USP announces revision schedule for Model Guidelines Version 5.0

USP begins revision process for model guidelines that define classes and categories of medicines for Medicare Part D formularies

As the Medicare Model Guidelines-a listing of therapeutic categories and pharmacologic classes that Medicare Part D plans can utilize when developing their formularies-undergo revision for the first time in three years, the U.S. Pharmacopeial Convention (USP) is announcing its revision schedule and the expanded opportunities for public input as it develops Version 5.0.

Medicare Model Guidelines Version 5.0 will be available for utilization by prescription drug plans for the plan years 2012�. USP, a nonprofit scientific organization that sets federally recognized standards for the quality of medicines, was charged with developing the guidelines for the Centers for Medicare and Medicaid Services (CMS) under the Medicare Prescription Drug Improvement and Modernization Act of 2003.

USP has maintained a public comment process and one-on-one manufacturer consultations for developing the USP Model Guidelines since the beginning of this activity in 2004. In this revision cycle, USP is initiating new public Open Microphone Web meetings to solicit specific feedback on the content and organization of the USP Model Guidelines (to be held November 4, 8, 11 and 16, 2010). The one-on-one manufacturer consultations will be held October 4󈝿, 2010, and are an opportunity for manufacturers to schedule 30-minute scientific and clinical presentations with USP scientific staff to present information related to their medicines. Information related to these activities can be found on www.usp.org, under "Model Guidelines."

The Medicare Model Guidelines, which were initially released annually, will be developed by the USP Model Guidelines Expert Panel consisting of clinical pharmacists and pharmacologists, formulary specialists, health care practitioners and academicians, providers, beneficiaries and other volunteer experts. The panel will deliberate on the categories and classes to be included in Version 5.0 to be used as a resource by drug plans, reviewing current scientific evidence related to newly approved drugs and indications.

The Expert Panel will release the draft USP Model Guidelines Version 5.0 for public comment through the USP Web site (www.usp.org) on November 1, 2010, commencing a 30-day public comment period closing November 30, 2010. The draft USP Model Guidelines Version 5.0 will be presented to USP's Nomenclature, Safety and Labeling Expert Committee, the Expert Committee to which the Expert Panel reports, for approval in mid-January 2011. The final USP Medicare Model Guidelines Version 5.0 will be presented to CMS in late January 2011, and posted on the USP Web site in early February 2011.