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USP Issues Statement on Model Guidelines

Rockville, Md., Jan. 3, 2005 — On December 31, 2004, the United States Pharmacopeia (USP) submitted its Medicare Prescription Drug Benefit Model Guidelines (Model Guidelines) to the Centers for Medicare and Medicaid Services (CMS). This document fulfills a cooperative agreement between USP and CMS entered into under the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). The MMA specifically named USP as the organization charged with developing a list of categories and classes that may be used by plans offering the Medicare drug benefit to develop their formularies. USP was chosen for this role based on its long-standing position as an independent, private, not-for profit standards-setting organization with recognized credibility and authority.

USP Model Guidelines
The Model Guidelines consist of a listing of therapeutic categories (first column of the Model Guidelines) and associated pharmacologic classes (second column of the Model Guidelines) that create a framework that plans offering the Medicare drug benefit may follow as they create a drug plan formulary. The Model Guidelines are not intended to serve as a formulary nor as a therapeutic guideline, but to provide a non-discriminatory classification system for the structure of a plan’s formulary.

The Model Guidelines represent the only classification system specifically developed for the Medicare Prescription Drug Benefit. The Model Guidelines were developed by USP’s Model Guidelines Expert Committee (MGEC), a committee drawn from USP’s Council of Experts and consisting of scientists and professionals in medicine, pharmacy, the pharmaceutical sciences, and other health care sectors. In creating the guidelines, the MGEC sought input from numerous sources, including an environmental scan, four Advisory Forums, USP’s standing information Expert Committees, public comments, and other sources of information. The Model Guidelines fulfill Congressional intent by creating a science-based standard that recognizes the needs of practitioners and patients for comprehensive pharmaceutical care while providing a useful framework for plans.

While plans are not required by law to use the Model Guidelines, the use of a single standardized structure will facilitate the implementation of the Part D benefit and will help make the benefit consistent and clear to all constituencies.

Recognizing that the Model Guidelines are dynamic, and as required by the MMA, USP will review the therapeutic categories and pharmacologic classes on a regular basis to accommodate changes in therapeutic uses of covered drugs and approvals of new Part D drugs.

USP List of Formulary Key Drug Types
While the Model Guidelines are an important tool that will help plans and CMS in the implementation of the Medicare drug benefit, the MGEC recognized that the formulary classification system is only the first step of a comprehensive formulary review process by CMS. Thus, in addition to establishing the categories and classes of the Model Guidelines, the MGEC also created a separate listing of formulary key drug types to assist CMS in this formulary review process.

The purpose of this listing is to provide additional guidance to CMS regarding drug types that the Expert Committee believes CMS should look for in plans’ formularies. By checking a plan’s formulary for at least one item in each of the formulary key drug types – and requesting justification if a formulary excludes any of these items – CMS can help ensure that a formulary provides access to needed medications and will not substantially discourage enrollment of eligible beneficiaries. This listing of formulary key drug types was submitted to CMS as part of USP’s comments to the Draft Guidelines - CMS Formulary Review Process issued on December 3, 2004.

Future Collaboration
USP fully supports CMS in its efforts to ensure the successful implementation of the Medicare prescription drug benefit and looks forward to continuing its collaboration with CMS and other key stakeholders to maintain and revise the Model Guidelines.

For more information, the media may send an email to . The Model Guidelines and related documents are posted on USP’s website at

Source: United States Pharmacopeia

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