The U.S. Pharmacopeia's expert committee on Medicare model guidelines will hold a public meeting Aug. 27 in Baltimore to discuss the design of the formulary template for the new outpatient prescription drug benefit.

Parties interested in making a presentation during the meeting should contact USP by Aug. 20. A public comment period will run through September. The meeting will be held at the Wyndham Baltimore Inner Harbor.

The 2003 Medicare Modernization Act directed the Centers for Medicare & Medicaid Services to work with USP to develop a drug classification system (¹ Also see "USP To Finalize Medicare Rx Model Formulary In 2004; VA System As Guide?" - Pink Sheet, 17 May, 2004., p. 15).

The implementing regulations for the Medicare drug benefit will treat the USP classification scheme as a "safe harbor" for formularies. Medicare drug plans could alter the scheme, but CMS will analyze the changes to ensure they are medically appropriate.

In conjunction with CMS' release of the draft regulations July 26, USP announced that it has entered into a cooperative agreement to develop the scheme. The group began its work in May.

The Aug. 27 forum will focus on USP's initial draft of the proposed classification system. USP expects to give CMS an interim report at the beginning of August and is planning to publish the draft guidelines on its website Aug. 17.

Based on feedback from the meeting, USP plans to submit a more fleshed out draft to CMS in November. The goal is to complete work on the model guidelines by the end of the year.

CMS hopes to finalize the Medicare implementing regulations by early 2005, at the latest.

The classification system development effort is being run by a Medicare Guidelines Expert Committee formed by USP.

The committee has already held six of 14 planned meetings as part of the drafting process.

Discussions so far are focusing on how to choose the appropriate level of subdivision for different kinds of drugs (see ² Also see "COX-2s May Be Grouped With NSAIDs In Model Medicare Formulary" - Pink Sheet, 2 August, 2004. ).

The 18-member committee is chaired by USP CEO Roger Williams. In addition to several academics, the panel includes representatives from Pfizer, CaremarkRx and Health Canada (see chart: " ³ The Modelers ").

During the Medicare debate, Pfizer paid particular attention to the formulary rules, arguing that the legislation should ensure that beneficiaries have access to medically necessary prescriptions at the lowest cost-sharing available (⁴ Also see "Medicare Rx Debate Will Define Formularies; Pfizer Takes Aim At Tiers" - Pink Sheet, 2 June, 2003., p. 5).

The implementing regulations for the Part D drug benefit, made available for public comment July 26, include a procedure to allow access to non-formulary drugs through an "exceptions" process (see ⁵ Also see "Formulary Balancing Act: Medicare Rules Weigh Access Versus Cost Control" - Pink Sheet, 2 August, 2004. ).

USP is taking two additional outreach steps to get feedback.

Beginning in mid-August, the committee will hold one-on-one consultations with "leading beneficiary/advocacy, trade, and professional organizations."

USP also created four advisory forums, each chaired by a member of the committee, to provide "access to the expertise and perspectives of key stakeholders" - namely, beneficiaries, drug plans, manufacturers and providers.

The advisory forums held separate meetings in June, and then each met with the expert committee in July. The committee expressed concern that more groups had not responded to invitations to participate in the advisory forums.

The advisory forum of beneficiaries includes AARP, the Consumers Union, the National Business Group on Health, and the National Organization for Rare Disorders.

The Drug Plan Advisory Forum includes the Alliance of Community Health Plans, America's Health Insurance Plans, the Blue Cross/Blue Shield Association, and the Pharmaceutical Care Management Association.

The Pharmaceutical Manufacturer Advisory Forum includes the Pharmaceutical Research & Manufacturers of America, the Biotechnology Industry Organization, the Consumer Healthcare Products Association, the Generic Pharmaceutical Association, and the National Pharmaceutical Council.

Members of the Provider Advisory Forum are the American Academy of Family Physicians, the American College of Physicians, the American Geriatrics Society, the American Nursing Association, and the Joint Commission of Pharmacy Practitioners.

USP Medicare Formulary Design Committee To Host Public Meeting Aug. 27

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