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8/20/2004

USP Releases Model Formulary for Medicare Part D

Kate Traynor

The United States Pharmacopeia (USP) yesterday released its draft model formulary guidelines (PDF) for the 2006 Medicare Part D outpatient drug benefit.

According to USP, the guidelines identify 43 major categories and 138 classes of drugs used to treat conditions described in the ninth revision of the International Classification of Diseases, or ICD-9. USP noted that its guidelines do not constitute a formulary but are instead "a first step in helping plans develop their formulary structures."

The classification scheme differs from that used for the Medicare-approved drug discount card program, which began this year and will expire when the Part D drug benefit begins. Discount card sponsors' formularies include 209 therapeutic categories that represent drugs most commonly used by Medicare beneficiaries.

USP's role in the creation of the guidelines was specified in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which was signed into law in December 2003. The legislation required that USP be asked to work with pharmacy benefit managers and other stakeholders to create "a list of categories and classes that may be used by prescription drug plans."

Although adherence to the formulary guidelines is voluntary, Centers for Medicare and Medicaid Services (CMS) Administrator Mark B. McClellan said in a statement that his agency's goal is "to make sure that all beneficiaries will have access to medically necessary drug therapies at the lowest possible cost."

The Pharmaceutical Research and Manufacturers of America (PhRMA) released a statement dated Aug. 18 claiming that USP's document "fails to provide patients with critical medicine options."

PhRMA's concern is that USP's classification scheme groups together "commonly prescribed types of medicines with outmoded forms of treatment." In other words, drug plan sponsors might be able to limit their formularies to older drugs in a given pharmacologic class, excluding newer treatment options.

For example, USP's therapeutic category "Blood Glucose Regulating Agents" contains the pharmacologic class of oral hypoglycemic agents. USP subdivided that class into five groups—alpha glucosidase inhibitors, meglitinides, biguanides, sulfonylureas, and thiazolidinediones—apparently leaving drug plan sponsors the option of picking some of these drug groups and excluding others.

MMA requires that Medicare beneficiaries have access to more than one drug in each therapeutic category and class in a plan sponsor's formulary.

ASHP will comment on the model formulary next Friday in Baltimore during an open public hearing on the model guidelines. Written public comments on the document can be sent to USP through Sept. 17. USP said it plans to release a final version of the model formulary in December.