Layzer v. Leavitt

Judith Layzer (plaintiff) suffered from a rare type of ovarian cancer. Layzer’s physician, Dr. Bast, prescribed Cetrotide to treat Layzer’s cancer. Ovarian cancer treatment was an off-label use of Cetrotide, but peer-reviewed medical research demonstrated that Cetrotide was a uniquely effective treatment. Ray Fisher (plaintiff) suffered from a rare form of muscular dystrophy that caused cardiac abnormalities. Fisher’s physician, Dr. Moxley, prescribed Increlex to slow Fisher’s muscular degeneration and restore function. Treating muscular dystrophy was an off-label use of Increlex. The secretary of Health and Human Services (secretary) (defendant) instructed insurance companies reviewing Medicare Part D claims to only approve coverage for a prescription drug if (a) the drug was prescribed for an on-label use, meaning that the condition being treated was listed on the Federal Drug Administration’s (FDA) label for that drug; or (b) the prescribed use met the compendia requirement, meaning that it was listed as an approved use in one of the drug compendia referenced in the Social Security Act. Because neither Fisher’s use of Increlex nor Layzer’s use of Cetrotide was an on-label use and neither met the compendia requirement, Fisher’s and Layzer’s Medicare Part D claims were denied. Fisher and Layzer appealed the denials to an independent review board, then to an administrative-law judge, and finally to the Medicare Appeals Council (MAC). The coverage denial was affirmed at all levels and became the secretary’s final decision. Fisher and Layzer sought judicial review in district court, arguing that the secretary’s compendia requirement was an improper interpretation of Medicare Part D.