Press Release             

Contact: Akiko Takano
Deputy Director of Communications

July 15, 2010

Consumer Group Supports Proposed Legislation to Expand Medicare Coverage of
Safe and Effective Off-Label Drugs under Part D

New York, NY—The Medicare Rights Center applauds Representative Mary Jo Kilroy, Democrat of Ohio, and Representative Mac Thornberry, Republican of Texas, for introducing the Part D Off-Label Prescription Parity Act (H.R. 5732). This important bill expands coverage under the Medicare prescription drug program to allow Medicare prescription drug plans (Part D plans) to cover drugs used for “off-label” indications if such use is supported by peer-reviewed medical literature, as is the case under Part B and for Part D cancer drugs. The Medicare Rights Center and the Multiple Sclerosis Society worked closely with Representative Kilroy and Representative Thornberry to develop the bill.

When the Medicare prescription drug coverage program (Part D) began in 2006, the law forbid Part D plans from covering off-label uses of drugs unless such use was listed in specific compendia that are identified in the law. Compendia are prescribing guides that are published by private companies. However, under Part B, Medicare allows coverage of drugs used off-label if the use is supported by peer-reviewed medical literature. Furthermore, as a result of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), off-label drugs used to treat cancer may be covered under Part D using the Part B standard. But those who suffer from conditions other than cancer are still subject to the more restrictive coverage rules.

“Since the implementation of Part D, the Medicare Rights Center continues to receive calls from Medicare consumers who are unable to access medically necessary prescriptions, even when the use is supported by the available medical literature,” said Medicare Rights Center President Joe Baker. “The Part D Off-Label Prescription Parity Act finally grants all Medicare consumers access to safe and effective prescription treatments, regardless of the condition from which they suffer. This legislation creates uniformity in the rules across the entire Medicare program, expanding treatment options for at-risk populations.”

The Part D Off-Label Prescription Parity Act uses the existing Part D determination and appeals processes to allow Medicare and Part D plans to make coverage decisions on a case-by-case basis, by examining the safety and efficacy of drugs, and consulting the most up-to-date evidence available in peer-reviewed medical literature. The bill expands treatment options for Medicare consumers, and brings Part D rules in line with other parts of the Medicare program, including Part B and the Part D coverage standard for drugs used to treat cancer.

The Medicare Rights Center has pursued two complementary strategies to secure Part D coverage for safe and effective off-label treatments. In addition to working toward a legislative remedy, the Medicare Rights Center has challenged in federal court the regulations that restrict coverage of off-label drug treatments only to those uses with support in the compendia. The suit was filed on behalf of two clients, one a widow who recently lost her battle with ovarian cancer, and a man who suffers from a rare form of muscular dystrophy. That suit is now pending in the United States District Court in the Southern District of New York.

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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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