Patients, providers, and manufacturers seeking Medicare coverage of cancer drugs now have a new source to consult. The Centers for Medicare & Medicaid Services (CMS) announced on August 12, 2015, that Wolters Kluwer Lexi-Drugs® (Lexi-Drugs) has met the requirements to be an authoritative compendium. It is now the fifth approved authoritative source for use in the determination of a "medically-accepted indication" of drugs and biologicals used off-label in anticancer chemotherapeutic treatment regimens under Medicare.1
By way of background, Medicare reimbursement for drugs and biologicals in anticancer chemotherapeutic regimens may be available even when such products are used for indications not listed on the FDA-approved label. Specifically, Medicare’s definition of “drugs and biologicals” includes any such off-label uses when it is for a "medically-accepted indication” that is supported by citations in certain compendia or peer-reviewed medical literature.2 Historically, only three compendia were recognized as authoritative sources for this purpose,3 two of which ceased publication. Congress therfore authorized CMS to revise the list of compendia, and, in 2008, CMS established a process for revising the list of compendia as authorized under section 1861(t)(2) of the Social Security Act.
Pursuant to this process, Wolters Kluwer requested the formal addition of Lexi-Drugs to the list of compendia used by the Medicare program. After review of the request and consideration of public comments, CMS determined that Lexi-Drugs meets the requirements of an authoritative compendium. As such, indications listed in Lexi-Drugs as "Use: Off-Label" and rated as "Evidence Level A" with a "Strong" recommendation for inclusion will be considered medically accepted indications for anticancer chemotherapeutic treatment regimens. Indications listed as “Use: Unsupported” will not be considered medically accepted. Indications listed as “Equivocal” are considered neither "supported" nor "identified as not indicated,” and CMS instructs Medicare contractors to consider the peer reviewed medical literature when deciding whether to cover these indications.
Lexi-Drugs joins American Hospital Formulary Service-Drug Information (AHFS-DI), Truven Health Analytics Micromedex DrugDEX (DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, and Elsevier/Gold Standard Clinical Pharmacology on Medicare’s list of recognized compendia.