U.S. Pharmacopeia released draft model guidelines for outpatient drugs that should be covered under the new Medicare drug benefit that starts in 2006. The not-for-profit organization, charged with developing initial guidelines under last year's Medicare law, proposed 146 unique therapeutic categories and pharmacologic classes for Medicare formularies. Health plans providing the drug benefit can use USP's model guidelines "as a starting point" for building their own formularies, CMS Administrator Mark McClellan said in a news release. The CMS, meanwhile, will use the guidelines to help it evaluate health plans' proposed formularies.
Representing pharmacy benefit managers, the Pharmaceutical Care Management Association issued a statement arguing that USP's proposal, if embraced, "would move far beyond how formularies are structured currently in the commercial marketplace" and could increase costs and jeopardize a "workable drug benefit." Drugmakers reportedly are urging the CMS to adopt a larger number of categories and classes to increase the likelihood their products will land on most plans' formularies. USP plans a public meeting Aug. 27 in Baltimore to discuss the draft guidelines and will take public comments through Sept. 17. Read USP's proposal. -- by Jeff Tieman