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 and v5.0 of the 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.
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
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
USP Medicare Model Guidelines v5.0 (2011)
Applicable to Medicare Part D formularies designed for benefit years 2012 through 2014:
For more information, contact Jami S. Earnest, Pharm.D., at ModelGuidelines@usp.org.