11th Circuit:  ‘Medically Accepted Indication’ Covers Medicare Drug Off-Label Use

Mealey's (February 16, 2022, 9:41 AM EST) -- ATLANTA — “[M]edically accepted indication” for off-label use of a Medicare Part D drug includes “off-label uses for which an approved medical compendium tends to show or helps prove the efficacy and safety of the prescribed off-label use,” the 11th Circuit U.S. Court of Appeals held Feb. 11, vacating a district court’s summary judgment in favor of the secretary of the U.S. Department of Health and Human Services where drug coverage was denied to a Medicare Part D beneficiary and remanding with instructions to enter judgment for the beneficiary....