Asclepios
A Good Decision
April 23, 2009 • Volume 9, Issue 16
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.
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. 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. MIPPA ensured there would not be a different coverage standard for chemotherapy drugs depending on whether they were administered by a doctor and covered under Part B, or purchased at a pharmacy and covered under Part D.
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. Such case-by-case decisions are the standard that now applies to Part B coverage of non-cancer medicines.
Medical Record
“FDA-approved drugs used for [non-cancer] indications other than what is indicated on the official label may be covered under Medicare [Part B] if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.” (Medicare Benefit Policy Manual, Centers for Medicare & Medicaid Services, December 2008)
“Treating physicians look to research published in peer-reviewed journals and to the compendia which review and compile this research to determine the potential risks and benefits of using drugs to treat indications not approved by the Food and Drug Administration. Such “off-label prescribing is an accepted medical practice and is particularly prevalent in the treatment of cancers, HIV/AIDS and rare disorders.” (Letter from Senate Cancer Coalition, May 2008)
“Some [Part D Plan] sponsors noted that, in determining whether a particular drug use is medically indicated, they have less flexibility in accepting evidence from peer-reviewed literature for drug coverage decisions under Part D than under commercial plans.” (Medicare Part D: Plan Sponsors’ Processing and CMS Monitoring of Drug Coverage Requests Could Be Improved, Government Accountability Office, January 2008)
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Medicare Rights Center’s new Medicare Part D Appeals: An advocate’s manual to navigating the Medicare private drug plan appeals process offers an easy-to-understand, comprehensive overview of the entire appeals process, including real-life case examples, a glossary of important appeals terms, a sample protocol for advocates, and links to important resources.
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Medicare Part D Monitoring Project
The Medicare Rights Center would like to hear about your experience, or that of someone you know, enrolled in a private drug plan. With information about what the issues are with Medicare Part D, we will be able to demand that those problems be fixed.
Submit your story at http://www.medicarerights.org/issues-actions/tell-your-story.php.
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The Louder Our Voice, the Stronger Our Message
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Asclepios—named for the Greek and Roman god of medicine who, acclaimed for his healing abilities, was at one point the most worshipped god in Greece—is a weekly e-newsletter designed to keep you up-to-date with Medicare program and policy issues, and advance advocacy strategies to address them. Please help build awareness of key Medicare consumer issues by forwarding this action alert to your friends and encouraging them to subscribe today.
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The 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.
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