USP 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.

The responsibility for implementing this provision of MMA rests with the Centers for Medicare & Medicaid Services (CMS). CMS and USP entered into a Cooperative Agreement for the initial development of the USP Model Guidelines on May 1, 2004, which concluded on December 31, 2004, with USP’s submission to CMS of its deliverables, including Version 1.0 of the USP Medicare Model Guidelines.

The Healthcare Safety and Quality Expert Committee retains the goal of the original Model Guidelines Expert Committee (2004)—to strike a balance of assuring beneficiary access to the safe and effective drugs that they need with the flexibility that Part D sponsors need to offer an affordable and effective benefit.

• Through the lens of equity and diversity, when appropriate, the USP Medicare Model Guidelines will consider issues such as genomic status, medical conditions, race, ethnicity, disability, sexual orientation, or gender identity in drug classification.
• The USP Medicare Model Guidelines utilize pharmacotherapeutic evidence within the context of FDA approved indications to create categories and classes.
• The USP Medicare Model Guidelines are composed of two organizational levels—USP Categories and USP Classes—which characterize the statutory requirement for Medicare Part D plan benefit design to include drugs from each category and class.

USP Categories and USP Classes are defined as follows:

• A USP Category is the broadest classification of the USP Medicare Model Guidelines and provides a high-level formulary structure designed to include all potential therapeutic agents for diseases and conditions of Part D beneficiaries.
• A USP Class is a more granular classification, occurring within a specific USP Category in the USP Model Guidelines, which provides for therapeutic or pharmacologic groupings of FDA approved medications, consistent with current U.S. healthcare practices and standards of care.

USP Medicare Model Guidelines v9.0 includes a list of associated drug examples that aligns with the Part D drugs reflected on the CMS Formulary Reference File (FRF).

• Generally, a drug in the associated list may appear in more than one USP Category or USP Class if there is a scientifically valid and clinically meaningful patient care issue.
• Combination drugs, and specific dosage forms/formulations/delivery systems, are generally not listed but may be included in the associated list if there is a scientifically valid and clinically meaningful patient care issue.

USP will advise CMS on issues it discovers during the revision process that are relevant to implementing the USP Medicare Model Guidelines.

Versions of MMG Archive:

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, 5.0, 6.0, 7.0, 8.0 and 9.0 of the USP Medicare 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 represented the first of a triennial review process and included consideration of drugs in the US market through December 31, 2010.

On September 29th, 2023, USP published v9.0 of the USP Medicare Model Guidelines which includes consideration of drugs in the US Market from November 1, 2019 through June 30, 2023.

• Download USP Medicare Model Guidelines v9.0 files

The v9.0 of USP MMG includes 7 files that can be downloaded

• USP Medicare Model Guidelines v9.0 (Categories and Classes)
• USP Medicare Model Guidelines v9.0 (With Example Part D Drugs)
• USP Medicare Model Guidelines v9.0 (Showing changes from v8.0)
• Summary of changes between MMGv8.0 and MMGv9.0
• USP Medicare Model Guidelines v9.0 (All Excel Spreadsheets)
• USP Medicare Model Guidelines v9.0 Alignment File
• Final Report and Summary of Methodology and Approach (New)

On February 1, 2020, USP published v8.0 of the USP Medicare Model Guidelines which includes consideration of drugs in the US market from January 2, 2017 through November 1, 2019.

• Download USP Medicare Model Guidelines v8.0 files

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

(updated 06–Feb–2017)

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.

(updated 04-Feb-2014)

USP Medicare Model Guidelines v6.0

The Medicare Modernization Act designates USP to develop the Medicare Model Guidelines and "to revise such classification from time to time to reflect changes in therapeutic uses of covered part D drugs and additions of new covered part D drugs." The links below provide access to v6.0 USP Medicare Model Guidelines (in PDF and Excel formats) along with information about USP's approach to the revision process. The Expert Committee uses a set of Guiding Principles in their consideration of new drugs and new therapeutic. These are fundamental in maintaining the consistency of the Model Guidelines throughout the revision process.

USP Therapeutic Information and Formulary Support Expert Committee (TIFS EC)

In accordance with the USP Rules and Procedures of the 2010–2015 Council of Experts, the Therapeutic Information and Formulary Support Expert Committee (TIFS EC) deliberate and create scientific standards for a wide agenda of healthcare practitioner issues. The TIFS EC is responsible for activities related to the revision of the USP Medicare Model Guidelines and other formulary standards.

The members of the TIFS EC comprise a range of expertise, including pharmacologists, clinical pharmacists, other health care practitioners, academicians, formulary specialists, providers, beneficiaries, drug information experts, healthcare policy experts, and others. According to Section 2 of the USP Rules and Procedures, TIFS EC members serve USP as individual experts, and do not serve any outside interest. TIFS EC members shall adhere to the Code of Ethics, Conflict of Interest, Disclosure and Confidentiality provisions set forth in USP Rules and Procedures.

Development of the USP Medicare Model Guidelines v6.0

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 & Medicaid Services (CMS). CMS and USP entered into a Cooperative Agreement (18-C-92305/3-01) for the initial development of the USP 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.

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, 5.0, and 6.0 of the USP Medicare 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 represented the first of a triennial review process and included consideration of drugs in the US market through December 31, 2010.

During 2013, the USP TIFS EC revised the USP Medicare Model Guidelines v6.0, focusing specifically on the needs of the Medicare population and the Part D utilization of the USP Medicare Model Guidelines. The USP Medicare Model Guidelines v6.0 are currently available for public use and may be found here.

Guiding Principles: USP Medicare Model Guidelines v6.0

• The Therapeutic Information and Formulary Support Expert Committee retains the goal of the original Model Guidelines Expert Committee (2004)—to strike a balance of assuring beneficiary access to the safe and effective drugs that they need with the flexibility that Part D sponsors need to offer an affordable and effective benefit.
• The USP Medicare Model Guidelines utilize pharmacotherapeutic evidence within the context of FDA approved indications to create categories and classes. The USP Medicare Model Guidelines are composed of two organizational levels—USP Categories and USP Classes—which characterize the statutory requirement for Medicare Part D plan benefit design to include drugs from each category and class.1,2
• USP Categories and USP Classes are defined as follows:
  • A USP Category is the broadest classification of the USP Medicare Model Guidelines, and provides a high level formulary structure designed to include all potential therapeutic agents for diseases and conditions of Part D beneficiaries.
  • A USP Class is a more granular classification, occurring within a specific USP Category in the USP Model Guidelines, which provides for therapeutic or pharmacologic groupings of FDA approved medications, consistent with current U.S. healthcare practices and standards of care.
• USP Medicare Model Guidelines v6.0 includes a list of associated drug examples that aligns with the Part D drugs reflected on the Centers for Medicare & Medicaid Services (CMS) Formulary Reference File (FRF).
  • Generally, a drug in the associated list may appear in more than one USP Category or USP Class if there is a scientifically valid and clinically meaningful patient care issue.
  • Combination drugs, and specific dosage forms/formulations/delivery systems, are generally not listed but may be included in the associated list if there is a scientifically valid and clinically meaningful patient care issue.
• USP will advise CMS on issues it discovers during the revision process that are relevant to implementing the USP Medicare Model Guidelines. USP Medicare Model Guidelines v6.0 (2014)-updated 04/21/2014

USP Medicare Model Guidelines v6.0 (2014)-updated 04/21/2014

Erratum: After the publication of the USP Medicare Model Guidelines v6.0 to the USP website on 2/4/2014, USP became aware of an erratum. According to USP Standard Operating Procedures "An Erratum/Errata is content erroneously published in a USP compendia that does not accurately reflect the intended requirements of a standard as approved by the responsible Expert Committee."

In this case, a transcription error misplaced the combination product of Efavirenz/ Emtricitabine/ Tenofovir (Atripla). The will and intent of the Expert Committee was to classify Atripla in the USP Category Antivirals, USP Class Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI). The materials below have been corrected to reflect this intent as of 4/21/2014.

Applicable to Medicare Part D formularies designed for benefit years 2015 through 2017:

• USP Medicare Model Guidelines v6.0 (Categories and Classes)—PDF
• USP Medicare Model Guidelines v6.0 (With Example Part D Drugs)—PDF
• USP Medicare Model Guidelines v6.0 (Showing changes from v5.0)—PDF
• Final Report and Summary of Methodology and Approach—PDF
• USP Medicare Model Guidelines v6.0 (All Excel Spreadsheets)—Excel
• USP Medicare Model Guidelines—CMS CY14 Formulary Reference File (FRF) Alignment—Excel

(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.

Applicable to Medicare Part D formularies designed for benefit years 2012 through 2014:

• USP Model Guidelines v5.0 (With Example Part D Drugs)—Excel

• Questions about the USP Medicare Model Guidelines may be directed to 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.

^{[1] §1860D-4(b)(3)(C)(ii)
(C) INCLUSION OF DRUGS IN ALL THERAPEUTIC CATEGORIES AND CLASSES.—
(i) IN GENERAL.—Subject to subparagraph (G), the formulary must include drugs within each therapeutic category and class of covered part D drugs, although not necessarily all drugs within such categories and classes.
(ii) 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.
[2]42 CFR 423.100
Part D drug definition:
(1) Unless excluded under paragraph (2) of this definition, any of the following if used for a medically accepted indication (as defined in section 1860D–2(e)(4) of the Act)—
(i) A drug that may be dispensed only upon a prescription and that is described in sections 1927(k)(2)(A)(i) through (iii) of the Act.
(ii) A biological product described in sections 1927(k)(2)(B)(i) through (iii) of the Act.
(iii) Insulin described in section 1927(k)(2)(C) of the Act
(iv) Medical supplies associated with the injection of insulin, including syringes, needles, alcohol swabs, and gauze.
(v) A vaccine licensed under section 351 of the Public Health Service Act and for vaccine administration on or after January 1, 2008, its administration.
(vi) Supplies that are directly associated with delivering insulin into the body, such as an inhalation chamber used to deliver the insulin through inhalation.
(2) Does not include—
(i) Drugs for which payment as so prescribed and dispensed or administered to an individual is available for that individual under Part A or Part B (even though a deductible may apply, or even though the individual is eligible for coverage under Part A or Part B but has declined to enroll in Part A or Part B); and
(ii) Drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under Medicaid under sections 1927(d)(2) or (d)(3) of the Act, except for smoking cessation agents [2]}