Medicare Model Guidelines

Model Guidelines Revisions

USP is working with the Centers for Medicare and Medicaid Services (CMS) to support the maintenance and revision of the Model Guidelines. See Version 4.0 of the Medicare Model Guidelines and the process used for revision.

Any and all interested parties are invited to propose revisions to the Medicare Model Guidelines and Formulary Key Drug Types for consideration by USP's Information Expert Committees of the Council of Experts and the Model Guidelines Expert Committee. There are two methods by which proposed revisions may be submitted. The first method is by way of an on-going review process. USP will accept information regarding new drugs or new therapeutic uses of drugs, the therapeutic categories or pharmacologic classes of the Model Guidelines, and Formulary Key Drug Types (FKDTs) throughout the year. To support the receipt of the most relevant information for committee review and to standardize the format of information received, it is preferred that submissions be accompanied by an application (download the application  (59KB)). Applications should be accompanied by documentation supportive of proposed revisions. The submission of information via application is strictly voluntary, is not required by CMS, and will not change the evaluative process by which the therapeutic categories and pharmacologic classes of the Model Guidelines or the FKDTs are determined.

The second method of proposing revisions is by way of a formal period of public comment on a draft of the Model Guidelines. During the public comment period, USP accepts comments on draft versions of the Model Guidelines and FKDTs. Comments received will be considered by the Information and Model Guidelines Expert Committees before release of the final documents to CMS.

Applications and information relative to Model Guidelines Version 5.0 are now being accepted.

  • Submit your applications and/or proposed revisions by email to (attachments are permitted).
  • Submit your applications and/or proposed revisions by letter to:
    United States Pharmacopeia
    Model Guidelines Submissions
    Department of Information Development
    12601 Twinbrook Parkway
    Rockville, MD 20852

Public Comments

USP solicited and received comments from advocacy groups, healthcare practitioners and providers, managed care organizations, pharmacy benefit managers, prescription drug manufacturers, prescription drug plans, trade and professional associations, and other interested parties in the process of developing and revising the Medicare Model Guidelines. These comments, organized and alphabetized by the name of the submitting organization, are available through the link below. All comments received on the drafts of the Model Guidelines and FKDTs during the public comment period have been made available for public viewing unless a specific request was made to keep the comments confidential.

USP and the Model Guidelines Expert Committee thank everyone who submitted comments.

Comments to Model Guidelines Version 4.0 for the 2009 benefit year (see below for instructions):

Summary of Public Comments  (102KB)

Instructions:
Self-Extracting Zip 1

  • When you select the link to the file, you should be prompted by your browser to save the file.
  • Choose a directory in which to save the .EXE file and note the location.
  • Use your file management program to locate the .EXE file. Double click to automatically un-zip or decompress the file and it will open the Public Comments table of contents in your browser.

Zip File Only 2

  • When you select the link to the file, you should be prompted by your browser to save the file.
  • Choose a directory in which to save the .ZIP file and note the location.
  • Use the program of your choice to un-zip or decompress the .ZIP file.
  • After you have un-zipped the file, double click the index file, indexAI.html for example, to open the Public Comments table of contents in your browser.