Medicare and Medicaid Coverage
Therapies and Supplies for Inflammatory Bowel Disease Gao ID: GAO-06-63 December 15, 2005Inflammatory 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. 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.
GAO-06-63, Medicare and Medicaid Coverage: Therapies and Supplies for Inflammatory Bowel Disease
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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
December 2005:
Medicare and Medicaid Coverage:
Therapies and Supplies for Inflammatory Bowel Disease:
GAO-06-63:
GAO Highlights:
Highlights of GAO-06-63, a report to congressional committees:
Why GAO Did This Study:
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.
What GAO Found:
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
[See Table 1]
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.
[End of table]
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.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Coverage of IBD Therapies Is Subject to Medicare and Medicaid
Standards:
Variation in Medicare and Medicaid Programs' Coverage of Specific
Supplies Related to IBD Therapies:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Reported State Medicaid Program Coverage of Therapies Used
by IBD Patients:
Appendix III: Reported Parenteral Nutrition Therapy Coverage Standards
by State Medicaid Program:
Appendix IV: Reported Enteral Nutrition Therapy Coverage Standards by
State Medicaid Program:
Appendix V: Reported Medically Necessary Food Products Coverage
Standards by State Medicaid Program:
Appendix VI: Reported Parenteral Nutrition Supplies Covered by Medicaid
in Home Health and Outpatient Delivery Settings:
Appendix VII: Reported Enteral Nutrition Supplies Covered by Medicaid
in Home Health and Outpatient Delivery Settings:
Appendix VIII: Reported Percent of States Covering Ostomy Supplies in
Home Health and Outpatient Delivery Settings:
Appendix IX: Reported Information on Medicaid Coverage of Ostomy
Supplies and Related Limits:
Appendix X: Reported Medically Necessary Food Products Covered by State
Medicaid Program:
Appendix XI: Summary of Drugs Listed in Our Survey to Treat IBD That
Are Covered by Medicaid for Adults and Children:
Appendix XII: Comments from the Centers for Medicare & Medicaid
Services:
Appendix XIII: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: State Medicaid Programs That Reported Coverage of Five IBD
Therapies for Adults and Children:
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:
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:
Table 4: Median Percent of State Medicaid Programs That Reported
Covering Ostomy Supplies in Home Health and Outpatient Delivery
Settings:
Table 5: Number of State Medicaid Programs Covering Medically Necessary
Food Products for Adults and Children:
Figure:
Figure 1: Number of State Medicaid Programs That Reported Covering
Drugs Listed in Our Survey to Treat IBD:
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:
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 IBD[Footnote 1]--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 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.[Footnote 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,[Footnote 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,[Footnote 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.[Footnote 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.[Footnote 6] The act
required us to focus on five specific therapies--in both home health
and outpatient delivery settings[Footnote 7]--parenteral nutrition,
enteral nutrition formula, ostomy care,[Footnote 8] medically necessary
food products, and drugs approved by the Food and Drug Administration
(FDA) for Crohn's disease and ulcerative colitis.[Footnote 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 Columbia[Footnote 10] 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 delivery settings, and to indicate whether
they had different coverage policies for adults and children.[Footnote
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.[Footnote 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.
Results in Brief:
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
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 self-administered, 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.
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.
Background:
IBD refers to Crohn's disease and ulcerative colitis.[Footnote 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 three-quarters 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.
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.
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.[Footnote 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.[Footnote 15] Tubing that goes inside the patient's body to
administer the 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.[Footnote
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.[Footnote 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 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.[Footnote 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.[Footnote 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.[Footnote 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.[Footnote 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 (LCD).[Footnote 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.[Footnote 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.[Footnote 24]
Coverage of IBD Therapies Is Subject to Medicare and Medicaid
Standards:
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:
Adults and children;
Parenteral nutrition: 50;
Enteral nutrition: 49;
Ostomy care: 51;
Medically necessary food products: 40;
Drugs[A]: 50.
Adults only;
Parenteral nutrition: 0;
Enteral nutrition: 0;
Ostomy care: 0;
Medically necessary food products: 0;
Drugs[A]: 1.
Children only;
Parenteral nutrition: 1;
Enteral nutrition: 1;
Ostomy care: 0;
Medically necessary food products: 6;
Drugs[A]: 0.
Not covered for adults or children;
Parenteral nutrition: 0;
Enteral nutrition: 1;
Ostomy care: 0;
Medically necessary food products: 5;
Drugs[A]: 0.
Total;
Parenteral nutrition: 51;
Enteral nutrition: 51;
Ostomy care: 51;
Medically necessary food products: 51;
Drugs[A]: 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.
[End of table]
Medicare and Medicaid Coverage Standards for Parenteral Nutrition:
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.[Footnote 25] CMS's coverage
standards for parenteral nutrition therapy are outlined in both an NCD
and in local coverage policy.[Footnote 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 tract[Footnote 27]
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 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.[Footnote 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.[Footnote 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--
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.
Medicare and Medicaid Coverage Standards for Enteral Nutrition:
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 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.[Footnote 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 Coverage Standards for Ostomy Care:
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 this therapy as a home health
benefit.[Footnote 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 and Medicaid Coverage Standards for Medically Necessary Food
Products:
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.[Footnote 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.[Footnote 33] For more
information on states' coverage standards for medically necessary food
products, see app. V.
Medicare and Medicaid Coverage Standards for Drugs to Treat IBD:
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.[Footnote 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.[Footnote 35] At that time, Medicare will begin to cover self-
administered drugs approved by the FDA to treat IBD.[Footnote 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 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.
Variation in Medicare and Medicaid Programs' Coverage of Specific
Supplies Related to IBD Therapies:
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.
Parenteral Nutrition Supplies Covered by Medicare and Medicaid:
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.
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 necessity[Footnote
37] 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.[Footnote 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.
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:
Supplies: Parenteral nutrition solution;
Adults: Home health: 34;
Adults: Outpatient: 42;
Children: Home health: 35;
Children: Outpatient: 44.
Supplies: Parenteral nutrition supply kit;
Adults: Home health: 35;
Adults: Outpatient: 43;
Children: Home health: 36;
Children: Outpatient: 44.
Supplies: Parenteral nutrition administration kit;
Adults: Home health: 36;
Adults: Outpatient: 45;
Children: Home health: 37;
Children: Outpatient: 46.
Supplies: Parenteral nutrition infusion pump;
Adults: Home health: 40;
Adults: Outpatient: 46;
Children: Home health: 40;
Children: Outpatient: 47.
Supplies: Intravenous pole;
Adults: Home health: 39;
Adults: Outpatient: 43;
Children: Home health: 40;
Children: Outpatient: 45.
Source: GAO survey of state Medicaid programs.
[End of table]
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.
Enteral Nutrition Supplies Covered by Medicare and Medicaid:
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.[Footnote 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 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:
Supplies: Enteral formula;
Adults: Home health: 35;
Adults: Outpatient: 42;
Children: Home health: 37;
Children: Outpatient: 44.
Supplies: Enteral feeding supply kit;
Adults: Home health: 40;
Adults: Outpatient: 45;
Children: Home health: 43;
Children: Outpatient: 46.
Supplies: Tubing;
Adults: Home health: 41;
Adults: Outpatient: 43;
Children: Home health: 42;
Children: Outpatient: 46.
Supplies: Additive for enteral formula;
Adults: Home health: 22;
Adults: Outpatient: 28;
Children: Home health: 24;
Children: Outpatient: 30.
Supplies: Enteral nutrition infusion pump;
Adults: Home health: 38;
Adults: Outpatient: 40;
Children: Home health: 40;
Children: Outpatient: 42.
Supplies: Intravenous pole;
Adults: Home health: 38;
Adults: Outpatient: 40;
Children: Home health: 40;
Children: Outpatient: 42.
Supplies: Percutaneous catheter/tube;
Adults: Home health: 30;
Adults: Outpatient: 33;
Children: Home health: 31;
Children: Outpatient: 38.
Source: GAO survey of state Medicaid programs.
[End of table]
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 for adults and
children. For specific results of enteral nutrition supplies provided
by each state, see app. VII.
Ostomy Supplies Covered by Medicare and Medicaid:
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
barrier[Footnote 40] 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.[Footnote 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,[Footnote 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.[Footnote 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 reason for home health
care, such as hip replacement surgery.[Footnote 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.[Footnote 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.[Footnote 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, 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): Drainable pouch with extended
wear barrier supplies (2 supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 84;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 88.
Ostomy categories (number of supplies): Drainable pouch with standard
barrier supplies (14 supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 84;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 85.
Ostomy categories (number of supplies): Irrigation supplies (6
supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 82;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 84.
Ostomy categories (number of supplies): Fluid discharge management item
(1 item);
Median percent of states that cover supplies in each category in home
health delivery settings: 75;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 75.
Ostomy categories (number of supplies): Adhering pouch barrier supplies
(2 supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 85;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 90.
Ostomy categories (number of supplies): Extended wear barrier supplies
(5 supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 84;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 86.
Ostomy categories (number of supplies): Barrier-skin protection
supplies (13 supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 86;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 88.
Ostomy categories (number of supplies): Closed pouch supplies (11
supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 84;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 88.
Ostomy categories (number of supplies): Other accessories (15
supplies);
Median percent of states that cover supplies in each category in home
health delivery settings: 80;
Median percent of states that cover supplies in each category in
outpatient delivery settings: 82.
Source: GAO survey of state Medicaid programs.
Note: Individual supplies under each category appear in app. VIII.
[End of table]
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 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.
Medically Necessary Food Products Covered by Medicaid:
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:
Adults and children;
Prescription strength vitamins: 29;
Oral nutritional formulas: 36;
Food thickeners: 28;
Baby food and other blenderized products: 2;
Other products: 12.
Children only;
Prescription strength vitamins: 6;
Oral nutritional formulas: 7;
Food thickeners: 5;
Baby food and other blenderized products: 2;
Other products: 5.
Neither adults nor children;
Prescription strength vitamins: 16;
Oral nutritional formulas: 8;
Food thickeners: 18;
Baby food and other blenderized products: 47;
Other products: 34.
Total;
Prescription strength vitamins: 51;
Oral nutritional formulas: 51;
Food thickeners: 51;
Baby food and other blenderized products: 51;
Other products: 51.
Source: GAO survey of state Medicaid programs.
For more details on states' payment of medically necessary food
products, see app. X.
[End of table]
Drugs Covered by Medicaid to Treat IBD:
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.[Footnote 47] The generic drugs available for
Azulfidine and Rowasa were covered by 48 and 46 states respectively.
Figure 1: Number of State Medicaid Programs That Reported Covering
Drugs Listed in Our Survey to Treat IBD:
[See PDF for image]
[End of figure]
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.
Agency Comments:
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.
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.
Signed by:
Leslie G. Aronovitz:
Director, Health Care:
[End of section]
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.
Medicare and Medicaid's Coverage Standards of IBD Therapies:
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.
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.[Footnote 48]
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 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 Association[Footnote 49]
Specific Supplies Paid for by Medicare and State Medicaid Programs:
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 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).[Footnote 50] 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.
[End of section]
Appendix II: Reported State Medicaid Program Coverage of Therapies Used
by IBD Patients:
[See PDF for image]
[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.
[End of section]
Appendix III: Reported Parenteral Nutrition Therapy Coverage Standards
by State Medicaid Program:
[See PDF for image]
[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.
[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.
[End of section]
Appendix IV: Reported Enteral Nutrition Therapy Coverage Standards by
State Medicaid Program:
[See PDF for image]
[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.
[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.
[End of section]
Appendix V: Reported Medically Necessary Food Products Coverage
Standards by State Medicaid Program:
[See PDF for image]
[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.
[End of section]
Appendix VI: Reported Parenteral Nutrition Supplies Covered by Medicaid
in Home Health and Outpatient Delivery Settings:
[See PDF for image]
[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.
[End of section]
Appendix VII: Reported Enteral Nutrition Supplies Covered by Medicaid
in Home Health and Outpatient Delivery Settings:
[See PDF for image]
[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.
[End of section]
Appendix VIII: Reported Percent of States Covering Ostomy Supplies in
Home Health and Outpatient Delivery Settings:
Drainable pouch with extended wear barrier:
Supply[A] name: Ostomy pouch, drainable, with extended wear barrier
attached;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy pouch, drainable, with extended wear barrier
attached, with built-in convexity;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Drainable pouch - standard barrier:
Supply[A] name: Ostomy pouch, drainable with faceplate attached,
plastic;
Home health delivery setting: 84;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy pouch, drainable with faceplate attached,
rubber;
Home health delivery setting: 84;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy pouch, drainable, for use on faceplate, plastic;
Home health delivery setting: 84;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy pouch, drainable, for use on faceplate, rubber;
Home health delivery setting: 84;
Outpatient delivery setting: 86.
Supply[A] name: Ostomy pouch, drainable, with barrier;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy pouch, drainable, high output, for use on a
barrier with flange (2 piece system), with filter;
Home health delivery setting: 80;
Outpatient delivery setting: 82.
Supply[A] name: Ostomy pouch, closed, for use on barrier with locking
flange, with filter (2 pieces);
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, drainable, with barrier attached, with
filter (1 piece);
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, drainable, for use on barrier with non-
locking flange, with filter (2 pieces);
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, drainable, for use on barrier with
locking flange (2 pieces);
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, drainable, for use on barrier with
locking flange, with filter (2 pieces);
Home health delivery setting: 78;
Outpatient delivery setting: 82.
Supply[A] name: Ostomy pouch, drainable, without barrier attached (1
piece);
Home health delivery setting: 86;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, drainable with barrier attached (1
piece);
Home health delivery setting: 88;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy pouch, drainable, for use on barrier with flange
(2 piece system);
Home health delivery setting: 90;
Outpatient delivery setting: 90.
Irrigation supply:
Supply[A] name: Irrigation supply; sleeve;
Home health delivery setting: 82;
Outpatient delivery setting: 86.
Supply[A] name: Ostomy irrigation supply; bag;
Home health delivery setting: 78;
Outpatient delivery setting: 82.
Supply[A] name: Ostomy irrigation supply; cone/catheter, including
brush;
Home health delivery setting: 80;
Outpatient delivery setting: 86.
Supply[A] name: Lubricant;
Home health delivery setting: 82;
Outpatient delivery setting: 84.
Supply[A] name: Continent device, plug for continent stoma;
Home health delivery setting: 82;
Outpatient delivery setting: 84.
Supply[A] name: Continent device, catheter for continent stoma;
Home health delivery setting: 82;
Outpatient delivery setting: 84.
Supply[A] name: Fluid discharge management:
Supply[A] name: Bedside drainage bottle;
Home health delivery setting: 75;
Outpatient delivery setting: 75.
Supply[A] name: Barrier with adhering pouch:
Supply[A] name: Ostomy barrier, with flange, with built-in convexity;
Home health delivery setting: 84;
Outpatient delivery setting: 92.
Supply[A] name: Ostomy skin barrier, with flange, without built-in
convexity, 4x4 inches or smaller;
Home health delivery setting: 86;
Outpatient delivery setting: 88.
Barrier - extended wear:
Supply[A] name: Ostomy skin barrier, solid 4x4 inches, extended wear,
without built-in convexity;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy skin barrier, with flange, extended wear, with
built-in convexity, 4x4 inches or smaller;
Home health delivery setting: 88;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy skin barrier, with flange, extended wear with
built-in convexity, larger than 4x4 inches;
Home health delivery setting: 84;
Outpatient delivery setting: 86.
Supply[A] name: Ostomy skin barrier, with flange, extended wear,
without built-in convexity, 4x4 inches or smaller;
Home health delivery setting: 84;
Outpatient delivery setting: 86.
Supply[A] name: Ostomy skin barrier, with flange, extended wear,
without built-in convexity, larger than 4x4 inches;
Home health delivery setting: 84;
Outpatient delivery setting: 86.
Barrier skin protection:
Supply[A] name: Skin barrier, solid; 4x4 inches;
Home health delivery setting: 86;
Outpatient delivery setting: 92.
Supply[A] name: Adhesive, liquid;
Home health delivery setting: 90;
Outpatient delivery setting: 92.
Supply[A] name: Ostomy skin barrier, liquid;
Home health delivery setting: 88;
Outpatient delivery setting: 94.
Supply[A] name: Ostomy skin barrier, powder;
Home health delivery setting: 88;
Outpatient delivery setting: 94.
Supply[A] name: Ostomy barrier, solid;
Home health delivery setting: 84;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy faceplate equivalent, silicone ring;
Home health delivery setting: 82;
Outpatient delivery setting: 86.
Supply[A] name: Ostomy ring;
Home health delivery setting: 88;
Outpatient delivery setting: 92.
Supply[A] name: Ostomy skin barrier, non-pectin based, paste;
Home health delivery setting: 86;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy skin barrier, pectin-based paste;
Home health delivery setting: 86;
Outpatient delivery setting: 84.
Supply[A] name: Skin barrier, wipes, box of 50;
Home health delivery setting: 86;
Outpatient delivery setting: 86.
Supply[A] name: Skin barrier, solid, 6x6 inches;
Home health delivery setting: 88;
Outpatient delivery setting: 86.
Supply[A] name: Skin barrier, solid, 8x8 inches;
Home health delivery setting: 86;
Outpatient delivery setting: 86.
Supply[A] name: Adhesive or non-adhesive, disk or foam pad;
Home health delivery setting: 86;
Outpatient delivery setting: 86.
Closed pouch:
Supply[A] name: Ostomy skin barrier, closed, with extended wear barrier
attached, with built-in convexity;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Supply[A] name: Ostomy pouch, closed, with barrier, with filter;
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, closed, with barrier attached, with built-
in convexity;
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, closed, without barrier, with filter (1
piece);
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy pouch, closed, fuse use on barrier with non-
locking flange (2 pieces);
Home health delivery setting: 78;
Outpatient delivery setting: 82.
Supply[A] name: Ostomy pouch, closed, fuse use on barrier with locking
flange (2 pieces);
Home health delivery setting: 77;
Outpatient delivery setting: 80.
Supply[A] name: Ostomy pouch, closed, with barrier attached;
Home health delivery setting: 88;
Outpatient delivery setting: 92.
Supply[A] name: Ostomy pouch, closed, without barrier attached;
Home health delivery setting: 90;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy pouch, closed, for use on faceplate;
Home health delivery setting: 86;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy pouch, closed, for use on barrier with flange;
Home health delivery setting: 90;
Outpatient delivery setting: 92.
Supply[A] name: Stoma cap;
Home health delivery setting: 86;
Outpatient delivery setting: 92.
Other accessories:
Supply[A] name: Ostomy faceplate;
Home health delivery setting: 84;
Outpatient delivery setting: 88.
Supply[A] name: Adhesive remover wipes;
Home health delivery setting: 82;
Outpatient delivery setting: 80.
Supply[A] name: Ostomy vent;
Home health delivery setting: 73;
Outpatient delivery setting: 80.
Supply[A] name: Ostomy belt;
Home health delivery setting: 88;
Outpatient delivery setting: 92.
Supply[A] name: Ostomy belt with peristomal hernia support;
Home health delivery setting: 75;
Outpatient delivery setting: 80.
Supply[A] name: Ostomy filter;
Home health delivery setting: 75;
Outpatient delivery setting: 82.
Supply[A] name: Ostomy deodorant, liquid;
Home health delivery setting: 73;
Outpatient delivery setting: 78.
Supply[A] name: Ostomy deodorant, solid;
Home health delivery setting: 73;
Outpatient delivery setting: 77.
Supply[A] name: Ostomy supply, miscellaneous;
Home health delivery setting: 80;
Outpatient delivery setting: 84.
Supply[A] name: Ostomy absorbent material for use in ostomy pouch to
thicken liquid stomal output;
Home health delivery setting: 73;
Outpatient delivery setting: 75.
Supply[A] name: Tape, non-waterproof;
Home health delivery setting: 88;
Outpatient delivery setting: 86.
Supply[A] name: Tape, waterproof;
Home health delivery setting: 88;
Outpatient delivery setting: 86.
Supply[A] name: Adhesive remover or solvent;
Home health delivery setting: 86;
Outpatient delivery setting: 90.
Supply[A] name: Ostomy accessory, convex insert;
Home health delivery setting: 82;
Outpatient delivery setting: 84.
Supply[A] name: Appliance cleaner, incontinence and ostomy appliances;
Home health delivery setting: 75;
Outpatient delivery setting: 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.
[End of table]
[End of section]
Appendix IX: Reported Information on Medicaid Coverage of Ostomy
Supplies and Related Limits:
State: Alabama;
Number of supplies covered: Home health: 14;
Number of supplies covered: Outpatient: 8;
Percent of covered supplies with dollar caps and/or supply limits: 20;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Alaska;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 81;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Arizona;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 26;
Percent of dollar caps or supply limits that are exceeded: Rarely: 23;
Percent of dollar caps or supply limits that are exceeded: Never: 51;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Arkansas[A];
Number of supplies covered: Home health: 54;
Number of supplies covered: Outpatient: 54;
Percent of covered supplies with dollar caps and/or supply limits: 78;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: California;
Number of supplies covered: Home health: 60;
Number of supplies covered: Outpatient: 59;
Percent of covered supplies with dollar caps and/or supply limits: 15;
Percent of dollar caps or supply limits that are exceeded: Often: 90;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
10.
State: Colorado;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Connecticut;
Number of supplies covered: Home health: 64;
Number of supplies covered: Outpatient: 0;
Percent of covered supplies with dollar caps and/or supply limits: 93;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 98;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
2.
State: Delaware;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 96;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: District of Columbia;
Number of supplies covered: Home health: 0;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 55;
Percent of dollar caps or supply limits that are exceeded: Rarely: 38;
Percent of dollar caps or supply limits that are exceeded: Never: 7;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Florida;
Number of supplies covered: Home health: 65;
Number of supplies covered: Outpatient: 66;
Percent of covered supplies with dollar caps and/or supply limits: 96;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 99;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
2.
State: Georgia;
Number of supplies covered: Home health: 0;
Number of supplies covered: Outpatient: 17;
Percent of covered supplies with dollar caps and/or supply limits: 25;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Hawaii;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 100;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Idaho[B];
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 44;
Percent of dollar caps or supply limits that are exceeded: Never: 57;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Illinois;
Number of supplies covered: Home health: 0;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 99;
Percent of dollar caps or supply limits that are exceeded: Often: 2;
Percent of dollar caps or supply limits that are exceeded: Rarely: 99;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Indiana;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Iowa;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 96;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 99;
Percent of dollar caps or supply limits that are exceeded: Never: 2;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Kansas;
Number of supplies covered: Home health: 57;
Number of supplies covered: Outpatient: 57;
Percent of covered supplies with dollar caps and/or supply limits: 83;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Kentucky[C];
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 55;
Percent of dollar caps or supply limits that are exceeded: Often: 100;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Louisiana;
Number of supplies covered: Home health: 63;
Number of supplies covered: Outpatient: 63;
Percent of covered supplies with dollar caps and/or supply limits: 65;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Maine;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Maryland;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Massachusetts;
Number of supplies covered: Home health: 67;
Number of supplies covered: Outpatient: 55;
Percent of covered supplies with dollar caps and/or supply limits: 97;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Michigan;
Number of supplies covered: Home health: 63;
Number of supplies covered: Outpatient: 63;
Percent of covered supplies with dollar caps and/or supply limits: 91;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Minnesota;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 47;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 29;
Percent of dollar caps or supply limits that are exceeded: Never: 71;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Mississippi;
Number of supplies covered: Home health: 67;
Number of supplies covered: Outpatient: 67;
Percent of covered supplies with dollar caps and/or supply limits: 97;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Missouri;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 46;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Montana;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Nebraska;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 99;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
1.
State: Nevada[D];
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 42;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: New Hampshire;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: New Jersey;
Number of supplies covered: Home health: 0;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 12;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: New Mexico;
Number of supplies covered: Home health: 0;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 96;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: New York;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: North Carolina;
Number of supplies covered: Home health: 23;
Number of supplies covered: Outpatient: 0;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: North Dakota[E];
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 96;
Percent of dollar caps or supply limits that are exceeded: Often: 99;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 2;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Ohio;
Number of supplies covered: Home health: 52;
Number of supplies covered: Outpatient: 52;
Percent of covered supplies with dollar caps and/or supply limits: 74;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Oklahoma;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 10;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Oregon;
Number of supplies covered: Home health: 68;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 99;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Pennsylvania;
Number of supplies covered: Home health: 57;
Number of supplies covered: Outpatient: 58;
Percent of covered supplies with dollar caps and/or supply limits: 45;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Rhode Island;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 100;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: South Carolina;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 99;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 97;
Percent of dollar caps or supply limits that are exceeded: Never: 3;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: South Dakota;
Number of supplies covered: Home health: 67;
Number of supplies covered: Outpatient: 67;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Tennessee;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Texas;
Number of supplies covered: Home health: 57;
Number of supplies covered: Outpatient: 0;
Percent of covered supplies with dollar caps and/or supply limits: 10;
Percent of dollar caps or supply limits that are exceeded: Often: 86;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
14.
State: Utah;
Number of supplies covered: Home health: 35;
Number of supplies covered: Outpatient: 35;
Percent of covered supplies with dollar caps and/or supply limits: 6;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Vermont;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Virginia;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 100;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Washington;
Number of supplies covered: Home health: 68;
Number of supplies covered: Outpatient: 68;
Percent of covered supplies with dollar caps and/or supply limits: 65;
Percent of dollar caps or supply limits that are exceeded: Often: 9;
Percent of dollar caps or supply limits that are exceeded: Rarely: 76;
Percent of dollar caps or supply limits that are exceeded: Never: 16;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: West Virginia;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 100;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 100;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Wisconsin;
Number of supplies covered: Home health: 62;
Number of supplies covered: Outpatient: 62;
Percent of covered supplies with dollar caps and/or supply limits: 90;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 100;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
0.
State: Wyoming;
Number of supplies covered: Home health: 69;
Number of supplies covered: Outpatient: 69;
Percent of covered supplies with dollar caps and/or supply limits: 0;
Percent of dollar caps or supply limits that are exceeded: Often: 0;
Percent of dollar caps or supply limits that are exceeded: Rarely: 0;
Percent of dollar caps or supply limits that are exceeded: Never: 0;
Percent of dollar caps or supply limits that are exceeded: No response:
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.
[End of table]
[End of section]
Appendix X: Reported Medically Necessary Food Products Covered by State
Medicaid Program:
[See PDF for image]
[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.
[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.
[End of section]
Appendix XI: Summary of Drugs Listed in Our Survey to Treat IBD That
Are Covered by Medicaid for Adults and Children:
[See PDF for image]
[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.
[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.
[End of section]
Appendix XII: Comments from the Centers for Medicare & Medicaid
Services:
DEPARTMENT OF HEALTH & HUMAN SERVICES:
Centers for Medicare & Medicaid Services:
Administrator:
Washington, DC 20201:
DATE: NOV 17 2005:
TO: Leslie G. Aronovitz:
Director, Health Care:
Government Accountability Office:
FROM: Mark B. McClellan, M.D., Ph.D.:
Administrator:
Centers for Medicare & Medicaid Services:
SUBJECT: Government Accountability Office's Draft Report: MEDICARE AND
MEDICAID COVERAGE: Therapies and Supplies for Inflammatory Bowel
Disease (GAO-06-63):
Thank you for the opportunity to review and comment on the Government
Accountability Office's (GAO) draft report entitled MEDICARE AND
MEDICAID COVERAGE: Therapies and Supplies for Inflammatory Bowel
Disease. The Centers for Medicare & Medicaid Services (CMS) support and
applaud the GAO's efforts in examining health care access issues that
affect Medicare beneficiaries and Medicaid recipients in order to
ensure that they receive adequate health care to treat their
inflammatory bowel disease (11313) condition. The draft report states
that 11313 advocates have expressed concern about the ability of
Medicare beneficiaries and Medicaid recipients to obtain access to
11313-related care, which has led the GAO to examine this matter.
With regard to the portions of the report that refer to the IBD
therapies and supplies currently covered under Part B of the Medicare
program, we have determined that the GAO has correctly described the
Medicare coverage policies for parenteral nutrition, enteral nutrition,
and ostomy supplies.
The CMS has the following comment to make concerning Medicare's
coverage policy for the Food and Drug Administration (FDA) approved
self-administered drugs:
On page 18, in the first full paragraph, the draft report states
"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 medications are not included in
any of the benefit categories contained in the Social Security Act."
The reason for non-coverage, rather, should be because while the law
does include a benefit category for drugs, the benefit category limits
coverage to those drugs that are usually not self-administered.
Specifically, section 1861(s)(2)(A) of the Social Security Act which
states that "services and supplies (including drugs and biologicals
which are not usually self- administered by the patient) [are]
furnished as an incident to a physician's professional service." This
means that although 11313- related self-administered drugs are not
covered by Medicare in the patient's home, IBD-related drugs could be
covered by Medicare when administered by a physician in a clinical
setting. We suggest that the GAO clarify this statutory limitation
throughout the document where they discuss Medicare's lack of coverage.
The current language implies Medicare has the authority to alter its
interpretation of the law to cover FDA-approved drugs.
It is important to know why Medicare does not generally cover self-
administered drugs, Medicare is currently operating a demonstration
that began in September 2004 and will end on December 31, 2005. This
demonstration, mandated under section 641 of the Medicare Modernization
Act of 2003, serves as a bridge until the Medicare Part D benefit
becomes available and covers a limited number of self-administered
drugs which can replace the need for drugs covered under Medicare Part
B.
We appreciate the effort that went into this report and as CMS proceeds
with policy development, we will continue to give deep consideration to
access issues that affect Medicare beneficiaries and Medicaid
recipients in their treatment of IBD.
[End of section]
Appendix XIII GAO Contact and Staff Acknowledgments:
GAO Contact:
Leslie G. Aronovitz (312) 220-7600 or aronovitzl@gao.gov:
Staff Acknowledgments:
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.
FOOTNOTES
[1] According to the Crohn's Disease and Colitis Foundation of America,
the number is evenly split between the two diseases.
[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.
[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).
[10] Throughout 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.
[11] Because 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.
[12] 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.
[13] About 10 percent of IBD patients exhibit symptoms of both Crohn's
disease and ulcerative colitis. This condition is referred to as
indeterminate colitis.
[14] Specific supplies included in the parenteral supply kits and
administration kits can vary, depending on the supplier.
[15] Specific supplies included in the enteral feeding supply kits can
vary depending on specific patient needs.
[16] The prescribing of a drug for treatments other than those
specified on the label approved by FDA is referred to as off-label use.
[17] Not 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.
[18] Congress gave the Secretary of Health and Human Services the
authority to decide which specific supplies and services within these
categories are covered by Medicare.
[19] Specifically, 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).
[20] The 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.
[21] NCDs 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.
[22] LCDs 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.
[23] The 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.
[24] Optional supplies and services include, among others, prescribed
drugs, prosthetic devices, home health care services, dental services,
and physical therapy.
[25] Covered 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).
[26] Per 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.
[27] The 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.
[28] The 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.
[29] For 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.
[30] For 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.
[31] Under 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.
[32] In addition, the NCD for parenteral and enteral nutrition
specifically excludes "nutritional supplementation" from coverage.
[33] For 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.
[34] Specifically, outpatient drugs and biologicals are covered when
they are furnished incident to a physician's professional service,
provided that they are not usually self-administered 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.
[35] Medicare 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).
[36] Under 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.
[37] A 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.
[38] Based 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.
[39] For 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.
[40] Skin barriers are used to protect the skin around the stoma and to
increase overall wear time.
[41] DMERCs 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.
[42] The 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.
[43] A 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.
[44] According 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.
[45] The 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.
[46] We 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.)
[47] Forty-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.
[48] 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.
[49] The United Ostomy Association permanently ceased operations on
September 30, 2005.
[50] 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.
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