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.

In response to the success and stabilization of recent versions, CMS has requested that the Model Guidelines and Formulary Key Drug Types now be updated on a triennial basis. The current Version 4.0 of the Model Guidelines and Formulary Key Drug Types will be utilized for CMS's formulary review process through the Part D plan year 2011 and will remain available on the USP Web site. We will begin the revision process for the next version in 2010. USP will not be accepting applications for information on new drugs or indications at this time. Please check our Web site for future announcements.

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 through 2011 benefit year (see below for instructions):

Self-Extracting Zip ¹: version4Comments.exe (11.3MB)
Zip File Only ²: version4Comments.zip (11.2MB)

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.