United States pharmacopeia development of the Medicare model formulary guidelines

Prescription drug formularies are a key element in prescription drug benefit management. The use of formularies can both increase the quality of prescribing and reduce the costs of prescription drug therapy. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 specified that an external agency, the United States Pharmacopeial Convention, Inc. (USP) through the Secretary of the United States Department of Health and Human Services develop model formulary guidelines for prescription drug plans. The model formulary guidelines are to assist individual drug plans in developing formularies that would qualify for participation in the Medicare Part D prescription program. The guidelines were developed through a Model Guidelines Expert Committee assisted by USP staff and following input from patient advocate groups, health care organizations, and pharmaceutical organizations over a period of 8 months (April 2004 to December 2004). The USP Model Formulary Guidelines organize prescription medications into 41 therapeutic categories (32 with associated pharmacologic classes and nine with no associated pharmacologic classes), 137 pharmacologic classes, and 146 unique therapeutic categories and pharmacologic classes.