United States Government Accountability Office

GAO Report to Congressional Committees

MEDICARE AND 

MEDICAID 

COVERAGE 

Therapies and 

Supplies for 

Inflammatory Bowel 

Disease 

December 2005 

 

GAO-06-63 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

December 2005

MEDICARE AND MEDICAID COVERAGE

Therapies and Supplies for Inflammatory 

Highlights of GAO-06-63, a report to Bowel Disease 

congressional committees 

Inflammatory bowel disease (IBD)

affects an estimated one million 

Americans. IBD patients often 

have difficulty digesting food. As a 

result, they may require parenteral

nutrition (intravenous feeding) or 

enteral nutrition (tube feeding), 

medically necessary food products

to supplement their diets, and 

medications. In addition, some 

IBD patients must care for their 

ostomies—surgically created 

openings for the discharge of 

digested food. 

IBD advocates have recently

expressed concerns regarding the 

ability of IBD patients to obtain the

health care they need. The 

Research Review Act of 2004

directed GAO to study the

Medicare and Medicaid coverage

standards for individuals with IBD, 

in both home health and outpatient 

delivery settings. GAO 

(1) identified the Medicare and

Medicaid coverage standards for 

five key therapies used for the

treatment of IBD and 

(2) determined what specific

supplies used in these therapies 

Medicare and Medicaid programs 

will pay for. In this work, GAO 

examined Medicare’s national and

local coverage policies and 

conducted a survey of Medicaid 

programs in the 50 states and the

District of Columbia. 

Medicare generally provides coverage for parenteral and enteral nutrition 

and ostomy supplies in both home health and outpatient delivery settings. 

However, specific standards regarding medical conditions and appropriate 

documentation must be met for parenteral and enteral nutrition to be 

covered. Medicare has one coverage standard governing the provision of 

ostomy supplies—that beneficiaries receiving these items have had an 

ostomy. Medicare does not cover medically necessary food products and 

generally does not cover self-administered drugs, which include most drugs 

taken by IBD patients. However, medically necessary drugs, including those 

that are self-administered, will be covered by Medicare’s voluntary 

prescription drug benefit, which becomes effective in January 2006. State 

Medicaid programs reported covering, at least partially, each of the five

therapies. The survey indicated that most states’ Medicaid coverage

standards are generally comparable to Medicare’s coverage for parenteral

and enteral nutrition and ostomy care.

State Medicaid Programs That Reported Coverage of Five IBD Therapies for Adults and 

Children 

Parenteral 

nutrition

Enteral 

nutrition Ostomy care 

Medically 

necessary 

food

products Drugsa

Adults and 

children 50 49 51 40 50

Adults only 0 0 0 0 1

Children only 1 1 0 6 0

Not covered 0 1 0 5 0

Total 51 51 51 51 51

Source: GAO survey of state Medicaid programs. 

Note: For purposes of this report, the District of Columbia is considered a state. 

a

For this analysis, GAO is defining states’ coverage of drugs to treat IBD as states’ coverage of at 

least one of the brand name drugs or generic drugs listed in GAO’s survey. 

Once Medicare coverage standards are met, the program will generally cover 

all medically necessary supplies associated with parenteral and enteral 

nutrition and ostomy care. The survey of state Medicaid programs showed 

variation in the specific supplies that states will provide. While many states

pay for most supplies associated with parenteral and enteral nutrition, the 

specific ostomy supplies states cover vary. Most states—46—reported 

covering at least some medically necessary food products. GAO also found 

that states generally cover the drugs listed in the survey. 

CMS said that GAO correctly described its Medicare coverage policies and 

suggested that we clarify our description of Medicare’s coverage policy for 

prescription drugs that are not self-administered. It also said that it will

continue to consider access issues for Medicare and Medicaid IBD patients. 

www.gao.gov/cgi-bin/getrpt?GAO-06-63.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Leslie G. 

Aronovitz, at (312) 220-7600 or 

aronovitzl@gao.gov. 
Contents 

Letter 1

Results in Brief 4 

Background 6

Coverage of IBD Therapies Is Subject to Medicare and Medicaid 

Standards 11

Variation in Medicare and Medicaid Programs’ Coverage of Specific 

Supplies Related to IBD Therapies 18 

Agency Comments 27 

Appendix I Scope and Methodology 29 

Appendix II Reported State Medicaid Program Coverage of 

Therapies Used by IBD Patients 33 

Appendix III Reported Parenteral Nutrition Therapy Coverage 

Standards by State Medicaid Program 35 

Appendix IV Reported Enteral Nutrition Therapy Coverage 

Standards by State Medicaid Program 38 

Appendix V Reported Medically Necessary Food Products 

Coverage Standards by State Medicaid Program 41 

Appendix VI Reported Parenteral Nutrition Supplies Covered by 

Medicaid in Home Health and Outpatient Delivery 

Settings 43 

Page i GAO-06-63 Inflammatory Bowel Disease
Appendix VII Reported Enteral Nutrition Supplies Covered by 

Medicaid in Home Health and Outpatient Delivery 

Settings 45 

Appendix VIII Reported Percent of States Covering Ostomy 

Supplies in Home Health and Outpatient Delivery 

Settings 47 

Appendix IX Reported Information on Medicaid Coverage of 

Ostomy Supplies and Related Limits 50 

Appendix X Reported Medically Necessary Food Products 

Covered by State Medicaid Program 52 

Appendix XI Summary of Drugs Listed in Our Survey to Treat 

IBD That Are Covered by Medicaid for Adults and 

Children 55 

Appendix XII Comments from the Centers for Medicare & Medicaid

Services 58 

Appendix XIII GAO Contact and Staff Acknowledgments 60 

Tables 

Table 1: State Medicaid Programs That Reported Coverage of Five 

IBD Therapies for Adults and Children 11 

Table 2: State Medicaid Programs That Reported Payment of

Common Parenteral Nutrition Therapy Supplies for Adults 

Page ii GAO-06-63 Inflammatory Bowel Disease
and Children in Home Health and Outpatient Delivery 

Settings 20

Table 3: State Medicaid Programs That Reported Payment for 

Common Enteral Nutrition Therapy Supplies for Adults 

and Children in Home Health and Outpatient Delivery 

Settings 21

Table 4: Median Percent of State Medicaid Programs That Reported 

Covering Ostomy Supplies in Home Health and Outpatient 

Delivery Settings 24 

Table 5: Number of State Medicaid Programs Covering Medically 

Necessary Food Products for Adults and Children 25 

Figure 

Figure 1: Number of State Medicaid Programs That Reported 

Covering Drugs Listed in Our Survey to Treat IBD 26 

Abbreviations 

BIPA Benefits Improvement and Protection Act of 2000

CMS Centers for Medicare & Medicaid Services 

DMERC Durable Medical Equipment Regional Carrier 

FDA Food and Drug Administration 

HCPCS Health Care Common Procedure Coding System 

HHS Department of Health and Human Services 

IBD inflammatory bowel disease 

LCD local coverage determination 

LMRP local medical review policies 

NCD national coverage determination 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

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other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 

Page iii GAO-06-63 Inflammatory Bowel Disease
United States Government Accountability Office

Washington, DC 20548 

December 15, 2005 

The Honorable Charles E. Grassley 

Chairman 

The Honorable Max Baucus 

Ranking Minority Member 

Committee on Finance 

United States Senate 

The Honorable Joe Barton 

Chairman 

The Honorable John D. Dingell 

Ranking Minority Member 

Committee on Energy and Commerce 

House of Representatives 

The Honorable William M. Thomas 

Chairman 

The Honorable Charles B. Rangell 

Ranking Minority Member 

Committee on Ways and Means 

House of Representatives 

Inflammatory bowel disease (IBD) refers to two chronic autoimmune 

diseases of the intestinal tract—Crohn’s disease and ulcerative colitis. 

These diseases may result in abdominal pain, weight loss, fever, rectal 

bleeding, and diarrhea, and are associated with a decreased quality of life.

IBD generally involves periods of active inflammation alternating with 

periods of remission. 

The estimated one million Americans with IBD1

—10 percent of whom are 

children—have difficulty digesting food and may require different 

treatments, depending on the specific nature of their condition. As a 

result, some IBD patients may periodically require parenteral nutrition—

the provision of nutrients intravenously. Others may receive enteral 

nutrition, which is delivered through a feeding tube inserted into their 

 1

According to the Crohn’s Disease and Colitis Foundation of America, the number is evenly 

split between the two diseases. 

Page 1 GAO-06-63 Inflammatory Bowel Disease
noses or stomachs. Some IBD patients may require nutrition in the form of 

medically necessary food products, such as formulas that are more easily 

digested than normal foods.2

 IBD patients may also require medication,

and some may have ostomies—surgically created openings in their 

abdominal wall for the discharge of digested food—and therefore depend 

on a pouching system to collect, contain, and manage disposal of solid 

body waste. 

A number of IBD patients depend on Medicare and Medicaid,3

 the nation’s 

largest health insurance programs, for coverage of their treatment. 

Medicare serves approximately 41 million elderly and certain disabled 

beneficiaries and is administered by the Centers for Medicare & Medicaid 

Services (CMS), an agency within the Department of Health and Human 

Services (HHS). Based on the Social Security Act,4

 CMS, and the claims 

administration contractors that assist it in administering the Medicare 

program, determine whether specific medical procedures, devices, and 

services should be covered. Medicaid is a federal-state program that 

finances health care coverage for approximately 54 million low income 

individuals, about half of whom are children. Under CMS’s oversight, each

state administers its own Medicaid program. Within broad coverage 

requirements set by law and CMS, states have discretion to develop 

specific coverage policies for their Medicaid programs. In fiscal year 2004, 

Medicare paid about $298 billion for services and supplies provided to 

beneficiaries while Medicaid programs paid close to $272 billion.5

Over the past few years, IBD advocates have tried to raise awareness 

about IBD and the challenges IBD patients face, including concerns about 

obtaining the health care that they need to manage their disease. The 

Research Review Act of 2004 contains several provisions related to IBD, 

including a mandate that we conduct a study on the Medicare and 

Medicaid coverage standards for IBD patients.6

 The act required us to 

 2

Enteral nutrition formula may be also consumed orally, depending on the patient’s

condition, instead of via tube-feeding. In this report, we consider enteral nutrition formulas

that are consumed orally as medically necessary food products. 

3

The number of Medicare and Medicaid beneficiaries who are IBD patients is not known. 

4

Medicare was established in 1965 in Title XVIII of the Social Security Act and is codified as 

amended at 42 U.S.C. §§ 1395-1395hhh. 

5

Medicaid payment includes federal and state contributions. 

6

Pub. L. No. 108-427, § 4, 118 Stat. 2430, 2431. 

Page 2 GAO-06-63 Inflammatory Bowel Disease
focus on five specific therapies—in both home health and outpatient 

delivery settings7

—parenteral nutrition, enteral nutrition formula, ostomy 

care,8

 medically necessary food products, and drugs approved by the Food

and Drug Administration (FDA) for Crohn’s disease and ulcerative colitis.9

In this report, we (1) identify the Medicare and Medicaid coverage

standards for these five therapies, and (2) determine which specific 

supplies used in these therapies Medicare and Medicaid programs will pay 

for in home health and outpatient delivery settings. 

To determine Medicare’s coverage standards for the five therapies, we 

obtained and reviewed relevant Medicare laws, regulations, national 

coverage policies, and manuals to identify pertinent material. We also 

interviewed CMS officials and the medical directors of the Durable 

Medical Equipment Regional Carriers (DMERC)—the four claims 

administration contractors involved in making local coverage decisions for 

applicable therapies in our study. In addition, we discussed and obtained 

documentation regarding specific supplies used in the five therapies that 

Medicare would pay for in both home health and outpatient delivery 

settings. 

To obtain information on Medicaid’s coverage of the five therapies, we 

developed a survey that we sent to Medicaid offices in all 50 states and the 

District of Columbia10 and asked them to identify applicable coverage

standards. The survey asked state officials to identify specific supplies 

their Medicaid program would pay for. It also asked them to note any 

distinctions between supplies covered in home health and outpatient 

 7

For purposes of this study, we defined home health care as a situation in which medical 

supplies are provided to the patient by a home health agency, in accordance with a plan 

provided by a physician. We defined outpatient care as any situation, in which a patient 

receives medical supplies, that does not require an overnight hospital stay, such as a visit to

a doctor’s office, or a situation where the patient self-administers the supplies at home,

without the assistance of a home health agency. 

8

The Research Review Act of 2004 specifically directed us to determine coverage of ostomy

supplies; consequently, we did not include any other items and services that may relate to

ostomy care in this study. 

9

In response to the Research Review Act of 2004, we also conducted a study of the 

problems IBD patients encounter when applying for disability insurance benefits under 

Title II of the Social Security Act. See GAO: Social Security Disability Insurance: SSA

Actions Could Enhance Assistance to Claimants with Inflammatory Bowel Disease and

Other Impairments, GAO-05-495 (Washington, D.C.: May 31, 2005). 

10Throughout the remainder of this report, we will refer to District of Columbia as a state 

and count it as such when describing our survey results. 

Page 3 GAO-06-63 Inflammatory Bowel Disease
delivery settings, and to indicate whether they had different coverage

policies for adults and children.11 Our survey was generally based on 

relevant Medicare coverage standards and provided states with the 

opportunity to describe how their coverage policies varied from 

Medicare’s policies and to report other pertinent standards they may have

established. In addition, our survey included a list of drugs to treat IBD 

that was developed in consultation with the FDA. Specifically, the survey 

listed nine brand name drugs and two generic drugs that the FDA told us it 

had approved to treat Crohn’s disease and ulcerative colitis.12

We received responses from all of the states and reviewed these data for 

obvious inconsistency errors and completeness. For responses that were 

unclear or incomplete, we contacted survey respondents to obtain 

clarification before conducting our analyses. When necessary, we 

compared our electronic data files of survey responses to the actual 

surveys that we obtained from states. Based on these efforts, we 

determined that the data were sufficiently reliable for the purposes of this 

report. To obtain detailed background on the specific supplies that are 

associated with each of the therapies, we also contacted representatives 

from eight organizations representing patients with IBD, and medical 

experts. (See app. I for additional information on our scope and 

methodology.) We conducted our work from December 2004 through 

November 2005, in accordance with generally accepted government 

auditing standards. 

Medicare generally provides coverage for three of the five therapies we 

reviewed—parenteral nutrition, enteral nutrition formula, and ostomy 

care—for beneficiaries with IBD. Coverage is available in both home 

health and outpatient delivery settings. Medicare has established 

standards that must be met for parenteral and enteral nutrition to be 

covered. Patients must have specific medical conditions in order to 

receive coverage. For example, Medicare will cover parenteral nutrition 

for a patient with a severe gastrointestinal condition that impairs 

Results in Brief 

 11Because Medicare does not cover children, except in very limited circumstances not 

applicable to this report, such a distinction was not necessary for the Medicare analysis. 

12The nine brand name drugs listed in our survey were Asacol, Azulfidine, Canasa, Colazal, 

Dipentum, Entocort, Pentasa, Remicade, and Rowasa. The survey also listed the generic

equivalents of two of these drugs, Azulfidine and Rowasa. After we administered our

survey, the FDA informed us that it also considers several additional drugs as valid 

treatments for IBD. These drugs are not discussed in this report. 

Page 4 GAO-06-63 Inflammatory Bowel Disease
absorption of nutrients, and enteral nutrition for a patient with a 

functioning gastrointestinal tract who cannot maintain adequate weight 

and strength because food cannot reach the digestive tract. In addition, 

Medicare requires such medical conditions to be well documented in order 

to cover these two therapies. Medicare has one coverage standard 

governing the provision of ostomy care—the beneficiaries receiving these 

supplies have had an ostomy. Medicare does not cover medically 

necessary food products. Similarly, Medicare does not cover most drugs 

used by IBD patients—these drugs are typically self-administered 

prescription drugs, and currently, they are not covered by the program. 

However, medically necessary drugs, including those that are selfadministered, will be covered by Medicare’s voluntary prescription drug 

benefit, which becomes effective in January 2006. Unlike Medicare, each 

state Medicaid program covers, to some extent, at least one of the five 

therapies, including medically necessary food products and drugs used to 

treat IBD. Our survey results also indicated that each state Medicaid 

program has its own coverage standards; however, most states’ standards 

are generally comparable to Medicare’s coverage for parenteral and 

enteral nutrition and ostomy care. 

Once Medicare coverage standards are met, the program will generally

cover—with very few restrictions—all medically necessary formulas, 

administration supplies, and equipment associated with both parenteral 

and enteral nutrition. Medicare will also provide beneficiaries who have 

had ostomies with supplies for their ostomy care. Although Medicare has 

established “usual maximum quantities” of supplies that typically meet the 

needs of ostomy patients, these amounts may be exceeded if the need is 

justified. Our survey of Medicaid programs shows variation in the specific 

supplies covered for the five therapies. We found that states generally 

cover supplies associated with parenteral nutrition therapy. Similarly, 

states cover most enteral nutrition supplies. However, states’ coverage of 

specific ostomy supplies varies. We found that twenty-four states covered 

all of the ostomy supplies listed in our survey in both home health and 

outpatient delivery settings. Fifteen of these 24 states imposed limits and 

monetary caps on these supplies. Further, 10 of these 15 states reported 

that, for certain supplies, the supply limits and monetary caps are rarely or 

never exceeded. Most states—46—reported covering at least some 

medically necessary food products with oral nutritional formulas being the 

item most commonly covered. Finally, our survey results show that 

Medicaid programs generally cover the brand name drugs and generic 

equivalent drugs listed in our survey to treat IBD. 

Page 5 GAO-06-63 Inflammatory Bowel Disease
In commenting on a draft of this report, CMS said that we correctly 

described the Medicare coverage policies for parenteral and enteral 

nutrition and ostomy supplies and provided clarification for our 

description of Medicare’s coverage policy for prescription drugs that are 

not self-administered. It also said that as it proceeds with policy 

development, it will continue to give consideration to access issues that 

affect Medicare beneficiaries and Medicaid recipients in their treatment of 

IBD. 

IBD refers to Crohn’s disease and ulcerative colitis.13 Crohn’s disease can 

involve any area of the gastrointestinal tract but most commonly affects 

the small intestine, which is responsible for the body’s absorption of most 

needed nutrients, and the beginning of the large intestine, or colon. This 

inflammation can result in excessive diarrhea, severe rectal bleeding,

anemia, fever, and abdominal pain. In addition, malnutrition or nutritional 

deficiencies are also common among Crohn’s disease patients, particularly 

if the disease is extensive and of long duration. Two-thirds to threequarters of patients with Crohn’s disease will require surgery—in most 

cases, to remove the diseased segment of the bowel and any associated 

abscess. In some cases, an ostomy to remove the colon also may be 

required. However, surgery is not considered a cure for Crohn’s disease 

patients because the disease frequently recurs. Ulcerative colitis only 

affects the colon. This condition causes diarrhea and bleeding, and can 

ultimately lead to colon cancer. In one-quarter to one-third of patients with 

ulcerative colitis, medical therapy is not completely successful or 

complications arise. Under these circumstances, an ostomy operation may 

be performed. Because inflammation in ulcerative colitis is confined to the 

colon, the disease is curable by this operation. 

Background 

IBD may occur at any age, but it most commonly develops between the 

ages of 10 and 30. One-third of IBD patients develop symptoms before 

adolescence. In such cases, the disease poses special problems because it 

can impair children’s bodies’ ability to absorb nutrients and thus adversely 

affects their growth and development. 

 13About 10 percent of IBD patients exhibit symptoms of both Crohn’s disease and ulcerative

colitis. This condition is referred to as indeterminate colitis. 

Page 6 GAO-06-63 Inflammatory Bowel Disease
IBD patients, depending on each individual’s unique circumstances, may 

rely on one or more of the following key therapies in either home health or 

outpatient delivery settings to manage their disease: 

• Parenteral nutrition is the intravenous administration of nutrients through 

a catheter that carries liquid nutrients directly into the bloodstream, where 

they are absorbed by the body, entirely bypassing the gastrointestinal 

tract. It is typically used to treat patients with severe cases of IBD. In such 

instances, patients’ gastrointestinal tracts cannot tolerate nutrition by 

mouth or a feeding tube. The provision of parenteral nutrition allows the 

intestines to rest and heal, and may relieve acute attacks and delay or 

avoid the need for surgery. Supplies used in parenteral nutrition include 

parenteral nutrition solutions and various products necessary to 

administer the solutions to the patient, such as infusion pumps and 

intravenous poles. Parenteral nutrition supply kits include supplies 

necessary to transfer the solution to the infusion pump, such as tubes, and 

sterilization pads. Parenteral nutrition administration kits include supplies 

necessary to transfer the solution from the pump to the patient, such as 

intravenous catheters, dressings, tapes, antiseptics, and sterile gloves.14

• Enteral nutrition is indicated for patients with a functioning 

gastrointestinal tract but whose oral nutrient intake is insufficient to meet 

their nutritional needs. Enteral nutrition employs a feeding tube to deliver 

a liquid nutritional formula to the stomach or small intestine—it is 

administered either through the nose or directly through the abdominal 

wall into the gastrointestinal tract. For IBD patients, and particularly for 

Crohn’s disease patients whose inflamed small intestine may not allow 

them to absorb enough nutrients, this method—either used alone, or in 

combination with food or liquids taken orally—may restore good nutrition 

to patients weakened by severe diarrhea and poor nutrition. In addition, 

according to gastrointestinal disease experts, enteral nutrition may have

therapeutic effects as well, by inducing remission. Supplies used in enteral 

nutrition include enteral formulas and supplies necessary to administer 

this therapy, such as enteral nutrition infusion pumps, intravenous poles,

catheters, and tubes. Enteral feeding supply kits include supplies 

necessary to administer the formula to the patient, such as syringes, tubing

to transfer the formula to the catheter, tube connectors, and sterile 

gloves.15 Tubing that goes inside the patient’s body to administer the 

 14Specific supplies included in the parenteral supply kits and administration kits can vary, 

depending on the supplier. 

15Specific supplies included in the enteral feeding supply kits can vary depending on

specific patient needs. 

Page 7 GAO-06-63 Inflammatory Bowel Disease
nutrients—i.e., nasogastric tubing that delivers the formula to the patient’s 

gastrointestinal system through the nose, or gastrostomy tubing that 

delivers the formula through a surgically created opening in the stomach—

is also necessary. Other supplies needed may include additives, such as 

fiber, to thicken enteral formulas. 

• Medically necessary food products are products that can be taken orally. 

They include food supplements, such as the formulas used in enteral 

nutrition, and prescription strength vitamins. For example, because 

Crohn’s disease and surgical procedures that remove parts of the small 

intestine can inhibit absorption of vitamins, fats, and other important 

nutrients, taking certain supplements, such as fish oil, antioxidants, and 

mineral supplements, may be beneficial for patients with Crohn’s disease.

• Medications are often required to treat Crohn’s disease and ulcerative 

colitis. The FDA has approved both brand name drugs and generic drugs 

to treat IBD. These drugs are typically self-administered and taken to 

reduce inflammation in the intestinal wall. In addition, there are other 

medications approved by the FDA—but not specifically to treat IBD—that 

may be effective in treating the disease.16

• IBD patients who have had an ostomy operation need to use specific 

supplies for their ostomy care. An ostomy surgery creates an opening in 

the abdomen. This opening, called a stoma, permits digested food to exit 

the body. In most cases, this type of surgery results in a permanent 

opening.17 Subsequent to the operation, ostomy patients need certain 

supplies to manage the abdominal opening and the waste. For example, 

the patient wears a pouch over the opening to collect the waste and then 

empties the pouch as needed. Other necessary supplies include skin 

barriers to protect the skin and irrigation and fluid discharge supplies. 

Medicare pays for beneficiaries’ medically necessary health care needs as

long as they fit into one of the broadly-defined categories of benefits 

established in the Social Security Act. Among other things, these 

categories include commonly used medical services and supplies such as 

physician visits, inpatient hospital stays, diagnostic tests, durable medical

 16The prescribing of a drug for treatments other than those specified on the label approved

by FDA is referred to as off-label use. 

17Not all ostomies are permanent. According to one gastrointestinal expert, about 

20 percent of ostomies are temporary. A temporary ostomy is more common among 

younger patients, while Medicare patients are more likely to have permanent ostomies. 

Page 8 GAO-06-63 Inflammatory Bowel Disease
equipment, and prosthetic devices. While the act provides for broad 

coverage of many medical and health care services, it does not provide an

exhaustive list of all services covered.18 Similarly, the act generally does 

not specify which medical devices, surgical procedures, or diagnostic 

services the program covers. In addition, the act states that the program 

cannot pay for any supplies or services that are not “reasonable and 

necessary” for the diagnosis and treatment of an illness or injury.19 With 

the Social Security Act serving as the primary authority for all coverage 

provisions, CMS has established coverage policies that specify the 

procedures, devices, and services that are covered in the broad benefit 

categories established in the act.20 In addition, CMS has established the 

criteria used to determine whether these supplies are reasonable and 

necessary for a beneficiary’s treatment. CMS’s national coverage 

determinations (NCDs) describe the circumstances for Medicare coverage 

for a specific medical service, procedure, or device and they outline the 

conditions for coverage.21 CMS interpretive manuals further define when 

and under what circumstances items or services may be covered. 

Claims administration contractors are required to follow CMS’s national 

coverage policies. However, if an NCD does not specifically exclude or 

limit coverage for an item or service, or if the item or service is not 

mentioned at all in an NCD or CMS manual, it is up to the contractors to 

determine whether they will cover a particular item or service within their 

geographic area. This is often done through a local coverage determination 

 18Congress gave the Secretary of Health and Human Services the authority to decide which 

specific supplies and services within these categories are covered by Medicare. 

19Specifically, the law states that Medicare cannot pay for any supplies or services that are 

not “reasonable and necessary for the diagnosis and treatment of an illness or injury or to 

improve functioning of a malformed body part.” 42 U.S.C. §1395y(a)(1)(A).

20The Secretary of Health and Human Services delegated the legal authority to specify 

which procedures, devices, and services are covered in the Social Security Act’s benefit 

categories to CMS and its contractors. 

21NCDs are typically issued as program instruction and are binding on all Medicare claims 

administration contractors. NCDs must be made available for public comment prior to

finalization. The law also requires proposed NCDs to be reviewed by either the Medicare

Coverage Advisory Committee or outside clinical experts. NCDs are also binding on 

Administrative Law Judges during the claims appeal process. 

Page 9 GAO-06-63 Inflammatory Bowel Disease
(LCD).22 LCDs specify under what circumstances the item or service is 

considered to be reasonable and necessary, in accordance with the Social 

Security Act, and are supplemented by additional instructions from the 

contractors. LCDs related to durable medical equipment, prosthetic 

devices, orthotics, and a number of other supplies are made by the 

DMERCs—the four CMS claims administration contractors that process 

claims exclusively for these supplies. The DMERCs are required by CMS to 

coordinate their coverage development process with one another and they 

publish identical LCDs.23

Medicaid coverage policies vary by state. While all state Medicaid 

programs must pay for certain services, such as inpatient and outpatient 

hospital services, and early and periodic screening, diagnostic, and 

treatment services for individuals under the age of 21, states have broad

discretion in setting up their Medicaid programs. They may set different 

eligibility standards, scope of services, and payments, and can elect to 

cover a range of optional populations and benefits.

24

 22LCDs are considered administrative and educational tools that provide guidance to the

public and medical community within the contractor’s jurisdiction, and assist providers in

submitting correct claims for payment. When developing LCDs, contractors consider 

medical literature, the advice of local medical societies and medical consultants, public 

comments, and comments from the provider community. LCDs must also be consistent 

with all statutes, rulings, regulations, and national coverage, payment, and coding policies. 

During the claims appeal process, administrative law judges may consider LCDs, but they 

are not bound by them. 

23The Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000

(BIPA) defined the term LCD as including only decisions as to whether items or services

are “reasonable and necessary.” Pub. L. No. 106-554, app. F, § 522(a), 114 Stat. 2763A, 

2763A-546. Prior to the passage of BIPA, the DMERCs had issued documents called Local 

Medical Review Policies (LMRPs) to indicate all coverage information for parenteral and 

enteral nutrition and ostomy supplies, including a determination of whether items and 

services are reasonable and necessary. CMS has required the DMERCs to convert existing 

LMRPs to LCDs. According to CMS guidance, these new LCDs should contain only

determinations on reasonableness and necessity, and other instructions from the DMERCs, 

such as coding guidelines, are issued in other publications called policy articles. As of 

September 2005, the DMERCs had issued LCDs and related policy articles for enteral 

nutrition and ostomy supplies, but not for parenteral nutrition. Throughout the report, we

use the term local coverage policy to describe all DMERC decisions and instructions, 

regardless of whether they are found in an LMRP, LCD, or policy article. 

24Optional supplies and services include, among others, prescribed drugs, prosthetic 

devices, home health care services, dental services, and physical therapy. 

Page 10 GAO-06-63 Inflammatory Bowel Disease
Medicare generally covers parenteral and enteral nutrition and ostomy 

care in home health and outpatient delivery settings for beneficiaries who 

meet certain medical standards. These three IBD therapies are included in

specific benefit categories established by the Social Security Act—

primarily the prosthetic devices benefit category, and in the case of 

ostomy care provided in a home health care delivery setting, the home 

health benefit category. Medicare does not cover medically necessary food

products or most drugs approved by the FDA that are used to treat IBD. 

However, in January 2006, Medicare will begin to cover medically 

necessary drugs when the program’s new prescription drug benefit 

becomes effective. None of the five therapies we examined for this report 

are mandatory services under Medicaid. However, our survey of Medicaid 

programs indicates that most of these programs provided eligible 

individuals some coverage for all five therapies. We also found that 

coverage standards that Medicaid recipients must meet to receive these 

therapies varied by state. Table 1 summarizes the number of states 

covering each of the five therapies. (See app. II for specific information on 

each state Medicaid program’s coverage of these therapies.) 

Table 1: State Medicaid Programs That Reported Coverage of Five IBD Therapies 

for Adults and Children

Coverage of IBD 

Therapies Is Subject 

to Medicare and 

Medicaid Standards 

Parenteral 

nutrition

Enteral 

nutrition

Ostomy

care 

Medically 

necessary 

food 

products Drugsa

Adults and 

children 50 49 51 40 50

Adults only 0 0 0 0 1

Children only 1 1 0 6 0

Not covered for 

adults or children 0 1 0 5 0

Total 51 51 51 51 51

Source: GAO survey of state Medicaid programs. 

a

For this analysis, we are defining states’ coverage of drugs to treat IBD as states’ coverage of at 

least one of the brand name drugs or generic equivalent drugs listed in our survey. 

Page 11 GAO-06-63 Inflammatory Bowel Disease
Our analysis showed that Medicare and state Medicaid programs will 

generally cover parenteral nutrition as follows: 

Medicare: Medicare generally covers parenteral nutrition, as CMS has 

determined that it falls under the prosthetic devices benefit category, 

established in the Social Security Act.

25 CMS’s coverage standards for 

parenteral nutrition therapy are outlined in both an NCD and in local 

coverage policy.26 Coverage is provided in both home health and outpatient 

delivery settings. The NCD requires the patient to have a severe pathology 

of the alimentary tract27 that does not allow absorption of sufficient 

nutrients to maintain weight and strength commensurate with the patient’s 

general condition. A period of hospitalization is required to initiate 

coverage for parenteral nutrition and to train the patient in how to 

prepare, manage, and administer the formula and equipment. The NCD 

also requires a physician’s written order or prescription and sufficient 

medical documentation to show that the prosthetic device coverage

requirements are met and that parenteral nutrition therapy is medically 

necessary. In addition, before approving coverage, the carrier must agree 

that a particular condition qualifies for parenteral nutrition therapy. 

Medicare will approve coverage of parenteral nutrition at periodic 

intervals of no more than three months. In addition, Medicare will pay for 

no more than one month’s supply of nutrients at a time. 

Building upon the coverage standards in the NCD, the DMERCs’ local 

coverage policy on parenteral nutrition provides significantly more 

detailed requirements. The policy consists of specific clinical criteria for 

showing that parenteral nutrition is considered reasonable and necessary.

Like the NCD, the local policy specifies that a patient must either have a 

condition involving the small intestine that significantly impairs the 

absorption of nutrients, or a disease of the stomach or intestine that 

impairs the ability of nutrients to be transported through the 

gastrointestinal system. The local coverage policy also requires that the 

Medicare and Medicaid 

Coverage Standards for 

Parenteral Nutrition 

 25Covered prosthetic devices are “devices (other than dental) which replace all or part of an

internal body organ (including colostomy bags and supplies directly related to colostomy 

care), including replacement of such devices.” 42 U.S.C. § 1395x(s)(8).

26Per CMS requirements, DMERCs have to establish identical coverage policies; therefore, 

their policies are worded the same. For simplification purposes, we will refer to these 

policies as a single policy throughout the rest of the report. 

27The alimentary tract consists of the passage that extends from the mouth to the anus and 

is responsible for the movement of food through the body and its digestion and absorption. 

Page 12 GAO-06-63 Inflammatory Bowel Disease
patient’s inability to maintain proper weight and strength necessitates 

intravenous nutrition, and that the patient is unable to be treated through 

either diet modification or with drugs.28 It also describes specific clinical

conditions that meet these criteria. For patients who do not meet the 

standards for these clinical conditions, coverage for parenteral nutrition 

will be considered on an individual basis if detailed documentation is 

submitted. However, some patients with moderate abnormalities may not 

be covered unless they have experienced an unsuccessful trial of enteral

nutrition. 

Medicaid: Our survey responses indicated that all states provide some 

parenteral nutrition coverage for children and all but one—Georgia—

provide such coverage for adults. However, Georgia reported that it would 

consider coverage for adults under an appeal process to its medical 

director. Our results showed variation among states in the standards used 

to determine coverage for parenteral nutrition. Seven states used all six of 

the coverage standards listed in our survey to determine whether Medicaid 

would cover parenteral nutrition therapy for adults and children.29 The 

remaining 44 states used a variety of the six coverage standards. For 

example, Arkansas, California, Kentucky, North Carolina, and Oregon 

require individuals to meet three of the six standards, including pathology 

and documentation. Forty-five states indicated that before covering 

parenteral nutrition therapy for individuals, they would require some form 

of documentation, such as proof of a medical condition. Forty-one of these 

same states also required individuals to have a severe pathology of the

gastrointestinal tract that would not allow absorption of sufficient 

nutrients to maintain weight and strength. Only one state—Minnesota—

 28The local coverage policy considers a total caloric daily intake (through parenteral, 

enteral and oral nutrition) of 20-35 calories per kilogram per day sufficient to achieve or 

maintain appropriate body weight. 

29For purposes of this survey, we used Medicare’s coverage standards for parenteral 

nutrition therapy as a basis for developing questions about the state Medicaid programs’ 

coverage standards. The primary Medicare coverage standards for parenteral nutrition 

therapy that we identified are as follows: (1) Patient has to have a severe pathology of the 

gastrointestinal tract that does not allow absorption of sufficient nutrients to maintain 

weight and strength; (2) Patient has to have a permanent impairment of the gastrointestinal 

tract, i.e., lasting at least 3 months; (3) The patient’s maintenance of weight and strength 

needs to be through intravenous nutrition only; (4) Other therapies—such as enteral 

nutrition and medication—need to have failed in order for the state to cover parenteral 

nutrition; (5) Patient must have a specific clinical condition to qualify for coverage of

parenteral nutrition; and (6) Specific documentation—such as proof of medical condition, 

duration of gastrointestinal impairment, or list of medications used—has to be indicated in 

the patient’s medical record. 

Page 13 GAO-06-63 Inflammatory Bowel Disease
provided coverage for parenteral nutrition therapy without listing any 

specific conditions that individuals must meet to receive therapy. For 

details on specific coverage standards for parenteral nutrition therapy by

state, see app. III. 

Our analysis showed that Medicare and most state Medicaid programs will 

generally cover enteral nutrition as follows: 

Medicare: Medicare covers enteral nutrition under the prosthetic devices 

benefit category. The NCD coverage standards for enteral nutrition are 

very similar to those for parenteral nutrition, with the primary difference 

being the requirements involving the patient’s clinical condition. As with 

parenteral nutrition, coverage for enteral nutrition is provided in both 

home health and outpatient delivery settings. However, for enteral 

nutrition, the patient may have a functioning gastrointestinal tract but 

must be unable to maintain appropriate weight and strength due to 

pathology to, or the nonfunction of, the structures that normally permit 

food to reach the digestive tract. The only other differing requirement in 

the NCD between the two therapies is that there is no hospitalization 

requirement for a patient seeking Medicare coverage for enteral nutrition. 

The NCD also requires a physician’s written order or prescription and 

sufficient medical documentation to show that the prosthetic device 

coverage requirements are met and that enteral nutrition therapy is 

medically necessary. 

The local coverage policy on enteral nutrition is simpler than the local

policy for parenteral nutrition. It provides coverage for enteral nutrition so 

long as adequate nutrition is not possible by either dietary adjustment or 

oral supplements. Tube feedings of enteral nutrition must be required to 

provide sufficient nutrients to maintain weight and strength 

commensurate with the patient’s overall health status due to either one of

two conditions: (1) a permanent non-function or disease of the structures 

that normally permit food to reach the small bowel, or (2) a disease of the 

small bowel which impairs digestion and absorption of an oral diet. 

However, coverage is possible for patients with partial impairments, such 

as a Crohn’s disease patient who requires prolonged infusion of enteral 

nutrients to overcome a problem with absorption. Enteral nutrition 

products administered orally are not covered. 

Medicaid: Forty-nine states reported that they provided some coverage for 

enteral nutrition therapy for both adults and children. One state—

Oklahoma—indicated that it provided coverage for children, but not for 

Medicare and Medicaid 

Coverage Standards for 

Enteral Nutrition 

Page 14 GAO-06-63 Inflammatory Bowel Disease
adults. West Virginia responded that it did not cover this therapy at all.

Analysis of survey results also indicated that there was some variation in 

coverage standards used among the 49 states that covered enteral 

nutrition therapy for adults and children. Six states reported that they 

cover enteral nutrition therapy for patients who meet all six coverage 

standards listed in our survey.30 The remaining states used a variety of the 

six coverage standards. For example, Arizona, Colorado, Michigan, New 

Mexico, and Wisconsin indicated that they use five of the six standards—

these states did not require the patient to have a permanent condition in 

order to be covered for this therapy. Washington reported that, in addition

to subjecting individuals to most of the criteria listed in our survey, it also 

requires prior approval of enteral nutrition therapy based on 

documentation showing that the therapy is medically necessary and 

outlining why traditional food is not appropriate. We also found that for 

both adults and children, 45 of the 49 states that cover enteral nutrition 

therapy require individuals to have specific documentation in their 

medical records before the states would render coverage. We also found

that 12 states had less restrictive coverage standards for children. See app.

IV for more details on enteral nutrition therapy and supplies coverage 

standards for each state.

Medicare and Medicaid provide at least some coverage of ostomy care. In

outpatient delivery settings, Medicare covers ostomy care for IBD patients 

under its benefit category of prosthetic devices—similar to parenteral and 

enteral nutrition. In home health care delivery settings, Medicare covers 

Medicare and Medicaid 

Coverage Standards for 

Ostomy Care 

 30For purposes of this survey, we used Medicare’s five coverage standards for enteral 

nutrition therapy as a basis for developing questions about the state Medicaid programs’ 

coverage standards. The primary Medicare coverage standards for enteral nutrition therapy 

that we identified are as follows: (1) Patient has to have a pathology or non-function of the 

structures that normally permit food to reach the small bowel (e.g., inability to swallow), 

which impairs the ability to maintain weight and strength; (2) The impairment has to be 

considered a permanent condition, (i.e., lasting at least 3 months); (3) Patient’s condition 

must necessitate tube feedings to provide sufficient nutrients to maintain weight and

strength (i.e., patient must be unable to obtain adequate nutrition through dietary 

adjustment and/or oral supplements); (4) Enteral nutrition for patients with partial 

impairments (e.g., Crohn’s disease patient who requires prolonged infusion of enteral 

nutrients to overcome an absorption problem) is possible; and (5) Specific documentation

has to be provided in the patient’s medical record. In addition, although Medicare does not

cover enteral nutrition products that are administered orally, we asked states whether they 

have established a sixth standard by covering such products and related supplies. 

Page 15 GAO-06-63 Inflammatory Bowel Disease
this therapy as a home health benefit.

31 While there is no NCD for ostomy 

care, the four DMERCs have established a local coverage policy for these 

supplies. According to the policy, the only Medicare coverage standard is 

that the patient must have had an ostomy. Similarly, all state Medicaid 

offices, according to our survey responses, provide coverage of ostomy 

care for adults and children who have had ostomies. 

Medicare does not cover medically necessary food products because such 

supplies are not included in any of the benefit categories contained in the 

Social Security Act.32 On the other hand, according to our survey results, 

Medicaid provides at least some coverage of medically necessary food 

products to its recipients in 46 of the states. Nevada, North Carolina, Ohio,

Utah, and West Virginia were the five states that did not provide any

coverage for medically necessary food products. Of those states reporting 

that they provided coverage, 14 also noted that they had a requirement 

that the individuals receive a certain percentage of their nutrition from 

oral supplements in order for these supplements to be covered. In some 

instances, this percentage was as high as 75 to 100 percent. For example, 

Florida, Georgia, Mississippi, Rhode Island, and South Dakota required 

some individuals to meet 100 percent of their nutritional requirements 

from oral supplements; however these individuals did not have to meet all 

of the other conditions listed in our survey. On the other hand, while North 

Dakota reported that individuals must receive at least 51 percent of their 

nutrition from oral supplements, it had the most stringent standards 

overall because it required that individuals meet all three conditions for 

coverage listed in our survey.33 For more information on states’ coverage 

standards for medically necessary food products, see app. V.

Medicare and Medicaid 

Coverage Standards for 

Medically Necessary Food 

Products

 31Under the home health benefit, Medicare pays for services provided to homebound 

beneficiaries by a home health agency under the care of a physician. Covered items and 

services under this benefit include physical therapy, medical supplies, and durable medical 

equipment as long as they are medically necessary. 

32In addition, the NCD for parenteral and enteral nutrition specifically excludes “nutritional 

supplementation” from coverage. 

33For purposes of this survey, states were asked to respond to three coverage standards as 

summarized from discussions with health experts and our review of relevant literature as

follows: (1) medically necessary food products are covered if they are an essential source 

of nutrition; (2) medically necessary food products are covered only for specific 

conditions; and (3) medically necessary food products are covered only during the period 

following hospitalization. 

Page 16 GAO-06-63 Inflammatory Bowel Disease
Medicare does not generally cover medications that are self-administered, 

including drugs approved by the FDA to treat IBD. Coverage is not 

provided because such self-administered medications are not included in

any of the benefit categories contained in the Social Security Act.34

However, in 2003, the Social Security Act was amended, establishing a 

new voluntary prescription drug benefit for Medicare beneficiaries that 

will become effective in January 2006.35 At that time, Medicare will begin to 

cover self-administered drugs approved by the FDA to treat IBD.36

States generally provide some coverage of drugs approved by the FDA to 

treat IBD. Generally, before covering a drug, states require that: (1) a 

physician or licensed practitioner writes the prescription; (2) a licensed 

pharmacist or licensed authorized practitioner dispenses the prescription; 

and (3) the drug is dispensed on a written prescription that is recorded 

and maintained in the pharmacist’s or practitioner’s records. Our survey 

did not ask state Medicaid programs about the standards used to 

determine coverage of drugs to treat IBD because state Medicaid programs 

are not required to cover prescription drugs. 

Our survey also asked state officials whether their Medicaid programs 

cover the off-label use of drugs to treat IBD. Responses to this question 

varied. Nineteen states responded that they had no policy for the use of 

Medicare and Medicaid 

Coverage Standards for 

Drugs to Treat IBD 

 34Specifically, outpatient drugs and biologicals are covered when they are furnished 

incident to a physician’s professional service, provided that they are not usually selfadministered by the patient. See 42 U.S.C. § 1395x(s)(2)(A). Therefore, medications used to

treat IBD therapy that are self-administered are not covered by Medicare, but those 

administered by a physician in a clinical setting may be covered as long as they are “not 

usually self-administered.” CMS has published a general policy for determining whether a

drug meets these statutory requirements, but the ultimate decision on a particular drug is 

made by each Medicare claims administration contractor. Of the drugs and biologicals used 

to treat IBD, only one would likely be considered “not usually self-administered” under

CMS guidelines—Remicade—because it is given intravenously. We did not survey the

Medicare claims administration contractors to determine whether each has issued 

coverage policies on Remicade. 

35Medicare Prescription Drug, Improvement, and Modernization, Act, Pub. L. No. 108-173, § 

101, 117 Stat. 2066, 2071-2152 (codified at 42 U.S.C. §§ 1395w-101 to 1395w-152). 

36Under the new prescription drug benefit, private plans will contract with Medicare to 

provide drug coverage for Medicare beneficiaries. In general, outpatient prescription drugs

will be covered if the drug is either (1) on the specific plan’s formulary, or (2) determined 

to be medically necessary. The medically necessary determination is made through 

Medicare’s exception/appeals process, which requires the plan to cover any drug that is

considered medically necessary for the beneficiary even if it is not on the plan’s formulary.

CMS has also indicated that the drug plans may cover off-label uses of drugs, if they are

prescribed for medically accepted indications; but they are not required to do so. 

Page 17 GAO-06-63 Inflammatory Bowel Disease
off-label drugs or that their state did not cover off-label use. Many of these 

respondents wrote that they only covered drugs approved by the FDA to 

treat IBD. Twenty-four states indicated that they cover off-label drug use. 

However, 20 of these 24 states responded that they would only cover the 

drug under certain conditions. Many of these states reported that 

individuals obtaining such prescriptions must receive prior approval or 

documentation justifying medical necessity. Michigan has the most 

detailed off-label coverage policy of all the states; it indicated that off-label

drugs must receive prior authorization as well as documentation outlining 

the (1) diagnosis, (2) medical reason why the individual cannot use 

another covered drug; (3) results of therapeutic alternative medication 

tried, and (4) medical literature citations supporting the off-label usage.

The remaining eight states did not respond to this question. 

Once coverage standards are met, Medicare generally covers all medically 

necessary supplies for the administration of parenteral and enteral 

nutrition and ostomy care—the three therapies that this program covers. 

On the other hand, our survey of Medicaid programs showed that although

most states provide eligible individuals at least some coverage of each of

the five therapies addressed in this report, the specific supplies that states 

will pay for vary and may be subject to restrictions. According to our 

survey results, most states will cover necessary supplies related to 

parenteral and enteral nutrition with only slight variations for the specific 

supplies supplied. We also found that, while all states provided some 

coverage of ostomy care, the specific supplies that states cover varied. Our 

survey also showed that, while most states will cover at least one of the 

five medically necessary food products listed in our survey, no state 

covers all of them for both adults and children. Finally, we found that most 

Medicaid programs generally covered many of the brand name drugs and 

equivalent generic drugs listed in our survey. 

Medicare will generally cover parenteral nutrition therapy supplies, such 

as nutrients and administration supplies, for beneficiaries who have met 

applicable coverage standards. Specifically, according to the applicable

local coverage policy, Medicare will cover necessary parenteral nutrition 

solutions. In addition, when coverage requirements for parenteral 

nutrition are met, Medicare will also pay for one supply kit and one 

administration kit for each day that parenteral nutrition is administered, if 

such kits are medically necessary and used. Medicare will also cover 

infusion pumps—only one pump will be covered at any one time. 

Variation in Medicare 

and Medicaid 

Programs’ Coverage 

of Specific Supplies 

Related to IBD 

Therapies 

Parenteral Nutrition 

Supplies Covered by 

Medicare and Medicaid 

Page 18 GAO-06-63 Inflammatory Bowel Disease
The local coverage policy also outlines several documentation 

requirements for ensuring that the patient’s medical records—including 

test reports and records from the physician’s office, home health agency,

hospital, nursing home, and other health care professionals—establish the 

medical necessity for the care provided. These records must be made 

available to the DMERC upon request. In addition, an order for each item 

billed and a certificate of medical necessity37 must be signed and dated by

the treating physician, kept on file by the supplier, and be made available 

to the DMERC. Besides the initial certification, there are also 

documentation requirements if recertifications or revised certifications are

necessary.38

States’ Medicaid coverage of the five most commonly used parenteral 

nutrition therapy supplies shows some variation, depending on the item 

and the delivery setting. As table 2 shows, parenteral nutrition therapy 

supplies—such as the infusion pump—are covered by more states than the 

parenteral nutrition solution. In addition, more states reported that they 

cover parenteral nutrition therapy supplies in outpatient delivery settings 

than in home health delivery settings. There was little difference in the

coverage of various supplies between adults and children. 

 37A certificate of medical necessity is required for Medicare reimbursement for 14 types of

durable medical equipment and supplies. This form, which should be personally signed by 

the treating physician or midlevel practitioner—i.e., a nurse practitioner or physician 

assistant trained to provide medical assistance that otherwise might be performed by a

physician—to attest to the accuracy of the information contained on the form, documents 

medical necessity. 

38Based on the clinical condition involved, there may also be other documentation 

requirements for parenteral nutrition therapy, such as evidence of malnutrition, a failed 

tube feeding trial, attempts to feed orally or enterally, and caloric intake and output. It may 

also be necessary to provide reports of small bowel motility studies, a list of medications 

used to treat certain conditions, and laboratory data such as a fecal fat test documenting 

malabsorption.

Page 19 GAO-06-63 Inflammatory Bowel Disease
Table 2: State Medicaid Programs That Reported Payment of Common Parenteral 

Nutrition Therapy Supplies for Adults and Children in Home Health and Outpatient 

Delivery Settings

Adults Children

Supplies Home health Outpatient Home health Outpatient

Parenteral nutrition 

solution 34 42 35 44

Parenteral nutrition 

supply kit 35 43 36 44

Parenteral nutrition 

administration kit 36 45 37 46

Parenteral nutrition 

infusion pump 40 46 40 47

Intravenous pole 39 43 40 45

Source: GAO survey of state Medicaid programs. 

Further analysis of survey results revealed that 28 states covered all 

supplies in both home health and outpatient delivery settings for adults 

and children. For more specific information on the parenteral nutrition 

supplies covered by each state, see app. VI. 

Medicare will generally cover supplies associated with enteral nutrition 

therapy for beneficiaries who meet coverage standards. According to the 

enteral nutrition local coverage policy, Medicare will cover all enteral 

formulas for covered beneficiaries.39 In addition, Medicare will also cover 

medically necessary equipment and supplies for this therapy, such as 

feeding supply kits and pumps that are associated with the specific 

method of administration used by the patient. However, a few limitations 

apply. For example, claims for more than one type of kit delivered on the 

same date will be denied as not medically necessary. Similarly, Medicare 

will rarely consider the use of more than three nasogastric tubes or one 

gastrostomy tube over a 3-month period as medically necessary. 

The local coverage policy also outlines several documentation 

requirements for coverage of enteral nutrition supplies. Similar to the 

parenteral nutrition local policy, the enteral nutrition policy requires that 

Enteral Nutrition Supplies 

Covered by Medicare and 

Medicaid 

 39For special formulas, the medical necessity will need to be justified for each patient.

Otherwise, Medicare payment will be based on the allowance for the least costly medically 

appropriate alternative. 

Page 20 GAO-06-63 Inflammatory Bowel Disease
the patient’s medical record reflect the need for the care provided. It also 

has requirements associated with the certification of enteral nutrition. For 

example, if the physician orders enteral nutrition supplies for a longer 

period of time than is indicated on the original certificate of medical 

necessity, the enteral nutrition policy will require recertification. However, 

the enteral nutrition policy generally has fewer documentation

requirements than that of parenteral nutrition. 

Based on our survey, state Medicaid programs’ payment for seven of the 

most commonly used enteral nutrition therapy supplies varies depending

on the type of product, delivery setting, and whether the patient is an adult 

or a child. Table 3 shows that states reported that their Medicaid programs 

pay for enteral feeding supply kits and tubing more than other therapy 

supplies. In addition, more states pay for enteral supplies for children than 

adults and more states pay for supplies in outpatient delivery settings than 

in home health delivery settings. 

Table 3: State Medicaid Programs That Reported Payment for Common Enteral 

Nutrition Therapy Supplies for Adults and Children in Home Health and Outpatient 

Delivery Settings

Adults Children

Supplies Home health Outpatient Home health Outpatient

Enteral formula 35 42 37 44

Enteral feeding supply kit 40 45 43 46

Tubing 41 43 42 46

Additive for enteral 

formula 22 28 24 30

Enteral nutrition infusion 

pump 38 40 40 42

Intravenous pole 38 40 40 42

Percutaneous 

catheter/tube 30 33 31 38

Source: GAO survey of state Medicaid programs. 

Further analysis revealed that 15 states pay for all seven supplies listed in

our survey in both home health and outpatient delivery settings for adults

and children. Thirty states pay for five or more enteral nutrition supplies 

for adults and children in these same settings. We also found that additives 

for enteral formula, such as fiber, are the least covered product, with only 

21 states covering it in both home health and outpatient delivery settings 

Page 21 GAO-06-63 Inflammatory Bowel Disease
for adults and children. For specific results of enteral nutrition supplies 

provided by each state, see app. VII. 

Medicare covers all of the types of ostomy supplies used by IBD patients 

who require ostomy care. However, there are two restrictions regarding 

the types of ostomy supplies covered. First, Medicare will only provide a 

beneficiary with one type of liquid skin barrier40 if one is needed—either a 

liquid or spray barrier, or individual wipes. Second, Medicare will only pay 

for one type of drainage supply—a stoma cap, a stoma plug, or gauze 

pads—on a given day. These restrictions are imposed by the DMERCs in a 

local coverage policy, which also specifies the “usual maximum quantity” 

of supplies that typically meet the needs of ostomy patients for a specific 

time period (generally for either 1 or 6 months) for each of the most 

commonly used ostomy supplies.41 However, according to the four DMERC 

medical directors, these quantities only serve as guidelines. Because the 

need for ostomy supplies can vary substantially among patients,42 DMERCs

may cover supplies that exceed the usual maximum quantities if the need 

is justified. 

Medicare’s coverage of ostomy supplies is different for IBD patients who 

receive care under a home health plan of care than for those who receive 

it in an outpatient delivery setting.43 If an IBD patient is being served by a 

home health agency and is under a home health plan of care, all of the 

patient’s medical supplies, including ostomy supplies, are considered part 

of the Medicare home health services benefit. This is generally the case 

even when the IBD is a pre-existing condition unrelated to the immediate 

Ostomy Supplies Covered 

by Medicare and Medicaid 

 40Skin barriers are used to protect the skin around the stoma and to increase overall wear 

time. 

41DMERCs have established usual maximum quantities of supplies for those ostomy 

supplies that are most commonly used because more claims data exist on these supplies 

and because there is a greater risk of overutilization. 

42The quantity and type of supplies needed by a patient is determined to a great extent by

the type of ostomy, its location, its construction, and the condition of the skin surface

surrounding the stoma. There will be variation according to individual patient need as well 

individual needs over time. 

43A United Ostomy Association survey of Medicare beneficiaries conducted in late 2004

showed that 45 percent of the respondents had received some kind of home health care

during a recent 3-year period. 

Page 22 GAO-06-63 Inflammatory Bowel Disease
reason for home health care, such as hip replacement surgery.44 Medicare 

pays a fixed amount determined under a prospective payment system to 

the home health agency for the cost of all covered home health visits, 

including ostomy supplies delivered during these visits.45 The home health 

agency is obligated to provide the beneficiary with the necessary ostomy 

supplies, which are bundled with all other necessary home health services. 

The home health agency selects the type of ostomy products to be used 

and if the patient wishes to use different products, the patient must do so 

at his or her own expense. This practice can be contrasted to the 

outpatient delivery setting, where the products are generally selected by

the patient, or the patient’s doctor.46

All states responded that their Medicaid programs pay for ostomy supplies 

for adults and children who have had ostomies; however the range of 

supplies covered varied. Because of the relatively large number of supplies 

commonly used by ostomy patients we grouped these supplies in nine 

categories, based on input from a representative of the United Ostomy 

Association. Table 4 shows the median percent of states covering ostomy 

supplies in home health and outpatient delivery settings, after they have 

been placed in these categories. For example, for the 14 supplies in the 

drainable pouch with standard barrier supplies category—half of supplies 

are covered by at least 84 percent of states in home health delivery 

settings and 85 percent of states in outpatient delivery settings. In general, 

 44According to the United Ostomy Association, almost two-thirds of the individuals who 

have ostomies and are receiving home care services, are receiving these services for 

reasons unrelated to their ostomy. 

45The Balanced Budget Act of 1997 mandated the implementation of the prospective 

payment system for home health agencies. Pub. L. No. 105-33, § 4603(a), 111 Stat. 251, 467-

72. Under this system, home health agencies receive a single payment, adjusted to reflect 

the care needs of the patient, for delivering up to 60 days of care, called a home health 

episode. This episode payment is based on the historical national average cost of providing 

care, not on a home health agency’s actual costs of treating any given patient. The episode 

payment is intended to cover the average costs of all home health visits and medical 

supplies provided during the episode. 

46We previously reported that, although Medicare’s home health payment includes the

average costs of nonroutine medical supplies, including ostomy supplies, this payment may 

not reflect variation in supply costs across types of patients. Home health agencies may be

paid the same amount for treating patients with quite different supply costs. Patients who 

require costly supplies may have problems accessing home health care, may have to switch 

supplies, or have a limited number of supplies provided to them during their period of 

home care. In addition, the agencies that treat them may be financially disadvantaged. See

GAO: Medicare Home Health Payment: Nonroutine Medical Supply Data Needed to 

Assess Payment Adjustments, GAO-03-878 (Washington, D.C., August 15, 2003.) 

Page 23 GAO-06-63 Inflammatory Bowel Disease
states’ coverage of ostomy supplies was greater in outpatient, than in 

home health delivery settings. For more details on the individual ostomy 

supplies included in each category and the percent of states covering each 

supply, see app. VIII. 

Table 4: Median Percent of State Medicaid Programs That Reported Covering

Ostomy Supplies in Home Health and Outpatient Delivery Settings 

Ostomy categories 

(number of supplies)

Median percent of states 

that cover supplies in 

each category in home 

health delivery settings

Median percent of states 

that cover supplies in 

each category in

outpatient delivery 

settings

Drainable pouch with 

extended wear barrier 

supplies 

(2 supplies) 84 88

Drainable pouch with 

standard barrier supplies 

(14 supplies) 84 85

Irrigation supplies 

(6 supplies) 82 84

Fluid discharge management 

item 

(1 item) 75 75

Adhering pouch barrier 

supplies 

(2 supplies) 85 90

Extended wear barrier 

supplies 

(5 supplies) 84 86

Barrier-skin protection 

supplies 

(13 supplies) 86 88

Closed pouch supplies 

(11 supplies) 84 88

Other accessories 

(15 supplies) 80 82

Source: GAO survey of state Medicaid programs. 

Note: Individual supplies under each category appear in app. VIII. 

Twenty-four states reported covering all of the ostomy supplies listed in 

our survey in both delivery settings. Nine of the 24 states that covered all

supplies imposed no supply limits or dollar caps on individuals. The 

remaining 15 states reported that they had supply limits or dollar caps; 

however five of these states—Arizona, Hawaii, North Dakota, Rhode 

Page 24 GAO-06-63 Inflammatory Bowel Disease
Island, and Virginia—added that they often allowed individuals to exceed 

these limits and caps for certain supplies. For example, one state reported 

that while it has a supply limit of one box of 50 skin barrier wipes and 

dollar cap of $9.36 per month, it will often allow individuals to exceed 

limits and caps. See app. IX for more details on individual states’ coverage

of supplies, including supply limits and dollar caps, in both home health 

and outpatient delivery settings. 

Unlike Medicare, which does not pay for any medically necessary food 

products, most state Medicaid programs pay for some products. These 

products include prescription strength vitamins, oral nutritional formulas, 

food thickeners, baby foods, blended grocery products, and other supplies. 

According to our survey, 46 states reported covering at least one of the 

five products listed in our survey for either adults or children.

As table 5 shows, out of the five food products, state Medicaid programs 

reported paying for oral nutritional formulas most often. Baby food and 

other blenderized products were the least common products covered with 

only four states—Missouri, New Jersey, Tennessee, and Texas—reporting 

that they paid for these products. In addition, more states paid for 

medically necessary food products for children than for adults. 

Table 5: Number of State Medicaid Programs Covering Medically Necessary Food 

Products for Adults and Children 

Medically Necessary Food 

Products Covered by 

Medicaid 

Prescription

strength 

vitamins

Oral 

nutritional 

formulas

Food

thickeners 

Baby food 

and other

blenderized 

products

Other

products

Adults and 

children 29 36 28 2 12

Children only 6 7 5 2 5

Neither adults 

nor children 16 8 18 47 34

Total 51 51 51 51 51

Source: GAO survey of state Medicaid programs. 

For more details on states’ payment of medically necessary food products, 

see app. X. 

Page 25 GAO-06-63 Inflammatory Bowel Disease
All states reported that their Medicaid programs paid for at least one of the 

nine brand name drugs or two of the generic drugs that were included in 

our survey and which were approved by the FDA to treat IBD. Figure 1 

shows the number of states covering each drug. The brand name drug 

Remicade was the most commonly paid for drug, with all states reporting 

payment.47 The generic drugs available for Azulfidine and Rowasa were 

covered by 48 and 46 states respectively. 

Drugs Covered by 

Medicaid to Treat IBD 

Figure 1: Number of State Medicaid Programs That Reported Covering Drugs Listed in Our Survey to Treat IBD 

0

10

20

30

40

50

Entocort

Canasa

Pentasa

Dipentum

Asacol

generic equivalent

Rowasa

Azulfidine

Azulfidine -

Colazal

Remicade

Number of states

Drugs

Source: GAO survey of state Medicaid programs.

Rowasa -

51

48

44

48

46 46 45 44

46 46 45

generic equivalent

 47Forty-eight survey respondents reported that their states would cover the brand name 

drug Remicade. One state—Ohio—wrote that it would cover the drug with prior

authorization. The remaining two states—California and Iowa—indicated that they would 

not cover the drug without prior authorization. Based on these responses, we concluded 

that all states would cover the drug. 

Page 26 GAO-06-63 Inflammatory Bowel Disease
Further analysis revealed that six states—Colorado, Minnesota, Montana,

Nevada, Oklahoma, and Wisconsin—reported that individuals must use 

generic drugs if they are available, before obtaining the equivalent, but 

more expensive brand name drugs. Three states—California, Iowa, and 

Ohio—indicated that they would not cover the brand name drug Remicade 

without prior authorizations. See app. XI for a listing of each state’s 

coverage of drugs listed in our survey to treat IBD for adults and children.

We provided a draft of this report to CMS. In its written comments, CMS 

said that it determined that we correctly described the Medicare coverage 

policies for parenteral and enteral nutrition and ostomy supplies. 

However, CMS suggested that we clarify our description of Medicare’s 

coverage policy for prescription drugs that are not self-administered. We 

revised our language to address this concern. It also said that, as it 

proceeds with policy development, it will continue to give consideration to 

access issues that affect Medicare beneficiaries and Medicaid recipients in

their treatment of IBD. We have reprinted CMS’s letter in app. XII. 

We also provided FDA with excerpts of the draft concerning drugs it has 

approved to treat Crohn’s disease and ulcerative colitis. FDA responded by

e-mail and provided a list that contained several additional drugs it said it 

considered as valid, labeled, treatments for IBD. FDA’s revised list was 

provided after our survey was administered and these drugs are not 

discussed in this report. We modified our report to note this. 

We are sending copies of this report to the Secretary of Health and Human 

Services, the Administrator of CMS, the Commissioner of FDA, and other

interested parties. In addition, this report will be available at no charge on

GAO’s Web site at http://www.gao.gov. We will also make copies available 

to others upon request. 

Agency Comments 

Page 27 GAO-06-63 Inflammatory Bowel Disease
If you or your staffs have any questions about this report, please contact 

me at (312) 220-7600 or aronovitzl@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs may be found on the last 

page of this report. Key contributors to this report are listed in app. XIII. 

Leslie G. Aronovitz 

Director, Health Care 

Page 28 GAO-06-63 Inflammatory Bowel Disease
Appendix I: Scope and Methodology 

Page 29 GAO-06-63

Appendix I: Scope and Methodology 

In this report, we (1) identify the Medicare and Medicaid coverage

standards for five therapies—parenteral nutrition, enteral nutrition 

formula, ostomy care, medically necessary food products, and drugs 

approved by the Food and Drug Administration (FDA) for inflammatory 

bowel disease (IBD); and (2) determine what specific supplies used in 

these therapies Medicare and state Medicaid programs pay for in home 

health and outpatient delivery settings. In examining Medicare and 

Medicaid coverage of these therapies and the related supplies, we 

considered whether each program would cover these items in both home 

health and outpatient settings. For purposes of this study, we defined 

these settings as follows:

• Home health care refers to the situation in which a medical supply is being 

provided to the individual by a home health aide or others through an 

arrangement made by a home health agency, in accordance with a plan for 

furnishing the supply that a physician has established and periodically 

reviews. The supply is provided through visits made to an individual’s 

residence. 

• Outpatient care refers to any situation in which a patient receives a 

medical supply but does not require an overnight hospital stay. This 

includes a situation in which the supply is provided to the individual 

during a visit with a physician in an office or hospital. It may include a

situation in which the individual obtains and self-administers the supply 

outside of the office or hospital setting, without the assistance of a home 

health aide or a home health agency.

To identify Medicare’s coverage standards for parenteral and enteral 

nutrition, ostomy care, medically necessary food products, and drugs 

approved by the FDA for the treatment of IBD in home health and 

outpatient delivery settings, we reviewed the standards established by the 

Centers for Medicare & Medicaid Services (CMS) in its national coverage

policies. Specifically, we examined CMS’s database of national coverage 

determinations (NCD) as well as its interpretive manuals, which address 

coverage policies. We also reviewed local coverage policies established by 

CMS’s four Durable Medical Equipment Regional Carriers (DMERC). In

addition, we reviewed relevant Medicare laws and regulations. To clarify 

our understanding of these materials, we interviewed CMS officials and 

the medical directors of the four DMERCs. We also reviewed relevant 

laws, and other CMS and DMERC documentation to determine if the 

program covers these therapies in both the home health and outpatient 

delivery settings. 

Medicare and Medicaid’s 

Coverage Standards of IBD 

Therapies

 Inflammatory Bowel Disease
Appendix I: Scope and Methodology 

To identify the Medicaid program’s coverage standards in each state for 

the five therapies addressed by our study in home health and outpatient 

delivery settings, we sent a survey to Medicaid offices in the 50 states and 

the District of Columbia. The survey addressed each state’s coverage

policies and medical criteria that an individual must meet to receive each 

of the five therapies as a Medicaid benefit. Specifically, we asked states to

indicate whether their program provides coverage of each of the five 

therapies and the criteria and conditions they have established, if 

applicable. In general, we used Medicare’s coverage policies as a basis for 

the survey’s coverage questions, and we provided states the opportunity to 

describe how their policies varied from Medicare’s policies. We also 

provided states with the option of describing other pertinent criteria they 

may have established. The survey asked them to indicate whether they had 

different coverage policies for adults and children for such therapies. 

Because Medicare does not cover medically necessary food products and 

self-administered prescription medications, we formulated our survey 

questions on applicable coverage standards for these two items based on 

discussions with medical experts and organizations that represent IBD 

patients, and our review of pertinent literature. Regarding drugs used to 

treat IBD, we consulted with the FDA, which provided us with a list of 

nine brand name drugs and two generic drugs that it had approved to treat

Crohn’s disease and ulcerative colitis. We included these drugs in our 

survey.1

We pretested our survey with Medicaid officials in the District of 

Columbia, Georgia, and Virginia. We selected the District of Columbia and

Georgia because of the contrasting sizes of these two Medicaid programs. 

We selected Virginia to obtain additional input on the structure of our 

questions related to prescription drug coverage. We received responses 

from all of the states and reviewed these data for obvious inconsistency 

errors and completeness. For responses that were unclear or incomplete, 

we contacted survey respondents to obtain clarification before conducting

our analyses. We did not verify all the information we received in the 

survey. When necessary, we compared our electronic data files of survey 

responses with the actual surveys we obtained from states. We also did 

several internal verification checks to ensure accuracy. Based on these 

 1

The nine brand name drugs listed in our survey were Asacol, Azulfidine, Canasa, Colazal, 

Dipentum, Entocort, Pentasa, Remicade, and Rowasa. The survey also listed the generic

equivalents of two of these drugs, Azulfidine and Rowasa. After we administered our

survey, the FDA informed us that it also considers several additional drugs as valid 

treatments for IBD. These drugs are not discussed in this report. 

Page 30 GAO-06-63 Inflammatory Bowel Disease
Appendix I: Scope and Methodology 

efforts, we determined that the data were sufficiently reliable for the 

purposes of this report. 

To improve our understanding of how Medicare’s and Medicaid’s coverage 

standards apply to the five therapies, we also reviewed pertinent literature,

interviewed two physicians who are regarded as experts in the field of 

gastrointestinal diseases, and convened a panel consisting of 

representatives of organizations that study or serve the needs of IBD 

patients. The following organizations participated in this panel: 

• American Society for Parenteral and Enteral Nutrition 

• American Gastroenterological Association 

• Coram Healthcare (provider of home infusion services) 

• Crohn’s Disease and Colitis Foundation of America 

• Digestive Disease National Coalition

• North American Society for Pediatric Gastroenterology, Hepatology, and 

Nutrition 

• The Oley Foundation for Home Parenteral and Enteral Nutrition 

• United Ostomy Association2

To identify the specific supplies used in the covered therapies that 

Medicare will pay for, we reviewed relevant NCDs, local coverage policies, 

and CMS interpretive manuals. We interviewed CMS officials and the four

DMERC directors about the supplies that Medicare will pay for, and any 

applicable limitations or restrictions. To improve our understanding of the 

various supplies used in each therapy, we obtained information from the 

two medical experts and representatives of organizations that participated

in our panel.

To determine the specific supplies that state Medicaid programs will pay 

for, we provided in our survey a list of commonly used supplies for each of 

the five therapies. To determine the supplies that are most commonly used 

in the five therapies, we interviewed the directors of the four DMERCs, 

representatives of some of the organizations that participated in our panel,

and the two medical experts, and reviewed relevant literature. States were 

asked to report whether or not the specific supplies listed were covered 

for adults and children, and whether their Medicaid program would cover 

these supplies in both home health and outpatient delivery settings. In the 

Specific Supplies Paid for 

by Medicare and State 

Medicaid Programs 

 2

The United Ostomy Association permanently ceased operations on September 30, 2005.

Page 31 GAO-06-63 Inflammatory Bowel Disease
Appendix I: Scope and Methodology 

case of parenteral and enteral nutrition, and ostomy supplies, we listed 

items by name and included their identifying codes as specified in the 

Health Care Common Procedure Coding System (HCPCS).3

 Because there

is no standard definition of what constitutes medically necessary food 

products, we developed a list of items that members of our panel and the 

physicians we spoke to generally considered commonly used. To 

determine whether states covered medications to treat IBD, we asked 

states to indicate whether they paid for the nine brand name drugs and 

two generic drugs listed in our survey. With the exception of drugs, we 

asked states to indicate whether they had established any restrictions, 

including supply limits and monetary caps, on the provision of covered

products. We conducted our work from December 2004 through 

November 2005, in accordance with generally accepted government 

auditing standards. 

 3

HCPCS was developed by CMS to standardize coding systems used to process Medicare 

claims for medical services and procedures furnished by physicians and other health care 

professionals, as well as other medical products, supplies, and services. 

Page 32 GAO-06-63 Inflammatory Bowel Disease
Appendix II: Re

Program Co

Patients 

ported State Medicaid 

verage of Therapies Used by IBD 

Page 33 GAO-06-63

Appendix II: Reported State Medicaid 

Program Coverage of Therapies Used by IBD 

Patients 

State

Alabama

Alaska

Arizona

Arkansasb

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Parenteral 

nutrition

Enteral

nutrition

Ostomy

care

Medically 

necessary 

food products Drugsa

 Inflammatory Bowel Disease
Appendix II: Reported State Medicaid 

Program Coverage of Therapies Used by IBD 

Patients 

a

For purposes of this analysis, we are defining coverage as any state that covers at least one of the 

brand name drugs or generic equivalent drugs listed in our survey for adults or children. 

b

Only total parenteral nutrition is covered. 

Source: GAO survey of state Medicaid programs.

Covered for both adults and children

Covered for adults only 

Covered for children only

State does not cover

State

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Wyoming

Parenteral 

nutrition

Enteral

nutrition

Ostomy

care

Medically 

necessary

food products Drugsa

Page 34 GAO-06-63 Inflammatory Bowel Disease
Appendix III: Reported Parent

Therapy Co

Medi

eral Nutrition 

verage Standards by State 

caid Program

Page 35 GAO-06-63

Appendix III: Reported Parenteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program 

State

Alabama

Alaska

Arizonag

Arkansash

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaiii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentuckyj

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missourik

Montanal

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Pathologya

Permanent

conditionb

Intravenous

onlyc

Other therapies

failedd

Clinical

conditione

Documentation 

requiredf

 Inflammatory Bowel Disease
Appendix III: Reported Parenteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program

a

Patient has to have a severe pathology of the gastrointestinal tract that does not allow absorption of 

sufficient nutrients to maintain weight and strength.

b

Patient has to have a permanent impairment of the gastrointestinal tract, i.e., lasting at least 3 

months. 

c

The patient’s maintenance of weight and strength needs to be through intravenous nutrition only. 

d

Other therapies—such as enteral nutrition and medication—need to have failed in order for the state 

to cover parenteral nutrition. 

e

Patient must have a specific clinical condition in order to qualify for coverage of parenteral nutrition.

f

Specific documentation—such as proof of medical condition, duration of gastrointestinal impairment, 

and list of medications used—has to be provided in the patients’ medical record. 

g

For acute care adults receiving total parenteral nutrition, parenteral nutrition therapy must be the sole 

source of nutrition. 

h

Only total parenteral nutrition is covered. Individuals must document the reason enteral feeding 

cannot be given.

i

The coverage standards related to partial impairment and clinical conditions are not mandatory. A 

state official reported that the state generally tries to follow these standards. 

j

The coverage standards related to pathology and clinical conditions are only applicable in home 

health delivery settings. 

Source: GAO survey of state Medicaid programs.

Applies to both adults and children

Applies to adults only 

Applies to children only

Coverage standard or requirement does not apply

State

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Wyoming

Pathologya

Permanent

conditionb

Intravenous

onlyc

Other therapies

failedd

Clinical

conditione

Documentation 

requiredf

Page 36 GAO-06-63 Inflammatory Bowel Disease
Appendix III: Reported Parenteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program

k

The recipient must require total parenteral nutrition to sustain life. Adequate nutrition must not be 

possible by dietary adjustment, oral supplements, or tube enteral nutrition. 

l

Parenteral nutrition therapy must be the primary source of nutrition. 

Page 37 GAO-06-63 Inflammatory Bowel Disease
Appendix IV: R

Therapy Co

Medi

eported Enteral Nutrition 

verage Standards by State 

caid Program

Page 38 GAO-06-63

Appendix IV: Reported Enteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program 

State

Alabama

Alaska

Arizonag

Arkansash

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowai

Kansas

Kentuckyj

Louisianak

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montanal

Nebraska

Nevada

New Hampshire

New Jersey

New Mexicom

New York

North Carolina

North Dakota

Pathologya

Permanent

conditionb

Tube 

feedingc

Partial

impairmentd

Products and

suppliese

Documentation 

requiredf

 Inflammatory Bowel Disease
Appendix IV: Reported Enteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program

a

Patient has to have a severe pathology or non-function of the structures that normally permit food to

reach the small bowel (e.g., inability to swallow), which impairs the ability to maintain weight and 

strength. 

b

The impairment has to be considered a permanent condition, i.e., lasting at least 3 months. 

c

The patient’s condition must necessitate tube feedings to provide sufficient nutrients to maintain 

weight and strength (i.e., patient must be unable to obtain adequate nutrition through dietary 

adjustment and/or oral supplements). 

d

Enteral nutrition for patients with partial impairments (e.g., Crohn’s disease patient who requires

prolonged infusion of enteral nutrients to overcome an absorption problem) is possible. 

e

The state covers enteral nutrition products, and related supplies, that are administered orally. 

f

Specific documentation related to enteral nutrition therapy has to be provided in the patients’ medical

record. 

g

For acute care adult patients, enteral therapy must be the sole source of nutrition. 

h

For adults, enteral nutrition is covered only if it is the sole source of nutrition. 

i

For adults and children, enteral nutrition must provide 51 percent of more of caloric intake. 

j

For adults, the tube feeding criterion is only applicable in home health delivery settings. 

k

The state does not require documentation for adults. It did not respond to this question for children. 

Source: GAO survey of state Medicaid programs.

Applies to both adults and children

Applies to adults only 

Applies to children only

State does not cover therapy

Coverage standard or requirement does not apply

State

Ohio

Oklahoman

Oregon

Pennsylvania

Rhode Island

South Carolinao

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsino

Wyoming

Pathologya

Permanent

conditionb

Tube 

feedingc

Partial

impairmentd

Products and 

suppliese

Documentation 

requiredf

Page 39 GAO-06-63 Inflammatory Bowel Disease
Appendix IV: Reported Enteral Nutrition 

Therapy Coverage Standards by State 

Medicaid Program

l

Enteral nutrition therapy must be the primary source of nutrition. The state may cover oral nutritional 

products for children who have had an early and periodic screening, diagnostic, and treatment 

screening which results in a diagnosed condition that impairs absorption of specific nutrients. 

m

Documentation must indicate that there is a defined pathologic process for which nutritional support 

is therapeutic. 

n

The state only covers this therapy for children. 

o

Tube feeding coverage standard is to sustain life rather than to maintain weight and strength. 

Page 40 GAO-06-63 Inflammatory Bowel Disease
Appendix V: Re

Food Products 

Medi

ported Medically Necessary

Coverage Standards by State 

caid Program

Page 41 GAO-06-63

Appendix V: Reported Medically Necessary 

Food Products Coverage Standards by State 

Medicaid Program 

State

Alabama

Alaska

Arizonad

Arkansas

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentuckye

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraskaf

Nevada

New Hampshire

New Jersey

New Mexicog

New York

North Carolina

North Dakota

Essential

sourcea

Specific

conditionb Hospitalizationc

 Inflammatory Bowel Disease
Appendix V: Reported Medically Necessary

Food Products Coverage Standards by State 

Medicaid Program

a

Medically necessary food products must be an essential source of nutrition. 

b

Medically necessary food products are covered only for specific conditions. 

c

Medically necessary food products are covered only during the period following hospitalization. 

d

For acute care adult patients, medically necessary food products must be the sole source of nutrition. 

e

The state covers medically necessary food products for certain inherited metabolic diseases. 

f

The state covers medically necessary food products if products are necessary to provide sufficient 

nutrients to maintain weight and strength commensurate with patient’s overall health status. 

g

To receive coverage, a patient must have a defined and specific pathologic condition for which 

nutritional support is therapeutic. If the purpose is simply to provide food, then it is not considered 

medically necessary. 

h

Nutritional therapy must be the sole source of nutrition. 

Source: GAO survey of state Medicaid programs.

Applies to both adults and children

Applies to adults only

Applies to children only

State does not cover therapy

Coverage standard or requirement does not apply

State

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakotah

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsin

Wyoming

Essential

sourcea

Specific

conditionb Hosptalizationc

Page 42 GAO-06-63 Inflammatory Bowel Disease
Appendix VI: R

Supplies Cover

and O

eported Parenteral Nutrition 

ed by Medicaid in Home Health

utpatient Delivery Settings 

Page 43 GAO-06-63

Appendix VI: Reported Parenteral Nutrition 

Supplies Covered by Medicaid in Home 

Health and Outpatient Delivery Settings 

State

Alabama

Alaska

Arizona

Arkansasd

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaii

Idaho

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Parenteral 

nutritiona

Parenteral

nutrition

supply kitb

Parenteral

nutrition

administration kit

Parenteral

nutrition

infusion pumpc

Intravenous

pole

 Inflammatory Bowel Disease
Appendix VI: Reported Parenteral Nutrition 

Supplies Covered by Medicaid in Home Health

and Outpatient Delivery Settings 

a

Parenteral nutrition solution includes all types of solutions. 

b

Parenteral nutrition supply kit which can be premixed or mixed at home. 

c Parenteral nutrition infusion pump can be portable or stationary. 

d

Supplies are covered only when administered at home. They are not covered in other outpatient 

delivery settings.

Source: GAO survey of state Medicaid programs. 

Covered for both adults and children

Covered for adults only 

Covered for children only

State does not cover supply

Outpatient settings

Home health setting 

Home health and outpatient settings

State

Ohio

Oklahoma

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont 

Virginia

Washington

West Virginia

Wisconsin

Wyoming

Parenteral 

nutritiona

Parenteral

nutrition

supply kitb

Parenteral

nutrition

administration kit

Parenteral

nutrition

infusion pumpc

Intravenous

pole

Page 44 GAO-06-63 Inflammatory Bowel Disease
Appendix VII: 

Supplies Cover

and O

Reported Enteral Nutrition 

ed by Medicaid in Home Health

utpatient Delivery Settings 

Page 45 GAO-06-63

Appendix VII: Reported Enteral Nutrition 

Supplies Covered by Medicaid in Home 

Health and Outpatient Delivery Settings 

State

Alabama

Alaska

Arizona

Arkansasg

California

Colorado

Connecticut

Delaware

District of Columbia

Florida

Georgia

Hawaii

Idaho

Illinoish

Indiana

Iowa

Kansas

Kentucky

Louisiana

Mainei

Maryland

Massachusetts

Michigan

Minnesota

Mississippi

MissouriJ

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexico

New York

North Carolina

North Dakota

Enteral

formulaa

Enteral

feeding

supply kitb Tubingc Additived

Infusion 

pumpe

Intravenous

pole Catheterf

 Inflammatory Bowel Disease
Appendix VII: Reported Enteral Nutrition 

Supplies Covered by Medicaid in Home Health

and Outpatient Delivery Settings 

a

Enteral formula includes all types.

b

Enteral feeding supply kit includes the syringe, pump, and gravity fed. 

c

Tubing includes all types including nasogastric, stomach, and gastrostomy. 

d

Additives for enteral formula. 

e

Enteral nutrition includes infusion pump with or without an alarm. 

f

Catheter includes percutaneous catheter, tube anchoring device and adhesive skin attachment. 

g

State’s coverage is limited to home health delivery settings. 

h

The state does not cover enteral nutrition infusion pump – without alarm. 

i

The state does not cover blenderized enteral formulas. 

j

For adults, the state handles coverage for enteral supplies on a case-by-case basis.

k

The state only covers specific enteral nutrition supplies. Nasogastric tubings with and without stylets 

along with stomach tubes are only covered for children. 

l

Pediatric enteral formula and blenderized enteral formula are only covered for children under the age

of 21. 

m

The state does not cover all enteral formulas. 

Source: GAO survey of state Medicaid programs.

Covered for both adults and children

Covered for adults only 

Covered for children only

State does not cover supply

State does not cover therapy

Outpatient settings

Home health setting 

Home health and outpatient settings

No response

State

Ohio

Oklahoma

Oregon

Pennsylvaniak

Rhode Island

South Carolina

South Dakotal

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsinm

Wyoming

Enteral

formulaa

Enteral

feeding

supply kitb Tubingc Additived

Infusion 

pumpe

Intravenous

pole Catheterf

Page 46 GAO-06-63 Inflammatory Bowel Disease
Appendix VIII: Reported Percent of States 

Covering Ostomy Supplies in Home Health

and Outpatient Delivery Settings 

Supplya name

Home health 

delivery setting

Outpatient 

delivery setting

Drainable pouch with extended wear barrier 

Ostomy pouch, drainable, with extended wear barrier attached 84 88

Ostomy pouch, drainable, with extended wear barrier attached, with built-in convexity 84 88

Drainable pouch – standard barrier 

Ostomy pouch, drainable with faceplate attached, plastic 84 90

Ostomy pouch, drainable with faceplate attached, rubber 84 90

Ostomy pouch, drainable, for use on faceplate, plastic 84 90

Ostomy pouch, drainable, for use on faceplate, rubber 84 86

Ostomy pouch, drainable, with barrier 84 88

Ostomy pouch, drainable, high output, for use on a barrier with flange (2 piece system), 

with filter 80 82

Ostomy pouch, closed, for use on barrier with locking flange, with filter (2 pieces) 80 84

Ostomy pouch, drainable, with barrier attached, with filter (1 piece) 80 84

Ostomy pouch, drainable, for use on barrier with non-locking flange, with filter (2 pieces) 80 84

Ostomy pouch, drainable, for use on barrier with locking flange (2 pieces) 80 84

Ostomy pouch, drainable, for use on barrier with locking flange, with filter (2 pieces) 78 82

Ostomy pouch, drainable, without barrier attached (1 piece) 86 84

Ostomy pouch, drainable with barrier attached (1 piece) 88 88

Ostomy pouch, drainable, for use on barrier with flange (2 piece system) 90 90

Irrigation supply

Irrigation supply; sleeve 82 86

Ostomy irrigation supply; bag 78 82

Ostomy irrigation supply; cone/catheter, including brush 80 86

Lubricant 82 84

Continent device, plug for continent stoma 82 84

Continent device, catheter for continent stoma 82 84

Fluid discharge management 

Bedside drainage bottle 75 75

Barrier with adhering pouch 

Ostomy barrier, with flange, with built-in convexity 84 92

Ostomy skin barrier, with flange, without built-in convexity, 4x4 inches or smaller 86 88

Barrier – extended wear 

Ostomy skin barrier, solid 4x4 inches, extended wear, without built-in convexity 84 88

Ostomy skin barrier, with flange, extended wear, with built-in convexity, 4x4 inches or 

smaller 88 88

Appendix VIII: Reported Percent of States 

Covering Ostomy Supplies in Home Health 

and Outpatient Delivery Settings 

Page 47 GAO-06-63 Inflammatory Bowel Disease
Appendix VIII: Reported Percent of States 

Covering Ostomy Supplies in Home Health

and Outpatient Delivery Settings 

Supplya name

Home health 

delivery setting

Outpatient 

delivery setting

Ostomy skin barrier, with flange, extended wear with built-in convexity, larger than 4x4 

inches 84 86

Ostomy skin barrier, with flange, extended wear, without built-in convexity, 4x4 inches or 

smaller 84 86

Ostomy skin barrier, with flange, extended wear, without built-in convexity, larger than 4x4

inches 84 86

Barrier skin protection

Skin barrier, solid; 4x4 inches 86 92

Adhesive, liquid 90 92

Ostomy skin barrier, liquid 88 94

Ostomy skin barrier, powder 88 94

Ostomy barrier, solid 84 90

Ostomy faceplate equivalent, silicone ring 82 86

Ostomy ring 88 92

Ostomy skin barrier, non-pectin based, paste 86 88

Ostomy skin barrier, pectin-based paste 86 84

Skin barrier, wipes, box of 50 86 86

Skin barrier, solid, 6x6 inches 88 86

Skin barrier, solid, 8x8 inches 86 86

Adhesive or non-adhesive, disk or foam pad 86 86

Closed pouch

Ostomy skin barrier, closed, with extended wear barrier attached, with built-in convexity 84 88

Ostomy pouch, closed, with barrier, with filter 80 84

Ostomy pouch, closed, with barrier attached, with built-in convexity 80 84

Ostomy pouch, closed, without barrier, with filter (1 piece) 80 84

Ostomy pouch, closed, fuse use on barrier with non-locking flange (2 pieces) 78 82

Ostomy pouch, closed, fuse use on barrier with locking flange (2 pieces) 77 80

Ostomy pouch, closed, with barrier attached 88 92

Ostomy pouch, closed, without barrier attached 90 90

Ostomy pouch, closed, for use on faceplate 86 90

Ostomy pouch, closed, for use on barrier with flange 90 92

Stoma cap 86 92

Other accessories 

Ostomy faceplate 84 88

Adhesive remover wipes 82 80

Ostomy vent 73 80

Ostomy belt 88 92

Page 48 GAO-06-63 Inflammatory Bowel Disease
Appendix VIII: Reported Percent of States 

Covering Ostomy Supplies in Home Health

and Outpatient Delivery Settings 

Supplya name

Home health 

delivery setting

Outpatient 

delivery setting

Ostomy belt with peristomal hernia support 75 80

Ostomy filter 75 82

Ostomy deodorant, liquid 73 78

Ostomy deodorant, solid 73 77

Ostomy supply, miscellaneous 80 84

Ostomy absorbent material for use in ostomy pouch to thicken liquid stomal output 73 75

Tape, non-waterproof 88 86

Tape, waterproof 88 86

Adhesive remover or solvent 86 90

Ostomy accessory, convex insert 82 84

Appliance cleaner, incontinence and ostomy appliances 75 77

Source: GAO survey of state Medicaid programs. 

a

Ostomy supplies were placed in related categories based on discussions with an official from the 

United Ostomy Association. 

Page 49 GAO-06-63 Inflammatory Bowel Disease
Appendix IX: Reported Information on

Medicaid Coverage of Ostomy Supplies and 

Related Limits

Number of supplies covered 

Percent of dollar caps or supply limits that

are exceeded: 

State Home health Outpatient

Percent of

covered supplies

with dollar caps

and/or supply

limits Often Rarely Never

No 

response

Alabama 14 8 20 0 0 100 0

Alaska 69 69 81 0 100 0 0

Arizona 69 69 100 26 23 51 0

Arkansasa 54 54 78 0 0 100 0

California 60 59 15 90 0 0 10

Colorado 69 69 0 0 0 0 0

Connecticut 64 0 93 0 98 0 2

Delaware 69 69 96 0 100 0 0

District of Columbia 0 69 100 55 38 7 0

Florida 65 66 96 0 99 0 2

Georgia 0 17 25 0 100 0 0

Hawaii 69 69 100 100 0 0 0

Idahob69 69 100 0 44 57 0

Illinois 0 68 99 2 99 0 0

Indiana 69 69 0 0 0 0 0

Iowa 69 69 96 0 99 2 0

Kansas 57 57 83 0 0 100 0

Kentuckyc 69 68 55 100 0 0 0

Louisiana 63 63 65 0 100 0 0

Maine 69 69 0 0 0 0 0

Maryland 69 69 0 0 0 0 0

Massachusetts 67 55 97 0 100 0 0

Michigan 63 63 91 0 100 0 0

Minnesota 69 47 100 0 29 71 0

Mississippi 67 67 97 0 100 0 0

Missouri 69 68 46 0 100 0 0

Montana 69 69 100 0 100 0 0

Nebraska 69 69 100 0 99 0 1

Nevadad69 69 42 0 100 0 0

New Hampshire 69 69 0 0 0 0 0

New Jersey 0 68 12 0 100 0 0

New Mexico 0 69 96 0 0 100 0

Appendix IX: Reported Information on 

Medicaid Coverage of Ostomy Supplies and 

Related Limits 

Page 50 GAO-06-63 Inflammatory Bowel Disease
Appendix IX: Reported Information on

Medicaid Coverage of Ostomy Supplies and 

Related Limits

Number of supplies covered 

Percent of dollar caps or supply limits that

are exceeded: 

State Home health Outpatient

Percent of

covered supplies

with dollar caps

and/or supply

limits Often Rarely Never

No 

response

New York 69 69 0 0 0 0 0

North Carolina 23 0 0 0 0 0 0

North Dakotae69 69 96 99 0 2 0

Ohio 52 52 74 0 100 0 0

Oklahoma 69 69 10 0 0 100 0

Oregon 68 68 99 0 100 0 0

Pennsylvania 57 58 45 0 100 0 0

Rhode Island 69 69 100 100 0 0 0

South Carolina 69 69 99 0 97 3 0

South Dakota 67 67 0 0 0 0 0

Tennessee 69 69 0 0 0 0 0

Texas 57 0 10 86 0 0 14

Utah 35 35 6 0 100 0 0

Vermont 69 69 0 0 0 0 0

Virginia 69 69 100 100 0 0 0

Washington 68 68 65 9 76 16 0

West Virginia 69 69 100 0 0 100 0

Wisconsin 62 62 90 0 100 0 0

Wyoming 69 69 0 0 0 0 0

Source: GAO survey of state Medicaid programs. 

Note: Responses for percent of monetary caps or supply limits may exceed 100 percent due to 

rounding. 

a

Supplies are only covered if they are used at home. Dollar caps and supply limits only apply to 

adults. 

b

The state has supply limits and dollar caps that can never be exceeded for certain supplies; however 

some of the limits and caps are very high. For example, for one item that can never be exceeded—

the ostomy belt with peristomal hernia support—the state reported that it will pay for up to 999 belts

and $38,571.39 per month. 

c

There are no supply limits or dollar caps for home health ostomy supplies. 

d

Supply limits or dollar caps are only for home health. 

e

Once the accumulated dollar value of all products reaches $300 or more in a year, the state looks at 

the usage patterns and other information. The state reported that IBD patients often reach or exceed

the $300 limit but it often allows individuals to exceed the amount with written justification. 

Page 51 GAO-06-63 Inflammatory Bowel Disease
Appendix X: Re

Food Products 

Program 

ported Medically Necessary

Covered by State Medicaid 

Page 52 GAO-06-63

Appendix X: Reported Medically Necessary 

Food Products Covered by State Medicaid 

Program 

State

Alabama

Alaskaa

Arizona

Arkansasb

California

Colorado

Connecticut

Delaware

District of Columbia

Floridac

Georgiad

Hawaii

Idahoe

Illinois

Indiana

Iowa

Kansas

Kentucky

Louisiana

Maine

Maryland

Massachusetts

Michigan

Minnesotaf

Mississippig

Missouri

Montana

Nebraska

Nevada

New Hampshire

New Jersey

New Mexicoh

New York

North Carolina

North Dakotai

Perscription

strength

vitamins

Oral

nutritional

formulas

Food

thickeners

Baby food and 

other blenderized 

products

Other

products

 Inflammatory Bowel Disease
Appendix X: Reported Medically Necessary

Food Products Covered by State Medicaid 

Program 

a

For prescription strength vitamins, the state covers prenatal vitamins for pregnant women only. 

Prescription fluoride vitamins are covered for children up to eight years of age. 

b

The state only covers prenatal vitamins. Food thickeners are covered for any condition, as long as

they are medically necessary. 

c

For prescription strength vitamins, the state limits coverage to prenatal vitamins, folic acid, pediatric 

vitamins with fluoride for children less than 13 years of age, multivitamins for dialysis patients, and

iron supplements. 

d

The state covers special metabolic formulas for oral administration for children under medically 

necessary food products. 

e

For prescription strength vitamins, multivitamins can be covered but they must have prior 

authorization and meet the state’s criteria for medically necessary. 

f

Coverage for prescription strength vitamins is based on documented vitamin deficiencies in the 

patient’s medical record. Nutritional formulas taken orally must have prior authorization. 

g

CMS standard exemptions related to legend vitamins are covered. Pediatric vitamin supplements 

with fluoride are covered. Other pediatric legend vitamins may be covered with statement of medical 

necessity. 

h

The state requires a defined/specific pathologic condition for which nutritional support is therapeutic.

If the purpose of the supply is simply to provide food, then it is not considered medically necessary. 

i

The state covers general nutritional supplements. Other disease specific products are not covered. 

Source: GAO survey of state Medicaid programs. 

Covered for both adults and children

Covered for adults only 

Covered for children only

State does not cover supply

State

Ohio

Oklahoma

Oregon

Pennsylvaniaj

Rhode Island

South Carolina

South Dakotak

Tennessee

Texas

Utah

Vermont

Virginia

Washingtonl

West Virginia

Wisconsin

Wyoming

Prescription

strength

vitamins

Oral

nutritional

formulas

Food

thickeners

Baby food and 

other blenderized

products

Other 

products

Page 53 GAO-06-63 Inflammatory Bowel Disease
Appendix X: Reported Medically Necessary

Food Products Covered by State Medicaid 

Program 

j

For prescription strength vitamins, the state limits coverage for children less than two years of age or 

for prenatal use.

k

For prescription strength vitamins, the state covers prenatal vitamins for women. 

l

The state does not cover nutritional shakes and vitamins. 

Page 54 GAO-06-63 Inflammatory Bowel Disease
Appendix XI: S

Surve

Medica

ummary of Drugs Listed in Our 

y to Treat IBD That Are Covered by 

id for Adults and Children 

Page 55 GAO-06-63

Appendix XI: Summary of Drugs Listed in 

Our Survey to Treat IBD That Are Covered by 

Medicaid for Adults and Children 

State

Alabama

Alaska

Arizona

Arkansas

California

Coloradoa

Connecticut

Delawareb

District of Columbia

Florida

Georgiac

Hawaii

Idaho

Illinoisd

Indiana

Iowae

Kansas

Kentucky

Louisiana

Mainef

Maryland

Massachusetts

Michigan

Minnesotag

Mississippi

Missouri

Montanah

Nebraskai

Nevadaj

New Hampshire

New Jersey

Drugs

Brand

Brand

Brand

 Generic

Brand

 Generic

Brand

Brand

Brand

Brand

Brand

RemicadeColazal AzulfidineRowasa Asacol Pentasa Canasa DipentumEntocort

Inflammatory Bowel Disease
Appendix XI: Summary of Drugs Listed in Our 

Survey to Treat IBD That Are Covered by 

Medicaid for Adults and Children 

a

The state requires patients to use a generic equivalent drug, if available. 

b

The state covers brand name drugs only after documentation of medical necessity is complete. The

documentation has to include a summary of benefit versus risk. 

c

The state will cover brand name drugs with prior authorization when there are generic equivalent 

drugs available. 

d

The state does not cover Remicade, Colozal, and Entocort for children age 11 or under. 

e

The state requires prior authorization for Remicade and Asacol. 

f

The state did not indicate whether it covered the generic drug for Azulfidine for children. 

g

The state will pay for brand name drugs after demonstrating failure of generic equivalent drugs.

h

The state will cover brand name drugs with prior authorization when there are generic equivalent 

drugs available. 

Source: GAO survey of state Medicaid programs. 

Covered for both adults and children

Covered for adults only 

Covered for children only

State does not cover supply

No response

State

New Mexico

New York

North Carolina

North Dakota

Ohiok

Oklahomal

Oregon

Pennsylvania

Rhode Island

South Carolina

South Dakota

Tennessee

Texas

Utah

Vermont

Virginia

Washington

West Virginia

Wisconsinm

Wyoming

Drugs

Brand

Brand

Brand

 Generic

Brand

 Generic

Brand

Brand

Brand

Brand

Brand

RemicadeColazal AzulfidineRowasa Asacol Pentasa Canasa DipentumEntocort

Page 56 GAO-06-63 Inflammatory Bowel Disease
Appendix XI: Summary of Drugs Listed in Our 

Survey to Treat IBD That Are Covered by 

Medicaid for Adults and Children 

i

The state requires prior authorization for Remicade.

j

The state requires patients to use a generic equivalent drug, if available. 

k

The state may require prior authorization if generic equivalent drug or therapeutic alternatives exist. 

l

The state requires prior authorization for brand name drugs when there is a generic equivalent drug 

available. 

m

The state will cover brand name drugs with prior authorization when there are generic equivalent 

drugs available. 

Page 57 GAO-06-63 Inflammatory Bowel Disease
Appendix XII: Comments from the Centers for Medicare & Appendix XII: Comments from the Centers Medicaid Services 

for Medicare & Medicaid Services 

Page 58 GAO-06-63 Inflammatory Bowel Disease
Appendix XII: Comments from the Centers for Medicare & 

Medicaid Services 

Page 59 GAO-06-63 Inflammatory Bowel Disease
Appendix XIII: GAO Contact and Staff Acknowledgments 

Page 60 GAO-06-63

Appendix XIII: GAO Contact and Staff 

Acknowledgments 

GAO Contact Leslie G. Aronovitz (312) 220-7600 or aronovitzl@gao.gov 

In addition to the contact named above, Geraldine Redican-Bigott, 

Assistant Director; Shaunessye Curry; Adrienne Griffin; Ba Lin; Janet 

Rosenblad; and Pauline Seretakis made key contributions to this report. 

 Inflammatory Bowel Disease

Staff 

Acknowledgments 

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