standard would create disinterest in adopting
EHRs in their practice. Second, the commenter said, the single MA organization requirement
standard would stymie competition. An unanticipated consequence of the requirement would be
providers dropping out of MA plans to consolidate revenue in order to meet the standard from a
single MA organization. Third, the commenter concluded, patients would have fewer options to
select among MA plans, and to a lesser degree, MA enrollees might be forced to discontinue care
with long time MA providers in light of the providers’ determination to consolidate revenue
under a single MA organization.
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Response: As noted above, the 80 percent of Medicare revenue standard is set forth in
the statute, and may not be changed by regulation. The 20 hour per week rule is also statutory
and based on section 1853(l)(2)(B) of the Act, as added by the HITECH Act. We note, however,
that it is not the case that all 20 hours of patient care services per week be provided by an EP to
MA enrollees of a single MA organization. Rather, the 20 hours of patient care services to
enrollees of a single MA organization can include both Medicare and non-Medicare services and
patients.
Comment: One commenter asked CMS to continue to work with Congress to develop an
equitable mechanism by which to provide incentives to physicians that provide health care
services through participation with more than one MAO.
Response: As previously mentioned in the preamble to this final rule, the statute clearly
limits payment related to any specific MA EP to a single qualifying MA organization. Potential
changes in the statute are outside the scope of this rulemaking.
After consideration of the public comments received, we are implementing the foregoing
provisions as proposed.
As discussed in section II.B. of this final rule relating to Medicare FFS EPs, a qualifying
MA EP is also defined as a physician under section 1861(r) of the Act. Section 1853(l)(1) of the
Act, as added by section 4101(c) of the HITECH Act, provides that the provisions of sections
1848(o) and 1848(a)(7) of the Act, as amended and added by sections 4101(a) and (b) of the
HITECH Act, respectively, which establish the incentive payments for EPs under Medicare FFS,
apply to a qualifying MA organization's qualifying MA EPs “in a similar manner” as they apply
to EPs under Medicare FFS. As discussed above in section II.A.6. of this final rule, section
1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of the HITECH Act, states that hospital-
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based EPs are not eligible for incentive payments. Therefore, we proposed that, similar to the
Medicare FFS incentive program, MA incentive payments would also not be available for
hospital-based EPs. We note that the hospital where a hospital-based EP provides his or her
Medicare covered services would be potentially entitled to an incentive payment either through
the Medicare FFS incentive program, or through the MA-affiliated hospital EHR incentive
program. Therefore, we proposed that for such a hospital-based MA EP, a qualifying MA
organization would be no more entitled to an MA EP incentive payment under the MA EHR
incentive program than a similarly situated EP would be entitled to an incentive payment under
the Medicare FFS EHR incentive program.
Comment: We received one comment related to hospital-based MA EPs, and specifically
to our proposal in the proposed rule that “similar to the Medicare FFS incentive program, MA
incentive payments would also not be available for hospital-based EPs.” The commenter noted,
however, that unlike the proposed regulatory definition of “Qualifying Eligible Professional
(EP)” under the Medicare FFS incentive program, the proposed regulatory definition of
“Qualifying MA EP” under the MA EHR incentive program did not expressly exclude hospitalbased EPs. The commenter went on to say that if hospital-based MA EPs are excluded from the
MA EHR incentive program (for example, because they provide 90% or more of their covered
services in the CY preceding the payment year in an outpatient hospital setting), unless there is
an exception for MA EPs who are hospital-based in qualifying MA-Affiliated Eligible Hospitals
that would not qualify for an incentive payment under the MA Affiliated hospital EHR incentive
program payment criteria, Qualifying MA Organizations with MA EPs who are hospital-based in
such qualifying MA-Affiliated Hospitals would not qualify for an incentive, with regard to those
MA EPs, under any HITECH Act Medicare incentive program. The commenter concluded that
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this outcome would not be consistent with the objective of the HITECH Act to promote
widespread adoption of HIT through the payment of monetary incentives for meaningful use of
EHRs. The commenter recommended that if hospital-based MA EPs are excluded from the MA
EHR incentive program, then we should include an exception for MA EPs who are hospitalbased in Qualifying MA-Affiliated Eligible Hospitals that would not qualify for an incentive
payment (or would only qualify for a very minimal incentive payment) under the MA-Affiliated
hospital EHR incentive program payment criteria.
Response: We thank the commenter for pointing out our oversight in not including the
hospital-based physician exclusion in the proposed regulation text related to the MA EP EHR
incentive program. We will include in regulation text the fact that an MA EP is not a “hospitalbased EP,” as that term is defined in §495.4 of this final rule. As to a possible exception for
hospital-based EPs who are practicing in MA-affiliated hospitals that do not qualify for incentive
payments (or that qualify for very minimal incentive payments), we cannot provide such an
exception. MA-affiliated eligible hospitals will receive EHR incentive payments based on the
same statutory formula used to make EHR incentive payments to other “subsection (d)” hospitals
– see section II.C.3. of this final rule, below. There is no statutory authority nor is there a valid
reason to treat MA EPs, in this respect, any differently that other EPs that are hospital-based.
After consideration of the public comment received, we are modifying the regulation text
related to the definition of MA EP by the additional of an item 5) to the definition of “Qualifying
MA EP” at §495.200 to add a specific hospital-based MA EP exclusion.
As discussed in the proposed rule, an MA EP must either be employed by the qualifying
MA organization, or be employed by, or be a partner of, an entity that through contract with the
qualifying MA organization furnishes at least 80 percent of the entity's Medicare patient care
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services to enrollees of the qualifying MA organization. With respect to the later criteria, we did
not propose to define the term “entity,” but instead recognized that there exist a range of entities
with which MA organizations contract for patient care services, including physician groups,
Independent Practice Associations (IPAs), Exclusive Provider Organizations (EPOs), Physician
Hospital Organizations (PHOs), and Preferred Provider Organizations (PPOs).
Moreover, we recognized that an EP may contract with more than one such entity, and
that these entities often contract with a number of MA organizations and other health care
insurers. An EP also may directly contract with more than one MA organization. In general, we
said, it is only when an EP is employed by a single qualifying MA organization, or is employed
by or in partnership with an entity that contracts with a single qualifying MA organization, that
an EP can satisfy the criteria to be an MA EP.
We said that the qualifying MA organization must attest to the fact that each MA EP is a
meaningful user of certified EHR technology in accordance with §495.4. If all of these
conditions are met, such an individual is identified as an MA EP. We proposed to define the
term “MA eligible professional (EP)” at §495.200 as an EP who satisfies all of these conditions.
Finally, we discussed section 4101(d) of the HITECH Act which directed the Secretary to
study and report on “nearly exclusive” physicians that primarily treat MA enrollees and that
would not otherwise qualify for incentive payments under current law. We explained that this
rule does not address such individuals, as it is limited to codifying in regulation existing statutory
language as discussed herein.
We did not receive any comments on these provisions and are finalizing them as proposed.
c. Qualifying MA-Affiliated Eligible Hospital
We proposed to define “qualifying MA-affiliated eligible hospital” in §495.200. A
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qualifying MA organization may receive an incentive payment only for a qualifying
MA-affiliated eligible hospital described under section 1853(m)(2) of the Act, as added by
section 4102(c) of the HITECH Act, that is a meaningful user of certified EHR technology as
defined in §495.4 . Section 1853(m)(2) of the Act provides that such MA-affiliated eligible
hospitals are “eligible hospitals” as defined under section 1886(n)(6) of the Act and must be
under common corporate governance with a qualifying MA organization that serves individuals
enrolled under MA plans offered by such organization where more than two-thirds of the
Medicare hospitals discharges (or bed-days) are Medicare individuals enrolled under MA plans
offered by such organization. As discussed in section II.A.1. of this final rule, section 1886(n)(6)
of the Act defines an “eligible hospital” as a subsection (d) hospital (as defined under section
1886(d)(1)(B) of the Act). In §495.200, we also proposed to define “under common corporate
governance”, as a qualifying MA organization and a qualifying MA-affiliated eligible hospital
that have a common parent corporation, where one is a subsidiary of the other, or where the
organization and the hospital have a common board of directors.
Section 1853(m)(3)(B)(i) of the Act, as added by section 4101(c) of the HITECH Act,
provides that if for a payment year at least one-third (33 percent) of a MA eligible hospital's
discharges (or bed-days) of Medicare patients are covered under Part A (rather than under Part
C), the hospital may only receive an incentive payment under section 1886(n) of the Act – the
Medicare FFS incentive program.
In §495.200 we proposed to define “inpatient-bed-days” in the same manner as that term
is defined for purposes of implementing section 4201(a) of the HITECH Act in the preamble of
this final rule. The term will be used in the same way in computing incentive payments due
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qualifying MA organizations under the qualifying MA-affiliated eligible hospital incentive
payment program.
We note that, as discussed in section II.B.2.b. of this final rule, under section
1886(n)(2)(D)(i)(II) of the Act, the portion of the Medicare FFS hospital incentive payment
comprising the discharge related amount, or Medicare share, is based in part on the estimated
number of inpatient-bed-days attributable to individuals enrolled in MA plans under Part C. This
means that hospitals that treat individuals enrolled in MA plans will receive a Medicare FFS
hospital incentive payment partially based on the number of MA-enrollee bed-days. To the
extent a hospital does not meet the 33 percent threshold requiring payment through the FFS
Medicare EHR hospital incentive program, incentive payments can be made to a qualifying MA
organization under common corporate governance to the extent other requirements of the MA
EHR hospital incentive program are met. (See section II.C.3 of this final rule for the
computation of incentive payments to qualifying MA organizations.)
Therefore, we proposed to make EHR incentive payments to qualifying MA-affiliated
eligible hospitals under the FFS EHR incentive program. Finally, we said that to the extent such
data necessary to estimate the inpatient-bed-days-related incentive payment amount are not
already available to us through the normal submission of hospital cost reports; we proposed to
require that qualifying MA organizations seeking reimbursement for qualifying MA-affiliated
eligible hospitals submit similar data.
We did not receive any comments on these provisions and are finalizing them as
proposed.
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2. Identification of Qualifying MA Organizations, MA EPs, and MA-Affiliated Eligible
Hospitals
In §495.202 we proposed to require an MA organization that intended to ask for
reimbursement under the MA EHR incentive payment program to so indicate as part of
submissions of their initial bid under section 1854(a)(1)(A) of the Act, and to attest, in some
cases, that they meet the requirements of a qualifying MA organization. For MA organizations
offering an MA HMO plan type, we proposed to deem such organizations to meet the definition
of HMO in 42 U.S.C. 300-gg(b)(3), (that is, section 2791(b)(3) of the PHS Act). As noted
previously, for MA organizations offering plan types other than HMOs, we proposed to require
an attestation by the organization that the MA organization is recognized under State law as an
HMO, or that it is a similar organization regulated under State law for solvency in the same
manner and to the same extent as an HMO before we would make a determination that the MA
organization is a qualifying MA organization for purposes of incentive payments. We proposed
to require this beginning with bids due in June 2010 (for plan year 2011) for MA organizations
seeking reimbursement for MA EPs and MA-affiliated eligible hospitals.
We also proposed requiring qualifying MA organizations, as part of their initial bids
starting with plan year 2011, to make a preliminary identification of potentially qualifying MA
EPs and potentially qualifying MA-affiliated eligible hospitals for which the organizations would
seek EHR incentive payments.
In developing the preliminary and final lists of potentially qualifying MA EPs, qualifying
MA organizations, we said that qualifying MA organizations must exclude hospital-based MA
EPs. We proposed that qualifying MA organizations identify hospital-based MA EPs using the
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same criteria outlined in section II.A.6 of this final rule for identifying hospital-based EPs in the
Medicare FFS EHR incentive program.
Along with both the preliminary and final lists of potentially qualifying MA EPs and
MA-affiliated hospitals, we said that qualifying MA organizations would be required to submit
an attestation that these professionals and hospitals meet the criteria to be considered eligible.
For example, for hospitals, the qualifying MA organization would need to attest that they are
under common corporate governance with the qualifying MA organization and for EPs, the
qualifying MA organization would need to attest that the list does not include any hospital-based
EPs.
We proposed requiring qualifying MA organizations to provide final identification of
potentially qualifying MA EPs by the end of the MA EP payment year (December 31), and final
identification of potentially qualifying MA-affiliated eligible hospitals by the end of the
MA-affiliated hospital payment year (the FFY ending on September 30), for which MA EHR
incentive payments were sought. We also proposed requiring qualifying MA organizations to
report the name, practice address, and other identifying information, like NPI, for all physicians
that meet the requirements of a qualifying MA EP for which the qualifying MA organization
would be requesting payment under the MA EHR incentive payment program.
We said that once a qualifying MA organization identifies potential EPs, we are required
to ensure that such EPs did not receive the maximum EHR incentive payment for the relevant
payment year under the Medicare FFS program under section 1848(o)(1)(A) of the Act, as added
by section 4101(a) of the HITECH Act, before releasing an incentive payment to a qualifying
MA organization related to such EP. (See section 1853(l)(3)(B)(i) of the Act, as added by
section 4101(c) of the HITECH Act). Therefore, in order to allow us time to determine whether
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an MA EP received the maximum EHR incentive payment under the Medicare FFS program, we
proposed not to make incentive payments to qualifying MA organizations for the MA EPs for a
payment year until after the final computation of EP incentive payments for that year under the
Medicare FFS program. Additionally, we proposed to require qualifying MA organization to
ensure that all MA EPs are enumerated through the NPI system, in order to detect and prevent
duplicate payment for EPs under both the FFS and MA EHR incentive payment programs.
Comment: Two commenters contended that requiring MA organizations to provide even
a preliminary list of MA EPs by June 2010 (for payment year 2011) would be unrealistic and
burdensome, especially when publication of a Final Rule seems unlikely before May 2010 at the
earliest. For 2011, any preliminary list will be inaccurate, despite good faith efforts and
reasonable due diligence. Moreover, CMS has not stated any justifiable purpose for requiring
such a preliminary list.
Response: We agree with the commenters that it would be unnecessarily burdensome
and unrealistic to require MA organizations to provide preliminary lists as early as June of 2010
of potential MA EPs for incentive payment year 2011. We will change the timing of this
requirement in §495.202(b)(1) to say that as part of initial bids for plan year 2012 MA
organizations will be required to submit preliminary lists in June of 2011 (when bids are due for
2012) of potential MA EPs for incentive payment year 2011. Thus, we will delay the
requirement for a full year. The purpose of such preliminary lists is to identify potential MA EPs
that have, for instance, registered as FFS Medicare or Medicaid EPs on the National Level
Repository. The intent of getting these lists before payment is due, or before a final
determination of eligibility can be made, is to help qualifying MA organizations know of any
potential conflicts in time to “cure” them before final payment determinations are made.
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Comment: One commenter objected to CMS’s proposal that MA organizations be
required to submit final lists of MA EPs and MA hospitals by the last day of the payment year,
including the attestations of meaningful use and accurate payment calculation. The commenter
argued that this timing would not allow sufficient time to ensure that data are complete and
accurate, especially considering that MA organizations bear the additional burden of having to
develop and support internal administrative systems to determine eligibility and to calculate
payment (we will calculate FFS EP payments based on claims submitted). The commenter
recommended that we extend the deadlines to produce both preliminary and final lists of MA
EPs and hospitals. The commenter suggested that MA organizations be given until 90 to 120
days after the close of the payment year to identify and list eligible EPs and hospitals (for
example, after 31 December 2011 for plan year 2011).
Response: We agree with the commenter that additional time should be permitted and we
are therefore adding a due date in §495.202(b)(3) for final identification of potentially qualifying
MA EPs and MA-affiliated eligible hospitals of 60 days after the close of the payment year. We
believe 60 days is reasonable, since it is the same as the time in which FFS EPs have to submit
claims for consideration under the Medicare FFS EHR incentive payment program.
After consideration of the public comments received, we are modifying the regulation
text related to the timing of both preliminary and final identification of MA EPs and MAaffiliated eligible hospitals. Preliminary identification of MA EPs and MA-affiliated hospitals
for payment year 2011 will need to occur by the bidding deadline in June 2011, and final
identification will need to occur within 60 days of the close of the payment year. Accordingly,
we are respectively modifying the regulation text at §495.202(b)(1) and §495.202(b)(3). We are
also modifying the regulation text at §495.204(b)(2) to be consistent with the change to
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§495.202(b)(3), since final identification in §495.202(b)(3) should occur at the same time as final
revenue reporting under §495.204(b)(2), so calculations of payments due under the MA EP
incentive payment program can be finalized. We are also modifying the regulation text at
§495.210(b) and (c) to be consistent with the changes to §495.204(b)(2) and §495.202(b)(3),
since the deadline for attestations of meaningful use should be consistent with deadlines for
revenue reporting for MA EPs, and final identification of MA EPs and MA-affiliated hospitals.
Finally, as noted (above) in our discussion of the definition of qualifying MA organization, we
are modifying the date in §495.202(a)(1) by which MAOs are required to identify themselves to
us from the bidding deadline in June 2010 (for plan year 2011) to the bidding deadline in June
2011 (for plan year 2012).
We also proposed to require all qualifying MA organizations to self-report and identify
themselves, regardless of whether they have qualifying MA EPs or MA-affiliated eligible
hospitals for whom or which the organization plans to claim incentive payments at the time the
initial bid is due (the first Monday of June, see section 1854(a)(1)(A) of the Act) beginning in
2014 for bids related to plan year 2015. We proposed to require this reporting by all qualifying
MA organizations in years beginning with 2014 in anticipation of the statutory requirement in
sections 1853(l)(4) and 1853(m)(4) of the Act, to negatively adjust our capitation payments to
qualifying MA organizations for MA EPs and MA-affiliated eligible hospitals that are not
meaningful users of certified EHR technology for years beginning with 2015.
We did not receive any comments on these provisions and are finalizing them as
proposed.
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3. Computation of Incentives to Qualifying MA Organizations for MA EPs and Hospitals
In §495.204, we proposed a methodology under which payments to qualifying MA
organizations for qualifying MA EPs will be computed. Section 1853(l)(3)(A) of the Act
provides that in applying section 1848(o), instead of the additional payment amount specified
under section 1848(o)(1)(A) of the Act, the Secretary may substitute an amount determined by
the Secretary, to the extent feasible and practical, to be similar to the estimated amount in the
aggregate that would be payable under, or would be based on, the Medicare physician fee
schedule under Part B instead of Part C. Section II.B.1. of this final rule discusses these
provisions.
Section 1853(m)(3)(A) of the Act provides that, in providing an incentive payment to
qualifying MA organizations for MA-affiliated hospitals, we substitute for the amount specified
under section 1886(n)(2) of the Act – the incentive payment amount under Medicare FFS for
qualifying eligible hospitals – an amount determined by the Secretary to be similar to the
estimated amount in the aggregate that would be payable if payment for services furnished by
such hospitals was payable under Part A instead of Part C. (For more detailed information see
section II.B.2. of this final rule.)
Sections 1848(o)(1)(D)(i) and 1886(n)(2)(F) of the Act permit us to make incentive
payments for a year in installments, although we proposed to make a single lump sum payment
with respect to MA EPs. With respect to MA EP incentive payments, we said we read the term
“aggregate” to mean the aggregate installment payments made by us under the FFS EHR
incentive program to a qualifying EP over the course of the relevant payment year.
The duplicate payment provisions in section 1853(l)(3)(B)(i)(II) of the Act direct us to
make payment for EPs “only under” the MA EHR incentive program “and not under” the
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Medicare FFS EHR incentive program to the extent any EP earned “less than [the] maximum
incentive payment for the same period” under the Medicare FFS EHR incentive program. We
noted in the proposed rule that section 1853(l)(1) of the Act provides that section 1848(o) of the
Act applies in a “similar,” but not the same, manner to qualifying MA organizations as it applies
to EPs under Part B. The Medicare FFS incentive payment program under section 1848(o) does
not include payment for professional services provided to MA enrollees, but rather only for
services paid under Part B. In a similar manner we proposed to limit payment to an MA
organization to only payment for their EPs' services to MA enrollees of plans offered by the MA
organization. We said we did not believe it would be appropriate to provide an incentive
payment to an MA organization for services provided to individuals covered under Part B.
Therefore, we proposed, that in calculating qualifying MA EP incentive payments, we would
only consider covered professional services provided to enrollees of MA plans offered by
qualifying MA organizations and would not include in the calculation any services reimbursed
by Medicare FFS.
Comment: Many commenters asked if MA plan beneficiaries and services would be
counted in the calculation of FFS EHR incentives and, if so, if it would require separate
submissions to each MA plan in the local market.
Response: As we explained in the preamble of the proposed rule, we cannot make MA
EP incentive payments for Part B services covered and paid for on a fee-for-service basis under
the original Medicare program. We also cannot make MA EP incentive payments to entities
other than qualifying MAOs. In short, the Medicare Advantage services provided by EPs that
are not qualifying MA EPs – defined in statute and in this rule at §495.200 – are not
reimbursable under the EHR incentive payment program.
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Comment: Two commenters contended that the proposed Medicare Advantage incentive
computation was inconsistent. They said that sections II.C.3. through 5. of this final rule discuss
compensation, but the preamble says that the Secretary may substitute a different amount. This
discrepancy should be clarified.
Response: We disagree. The statute says that we can substitute an amount “that is
similar to the estimated amount that would be payable or based on the fee schedule.” It does not
say that we can substitute a different amount.
After consideration of the public comments received, we are implementing these
provisions as proposed.
We also said that under the Medicare FFS EHR incentive program, an EP's incentive
payment could not exceed the annual limits specified under section 1848(o)(1)(B)(i) of the Act.
We proposed that similar payment limits apply to qualifying MA organizations for their
qualifying MA EPs. Specifically, section 1848(o)(1)(B) of the Act provides that the incentive
payment for an EP for a given year shall not exceed the following amounts:
• For the EP's first payment year, $15,000 (or, if the first payment year is 2011 or 2012,
$18,000).
• For the EP's second payment year, $12,000.
• For the EP's third payment year, $8,000.
• For the EP's fourth payment year, $4,000.
• For the EP's fifth payment year, $2,000.
• For any succeeding year, $0.
Note that, similar to the Medicare FFS EHR incentive program, there will be no incentive
payments made with respect to a year after 2016. We proposed similar restrictions related to
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qualifying MA organizations. So, the maximum cumulative incentive payment over 5 years to a
qualifying MA organization for each of its qualifying MA EPs that meaningfully use certified
EHRs beginning on or before 2012 would be $44,000 per qualifying MA EP. For qualifying MA
organizations first reporting the meaningful use of certified EHRs by qualifying MA EPs after
2014, there is no incentive payment amount available. Subject to an exception discussed below,
for MA organizations first reporting the meaningful use of certified EHRs by qualifying MA EPs
in 2013 or 2014, the maximum potential incentive payment per qualifying EP is, respectively,
$39,000 over 4 years, and $24,000 over 3 years.
We did not receive any comments on these provisions and are finalizing them as
proposed.
We proposed to make MA EP incentive payments to qualifying MA organizations on the
same payment cycle for all employed/partnering qualifying EPs of the organization. In other
words, all MA EPs of a specific qualifying MA organization will be in the same payment year
with respect to the amount of the incentive payment per qualifying EP that we will make. So, for
instance, if a qualifying MA organization is in its second payment year in 2013 and it hires a new
EP for which the qualifying MA organization had not previously received an EHR incentive
payment, we will nevertheless make a second year incentive payment (up to $12,000 in 2013)
with respect to such an MA EP – assuming all other conditions are met. Thus, the limits on MA
EP incentive payments discussed above are applied to the qualifying MA organization's entire
MA EP population in any specific payment year relative to that MA organization, regardless of
the length of employment/partnership of/between that specific MA EP and that specific
qualifying MA organization.
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Under section 1848(o)(1)(B)(iv) of the Act, the annual incentive payment limit for EPs
who predominantly furnish Part B services in a geographic health professional shortage area
(HPSA) is increased by 10 percent. While we do not anticipate that MA EPs would generally
practice in a HPSA area, to the extent that an MA EP practices in an area where he or she would
be entitled to the 10 percent increase, that amount would apply to MA EPs as well.
We did not receive any comments on these provisions and are finalizing them as
proposed.
We explored various ways of computing the EP-level incentive payments due qualifying
MA organizations whose qualifying MA EPs meaningfully use certified EHR technology. One
option that we considered was using MA plan bidding and payment data to estimate average
annual MA revenue for qualifying MA EPs with respect to a qualifying MA organization.
However, we did not pursue this option because the approach results in an average revenue
amount across all potentially qualifying MA EPs with respect to a qualifying MA organization
and, therefore, would include revenue amounts that exceed the annual per-professional ceiling on
incentive payments under FFS for all EPs. We said we believed such a result is contrary to the
legal requirement that qualifying MA organizations are to receive incentive payments only for
qualifying MA EPs that actually provide at least 20 hours per week of patient care services.
Under this method there would be also be no way to know if the EP provided 80 percent of
his/her professional Medicare services to enrollees of the organization.
We also considered a reporting system for which qualifying MA organizations would be
required to report eligible-professional-specific information along with MA patient encounters
for nonhospital-based office visits. Specifically, we examined requiring qualifying MA
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organizations reporting qualifying MA EP encounters with MA plan enrollees based on the five
levels of office visit codes recognized by Medicare FFS.
We said we believed that such a process would be administratively burdensome and
difficult to operationalize. Therefore, we proposed an alternative approach, but sought input
from interested parties as to which of the approaches, or perhaps others, would best address the
statutory requirement to compensate qualifying MA organizations for qualifying MA EPs the
amount that would be payable if payment for services furnished by such professionals were made
under Part B instead of Part C.
Therefore, in §495.204(b)(1) through (3) we proposed an approach in which the revenue
received by the qualifying MA EP for services provided to enrollees of the qualifying MA
organization would serve as a proxy for the amount that would have been paid if the services
were payable under Part B. Under our proposed approach, the qualifying MA organization
would report to us the aggregate annual amount of revenue received by each qualifying MA EP
for MA plan enrollees of the MA organization. We said we would calculate the incentive
payment amount due the qualifying MA organization for each qualifying MA EP as an amount
equal to 75 percent of the reported annual MA revenue of the qualifying MA EP, up to the
maximum amounts specified under section 1848(o)(1)(B) of the Act.
For qualifying MA EPs who were compensated on a salaried basis, we proposed in
§495.204(b)(4) requiring the qualifying MA organization to develop a methodology for
estimating the portion of the qualifying MA EP's salary attributable to providing services that
would otherwise be covered as professional services under Part B of Medicare to MA plan
enrollees of the MA organization. The methodology, which would require review and approval
by us, could be based on the relative share of patient care hours spent with MA enrollees of the
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organization or another reasonable method. So, for instance, if a qualifying MA EP spends 30
percent of his or her time providing covered Part B physician office services to MA plan
enrollees, then the qualifying MA organization would report 30 percent of the qualifying MA
EP's salary as annual revenue, which would be used to compute the amount of the MA incentive
payment due to the qualifying MA organization for the qualifying MA EP. Thus, if the
qualifying MA EP had a base salary of $150,000, 30 percent would be $45,000 – which is well
over the threshold of $24,000 needed by the MA organization to qualify for a maximum
incentive payment of up to $18,000 (70 percent of $24,000) for such a qualifying MA EP in any
year. We also proposed to require that salaries be prorated to ensure that the amount reported
reflects the salary paid for the applicable year, where necessary.
We also said that salaried physicians' compensation typically does not include an
allowance for administrative practice costs. Given that Part B allowed amounts do include
practice expense costs, we proposed allowing qualifying MA organizations to identify, where
appropriate, an additional amount related to overhead that would be added to the qualifying MA
EP's estimated Part B compensation. To the extent Medicare FFS compensation to physicians
includes an amount for office space rental, office staffing, and equipment, we believe that
qualifying MA organizations should also be permitted to include an amount for overhead related
to such costs not directly experienced by salaried qualifying MA EPs. In §495.204(b)(4)(ii), we
proposed requiring qualifying MA organizations to develop a methodology for estimating the
additional amount related to overhead attributable to providing services that would otherwise be
covered under Part B of Medicare. We said the methodology would require review and approval
by us.
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For qualifying MA EPs who are not salaried, (that is, who are paid on a capitated or
fee-for-service basis), we proposed in §495.204(b)(5) to require qualifying MA organizations to
obtain attestations from such EPs and to submit to us information from the attestations as to the
amount of compensation received by the EPs for MA plan enrollees of the MA organization.
We are proposing such attestations because many EPs are not paid directly by MA organizations,
but rather by intermediary contracting entities, such as physician groups, and as a result the
qualifying MA organization may not otherwise know how much compensation is received by
each qualifying MA EP. In reporting compensation, we are proposing that the EPs include only
those amounts for professional services that would otherwise be payable under Part B and for
which payment would be made under, or would be based on, the Medicare physician fee
schedule.
Comment: One commenter recommended that final CMS regulations retain the exact
requirements outlined in §§495.204(b)(4) and (5). Two commenters said that CMS should allow
flexibility in methods MA organizations propose for computing incentive payments so long as
the organization’s approach is reasonable, straightforward, and fairly equates to the Medicare
fee-for-service approach without imposing undue burdens on MA organization systems or
compromising EP privacy. The proposed rule describes how incentive payment amounts will be
calculated for eligible hospitals and EPs. The proposed rule presents options for a MA payment
methodology, but expressly solicits comments from MA organizations about how such a
methodology could be designed to fairly approximate the FFS payment calculation. The
commenters included recommendations about how MA organizations could be reimbursed and
what methodology would be a reasonable proxy for the Part B-based payment applied to FFS
physicians, based on the amount of individual physician care provided to MA members. The
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commenters said that MA EPs who are employed by their organizations are independent
physician group practices that contract exclusively with their organizations to meet the health
needs of their members, including MA enrollees. Their organizations do not pay the salaries of
MA EPs who provide patient care services to their members and patients. They said that CMS
has proposed that the organization that directly pays the EP salaries would perform a calculation
and attest to the MA organization about the amount of payment. They said that while this would
mitigate some of the confidentiality concerns related to sharing salary information with the
health plans, salary information would still be potentially exposed to CMS. They said that
another disadvantage of using actual salary as a basis for calculating the incentive payment is
that this approach potentially introduces unacceptable variability into the estimation of proxy
amounts for Medicare services. For example, two MA EPs, whose salaries vary significantly but
provide the same Medicare services in a reporting period, would have different proxy amounts.
Further, they said, if such EPs were billing under Part B, the amount of Medicare services each
billed would be the same, regardless of whether their incomes were the same. These
commenters went on to propose an alternative method of computing a proxy Part B amount.
They said that as a first step, the MA organization would calculate the percentage of clinic time
each physician spends caring for MA members. This MA Practice percentage could be derived
by either: 1) capturing the total scheduled appointment time for MA members for each MA EP
and dividing that amount by the total scheduled time for that MA EP (for all appointments); or 2)
capturing the number of MA member visits/procedures for each MA EP and dividing that
amount by the total number of visits/procedures for that MA EP (for all members). The
organization would then calculate the average practice cost by specialty for all specialties
identified in the annual American Medical Group Association’s (“AMGA”) salary survey. The
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commenters explained that AMGA survey provides the median compensation per physician in
most specialties as well as the non-compensation related clinic costs per physician (staffing,
supplies, overhead, etc.) in most specialties. Adding specialty specific compensation data (for
groups > 100 physicians) to the combined average non-compensation related clinic costs for that
specialty (for all sized groups) would provide a surrogate amount for each specialty’s total
operating costs. This would produce the Average Operating Costs by Specialty. Multiplying
each MA EP’s MA Practice percentage and the Average Operating Costs by Specialty for that
MA EP’s practice specialty would produce a surrogate Medicare Part B amount. For each MA
EP, the MA organization would be paid an incentive equal to 75 percent of the surrogate
Medicare billing amount for that physician, such incentive not to exceed the maximum incentive
for each payment year of the program (for example, $18,000 if the first year of participation is
2011).
Response: While we appreciate the thought and effort that went into this proposed
alternative method of calculating MA EP incentive payments, we are reluctant to adopt it for the
simple reason that where salaries, practice costs, or actual MA EP compensation can be known,
we believe it is a better read of statutory requirements to work from that actual compensation and
cost data than it would be to allow estimation of both. In many respects the proposed alternative
method is similar to the method discussed and disposed of in the proposed rule related to
estimating physician compensation based on MA bidding and payment data. Although the
commenters’ alternative version factors in actual practice time, we believe using AMGA salary
survey data would be inferior to using actual physician compensation practice cost information.
To the extent actual salary information is unknown or unavailable to the MA organization, we
believe it could be provided to us in a manner that would protect the privacy of individual MA
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EPs and physician groups. Furthermore, the proposal also estimates “non-compensation related
clinic costs” based on AMGA data, which is, again, inappropriate, when actual overhead costs
might be quite different in a specific MA organization. However, based on the commenters
concerns regarding provider privacy and the need to develop a consistent and verifiable method
of computing the amount payable to qualifying MA organizations for MA EPs we are modifying
the regulation text at §495.204(b)(5) to say that qualifying MA organizations “may” obtain
attestations from qualifying MA EPs and “may” submit such information to us – rather than
“must.” And, we add a new subparagraph (6) that allows the physician group or other payer to
provide EP reimbursement information directly to us. We also provide assurances that we will
use the EP reimbursement data for no other purpose than to compute the MA EP incentive
payment due the qualifying MA organization.
Comment: One commenter said that in the proposed rule the methodology for estimating
the portion of the qualifying MA EP’s salary attributable to providing services that would
otherwise be covered as professional services under Part B of Medicare to MA plan enrollees of
the MA organization would require review and approval by CMS; and that such methodology
“could be based on the relative share of patient care hours spent with MA enrollees of the
organization or another reasonable method.” However, the commenter opined, the proposed rule
offers no details about how the review and approval process would be conducted, including dates
and timelines for the process. Thus, the commenter recommended that CMS permit flexibility in
allowing MA organizations to develop methodologies that will be reasonable in light of
organization structure and systems, it is important to provide some guidance about how CMS
will review and approve such proposals. CMS should permit, the commenter said, any
reasonable payment methodology method that is fair, relatively easy to administer, subject to
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audit and that provides a reliable approximation of Medicare Part B billing. In addition, the
commenter concluded, CMS should provide a simple process for submission and approval of
MA payment methodologies.
Response: In the proposed rule at §495.204(b)(4) we offered flexibility related to the
“methodology for estimating the portion of each qualifying MA EP’s salary attributable to
providing services that would otherwise be covered as professional services under Part B,” said
that the methodology had to be “approved by CMS,” and that the amount could include an
“additional amount related to overhead.” Based on this comment we are adding a new clause
(iii) that says that such methodological proposals must be submitted to CMS by June of the
payment year, must be auditable by an independent third-party, and that CMS will review and
approve or disapprove such proposals in a timely manner.
Comment: One commenter wanted to know what percentage of the incentive payments
will go to eligible professionals under Medicare Advantage.
Response: No known percentage of incentive payment will go to eligible professionals
under Medicare Advantage, since MA EP payments are made solely to qualifying MA
organizations.
In the proposed rule we said that in applying the instruction in section 1853(m)(3)(A) of
the Act to substitute for the amount specified under section 1886(n)(2) of the Act an amount
similar to the estimated amount in the aggregate that would be payable if payment for the
hospitals' services were made under Part A instead of Part C, we read the term “aggregate” to
mean the aggregate installment payments made by us if EHR incentive payments were made
under Part A instead of Part C.
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Incentive payments to eligible hospitals under the Medicare FFS EHR incentive program
are comprised of three components: (1) an initial amount composed of a base incentive payment
of $2,000,000 and a second incentive payment amount of $200 per discharge for discharges
1,150 – 23,000 during a 12- month period selected by the Secretary; (2) the Medicare share; and
(3) a transition factor. As discussed in the preamble related to §495.104(c), for purposes of
calculating incentive payments to eligible hospitals under the Medicare FFS EHR incentive
program, we are proposing that the 12-month period be based on the FFY. For the purpose of
calculating incentive payments for qualifying MA-affiliated eligible hospitals, we similarly are
proposing that the 12-month period be based on the FFY.
Section II.B. of this final rule discusses our methodology for calculating the incentive
payment for qualifying eligible hospitals under the Medicare FFS EHR program. As set forth in
§495.204(c)(2), we proposed to use the FFS EHR hospital incentive program for purposes of
calculating and making the incentive payment for qualifying MA-affiliated hospitals. To the
extent data are not available to reimburse MA-affiliated hospitals through the FFS hospital
incentive program, we proposed to require submission of such data to us and adopt the same
definition of “inpatient-bed-days” and other terms under the Medicare FFS EHR hospital
incentive program specified in §495.104 of this final rule. In such a case we proposed in
§495.204(c)(1) to make payment for such MA-affiliated eligible hospitals to the qualifying MA
organization.
The formula for calculating the hospital incentive payment under the Medicare FFS
hospital incentive program is an initial amount of the sum of the base amount of $2,000,000 per
hospital plus an additional $200 per discharge for discharges 1,150 through 23,000 for that
hospital in that payment year. This initial amount is then multiplied by a transition factor and
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then again by the Medicare share. These last two numbers are fractions and will tend to reduce
the initial amount computed in the first step.
Similar to the Medicare FFS EHR hospital incentive program, we proposed to use
inpatient-bed-day data, discharges, and other components of the FFS calculation for each
qualifying MA-affiliated eligible hospital from the hospital-specific fiscal year that ends during
the FFY prior to the FFY that serves as the payment year. To the extent such data are not
already available to us through the normal submission of hospital cost reporting data; we
proposed requiring qualifying MA organizations seeking reimbursement for their qualifying
MA-affiliated eligible hospitals to submit similar data.
We said we can only pay for qualifying MA-affiliated eligible hospitals under common
corporate governance based on inpatient-bed-days computed on a fiscal year basis where less
than one third of the inpatient-bed-days of Medicare patients are covered under Medicare FFS Part A. However, it does not appear that reimbursement only under the MA EHR incentive
program is required for qualifying MA-affiliated eligible hospitals that are under common
corporate governance. Rather, section 1853(m)(3)(B), of the Act only prohibits payment under
the MA EHR incentive program when Medicare hospital inpatient-bed-days covered under Part
A exceed 33 percent of all Medicare inpatient-bed-days. Although eligibility under the MA
EHR hospital incentive program is not available to qualifying MA organizations for any specific
hospital when FFS inpatient-bed-days exceed 33 percent of the Medicare total, a qualifying MA
organization could be reimbursed through the Medicare FFS EHR hospital incentive payment
program for qualifying hospitals under common corporate governance even for hospitals with
very low ratios of FFS to MA inpatient-bed days.
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Given that the hospital incentive payment methodology and payment amount will be
identical under the Medicare FFS EHR incentive program and the MA EHR incentive program,
and given that there is no statutory prohibition on reimbursing a qualifying MA-affiliated eligible
hospital through the Medicare FFS EHR incentive program, for purposes of administrative
efficiency, and pursuant to our authority under section 1857(e) of the Act to add new
“appropriate” contract terms (incorporated for Part D by section 1860D-12(b)(3)(D) of the Act),
we proposed requiring that qualifying MA organizations receive incentive payments for
qualifying MA-affiliated eligible hospitals through their affiliated hospitals under the Medicare
FFS EHR incentive program if they are eligible for such payments, rather than through the MA
EHR incentive program. We believe this is the most efficient way in which to administer the
MA EHR hospital incentive program in light of the expected low volume of MA-affiliated
eligible hospitals (approximately 50 hospitals), and in light of preliminary data which indicates
that MA-affiliated eligible hospitals already submit Medicare cost reporting data to us from
which we can compute hospital incentive payments due. To the extent sufficient data do not
exist to make such payments under the Medicare FFS EHR incentive program, qualifying MA
organizations will be required to submit additional data to us.
We did not receive any comments on these provisions and are finalizing them as
proposed.
To the extent payments are made to qualifying MA organizations for qualifying MA EPs
or qualifying MA-affiliated eligible hospitals, we proposed to conduct selected compliance
reviews to ensure that EPs and eligible hospitals for which such organizations received incentive
payments were actually meaningful users of certified EHR technology, in accordance with our
existing authority in section 1857(d) of the Act and 42 CFR 422.504 of the regulations related to
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protections against fraud. The reviews would include validation of meaningful user attestations,
the status of the organization as a qualifying MA organization, and verification of both
meaningful use and data used to calculate incentive payments. We proposed requiring MA
organizations to maintain evidence of compliance with all aspects of the MA EHR incentive
payment program for 10 years after the date payment is made with respect to a given payment
year. Payments that result from incorrect or fraudulent attestations, cost data, or any other
submission required to establish eligibility or to qualify for a payment, will be recouped by CMS
from the MA organization.
We did not receive any comments on these provisions and are finalizing them as
proposed.
Finally, as we indicated above in section II.C.2. of this final rule, we are modifying the
regulation text at §495.204(b)(2) to be consistent with the change to §495.202(b)(3), since final
identification in §495.202(b)(3) should occur at the same time as final revenue reporting under
§495.204(b)(2), in order to ensure that calculations of payments due under the MA EP incentive
payment program can be finalized.
4. Timeframe for Payment
For payments to qualifying MA EPs, in §495.206 we proposed the timeframe for
payment to be after the Medicare FFS program computes incentive payments due under the
Medicare FFS EHR incentive program – so the first possible incentive payments would be made
sometime in early 2012. We proposed that payments for qualifying MA-affiliated eligible
hospitals under common corporate governance occur in the same manner and in the same time
frame as payments made under the Medicare FFS EHR incentive program to “subsection (d)”
hospitals as discussed in section II.B.2.d. of this final rule.
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We proposed to define “payment year” with respect to qualifying MA EPs in §495.200.
Section 1853(l)(3)(C) of the Act directs us to establish the same first payment year for all EPs
with respect to any specific qualifying MA organization. Consistent with the statute, we
proposed to pay a qualifying MA organization on the same schedule for all of its qualifying MA
EPs. In other words, the first year during which the qualifying MA organization receives an
incentive payment for its qualifying EPs will be considered the first payment year for all of its
qualifying EPs. Accordingly, for purposes of determining the applicable incentive payment
limits, the second, third, fourth, and fifth years during which the qualifying MA organization
receives an incentive payment for its qualifying EPs will be considered the second, third, fourth,
and fifth payments years for each of its qualifying EPs, regardless of whether the MA
organization claimed an incentive payment for a particular EP for a prior payment year. Such a
consistent payment cycle relative to qualifying MA organizations and qualifying MA EPs
obviates the need to track payment years and payment adjustment years based on prior payments
or adjustments with respect to any individual qualifying MA EP. Rather, for purposes of
payment years and payment adjustment years, any EP employed by or partnering with any
specific MA organization will be on the same cycle with respect to that organization.
We said that similar to the Medicare FFS EHR incentive program, payment to qualifying
MA organizations for qualifying MA EPs and payment for qualifying MA-affiliated eligible
hospitals is available only for a finite number of years. As previously discussed in the section on
the calculation of MA incentive payments, above, a qualifying MA organization can receive an
incentive payment of up to $18,000 for each of its qualifying MA EPs for its first payment year
if its first payment year is 2011 or 2012, or up to $15,000, if its first payment year is 2013, or up
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to $12,000, if its first payment year is 2014. Note that, similar to the Medicare FFS EHR
incentive program, there would be no incentive payments made with respect to a year after 2016.
We proposed to define “payment year” with respect to qualifying MA-affiliated eligible
hospitals in §495.200. For incentive payments for qualifying MA-affiliated eligible hospitals,
the first year for which an MA organization may claim payment is FY 2011. Similar to the
Medicare FFS EHR hospital incentive program, we proposed to use the hospital inpatient
bed-days data from the hospital FY that ends during the FFY prior to the FY that serves as the
payment year. For qualifying MA-affiliated eligible hospitals, we proposed to compute hospital
EHR incentive payments due in the same manner as they are being computed in the Medicare
FFS hospital incentive payment program. For qualifying MA-affiliated eligible hospitals for
which the first payment year is 2011 through 2013, up to 3 additional years of incentive
payments are available. For qualifying MA-affiliated eligible hospitals for which the first
payment year is after 2015, no EHR payment incentive can be made for that year or any
subsequent year. Finally, for qualifying MA-affiliated eligible hospitals for which the first
payment year is 2014 or 2015, only 2 (or 1) additional year(s) of hospital incentive payments
will be available.
Unlike the fixed schedule for application of limitation on incentive payments for MA EPs
discussed previously in this section of the final rule in which all employed/partnering MA EPs
will be paid on the same schedule (first payment year, second payment year, etc.) with respect to
any specific qualifying MA organization, we proposed to make payments to MA organizations
for MA-affiliated eligible hospitals on a hospital specific basis. In other words, if a qualifying
MA organization has some MA-affiliated eligible hospitals with a first payment year of FY
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2011, it may have other MA-affiliated eligible hospitals with a first payment year of FYs 2012
through 2015.
Comment: Two commenters said that payments to MA organizations will be delayed
every year by an unspecified amount of time. The commenters said that it was understood that
CMS is charged by statute to avoid making duplicate payments, however MA organizations
should be paid without unspecified delay. A suggested alternative by the commenters was to
permit MA organizations to attest that their MA EPs will not seek any payment under the
Medicare FFS Incentive Program. Alternatively, the commenters suggested, CMS could use an
installment payment system (permitted under statute as stated) for MA organizations. The
commenters said that this would permit partial payment until the resolution of the duplicate
payment issue and would avoid long delays in paying MA incentives.
Response: We do not agree that MA organization EHR incentive payments are subject to
“unspecified delay.” Rather, since MA organizations will be paid for MA EPs only if such EPs
were not paid the maximum incentive payment under the FFS EHR incentive payment program,
and since final claims data will not be available until two months after the close of the payment
year – see §495.102(a)(2) – CMS will not be able to compute MA EP payments until the FFS
EHR incentive payment program has completed its calculations. This will occur in the early
spring of the year after the close of a payment year. Moreover, MA-affiliated eligible hospitals
will receive EHR incentive payments on the same schedule as other “subpart (d)” hospitals.
Finally, note that MA EPs are free to leave qualifying MA organizations at any time, and since
EPs are also free to register for eligibility under FFS Medicare or Medicaid EHR incentive
payments, an attestation by a qualifying MA organization would have little merit. For these
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reasons we cannot accept the suggestion that qualifying MA organizations receive interim or
partial mid-year payments for MA EPs.
After consideration of the public comment received, we are implementing these
provisions as proposed.
5. Avoiding Duplicate Payment
We proposed duplicate payment avoidance provisions in §495.208. Section
1853(l)(3)(B) of the Act, as added by the HITECH Act, is entitled “Avoiding Duplication of
Payments.” Subclause (I) of clause (i) of this paragraph of the Act states that to the extent an
MA EP is entitled to the maximum incentive payment under section 1848(o)(1)(A) of the Act,
the Medicare FFS EHR incentive payment program, such incentive payment will only be made
under the Medicare FFS EHR incentive program. Therefore, before payments can be made to
qualifying MA organizations for MA EPs, we must first determine if a maximum incentive
payment under the Medicare FFS program has been previously earned by potential MA EPs.
Under the Medicare FFS incentive payment program, incentive payment calculations will not be
completed for the first payment year, 2011, until the early part of 2012. Therefore, we said we
would not be able to make payments to qualifying MA organizations for MA EPs until claims
submissions counted for Medicare FFS incentive payments for CY 2011 have been closed, and
payment calculations for participating EP under the Medicare FFS EHR incentive program have
been completed. This will occur in the early part of CY 2012. In the MA EHR incentive
payment program we proposed to follow the FFS EHR incentive payment program schedule –
first computing Medicare FFS incentive payments for EPs and then computing and paying MA
EP incentive payments, where appropriate – in all subsequent payment years.
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We went on to explain that subclause (II) of section 1853(l)(3)(B)(i) of the Act further
states that to the extent an MA EP is entitled to less than the maximum incentive payment under
the Medicare FFS EHR incentive program, that payment is to be made solely under the MA
provision. In other words, we will need to withhold Medicare FFS incentive payments from EPs
of less than the maximum to the extent such professionals are also identified as MA EPs under
section 1853(l)(2) of the Act. Again, we would need to await the computation of payments due
EPs under the Medicare FFS EHR incentive program before we can determine whether the EP is
entitled to less than the maximum payment amount under the Medicare FFS EHR program, in
which case any incentive payment for the EP will only be made to the qualifying MA
organization under the MA EHR program, and not to the EP under the Medicare FFS EHR
program.
We also said that section 1853(m)(3)(B) of the Act states that incentive payments for
qualifying MA-affiliated eligible hospitals are to be made under either the Medicare FFS hospital
incentive payment program, or under the MA hospital incentive payment program. If more than
33 percent of discharges or bed-days of all Medicare patients for a year are covered under Part A,
then payment for that year is to only be made under section 1886(n) of the Act – the Medicare
FFS EHR incentive program - and no payment is to be made under the MA hospital incentive
payment program. Otherwise, to the extent less than 33 percent of bed days of all Medicare
patients for an incentive payment year are covered under Part A, then payment for that incentive
payment year may be made under the MA EHR incentive payment program.
Unlike the process we proposed to follow related to qualifying EPs (where we will wait
for the Medicare FFS incentive payment program to compute eligible physician incentive
payments due under that program before determining the amount due under the MA EHR
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incentive program), we would not need to rely on Medicare FFS EHR incentive payment
program calculations before determining eligibility for MA-affiliated hospital incentive
payments. We said we would reimburse all hospitals, including MA-affiliated eligible hospitals,
under the Medicare FFS hospital incentive program. We believe that by doing so, we will
prevent duplicate payments being made for the same hospitals by Medicare FFS and the MA
incentive payment programs. To the extent that qualifying MA organizations are to receive
incentive payments through the MA program rather than through their hospitals under the
Medicare FFS EHR incentive program due to a lack of sufficient data to make payments under
the FFS program, we would identify and reimburse only appropriate qualifying MA
organizations for qualifying MA-affiliated eligible hospitals. Such reimbursement will be in a
manner similar to the manner in which the Medicare FFS EHR incentive program will reimburse
eligible hospitals due an incentive payment under the Medicare FFS EHR incentive program.
Finally, we said that in order to avoid duplicate payments and in accordance with section
1853(m)(3)(B)(ii)(II) of the Act, we will not make MA EHR hospital incentive payments to
qualifying MA organizations for MA-affiliated eligible hospitals other than through the
Medicare FFS EHR hospital incentive payment program without first ensuring that no such
payments under the Medicare FFS EHR hospital incentive payments were made.
We did not receive any comments on these provisions and are finalizing them as
proposed.
6. Meaningful User Attestation
We proposed meaningful user attestation requirements in §495.210. For each MA EP
and MA-affiliated hospital for which a qualified MA organization seeks an incentive payment,
the organization must attest, in a form and manner specified by us, that its MA EPs and
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MA-affiliated eligible hospitals are meaningful EHR users, as required by sections 1853(l)(6)
and 1853(m)(1) of the Act. We further proposed to adopt the definitions of meaningful user
under the Medicare FFS program related to EPs and eligible hospitals in §495.4. We are
requiring qualifying MA organizations to attest each payment year whether each of its MA EPs
and MA-affiliated eligible hospitals for which it is seeking an incentive payment was a
meaningful EHR user for the EHR reporting period for a payment year. A qualifying MA
organization must make this attestation for each payment year for which it is seeking an
incentive payment for MA EPs and MA-affiliated eligible hospitals. We believe attestations
should occur toward the end of a year with respect to that year, since qualifying MA
organizations will need to attest to, based on our proposed rule, meaningful use for the
appropriate duration and during the appropriate period related to MA EPs and MA-affiliated
eligible hospitals before claiming incentive payments for them.
In the proposed rule we said that unlike the Medicare FFS EHR incentive program, where
we will require the reporting of clinical quality measures – see §495.8 – we will not require
qualifying MA organizations to submit clinical quality measures per section 1848(o)(2)(B) of the
Act, with respect to EPs, and section 1886(n)(3)(B) of the Act, with respect to eligible hospitals.
Consistent with sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act, we note that
qualifying MA organizations sponsoring coordinated care MA plans are already required to
submit Healthcare Effectiveness Data and Information Set (HEDIS), Health Outcomes Survey
(HOS), and Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures per
§422.152 and §422.516. Coordinated care MA plans include HMO, PPO and RPPO (Regional
PPO) plans. Beginning with CY 2010, PFFS and MSA plans will also be required to begin
collecting and submitting administrative HEDIS measures.
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We believe that all qualifying MA organizations will be organizations offering MA
coordinated care plans, and therefore; those MA organizations from which we routinely receive
complete HEDIS dataset reporting. Pursuant to sections 1848(o)(2)(B)(iii) and
1886(n)(3)(B)(iii) of the Act, for clinical quality measures which overlap between the existing
MA quality reporting program and under the EHR incentive program, we proposed to allow
qualifying MA organizations to continue reporting under the existing MA quality reporting
program. For those HITECH clinical quality measures that do not overlap and that are
appropriate for the MA program, we are considering requiring that qualifying MA organizations
that receive an incentive payment report those measures to CMS. This would ensure that clinical
quality measure reporting under HITECH is consistent between the FFS program and MA. An
alternative approach would be to require that qualifying MA organizations that receive an
incentive payment report all of the HITECH clinical quality measures under section II.A.2 of this
final rule that are appropriate for the MA program directly to CMS, while also reporting those
HEDIS, HOS, and CAHPS measures under the existing MA quality program. This may result in
duplicative reporting under the HITECH program and current MA quality reporting, but may
provide us with more direct access to quality data under the HITECH program. We invite public
comment on these approaches, including alternative methods to consistently treat MA-affiliated
providers and FFS providers under the HITECH Medicare incentive program.
Comment: The meaningful use criteria make reference to checking eligibility
electronically and submitting claims electronically for 80 percent of patients seen. This would
not be possible for us because, for most of our visits, there is no insurance company with which
to check, and there is no eligibility to submit claims to. We are a capitated system and for most
of the patient visits, the concept of checking eligibility and submitting claims in not relevant.
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Response: This comment points out the difficulty in adopting FFS Medicare meaningful
use measures for qualifying MA organizations, MA-affiliated hospitals and MA EPs. For
purposes of determining meaningful use in a Medicare Advantage environment, we agree that
submitting claims electronically is not a useful standard in a capitated environment where
virtually all patients are members of the same insurance plan.
Comment: One commenter said that given the sensitivity of the data, and the
RHQDAPU program specifications, the commenter believes CMS should never request that
hospitals submit patient-level data to CMS, but that the data submitted should always be at the
aggregated, summary level. The commenter encouraged us to state specifically that this is its
intention in FY 2012 and all future years of EHR incentive program reporting. Some other
commenters said that their health care delivery systems were based on an integrated care delivery
model, where coordination of care is supported through program-wide EHR implementation that
enables a patient’s medical record to be shared among the members of the patient’s care team.
The commenters said they believed patient-centric electronic medical record models that
integrate clinical information across providers align with goals of ONC’s Strategic Plan and
reform efforts that seek to enable more patient-centric integration of care. The commenters said
that during any given reporting period under the EHR incentive payment program, patients may
receive health care services from various providers (for example, the primary care physician, one
or more specialists, nurse practitioners, etc.). The commenters said they had adopted programwide policies and procedures for using their EHR system to promote coordinated delivery of
care. Thus, the commenters said they intended to use their EHR system to support the
functionality and care delivery criteria of meaningful use for all providers across their
organizations. Within their organizations, they said, a single provider is never solely responsible
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for all the information in a given patient’s electronic medical record. In fact, they said, many
providers may access the patient’s electronic record to view or add information, order tests or
medications, review results, etc. They said the shared record makes it extremely difficult to
reliably track all the meaningful use criteria to each EP in their organizations without adding
additional administrative functionality to their systems that would do nothing to improve patient
care. It would be inappropriate and not the intent of the EHR incentive payment program, they
said they believed, to add unnecessary redundancy in care delivery (that is, providers re-entering
correct demographic information to get “credit” for that measure). They said they intended to
participate in the EHR incentive payment program under provisions for Medicare Advantage
organizations. They went on to say that since the proposed rule states, “the qualifying MA
organization must attest to the fact that each MA EP is a meaningful user of certified EHR
technology….,” they believed such attestation can be based on measuring criteria at a MA
organizational level. While they acknowledged that meeting basic eligibility criteria is
appropriate on an individual provider level (that is, the MA EP must meet the same definition for
EP under FFS, satisfy minimum hours per week delivering patient care services, not be hospitalbased, etc.), they said they should be able to meet meaningful use criteria as a MA organization
on behalf of all of their individual EPs, so long as they are able to demonstrate that their EHR
system itself meets the criteria and its use is pervasive and consistent throughout their healthcare
delivery sites. They recommended that where a patient’s electronic medical record is shared
among a team of providers within a MA organization, the meaningful use criteria be measured
on an organizational versus an individual provider level. As an alternative they proposed that for
any provider who treats a given patient, if the criterion is met in that patient’s electronic record,
all EPs who are members of the patient’s care delivery team would receive “credit” for meeting
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that measure.
Response: We agree with the commenters in large part. We believe that continued
reporting by qualifying MA organizations under the HEDIS program is the most appropriate way
to protect personally identifiable patient information. We also believe that in integrated care
delivery systems, it does not make sense to require specific individuals to enter specific data in
order to obtain meaningful user status – especially in a Medicare Advantage environment where
we will require only continued HEDIS reporting as a demonstration of meaningful use. Finally,
we believe that reporting of clinical quality measures at the MA organization level is the most
effective and appropriate means of attaining the ultimate goal of EHR adoption – improved
patient outcomes and reduced healthcare costs.
Comment: Some commenters said that the proposed rule states that, “unlike the
Medicare FFS EHR Incentive Program, where we will require the reporting of clinical quality
measures…we will not require qualifying MA organizations to submit clinical quality
measures…with respect to EPs…and with respect to eligible hospitals….[W]e note that
qualifying MA organizations sponsoring coordinated care plans are already required to submit
Healthcare Effectiveness Data and Information Set (“HEDIS”), Health Outcomes Survey
(“HOS”), and Consumer Assessment of Healthcare Providers and Systems (“CAHPS”)
measures.” The proposed rule suggests allowing MA organizations to continue reporting these
measures, but also considers requiring that MA organizations report those HITECH clinical
quality measures that do not overlap with these currently reported measures “and are appropriate
for the MA program.” We believe this current reporting is both appropriate and sufficient to
measure the clinical quality of MA programs and should be deemed to satisfy the clinical quality
reporting requirements under the EHR incentive payment program. HEDIS, HOS and CAHPS
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reporting are well-established and subject to audit. The measures are specifically chosen to
capture quality within MA organizations, in particular to measure the clinical quality of the team
approach we use to deliver care. While we support consistency across the EHR incentive
payment program, we are concerned that requiring MA organizations to create new mechanisms
for this additional reporting would be unduly burdensome, especially if these additional
measures would have to be reported at the individual provider or patient level. Another
commenter said that their considerable experience with developing responses for new measures
demonstrated how resource and labor intensive clinical quality measurement can be. For
example, the commenter continued, during a recent effort to automate ten TJC (The Joint
Commission) measures, we identified 87 data elements, only 37 of which are captured as discrete
data. Of the remaining 50 measures, some are captured using discrete data in different places in
the EHR, and some are captured using free text (for example, clinical trials and other irregular
exclusion criteria) and will require the creation of new documentation tools. We estimate it will
take one to two years of work for these ten measures to be fully automated, despite our relatively
sophisticated use of data warehousing tools and our high level of automation in the data
management process. The burden is especially heavy when measurement elements are illdefined. Under meaningful use clinical quality reporting, over 120 measures have been
proposed. Of these, 94 would be measures not currently calculated or reported on a routine
basis. We anticipate a considerable increase in workload to create and maintain these measures.
Adding new and duplicate – possibly less reliable – measures and reporting systems will be
costly, time-consuming and may not have an incrementally significant impact on improving
patient care. While we are not opposed to new metrics (those without similar known
specifications), such measures should be field tested prior to becoming requirements; in
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particular, subject to rigorous testing of the electronic specifications. Such measures should also
be supported by robust clinical evidence to show they will impact clinical outcomes. MA
organizations should be deemed to have satisfied all clinical quality reporting required in the
EHR incentive payment program by meeting their current reporting requirements. If additional
measures are required, we recommend staged adoption, beginning with those measures that MA
organizations already report or can report in the near future. We recommend eliminating
measures that have little or no evidence to link them to improved outcomes. Overall, we
strongly recommend that CMS significantly reduce the overall number of clinical quality
measures that would be required for meaningful use.
Response: We agree with the commenters and believe that HEDIS, HOS and CAHPS are
the appropriate means of reporting measures for both MA EPs and MA-affiliated hospitals.
Where appropriate we will consider adding elements to these already existing quality reporting
programs. We will consider adding HEDIS elements over time, as experience and clinical data
warrant.
Comment: One commenter said one of the five priorities specified by CMS is to improve
care coordination. However, the siloed nature of the incentive payments, lack of a robust set of
care coordination measures, and the narrow definition of eligible professionals do not fully
support this priority. The commenter also said that the current structure of the proposed
incentive program, as required by statute, maintains the current siloed structure of Medicare and
Medicaid payments. The selected functionality and quality measures in large part do the same.
However, this siloed structure does not support or encourage integrated coordinated care across
providers and settings. As greater attention is paid to improving care coordination and the
quality of care through integrated care models (for example, accountable care organizations,
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patient-centered medical homes), greater attention should be given to selecting measures that
focus on patient-centered episodes of care. Furthermore, consideration should be given to
refining the incentive payment structure to foster integration and accountability among and
across providers and settings.
Response: We believe that HEDIS reporting and other existing quality reporting
programs (that is, HOS and CAHPS) go a long way toward assuring that coordination and
integration of care will continue to occur in the Medicare Advantage environment. One of the
purposes of EHR adoption is to facilitate the coordination of care in health care environments
where care coordination is not currently perceived to occur. We are asking providers to pick a
program through which they are most likely to be eligible for EHR incentive payments. For MA
organizations that treat Medicare, Medicaid and dually-eligible patients, EHR incentive
payments will be made only under one program (Medicare or Medicaid) with respect to any
specific EP. However care coordination should occur regardless of health insurance or EHR
incentive payer. After consideration of the public comments received we are not changing our
proposed policy to allow qualifying MA organizations to establish meaningful use through
attestation and to demonstrate meaningful use through continued HEDIS reporting.
Finally, we proposed requiring qualifying MA organizations to submit attestations to us
related to meaningful use by MA-affiliated hospitals within 30 days of the close of the FFY –
which is the payment year for MA-affiliated hospitals – by October 30. We also proposed
requiring qualifying MA organization to submit attestations to us related to meaningful use by
MA EPs within 30 days of the close of the MA EP payment year – which is a CY – by
January 30. In this final rule we are modifying the regulation text at §495.210(b) and (c) to be
consistent with the changes to §495.204(b)(2) and §495.202(b)(3), since the deadline for
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attestations of meaningful use should be consistent with deadlines for revenue reporting for MA
EPs, and final identification of MA EPs and MA-affiliated hospitals. We are extending the
timeframe for reporting meaningful use to 60 days after the close of the payment year.
7. Posting Information on the CMS Website
In the proposed rule we said that sections 1853(l)(7) and 1853(m)(5) of the Act require us
to post information on an Internet website related to the receipt of incentive payments under the
MA EHR incentive program. We said posted information would include the names, business
addresses, and business phone numbers of each qualifying MA organization receiving an
incentive payment under this section for qualifying MA EPs and hospitals. A list of the names of
each qualifying MA EP and qualifying MA-affiliated eligible hospital for which an incentive
payment has been made would also be posted. Since this requirement is applicable to other
Medicare EPs and eligible hospitals, we have included this requirement in §495.108.
We did not receive any comments on these provisions and are finalizing them as
proposed.
8. Limitation on Review
In the proposed rule we said that section 1853(l)(8) of the Act states that there shall be no
administrative or judicial review under section 1869 of the Act, section 1878 of the Act, or
otherwise of the methodology and standards for determining payment amounts and payment
adjustments under the MA EHR EP incentive program. We said this includes provisions related
to duplication of payment avoidance and rules developed related to the fixed schedule for
application of limitation on incentive payments for all qualifying MA EPs related to a specific
qualifying MA organization. This also includes the methodology and standards developed for
determining qualifying MA EPs and the methodology and standards for determining a
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meaningful EHR user, including the means of demonstrating meaningful use and the selection of
measures. We proposed to codify these requirements in §495.212(b).
Section 1853(m)(6) of the Act, as added by the HITECH Act, states that there shall be no
administrative or judicial review under section 1869, section 1878, or otherwise of the
methodology and standards for determining payment amounts and payment adjustments under
the MA EHR hospital incentive program. This includes provisions related to duplication of
payment. This also includes the methodology and standards developed for determining
qualifying MA hospitals and the methodology and standards for determining a meaningful EHR
user, including the means of demonstrating meaningful use and the selection of measures. We
proposed to codify these requirements in §495.212(c).
We did not receive any comments on these provisions and are finalizing them as
proposed.
9. Conforming Changes
In the proposed rule we said that sections 4101(e) and 4201(d)(2) and (3) of the HITECH
Act provide conforming amendments to Part C of the Social Security Act. Therefore, we
proposed the following conforming changes to the regulations text:
• Revising §422.304 by adding a new paragraph (f) to account for the amendment to
section 1853(a)(1)(A) of the Act referencing the additional EHR incentive payments that may be
made to qualifying MA organizations in the section of the statute that provides for monthly
capitation payments to MA organizations. (This addition would also act as a cross-reference to
MA EHR incentive payment rules in subpart C of part 495 of this chapter.)
• Revising §422.306(b)(2) by adding a new paragraph (iv) to address the amendments to
section 1853(c)(1)(D)(i) of the Act which exclude the EHR incentive payments made to EPs and
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hospitals under the Medicare FFS program from the computation of FFS costs in a year for the
purpose of computing MA monthly capitation amounts.
• Revising §422.308 by adding a new paragraph (a)(1) to address the amendments to
section 1853(c)(1)(D)(1) and (c)(6)(A) of the Act regarding the exclusion of FFS Medicare EHR
incentive payments and adjustments from the calculation of the national per capita growth
percentage.
• Revising §422.322 by adding a new paragraph (a)(3) to account for the amendments to
section 1853(c)(6)(A) and (f) of the Act specifying that the source of EHR incentive payments to
qualifying MA organizations are from the Federal Hospital Insurance Trust Fund or the
Supplementary Medical Insurance Trust Fund.
• Revising §422.322(b) by adding a reference to §495.204 to address the amendment to
section 1851(i)(1) of the Act that indicates that EHR incentive payments are instead of incentive
payments that would otherwise be payable under original Medicare.
We did not receive any comments on these provisions and are finalizing them as
proposed.
10. Payment Adjustment and Future Rulemaking
In the proposed rule we said that in future rulemaking we will develop standards related
to payment adjustments to qualifying MA organizations related to MA EPs and MA-affiliated
eligible hospitals that are not meaningful users of certified EHR technology. We solicited
comment on how we can most effectively and efficiently apply payment adjustments to
qualifying MA organizations whose MA eligible EPs and hospitals have not successfully
meaningfully used certified EHR technology.
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The statutory requirement related to imposition of payment adjustments with respect to
MA EPs is set forth in section 1853(l) of the Act. Specifically, section 1853(l)(4) of the Act
requires that instead of applying the payment adjustment in section 1848(a)(7) of the Act, we
apply the payment adjustment to the Medicare physician expenditure proportion. This is our
estimate of the proportion of the expenditures under Parts A and B paid to the qualifying MA
organization in the form of capitation payments under section 1853 of the Act that are not
attributable to the EHR incentive payment program, that are attributable to expenditures for
physician services. In the case of a qualifying MA organization that attests that not all MA EPs
of the organization are meaningful EHR users with respect to years beginning with 2015, we are
directed to apply the payment adjustment on the proportion of the capitation payment with
respect to all such EPs of the organization that are not meaningful users for such year. The
adjustment amount is 1 percent for 2015, 2 percent in 2016, and 3 percent in 2017 and
subsequent years.
Comment: Two commenters said that the EHR Incentive Program (the Medicare
component) is limited to providers who bill for Part B covered services under traditional FFS
Medicare or for MA organizations that provide equivalent services to MA beneficiaries. In
addition to incentive payments, the program will impose penalties on providers who do not adopt
technology and meet criteria for meaningful use of electronic health records; those penalties will
be in the form of percentage reductions in Medicare reimbursements, beginning in 2016.
Medicare section 1876 (of the Act) cost contract programs by statute are not eligible for the EHR
Incentive Program. The proposed rule does not expressly state whether physicians paid under a
cost plan will be required to meet meaningful use criteria to avoid the payment adjustments that
will take effect after 2015. CMS should clearly state that those providers who are not eligible to
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participate in the EHR Incentive Program will not be subject to reductions in payment for not
achieving meaningful use, for instance any providers reimbursed under Medicare cost contract
arrangements.
Response: While it is true that current statute applies payment adjustments beginning in
2015 only to FFS and MA providers, it is also true that cost plan providers might provide either
FFS or MA services to which adjustments would apply. So, while it is true that cost plan
payments are unaffected, a blanket statement that cost plan providers are unaffected is not
possible.
The statutory requirement related to imposition of payment adjustments with respect to
MA-affiliated eligible hospitals is provided in section 1853(m) of the Act. Specifically, section
1853(m)(4) of the Act requires us to apply the adjustment to the hospital expenditure proportion,
which is our estimate of the proportion of the expenditures under Parts A and B paid to the
qualifying MA organization in the form of capitation payments under section 1853 of the Act
that are not attributable to the EHR incentive payment program, that are attributable to
expenditures for inpatient hospital services. In the case of a qualifying MA organization that
attests that not all MA-affiliated eligible hospitals of the organization are meaningful EHR users
with respect to years beginning with 2015, we are directed to apply the payment adjustment on
the proportion of all such MA-affiliated eligible hospitals of the organization that are not
meaningful users for such year. The adjustment amount is of three-fourths of the market basket
increase related to a hospital by a 33 1/3 percent reduction in 2015, by a 66 2/3 percent reduction
in 2016, and by a 100 percent reduction in 2017 and all subsequent years. Effectively, the
reduction is of all but 25 percent of the market basket increase for a specific hospital in years
after 2016.
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We received no additional comments.
D. Medicaid Incentives
1. Overview of Health Information Technology in Medicaid
Under the HITECH Act, State Medicaid programs, at their option, may receive Federal
financial participation (FFP) for expenditures for incentive payments to certain Medicaid
providers to adopt, implement, upgrade, and meaningfully use certified EHR technology.
Additionally, FFP is available to States for reasonable administrative expenses related to
administration of those incentive payments as long as the State meets certain conditions. Section
1903(a)(3)(F)(i) of the Act, as amended by section 4201 of the HITECH Act, establishes 100
percent FFP to States for providing incentive payments to eligible Medicaid providers (described
in section 1903(t)(2) of the Act) to adopt, implement, upgrade, and meaningfully use certified
EHR technology. The incentive payments are not direct reimbursement for the purchase and
acquisition of such technology, but rather are intended to serve as incentives for EPs and eligible
hospitals to adopt and meaningfully use certified EHR technology.
Section 1903(a)(3)(F)(ii) of the Act, as amended by section 4201 of the HITECH Act,
also establishes 90 percent FFP to States for administrative expenses related to carrying out the
substantive requirements associated with the incentive payments.
Finally, as required by section 1903(t)(10) of the Act, CMS will be reporting to Congress
on the status, progress, and oversight of the overall EHR incentive program. These reports will
discuss steps taken to avoid duplicate Medicare and Medicaid incentive payments to EPs, the
extent to which Medicaid EPs and hospitals have adopted certified EHR technology as a result of
the incentive payments, and any improvements in health outcomes, clinical quality, or efficiency
resulting from the adoption of such technology.
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Comment: A commenter requested additional discussion in the final rule of the many
challenges that exist to adopting electronic health record technology experienced by the
Medicaid Transformation Grantees.
Response: The primary challenges faced by the Medicaid Transformation Grantees
involved assisting providers to adopt the EHRs and to successfully integrate utilization of the
EHRs into their practice workflow. Workflow redesign is unique to each practice based upon
practice size, clinical specialty area, practice operation (for example, medical home teams or
specialty care) and the providers' hardware and software. In addition, Grantees reported that
providers value the EHRs only in so far as the patient data in the EHR is timely and complete.
Therefore lagging data feeds or gaps in data from certain sources, such as labs or Part D claims
for dual eligibles, were observed to discourage providers from investing their time and effort into
learning how to use the EHRs. Many Grantees noted that early negative experiences with
workflow or with timely and accurate access to relevant data discouraged providers from using
the system. They reported needing to dedicate significant time and resources to provider
outreach, technical assistance and training. Some Grantees focused on identifying or developing
the right EHR product only to conclude afterwards that their focus needed to be equally, if not
more, on supporting their providers’ use of the EHR, including fostering health information
exchange through interface development. In summary, the Medicaid Transformation Grantees
affirmed that the barriers faced by Medicaid providers to EHR adoption and use were not unique
to Medicaid. There were several challenges to HIT/EHR implementation that were specific to
Medicaid programs that may be useful for States in light of HITECH. These include, integration
of HIT into the State Medicaid Management Information System (MMIS); churning of Medicaid
patients on/off Medicaid eligibility; issues of consent with patients with diminished capacity,
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children and their parents and caregivers, and foster children/wards of the State; costs associated
with transaction fees for pharmacy hubs on a statewide scale; and how to calculate return on
investment and quality outcomes as a result of HIT programs that are running concurrent with
other quality initiatives with the same goals, such as the medical home model, disease
management/care coordination and provider pay-for-performance.
While this information is valuable in terms of understanding and addressing the
challenges to EHR adoption, we continue to believe that the benefits of meaningful use of EHRs
far outweigh the implementation challenges.
2. General Medicaid Provisions
In §495.320 and §495.322 we provide the general rule that States, at their option, may
receive: (1) 90 percent FFP for State expenditures related to the administration of an EHR
incentive program for certain Medicaid providers that are adopting, implementing, or upgrading
and meaningfully using certified EHR technology; and (2) 100 percent FFP for State
expenditures for those incentive payments.
We did not receive any comments and we are finalizing these provisions as proposed.
3. Identification of Qualifying Medicaid EPs and Eligible Hospitals
a. Overview
As specified in section 1903(t)(2) of the Act, only certain Medicaid providers will be
eligible for incentive payments. This section discusses some of these eligibility requirements,
including requirements relating to patient volume, whether a provider is hospital-based, and
whether an EP is practicing predominantly in a federally-qualified health center (FQHC) or a
rural health clinic (RHC). Regulations relating to these requirements may be found at §495.304
through §495.306.
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b. Program Participation
As specified under section 1903(t)(2)(A) of the Act, Medicaid participating providers
who wish to receive a Medicaid incentive payment must meet the definition of a “Medicaid EP.”
This definition (1903(t)(3)(B) of the Act) lists five types of Medicaid professionals: physicians,
dentists, certified nurse-midwives, nurse practitioners, and physician assistants practicing in an
FQHC or RHC that is so led by a physician assistant.
Additionally, to qualify for incentives, most Medicaid EPs cannot be “hospital-based.”
We will use the same definition of “hospital-based” as used in the Medicare EHR incentive
program, as sections 1848(o)(1)(C) and 1903(t)(3)(D) of the Act use almost identical definitions
of the term. We refer readers to section II.A. for a definition of “hospital-based,” and for a
thorough discussion of our methodology.
The only exception to this rule is that Medicaid EPs practicing predominantly in an
FQHC or RHC are not subject to the hospital-based exclusion.
Medicaid EPs must also meet the other criteria for Medicaid incentive payment
eligibility, such as the patient volume thresholds or practicing predominantly in an FQHC or
RHC, as described in this subpart. Since the statute at 1903(t)(2)(A)(iii) of the Act does not
define “practices predominantly,” we specify that an EP practices predominantly at an FQHC or
an RHC when the clinical location for over 50 percent of his or her total patient encounters over
a period of 6 months occurs at an FQHC or RHC.
Acute care and children's hospitals are listed in section 1903(t)(2) of the Act as the only
two types of institutional providers potentially eligible for Medicaid incentive payments. These
terms are specific to the Medicaid EHR incentive program and are not currently defined in the
Medicaid regulations. Consequently, we define these terms in §495.302.
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As specified under section 1903(t)(2)(B) of the Act, to qualify for incentive payments
acute care hospitals also must meet patient volume threshold requirements, as specified in
§495.306. Children's hospitals do not have patient volume requirements for Medicaid incentive
program participation.
Comment: Commenters expressed confusion about the restrictions on physician
assistants' (PAs) participation. Numerous commenters suggested that PAs should be eligible
without conditions, particularly the condition that they are practicing in an FQHC or RHC that is
"so led by a physician assistant" and/or CMS should exercise flexibility in