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 resources below can be used as a guide for obtaining Medicare pre-approval.
Medically accepted indications:
- FDA approved indication (labeled indication) or a use supported in the approved drug compendium
- Articles or Local Coverage Determinations (LCDs) published by National Government Services (NGS)
- Pre-approval from National Government Services