Department of Health and Hfiman Services 

OFFICE OF 

INSPECTOR GENERAL 

Coverage of Enteral Nutrition Therapy: 

Medicare and Other Payers 
.

OFFICE OF INSPE~OR GENERAL 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services’ (HHS) 

programs as well as the health and welfare of beneficiaries sewed by those programs. This 

statutory mission is carried out through a nationwide network of audits, investigations, and 

inspections conducted by three OIG operating components: the Offke of Audit SeMces, the 

Office of Investigations, and the Office of Evaluation and Inspections. The OIG also informs 

the Secretary of HHS of program and management problems and recommends courses to 

correct them. 

OFFICE OF AUDIT SERVICES 

The OIGS Office of Audit Sax&s (OAS) provides all auditing setices for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by others. 

Audits examine the performance of HHS program- and/or its ~antees and contractors in 

carrying out their respective responsibilities and are intended to provide independent 

assessments of HHS programs and operations in order to reduce waste, abuse, and 

mismanagement and to promote economy and efficiency throughout the Department. 

OFFICE OF INVESTIGATIONS . 

The OIGS Office of Investigations (01) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries and of 

unjust enrichment by providers. The investigative efforts of 01 lead to criminal convictions, 

administrative sanctions, or civil money penalties. The 01 also oversees State Medicaid fraud 

control units which investigate and prosecute fraud and patient abuse in the Medicaid program. 

OFFICE OF EVMX.JATION AND INSPECHONS 

The OIGS Office of Evaluation and Inspections (OEI) conducts short-term management and 

program evaluations (called inspections) that focus on issues of concern to the Department, 

the Congress, and the public. The findings and recommendations contained in these inspection 

reports generate rapid, accurate, and up-to-date information on the efficiency, vulnerability, 

and effectiveness of departmental programs. This report was prepared in the Philadelphia 

Regional Office, under the direction of Robert A. Vito, Acting Regional Inspector General. 

Project staff included: 

PHILADELPHIA REGION HEADQUARTERS 

Donna M. Millan, Lead Program AnaZyst Jennifer AntiCo,Program Spcialist 

Linda M. Ragone, Program Analyst 

Cynthia Hansford, Rogram Asszkant


Nancy J.W. Lewis, PharmD, MPH, Consultant


% . .. 
Department of Health and Hfiman Services 

OFFICE OF 

INSPECTOR GENERAL 

Coverage of Enteral Nutrition Therapy: 

Medicare and Other ‘Payers 

. 
EXECUTIVE SUMMARY 

PURPOSE 

This report describes and compares Medicare and non-Medicare payers’ coverage 

policies for enteral nutrition therapy. 

BACKGROUND 

Enteral nutrition therapy provides liquid nourishment directly to the digestive tract of 

a patient who cannot ingest an appropriate amount of calories to maintain an 

acceptable nutritional status. 

Medicare classifies enteral nutrition therapy under the prosthetic device benefit. 

Coverage is only for therapy required due to the absence or malfunctioning body part 

which normally permits food to reach the digestive tract. 

The Health Care Financing Administration (HCFA) administers the Medicare 

program. In an effort to aid the Durable Medical Equipment Regional Carriers’ 

revision and standardization of Medicare coverage policy, HCFA requested the Office 

of Inspector General to sulvey other payers to determine their coverage policies for 

enteral therapy. 

We surveyed Medicare risk-contracted and private health maintenance organizations, 

facilities from Department of Veterans Affairs, Medicaid State agencies, commercial 

payers, and Blue Cross/Blue Shield associations. 

FINDINGS 

MOST PAYERS SURVEYED ROUTINELY COVER ENTERAL NUTRITION 

THERAPY. 

Twenty out of 25 different payers routinely cover enteral nutrition therapy. The five 

payers who do not would only cover it under extraordinary circumstances. 

COMPARED TO OTHER PAYERS, MEDICARE’S COVERAGE 

REQWNWENTS ARE SIMILAR IN SOME AREAS AND MORE 

Restrictive IN OTHERS. 

Both Medicare and other-payers routinely cover enteral nutrition therapy when the 

patient requires tube feeding, when enteral nutrition is the patient’s exclusive source of 

nutrition, and if the patient has an anatomical or physiological malfunction of the 

gastrointestinal tract. Both types of payers also require a certificate of medical 

necessity or a prescription for coverage. Like Medicare, about half of the other 

payers do not routinely cover cognitive disorders such as Alzheimer’s Disease. 

i 
ldedicare’s coverage requirement is based on the malfunction of the gastrointestinal 

tract. Medical documentation must then prove the beneficia~’s need for enteral 

nutrition therapy meets this criteria. Although some other payers classify enteral 

therapy as a prosthetic device as Medicare does, these other payers still provide 

coverage for patient’s with a functioning gastrointestinal tract and special nutrient 

needs; Medicare does not. Medicare guidelines require specific documentation for 

category of nutrient product and caloric intake, and the use of pumps, while other 

payers do not. 

We hope the issues resulting from this report answer HCFA’S request for information 

on other payers’ coverage policies for enteral nutrition therapy, and aid HCFA in their 

effort to revise and standardize Medicare policy. 

Our work is continuing. We will review how other payers price enteral nutrition 

therapy products and compare their units of pricing, payment mechanisms, and 

supplier networks to Medicare’s policy. 

ii 
TABLE OF CONTENTS 

PAGE 

EXECUTIVE SUMMARY 

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...6


●Most Payers CoverEnteral Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..6


●Medicare’s PolicyIs Similar To Other Payers . . . . . . . . . . . . . . . . . . . . . . ...7


CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...12

INTRODUCTION 

PURPOSE 

This report describes and compares Medicare and other payers’ coverage policies for 

enteral nutrition therapy (ENT). 

BACKGROUND 

Me&are covers ENT underthe PartB prostheticdevicebenejit 

Enteral nutrition therapy (ENT) is a means to provide nourishment directly to the 

digestive tract of a patient who cannot, for a variety of reasons, ingest an appropriate 

amount of calories to maintain an acceptable nutritional status. The beneficiary 

consumes a liquid nutrient formula which can be administered one of three ways: 

● nasogastric tube: inserted through the nostril, 

.	 jejunostomy tube: inserted through a surgical incision leading to the small 

intestine, 

● gastrostomy tube: inserted through a surgical incision leading to the stomach. 

The Medicare guidelines classi~ ENT under the prosthetic device benefit because 

coverage is only for therapy required due to an absent or malfunctioning body part 

which normally permits food to reach the digestive tract.l 

Medicare covers ENT for conditions based on the malfunction of the gastrointestinal 

tract. According to Medicare guidelines, ENT is reasonable for: 

●❨ a beneficiary with a non-functioning gastrointestinal tract, who cannot maintain 

appropriate weight due to disease or non-function of the structures that 

normally permit food to reach the digestive tract, or 

●❨ a beneficiary with a disease of the small bowel that precludes digestion and 

absorption of sufficient nutrients and necessitates tube feeding to maintain the 

appropriate weight. 

Many medical conditions can cause malfunction of structures so as to preclude normal 

ingestion of food. Examples of conditions that would quali& for coverage are head 

and neck cancer with reconstructive surgery and central nervous system disease which 

lMedicare Carrier’s Manual, section 2130 and Medicare Coverage Issues Manual, 

section 65-10. 

1
leads to interference with the neuromuscular mechanisms of digestion so severe as to 

prohibit oral feeding. Medicare does notallow coverage for beneficiaries witha 

normally functioning gastrointestinal tract whose only need for ENT stems from lack 

of appetite or an organic brain syndrome2. 

Me&are nquiies-h dkummdm fix the medical necessity of ENT

Under Medicare guidelines, all enteral nutrition claims submitted to the Durable 

Medical Equipment Regional Carrier (DMERC) must be approved on an individual 

case-by-case basis. Each claim must have a certificate of medical necessity (CMN) 

signed by the attending physician and sufficient medical documentation (such as 

medical records and clinical findings from the attending physician) to permit an 

independent conclusion that the beneficiary meets the requirements of the prosthetic 

device benefit. A CMN must be renewed three, nine, and 24 months after the initial 

CMN. A new CMN is additionally required under these circumstances: 

s when there is a change in the category of nutrients or calories prescribed,


● a change horn enteral to parenteral (intravenous) therapy,


● or when there is a need for a pump.


If a documented need exists for ENT, Medicare will cover related supplies, equipment, 

and nutrients. Additional documentation is needed for the use of a pump to 

administer ENT. Only services rendered by a physician or by a non-physician 

professional whose services are incident to a physician’s semice are covered. 

Mdicare @deli&s&o requirejusiijicatbra fcucdtzin types of ENTproductr.

Medicare classifies ENT products into six categories based on the composition and 

source of ingredients in each product. Category I products are the most commonly 

used; they consist of natural intact protein or protein isolates. The guidelines state 

that if a physician prescribes a formula from Categories III through V, additional 

documents must justify the reason for prescribing a higher category formula. 

According to the policy, if the request cannot be substantiated, payment is based on 

the allowance for the least costly alternative. The categories of products, their 

composition and indications for use are listed in the table on the following page: 

2Any mental disorder, such as senile dementia or Alzheimer’s disease, resulting 

from or associated with organic changes in brain tissue. 

2 
MEDICARE’S CLASSIFICATION OF ENTERAL NUTRITION PRODUCTS 

BY COMPOSITION AND INDICATIONS FOR USE 

Category I 

F 

Categoxy III 

Category IV 

Category V 

Category VI 

semi-synthetic intact protein/protein 

isolates which are standard products for 

most patient use 

intact protein/natural protein isolates 

that are low sodium, high calorie products 

hydrolyzed amino acid formula used for 

patients unable to absorb intact protein 

isolates 

formulas designed to meet metabolic needs 

associated with specific disease conditions 

individual nutrition components (fat, 

protein, carbohydrates) that allow the 

making of customized formulas 

formulas with high protein content 

l'7aeDurablkiUedME@pmentRegionalc i-wimpnXeSEA7Tcti. 

The Health Care Financing Administration (HCFA) administers the Medicare Part B 

program. In October 1993, HCFA designated four DMERCS to process claims for 

durable medical equipment, prosthetics, orthotics, and supplies, including ENT. The 

DMERCS replace two previous carriers who had processed ENT claims. Each 

DMERC is responsible for its specific region of the country and processes claims 

originating from its respective geographic region. The HCFA has been active in 

aiding the DMERCS in transitioning to their new responsibility for ENT. The HCFA 

has also used this transition period to reexamine coverage policies and to standardize 

coverage decisions. On-going meetings led by HCFA have included discussions among 

DMERC representatives and nutritional experts. 

To aid the DMERCS in their evaluation and application of Medicare coverage policy, 

HCFA requested the Office of Inspector General to survey other payers about their 

ENT coverage policies. The request included gathering information related to criteria 

and documentation required for coverage. The HCFA also specifically expressed 

interest in information on the coverage of products designed for patients with special 

metabolic conditions. 
METHODOLOGY 

Using a standardized data collection instrument, we obtained information on each 

payer’s coverage criteria, documentation requirements, and product information. We 

also asked respondents to enclose a copy of their medical review guidelines and/or 

coverage policies for additional review. 

Individuals from each HCFA bureau reviewed our instrument and provided insight on 

appropriate questions and pertinent issue areas. We also pre-tested the questions with 

two payers not in our sample. We consulted with DMERC medical directors and their 

medical review staff as well. Each offered input on the questions and issues we should 

address. 

We sulveyed Medicare contractors to assess payment policies for beneficiaries under 

fee-for-service claims and services under managed care arrangements. Non-Medicare 

payers include the Department of Veterans’ Affairs (VA), Medicaid agencies, and 

private payers. The largest payers were selected from each group (with the exception 

of the VA facilities which are selected randomly in the Medicaid States in the sample). 

We surveyed a total of 34 payers and received responses from 28 respondent. Our 

analysis is based on the information from these payers: 

●four DMERCS 

● four Medicare risk. 

contracted health 

maintenance organizations 

(HMos) 

●four Department of 

Veterans Affairs (VA) 

facilities 

five Medicaid State 

agencies 

●four private HMOs 

●three private 

indemnity/commercial 

insurers 

four Blue Cross/Blue 

Shield Associations 

(BC/13S) 

Although, not all payers responded to all our questions, we grouped valid responses 

into pertinent coverage issues such as benefit classification, patient condition,-and 

documentation. We report how other payer’s policies differ or correspond with 

Medicare’s policies for ENT. 

4

For the purposes of our analysis, we designate the four DMERCS as representing one 

payer, Medicare. Where the Medicare risk-contracted HMOS’ coverage policies are 

similar to that of the DMERCS, we also designate the Medicare risk-contracted HMOS 

as Medicare. We also distinguish any issues where Medicare risk-contracted HMOS 

differ in their application of Medicare policy. These risk-contracted HMOS must 

provide, at minimum, what Medicare guidelines require for coverage; Medicare riskcontracted HMOS can also be more generous in benefit coverage. 

We gathered and analyzed this information ffom August through early November, 

1994. This inspection was conducted in accordance with the Quali~ Standards for 

Inspections issued by the President’s Council on Integrity and Efficiency. 

J 
FINDINGS€

MOST PAYERS SURVEYED ROUTINELY COVER ENTERAL NUTRITION 

THERAPY BUT CLASSIFY THE BENEFIT SEVERAL DETERENT WAYS. 

Twenty out of 25 different payers routinely cover enteral therapy, while five payers do 

not. Those five payers gave different reasons for not routinely covering it. Two Blue 

Cross/Blue Shield (BC/BS) payers stated that it is not a standard benefit in their plans. 

One Medicaid payer only covers ENT for individuals under the age of 21 because the 

cost of ENT is seen as prohibitive. One Veterans’ Affairs (VA) payer only covers 

persons on an inpatient basis. The fifth, a private indemnity payer, stated that while it 

covers the supplies and pumps, it does not cover the nutritional product since it is 

considered food. 

These five payers would cover ENT under exceptional circumstances. For example, 

the private indemnity payer would cover the product where it is mandated by State 

law. The BC/BS payers provide coverage if it were included in a specific group 

contract. The inpatient VA payer would provide ENT on an outpatient basis if the 

individual were indigent and if ENT were the patients’s sole source of nutrition. 

According to Medicare, ENT is a prosthetic device; however, other payers differ in 

their classification of ENT. Medicare’s classification of ENT as a prosthetic device 

benefit comes from the basis that ENT serves the function that an otherwise normal 

gastrointestinal structure would perform. Different classifications of ENT may result 

from other medical reasoning. Table 1 below illustrates how payers classi% the ENT 

benefit. 

HOW PAYERS CLASSIFY ENT AS A BENEFIT€

4/18 5/18 6/18 1/18€ 41 “18 

%is term includes the following classifications: “major medical benefit,” “under 

the benefit plan,” “as part of total care,” and “expendable medical supply.” 

6€
Three Medicare risk-contracted HMOS designate ENT as a prosthetic device benefit. 

Three other payers put ENTunder prosthetic device aswell. Five non-Medicare 

payers grouped ENT as a pharmaceutical benefit, while six place ENT in the durable 

medical equipment (DME) category. One Medicare HMO also classifies ENT under 

general durable medical equipment. The remaining payers cover ENT as a major 

medical/standard benefit or as nutrition. 

Note that the 18 other payers include the Medicaid agency who only covers children, 

the inpatient VA facility, and the private indemnity/commercial payer who only covers 

the pumps and supplies, not the product. It does not contain the two BC/13S payers 

who do not routinely cover ENT. In addition, four other (non-Medicare) payers use 

dual classifications for the ENT benefit. These four specifically differentiate between 

the actual ENT product and the supplies and pumps to administer the nutrition. In 

this case, typically, the ENT product is a pharmaceutical benefit, while the supplies 

and pumps are covered as DME or as a prosthetic device. 

Medicare and other payers use similar strategies to formulate their coverage policies. 

In defining their coverage policy for ENT, payers employed a combination of common 

strategies to compose their ENT policies, including consultation with nutritional 

experts, individual providers and manufacturers, and review of scientific literature. 

COMPARED TO OTHER PAYERS, MEDICARE’S COVERAGE 

REQUIWMmTS ARE MORE RESTRICI’IV EINSOMEAREASAND 

SIMILAR INOTHERS.

While almost all payers require their beneficiaries to have specific health conditions 

for ENT coverage, the Medicare guidelines dictate that ENT must serve the purpose 

of a prosthetic device, which is to replace a malfunctioning body part. 

PatientChditiom and ctnwmmwa “

As Table 2 on the following page illustrates, both Medicare and other payers routinely 

cover ENT under three circumstances: 1) when the patient requires tube feedings, 2) 

when ENT is the patient’s exclusive source of nutrition, and 3) when the patient has 

an anatomical or physiological malfunction of the gastrointestinal tract. For these 

three circumstances, both Medicare and other payers policies’ appear to be similar. 

7

.....................

............

.....

clRcuMsrANcEs WHERE MEDICARE COVERS ENT€

AND HOW OTHER PAYERS RESPOND€

*.:?..’*.:,.’. *.:<W.W+/:. COVERED 16/17 

~-;; , . . ....!

The seventeen other payers include the inpatient VA facility and the Medicaid State 

agency who serves only children. This figure does not include the two BC/BS payers 

who do not routinely cover ENT and a private indemnity payer who only covers 

pumps and supplies, not the product. 

The table below shows circumstances where payers and non-Medicare payers differ in 

their coverage policies. Medicare does not cover ENT that is orally ingested, while 

:@:::: ~;;’ : 

NOT COVERED 0/4 7/17

. 

;;.~~~;;,;:,;.~:s? NOTCOVERED 2J4 13/17 

. 

For some non-Medicare payers, patient diagnosis is sufficient to warrant routine 

coverage of ENT, while other non-Medicare payers will initially only cover ENT for 

specific diagnoses. Three non-Medicare respondents require that the patient have one 

of a variety of specific diagnoses, such as Crohn’s disease or enteritis. For other 

payers, another circumstance warranting ENT coverage is if a physician declares ENT 

medically necessary to maintain the patient’s body weight and general nutritional 

status. If the physician’s order in the patient’s medical record states a need for ENT 

or if prior authorization is issued, it is covered. An individual medical review for 

appropriateness can also be required. In two instances, State law mandated coverage 

of ENT for specific diseases. Often, for non-Medicare payers, physician evidence and 

documentation for the medical need of the therapy can repeal most coverage 

restrictions. 

8€
Non-G@rointminal ReLz&dDimziem 

In contrast to Medicare guidelines, just over two-thirds of non-Medicare payers will 

cover ENT for patients with a functioning gastrointestinal tract, but still have special 

nutritional needs. Three Medicare risk-contracted HMOS classi& ENT as a prosthetic 

device, but do cover patients with special nutritional needs. Again, Medicare HMOS 

may offer more coverage according to their negotiated contracts. Also, even though 

some non-Medicare payers classified ENT as a prosthetic device, they would still cover 

the therapy for a person with a functioning gastrointestinal tract. Table 4 below 

illustrates this point. 

I I I I 

1 1’ 1 1€

3 1 1€

1 1€

1 1 2€

According to the current Medicare definition of ENT, unless the criteria for a 

prosthetic device benefit is met, patients with cognitive disorders cannot be covered. 

Technically, with a cognitive disorder, the malfunctioning body organ is the brain, not 

a gastrointestinal structure. During this condition, the brain is unable to transmit the 

4Again, note that some payers use dual classification for defining the ENT benefit. 

We counted each classification separately. 

5This figure does include the private indemnity/commercial payer who only covers 

the pump and supplies for ENT, not the product. 

9€

II 
appropriate neme impulses to direct the activity of other body organs. Cognitive 

disorders such as Alzheimer’s Disease or pre-senile dementia can make chewing and 

swallowing difficult for a patient with an otherwise functioning gastrointestinal tract. 

Defining the therapy under the prosthetic device benefit narrows the scope for its 

application to patients with cognitive disorders. The table below shows the number of 

payers who routinely cover ENT for patients with cognitive disorders. 

PAYERS WHO ROUTINELY COVER ENTERAL NUIIUITON€

FOR PATIENTS WllH COONITIVE DISORDERS€

Table5.€

Medicare does not routinely cover patients with cognitive disorders unless very specific 

medical evidence can supp&t the need for ENT. Documentation for the patien~s 

functional inability to swallow are necessaly. Abnormal results from a swallowing 

function test and the absence of a gag reflex (of the muscular reflex contraction in the 

throat which enables one to swallow) and additional related laboratory and blood tests 

build a case for coverage under the prosthetic device benefit. 

The Medicare risk-contracted HMOS do not routinely cover patients who only have a 

cognitive disorder and no digestive track malfunction. These respondents would make 

exceptions to this rule if ENT were the patient’s only source of nutrition. Additional 

documentation of abnormal swallowing function tests and loss of gag reflex are also 

necessa~. 

In contrast, almost half of non-Medicare payers would routinely cover ElVI’ for 

persons with cognitive disorders. Other additional payers would cover patients with 

cognitive disorders as long as the ENT is the patient’s sole source of nutrition, or if 

the patient is only able to obtain nutrition through a tube. Some additional 

documentation for swallowing tests and severity of the dysfunction are necessary, but 

as long as the prima~ physician or physician reviewer deems therapy medically 

necessary, it is covered. 

Enteral Ni@iion l%qNand Sqp@es 

Pumps may administer ENT for patients whose medical conditions require a calibrated 

and timed flow of nutrients. As Table 6 on the following page shows, Medicare policy 

requires separate documentation for the pump, while tw~ ‘M&iicare risk-contract~d -

HMOS automatically cover the pump. In contrast, more than three-quarters of nonMedicare payers automatically cover the pump when therapy is needed. 

10
PAYERS WHO AU’17)MATKAUY COVER PUMPS€

WITH ENTERAL NUITUTION THERAPY€

Table6.€

NOTCOVEREDWITHOUT q4 14/186 

SEPARATE 

DOCUMENTATIONFOR 

NEED 

Supplies such as tubing and administration kits are necessary for using ENT. 

Medicare automatically provides these items with the therapy. Similarly, three 

Medicare risk-contracted HMOS and fifteen other payers also follow this coverage 

practice. 

Cenificates of M&al Nwedy and Ikmi@om 

Medicare guidelines are explicit in their requirements for documentation for 

determining coverage. Medicare policy requires a CMN for ENT coverage. Three 

Medicare risk-contracted HMOS do not require a Cm, instead they require a 

physician’s prescription. Eleven out of seventeen non-Medicare payers require a letter 

of need or CMN for ENT coverage. 

In addition to a CMN, more than half of the non-Medicare payers also require a 

prescription forthecoverage of ENT. Those whodonot initially require aCMN 

either require a prescription or allow the patient’s diagnosis or the physician’s order in 

the medical chart to suffice. 

Medicare not only requires a new CMN for reassessment, but a new CMN must be 

revised whenever there is a change in the caloric intake, a change in nutrient products, 

and also when there is a need for a pump. 

Reassesmenzfw Th?r&l’ 

Both Medicare and non-Medicare payers require patient reassessment to determine 

whether the patient still needs ENT. This reassessment calls for an update on the 

beneficiary’s medical condition and a new CMN. The Medicare risk-contracted 

HMOS also require periodic assessment for ENT coverage. Their intervals for 

reassessment range from monthly to every three months continually. 

Almost all non-Medicare respondents require periodic assessment to continue therapy. 

The intervals for continued assessment vary from monthly to quarterly. Two payers 

call for yearly assessments. Unlike Medicare, non-Medicare payers require on-going 

assessment even after 24 months. An update on the patient’s condition is the most 

. 

%is figure includes the private indemnity/commercial payer who only covers 

pumps and supplies for ENT, not the product. 

11 
common information required. These payers require renewed letters of need or 

CMNS on a continuing basis ranging horn every 30 days to 6 months. One nonMedicare payer reported an interval of one year. 

Doammwa fw Types of Rtxlucls�

Medicare also has special documentation provisions for the kinds of products that 

physicians prescribe. The Medicare risk-contracted HMOS did not speci& that they 

use categories of products. 

Only one non-Medicare payer’s coverage policy contained a similar distinction for 

groups of products. This payer reported that if a physician requests a product not 

listed on the “First Line Usage Enteral Nutrition Product Table,” additional 

documentation must accompany the physician’s prior authorization request. The extra 

information must show the patient experienced “therapeutic failure” with the “First 

Line” product or state results of a consultation between the physician and a registered 

dietitian. Other payers did not provide information about product distinction. 

CWxic Re@emem 

Medicare policy requires documentation to justi@ any caloric intake less than 20 

calories/kilogram or greater than 35 calories/kilogram per day. The Medicare riskcontracted HMOS do not have this requirement, while only one non-Medicare payer 

requires a minimum number of calories/kilogram per day. 

CONCLUSION€

We hope the issues resulting from this report answer HCFA’S request for information 

on other payers’ coverage policies for ENT, and will aid HCFA in their effort to revise 

and standardize Medicare policy. 

Our work is continuing. We will review how other payers price ENT products and 

compare their units of pricing, payment mechanisms, and supplier networks to 

Medicare’s policy. 

12