CMS Adopts Process For Evaluating Official Compendia

Main Category: Medicare / Medicaid / SCHIP
Article Date: 12 Nov 2007 - 10:00 PDT

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A new rule issued this week by the Centers for Medicare & Medicaid Services (CMS) will ensure that patient care involving off-label medications will be guided by objective, evidence-based drug information, a move championed by ASHP.

CMS's process for determining changes to the list of compendia used to determine medically accepted off-label uses of drugs and biologicals in chemotherapy regimens will place a high priority on whether a publication's evidence evaluation process is transparent and free from conflicts of interest.

In comments submitted to the agency and in meetings with CMS officials in August, ASHP pushed for greater reliance on editorial independence and adherence to a rigorous review process when determining the merits of a drug compendium.

ASHP argued that health care practices (including the use of prescription medicines) must be based on evidence of net benefit to the patient. A standard that is too lax or too rigid for assessing the evidence supporting off-label use could have real consequences for the patient such as delaying or precluding more effective treatment or fostering unfounded hope for improvement in health status.

The Society is the publisher of AHFS DI, a comprehensive, independent reference on the clinical use of medications marketed in the United States. Published continuously for 49 years, AHFS is recognized through federal legislation and regulation as an official compendium for information on medically accepted uses of medications.

CMS will consider requests to review compendia annually during a 30-day window starting January 15th each year. CMS will accept public comments and then make a determination about the compendium based on the comments received and a set of desirable characteristics established by the agency.

ASHP's comments are online here.

http://www.ashp.org