The Veterans Affairs medication classification system is likely to serve as a starting point for the U.S. Pharmacopeia's development of a model formulary for the Medicare prescription drug benefit.

Under the new Medicare law, USP is charged with developing, in consultation with pharmacy benefit managers and other interested parties, a model list of therapeutic classes and categories that will serve as a "safe harbor" for prescription drug plan formularies (¹ Also see "Medicare Formularies Will Have Two Drugs Per Class; CMS To Track Atypicals" - Pink Sheet, 22 March, 2004., p. 5).

The language is understood to have been included at the suggestion of a congressional staffer who had worked at USP.

USP is the right organization for that role because it "has had a very strong role in history in working on these categories and classes to the benefit of formularies," CEO Roger Williams, MD, said May 12 at an American Health Quality Association conference in Washington, D.C.

For example, "USP, very significantly, actually created a system of categories and classes that is now used by the VA system," Williams said.

USP developed the VA's system of categories and classes in the mid-1980s, Williams noted. The system "has stood the test of time...the VA still uses it, still maintains it and is quite pleased with it."

"So if you want to see one of the archetypal sets of categories and classes, you can look at the back of the" USP Drug Information compendium, Williams said.

The USPDI lists 31 categories with 202 subcategories for the VA medication classification system.

The list includes categories that are unlikely to appear in USP's model guidelines for the Medicare drug benefit, such as investigational agents, vitamins and prosthetics/supplies/devices.

The USP Medicare model list is likely to include a category for compounded drugs.

"We have heard from people who should know that the CMS benefit will include compounded preparations," Williams said. "How we think about that will merit some further discussion."

USP plans to finalize the Medicare model formulary by the end of the year.

"We're working very actively on the draft model guidelines with the expert committee," Williams said. "Our goal is to get this deliverable to CMS by the end of calendar year 2004."

USP has established a "Model Guidelines Expert Committee" that will create the list of categories and classes. Williams is chairing that committee.

The model guidelines committee will seek input from USP's 31 "information committees" to "help develop the information and make sure we're doing it appropriately," Williams said.

"These are the committees that evaluate the content for the USPDI," Williams said. The members represent "a cadre of about 300" volunteers. The information committees handle a wide range of topics, from specific therapeutic areas to "safe medical use."

The model guidelines committee is in the process of forming "advisory panels" that will "provide additional expertise that didn't already exist within" the committee.

"We very carefully picked them to represent key constituencies who care about this," such as "drug plans, beneficiaries, pharmaceutical manufacturers and providers," Williams said.

USP plans to hold public meetings about its draft model guidelines.

"We'll announce that very carefully so that you're all aware of it, but we're not quite there yet because we're working on our agreement with CMS, " Williams said.

The Centers for Medicare & Medicaid Services is in the process of developing its draft implementing regulations for the Medicare drug benefit. The regs are expected to be published in June (see ² Also see "Medicare Part D Regs Coming Soon; CMS Plans To Finalize Regions In 2004" - Pink Sheet, 17 May, 2004. ).

USP To Finalize Medicare Rx Model Formulary In 2004; VA System As Guide?

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