Section 1861 of the Social Security Act established AHFS DI as an official compendium for determining medically accepted indications of drugs and biologics used in anti-cancer chemotherapeutic regimens under Medicare Part B.
A formal determination process has been developed to supplement the long-standing evidence-based process by AHFS for evaluation of off-label cancer uses of drugs and biologics.
A Final Determination Report for each off-label use will be published on the AHFS website and will reflect the consensus vote of the members of the AHFS Oncology Expert Committee.
Determinations that appeared on this portion of the website prior to January 1, 2010, have been incorporated into the respective drug monographs in the AHFS DI database. Determinations subject to CMS’ revised definition of medically accepted indications, related to Section 182(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and effective as of January 1, 2010, will be posted on this portion of the website as they are finalized.
Final Determination Reports
Listed below are the Final Determination Reports published for each off-label use. These reports reflect the consensus vote of the members of the AHFS Oncology Expert Committee.