Medicare Part B Enteral Nutrition Reimbursement Manual

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Medicare Part B
Enteral Nutrition
Diana Bowers, PhD, RD, CPC-H
This manual is intended as a guide to Medicare enteral nutrition claims. Medicare is a federal
health insurance program in the United States for people age 65 years or older, some disabled
people under age 65, and people of all ages with permanent kidney failure. Medicare Part A
provides hospital insurance, and Medicare Part B provides medical insurance (see page 2).
Enteral nutrition costs for qualified Medicare beneficiaries may be reimbursed under Part B.
For specific questions, you may call the Abbott Nutrition Helpline, 1-800-558-7677, or log on
to under “Medicare, Medicaid and Private Insurance.”
Information contained in this manual is taken from a variety of sources including but not limited
to official published government documents. The editor, publisher, and distributor of this manual
assume no responsibility for changes in Medicare guidelines or interpretation by Medicare
carriers. Information in this manual in no way implies acceptance of any individual claim by
Medicare and/or its carriers. Each health care supplier is ultimately responsible for verifying
codes, coverage, and payment policies used for individual patient claims to ensure they are
accurate and appropriate for the services and items provided.
©2000-2011 Abbott Nutrition, Abbott Laboratories, Inc.
  TOC
Payment Sources for Enteral Nutrition for Medicare Beneficiaries..................................... 2
Medicare Part A..................................................................................................................................................2
Medicare Part B..................................................................................................................................................2
Managed Care, HMO, or VA Patients...............................................................................................................3
Third-Party Insurance........................................................................................................................................3
Direct Patient Payment . ...................................................................................................................................3
Medicare..................................................................................................................................... 4
Medicare Carriers and DME MACs...................................................................................................................4
Jurisdiction of DME MACs................................................................................................................................5
General Information for Billing Enteral Therapy............................................................................................6
Enteral Nutrition Coverage Requirements.............................................................................. 8
Permanence of the Condition.............................................................................................................................8
International Classification of Diseases, 10th Revision, Clinical Modification...............................................9
Functional Impairment of the Gastrointestinal Tract....................................................................................10
Enteral Feeding Pumps....................................................................................................................................11
General Purpose and Calorically Dense Enteral Formulas...........................................................................11
Specialized Enteral Formulas..........................................................................................................................11
Other HCPCS Codes Rarely Used for Medicare Claims.................................................................................12
Tube Usage........................................................................................................................................................13
Medicare Coverage Principles..........................................................................................................................14
Billing Requirements............................................................................................................... 15
How To Become a Medicare Supplier....................................................................................................................15
1. Authorization and Release...........................................................................................................................16
2. Advance Beneficiary Notice of Noncoverage (ABN) . .................................................................................18
3. DME Information Forms (DIF)....................................................................................................................19
4. CMS-1500 Form............................................................................................................................................23
5. Filing Claims Electronically.........................................................................................................................23
6. Physician National Provider Identifier (NPI) Directory.............................................................................24
Pump Billing Information................................................................................................................................24
Proof-of-Delivery Requirements.......................................................................................................................27
How To Appeal Medicare Claims Decisions......................................................................... 29
First Appeal: Redetermination .......................................................................................................................31
Second Appeal: Reconsideration by Qualified Independent Contractors (QIC)............................................33
Third Appeal: Administrative Law Judge (ALJ) Hearing..............................................................................33
Fourth Appeal: Departmental Appeals Board (DAB) Review.......................................................................35
Final Appeal: Federal Court Review ..............................................................................................................36
Corrected Claims.................................................................................................................... 38
Fraud and Abuse..................................................................................................................... 39
Program Safeguard Contractors (PSCs) and Zone Program Integrity Contractors (ZPICs)........................39
Supplier Standards...........................................................................................................................................40
Competitive Bidding.........................................................................................................................................42
Quality Standards and Accreditation..............................................................................................................43
Office of Inspector General’s Compliance Guidance ......................................................................................43
Audit Process....................................................................................................................................................45
Glossary................................................................................................................................... 50
  TOC
Payment Sources for Enteral Nutrition for
Medicare Beneficiaries
Medicare Part A (Hospital Insurance)
Medicare Part A helps cover costs of
hospital inpatient stays, post-hospital
extended care in skilled nursing facilities
(SNFs), and post-hospital care furnished by
a home health agency in the patient’s home.
Program payments for services rendered to
beneficiaries by providers (i.e., hospitals,
SNFs, and home health agencies) are
generally made to the provider. The cost of
the insurance includes an annual deductible
along with monthly premiums. The monthly
premiums are usually deducted from the
individual’s monthly Social Security check.
Hospices also provide Part A hospital
insurance services such as short-term
inpatient care. In order to be eligible to elect
hospice care under Medicare, an individual
must be entitled to Part A of Medicare
and be certified as being terminally ill. An
individual is considered to be terminally ill
if the individual has a medical prognosis
that his or her life expectancy is 6 months
or less if the illness runs its normal course.
Medicare Part B
Each beneficiary must pay an annual
deductible expense before a benefit
payment can be made. Expenses are based
on Medicare-allowed amounts and allocated
to the deductible in the order in which the
bills are received by Medicare. After the
deductible has been satisfied, Medicare
Part B pays 80% of allowable charges
for physician services, durable medical
equipment (DME), parenteral and enteral
nutrition, and other medical services
such as speech and physical therapy. The
remaining 20% of the allowed amount is
the responsibility of the beneficiary and is
referred to as “coinsurance.” Suppliers are
required to bill the coinsurance. Failure
to do so could result in fines and penalties
being imposed on the supplier (see the
Fraud and Abuse section of this publication
on page 43). Patients may purchase private
insurance policies (“Medigap”) to cover
coinsurance and deductible amounts not
covered by Medicare.
Tube-fed residents of Skilled Nursing
Facilities will have enteral nutrition
covered during the initial 100 days of the
stay by Medicare Part A’s facility payment.
Part B coverage can begin for eligible
patients after the patient’s Part A benefit
is completed.
Enteral nutrition benefits are covered
under Medicare Part B, also known as
Supplementary Medical Insurance or SMI.
Part B coverage may be purchased with or
without accompanying Part A coverage.
The cost of the insurance is usually
deducted from the individual’s monthly
Social Security check. If the beneficiary
is not enrolled in Part B, he/she does not
have coverage for enteral nutrition in the
home setting or beyond a Part A skilled care
nursing home stay.
  TOC
Managed Care, HMO, or VA Patients
Direct Patient Payment
If the facility or home care agency has
negotiated a contract with a managed care
organization, an HMO, or the Veterans
Administration, the cost of enteral
nutritional therapy may be included in the
negotiated price. If the contract does not
include nutritional therapy, the provider
can bill the managed care, HMO, or VA
organizations for enteral formulas and
supplies. However, payment rates and
coverage policies vary by payer.
Patients may pay directly for enteral
nutrition care if other insurance sources
are not available.
Third-Party Insurance
An increasing number of patients have
private insurance that covers enteral
nutrition expenses. Other private
insurance policies called “Medigap” policies
are designed to cover coinsurance and
deductible expenses not fully reimbursed by
Medicaid is a federal-state program enacted
in 1965. Medicaid provides health insurance
for people who are poor, blind, or have a
disability. Funds come from the federal
government and state tax revenues.
In nearly all states, Medicaid has coverage
policies for residents of nursing facilities
who are not under a Medicare Part A
skilled benefit period. People who do not
have Part B coverage may have enteral
nutrition coverage under the state Medicaid
daily rate payment system if they are
eligible. Policies and payment rates vary by
state. Consult your state Medicaid carrier
for more details.
  TOC
Medicare is a federal health insurance
program for people who are:
• 65 years of age or older
• some disabled people under age 65
• under 65 with permanent
kidney failure
Medicare eligibility is determined by the
Social Security Administration and is
administered by the Centers for Medicare
and Medicaid Services (CMS). An individual
may become entitled through Social
Security based on his or her own earnings
or those of a spouse, parent, or child.
Medicare Carriers and DME MACs
Medicare does not process claims for
covered services itself. Claims are processed
by independent insurers who have contracts
with CMS to pay claims and administer
the Medicare program subject to national
Medicare guidelines and regulations.
There are two basic types of contractors
for Medicare Part B: 1) Carriers and 2)
Durable Medical Equipment Medicare
Administrative Contractors (DME MACs).
Carriers process claims for physician
services, outpatient care, laboratory
services, ambulance services, radiology
services, and certain medications. DME
MACs process Part B claims for durable
medical equipment, prosthetics, orthotics
and supplies (DMEPOS).
Enteral therapy is classified as a prosthetic
benefit that is payable as DMEPOS,
therefore, enteral nutrition claims
fall under the jurisdiction of the four
Jurisdictional DME MACs. One of the main
goals of DME MAC regionalization is the
application of more uniform pricing and
coverage criteria to all DME claims. The
Centers for Medicare and Medicaid Services
also closely monitor DMEPOS payment
criteria to control potential fraud and abuse.
Claims are filed to one of the four DME
MACs based on the permanent residence
(defined as the address to which the Social
Security check is mailed) of the beneficiary.
The following page provides information
about which states are covered by each
of the DME MACs. Again, claims-filing
jurisdiction is based upon beneficiary
residence, not on supplier location.
  TOC
Jurisdiction of DME MACs
Claims jurisdiction is determined by the state in which the beneficiary permanently resides.
Connecticut, Delaware, District
of Columbia, Maine, Maryland,
Massachusetts, New Hampshire,
New Jersey, New York, Pennsylvania,
Rhode Island, and Vermont
National Heritage Insurance Company
DME-Written Inquiries
P.O. Box 9146
Hingham, MA 02043-9146
(866) 590-6731
Illinois, Indiana, Kentucky, Michigan,
Minnesota, Ohio, and Wisconsin
National Government Services, Inc.
P.O. Box 6036
Indianapolis, IN 46206-6036
(866) 590-6727
Alabama, Arkansas, Colorado, Florida,
Georgia, Louisiana, Mississippi, New
Mexico, North Carolina, Oklahoma,
Puerto Rico, South Carolina,
Tennessee, Texas, Virgin Islands,
Virginia, and West Virginia
Alaska, American Samoa, Arizona,
California, Guam, Hawaii, Idaho,
Iowa, Kansas, Missouri, Montana,
Nebraska, Nevada, North Dakota,
Northern Mariana Islands, Oregon,
South Dakota, Utah, Washington,
and Wyoming
CIGNA Government Services
P.O. Box 20010
Nashville, TN 37202
(866) 270-4909
Noridian Administrative Services (NAS)
P.O. Box 6727
Fargo, ND 58108-6727
(866) 243-7272
  TOC
Durable Medical Equipment
Medicare Administrative Contractors (DME MACs)
Noridian Administrative Services
CIGNA Government Services
National Government Services
General Information for Billing Enteral Therapy
1. To be eligible to receive Medicare
payment for covered services provided
to Medicare beneficiaries, DMEPOS
providers must enroll in the Medicare
Program by submitting the Medicare
enrollment application (form CMS-855S)
to the National Supplier Clearinghouse
(NSC). An enrollment application may be
obtained by downloading form CMS-855S
from the CMS website:
cmsforms/downloads/cms855s.pdf. New
applicants must include a National
Provider Identifier (NPI) number on
the CMS 855S enrollment application.
NPI applications are available online at or by calling
the Enumerator at (800) 465-3203 or
TTY (800) 692-2326.
In lieu of the Medicare paper enrollment
application, providers may enroll in
the Medicare program via the Internetbased Provider, Enrollment, Chain
and Ownership System (PECOS).
Information on this method of enrollment
may be found at https://www.cms.
Enrollment data for all active DMEPOS
suppliers will eventually be moved from
the enrollment system at the National
Supplier Clearinghouse to the online
PECOS system.
2. A
ll DMEPOS suppliers must obtain
accreditation through a CMSdeemed accreditation organization.
Further information on the DMEPOS
accreditation requirements can be found
at the CMS website: http://www.cms.
  TOC
3. Some DMEPOS suppliers are required
to obtain and submit a surety bond
on a continuing basis of not less than
$50,000 for each practice location (NPI
number). Additional information about
Surety Bond requirements, including a
list of DMEPOS suppliers exempt from
the bonding requirements, can be found
at the CMS website: http://www.cms.
4. Enteral nutrition providers should
frequently review patients receiving
enteral nutrition to determine whether
they continue to meet Medicare
eligibility and coverage requirements
for reimbursement on pages 8-14.
5. For qualified patients, claims are
typically submitted monthly to the
appropriate DME MAC for processing.
Retrospective billing is recommended
since billing must be for actual days
patients used supplies during a month.
Retrospective billing reduces the need
for claim adjustments based on hospital
admission or other interruption of
6. Normally, two to five procedure codes are
needed for billing each month of enteral
therapy. Procedure codes are assigned to
enteral items or groups of items supplied
to a patient. These codes are referred
to as HCPCS codes and are linked to
Medicare-allowed payment amounts.
Separate codes are required for billing
the following:
• Enteral nutritional formula(s)
• Supply kits (pump, gravity, or syringe),
including all supplies needed to
administer enteral therapy
• Feeding tubes (nasogastric,
gastrostomy, or jejunostomy)
7. Unless a supplier meets specific
exception criteria for paper claim
submission, claims must be submitted
electronically via the HIPAA compliant
ASC X12N 837 format, Version 4010.
The transition to the Version 5010
format is currently underway, and must
be in place for all electronic claims by
January 1, 2012. More information
on the Version 5010 format and
transition may be found at https://www.
Electronic claim submissions must also
include a DME Information Form (DIF)
completed and signed by the supplier.
(See details concerning DIFs on pages
8. Fees have been set by Medicare for
reimbursement of enteral therapy. You
can access HCPCS codes and fees in
effect by date of service from the Durable
Medical Equipment Coding System
(DMECS) available online at https://
You may download (unzip) DMEPOS
fee schedules from the CMS website,
accessed from DME MACs websites
listed on page 5.
9. Enteral nutrition formula is billed in
“units.” A unit is defined as 100 Calories.
• Calculation of units:
Cal per day÷100 = units per day
• e.g., 6 cans/day x 250 Cal/can =
1500 Cal/day ÷100 = 15 units/day
• 15 units per day x 30 days per month =
450 units per month
10. C
oinsurance and deductibles must be
billed to appropriate payers. Routine
waiver of coinsurance is considered
Medicare abuse and can result in fines
and penalties.
• Enteral feeding pump (rental or
• IV pole
  TOC
Enteral Nutrition Coverage Requirements
Medicare considers enteral nutritional
therapy as a prosthetic device benefit.
This benefit pays for prosthetic devices
that replace missing, inoperable, or
malfunctioning body organs. In the case of
enteral nutritional therapy, the prosthetic
device is the nasogastric, gastrostomy, or
jejunostomy tube. Accordingly, to qualify
for Medicare coverage, enteral nutritional
therapy must be given via an enteral
feeding tube. Medicare does not cover oral
nutritional supplements.
In addition to having the feeding
administered via a feeding tube, the patient
must also have permanent nonfunction
or disease of the structures that normally
permit food to reach the small bowel, or
a disease of the small bowel that impairs
digestion and/or absorption of an oral
diet. Either condition must necessitate
reliance on enteral nutritional therapy to
provide sufficient nutrients to maintain
the patient’s weight and strength
commensurate with his or her overall
health status. The patient’s medical record
must identify and document this physiologic
need for therapy, and the following two
basic criteria must be met:
1. A diagnosed functional impairment
of the gastrointestinal (GI) tract
necessitating enteral feeding, and
2. Permanence of that condition
necessitating enteral feeding.
enteral formulas consisting of semisynthetic intact protein or protein
isolates with a caloric density of 1.0 to
2.0 Cal/mL.
When the above coverage requirements
are met, medically necessary supplies,
equipment, and nutrients may be
reimbursed for beneficiaries enrolled in
Medicare Part B. The beneficiary must
be enrolled in Medicare Part B to receive
enteral nutritional therapy coverage.
Medicare does not reimburse professional
services used to administer or monitor
enteral nutritional therapy.
Permanence of the Condition
A condition is deemed permanent if, in
the judgment of the attending physician
and substantiated in the medical record,
the condition is of long and indefinite
duration—ordinarily, but not limited to, at
least 3 months. If the physician believed
the condition would last at least 90 days,
but the actual time the patient required
tube feeding was less than 90 days, the
therapy may still be covered if proper
documentation was made in the medical
record. Enteral nutritional therapy is not
covered in situations involving temporary
conditions or impairments.
Additional documentation is required if:
• The feeding is administered via an
enteral feeding pump, and/or
• The formula is other than one
classified as HCPCS B4150 or
B4152 — nutritionally complete
For a patient to qualify for enteral therapy
reimbursement, he or she must have a
diagnosis that directly contributes to the
nonfunctioning of part of the digestive tract.
Claims submitted for enteral nutrition will
be paid or reimbursed by Medicare only if
  TOC
the therapy is covered, reasonable, and
necessary to treat the particular patient,
given his or her clinical condition. Medical
necessity is determined on a case-by-case
basis. While there is no single authoritative
list of acceptable diagnoses, enteral
nutrition is likely to be considered medically
necessary and therefore appropriate if
ordered for patients with the conditions
listed below. For patients who may qualify
due to a swallowing disorder, an assessment
by a speech therapist and/or a radiographic
swallowing study to document the condition
is strongly recommended.
Generally accepted diagnoses, when
associated with a functional impairment of
the gastrointestinal tract:
• Alzheimer’s disease
• Amyotrophic lateral sclerosis
• Aneurysm
• Anoxic encephalopathy
• Bowel infarction
• Cancer of any part of the upper GI
• Cancer of the brain
• Cerebral palsy
• Cerebrovascular accident (CVA)
• CVA history with residual effects
• Cerebrovascular insufficiency
• Closed head injury
• Comatose
• Degenerative brain disease
• Duodenal obstruction (J tube only)
• Encephalopathy
• Esophageal obstruction
• Esophageal paralysis
• Esophageal perforation
• Gastrectomy—total or partial
(J tube only)
• Gastric outlet obstruction (J tube only)
• Gastrointestinal fistula
• Gastrointestinal hemorrhage
• Guillain-Barré syndrome
• Hepatic encephalopathy
• Multi-infarct dementia
• Multiple sclerosis
• Organic brain syndrome
• Parkinson’s disease
• Quadriparesis
• Senile dementia
Diagnoses are currently classified by the
ICD-9-CM diagnosis codes in International
Classification of Diseases, 9th Revision,
Clinical Modification (ICD-9-CM). Books
containing the codes can be obtained from
many publishers and from the Supervisor
of Documents at the Government Printing
Office. ICD-9-CM codes are required on
paper or electronic CMS-1500 claims as
well as on the DME Information Forms
(DIF) for enteral and parenteral nutrition.
Up to four diagnoses pertaining to the
patient’s enteral nutrition claim may be
placed on the claim and DIFs. Diagnosis
codes entered on claims and referenced on
individual claim lines must be valid for the
date of service on the claim and must be
reported to the highest level of specificity
(three, four, or five digits) for that category
of codes.
International Classification of
Diseases, 10th Revision, Clinical
Modification (ICD-10-CM)
The compliance date for implementation of
the International Classification of Diseases,
10th Edition, Clinical Modification (ICD10-CM) is October 1, 2013 for all covered
entities. The ICD-10-CM diagnosis codes
are three to seven digits in length and
incorporate both alpha and numeric
characters, providing much greater
clinical detail and specificity than ICD9-CM. The HIPAA electronic transaction
Version 5010 accommodates the ICD-10
codes, and therefore must be in place first
before the changeover to ICD-10. For more
information concerning the transition to
ICD-10-CM, visit
  TOC
Functional Impairment of the
Gastrointestinal Tract
To meet this coverage requirement, a
patient’s condition may result from an
anatomic abnormality, a motility disorder,
or a disease of the small bowel that impairs
digestion and absorption of an oral diet.
The functional impairment must be severe
enough that adequate oral nutrition
cannot be achieved by dietary adjustment
(e.g., puréed foods and/or oral nutritional
supplements). In policy articles that support
Local Coverage Determinations (LCDs) for
enteral nutrition, the DME MACs indicate
that coverage is possible for patients with
partial impairments (e.g., a patient with
dysphagia who can swallow small amounts
of food, or a patient with Crohn’s disease
who requires prolonged infusion of enteral
nutrients to overcome a problem with
absorption). In all cases, however, the
tube feeding must be the primary source
of nutrition.
Important: Enteral nutritional therapy
coverage is for patients who cannot
swallow and/or digest and absorb adequate
nutrition. Therapy is not covered for
patients who refuse to consume adequate
oral nutrition due to anorexia, nausea,
depression, etc, or who have no GI
functional impairment.
Dysphagia resulting from muscular
When muscular paralysis occurs, the
patient is unable to swallow because the
damaged brain or spinal cord can no longer
signal the muscles of the alimentary tract to
function. Paralysis can occur as a result of
many diseases and disorders, including:
• CVA (cerebrovascular accident,
infarction, or “stroke”)—when certain
parts of the brain are deprived of
blood/oxygen, paralysis, loss of gag
reflex, and other disorders can occur.
• Anoxia—paralysis is caused by lack
of oxygen to the brain (e.g., following
cardiac or respiratory arrest).
• Spinal cord injury—an injury high
on the spine can affect the portion of
the neurologic system that controls
• Birth defects, cerebral palsy.
• Parkinson’s disease.
• Amyotrophic lateral sclerosis,
multiple sclerosis, myasthenia gravis,
Huntington’s chorea—the patient’s
brain and muscles cease to function,
causing a loss of the ability to swallow.
Dysphagia resulting from cognitive
neurologic disorders
Cognitive neurologic disorders are disease
processes that cause the patient to forget
how to swallow. Some diseases that
may create a functional impairment of a
patient’s capacity to swallow include:
• Senile dementia, Alzheimer’s
disease, organic brain syndrome—
the patient is in the end stages of
mental deterioration and no longer
understands what food is or
how to swallow.
Patients with a cognitive/neurologic
disease usually have medical record
documentation that supports a dysfunction
of the swallowing mechanism. Swallowing
assessments or evaluations are recommended.
Mechanical dysfunction of the GI tract
Esophageal obstruction, cancer of the
larynx or tongue, esophageal stricture, and
gastroparesis are examples of anatomic
impairments that physically limit or
prevent the passage of oral nutrients
into the small bowel. Gastrostomy or
jejunostomy feeding tubes are typically
placed in these patients.
• Trauma/Accident—muscular paralysis
can occur as a result of traumatic
  TOC
Enteral Feeding Pumps
Enteral feeding pump supplies (B4035,
B9000-B9002 and E0776) will be paid by
Medicare only if the pump is medically
necessary to administer the feeding. There
must be documentation in the medical
record to justify the use of a feeding pump.
Medical necessity is determined on a caseby-case basis. While there is no single
authoritative list of acceptable diagnoses,
pump feeding is likely to be considered
medically necessary if ordered for patients
with the following conditions:
• Severe diarrhea
• History or risk of aspiration
• Severe reflux/vomiting
• Regurgitation/aspiration
• Dumping syndrome
• Unstable diabetes mellitus
• Circulatory overload secondary to
renal failure or congestive heart
failure (fluid-restricted patients)
• Documented medical condition that
requires flow rate less than 100 mL/hr
• Jejunal tube feeding
Pump administration must be indicated in
box 5 of the DIF. If the medical necessity for
the pump is not documented in the patient’s
medical record, payment for the pump and
the pump supply kit will be denied as not
medically necessary.
General Purpose and
Calorically Dense Enteral Formulas
enteral nutrition. General purpose formulas
providing 1.0 to 1.2 Cal/mL are categorized
under the Medicare B4150 code. Their use
does not require any additional written
justification by the physician or the supplier
for reimbursement. Examples of B4150
general purpose formulas include Ensure®,
Ensure® Bone Health, Ensure® High
Protein, Ensure® Muscle Health, Ensure®
Immune Health, Ensure® Powder, Jevity®
1.0 Cal, Jevity® 1.2 Cal, Osmolite® 1 Cal,
Osmolite® 1.2 Cal, Promote®, and Promote®
With Fiber.
Nutritionally complete, calorically dense
formulas with semi-synthetic intact protein
or protein isolates provide 1.5 to 2.0 Cal/mL
and are categorized as HCPCS B4152. They
are typically prescribed for patients who
may need to limit their overall fluid intake
or increase caloric intake, and, if deemed
medically necessary, are also reimbursed
without additional medical justification.
Examples of calorically dense formulas
include Ensure Plus®, Ensure® Clinical
Strength, Hi Cal, Jevity® 1.5 Cal, Osmolite®
1.5 Cal, and TwoCal® HN.
Specialized Enteral Formulas
The remaining Medicare categories
for adult enteral formulas (B4149 and
B4153-B4155) require written justification
of their medical necessity before they
will be covered. This justification must
be maintained in the patient’s medical
record. If the medical necessity for specialty
nutrients is not met, the formula will be
denied as not reasonable and necessary.
Medicare does not cover foods that are or
can be blenderized and given via an enteral
feeding tube.
General purpose and calorically dense
formulas are nutritionally complete with
semi-synthetic intact protein or protein
isolates (B4150 and B4152). Medicare
considers these formulas appropriate
for the majority of patients who require
  TOC
B4149 —Blenderized Natural Foods .
With Intact Nutrients
These formulas contain natural intact protein
or protein isolates. They are appropriate
for patients with a documented allergy or
intolerance to semi-synthetic formulas.
B4153 —Hydrolyzed Protein/Amino Acids
These formulas contain combinations of
partially and fully hydrolyzed protein
and are typically used for patients whose
functional coverage qualifier is a disease of
the bowel that impairs nutrient digestion
and absorption. Examples of these
formulas include Optimental®, Perative®,
Pivot® 1.5 Cal, Vital® 1.0 Cal, Vital® 1.5 Cal,
Vital AF 1.2 Cal™, and Vital® HN.
Other HCPCS Codes Rarely Used
for Medicare Claims
HCPCS codes B4102 (hydration formulas
for adults) and B4103 (pediatric hydration
formulas) are not covered by Medicare.
The following six additional codes describe
pediatric formulas that are rarely used by
Medicare patients:
B4157 Nutritionally Complete Formulas
for Inherited Diseases of Metabolism
B4158 Pediatric General Purpose
B4159 Pediatric Soy-Based Formulas
B4154 —Defined Formula for Specialized
Non Inherited Metabolic Need
These formulas are designed to provide
defined nutrients for specific disease
states. Examples of these formulas
include Glucerna® 1.0 Cal, Glucerna®
1.2 Cal, Glucerna® 1.5 Cal, Nepro® with
Carb Steady™, Oxepa®, Pulmocare®, and
Suplena® with Carb Steady™. The diagnosis
code supporting the need for the B4154
formula should be included on the CMS1500 claim and DIF.
B4160 Pediatric Calorically Dense
B4155 —Modular Nutrients
This category includes modular formula
nutrients that are added to an existing
formula. These components are designed
to supply additional nutrition in the form
of carbohydrate or protein. Examples are
Juven®, Polycose®, and ProMod® Liquid
1. Documenting the diagnosis that
supports the need for specific nutritional
requirements that cannot be effectively
satisfied by general purpose formulas.
This diagnosis needs to be recorded in
the electronic claim to the highest level
of specificity and on the DIF.
B4161 Pediatric Enteral Formulas With
Hydrolyzed Proteins
B4162 Pediatric Formulas for Special
Metabolic Needs of Inherited Diseases of
Documentation of specialized enteral
formulas requires two steps:
2. Maintaining additional medical record
documentation in the patient’s record
to support the medical necessity of the
defined formula (B4154).
  TOC
Tube Usage
Medicare allows for payment of one
gastrostomy tube or three nasogastric tubes
every 90 days. If additional tubes are used
for a Medicare beneficiary, the supplier
must provide documentation to support the
medical necessity of the extra usage. The
most common reasons for more frequent
tube replacement are that the tube became
clogged or was accidentally dislodged or
removed. Medical necessity documentation
for replacement of a clogged tube includes
explanations of what was done to prevent
the tube from clogging and what was done
to attempt to restore the tube patency
before it was replaced. Medical necessity for
replacement of dislodged or inadvertently
removed feeding tubes includes
documentation of what was done to secure
the tube or to prevent the tube’s removal.
The documentation must be patient-specific
and must provide a convincing reason
for replacement of the feeding tube more
frequently than Medicare generally allows.
References to “facility policy” are generally
not convincing. Payment for frequently
replaced tubes may require individual case
review via the Medicare appeals process.
  TOC
Medicare Coverage Principles
The following statements may help describe
a patient’s need for enteral nutrition and
may be included in communications with
DME MACs about specific patient claims.
The Medicare National Coverage
Determinations (NCD) Manual
(PUB. 100-03 Chapter 1 Coverage
Determinations § 180.2; http://www.cms.
pdf) states:
Enteral nutritional therapy is covered for
those patients “who, because of chronic
illness or trauma, cannot be sustained
through oral feeding….”
“Coverage of nutritional therapy as a Part
B benefit is provided under the prosthetic
device benefit provision which requires
that the patient must have a permanently
inoperative internal body organ or function
thereof. Therefore, enteral and parenteral
nutritional therapy is not covered under
Part B in situations involving temporary
“Typical examples of conditions that would
qualify for coverage are head and neck
cancer with reconstructive surgery and
central nervous system disease leading
to interference with the neuromuscular
mechanisms of ingestion of such severity
that the beneficiary cannot be maintained
with oral feeding….”
“If the claim involves a pump, it must
be supported by sufficient medical
documentation to establish that the pump is
medically necessary, i.e., gravity feeding is
not satisfactory due to aspiration, diarrhea,
dumping syndrome. Program payment for
the pump is based on the reasonable charge
for the simplest model that meets the
medical needs of the patient as established
by medical documentation.”
“Coverage of such therapy, however, does
not require a medical judgment that the
impairment giving rise to the therapy will
persist throughout the patient’s remaining
years. If the medical record, including
the judgment of the attending physician,
indicates that the impairment will be of
long and indefinite duration, the test of
permanence will be considered met.”
Enteral Nutrition Therapy.
“Enteral nutrition is considered reasonable
and necessary for a patient with a
functioning gastrointestinal tract who,
due to pathology to, or nonfunction of, the
structures that normally permit food to
reach the digestive tract, cannot maintain
weight and strength commensurate with his
or her general condition….”
  TOC
Billing Requirements
How To Become a Medicare Supplier
To be eligible to receive Medicare payment
for covered services provided to Medicare
beneficiaries, DMEPOS providers must
enroll in the Medicare Program either
by submitting the Medicare enrollment
paper application (form CMS-855S) to the
National Supplier Clearinghouse (NSC),
or by enrolling online via the Internetbased Provider, Enrollment, Chain and
Ownership System (PECOS).
The paper enrollment application may
be downloaded from http://www.cms.
Information regarding PECOS online
enrollment may be found at https://www.
Enrollment data for all active DMEPOS
suppliers will eventually be moved from the
enrollment system at the National Supplier
Clearinghouse to the online PECOS system.
New applicants must include a National
Provider Identifier (NPI) number on the
paper or electronic enrollment application.
NPI applications are available online at
The first decision to be made in Medicare
billing is whether to become a participating
provider. There are benefits to becoming a
participating provider. When the supplier’s
name is added to the list of participating
suppliers, the supplier’s name is given
to patients when an inquiry is made. In
addition, several electronic reports and
information sources are available only
to participating suppliers.
Participating providers agree to accept
assignment on all Medicare claims.
Accepting assignment means that the
supplier agrees to accept the amount
determined by Medicare as the total
amount of the claim. Nonparticipating
providers have the option of accepting
assignment on a case-by-case basis. The
benefits of accepting assignment are direct
Medicare payment and the transfer of
claims payment information to Medigap
insurers. Under special arrangement,
the DME MACs forward claims payment
information to some Medicaid carriers and
secondary insurers—regardless of whether
a supplier accepts assignment.
If a supplier does not accept assignment,
the DME MAC will make payment to the
patient. The supplier must then collect
payment from the patient for products
Retrospective billing
The time period for submission of DMEPOS
claims to Medicare is 1 calendar year after
the date of service. Medicare will deny
claims submitted beyond 1 year after the
date of service.
  TOC
1. Authorization and Release
To meet the billing requirements set
forth by Medicare, certain forms must
be maintained in supplier files. An
“Authorization and Medical Release
Statement” or “Assignment of Benefits
(AOB)” gives the supplier the authority to
bill Medicare on the patient’s behalf and
receive payment directly from Medicare.
At the same time, it allows the supplier to
release any pertinent medical information
that may be required by Medicare or the
Social Security Administration to process
the claim. This “Authorization and Release”
form must be signed by the patient or his/
her legal representative to be valid.
2. Advance Beneficiary Notice of
Noncoverage (ABN)
As previously discussed, suppliers accepting
assignment agree to accept the claim
determination made by Medicare; any
remaining claim balances, except deductible
and coinsurance charges cannot be billed
to the patient under normal circumstances.
The only method by which a supplier can
bill the patient for remaining balances or
denied claims is with “Advance Beneficiary
Notice of Noncoverage,” which is written
notification provided to the patient or his/
her legal representative prior to delivery
of supplies or services. In it, the supplier
details why it believes the services may
not be covered, or not covered in full, by
Medicare. The supplier must detail specific
reasons for this belief. The notice must be
date-specific as well as product-specific and,
finally, be signed by the patient or his/her
legal representative. An example of an ABN
follows as Exhibit 1 on page 18.
ABNs are designed for use with Medicare
patients only, including those who are
dually eligible for Medicare and Medicaid.
When an ABN is obtained, suppliers submit
claims to Medicare using the GA modifier,
indicating that they have an ABN on file.
ABNs should only be provided to patients
enrolled in Original (Fee-for-Service)
Medicare, including those who are dually
eligible for Medicare and Medicaid. An ABN
should not be given to a Medicare patient
unless the supplier has a genuine reason
to expect that Medicare will deny payment
for some or all of the services. For example,
ABNs should be given to Medicare patients
receiving enteral therapy if the enteral
feeding is expected to last fewer than 90
days, or if enteral feeding is not the primary
source of nutrition.
Common reasons cited on the form for
Medicare nonpayment include “Medicare
does not pay for this item or service for
your condition” and “Medicare does not
pay for this item or service more often than
Frequency Limit.” A single ABN covering an
extended course of treatment is acceptable
provided the ABN identifies all items and
services for which the supplier believes
Medicare will not pay. For example, if the
supplier believes Medicare will not pay for
enteral nutrition because the patient does
not have a qualifying diagnosis, the ABN
must identify the formula, pump, IV pole,
and all administration supplies, including
the administration bag and tubing. The
items or services at issue must be described
in sufficient detail so that the patient can
understand which items or services may
not be paid. HCPCS codes by themselves
are not acceptable as descriptions. One year
is the limit for use of a single ABN for an
extended course of treatment; if the course
of treatment extends beyond one year, a
new ABN is required for the remainder of
the course of treatment.
The supplier must provide the patient
with an estimated cost of the items and/or
services provided (section F of the ABN).
In general, a reasonable estimate will be
within $100 or 25% of the actual costs,
whichever is greater. Multiple items that
are routinely grouped may be bundled into
a single-cost estimate.
  TOC
If a patient receives an ABN, refuses to
sign it, but still demands to receive the
services specified, the supplier can annotate
the form, with the signature of a witness,
that the beneficiary received notice but
refused to sign the form. Claims can then be
submitted to Medicare with a GA modifier
by each HCPCS code, indicating that an
ABN was given. A patient who receives a
service for which payment is subsequently
denied for the reasons cited on the ABN can
be held liable, whether or not the patient
agreed to make payment. However, if a
patient refuses to sign a properly delivered
ABN, the supplier should consider not
furnishing the item/service unless the
consequences (health and safety of the
patient, or civil liability in case of harm)
are such that this is not an option.
Despite these difficulties, there may be
situations in which products may be
prescribed that do not meet Medicare
payment standards and a claim denial is
expected. In these situations, the provider
should fully explain the difficulties involved
to the patient and/or the patient-responsible
party, and an ABN should be signed.
Additional information regarding ABNs
may be found at the following weblink:
One problem faced by providers of enteral
products is that supplies are often provided
on admission or as orders change. In
these situations, a supplier may not have
the opportunity to evaluate each patient
to determine whether he/she meets all
of the established Medicare criteria for
the feeding, particularly in cases where
specialty formulas and enteral feeding
pumps are ordered. Bearing in mind that
an ABN must be signed before delivery of
service, it may be difficult for the supplier to
comply with this requirement. Even if the
supplier can determine the eligibility of the
beneficiary, the responsible party may not
be readily available to sign the waiver—and
some beneficiaries are not competent or
capable of signing.
  TOC
(A) Notifier(s):
(B) Patient Name:
(C) Identification Number:
NOTE: If Medicare doesn’t pay for (D)_____________ below, you may have to pay.
Medicare does not pay for everything, even some care that you or your health care provider have
good reason to think you need. We expect Medicare may not pay for the (D)_____________ below.
(E) Reason Medicare May Not Pay:
(F) Estimated
Read this notice, so you can make an informed decision about your care.
Ask us any questions that you may have after you finish reading.
Choose an option below about whether to receive the (D)_____________listed above.
Note: If you choose Option 1 or 2, we may help you to use any other
insurance that you might have, but Medicare cannot require us to do this.
Check only one box. We cannot choose a box for you.
I want the (D)__________ listed above. You may ask to be paid now, but I
also want Medicare billed for an official decision on payment, which is sent to me on a Medicare
Summary Notice (MSN). I understand that if Medicare doesn’t pay, I am responsible for
payment, but I can appeal to Medicare by following the directions on the MSN. If Medicare
does pay, you will refund any payments I made to you, less co-pays or deductibles.
I want the (D)__________ listed above, but do not bill Medicare. You may
ask to be paid now as I am responsible for payment. I cannot appeal if Medicare is not billed.
❏ OPTION 3. I don’t want the (D)__________listed above.
I understand with this choice
I am not responsible for payment, and I cannot appeal to see if Medicare would pay.
(H) Additional Information:
This notice gives our opinion, not an official Medicare decision. If you have other questions
on this notice or Medicare billing, call 1-800-MEDICARE (1-800-633-4227/TTY: 1-877-486-2048).
Signing below means that you have received and understand this notice. You also receive a copy.
(I) Signature:
(J) Date:
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control
number. The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to
average 7 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the
information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500
Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.
Form CMS-R-131 (03/08)
Form Approved OMB No. 0938-0566
  TOC
3. DME Information Forms (DIF)
New initial DIFs must be filed with the
first enteral claim and 1) if the formula
is changed to a product with a different
HCPCS code, 2) if there is a 60-day break
in service, and/or 3) if there is a change
in feeding method from gravity or syringe
to pump. The CMS-1500 claim and the
DIF must be transmitted electronically.
Regularly scheduled recertifications are not
required unless therapy continues beyond
the number of months indicated by the
physician on the written order.
When there is a change in enteral
prescription, a revised DIF is required,
showing the effective date of the prescription
change. Examples of circumstances that
require a revised DIF include:
• Change in the physician’s orders for
the number of calories prescribed
or in the days/weeks administered.
• Change in the method of infusion.
• Change in the route of administration.
Suppliers must retain a DME MACacceptable copy of the DIF. These files
are subject to audit by the DME MACs.
An acceptable form of a DIF includes
the original “pen and ink” document,
a photocopy, a facsimile image, or an
electronically maintained document.
All information contained on the DIF
should agree with the information listed on
the claim form. Any differences may result
in a denial. Information contained on the
DIF should be substantiated in the patient’s
medical record.
DIFs should not be altered with white-out
or crossovers. If a correction must be made,
the change must be initialed and dated by
the supplier representative (to indicate he/
she was aware of the change).
DIF, the DME MAC should accept, where
feasible, the copied, faxed, or electronic
document as fulfilling requirements for
these documents. If evidence indicates
that the DIF being reviewed has been
falsified, or the supplier is unable to provide
adequate assurance of the medical necessity
of the items or services, the DME MAC can
request additional information, including
an original signature, in order to obtain
that assurance.
Physician orders
The supplier is required to keep on file a
physician prescription (order). The treating
physician must sign and date the order.
A supplier must have an order from the
treating physician before dispensing a
DMEPOS item to a beneficiary.
Verbal orders
Suppliers may dispense enteral nutrition
formula and related supplies based on
a physician’s verbal order. The verbal
dispensing order must include:
• A description of the item.
• The beneficiary’s name.
•The physician’s name.
• The start date of the order.
Suppliers must maintain written
documentation of the verbal order and this
documentation must be available to the
DME MACs upon request. If the supplier
does not have an order from the treating
physician before dispensing an item, the
item is noncovered, and the supplier must
not submit a claim for the item to the DME
For items dispensed on a verbal order,
suppliers must obtain a detailed written
order that confirms the verbal order before
submitting the claim to Medicare.
DME MACs accept faxed, copied, and
electronic orders and DIFs. When reviewing
claims where the medical record contains a
copied, faxed, or electronically maintained
  TOC
Someone other than the physician may
Detailed written orders (DWO) are required complete the detailed description of the
item. However, the treating physician
for all transactions involving DMEPOS.
must review the detailed description and
They may take the form of a photocopy,
personally sign and date the order to
facsimile image, electronically maintained,
indicate agreement. If a supplier does not
or original “pen-and-ink” document and
have a faxed, photocopied, electronic, or
must include the following:
pen-and-ink signed DWO in the patient’s
• The start date of the order.
record before submitting a claim to
Medicare, the claim is subject to denial
• Quantity and frequency of change
upon review by the DME MAC or other
for supplies and duration of need for
authorized Medicare review contractor
supplies (quantity used and method of including Recovery Audit Contractors
(RACs) and Zone Program Integrity
Contractors (ZPICs). Medical necessity
• Sufficient detail including all options
information (e.g., an ICD-9-CM diagnosis
or additional features that will be
code, narrative description of the patient’s
billed or require an upgraded code. The
condition, abilities, and limitations) is
description can be either a narrative
NOT in itself considered to be part of the
description or a brand name/model
order although it may be put on the same
document as the order.
• Length of need.
Detailed written orders
• Physician’s signature and date.
Written orders are required for the initial
enteral nutrition therapy prescription as
well as for any subsequent changes made to
the original prescription.
See CMS Pub 100-08 Chapter 5 §5.2 for
more information.
Ordering/referring providers and
PECOS enrollment
Only Medicare-enrolled physicians and
non-physician practitioners are eligible
to order or refer services for Medicare
beneficiaries. A provider is considered
enrolled in Medicare for the purpose
of ordering or referring a service to a
beneficiary if their enrollment is current
in the CMS internet based PECOS
system. The transition is underway to
deny Medicare claims if the ordering/
referring physician or non-physician
practitioner identified on the claim is not
enrolled in PECOS. To avoid claim denial,
suppliers should verify that the ordering/
referring physician or non-physician
practitioner is enrolled in the CMS PECOS
system via this weblink: https://www.
  TOC
EXHIBIT 2. CMS-10126
Form Approved
OMB No. 0938-0679
DME 10.03
Certification Type/Date: INITIAL ___/___/___
REVISED ___/___/___
(__ __ __) __ __ __ - __ __ __ __ HICN _______________________
(__ __ __) __ __ __ - __ __ __ __ NSC or NPI #_________________
PLACE OF SERVICE______________
if applicable (see reverse)
PT DOB ____/____/____ Sex ____ (M/F) Ht. ____(in) Wt ____(lbs.)
(__ __ __) __ __ __ - __ __ __ __ UPIN or NPI #_________________
DIAGNOSIS CODES (ICD-9): ______ ______ ______ ______
(Circle Y for Yes, N for No, Unless Otherwise Noted)
1. Is there documentation in the medical record that supports the patient having a permanent non-function or disease of
the structures that normally permit food to reach or be absorbed from the small bowel?
2. Is the enteral nutrition being provided for administration via tube? (i.e., gastrostomy tube, jejunostomy tube,
nasogastric tube)
3. Print HCPCS code(s) of product.
4. Calories per day for each corresponding HCPCS code(s).
5. Circle the number for method of administration?
1 – Syringe
2 – Gravity
3 – Pump
4 – Oral (i.e. drinking)
6. Days per week administered or infused (Enter 1 – 7)
7. Is there documentation in the medical record that supports the patient having permanent disease of the gastrointestinal
tract causing malabsorption severe enough to prevent maintenance of weight and strength commensurate with the
patient's overall health status?
8. Formula components:
Amino Acid ___________(ml/day) _____________concentration % _______gms protein/day
Dextrose _____________(ml/day) _____________concentration %
Lipids _______________(ml/day) _____________days/week ___________concentration %
9. Circle the number for the route of administration.
1 – Central Line (Including PICC)
2 – Hemodialysis Access Line
3 – Peritoneal Catheter
Supplier Attestation and Signature/Date
I certify that I am the supplier identified on this DME Information Form and that the information provided is true, accurate and complete, to the best
of my knowledge. I understand that any falsification, omission, or concealment of material fact associated with billing this service may subject me to
civil or criminal liability.
SUPPLIER SIGNATURE___________________________________________________________________________ DATE _____/_____/_____
Form CMS-10126 (09/05) EF 08/2006
  TOC
EXHIBIT 3. CMS-10126
If this is an initial certification for this patient, indicate this by placing date (MM/DD/YY) needed initially in
the space marked “INITIAL.” If this is a revised certification (to be completed when the physician changes
the order, based on the patient's changing clinical needs), indicate the initial date needed in the space
marked “INITIAL,” and also indicate the revision date in the space marked “REVISED.” If this is a
recertification, indicate the initial date needed in the space marked “INITIAL,” and also indicate the
recertification date in the space marked “RECERTIFICATION.” Whether submitting a REVISED or a
RECERTIFICATION DIF, be sure to always furnish the INITIAL date as well as the REVISED or
Indicate the patient's name, permanent legal address, telephone number and his/her health insurance
claim number (HICN) as it appears on his/her Medicare card and on the claim form.
Indicate the name of your company (supplier name), address and telephone number along with the
Medicare Supplier Number assigned to you by the National Supplier Clearinghouse (NSC) or applicable
National Provider Identifier (NPI). If using the NPI Number, indicate this by using the qualifier XX followed
by the 10-digit number. If using a legacy number, e.g. NSC number, use the qualifier 1C followed by the
10-digit number. (For example. 1Cxxxxxxxxxx)
Indicate the place in which the item is being used, i.e., patient’s home is 12, skilled nursing facility (SNF)
is 31, End Stage Renal Disease (ESRD) facility is 65, etc. Refer to the DMERC supplier manual for a
complete list.
If the place of service is a facility, indicate the name and complete address of the facility.
List all HCPCS procedure codes for items ordered that require a DIF. Procedure codes that do not require
certification should not be listed in this section of the DIF.
PATIENT DOB, HEIGHT, Indicate patient’s date of birth (MM/DD/YY) and sex (male or female); height in inches and weight in
pounds, if required.
Indicate the physician’s name and complete mailing address.
Accurately indicate the treating physician’s Unique Physician Identification Number (UPIN) or applicable
National Provider Identifier (NPI). If using the NPI Number, indicate this by using the qualifier XX followed
by the 10-digit number. If using UPIN number, use the qualifier 1G followed by the 6-digit number.
(For example. 1Gxxxxxx)
Indicate the telephone number where the physician can be contacted (preferably where records would be
accessible pertaining to this patient) if more information is needed.
This section is used to gather clinical information about the item or service billed. Answer each question
which applies to the items ordered, circling “Y” for yes, “N” for no, a number if this is offered as an answer
option, or fill in the blank if other information is requested.
The supplier’s signature certifies that the information on the form is an accurate representation of the
situation(s) under which the item or service is billed.
SUPPLIER SIGNATURE After completion, supplier must sign and date the DME Information Form, verifying the Attestation.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for
this information collection is 0938-0679. The time required to complete this information collection is estimated to average 12 minutes per response, including the time to review instructions, search existing
resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate or suggestions for improving this form,
please write to: CMS, Attn: PRA Reports Clearance Officer, 7500 Security Blvd. Baltimore, Maryland 21244.
DO NOT SUBMIT CLAIMS TO THIS ADDRESS. Please see for information on claim filing.
Form CMS-10126 (09/05) INSTRUCTIONS EF 08/2006
  TOC
4. CMS-1500 Form
5. Filing Claims Electronically
The Administrative Simplification
Compliance Act (ASCA) requires all
initial claims for Medicare to be submitted
electronically. Suppliers with fewer than
10 FTEs are exempt from this requirement
and may submit claims on paper using
the CMS-1500 claim form, version 08/05
(Exhibit 4 on pages 25-26). The only
acceptable claim forms are those printed in
Flint OCR Red, J6983, (or exact match) ink.
Although a copy of the CMS-1500 form can
be downloaded, copies of the form cannot
be used for submission of claims, since
copies may not accurately replicate the
scale and OCR color of the form, creating
problems with data scanning. You can
find Medicare CMS-1500 completion and
coding instructions, as well as the print
specifications in Chapter 26 of the Medicare
Claims Processing Manual (Pub.10004):
Medicare requires most suppliers to
submit claims electronically. There are
many benefits to filing Medicare claims
electronically, both for suppliers and for
DME MACs. For suppliers, filing claims
electronically means better cash flow.
“Clean claims” received via electronic media
may be paid after 14 days; the minimum
time for paper claims is 29 days. Additional
benefits include on-line claim status
inquiry, electronic funds transfer, electronic
remittance advice, and the ability to submit
claims any time of any day. Furthermore,
sending claims electronically avoids mailing
costs, delays, and possible lost documents.
CMS-1500 forms may be ordered from
private printing companies or directly from
the Government Printing Office. Credit
card orders are accepted at (202) 512-1800
between 8:00 AM and 4:30 PM Eastern time.
Direct-mail orders are accepted with check
or money order through:
Superintendent of Documents
US Government Printing Office
Washington, DC 20402
The forms are available at varying prices
in several formats: single sheet, 2-part
snap-apart, and 1-part or 2-part continuous
feed. A print negative is also available for
purchase for large companies with print
offices. Bulk orders are subject to discount,
and some customization is available.
The first step to begin electronic claims
submission is to acquire HIPAA compliant
software. DME MAC e-commerce
consultants are available to help suppliers
analyze their claims submission needs
and to assist in the process of becoming
an electronic claims submitter. Once a
software package is selected, the supplier
must apply for an electronic sender
number by completing an Electronic
Data Transmission Agreement. Contact
your DME MAC for the appropriate
forms. The electronic sender number
identifies the supplier to Medicare and
may be used to submit claims to any of
the four DME MACs. Each DME MAC
has its own Electronic Data Interchange
(EDI) or Electronic Media Claims (EMC)
department. The personnel in these
departments will process the agreement
and assign the supplier an “electronic
sender number.”
Once a sender number is obtained,
suppliers are encouraged to send “test”
claims to ensure that all data are properly
encoded and that Medicare can read the
files. Claims submitted with errors will be
rejected on the front-end and will not enter
the DME MAC processing system. These
claims will be listed on a front-end error
report. It is the submitter’s responsibility
to correct the error(s) and retransmit any
rejected claims.
  TOC
6. Physician National Provider Identifier
(NPI) Directory
One of the items to complete when
submitting the CMS 1500 form is field
17b – the prescribing physician’s NPI
number. NPI numbers for individual and
organizational providers may be found
Pump Billing Information
Rental payments for enteral pumps are
limited to 15 months, assuming that all
other medical criteria are met by the
beneficiary. Medicare has determined that
medical need is exhausted if the pump
is not medically needed for 2 consecutive
months. After a break of 2 months in
receiving enteral services, Medicare may
grant an additional 15-month rental period
if the patient requalifies. Medicare may
request medical record documentation to
substantiate resumption of pump use after
the 2-month break in service. Hospital stays
and voluntary nonbilling do not qualify as
legitimate breaks in service.
A beneficiary is granted 15 months of pump
rental even if there is a change in supplier.
After 15 months of rental payments are
made, the supplier must continue to provide
the feeding pump as long as it is medically
necessary; however, no additional rental
payments will be made. Medicare will
allow maintenance and servicing charges
after the rental period is exhausted. A
maintenance charge of half of 1 month’s
rental will be allowed every 6 months after
the rental period has been completed. The
supplier should have documentation of
pump maintenance each time maintenance
is billed.
Payment policies for enteral feeding pumps
generally follow the rules for capped rental
items. The beneficiary must be given the
option of purchasing the pump at the
initial time of service, and has the option
to purchase the pump at any time during
the rental period. Documentation that the
beneficiary was notified of the rent/purchase
option should be maintained in the medical
If the beneficiary chooses to purchase a
new pump, append the modifier NU to the
pump HCPCS code (B9000 or B9002). If a
used pump is purchased, the modifier UE
is appended. Medicare issues lump sum
reimbursement for purchased pumps. If the
pump is rented, append the modifier RR to
the initial claim and all subsequent claims.
If the beneficiary decides to purchase the
pump after rental payments have been
made, the rental payments will be deducted
from the purchase allowance.
Additional modifiers for enteral pumps
include BP if the pump is purchased,
BR if the pump is rented, and BU if the
beneficiary is undecided. These modifiers
need to be appended only once during the
rental period, ideally with the first claim
submission. The modifiers BU and BR may
be changed in subsequent rental months if
the beneficiary is initially undecided and
then decides to rent or purchase the pump,
or if the beneficiary initially rents the pump
and then decides to purchase the pump.
The capped rental modifiers KH, KI, and
KJ also apply to enteral feeding pumps.
The KH modifier is appended to the pump
HCPCS code with the initial claim; modifier
KI is appended for the second and third
pump rental months and KJ is appended for
rental months 4 through 15.
  TOC
(Medicare #)
(Medicaid #)
(Sponsor’s SSN)
(SSN or ID)
(Member ID#)
2. PATIENT’S NAME (Last Name, First Name, Middle Initial)
5. PATIENT’S ADDRESS (No., Street)
4. INSURED’S NAME (Last Name, First Name, Middle Initial)
7. INSURED’S ADDRESS (No., Street)
TELEPHONE (Include Area Code)
(For Program in Item 1)
TELEPHONE (Include Area Code)
9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial)
a. EMPLOYMENT? (Current or Previous)
PLACE (State)
12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessary
to process this claim. I also request payment of government benefits either to myself or to the party who accepts assignment
If yes, return to and complete item 9 a-d.
payment of medical benefits to the undersigned physician or supplier for
services described below.
ILLNESS (First symptom) OR
INJURY (Accident) OR
17b. NPI
21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY (Relate Items 1, 2, 3 or 4 to Item 24E by Line)
(Explain Unusual Circumstances)
govt. claims, see back)
(I certify that the statements on the reverse
apply to this bill and are made a part thereof.)
NUCC Instruction Manual available at:
Plan QUAL.
24. A.
APPROVED OMB-0938-0999 FORM CMS-1500 (08/05)
  TOC
NOTICE: Any person who knowingly files a statement of claim containing any misrepresentation or any false, incomplete or misleading information may
be guilty of a criminal act punishable under law and may be subject to civil penalties.
MEDICARE AND CHAMPUS PAYMENTS: A patient’s signature requests that payment be made and authorizes release of any information necessary to process
the claim and certifies that the information provided in Blocks 1 through 12 is true, accurate and complete. In the case of a Medicare claim, the patient’s signature
authorizes any entity to release to Medicare medical and nonmedical information, including employment status, and whether the person has employer group health
insurance, liability, no-fault, worker’s compensation or other insurance which is responsible to pay for the services for which the Medicare claim is made. See 42
CFR 411.24(a). If item 9 is completed, the patient’s signature authorizes release of the information to the health plan or agency shown. In Medicare assigned or
CHAMPUS participation cases, the physician agrees to accept the charge determination of the Medicare carrier or CHAMPUS fiscal intermediary as the full charge,
and the patient is responsible only for the deductible, coinsurance and noncovered services. Coinsurance and the deductible are based upon the charge
determination of the Medicare carrier or CHAMPUS fiscal intermediary if this is less than the charge submitted. CHAMPUS is not a health insurance program but
makes payment for health benefits provided through certain affiliations with the Uniformed Services. Information on the patient’s sponsor should be provided in those
items captioned in “Insured”; i.e., items 1a, 4, 6, 7, 9, and 11.
The provider agrees to accept the amount paid by the Government as payment in full. See Black Lung and FECA instructions regarding required procedure and
diagnosis coding systems.
I certify that the services shown on this form were medically indicated and necessary for the health of the patient and were personally furnished by me or were furnished
incident to my professional service by my employee under my immediate personal supervision, except as otherwise expressly permitted by Medicare or CHAMPUS
For services to be considered as “incident” to a physician’s professional service, 1) they must be rendered under the physician’s immediate personal supervision
by his/her employee, 2) they must be an integral, although incidental part of a covered physician’s service, 3) they must be of kinds commonly furnished in physician’s
offices, and 4) the services of nonphysicians must be included on the physician’s bills.
For CHAMPUS claims, I further certify that I (or any employee) who rendered services am not an active duty member of the Uniformed Services or a civilian employee
of the United States Government or a contract employee of the United States Government, either civilian or military (refer to 5 USC 5536). For Black-Lung claims,
I further certify that the services performed were for a Black Lung-related disorder.
No Part B Medicare benefits may be paid unless this form is received as required by existing law and regulations (42 CFR 424.32).
NOTICE: Any one who misrepresents or falsifies essential information to receive payment from Federal funds requested by this form may upon conviction be subject
to fine and imprisonment under applicable Federal laws.
We are authorized by CMS, CHAMPUS and OWCP to ask you for information needed in the administration of the Medicare, CHAMPUS, FECA, and Black Lung
programs. Authority to collect information is in section 205(a), 1862, 1872 and 1874 of the Social Security Act as amended, 42 CFR 411.24(a) and 424.5(a) (6), and
44 USC 3101;41 CFR 101 et seq and 10 USC 1079 and 1086; 5 USC 8101 et seq; and 30 USC 901 et seq; 38 USC 613; E.O. 9397.
The information we obtain to complete claims under these programs is used to identify you and to determine your eligibility. It is also used to decide if the services
and supplies you received are covered by these programs and to insure that proper payment is made.
The information may also be given to other providers of services, carriers, intermediaries, medical review boards, health plans, and other organizations or Federal
agencies, for the effective administration of Federal provisions that require other third parties payers to pay primary to Federal program, and as otherwise necessary
to administer these programs. For example, it may be necessary to disclose information about the benefits you have used to a hospital or doctor. Additional disclosures
are made through routine uses for information contained in systems of records.
FOR MEDICARE CLAIMS: See the notice modifying system No. 09-70-0501, titled, ‘Carrier Medicare Claims Record,’ published in the Federal Register, Vol. 55
No. 177, page 37549, Wed. Sept. 12, 1990, or as updated and republished.
FOR OWCP CLAIMS: Department of Labor, Privacy Act of 1974, “Republication of Notice of Systems of Records,” Federal Register Vol. 55 No. 40, Wed Feb. 28,
1990, See ESA-5, ESA-6, ESA-12, ESA-13, ESA-30, or as updated and republished.
FOR CHAMPUS CLAIMS: PRINCIPLE PURPOSE(S): To evaluate eligibility for medical care provided by civilian sources and to issue payment upon establishment
of eligibility and determination that the services/supplies received are authorized by law.
ROUTINE USE(S): Information from claims and related documents may be given to the Dept. of Veterans Affairs, the Dept. of Health and Human Services and/or
the Dept. of Transportation consistent with their statutory administrative responsibilities under CHAMPUS/CHAMPVA; to the Dept. of Justice for representation of
the Secretary of Defense in civil actions; to the Internal Revenue Service, private collection agencies, and consumer reporting agencies in connection with recoupment
claims; and to Congressional Offices in response to inquiries made at the request of the person to whom a record pertains. Appropriate disclosures may be made
to other federal, state, local, foreign government agencies, private business entities, and individual providers of care, on matters relating to entitlement, claims
adjudication, fraud, program abuse, utilization review, quality assurance, peer review, program integrity, third-party liability, coordination of benefits, and civil and
criminal litigation related to the operation of CHAMPUS.
DISCLOSURES: Voluntary; however, failure to provide information will result in delay in payment or may result in denial of claim. With the one exception discussed
below, there are no penalties under these programs for refusing to supply information. However, failure to furnish information regarding the medical services rendered
or the amount charged would prevent payment of claims under these programs. Failure to furnish any other information, such as name or claim number, would delay
payment of the claim. Failure to provide medical information under FECA could be deemed an obstruction.
It is mandatory that you tell us if you know that another party is responsible for paying for your treatment. Section 1128B of the Social Security Act and 31 USC 38013812 provide penalties for withholding this information.
You should be aware that P.L. 100-503, the “Computer Matching and Privacy Protection Act of 1988”, permits the government to verify information by way of computer matches.
I hereby agree to keep such records as are necessary to disclose fully the extent of services provided to individuals under the State’s Title XIX plan and to furnish
information regarding any payments claimed for providing such services as the State Agency or Dept. of Health and Human Services may request.
I further agree to accept, as payment in full, the amount paid by the Medicaid program for those claims submitted for payment under that program, with the exception
of authorized deductible, coinsurance, co-payment or similar cost-sharing charge.
SIGNATURE OF PHYSICIAN (OR SUPPLIER): I certify that the services listed above were medically indicated and necessary to the health of this patient and were
personally furnished by me or my employee under my personal direction.
NOTICE: This is to certify that the foregoing information is true, accurate and complete. I understand that payment and satisfaction of this claim will be from Federal and State
funds, and that any false claims, statements, or documents, or concealment of a material fact, may be prosecuted under applicable Federal or State laws.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB
control number for this information collection is 0938-0008. The time required to complete this information collection is estimated to average 10 minutes per response, including the
time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland
21244-1850. This address is for comments and/or suggestions only. DO NOT MAIL COMPLETED CLAIM FORMS TO THIS ADDRESS.
  TOC
item(s) being delivered, the brand name,
and serial number if applicable. If a
designee signs the delivery slip, their
relationship to the beneficiary should
be noted on the delivery slip and the
signature should be legible. The date of
signature on the delivery slip must be the
date that the item was received and shall
also be the date on the claim for payment.
Proof-of-Delivery Requirements*
Suppliers are not required to submit proof
of delivery with their claims. However,
they are expected to retain proof-of-delivery
documentation as described herein to be
furnished to the DME MAC on request.
Documentation must be maintained by the
supplier for 7 years.
All services that do not have appropriate
proof of delivery from the supplier will
be denied and overpayment refund will
be requested. Suppliers who consistently
do not provide documentation to support
their services may be referred to the Office
of Inspector General (OIG) for imposition
of Civil Monetary Penalties (CMPs) or
Administrative Sanctions. Suppliers or
anyone having a financial interest in the
delivery of an item may not sign or accept
an item on behalf of the patient.
The proof-of-delivery requirements are
outlined below according to the method of
delivery. The three methods of delivery are:
Supplier delivers items directly to the beneficiary or designee (any person who can sign and accept the delivery on behalf of the patient).
2. Supplier uses a delivery/shipping service to deliver items.
3. Supplier utilizes a return postage-paid delivery invoice from the beneficiary or designee as a form of proof of delivery.
The general requirements for each method
of delivery are as follows:
1. If the supplier delivers items directly to
the beneficiary or designee, a delivery
slip that has been signed and dated by
the beneficiary or designee is required
to verify the DMEPOS item(s) received.
The delivery slip should include the
beneficiary’s name, the quantity of items
delivered, a detailed description of the
2. If the supplier uses a delivery/shipping
service to deliver items, acceptable proof
of delivery would include the delivery
service’s tracking slip and a supplier’s
shipping invoice. If possible, the supplier’s
records should also include the delivery
service’s package identification number
for the package sent to the beneficiary.
The delivery service’s tracking slip should
reference each individual package, the
delivery address, the corresponding
package identification number given by
the shipping service, and, if possible, the
date delivered. The shipping date should
be the date of service on the claim.
When performing compliance audits or
developing complaints, Medical Review
Departments may request documentation
to support claims submitted by the
supplier. Often, the documentation
returned from the supplier does not
include a delivery service log, or includes
a delivery service log that only indicates
that numerous packages were picked up
from the supplier—but not the individual
package identification numbers associated
with each patient. Without a delivery
service’s tracking log that identifies
each individual package with a unique
identification number and the delivery
address, the services may be denied and
an overpayment refund may be requested.
  TOC
3. If the supplier utilizes a return postagepaid delivery invoice from the beneficiary
or designee as a form of proof of delivery,
descriptive information including the
beneficiary’s name, the quantity and
detailed description of the DMEPOS item,
and brand name and serial number should
be on the invoice. The invoice must also
be signed and dated by the beneficiary or
their designee.
Audits indicate that packages are often
delivered to the wrong address or left at
the door or on the porch of the patient’s
residence. Patients often indicate they did
not receive the items/supplies that were
shipped by the supplier. In situations
where the patient denies receipt of the
items/services, these services may be
denied and an overpayment refund may
be requested unless the supplier proves
delivery with detailed documentation as
When enteral nutrition therapy is
delivered to nursing facility residents,
suppliers should obtain copies of
documentation necessary to prove both
delivery to and usage by the beneficiary.
Suppliers may work with the nursing
facility staff to implement an inventory
control to ensure that supplies are
identified and retained for use only by
the specific beneficiary for whom the
supplies are intended. Medical records
in the nursing facility must document
the beneficiary’s use of all supplies/items
billed to Medicare. The documentation
may be in the nurse’s notes or in a special
treatment record or form. The date of the
service on the claim should be the date
the DMEPOS item(s) was received by the
nursing facility.
*From CMS Manual System Pub. 100-08 Medicare Program
Integrity Manual Chapter 4 – Benefit Integrity § 4.26, Rev. 176,
  TOC
How to Appeal Medicare Claims Decisions
If a Medicare claim is denied or partial
payment made, payment may be obtained
through Medicare’s structured appeals
process. Requesting a redetermination or
reconsideration can be a difficult and timeconsuming process. On the other hand, an
understanding of the rules and regulations
can make the appeals process run more
smoothly. See the appeals process flow
chart (Exhibit 5).
This section will clarify the Medicare claims
appeals process. It answers important
questions such as:
• Wrong Medicare number submitted
• Wrong name entered
• Improper charge submitted
In cases that require a simple adjustment,
a request for an adjustment should be
submitted to the appropriate DME MAC. If
the claim remark and reason codes indicate
that it was never adjudicated, it can simply
be reverted in your billing software and
resubmitted. If a claim was adjudicated
and denied completely, the claim must go
through the appeals process. Appeals must
be requested based on the original denial or
first claim submitted.
• Who may request a redetermination or
There are five levels of appeal:
• How does the appeals process begin?
• First Appeal: Redetermination
• What supporting documentation should
be provided?
• Second Appeal: Reconsideration
• How long will it take to receive a
by a Qualified Independent Contractor
• What can be done if a claim is denied at
• Third Appeal: Administrative Law
the first appeal (redetermination)?
Judge (ALJ) Hearing
• What does reconsideration by a
Qualified Independent Contractor
• Fourth Appeal: Departmental Appeals
(QIC) involve?
Board (DAB) Review
• What are the options if a claim is
• Final Appeal: Federal Court Review
denied again?
A redetermination or QIC reconsideration
may be requested by any of three parties:
The first thing to do when Medicare denies
or partially pays a claim for services
rendered is to decide whether to request
a redetermination or an adjustment.
Begin by reviewing the claims group,
reason, Medicare Outpatient Adjudication
(MOA), and remark and reason codes on
the remittance notice. An adjustment is
appropriate in cases of clerical errors and
similar mistakes. Examples of situations
calling for adjustments include, but are not
limited to, the following:
•The beneficiary who received the
•A participating supplier (i.e., one who
has agreed to take assignment on all
items or services payable on behalf of a
Medicare beneficiary).
•A nonparticipating supplier who has
accepted assignment with respect
to items or services furnished to a
beneficiary, but only for those items or
services billed on an assigned basis.
• Wrong date of service entered
  TOC
Medicare Appeals Process
EXHIBIT 5. Medicare Appeals Process Flow Chart
Claim Denied or Partially Paid
Clerical Adjustment
involving minor
errors or omissions
in an initial
Redetermination Request
Reconsideration by a Qualified
Independent Contractor (QIC) –
an independent on-the-record review.
Reopening Request
In person, video-teleconference, or
telephone Administrative Law Judge
(ALJ) Hearing conducted by an ALJ
at an Office of Medicare Hearings
and Appeals (OMHA) field office.
Departmental Appeals Board
(DAB) Review
Judicial Review by Federal Court
System. May file lawsuit.
Reference: Medicare Claims Processing Manual 100-04, Chapter 29.
  TOC
First Appeal: Redetermination
A redetermination is an independent
evaluation of a previously processed claim
by someone who was not the original
processor. Medicare allows 120 days from
the initial determination date on the
remittance advice to file a redetermination
request and there is no monetary threshold
to be met. A redetermination can be
requested in several ways:
• By a letter from the supplier or
• Through the use of Form CMS-20027
(Exhibit 6).
Regardless of the method chosen, the
redetermination request must include the
beneficiary’s name, health insurance claim
number, name and address of supplier,
date of initial determination, the specific
service(s) and/or item(s) for which the
redetermination is being requested, the
specific dates of service, and the name and
signature of the person filing the request.
It must also specifically state that a
redetermination is requested and precisely
state the reason for the request. Any
additional information that may help the
requester to receive payment for the claim
should also be provided.
Supporting documentation for a
If the denial or partial payment of a claim
involved a medical necessity reason, several
types of documents to support the claim
may be provided:
• A detailed letter from the patient’s
physician. This letter should be
patient and diagnosis specific. For
example, if payment for a specialized
metabolic need formula (B4154) is
denied, the letter should clearly state
why the patient needs a specialized
metabolic formula rather than a
standard product. Generalizations
like “physician protocol” or “required
by policy” should be avoided. In cases
involving specialized enteral formulas,
the letter from the physician should
state whether a B4150 product was
tried first.
• Laboratory reports or clinical studies
that support the physician’s letter or a
statement from the supplier.
• Nursing home records.
• Physician’s records.
• Notes of conversations between the
physician and the hospital, nursing
home, or supplier.
Extension of the filing deadline
The 120-day period to file for a
redetermination may be extended for
“good cause.” Examples of good cause for
a supplier to request an extension may be,
but are not limited to:
•Incorrect or incomplete information about the subject claim and/or appeal was furnished by official sources (CMS, the contractor, or the Social Security Administration)
to the supplier; or,
•Unavoidable circumstances such as major floods, fires, tornados, and other natural catastrophes prevented the supplier from timely filing a request for redetermination.
When seeking an extension of a filing
deadline based on good cause, the requestor
must write to the DME MAC and state
the specific reason an extension is being
requested. The requestor can mention that
he/she is aware that a waiver of timely
filing for a review or hearing is allowed
under 42 CFR §405.942. The DME MAC
may or may not honor the request for
additional time.
  TOC
EXHIBIT 6. CMS-20027
1. Beneficiary’s Name:_____________________________________________________________________
2. Medicare Number: ______________________________________________________________________
3. Description of Item or Service in Question: __________________________________________________
4. Date the Service or Item was Received: _____________________________________________________
5. I do not agree with the determination of my claim. MY REASONS ARE:
6. Date of the initial determination notice ______________________________________________________
(If you received your initial determination notice more than 120 days ago, include your reason for not making this request earlier.)
7. Additional Information Medicare Should Consider: ____________________________________________
8. Requester’s Name:______________________________________________________________________
9. Requester’s Relationship to the Beneficiary: _________________________________________________
10. Requester’s Address: ____________________________________________________________________
11. Requester’s Telephone Number: ___________________________________________________________
12. Requester’s Signature: ___________________________________________________________________
13. Date Signed: __________________________________________________________________________
I have evidence to submit. (Attach such evidence to this form.)
I do not have evidence to submit.
NOTICE: Anyone who misrepresents or falsifies essential information requested by this form may upon
conviction be subject to fine or imprisonment under Federal Law.
  TOC
DME MAC response to a redetermination
CMS allows 60 days for the DME
MAC to respond to a request for
redetermination. Sometimes the DME
MAC will request additional information.
In most cases, however, the DME MAC
will make a disposition on the claim
with the information at hand. The
redetermination decision is considered
final, unless reconsideration is requested.
Redetermination is a prerequisite for a
reconsideration. The only exception would
be if the DME MAC takes an unusually long
time to respond to the initial claim.
Second Appeal: Reconsideration
by Qualified Independent
Contractors (QIC)
The Medicare Benefits Improvement
and Protection Act (BIPA) of 2000
mandates that all second level appeals
or reconsiderations of Medicare claims
are conducted by Qualified Independent
Contractors (QICs). A QIC is an
independent adjudicator, unaffiliated with
the DME MAC, who has medical, legal,
and other relevant expertise. RiverTrust
Solutions, Inc. is the QIC for all DME MAC
reconsideration requests.
The QIC reconsideration is an
independent, on-the-record review of
an initial determination, including the
redetermination and all issues related
to payment of the claim. In conducting
a reconsideration, the QIC reviews the
evidence and findings upon which the
initial determination, including the
redetermination, was based, and any
additional evidence the parties submit
or that the QIC obtains on its own. If
the initial determination involves a
finding on whether an item or service is
reasonable and necessary for the diagnosis
or treatment of illness or injury (under
section 1862(a)(1)(A) of the Act), the QIC’s
reconsideration must involve consideration
by a panel of physicians or other
appropriate health care professionals and
be based on clinical experience, the patient’s
medical records, and medical, technical,
and scientific evidence of record to the
extent applicable. It is important to note
that all evidence to support the claim must
be submitted at the QIC reconsideration
level. New evidence cannot be introduced
after the QIC reconsideration at the next
level of appeal without a good explanation
and a favorable ruling as to whether that
explanation meets the good faith standard.
Intepretive CMS and DME MAC documents
such as National Coverage Determinations
(NCDs), Local Coverage Determinations
(LCDs), and CMS Transmittals and manual
instructions are given substantial deference
by the QIC officials.
A QIC reconsideration request does not
have a minimum dollar limit. A written
reconsideration request must be made to
the QIC within 180 days of the DME MAC
redetermination decision. As with DME
MAC redetermination requests, a request
to extend the 180-day filing period may be
filed with the QIC. Reconsideration requests
may include multiple claims within the
180-day period and may be requested using
Form CMS-20033 (Exhibit 7). The QIC
must notify the appellant of its decision
within 60 days of receiving the written
redetermination request.
Third Appeal: Administrative
Law Judge (ALJ) Hearing
If a party is dissatisfied with a QIC’s
reconsideration or if the adjudication period
for the QIC to complete its reconsideration
has elapsed, an ALJ hearing may be
requested. Each calendar year the dollar
amount for both ALJ hearings and Federal
Court Review (the final appeal level)
is recalculated in accordance with the
percentage increase in the medical care
component of the consumer price index
for all urban consumers. An ALJ hearing
request must meet the current dollar
  TOC
,EXHIBIT 7. CMS-20033
1. Beneficiary’s Name:_____________________________________________________________________
2. Medicare Number: ______________________________________________________________________
3. Description of Item or Service in Question: __________________________________________________
4. Date the Service or Item was Received: _____________________________________________________
5. I do not agree with the determination of my claim. MY REASONS ARE:
6. Date of the redetermination notice__________________________________________________________
(If you received your redetermination more than 180 days ago, include your reason for not making this request earlier.)
7. Additional Information Medicare Should Consider: ____________________________________________
8. Requester’s Name:______________________________________________________________________
9. Requester’s Relationship to the Beneficiary: _________________________________________________
10. Requester’s Address: ____________________________________________________________________
11. Requester’s Telephone Number: ___________________________________________________________
12. Requester’s Signature: ___________________________________________________________________
13. Date Signed: __________________________________________________________________________
I have evidence to submit. (Attach such evidence to this form.)
I do not have evidence to submit.
15. Name of the Medicare Contractor that Made the Redetermination:________________________________
NOTICE: Anyone who misrepresents or falsifies essential information requested by this form may upon
conviction be subject to fine or imprisonment under Federal Law.
Form CMS-20033 (05/05
  TOC
threshold. Suppliers may be able to meet
the dollar threshold for an ALJ hearing by
combining the disputed claim with other
claims that have had unsatisfactory QIC
reconsideration decisions.
The request for the ALJ review must be
made in writing within 60 days after receipt
of the reconsideration notice. The request
must include all of the following:
1. The name, address, and Medicare
health insurance claim number of
the beneficiary whose claim is being
2. The name and address of the appellant,
when the appellant is not the
3. The name and address of the designated
representatives, if any.
4. The document control number assigned
to the appeal by the QIC, if any.
5. The dates of service.
6. The reasons the appellant disagrees
with the QIC’s reconsideration or other
determination being appealed
7. A statement of any additional evidence
to be submitted and the date it will be
The QIC reconsideration notice will specify
where to send the ALJ hearing request,
and the QIC will forward the case file to
the appropriate HHS Office of Medicare
Hearings and Appeals (OMHA) field office.
The supplier may also request a complete
copy of the case file. OMHA jurisdiction is
based on the appellant’s address of record.
Once the request is received by the OMHA
field office, the case is assigned to an ALJ.
The ALJ notifies the supplier of the hearing
date. If you have questions concerning
a pending appeal or about appealing a
decision, contact the OMHA field office that
serves your state or territory (see page 40).
Fourth Appeal: Departmental
Appeals Board (DAB) Review
If the appellant does not agree with
the ALJ’s decision, he/she may ask the
Departmental Appeals Board to review the
decision. There is no monetary threshold
to be met with a DAB appeal, however
a written appeal request must be made
within 60 days of the ALJ decision. The
request must specify the issues and findings
that are being contested. The ALJ written
decisions will provide details regarding
the procedures to follow when filing a
request for DAB review. Generally, the
Departmental Appeals Board will issue
a decision within 90 days of receipt of a
request for review.
Reopenings of initial determinations,
redeterminations, reconsiderations,
hearings and reviews
A reopening is a remedial action taken to
change a final determination or decision
that resulted in either an overpayment
or underpayment, even though the final
determination or decision may have been
correct at the time it was made based on
the evidence of record. The action may be
taken by:
•a DME DAB to revise the initial
determination or redetermination;
•a QIC to revise the reconsideration;
•an ALJ to revise the hearing decision;
•the DAB to revise the hearing or
review decision.
Granting a supplier’s request for a
reopening is at the discretion of the
contractor and is not mandatory. The
contractor’s decision on whether to reopen
is final and not subject to appeal. Specific
time frames are defined for reopenings in
accordance with which Medicare contracted
entity is reopening the claim. The right for
  TOC
a reopening may be exercised if it is felt
that the contractor made a mistake or if
there is additional information to provide.
There is no dollar limit for reopenings,
so this route may be appropriate if a
claim amount is less than that needed
for a specific level of appeal. To begin the
process, a letter requesting a reopening is
initiated. Forms to request a reopening of
initial and redeterminations may be found
at the respective DME MAC websites. If
the reopening request is denied, the appeal
process may still be undertaken if the time
and dollar requirements for the specific
level of appeal are met. More information
on claim reopenings may be found in the
Medicare Claims Processing Manual 10004, Chapter 34.
Final Appeal: Federal Court Review
If the appellant is not satisfied with the
ALJ decision and the amount in controversy
meets the current year minimum, a judicial
review before a Federal District Court judge
may be requested. The request must be
made within 60 days of receipt of the DAB’s
decision. The DAB’s decision notice will
contain information about the procedures
for requesting a judicial review.
  TOC
HHS Office of Medicare Hearings and Appeals (OMHA)
Field Offices and State Jurisdictions
Arlington, Virginia
(Mid-Atlantic Field Office)
1700 N. Moore St., Suite 1600
Arlington, VA 22209
Phone: 866-231-3087
Cleveland, Ohio
(Mid-West Field Office)
Mid-Atlantic Field Office Jurisdiction
HHS Region 3
District of
Mid-West Field Office Jurisdiction
HHS Region 1
HHS Region 2
HHS Region 3
HHS Region 4
HHS Region 5
BP Tower, Suite 1300
200 Public Square
Cleveland, OH 44114-2316
Phone: 866-236-5089
New Hampshire
Rhode Island
New York
New Jersey
West Virginia
Irvine, California
(Western Field Office)
Western Field Office Jurisdiction
27 Technology Drive, Suite 100
Irvine, CA 92618-2364
Phone: 866-495-7414
Miami, Florida
(Southern Field Office)
100 SE 2nd Street, Suite 1700
Miami, FL 33131-2100
Phone: 866-622-0382
HHS Region 7
HHS Region 8
HHS Region 9
HHS Region 10
North Dakota
South Dakota
Trust Territory
of the Pacific Islands
American Samoa
Southern Field Office Jurisdiction
HHS Region 2
HHS Region 4
HHS Region 6
Puerto Rico
Virgin Islands
North Carolina
South Carolina
New Mexico
42CFR Part 405, Subpart 1, provides a full and accurate description of the appeal process.
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Corrected Claims
Medicare will allow an enteral provider
to bill prospectively for 1 month only.
However, retrospective billing may
include multiple months, is simpler, and
makes it easier to confirm correct patient
information. Prospective claims may be
created and filed with Medicare only to
learn later that the patient had an order
change or therapy was discontinued. When
this happens, an under/overbilling situation
may occur. In the event that a claim has
been under/overbilled, the provider is
expected to notify the DME MAC of the
billing error. Fines and penalties can be
imposed if a Medicare audit shows that
overpayments have not been refunded.
(See Fraud and Abuse on the next page.)
If a claim is underbilled, the supplier may
be able to resolve the problem via the
telephone reopening process. This process
is used to resolve minor errors or omissions
involving units of service, service dates,
HCPCS code issues, diagnosis codes and
diagnosis reference, modifiers, place of
service, and claims incorrectly denied as
duplicate charges. If the claim issue cannot
be resolved using the telephone reopening
process, the supplier may need to appeal
the claim through the Medicare appeals
If a supplier receives an overpayment for
DMEPOS items, the supplier should initiate
a voluntary refund to the appropriate DME
MAC. Each of the four DME MACs provide
instructions and forms for voluntary
refunds of overpayments. If the specific
DME MAC form is not used, a similar
document containing all of the required
information should accompany the refund
check so that the receipt of the check is
properly recorded and applied.
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Fraud and Abuse
Program Safeguard Contractors (PSCs) and Zone Program Integrity
Contractors (ZPICs)
PSCs and ZPICs are contractors affiliated
with the DME MACs that specialize in
benefit integrity (BI) work. The primary
goal of the BI unit is to identify cases of
suspected fraud and take immediate action
to ensure that Medicare Trust Fund monies
are not inappropriately paid out and that
any mistaken payments are recouped. All
suspected cases of fraud are referred to the
Office of Inspector General (OIG), Office
of Investigations field office (OIFO) for
consideration and initiation of criminal or
civil prosecution, civil monetary penalty,
or administrative sanction actions. Having
specific entities that focus on BI enables
the four DME MACs to place greater focus
on claims processing and customer service.
CMS is in the process of transitioning all BI
work from PSCs to ZPICs.
Benefit integrity units use a variety
of tools including data analysis, fraud
complaints, and referrals. They also develop
innovative tools and techniques to identify
potential Medicare fraud and abuse.
These approaches are used in building and
referring cases to law enforcement involving
those who are suspected of perpetrating
Medicare fraud. More information on BI
units may be found in chapter 4 of the
Medicare Program Integrity Manual (Pub.
100-08) at:
Fraud is intentional deception or
misrepresentation that the individual
makes, knowing it to be false and that it
could result in some unauthorized benefit to
them. Abuse describes incidents or practices
of providers, physicians, or suppliers, or
services and equipment which, although not
usually fraudulent, are inconsistent with
accepted sound medical, business, or fiscal
practices. These practices may, directly or
indirectly, result in unnecessary costs to the
program, improper payment, or payment for
services which fail to meet professionally
recognized standards of care, or which are
medically unnecessary.
Examples of fraud include but are not
limited to:
• Incorrect reporting of diagnoses or
procedures to maximize payments.
• Billing for services not furnished and/
or supplies not provided.
• Billing that appears to be a deliberate
application for duplicate payment for
the same services or supplies, billing
both Medicare and the beneficiary
for the same service, or billing both
Medicare and another insurer in an
attempt to get paid twice.
• Soliciting, offering, or receiving a
kickback, bribe, or rebate, e.g., paying
for a referral of patients in exchange
for the ordering of diagnostic tests and
other services or medical equipment.
Examples include:
– P
hysicians acting either in
the capacity of a consultant or
attending physician who are offered
percentages of Medicare payment if
they refer patients needing Durable
Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)
services to specific DMEPOS
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– Skilled nursing facilities or nursing
homes that are offered—at no
charge—durable medical equipment,
formula for Part A patients,
computers, billing services, or
rebates as an inducement to refer
patients to a specific PEN supplier.
– Unbundled or fragmented charges.
– Falsification of DIFs
(i.e., misrepresenting the diagnosis
for the patient to justify the services
or equipment furnished—e.g.,
indicating the patient cannot
swallow, when in fact he or she can).
The CMS Office of the Inspector General
regularly issues Fraud Alerts, Advisory
Opinions, and reports of these topics. For
more information, visit the OIG website at
Supplier Standards
CMS has established 30 Supplier Standards
that govern the business practices of
the DMEPOS supplier industry. These
standards are defined in the Medicare
Enrollment Application (
cmsforms/downloads/cms855s.pdf), and
suppliers must follow these standards and
disclose them to all customers/patients who
are Medicare beneficiaries.
Note: This is an abbreviated version of
the supplier standards every Medicare
DMEPOS supplier must meet in order to
obtain and retain their billing privileges.
These standards, in their entirety, are listed
in 42 C.F.R. 424.57(c).
1. A supplier must be in compliance
with all applicable Federal and State
licensure and regulatory requirements
and cannot contract with an individual
or entity to provide licensed services.
2. A supplier must provide complete and
accurate information on the DMEPOS
supplier application. Any changes to
this information must be reported to the
National Supplier Clearinghouse within
30 days.
3. An authorized individual (one whose
signature is binding) must sign the
application for billing privileges.
4. A supplier must fill orders from its own
inventory, or must contract with other
companies for the purchase of items
necessary to fill the order. A supplier
may not contract with any entity that
is currently excluded from the Medicare
program, any State health care
programs, or from any other Federal
procurement or non-procurement
5. A supplier must advise beneficiaries
that they may rent or purchase
inexpensive or routinely purchased
durable medical equipment, and offer
the purchase option for capped rental
6. A supplier must notify beneficiaries
of warranty coverage and honor all
warranties under applicable State law,
and repair or replace free of charge
Medicare covered items that are under
7. A supplier must maintain a physical
facility on an appropriate site. This
standard requires that the location
is accessible to the public and staffed
during posted hours of business. The
location must be at least 200 square feet
and contain space for storing records.
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8. A supplier must permit CMS or its
agents to conduct on-site inspections to
ascertain the supplier’s compliance with
these standards. The supplier location
must be accessible to beneficiaries
during reasonable business hours, and
must maintain a visible sign and posted
hours of operation.
9. A supplier must maintain a primary
business telephone listed under the
name of the business in a local directory
or a toll free number available through
directory assistance. The exclusive
use of a beeper, answering machine,
answering service, or cell phone during
posted business hours is prohibited.
10. A supplier must have comprehensive
liability insurance in the amount of
at least $300,000 that covers both
the supplier’s place of business and
all customers and employees of the
supplier. If the supplier manufactures
its own items, this insurance must also
cover product liability and completed
11. A supplier must agree not to initiate
telephone contact with beneficiaries,
with a few exceptions allowed. This
standard prohibits suppliers from
contacting a Medicare beneficiary based
on a physician’s oral order unless an
exception applies.
12. A supplier is responsible for delivery
and must instruct beneficiaries on
use of Medicare-covered items, and
maintain proof of delivery.
13. A supplier must answer questions and
respond to complaints of beneficiaries,
and maintain documentation of such
14. A supplier must maintain and replace
at no charge or repair directly, or
through a service contract with another
company, Medicare-covered items it has
rented to beneficiaries.
15. A supplier must accept returns of
substandard (less than full quality for
the particular item) or unsuitable items
(inappropriate for the beneficiary at the
time it was fitted and rented or sold)
from beneficiaries.
16. A supplier must disclose these supplier
standards to each beneficiary to whom
it supplies a Medicare-covered item.
17. A supplier must disclose to the
government any person having
ownership, financial, or control interest
in the supplier.
18. A supplier must not convey or reassign
a supplier number; i.e., the supplier
may not sell or allow another entity to
use its Medicare billing number.
19. A supplier must have a complaint
resolution protocol established to
address beneficiary complaints that
relate to these standards. A record of
these complaints must be maintained at
the physical facility.
20. Complaint records must include: the
name, address, telephone number
and health insurance claim number
of the beneficiary, a summary of the
complaint, and any actions taken to
resolve it.
21. A supplier must agree to furnish
CMS any information required by the
Medicare statute and implementing
22. All suppliers must be accredited
by a CMS-approved accreditation
organization in order to receive and
retain a supplier billing number. The
accreditation must indicate the specific
products and services, for which the
supplier is accredited in order for the
supplier to receive payment of those
specific products and services (except
for certain exempt pharmaceuticals).
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23. All suppliers must notify their
accreditation organization when a new
DMEPOS location is opened.
24. All supplier locations, whether owned or
subcontracted, must meet the DMEPOS
quality standards and be separately
accredited in order to bill Medicare.
25. All suppliers must disclose upon
enrollment all products and services,
including the addition of new product
lines for which they are seeking
26. Must meet the surety bond
requirements specified in
42 C.F.R. 424.57(c).
27. A supplier must obtain oxygen from a
state-licensed oxygen supplier.
28. A supplier must maintain ordering and
referring documentation consistent with
provisions found in 42 C.F.R. 424.516(f).
29. DMEPOS suppliers are prohibited from
sharing a practice location with certain
other Medicare providers and suppliers.
30. DMEPOS suppliers must remain open
to the public for a minimum of 30 hours
per week with certain exceptions.
Competitive Bidding
According to,
the DMEPOS Competitive Bidding Program
was mandated by Congress through the
Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA).The
statute requires that Medicare replace the
current fee schedule payment methodology
for selected Durable Medical Equipment,
Prosthetics, Orthotics and Supplies
(DMEPOS) items with a competitive
bid process. The intent is to improve the
effectiveness of the Medicare methodology
for setting DMEPOS payment amounts,
which will reduce beneficiary out-of-pocket
expenses and save the Medicare program
money while ensuring beneficiary access to
quality items and services.
Under the program, a competition among
suppliers who operate in a particular
Competitive Bidding Area (CBA) is
conducted. Suppliers are required to
submit a bid for selected products. Enteral
Nutrients, Equipment and Supplies is
a category subject to bidding. Bids are
submitted electronically through a webbased application process and required
documents are mailed. Bids are evaluated
based on the supplier’s eligibility, its
financial stability and the bid price.
Contracts are awarded to the Medicare
suppliers who offer the best price and meet
applicable quality and financial standards.
Contract suppliers must agree to accept
assignment on all claims for bid items and
will be paid the bid price amount. The
amount is derived from the median of all
winning bids for an item.
Beneficiaries with original Medicare who
obtain enteral nutrients, equipment and
supplies in Competitive Bidding Areas must
obtain these items from a winning contract
supplier in order for Medicare to pay. This
also applies to beneficiaries who do not live
in a Competitive Bidding Area but who
obtain these items while traveling in an
area. For areas not currently impacted by
the Medicare Competitive Bidding program,
the current Medicare fee schedule payment
amounts will continue to be paid.
The Medicare Competitive Bidding Program
will be implemented in phases. Round One
Rebid phase was fully implemented in
2011 and impacted 9 specific areas of the
country. Round Two is scheduled to be fully
implemented in 2013 and will impact 91
additional areas in the country.
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The Centers for Medicare & Medicaid
Services (CMS) has contracted with
Palmetto GBA to administer the DMEPOS
Competitive Bidding Program. Palmetto
GBA is responsible for conducting certain
functions including performing bid
evaluations, selecting qualified suppliers,
setting payments for all competitive bidding
areas and overseeing an education program.
Palmetto GBA also assists CMS and its
contractors in monitoring the program’s
effectiveness, access, and quality.
Quality Standards and Accreditation
CMS published the final quality standards
for DMEPOS suppliers in October
2008 in accordance with the Medicare
Modernization Act. The standards help
ensure that Medicare beneficiaries
receive quality health care services
and include requirements for supplier
business services and supplier productspecific services. Suppliers must comply
with the quality standards in order to 1)
furnish any DMEPOS item or service,
for which Medicare Part B makes
payment, and 2) to receive or retain
a provider or supplier billing number
used to submit claims to Medicare for
reimbursement. The quality standards
may be viewed at:
All DMEPOS suppliers of enteral nutrients,
equipment, and supplies need to comply
with Section I (Supplier Business Service
Requirements) and Section II (Supplier
Product-Specific Service Requirements) of
the quality standards.
All DMEPOS suppliers must also be
accredited by a CMS-approved Deemed
Accreditation Organization, including
those suppliers who are initially enrolling
in Medicare. Accrediting organizations
are responsible for ensuring suppliers
meet the quality standards. The National
Supplier Clearinghouse (NSC) will
not approve any DMEPOS supplier’s
enrollment application if the enrollment
package does not contain an approved
accreditation upon receipt or in response
to a developmental request. The NSC shall
reject the enrollment application unless
the DMEPOS supplier provides supporting
documentation that demonstrates that the
supplier has an approved accreditation.
The following weblink provides more
information on accreditation and a list
of CMS-approved Deemed Accreditation
Organizations: https://www.cms.
Office of Inspector General’s
Compliance Guidance
In June 1999, the Department of Health
and Human Services’ Office of Inspector
General (OIG) issued compliance program
guidance that details actions that suppliers
of enteral nutrition can take to help
prevent violations of the Medicare fraud
and abuse laws. The document, titled
“Office of Inspector General’s Compliance
Program Guidance for the Durable Medical
Equipment, Prosthetics, Orthotics and
Supply Industry,” provides general and
specific guidance about various internal
anti-fraud and abuse controls suppliers can
voluntarily implement. Additionally, the
OIG has released guidance for third-party
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medical billing companies that parallels
the requirements for the DME compliance
program. Both guidances are available on
the internet at
complianceguidance.asp It is strongly
recommended that providers or billers of
enteral nutrition review these documents
and ensure that their program meets the
recommendations found in the guidances.
The guidance suggests that every company
implement a compliance program. At a
minimum, seven elements of a compliance
program should be in place:
1.Development and distribution of written
standards of conduct, as well as written
policies and procedures that promote the
supplier’s commitment to compliance.
These policies should address specific
areas of potential fraud, such as the
claims development and submission
process, completing DIFs, cover letters,
retention of records, and waivers of
coinsurance and deductibles.
2.Designation of a compliance officer and
other appropriate bodies charged with
the responsibility for operating and
monitoring the compliance program and
who report directly to the CEO and the
governing body.
3.Development and implementation of
regular, effective education and training
for all affected employees.
4.Development of effective lines of
communication between the compliance
officer and all employees, including
a process to receive complaints, and
the adoption of procedures to protect
the anonymity of complainants and to
protect callers from retaliation.
5.Use of audits and/or other risk
evaluation techniques to monitor
compliance, identify problem areas,
and assist in the reduction of identified
problem areas.
Development of policies addressing
employees who have violated internal
compliance policies, applicable statutes,
regulations, or federal, state, or
private payer or health care program
requirements and the employment
of sanctioned and other specified
7.Development of policies to respond
to detected offenses and to initiate
corrective action to prevent similar
Beyond the seven basic elements, the
guidance addresses 47 compliance risk
areas specific to DMEPOS suppliers that
are of particular concern to the OIG.
They range from improper telemarketing
practices and paying kickbacks for referrals
to double billing and falsifying information.
Among other things, the guidance cautions
•Providing and/or billing for
substantially excessive amounts of
DMEPOS items or supplies. The
OIG recommends that if a DMEPOS
supplier is providing and billing for
a large number of items or supplies
for the same patient, it periodically
contact the treating physician to
confirm the medical necessity of the
items and supplies. Such contact
should be documented.
•Engaging in business arrangements
that may violate anti-kickback statutes
or other similar federal and state
statutes or regulations, e.g., providing
something of value in exchange for the
referral of federal health care program
•Improper conduct relevant to
completing DIFs. This includes
billing for items or supplies prior to
receiving a written order or falsifying
information on the DIF.
6.Development of appropriate disciplinary
mechanisms to enforce standards.
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•Billing for services not provided. This
guideline includes not fulfilling a
contractual agreement, such as when
the DMEPOS supplier has agreed to
service rental equipment and does not
fulfill this obligation. For example, the
government assigns the responsibility
for maintenance of a rental pump
to the supplier who was paid for
the 15th month of rental. If another
provider accepts the responsibility for
ongoing rentals after the 15th month,
no additional rental charges will be
•Billing patients for denied charges
without a written notice.
•Using a billing agent whose
compensation arrangements violate
the reassignment rule.
•Refusing to submit a claim to Medicare
for which payment is made on a
reasonable charge or fee-schedule
basis. If a supplier provides an
item or service that is a Medicare
benefit and reimbursable under the
Medicare program, it is responsible for
submitting the claim to Medicare even
if it does not accept assignment.
•Failing to maintain medical
necessity documentation. DMEPOS
providers need to ensure that the
patient’s medical record contains and
substantiates all of the information
contained on the DIF.
•Providing actual or potential referral
sources with incentives that may
violate the anti-kickback statutes.
Examples of arrangements that may
run afoul of anti-kickback statutes
include practices in which a supplier
pays a fee or provides a free gift to a
physician for each written order.
•Not notifying the National Supplier
Clearinghouse of changes to the
information previously provided on the
DMEPOS supplier enrollment form
within 30 days of the effective date of
the change. This includes change of
address or ownership.
•Failing to refund overpayments to a
health care program or to the patient.
This doesn’t mean just repaying an
overpayment that the DME MAC
requests; it puts the responsibility
on the supplier to identify any
overpayment received for whatever
reason. The OIG strongly recommends
that the DMEPOS supplier institute
procedures to detect overpayments and
to promptly remit such overpayments
to the affected payer.
•Employing persons who have been
excluded from participation in federal
health care programs.
The OIG has made it known that the
existence of an effective compliance
program will be a factor in determining
the administrative sanctions, penalties, or
other action to be taken against a supplier
who self-reports or is caught in subsequent
wrongdoing. All suppliers should review
these documents carefully and assure
themselves that their programs comply
with the examples given in the guidelines.
Audit Process
The emphasis of fraud and abuse audits
has recently increased. Suppliers of enteral
nutrients, equipment, and supplies to
Medicare beneficiaries may be audited
by the National Supplier Clearinghouse
(NSC), Program Safeguard Contractor
(PSC) or Zone Program Integrity Contractor
(ZPIC), Comprehensive Error Rate Testing
Contractors (CERT), or Recovery Audit
Contractors (RAC). Suppliers should be
prepared for a review of their company and
their billing processes.
National Supplier Clearinghouse
The National Supplier Clearinghouse (NSC)
is responsible for ensuring suppliers are
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in compliance with the DMEPOS supplier
standards. The NSC may conduct site
visits or surveys to determine a supplier’s
compliance in response to initial enrollment
applications, re-enrollments, reactivation
of billing privileges, and at any other time
deemed necessary. The authorized site
inspector will examine documentation of
a supplier’s compliance with all Supplier
Standards including:
• Local, state, and federal licensure
(including the business license)
• Day-to-day operating procedures—
physical setup of the facility, its
address and business hours (make
sure the company is listed in the
telephone book)
• Supplier inventory, records, lease/
vendor agreements, and invoices
• Beneficiary files, including proof of
delivery, written orders, and DIFs
• Disclosure of supplier standards to
• Proof of general liability insurance
Site visits are unannounced and will take
place during your posted hours of operation.
The authorized site inspector, whether an
NSC employee or a contractor, will have
with them a photo identification card and a
signed letter on CMS letterhead authorizing
the individual to conduct the visit. Please
note the inspector will have a camera to
take various pictures of the facility, sign,
inventory, etc. The inspector will also have
a questionnaire to complete based on the
supplier standards. The inspector will ask
to review your files to determine if you are
in compliance with certain requirements of
the supplier standards. However, the site
inspector should not take the files, make
copies, or take pictures of the information
contained in the files.
Notify the NSC immediately if the site
inspector requests to take the original
or make copies of the beneficiary files or
fails to present the photo ID or signed
authorization letter. Do not give any
information to an individual who is not
properly credentialed. Call the NSC at
(866) 238-9652 to report any concerns.
It is important to note the DMEPOS site
visit process is a completely separate
process from accreditation. The NSC and
the accrediting organizations appointed
by CMS are enforcing two different sets
of standards. The NSC will not conduct a
site visit with regards to the accreditation
process. Suppliers can expect to receive site
visits or surveys from both the NSC and the
accrediting organizations.
DMEPOS suppliers must renew their
provider numbers every 3 years. The NSC
will send a re-enrollment package to the
address on file as the provider’s physical
location. Suppliers have 30 days to respond
or their number will be canceled. This reenrollment may also trigger an onsite audit.
Make sure that all address changes are
communicated to the NSC within 30 days of
the change (as required under the provider
agreement) to ensure that the re-enrollment
packet goes to the correct address. Provider
enrollment updates may be in writing to the
NSC or via the CMS online PECOS system.
More information on conditions a supplier
must meet to be eligible to receive payment
for a Medicare-covered item may be found
at 42 CFR §424.57. Visit the NSC website for more
information on DMEPOS supplier NSC
site visits.
Program Safeguard Contractors (PSC)
and Zone Program Integrity Contractors
(ZPIC) Benefit Integrity Audits
As previously mentioned, PSCs and ZPICs
are responsible for DME MAC benefit
integrity (BI) and all fraud and abuse
activities, including pre- and post-payment
reviews, audits, and anti-fraud functions.
The BI units are responsible for preventing,
detecting, and deterring Medicare fraud by:
• Identifying program vulnerabilities.
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• Proactively identifying incidents of
potential fraud that exist within its
service area and taking appropriate
action on each case.
• Investigates (determining the factual
basis of) allegations of fraud made by
beneficiaries, providers, CMS, OIG,
and other sources.
• Exploring all available sources
of fraud leads in its jurisdiction,
including state Medicaid fraud control
units and its corporate anti-fraud unit.
• Initiating appropriate administrative
actions to deny or to suspend
payments that should not be made
to providers where there is reliable
evidence of fraud.
• Referring cases to the Office of
the Inspector General/Office
of Investigations (OIG/OI) for
consideration of civil and criminal
prosecution and/or application of
administrative sanctions.
• Referring any necessary provider and
beneficiary outreach to the POE staff
at the DME MAC.
• Initiating and maintaining networking
and outreach activities to ensure
effective interaction and exchange of
information with internal components
as well as outside groups.
Benefit integrity units are required to use
a variety of techniques, both proactive
and reactive, to address any potentially
fraudulent billing practices. Proactive (selfinitiated) leads may be generated and/
or identified by any internal PSC, ZPIC,
or DME MAC component, not just the BI
unit. DME MAC personnel conducting each
segment of claims adjudication, medical
review (MR), and professional relations
functions are responsible for identifying
fraud and forwarding potential fraud cases
to a BI unit. Benefit integrity units will
also pursue leads through data analysis,
the internet, the Fraud Investigation
Database (FID), news media, etc. Each BI
unit investigation is unique and tailored
to the specific circumstances. If a BI unit
determines that a situation is not fraud,
the case is referred to the appropriate unit
at the DME MAC. For more information,
refer to CMS Program Integrity Manual
(PUB. 100-08) Chapter 4 - Benefit Integrity
Comprehensive Error Rate Testing (CERT)
CMS established the Comprehensive Error
Rate Testing (CERT) program to calculate
a national paid claims error rate for the
Medicare Fee-For-Service program. On a
post-payment basis, the CERT program
randomly samples and reviews submitted
claims in accordance with Medicare
coverage, coding, and billing rules.
Supporting medical records are requested
from the DMEPOS supplier paid for the
claim and evaluated during claim review.
The CERT program considers improper
payment as any claim that was paid when
it should not have been. When requested
medical records are not submitted by the
provider, CERT classifies the case as a
“no documentation” claim and counts it
as an improper payment. Based on claim
review, CERT sends providers overpayment
letters/notices or makes adjustments for
claims where an overpaid or underpaid
determination was made. CERT claim
denials may be appealed through the
Medicare appeals process.
The CERT program uses random samples to
select claims and reviewers are often unable
to see provider billing patterns that indicate
potential fraud when making payment
determinations. The CERT program does
not, and cannot, label a claim fraudulent.
Each of the four DME MACs provides
CERT information on their websites.
Additional information on CERT, including
published error rate reports, may be found
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Recovery Audit Contractors (RAC)
Recover audit contractors are also
contracted by CMS to detect and
correct improper Medicare payment on
a post-payment basis. RACs are paid
based on a contingency fee which is a
negotiated percentage of the amount of
improper payments they correct for both
overpayments and underpayments. CMS
must approve issues for RAC review and
a review notice must be posted before
the review can begin. A RAC Validation
Contractor (RVC) works with CMS and the
RACs to approve new issues the RACs want
to pursue for improper payments. The RVC
also monitors RACs by performing accuracy
reviews on a sample of randomly selected
claims on which the RACs have already
collected overpayments.
RACs apply statutes, regulations, CMS
national coverage, payment and billing
policies, as well as LCDs that have been
approved by the Medicare claim processing
contractors in claim reviews. In general,
claims previously reviewed by another
entity are not subject to RAC review. RAC
reviews may be automated or complex.
Automated reviews typically evaluate
claims payments based on technical issues
such as units of service billed vs. allowed,
while complex reviews may focus on
medical record review to determine medical
RACs may request records for complex
review every 45 days (eight times per
year). Request limits are set at 10% of
all claims submitted for the previous full
calendar year, divided into eight periods
(45 days), up to a current cap of 250 records
per request period. RACs may request
permission from CMS to exceed the cap
limit. Although the RACs may go more than
45 days between record requests, in no case
may they make requests more frequently
than every 45 days.
Each RAC works with one of the four DME
MAC regions. DMEPOS issues currently
under review are listed at each RAC
website. More information may also be
found at:
• Region A RAC: DCS Healthcare
• Region B RAC: CGI Federal,
• Region C RAC: Connolly Healthcare,
• Region D RAC: HealthDataInsights,
Audit Preparation
Suppliers are encouraged to be prepared
for Medicare audits before they happen.
Suggestions for preparedness include:
• Keep up-to-date on LCDs, NCDs,
and related articles. Know what
documentation is needed for each
item you provide. When Medicare
audits a claim, they make sure the
requirements outlined in LCDs,
NCDs, and related articles are met.
Develop documentation checklists for
your files to assure you always have
all of the necessary documentation.
Keep records orderly and consistent.
• Whenever possible, get as much
clinical documentation up front for the
services you provide. It is much easier
to get the documentation you need at
the time the service is ordered rather
than having to go back if faced with
an audit.
• Make sure your referral sources know
the coverage guidelines and conditions
for the items they order.
• Do not rely on supplier-generated
forms to document medical necessity.
They are not considered part of the
medical record and may discourage
physicians from documenting the
information in their own record.
  TOC
• Make sure every record has a copy
of a signed and dated Assignment of
Benefits (AOB) as well as sufficiently
detailed, signed, and dated dispensing
and detailed written orders.
• Be certain that delivery documentation
is sufficiently detailed, signed, and
• Keep current on local, state, and
federal licensure requirements. Make
copies of licenses, insurance policies,
and vendor contracts and store them
in a designated place.
• Attend workshops, read advisories,
and consult ombudsmen for education
updates regarding medical necessity
and billing practices for the DMEPOS
items you supply.
• Be proactive—it is much more costeffective to review documentation
and files in advance to determine
if you have any issues rather than
waiting for an auditor to review your
claims and potentially extrapolate any
identified overpayments.
necessity for the items being audited.
This may include information from
hospital admissions and physician
office notes. Medicare policies state
that supporting documentation must
be provided if requested. If necessary,
contact the ordering physicians and
request specific documentation related
to why they prescribed the item in
• Conduct a comprehensive review
of the documentation prior to
submitting it. If you identify issues
in your review, prepare a corrective
action plan to address those issues
• Keep copies of all records sent to the
auditing agency.
• Continue working with referral
sources to obtain needed clinical
documentation even after record
requests have been submitted.
Additional documentation may be
helpful if an appeal is needed.
When you receive a record request:
• Begin compiling the documentation
immediately. Claims are often denied
because deadlines are missed. If you
cannot meet a deadline, call and
request an extension.
• Include all medical record
documentation supporting the medical
  TOC
Administrative Law Judge (ALJ)—Hearing official assigned to the HHS Office of
Hearing and Appeals. Conducts evidentiary hearings on appeals from Medicare Part A
and B determinations.
ALJ hearing—A quasi-judicial administrative hearing conducted by a federal ALJ. It
results in a new decision by an independent reviewer. An ALJ hearing is the third level
of appeal following reconsideration by a QIC.
Amount in controversy—The difference between the amount charged the beneficiary
and the amount Medicare allowed, less any remaining Part B deductible, less 20% of
the remainder. To meet the amount-in-controversy requirements of the various levels of
appeal, a beneficiary or provider may combine claims for Part B services.
Appeal requests—Written statements asking for review of an initial payment
Appeals adjustments—Changes in payment resulting from reconsiderations,
redeterminations, ALJ hearings, Departmental Appeals Board reviews, judicial reviews,
or reopenings.
Assignee—A representative given authority by the beneficiary to act on his or her behalf.
Beneficiary—A person entitled to receive Medicare benefits.
CMS—Centers for Medicare and Medicaid Services.
CEDI—Common Electronic Data Interchange.
Common working file—A shared database of Medicare claims information used to verify
diagnosis, treatment, and payment by various Medicare carriers.
Comprehensive Error Rate Testing (CERT) Program—A program contracted by
CMS to calculate the national paid claims error rates for the Medicare Fee-For-Service
program. CERT randomly reviews DMEPOS claims on a post-payment basis.
DME MAC Information Form (DIF)—An essential tool in determining coverage. The
form is used to document the patient’s physiological need and prescription for parenteral
or enteral nutritional therapy (CMS form 10126).
DMEPOS—Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.
Dumping syndrome—Rapid emptying of food out of the stomach and into the intestine,
which draws fluid into the intestine and causes nausea, light-headedness, weakness, and/
or vomiting.
  TOC
Durable Medical Equipment Medicare Administrative Contractor (DME MAC) —
A private company with a government contract to administer Medicare Part B DMEPOS
Enteral nutrition (EN)—Nutrition provided directly into GI tract rather than orally or
Enteral supply kit—Contains all the necessary supplies for an enteral patient using the
syringe (B4034), pump (B4035), or gravity (B4036) method of nutrient administration.
Products such as syringes, split 4 x 4 gauze, feeding bags, and tubing may be included in
enteral supply kits.
EOMB—Explanation of Medical Benefits. A form sent to Medicare beneficiaries
explaining Medicare payment of DMEPOS items.
Full reversal—Payment of an appealed claim in the allowable amount less co-insurance
and deductible.
Functional impairment—A permanent nonfunction or disease of the structures that
normally permit food to reach the small bowel, or a disease of the small bowel that impairs
digestion and absorption of an oral diet.
Gastrointestinal (GI) tract—The digestive tube from the mouth to the anus, including
mouth or buccal cavity, pharynx, esophagus, stomach, small and large intestines, and
Gastrostomy tube (G tube)—Silicone tube that provides direct access into the stomach.
Gravity feeding—Nutrients delivered into the GI tract by a feeding tube via a drip
administration set.
HHA—Home health agency.
ICD-9-CM—International Classification of Diseases, 9th Revision, Clinical Modification.
Inquiries—All oral and written contacts of a claimant that do not request a reexamination or state dissatisfaction with the previous determination.
Interactive Voice Response (IVR) System­—A system that enables providers to obtain
claim information electronically by pressing various numbers on a touch-tone telephone.
Jejunostomy tube—A tube placed through or into the jejunal portion of the small bowel.
Malabsorption syndrome—Inadequate absorption of nutrients from the intestinal tract.
May be associated with or due to a number of diseases.
Medigap insurance—Private insurance policies designed to cover medical expenses,
including co-insurance and deductible expenses not fully reimbursed by Medicare.
  TOC
Nasogastric tube—Tube inserted into the nose and passing through the esophagus into
the stomach.
National Provider Identifier (NPI)—A 10-digit standard unique identifying number for
health care providers. NPI replaced UPIN, OSCAR, PIN, and NSC.
New and material evidence—Evidence that was not considered when a previous
decision was made and that provides facts that may result in a different conclusion. The
information must be “new,” that is, not readily available or known to exist at the time of
the initial determination.
NG tube—Nasogastric tube.
NSC—National Supplier Clearinghouse.
OBRA—Omnibus Budget Reconciliation Act.
OIG—Office of Inspector General.
Parenteral nutrition—Nutrition provided by means of direct infusion of nutrients into a
patient’s bloodstream.
PECOS—The Medicare internet-based Provider, Enrollment, Chain and Ownership
System. In lieu of the Medicare paper enrollment application, providers may enroll and
update information in the Medicare program via PECOS.
PEN—Parenteral/enteral nutrition.
PPS—Prospective Payment System.
Pulmonary aspiration—Involuntary passage of fluids or nutritional substances into the
Pump feeding—Nutrients delivered into the GI tract via a feeding tube administration
set controlled by a volumetric pump.
Qualified Independent Contractor (QIC)—A CMS-contracted agency that considers
and rules on all DME MAC PEN reconsideration requests. A QIC reconsideration request
must be made in writing using CMS form 20033.
RAC—Recovery audit contractors. CMS-contracted companies that work on a contingency
fee reviewing Medicare claims on a post-payment basis.
Reconsideration—An independent determination of claims rendered by a QIC in
an appeal made within 180 days of the redetermination decision by the DME MAC.
Reconsideration is the second level of appeal following a redetermination.
Redetermination—The first level of appeal when a Part B claim has been denied;
a second look at the claim and supporting documentation by a different DME MAC
employee. Use CMS form 20027 to request a redetermination.
  TOC
Reflux—Involuntary return of gastric contents into the esophagus.
Remittance advice—A notice of payments and adjustments sent to providers,
billers, and suppliers after a claim has been received and processed. The remittance
advice explains the reimbursement decisions including the reasons for payments and
adjustments of processed claims.
Reopening—Re-evaluation of the claim determination, but not an appeal right.
Discretionary action in response to identification of a clerical error or to new and material
information not available at the time of the last adjudication.
SNF—Skilled Nursing Facility.
Supplemental nutrition—Nutritional supplements are required by some home care
patients for additional protein and calories. Oral nutritional supplements are often given
between meals to boost protein-calorie intake or as the mainstay of the daily nutritional
plan. Oral nutritional supplements are not covered under Medicare Part B.
Syringe feeding (bolus)—Delivery of nutrients into the feeding tube via a syringe.
Test of permanence—Met if, at the initiation of treatment, the physician and medical
record indicate that the condition is not temporary but is of long/indefinite duration,
ordinarily at least 3 consecutive months or 90 consecutive days.
  TOC
© 2011 Abbott Laboratories
77663/MARCH 2011

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