Medicare Model Guidelines

Medicare Model Guidelines

In December 2003, the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) was signed into law. The United States Pharmacopeial Convention (USP) is named in Section 1860D–4(b) (3) (C) (ii) of the Act, which states:

    MODEL GUIDELINES—The Secretary shall request the United States Pharmacopeia to develop, in consultation with pharmaceutical benefit managers and other interested parties, a list of categories and classes that may be used by prescription drug plans under this paragraph and to revise such classification from time to time to reflect changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs.

In accordance with this provision, USP developed Versions 1.0–5.0 of the Model Guidelines in 2005, 2006, 2007, and 2010 respectively and submitted these versions to the Centers for Medicare and Medicaid Services (CMS) for the benefit years of 2006, 2007, 2008, 2009, and 2012.

Medicare Model Guidelines v5.0

(posted 15–Apr–2011)

USP received approval from CMS to post Version 5.0 of the Model Guidelines (March 2011), which were developed by the USP Model Guidelines Expert Panel and approved by the Nomenclature, Safety and Labeling Expert Committee in January 2011. At CMS' request, USP has retained Version 4.0 of the Model Guidelines for plans who wish to use this version. According to CMS, "...Part D sponsors utilizing the Model Guidelines are permitted to submit their formulary based on either version 4.0 or 5.0. However, CMS will be utilizing version 4.0 in the CY 2012 formulary review process."

Questions about Version 5.0 may be directed to Dr. Jami S. Earnest at USP. Media inquiries about Version 5.0 should be directed to mediarelations@usp.org. Questions regarding CMS’ use of the Model Guidelines in its formulary review process should be directed to CMS.

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