CMS Issues Compendia-based Off-label Cancer Chemotherapy Instructions

The following information has been received by ANCO.

CMS's instructions to Medicare Fiscal Intermediaries, Carriers and Medicare Administrative Contractors (MACs) regarding Compendia interpretation and application has been released. CR 6191, with an implementation date of November 25, 2008, attempts to clarify for Medicare contractors how to utilize the four authoritative sources of Compendia when granting an approval or denial for a “medically-accepted” indication of a drug or biological used off-label in an anti-cancer chemotherapeutic regimen.

The four approved sources are:

1) American Hospital Formulary Service-Drug Information, existing
2) National Comprehensive Cancer Network Drugs and Biologics Compendium, effective June 5, 2008
3) Thomson Micromedex DrugDex, effective June 10, 2008
4) Clinical Pharmacology, effective July 2, 2008


The complete CMS Compendia Update may be downloaded by clicking on the link: www.cms.hhs.gov/transmittals/downloads/R96BP.pdf

Within the document, CMS instructs:

Contractors shall recognize medically accepted indications as those that:

· are favorably listed in one or more of the compendia listed above, or,
· the contractor determines from a review of the peer-reviewed literature as described above that it is a medically accepted indication, unless CMS has determined that the use is not medically accepted, or any of the listed compendia list the use as not medically accepted, or words to that effect.

CMS is aware that the listed compendia employ various rating and recommendation systems that may not be readily cross-walked from compendium to compendium. In general, a use is identified by a compendium as medically accepted if the:

1) indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or,
2) narrative text in AHFS or Clinical Pharmacology is supportive.

A use is not medically accepted by a compendium if the:

1) indication is a Category 3 in NCCN or a Class III in DrugDex; or,
2) narrative text in AHFS or Clinical Pharmacology is “not supportive.”