Compendia 1861 (t)(2) - Anti-cancer
The Social Security Act Section 1861(t)(2)(B)(ii)(I) recognizes the following compendia: American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication [amended in Section 6001 (f)(1) of the Deficit Reduction Act of 2005] and American Hospital Formulary Service-Drug Information (AHFS-DI) as authoritative sources for use in the determination of a "medically-accepted indication" of drugs and biologicals used off-label in an anticancer chemotherapeutic regimen. Due to changes in the pharmaceutical reference industry, fewer of these statutorily named compendia are available for our reference. (AMA DE and USP-DI are no longer published - Thomson Micromedex has designated Drug Points as the successor to USP-DI.) CMS received requests from the stakeholder community for a process to recognize the addition and/or deletion of existing compendia. The final rule published in the CY 2008 Physician Fee Schedule establishes a sub-regulatory process by which we can accept and definitively act on such requests. In addition, CMS increased the transparency of the decision making process through the use of desirable characteristics outlined by the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for this purpose.
On March 30, 2006, the MEDCAC met in public session to review the evidence and advise CMS on the desirable characteristics of compendia for use in the determination of medically-accepted indications of drugs and biologicals in anti-cancer therapy. As a result of this meeting, the MEDCAC generated the following list of desirable characteristics:
- Extensive breadth of listings.
- Quick processing from application for inclusion to listing.
- Detailed description of the evidence reviewed for every individual listing.
- Use of pre-specified published criteria for weighing evidence.
- Use of prescribed published process for making recommendations.
- Publicly transparent process for evaluating therapies.
- Explicit "Not recommended" listing when validated evidence is appropriate.
- Explicit listing and recommendations regarding therapies, including sequential use or combination in relation to other therapies.
- Explicit "Equivocal" listing when validated evidence is equivocal.
- Process for public identification and notification of potential conflicts of interest of the compendia's parent and sibling organizations, reviewers, and committee members, with an established procedure to manage recognized conflicts.
CMS plans to use these desirable characteristics as framework and guidance in the compendia review process. However, CMS recognizes that individual compendia may incorporate these characteristics differently.
Please see the Compendia Request Review Process below. Submit requests to email@example.com.
Compendium Update: Thomson Reuters has legally changed its name to Truven Health Analytics as of June 6, 2012. Truven Health Analytics made CMS aware of this change and has attested that it has not made any changes to its editorial, conflict of interest or transparency processes. Therefore, CMS continues to recognize Micromedex® DrugDex® as an authoritative source for use in the determination of a "medically-accepted indication" of drugs and biologicals used off-label in an anticancer chemotherapeutic regimen.
Compendia Request Review Process (PDF)
Compendia Preamble - § 414.930 Pages 66303-66306. Vol.72 FR (PDF)
Compendia Regulation Text – § 414.930 Page 66404 of the FR (PDF)
Revised Compendia Preamble - § 414.930 Pages 61901 - 61904. Vol.74 FR (PDF)
Revised Compendia Regulation Text - § 414.930 Pages 62013 - 62014. Vol.74 FR (PDF)
Chapter 15 – Covered Medical and Other Health Services (PDF)