Life Sciences

Medicare beneficiary sues over Part D non-coverage of off-label use

Pharma Compliance Alert, December 4, 2007

A 66-year-old widow is suing the Department of Health and Human Services (HHS) because Medicare Part D will not pay for Cetrotide to treat her ovarian cancer. Prior to being switched to Medicare Part D, the plaintiff was covered for Cetrotide.

Cetrotide is approved as a fertility drug, but ovarian cancer is an off-label use. The off-label use is not approved in any major pharmaceutical compendia recognized by HHS.

The lawsuit, filed by the Medicare Rights Center on November 26 in federal district court, claims the denial of coverage is unlawful and should be set aside. The complaint also claims 20% of prescriptions are written for off-label uses.

Click here to read the complaint.

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