• CMS Names New Compendium to Approved List for Off Label Coverage Determinations
  • June 26, 2008 | Author: Laura E. Loeb
  • Law Firms: King & Spalding LLP - Washington Office; King & Spalding LLP - Atlanta Office
  • On June 5, 2008, CMS added the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium to its list of approved sources for making off-label coverage determinations for Part B anti-cancer drugs. Under the Medicare statute, local Medicare contractors are required to cover off-label uses of anti-cancer Part B drugs if these uses are included in at least one of the approved compendia listed in the statute or are an approved compendium named by the Secretary of Health and Human Services. Three approved compendia had been listed in the statute:

    • American Hospital Formulary Service -- Drug Information (AHFS-DI)
    • AMA Drug Evaluations (AMA-DE)
    • US Pharmacopoeia Drug Information (USP-DI)

    The AMA-DE is no longer in publication and CMS just deleted it from the list. USP-DI has been purchased by Thomson Micromedex and the name USP-DI is no longer used. Patient groups have long criticized CMS for not naming any other approved compendia to this list. The NCCN Compendium is the first new source to be named. In subsequent weeks, CMS might name others. There are also legislative efforts underway to have this process for updating the Part B compendia list also apply to the compendia used for Part D drugs.