Guidelines Are Proposed for Types Of Drugs Medicare Should Cover
By SARAH LUECK
Staff Reporter of THE WALL STREET JOURNAL
January 4, 2005; Page B7
WASHINGTON -- A private organization hired by the government released its proposed guidelines for what types of medications should be included in the new Medicare drug benefit.
The list included fewer categories and classes of drugs than the drug industry pushed for, but the list isn't the final word on what drugs Medicare will cover. The list, compiled by the U.S. Pharmacopeia, a nonprofit organization that sets quality and consistency standards for medicines, includes 146 distinct categories and classes of drugs, and is intended to be a model for private health insurers looking to offer drug coverage to Medicare's elderly and disabled beneficiaries beginning in 2006.
Insurers, however, don't have to stick to the USP list, and the government has signaled it is open to approving drug plans with different structures. But the agency that runs Medicare will use the list to help determine whether insurers are proposing adequate coverage to meet beneficiaries' needs, said Mark McClellan, administrator of the Centers for Medicare and Medicaid Services.
For months, the list has been the subject of intense lobbying by the pharmaceuticals industry, health insurers and pharmacy-benefit managers, which run drug benefits for big buyers like employers and insurers. The drug industry urged the USP to write a drug list that includes 200 or more drug classes, to give drug makers a broad ability to get coverage for their products. Health insurers and pharmacy-benefit managers, on the other hand, have argued for a much narrower list, saying that requiring coverage of too many types of drugs reduces their ability to bargain with drug makers for lower prices.
The USP list is organized into 41 categories, such as antidepressants and gastrointestinal drugs. Of those, 32 are further broken down into drug classes, such as reuptake inhibitors, a class that includes Prozac and other drugs.
The guidelines "are one of several factors" the government will weigh as it reviews drug plans, said Paul Antony, chief medical officer of the Pharmaceutical Research and Manufacturers of America, in a statement. "We expect the full process will meet the needs of patients and physicians," he said.
The trade group for pharmacy-benefit managers, the Pharmaceutical Care Management Association, was more upbeat. In a statement, the group said the USP guidelines "preserve the ability of PBMs to develop formularies" similar to those available in the existing private market.
Ultimately, the Medicare agency will have to decide how to strike the right balance. The USP guidelines will be incorporated into a final regulation that is expected to be released soon.
"We will use the USP's work to make sure that beneficiaries will have access to the prescription drugs they need at the most affordable price," Dr. McClellan said in a statement.
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