Judith Layzer, a 66-year-old ovarian-cancer survivor, and the Medicare Rights Center filed a $100,000 lawsuit against HHS Secretary Mike Leavitt that claims that the nations top healthcare administrator failed to provide prescription-drug coverage to an otherwise eligible Medicare beneficiary.
The lawsuit, filed in U.S. District Court in New York, aims to overturn a regulation issued last year by the HHS that greatly restricts Part D coverage of so-called off-label prescriptions, said Deane Beebe, director of public affairs for the Medicare Rights Center.
When a drug manufacturer gets approval from the Food and Drug Administration, it must sell the drug with a label that lists only its approved uses. Any other use is referred to as off-label, the lawsuit states. According to the Medicare Rights Center, more than 20% of prescriptions written for the 500 most commonly used drugs are for off-label purposes.
That said, medically its not unusual for people with certain conditionsespecially rare conditionsto be prescribed drugs approved by the FDA for one condition but that work for another condition, Beebe said.
Medicares Part D prescription drug plan does cover some off-label drugs, but only if they are first included on one of three specified medical compendiums.
Layzer, who is named as the plaintiff in the lawsuit, has been taking Cetrotide since 1999 after having a cancer recurrence more than 10 years earlier. After the implementation of Part D in 2006, however, her retiree drug coverage was moved to a Medicare private plan, which has continuously denied coverage of the drug. As a result, Layzer has had to pay $7,000 per month for the prescription, the lawsuit states. The CMS had no immediate comment on the lawsuit. -- by Matthew DoBias
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