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Compendia 1861(t)(2) – Anti-cancer


Compendia History

Compendia recognized by CMS [per SSA 1861(t)(2)(B)(ii)(I)]:

  1. American Medical Association Drug Evaluations (AMA-DE)
  2. United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication [amended in Section 6001 (f)(1) of the Deficit Reduction Act of 2005]
  3. American Hospital Formulary Service-Drug Information (AFHS-DI)

However:

  • AMA-DE no longer published.
  • USP-DI no longer published, and Thomson Micromedex has designated Drug Points as the successor to USP-DI.  However, in the 2008 MPFS Proposed Rule, CMS questioned whether Drug Points is a successor or substitute to USP-DI, which would affect recognition as a compendia. [72 Fed Reg 38177]
  • Requests for publications to be added as compendia
    • NCCN Drugs and Biologics Compendium
      • NCCN request to add NCCN Drugs and Biologics Compendium as mandated reference for Medicare coverage decisions (i.e., as one of compendia recognized by Medicare) on February 8, 2008
      • CMS added NCCN Drugs and Biologics Compendium to compendia list on June 5, 2008
    • Elsevier Gold Standard’s Clinical Pharmacology 

CURRENT CMS-RECOGNIZED COMPENDIA (as of 2 July 2008)

  • NCCN Drugs & Biologics Compendium™
  • Thomson Micromedex DrugDex®
  • Elsevier Gold Standard’s Clinical Pharmacology 

 

Compendia Policy Descriptions

Technology Assessment: Compendia for Coverage of Off-Label Uses of Drugs and Biologics in an Anticancer Chemotherapeutic Regimen
 (May 7, 2007)
  • Excellent discussion and background

MedLearn: Unlabeled Use for Anti-Cancer Drugs:  Medical Literature used to Determine Medically Accepted Indications for Drugs and Biologicals used in Anti-Cancer Treatment, September 21, 2007