We did not in regulation assign relative weights to these characteristics. 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. Publicly transparent process for evaluating therapies.ħ.Ğxplicit "Not recommended" listing when validated evidence is appropriate.Ĩ.Ğxplicit listing and recommendations regarding therapies, including sequential use or combination in relation to other therapies.ĩ.Ğxplicit "Equivocal" listing when validated evidence is equivocal.ġ0. Use of prescribed published process for making recommendations.Ħ. Use of pre-specified published criteria for weighing evidence.ĥ. Quick processing from application for inclusion to listing.ģ.ĝetailed description of the evidence reviewed for every individual listing.Ĥ. As a result of this meeting, the MEDCAC generated the following list of desirable characteristics:Ģ. ![]() The goal of this session was 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. The list of desirable compendium characteristics was developed by the MEDCAC during a public session on March 30, 2006. In addition, CMS increased the transparency of the process by incorporating a list of desirable compendium characteristics outlined by the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) as criteria for decision-making. Under 42 C.F.R.§ 414.930(a), a compendium is defined "as a comprehensive listing of FDA-approved drugs and biologicals or a comprehensive listing of a specific subset of drugs and biologicals in a specialty compendium, for example, a compendium of anti-cancer treatment." A compendium: (1) includes a summary of the pharmacologic characteristics of each drug or biological and may include information on dosage, as well as recommended or endorsed uses in specific diseases (2) is indexed by drug or biological. In the Physician Fee Schedule final rule for calendar year 2008, CMS established a process for revising the list of compendia, as authorized under section 1861(t)(2) of the Act, and also established a definition for "compendium." See 72 Fed. Consequently, CMS received requests from the stakeholder community for a process to revise the list of compendia. ![]() Law 109-171, recognized three compendia: American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication 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, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia.ĭue to changes in the pharmaceutical reference industry, fewer of these statutorily-named compendia are available for our reference (e.g., the AMA- DE and the USP-DI are no longer published). Section 1861(t)(2)(B)(ii)(I) of the Social Security Act (the Act), as amended by Section 6001 (f)(1) of the Deficit Reduction Act of 2005, Pub. ![]() Indication for the off-label uses of drugs and biologicals in an anticancer chemotherapeutic regimen Subject: Wolters Kluwer Lexi-Drugs® - Request for addition to the list of compendia for the identification of a medically accepted Lead Medical Officer(s): James Rollins, MD, MSHA, PhDĭeputy Director, Coverage and Analysis Group Lead Analyst(s) Cheryl Gilbreath, PharmD, MBA, RPh Requestor Name(s): Wolters Kluwer Clinical Drug Informationįormal Request Accepted and Review Initiated: April 21, 2015Įxpected Completion Date: August 19, 2015 The Social Security Act Section 1861(t)(2)(B)(ii)(I) recognizes the following compendia: American Hospital Formulary Service-Drug Information (AHFS-DI), Truven Health Analytics Micromedex DrugDEX (DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, and Elsevier/Gold Standard Clinical Pharmacology for use in the determination of medically-accepted indications of drugs/biologicals used off-label in anti-cancer chemotherapeutic regimens.ĬMS received a timely complete request for the addition of the Wolters Kluwer Clinical Drug Information Lexi-Drugs database to the list of compendia for use in the determination of medically-accepted indications of drugs/biologicals used off-label in anti-cancer chemotherapeutic regimens.
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