The Center Medicare and Medicaid Services (CMS) has proposed guidelines excluding coverage for thalidomide in an oral drug demonstration project that was a part of the Medicare Modernization Act of 2003 (MMA).
Congress provided $500 million in the MMA for the demonstration project—intending to cover 50,000 patients until the full prescription drug benefit is scheduled to go into effect on January 1, 2006. Under the terms of the legislation, 40% of the project is intended to serve cancer patients. The other 60% is reserved for self-administered drugs for patients of neurological and other diseases including multiple sclerosis and Alzheimer’s disease.
CMS decided not to cover off-label use of drugs in the cancer portion of the demonstration project in order to limit costs.
IMF President Susie Novis wrote to CMS Administrator Mark McClellan objecting to the proposed rules as being “highly punitive to patients with certain types of cancer that have limited treatment options, specifically including myeloma.”
According to the IMF letter, the CMS proposed rules did not take into account the fact that “[t]halidomide is now a standard, widely accepted, frontline therapy for a majority of myeloma patients” and that “its exclusion from the demonstration project is not reflective of the Medicare statute that provides coverage for drugs used to treat off-label cancer indications as cited by the Compendia and other peer-reviewed published literature.”
CMS held an Open Door Meeting to take public comments on the program in Baltimore, MD on Friday, April 23, 2003. After hearing from a number of individuals testifying to include thalidomide in the project, CMS Chief Medical Officer Sean Tunis indicated that CMS was open to revising the rules to include thalidomide and other off-label drugs if clearly understood and accepted rules could be identified. The points raised in the IMF letter should serve as a guide for such a justification.
The IMF was represented by Greg Brozeit. Others commenting on the exclusion of thalidomide from the demonstration projects included the Celgene Chief Operating Officer Sol Barer, James Christoferson from the staff of Sen. Kay Bailey Hutchison, Sam Turner of Ropes & Gray representing the Cancer Leadership Council, and George Dahlman of the Leukemia & Lymphoma Society. Myeloma patient Jeanne Bechtel of the Philadelphia Multiple Myeloma Networking Group submitted at personal statement to CMS urging the adoption of thalidomide and Kathy Giusti also participated by phone.
If you have any additional questions, please contact IMF Director of Advocacy Greg Brozeit at firstname.lastname@example.org.