USP Medicare Model Guidelines v7.0

Status Updates

Public Comment Period is now closed.

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 Healthcare Quality Expert Committee

USP’s volunteer Healthcare Quality Expert Committee—comprised of pharmacologists, clinical pharmacists and other health care practitioners, academicians, formulary specialists, providers, beneficiaries, drug information experts, and healthcare policy experts—are responsible for activities related to revising USP’s Medicare Model Guidelines, including developing drafts, reviewing public comments, and finalizing the submission to the Centers for Medicare and Medicaid Services (CMS). 
The Expert Committee will utilize its processes to evaluate and update the USP Categories and Classes as necessary 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 Medicare Modernization Act. 
Expert Committee members serve USP as individual experts, and do not serve any outside interest.

Development Roles

USP’s Role

  • Systematically review all FDA actions and biologic approvals between December 31, 2013, and December 31, 2016. 
  • Review drug information that is authoritative, credible, and unbiased to supplement Expert Committee knowledge

Expert Committee’s Role

  • Consider covered Part D drugs as defined in 42 CFR 423.100, assessing new Part D drugs and changes in therapeutic use.
  • Utilize the Guiding Principles which have been established through the previous Model Guideline revisions.


Updates to the timeline will be posted once a new cycle is established.

How to Engage

Revision process is currently on a three-year cycle, and anticipated to begin in 2019. 

Check back to website for updates, or sign up for Healthcare Quality Updates.

[1] §1860D-4(b)(3)(C)(ii)
(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