Drug & Device News

In Layzer v. Leavitt, 07 Civ. 11339 (HB), NYLJ 1202485563289, at *1 (SDNY, Decided March 7, 2011), the U.S. Court of Appeals for the Southern District of New York recently concluded that the Department of Health and Human Services must cover the costs of prescription medications prescribed “off label.” The case involved two patients, one prescribed Cetrotide to treat a rare form of ovarian cancer and the other prescribed Increlex to treat a rare and degenerative form of muscular dystrophy. Their Medicare Part D plan sponsors denied coverage for the drugs because they had not been approved by the Food and Drug Administration (FDA) for treatment of the two patients' conditions. On appeal, a Medicare Part D Independent Review Entity affirmed the denials, concluding that the plan sponsors were not required to provide coverage because the drugs were not being used for a medically accepted indication. The appeals authority explained that “a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in ' drug compendia.” (The compendia are: 1) the American Hospital Formulary Service Drug Information; 2) the United States Pharmacopeia-Drug Information; and 3) the DRUGDEX Information System. 42 U.S.C. ' 1396r-8(g)(1)(B)(i).) When the plaintiffs sought final review of the Health and Human Services secretary's denial of reimbursement under 42 USC ' 405(g), the federal court reversed and ordered coverage. It found that the definition of a “covered part D drug” in the Social Security Act, 42 USC ' 1395 et seq., did not impose the so-called compendia requirement.