IBD patients who have had an ostomy operation need to use specific  supplies for their ostomy care. However, in January 2006, Medicare will begin to cover medically  necessary drugs when the program’s new prescription drug benefit  becomes effective. 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. 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. We also found that, while all states provided some  coverage of ostomy care, the specific supplies that states cover varied. Medicare will also cover  infusion pumps—only one pump will be covered at any one time. Enteral Nutrition Supplies Covered by Medicare and Medicaid

Medicare will generally cover supplies associated with enteral nutrition  therapy for beneficiaries who meet coverage standards. 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. 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. 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. We pretested our survey with Medicaid officials in the District of  Columbia, Georgia, and Virginia. The state does not require documentation for adults.
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. 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.