CMS RULES ON PART D COVERAGE FOR OFF-LABEL CANCER DRUG USE

The Centers for Medicare & Medicaid Services (CMS) recently released an interim final rule that codifies regulation changes to the definition of “medically accepted indications” for Part D cancer drugs. This change was required by the Medicare Improvements for Patients and Providers Acts of 2008 (MIPPA). Effective January 1, 2009, Part D providers must use the same definition for a "medically accepted indication" for Part D anti-cancer drugs as that used under Medicare Part B.

Before the passage of MIPPA, Medicare covered drugs only for uses listed in three medical compendia, even if the use is supported by studies published in reputable, peer-reviewed medical journals. To allow access to medically necessary drugs for people with Medicare suffering from cancer, the regulation expands the list of compendia and includes the compendium published by the National Comprehensive Cancer Network. Also, when making coverage determinations for anti-cancer drugs, plans can consult peer-reviewed medical literature that might include indications for medications that are not listed in the compendia.

-From: “CMS Releases Rule on Part D Drug Coverage”, MEDICARE WATCH, a biweekly electronic newsletter of the Medicare Rights Center,Vol. 12, No. 2: January 27, 2009.

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