USP Medicare Model Guidelines

Important Updates

  • September 15, 2023 – USP Medicare Model Guidelines v9.0 Intended Publication Date
  • June 1-30, 2023 – Draft of USP Medicare Model Guidelines v9.0 will be posted for Public Comment
  • September 26, 2022 – USP Medicare Model Guidelines v9.0 contract with CMS (Centers for Medicare and Medicaid Services) finalized
  • February 1, 2020 - USP Medicare Model Guidelines v8.0 Published

 

The Centers for Medicare and Medicaid Services (CMS) and the United States Pharmacopeia (USP) entered a Cooperative Agreement (1C0CMS331883-01-00 ) for version 9.0 of the USP Medicare Model Guidelines. This activity commenced on September 30, 2022 and will conclude by September 29, 2023 with USP’s submission to CMS of its deliverables, including Version 9.0 of USP Medicare Model Guidelines (Model Guidelines, MMG).

As stipulated in the law, USP is responsible for revising the 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." Historically, every 3 years, USP publishes an updated version of MMG, which includes a list of categories and classes that may be used by prescription drug plans.

Lastest Version:

On February 1, 2020, USP published v8.0 of the USP MMG which includes consideration of drugs in the US market through November 1, 2019.

The v8.0 of USP MMG includes 7 files that can be downloaded:

  • USP Medicare Model Guidelines v8.0 (Categories and Classes)
  • USP Medicare Model Guidelines v8.0 (With Example Part D Drugs)
  • USP Medicare Model Guidelines v8.0 (Showing changes from v7.0)
  • Final Report and Summary of Methodology and Approach
  • Summary of changes between MMGv7.0 and MMGv8.0
  • USP Medicare Model Guidelines v8.0 (All Excel Spreadsheets)
  • USP Medicare Model Guidelines v8.0 Alignment File

Origins of Development:

In December 2003, the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) was signed into law. The United States Pharmacopeia(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).

Versions of MMG:

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, and 4.0 of the Model Guidelines and related deliverables, similarly developed through a process that included comprehensive reviews 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; Versions 5.0 through 8.0 represent a triennial review process and include consideration of drugs in the US market in v8.0 through November 1, 2019.

USP Medicare Model Guidelines v8.0

(updated 01–Feb–2020)

Versions of MMG Archive:

USP Medicare Model Guidelines v8.0 (updated 01–Feb–2020)

USP Medicare Model Guidelines v7.0

(updated 06–Feb–2017)

Downloadable Files for USP Medicare Model Guidelines v7.0:

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

(updated 04–Feb–2014)

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).

USP Medicare Model Guidelines v5.0

(updated 04–Feb–2014)

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.

Additional Information

  • Questions about the USP Medicare Model Guidelines may be directed to Diana Kwan, PharmD (modelguidelines@usp.org).
  • Media inquiries about the USP Medicare Model Guidelines should be directed to mediarelations@usp.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.