Anti-Cancer Off-Label Drug Approval
Medicare may cover FDA approved drugs used for purposes other than what is indicated on the official label if Medicare determines the use to be medically accepted. In order to make this determination, Medicare will take into consideration the major drug compendia, authoritative medical literature and/or accepted standards of practice.
The Social Security Act Section 1861(t)(2)(B)(ii)(I) recognizes the following compendia:
- American Medical Association Drug Evaluations (AMA-DE),
- United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication [amended in Section 6001 (f)(1) of the Deficit Reduction Act of 2005]
- American Hospital Formulary Service-Drug Information (AFHS-DI)