Immunosuppressive Drugs

Medicare covers immunosuppressive drugs when they are FDA-approved for preventing or treating transplant rejection, when labeled for adjunctive use to prevent/treat rejection, or when the DME MAC determines them reasonable and necessary; compounded oral/enteral formulations derived from such drugs are also covered. Coverage requires conformity with accepted medical practice, dispensing by licensed entities (or authorized DMEPOS-enrolled practitioners), a Standard Written Order before claim submission, proof of delivery, and is limited to a 90-day supply with specific refill contact and delivery timing requirements; certain parenteral drugs are not covered for home administration and parenteral azathioprine/methylprednisolone are covered only when oral administration is not tolerated and the beneficiary self-administers.

"Immunosuppressive drugs are covered when FDA-approved and the approved labeling includes an indication for preventing or treating rejection of a transplanted organ or tissue."