USP Will Develop Guidelines for Medicare Drug Benefit

Acting on a request from theDepartment of Health and Human Services,the United States Pharmacopeia(USP) has entered into an agreementwith the Centers for Medicare andMedicaid Services (CMS) to create"Model Guidelines" for the new Medicaredrug benefit program. Theseguidelines are being developed inresponse to the Medicare PrescriptionDrug, Improvement, and ModernizationAct (MMA) of 2003.

In addition to developing ModelGuidelines, the USP's tasks will includeconducting public outreach for feedbackregarding the guidelines, providinga comprehensive listing of all drugsin each category, and providing a proposedplan for revision of the guidelinesas needed.

Pharmacy benefit managers mayuse the classes and categories developedby the USP and prescription drugplan sponsors as a foundation fordesigning their formularies under theMedicare drug law. CMS will use theguidelines to help assess plans submittedby insurers. The Model Guidelines,and the assignment of drugs to anyclass or category, are made only for thepurpose of plan design evaluationunder Part D of MMA and will notaffect any other activity or activitiesrelated to the legislation.