Off-Label Use

Off-label use of a medication is a use that is not included as an indication on the medication's label as approved by the Food and Drug Administration (FDA). FDA-approved medications used for indications other than what is indicated on the official label may be covered under Medicare if the carrier determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice. In the case of medications used in an anti-cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in the Medicare Carriers Manual, Section 2049.4.C.

Unlabeled use of FDA-approved medications and biologicals used in anti-cancer chemotherapeutic regimens for medically accepted indications are covered as described in the Medicare Benefit Policy Manual (100-02), Chapter 15 - Covered Medical and Other Health Services; 50.4.5 - Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen (Rev. 96, Issued: October 24, 20014, Effective: June 5, 2008; NCCN/06-10-08 Thomson Micromedex/July 2, 2008, Clinical Pharmacology, Implementation: November 25, 2008).