The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.
The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.
“The model guidelines are not a formulary,” said Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.
The group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.
Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.
CMS officials will use the guidelines to help evaluate proposed formularies.
After USP issued draft guidelines for evaluating proposed formularies last August, physician groups and patient advocates complained that too many critical drugs were in a third category, where they would not be required to be covered.
The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes include additional antidementia drugs and expanded dermatologic agents.
Dr. Williams said he hopes all parties will see this as “workable compromise.”
The National Mental Health Association (NMHA) warned that the USP guidelines ignored recommendations from the mental health field not to group older medications with newer therapies. The association said that because these different medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said in a statement that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.
But America's Health Insurance Plans (AHIP) praised the USP's final document.
“The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed,” said Karen Ignagni, AHIP president and CEO. “The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries.”
Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.