The Ostomy Files: The New Year Holds Great Promise for IBD Patients: The Research Review Act of 2004

    H .R. 5213, The Research Review Act,¹ was passed unanimously by the House of Representatives on October 7, 2004 and unanimously by the Senate on November 16, 2004 during the 108th Congress. It was sent to President Bush for his signature on November 20, 2004.

    According to Gavin Lindberg, the Crohn’s Colitis Foundation of America’s (CCFA) Washington Representative, “This is the first bill ever passed by the Congress that focuses on inflammatory bowel disease. It represents a significant victory for the IBD community.”²

    This bill was developed in coordination with Congress, the CCFA, the Christopher Reeve Paralysis Foundation, and letters sent to congressmen by members of the United Ostomy Association (UOA) and others afflicted with inflammatory bowel disease such as Crohn's Disease and ulcerative colitis.

    Three sections (Sections 3, 4, and 5) of the Act directly affect people living with Crohn’s Disease, ulcerative colitis, or a stoma resulting from one of these diseases. Section 3 of the Act requires that the Centers for Disease Control and Prevention (CDC) conduct an epidemiological report into the status of clinical studies of inflammatory bowel disease currently underway and planned, as well as the criteria involved in deciding which studies should be suspended, moved forward, or deferred. This report, due not later than May 1, 2005, is also to include a description of any activities taken by the CDC to expand and establish partnerships with research and patient advocacy groups (such as CCFA and the UOA). Lindberg also notes that the 2005 fiscal appropriations bill has designated funding for this study — the first time this annual bill has allocated specific funding for IBD study.²

    Section 4 of the Act requires the Government Accountability Office (GAO) to conduct a study on the coverage benefits under Medicare and Medicaid for products and services required by patients living with inflammatory bowel disease. Among other items, the list includes ostomy supplies, enteral nutrition, and therapies approved by the Food and Drug Administration (FDA) for Crohn’s Disease and ulcerative colitis. This report is due not later than 6 months after the enactment of the ruling.

    According to Linda Aukett, Chair of the UOA Government Affairs Committee, the UOA “stands ready today to tell the GAO all we have learned about how well or how poorly these programs cover ostomy supplies.”³ Over the past several years, the UOA, under Aukett’s guidance, has been working diligently with insurers, including Medicare and Medicaid, to try to improve coverage and payment for ostomy supplies. This law appears to provide a more favorable opportunity for the ostomy community to be heard by lawmakers.

    Finally, Section 5 of the Act requires the US Comptroller General to investigate the problems patients face when applying for Social Security disability (SSI) insurance and to make recommendations for improving the application process for people with inflammatory bowel disease. Like the GAO report, this report is due 6 months after the enactment of the ruling.

    The passage of this Act is the result of 2 years of hard work and advocacy by the IBD community, resulting in powerful relationships with members of Congress who have pledged in the 109th Congress to further the cause of IBD patients and their families.

1. H.R. 5213 Research Review Act of 2004. Available at: http://thomas.loc.gov. Accessed December 3, 2004.

2. Lindberg G. Senate passes research review Act. Available at: www. ccfa.org/advocacy/ibdhearing2004. Accessed November 29, 2004.

3. Aukett L. Good news: an important bill has been passed by congress. Available at: http://capwiz.com/uoa/issues/alert/?alertid=6686881&type=CO. Accessed December 3, 2004.