USP's GUIDELINES FOR Rx FORMULARIES MAINTAIN CATEGORIES, CLASSES
The U.S. Pharmacopeia's (USP) final model guidelines for Medicare drug formularies maintain the same number of categories and classes as the earlier draft guidelines -- a move that rebuffs calls by the pharmaceutical industry to give the plan a comprehensive revision.
The USP guidelines call for 146 therapeutic categories and classes, which must contain at least two drugs each. The final model guidelines, however, scrap the draft's recommended 235 subcategories, which would have required at least one drug each.
Instead, the final model guidelines now include a separate listing of "formulary key drug types," which USP says aims to assist the Centers for Medicare & Medicaid Services (CMS) in the formulary review process. "The purpose of this listing is to provide additional guidance to CMS regarding drug types that the [USP] Expert Committee believed CMS should look for in the plans' formularies," according to the guidelines.
The USP model guidelines will help Medicare prescription drug plan sponsors develop formularies for the $534 billion Medicare Modernization Act. The model provides a "safe harbor" -- meaning that if a drug plan uses the model, it would avoid some regulatory review of its formulary's categories and classes.
CMS is scheduled to issue final regulations on the Medicare bill by mid-January, including guidance on the final formulary guidelines. For more information, and to view the Medicare Prescription Drug Benefit Model Guidelines, go to http://www.usp.org/drugInformation/mmg/ (http://www.usp.org/drugInformation/mmg/).