STATEMENT OF MARK B. MCCLELLAN, M.D., PH.D., ADMINISTRATOR, CENTERS FOR MEDICARE & MEDICAID SERVICES
ON THE MODEL DRUG CATEGORIES AND CLASSES ANNOUNCED BY US PHARMACOPEIA
The Centers for Medicare & Medicaid Services (CMS) commends the US Pharmacopeia (USP), its expert committee, and the many public commenters for their hard work on the USP model guidelines. The model categories and classes are a key approach for meeting one aspect of our comprehensive oversight of the Medicare drug benefit – the determination that a formulary classification system does not discriminate and provides the scope and level of detail necessary to describe a clinically adequate benefit.
Our goal is to make sure that all Medicare beneficiaries will be able to get the prescription drugs they need at the lowest possible cost when the new benefit becomes available next year and USP’s fast work moves us one step closer to that goal.
The model categories and classes issued by USP provides an important option that will be of general use to Medicare prescription drug plans. The model also represents an important element of our comprehensive oversight of the Medicare drug benefit– the determination that a formulary classification system does not discriminate and provides the scope and level of detail necessary to describe a clinically adequate prescription drug benefit.
We have outlined our proposed oversight strategy for the Medicare drug benefit in our recently published draft formulary guidance and our proposed regulation. Our oversight will involve review of pharmacy and therapeutics committee practices, formulary drug lists and benefit management tools, as well as a straightforward and timely exceptions and appeals process. We will soon issue a final regulation and guidance incorporating public comments, including the important contributions from USP.
We will use USP’s work to make sure that beneficiaries will have access to the prescription drugs they need at the most affordable price. With USP’s help, our oversight of the Medicare drug benefit will give all beneficiaries access to Medicare drug coverage that provides the high-quality formularies and benefits that millions of Americans use today to get the drugs they need—including millions of seniors and people with disabilities.
CMS looks forward to a continued dialogue and ongoing relationship with USP as we implement the Medicare Prescription Drug Benefit in January 2006.