By Christopher D. Adams, MS, Program Manager, and Jon Larsen, MPP, Program Coordinator
In 2008, the Centers for Medicare & Medicaid Services (CMS) updated their list of recognized compendia for use in off-label coverage determinations regarding drugs and biologics in cancer care. This update was welcomed and largely overdue given that two of the compendia, American Medical Association-Drug Evaluations (AMA-DE) and United States Pharmacopeia-Drug Information (USP-DI), were obsolete, and others, such as the NCCN Drugs & Biologics Compendium (NCCN Compendium™), had proven worthy of inclusion.1 This updated list of compendia continues to influence how CMS and Medicare’s intermediaries and carriers set related coverage policy in the oncology space.
While this change for the Medicare program was a positive development, it has become clear that some states have neglected to keep pace. For background, many states have existing laws that prescribe which compendia may be used in determining coverage policy for off-label drug use in cancer care. At the time of enactment, many of these state laws were in concert with existing CMS requirements. However, now that CMS has revised their list of recognized compendia, some of these state laws are out-of-date and need to be updated. For example, Massachusetts has an existing off-label drug use law that defines “standard reference compendia” as USP-DI, AMA-DE, and the American Hospital Formulary Service Drug Information (AHFS DI).2 While AHFS DI continues to be published and is currently recognized by CMS as a mandated reference, AMA-DE is defunct and USP-DI has been succeeded by a subsequent publication.3 Massachusetts is certainly not alone as several other states also continue to refer to outdated compendia in their off-label drug use laws. While bills were introduced to address this issue in Michigan and Ohio during their most recent legislative sessions, both fell short of achieving final passage.4
State laws that support the use of up-to-date compendia are critically important because they impact patient access to appropriate therapies. Those states that continue to refer to outdated compendia and/or exclude CMS-recognized compendia from their existing off-label drug use laws unnecessarily reduce the pool of resources that should otherwise be made available in related coverage determinations. While updating these laws may not grab the headlines, it is a surefire way to benefit patients as they seek to navigate the continuum of cancer care.
1Medicare Updates Its List of Recognized Sources to Help Make Coverage Decisions for Anti-Cancer Chemotherapy Drugs. Centers for Medicare & Medicaid Services website. http://www.cms.gov/apps/media/press/release.asp?Counter=3145&intNumPerPage=10&checkDate=&checkKey=&srchType=1&
=&year=&desc=false&cboOrder=dateChemotherapy Drugs. (Accessed February 5, 2011).
2Commonwealth of Massachusetts. General Laws, Part I, Title XXII, Chapter 175, Section 47K (Accessed February 6, 2011).
3 Change Request 6191: Compendia as Authoritative Sources for Use in the Determination of a “Medically Accepted Indication” of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen. Centers for Medicare & Medicaid Services website. http://www.cms.gov/transmittals/downloads/R96BP.pdf (Accessed February 6, 2011).
4Michigan H.B. 6250 and Ohio H.B. 384. (Accessed February 6, 2011).