USP Will Develop Guidelines for Medicare Drug Benefit

Published Online: Friday, October 1, 2004

Acting on a request from the Department of Health and Human Services, the United States Pharmacopeia (USP) has entered into an agreement with the Centers for Medicare and Medicaid Services (CMS) to create "Model Guidelines" for the new Medicare drug benefit program. These guidelines are being developed in response to the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003.

In addition to developing Model Guidelines, the USP's tasks will include conducting public outreach for feedback regarding the guidelines, providing a comprehensive listing of all drugs in each category, and providing a proposed plan for revision of the guidelines as needed.

Pharmacy benefit managers may use the classes and categories developed by the USP and prescription drug plan sponsors as a foundation for designing their formularies under the Medicare drug law. CMS will use the guidelines to help assess plans submitted by insurers. The Model Guidelines, and the assignment of drugs to any class or category, are made only for the purpose of plan design evaluation under Part D of MMA and will not affect any other activity or activities related to the legislation.

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