Drugs and Biologicals, Coverage of, for Label and Off-Label Uses

Medicare (NGS) covers drugs for FDA‑approved labeled uses and for off‑label uses that are 'medically accepted'—defined as FDA labeling, specified levels of support in accepted compendia, or NGS articles/LCDs—and may also cover off‑label uses supported by strong peer‑reviewed evidence or authoritative guidelines. Coverage determinations require that the use be reasonable and necessary (including route), be supported by specified evidence standards (e.g., multi‑center Phase III or comparable Phase II data when applicable), and will specify diagnosis, dose, route, duration, frequency, and patient population; uses not supported by FDA, compendia, or NGS publications are not covered though may be appealed.

"Medicare covers a drug when used for an FDA‑approved labeled indication or for an off‑label indication that is a 'medically accepted indication' supported by accepted compendia (AHFS‑DI; NCCN Categ..."