Suit opposes Medicare denials of off-label, non-compendia drugs

The administration is interpreting Medicare law in a way that prevents coverage of lifesaving medications for people with rare diseases, a patient advocacy group says.

By David Glendinning, AMNews staff. Jan. 21, 2008.

Washington -- Cancer patient Judith M. Layzer has come to the conclusion that the administrators of the Medicare drug benefit are forcing her to choose between her money and her life.

Layzer, a 66-year-old retired widow from New York, has a granulosa cell tumor, a rare form of ovarian cancer that no longer responds to the more traditional treatments for the condition. So for the past eight years, her doctor has had her on daily doses of Cetrotide (cetrorelix acetate), a drug that is normally used to prevent premature ovulation in women undergoing fertility treatments. She and her doctor are convinced that this off-label use of the drug has kept her alive.

The trouble started in 2006, when Layzer enrolled in Medicare Part D after leaving her former employer's health plan. Her Medicare drug plan denied coverage of the costly medication on the basis that it was not an approved therapy for ovarian cancer. Even though she, her doctor and several other physicians eventually were able to convince an administrative law judge and the Medicare Appeals Council that her course of treatment was her only medical option, the officials hearing the appeal were forced to rule that federal regulations did not allow the Medicare drug plan to pay for the medication. Layzer cannot afford it on her own.

"Even the [administrative law judge] and the MAC said that this was medically necessary, but Medicare wants me to go on the private market for this drug because it costs over $300,000," Layzer said. "What else can you think about this except that it seems to be coming down to money? It could cost me my life."