Date

Press release

STATEMENT OF MARK B. MCCLELLAN M.D. PH.D., ADMINISTRATOR CENTERS FOR MEDICARE & MEDICAID SERVICES, ON US PHARMACOPEIA’S DRAFT

STATEMENT OF MARK B. MCCLELLAN M.D. PH.D., ADMINISTRATOR CENTERS FOR MEDICARE & MEDICAID SERVICES, ON US PHARMACOPEIA’S DRAFT
FORMULARY CLASSIFIATION GUIDELINES FOR THE MEDICARE PART D DRUG BENEFIT

The Centers for Medicare & Medicaid Services welcomes the advance draft model Guidelines from the US Pharmacopeia (USP). We appreciate the hard work that went into this draft, as well as USP’s commitment to getting input from all interested parties as they work to finalize their guidelines. Our goal is to make sure that all beneficiaries will have access to medically necessary drug therapies at the lowest possible cost.

This is an important first step toward clear guidance on how plans can design formularies that appropriately reflect current medical practice for the Medicare Prescription Drug Benefit.

These new guidelines, mandated by the Medicare Modernization Act of 2003 (MMA), are a broad classification system that will serve as a starting point for plans to create their own formularies that give beneficiaries access to medically necessary drug therapies at the lowest possible cost.

These model guidelines will help plans organize their formularies into appropriate, and commonly agreed upon clinical categories. They reflect classification systems already in widespread use, and are a starting point for building comprehensive drug lists.

CMS will be developing explicit standards to review drug plans’ formularies and we will share those draft standards in order to gather public comment and input in the fall. Those standards will require drug plan formularies to provide a reasonable choice of drugs that reflects current medical practice. We will also review individual formularies to make sure that each plan’ s drug benefit is adequate and to prevent any discriminatory practices against beneficiaries suffering from specific types of diseases.

CMS Discussion Paper on USP Draft Model Guidelines (PDF, 49 KB)