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.

Use Supported By Approved Compendium

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)

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Uses Supported By Articles Or LCDs

Click to see use supported by articles or local coverage determinatinos (LCDs) published by National Government Services (NGS).

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Use Supported By Clinical Research That Appears In Peer-Reviewed Medical Literature

This applies only when unlabeled use does not appear in any of the compendia or is listed as insufficient data or investigational and NGS has not published an LCD to support.

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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.

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