USP has been awarded a cooperative agreement with the Centers for Medicare and Medicaid Services (CMS) to revise the Part D Prescription Drug Benefit Model Guidelines.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) specifically named USP as the organization charged with developing the list of categories and classes, referred to as the Model Guidelines, that may be used by plans offering the Medicare drug benefit to develop their formularies. Under an earlier cooperative agreement with CMS, USP submitted the Model Guidelines to CMS on December 31, 2004. A majority of the formularies submitted to CMS for approval utilized the USP Model Guidelines.

The Act also directs the Secretary of Health and Human Services to request USP to revise the Model Guidelines "from time to time to reflect changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs."

The current cooperative agreement provides that USP will:
1. Revise the Model Guidelines accounting for new Part D drugs and new therapeutic uses of Part D drugs;
2. Consider issues raised by interested parties (i.e., pharmacies, Medicare physicians and other practitioners, provider groups, the managed care industry, the health insurance industry, pharmacy benefit managers, and beneficiary advocacy groups); and
3. Submit a draft and a final report to CMS by January 30, 2006.

USP's Model Guidelines Expert Committee was scheduled at press time to convene on November 1 and 2 to begin the revision process. USP leaders said they were looking forward to continuing their activities related to the maintenance of the Model Guidelines.

USP will publish information regarding the process and the work product on its website as it becomes available.