Medicare drug plans that choose not to follow the U.S. Pharmacopeia's model formulary drug classes will have their formularies compared to other classification systems, the Centers for Medicare & Medicaid Services' draft Medicare formulary review guidelines state.

"For plans that choose to adopt an alternative to the USP's structure, CMS will check the plan's proposed classification system to determine if it is similar to other commonly used classification systems, such as American Hospital Formulary System or those used in popular [Federal Employees Health Benefits Program] plans and other plans that serve many seniors and persons with disabilities," the ¹ draft guidelines released Dec. 3 state.

The agency is seeking comments on what existing classification systems could provide appropriate standards.

CMS will have the authority to approve or deny each prospective drug plan's formulary based on the agency's review standards. USP is developing model formulary guidelines that will serve as a "safe harbor."

The group is making changes to its draft model formulary based on public comments and expects to provide CMS with revisions by mid-December so USP can finalize the model by the end of the year.

USP's draft included 146 unique therapeutic categories and pharmacologic classes, each of which would be required to contain at least two covered drugs, as well as "recommended subdivisions" of many classes (² Also see "USP Draft Medicare Formulary Sets 146 Drug Categories And Classes" - Pink Sheet, 19 August, 2004.).

CMS' draft guidelines make it clear that drug plans will have considerable leeway in developing formularies that do not follow USP's model.

"Plans can choose to adopt a classification system that is consistent with the USP's drug categories and classes or may use other classification systems," the guidelines say. They add that "a system with a smaller number of classes may be acceptable if it nonetheless provides preferred access to a relatively broad range of widely used medicines."

CMS will also look closely at "drug lists," regardless of the classification system used. The agency will compare each list to "existing widely-used formularies and Medicaid preferred lists...and against other proposed Part D formularies, to identify outliers in formulary and pharmacy benefit management best practices."

Formulary benchmarks CMS is considering include an analysis of the "availability and tier position of the commonly prescribed drugs, particularly the top 25-50 drugs for the Medicare population in terms of cost and utilization."

Other possible benchmarks are "widely accepted treatment guidelines" and "a check of whether the formulary includes at least one drug from each of USP's recommended categories and classes and subdivisions...as a proxy for comprehensiveness."

- Scott Steinke

USP Drug Class Alternatives Include FEHBP, American Hospital System, CMS Says

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