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.
The responsibility for implementing this provision of MMA rests with the Centers for Medicare and Medicaid Services (CMS). CMS and USP entered into a Cooperative Agreement (18-C-92305/3-01) for the initial development of the Model Guidelines. This activity commenced on May 1, 2004 and concluded on December 31, 2004 with USP’s submission to CMS of its deliverables, including Version 1.0 of the USP Medicare Model Guidelines (Model Guidelines).
As stipulated in the law, USP is also responsible for revising the USP Medicare Model Guidelines on a continuous basis, based on “changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs.” Thus, in subsequent years USP and CMS entered into annual Cooperative Agreements that resulted in Versions 2.0, 3.0, 4.0 and 5.0 of the Model Guidelines and related deliverables, similarly developed through a process that included comprehensive review of available information and evidence, public outreach and input, and deliberation and approval by the USP Council of Experts. Versions 2.0, 3.0, and 4.0 were part of a continuous revision process; Version 5.0 and 6.0 represent a triennial review process and included consideration of drugs in the US market in v6.0 through December 31, 2013.
Through written correspondence dated February 29, 2016, CMS has requested USP to engage in the revision process to update the Model Guidelines to Version 7.0, in order to address the current needs of the Medicare Part D beneficiaries.
USP Medicare Model Guidelines v7.0
Downloadable Files for USP Medicare Model Guidelines v7.0:
- USP Medicare Model Guidelines v7.0 (Categories and Classes)
- USP Medicare Model Guidelines v7.0 (With Example Part D Drugs)
- USP Medicare Model Guidelines v7.0 (Showing changes from v6.0)
- Final Report and Summary of Methodology and Approach
- Summary of changes between MMGv6.0 and MMGv7.0
- USP Medicare Model Guidelines v7.0 (All Excel Spreadsheets)
- Please complete the form to download the USP Medicare Model Guidelines v7.0 Alignment File. This information is needed to inform you of any changes to the alignment file.
The USP MMG v7.0, MMG-FRF Alignment File maps the USP MMG v7.0 to the CMS CY16 Formulary Reference File (FRF) (v09.26.16), a list of potentially eligible Part D drugs published by CMS.
USP Medicare Model Guidelines v6.0
USP Therapeutic Information and Formulary Support Expert Committee (TIFS EC) has developed the USP Medicare Model Guidelines v6.0, available for use by Part D plans for benefit years 2015–2017. TIFS EC conducted a clinically-based review of Part D drugs approved since Version 5.0, and updated 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).
- Access and Download USP Medicare Model Guidelines v6.0 (2014)
- Information about the USP Medicare Model Guidelines v6.0
USP Medicare Model Guidelines v5.0
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.
- Questions about the USP Medicare Model Guidelines may be directed to Donna Bohanon, RPh., CPPS (email@example.com).
- Media inquiries about the USP Medicare Model Guidelines should be directed to firstname.lastname@example.org.
- Questions regarding CMS' use of the Model Guidelines or the CMS formulary review process should be directed to the Medicare Drug Benefit Group, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244.