Proposed Drug Guidelines Get Negative APA Review

APA added its voice to a wide-ranging chorus of dissatisfaction at a public hearing last month on the proposed framework of drug categories and classes to be covered by the new Medicare Part D prescription drug benefit that starts in 2006. The framework, said APA and others, is wholly inadequate to address the diverse clinical needs of a heterogeneous patient population, such as those with mental illness.

The proposed framework of categories and classes, referred to as the Model Guidelines, was developed by the United States Pharmacopeia (USP). The USP was contracted by the Centers for Medicare and Medicaid Services (CMS) to produce a list of categories and classes that must be covered by any private prescription drug plan (PDP) or Medicare Advantage plan seeking to participate in Medicare Part D (Psychiatric News, December 19, 2003).

Under the Medicare Prescription Drug Improvement and Modernization Act (MMA), signed into law by President Bush last December, any drug plan participating in Medicare Part D would be required to cover at least two medications “within each therapeutic category and class of covered Part D drugs, although not necessarily all drugs within such classes.”

In accord with the MMA, CMS noted two key objectives regarding the therapeutic categories and classes: to prevent undue discouragement of enrollment by intended beneficiaries and to prevent discriminatory formulary practices by drug plans.

“Our preliminary evaluation is straightforward,” Steven Daviss, M.D., president of the Maryland Psychiatric Society, testified on behalf of APA. “The USP draft categories and classes compress the available pharmacologic agents in a manner that is inconsistent with appropriate organizing principles for these drugs and inconsistent with accepted practice in the field. We find that the draft categories and classes are wholly inadequate.”

The USP noted in the draft Model Guidelines that indeed the guidelines are not a formulary—“they represent a first step in helping plans develop their formulary structures.” The USP established an Expert Committee to develop the guidelines and also formed “advisory forums” to represent beneficiaries, drug plans, pharmaceutical manufacturers, and providers.

In all, the expert committee was made up of 18 members from academia, the National Institutes of Health, large health systems and health insurers, and pharmacy benefit providers. The four advisory forums drew input from an equally broad array of experts, representing 20 groups. For example, AARP and Consumers Union representatives served on the beneficiary advisory forum, and the providers advisory forum was made up of representatives from the American Academy of Family Physicians, American College of Physicians, American Geriatrics Society, and American Nurses Association. Representing pharmacists as providers were the Academy of Managed Care Pharmacy, American Society of Consultant Pharmacists, and American Society of Health System Pharmacists.

Between January and August, the Expert Committee met numerous times and contracted with outside consultants to advise in the development process. The committee developed a classification system “that begins with a disease-linked therapeutic category (generally reflective of indication), follows with pharmacologic class (primarily based on mechanism of action), and includes a further subdivision where needed.”