New York, NY – More than two years after it first filed an appeal, the Medicare Rights Center has secured coverage under the Medicare Part D prescription drug benefit for a New York woman’s ovarian cancer treatment. As a result, Judith M. Layzer will obtain coverage from her Part D plan of Cetrotide, a hormone treatment costing upwards of $35,000 per month, which has been shown effective against ovarian cancer, with minimal toxicity, in a study in the journal Gynecologic Oncology.
“This decision means I will be able to afford to continue an effective treatment prescribed by my doctor,” Mrs. Layzer said. “I have been energetically pursuing this approval and so has the Medicare Rights Center and we finally won, but it should not be this hard, or take this long, to obtain coverage for medically necessary drugs.”
The victory, handed down in an April 20, 2009 decision by the Part D independent review entity, follows passage last summer of the Medicare Improvements for Patients and Providers Act (MIPPA). MIPPA clarified the standard of coverage for off-label drug treatments—uses of drugs that are different from the use approved by the Food and Drug Administration. The clarification, which took effect January 1, 2009, explicitly allows coverage determinations to be based on research in peer-reviewed literature—respected journals like the New England Journal of Medicine and the Journal of the American Medical Association—in determining when an off-label use is “medically accepted.”
Before passage of MIPPA, drug plans were prohibited by regulation from covering such treatments unless there was support in drug compendia—privately published reference manuals—designated by statute. Numerous studies, including a recent study in the Annals of Internal Medicine, have highlighted the failure of compendia publishers to keep current with the research on off-label drug treatments.
“This victory is important for Mrs. Layzer and for all cancer patients,” said Paul Precht, Medicare Rights Center Director of Policy and Communications. “It is also a sign for policymakers on Capitol Hill and in the Obama administration that coverage decisions in these types of drug treatments can, and should, be made case-by-case on the basis of sound evidence vetted through the peer-review process.”
The Medicare Rights Center has pursued two complementary strategies to secure Part D coverage for safe and effective off-label treatments. The Medicare Rights Center, on behalf of Mrs. Layzer and Ray J. Fischer, who suffers from a rare form of muscular dystrophy, has challenged in federal court the regulations that restrict coverage of off-label drug treatments only to those uses with support in the compendia. That suit is now pending in the US District Court in the Southern District of New York.
At the same time, the Medicare Rights Center has pursued a legislative remedy, seeking clarification from Congress that off-label drug treatments can be covered under Part D if there is evidence of efficacy in peer-reviewed literature. That effort was successful with respect to anticancer chemotherapy drugs only with the passage of the MIPPA. The Medicare Rights Center continues to advocate for passage of legislation that would explicitly require case-by-case coverage determinations for off-label uses of non-cancer drugs on the basis of sound research published in peer-reviewed journals showing off-label use is effective.
Medicare Rights Center is a national, nonprofit consumer service organization that works to ensure access to affordable health care for older adults and people with disabilities through counseling and advocacy, educational programs, and public policy initiatives. www.medicarerights.org