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

(updated 16–May–2013)

Version 5.0 of the Model Guidelines were developed by the USP Model Guidelines Expert Panel and approved by the Nomenclature, Safety and Labeling Expert Committee in January 2011.

Medicare Model Guidelines v6.0

(posted 16–May–2013)

In March 2013, USP received a request from CMS to conduct a clinically-based review of Part D drugs approved since Version 5.0, and to update the USP Categories and Classes to accommodate changes in therapeutic uses and the additions of new Part D drugs (as specified in §1860D-4(b)(3)(C)(ii) of the Social Security Act ). USP has formed the Therapeutic Information and Formulary Support Expert Committee to develop the USP Medicare Model Guidelines v6.0 during the summer and fall of 2013.

Additional Information

  • Questions about the USP Medicare Model Guidelines may be directed to Dr. Jami S. Earnest (modelguidelines@usp.org).
  • Media inquires about the USP Medicare Model Guidelines should be directed to mediarelations@usp.org.
  • Questions regarding CMS' use of the Model Guidelines in its forumlary review process should be directed to CMS.