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.

If a research subject is not insured by Medicare, the insurance coverage for the costs of anti-cancer drug given off-label should consider the subject’s insurance plan benefits. 

Uses Supported by Medicare through Approved Compendium

Medicare’s coverage of drugs and biologicals used off-label in an anticancer chemotherapeutic regimen is based upon information published in different drug compendium.

Uses Supported by our Local Medicare Contractor

National Government Services (NGS) is the local Medicare Contractor for Connecticut.  Click to see when the usage of a drug off-label may be supported by NGS.

Use Supported By Medicare using Peer-Reviewed Medical Literature

When unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational and our local Medicare contractor has not published a coverage determination to support off-label usage, peer-reviewed medical literature may be submitted to Medicare to support coverage of off-label anti-cancer chemotherapeutic regimen drugs and biologics.

Additional Medicare Off-Label Approval Requirements

Providers may request that a drug be approved for off-label use by submitting a request in writing and including the data supporting its use.

FDA's Information for Off-Label Drugs

The U.S. Food and Drug Administration requirements for Off-Label Drug Usage should be considered prior to billing subject’s for drugs used off-label.