The Centers for Medicare & Medicaid Services (CMS) today announced additional updates to the information it uses in determining which drugs may be covered under Medicare Part B when used to treat patients undergoing cancer treatment through chemotherapy.

CMS will add Elsevier Gold Standard’s Clinical Pharmacology compendium to the list of Medicare anti-cancer treatment compendia.

“Today’s decision completes our review of the compendia requests received earlier this year and we remain committed to this compendia process that allows for updating the Medicare compendia in a transparent way,” said CMS Acting Administrator Kerry Weems .

A compendium is a listing of U.S. Food and Drug Administration (FDA) -approved drugs and biologics.   In some cases, compendia specialize in a particular subset of drugs, such as those used for anti-cancer treatment.  Compendia include a summary of how each drug works in the body, as well as information for health care practitioners about proper dosing and whether the drug is recommended or endorsed for use in treating a specific disease. 

Medicare local contractors, which process and pay Medicare claims and approve coverage for drugs under Medicare Part B, use compendia as one of several tools to determine whether an anti-cancer drug may be covered under Medicare Part B.

To ensure that Medicare contractors continue to have access to up-to-date drug compendia to make coverage decisions for anti-cancer drugs, CMS created a process to revise its compendia reference list.

This process included the recommendations from CMS’ Medicare Evidence Development & Coverage Advisory Committee (MedCAC), which advised CMS on the factors the Agency should consider when updating the list of compendia.  The MedCAC recommendations include criteria that a compendium should meet before Medicare includes it as a drug reference guide.  These include, among others, a transparent process for evaluating therapies and a process for public identification and notification of potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members. CMS’ compendia-revising process also includes a 30-day public comment period.

Before approving coverage for a drug, Medicare contractors consider whether the drug is FDA approved for use in treating the beneficiary’s type of cancer in the beneficiary’s specific clinical circumstances.  In some instances, however, the medical community may have scientific evidence that supports using a drug to treat a disease even if the drug’s FDA-approved label does not include those clinical conditions.  In these instances, certain drug compendia may recommend uses beyond those included in the FDA approved labels.

While these changes affect only the compendia CMS uses to make determinations for anti-cancer chemotherapy drugs, CMS also recognizes compendia for determination of covered drugs under Medicare Part D and Medicaid.  CMS is interested in updating these lists to include current, well-respected compendia, and is exploring options to do so for these programs.

As part of CMS’ comprehensive efforts to review and update the Medicare Part B program, CMS has now approved three national compendia for the program.   Earlier this year, CMS approved the NCCN Drugs & Biologics Compendium™ and Thomson Micromedex DrugDex ®.

For more information about these compendium decisions, please visit the CMS website at

http://www.cms.hhs.gov/CoverageGenInfo/02_compendia.asp.

http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=17

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