Public Opinion Sought on USP Medicare Model Guidelines

Oct 17, 2013

The US Pharmacopeial Convention (USP) posted for public comment on its recommended revisions to the USP Medicare Model Guidelines, a listing of categories and classes of medicines that Medicare Part D plan sponsors can use when developing their Part D formularies. USP is seeking public input to its revisions, which are posted for a 30-day public comment period, that began Oct. 1, 2013.

Under the Medicare Prescription Drug Improvement and Modernization Act of 2003, USP was charged with developing the Medicare Model Guidelines, which are periodically revised by request of the Centers for Medicare & Medicaid Services (CMS). In March 2013, USP received a request from CMS to conduct a clinically based review of Part D drugs approved since version 5.0 and to update the USP Medicare Model Guidelines to accommodate changes in therapeutic uses and the additions of new Part D drugs.

The draft USP Medicare Model Guidelines v6.0 comprises 50 categories and 154 classes, which include nine new class designations. The increased number of classes represents a greater breadth of medicines approved by FDA and potentially covered by Part D plans.

In addition to accepting written public comments via its website, USP will conduct Open Microphone Web Meetings to solicit specific feedback on the content and organization of the draft guidelines from beneficiaries, drug plans, pharmaceutical manufacturers, and providers. These will be held on Oct. 21, 22, 24, and 25.

The USP Therapeutic Information and Formulary Support Expert Committee is responsible for developing and drafting the USP Medicare Model Guidelines v6.0 as well as reviewing input received during the public-comment period. The final USP Medicare Model Guidelines v6.0 will undergo approval in mid-December 2013 and will be presented to CMS in early January 2014.  The USP Medicare Model Guidelines v6.0 will be available for use by prescription drug plans for the plan years 2015-2017.

Source: US Pharmacopeial Convention

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