Group Sues HHS Over Rules Against Coverage Of Medications Prescribed For Off-Label Uses Under Medicare Prescription Drug Benefit

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Litigation / Medical Malpractice
Article Date: 29 Nov 2007 - 12:00 PST

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The Medicare Rights Center on Monday filed a lawsuit in U.S. District Court in New York City over CMS rules under which the Medicare prescription drug benefit does not cover medications prescribed for off-label uses, The Hill reports. MRC filed the lawsuit, which also names HHS and department Secretary Mike Leavitt as a defendant, on behalf of a Medicare beneficiary who seeks coverage under her prescription drug plan for a fertility medication that she has taken to treat ovarian cancer since 1999.

Under CMS rules, Medicare prescription drug plans cannot cover medications prescribed for off-label uses unless those uses appear in one of four official medical compendia, such as those published by the American Medical Association and U.S. Pharmacopeia.

According to the lawsuit, the "exclusion from Medicare Part D coverage of off-label prescriptions that lack support in the compendia hurts the most vulnerable people with Medicare" and "conflicts with standard medical practice." The lawsuit asks the court to require CMS to reimburse the plaintiff for the more than $100,000 she has paid out of pocket for the fertility medication and to allow her Medicare prescription drug plan to cover the treatment (Young, The Hill, 11/28).

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