A federal advisory panel, working closely with the Bush administration, announced a list of 146 types of prescription drugs on Monday that should be covered under Medicare's new drug benefit.
The panel, the U.S. Pharmacopeia, a venerable organization that sets standards for the pharmaceutical industry, said prescription drug plans should offer beneficiaries at least two drugs of each type. Insurers that follow the recommendations will be presumed to meet one of the major criteria in the new Medicare law.
The executive vice president of the panel, Dr. Roger L. Williams, said its guidelines were "the only classification system specifically developed" to ensure that beneficiaries had access to all the drugs that they needed.
Some advocates for patients said the guidelines did not guarantee coverage for costly new drugs that might be needed to treat certain disorders, including some mental impairments.
Stephen R. McConnell, senior vice president of the Alzheimer's Association, said: "People with Alzheimer's often suffer from other chronic conditions, including heart and lung disease, and they may not be able to get the drugs they need for those conditions. In addition, some of the newer antidepressants may not be available."
Dr. C. Conrad Johnston, former president of the National Osteoporosis Foundation, said the guidelines appeared to provide "little assurance of protection for millions of Medicare beneficiaries with osteoporosis," a disease that weakens the bones so that they are more likely to break.
The writing of the guidelines touched off a huge battle between insurance and drug companies that could determine how many medicines will be readily available to beneficiaries.
Under the law, officials will rely on private health plans to deliver drug benefits to the elderly and disabled starting next year. The government will not establish a uniform list of drugs that have to be covered. Rather, each plan will develop a list of drugs approved for reimbursement.
In general, drug companies want as many drugs as possible on each list, known as a formulary. Many doctors and consumer groups agree. But insurers and drug benefit managers generally want to limit the number and types of drugs. Otherwise, they say, the cost of the new drug benefit will soar out of control.
The guidelines issued Monday juggle the competing concerns but appear to come down in favor of the insurers more than the drug companies.
The panel rejected advice from the chief lobby for the brand-name drug industry, the Pharmaceutical Research and Manufacturers of America, which had urged the group to scrap its first draft and start over.
The top Medicare official, Dr. Mark B. McClellan, praised the framework devised by U.S. Pharmacopeia, which is posted on its Web site, www.usp.org. McClellan emphasized that his agency would be the final arbiter of what kinds of drugs must be covered.
In deciding whether a drug plan provides acceptable coverage, he said, the government will analyze not only the list of drug classes, but also the specific drugs in each class, the copayments charged for each drug, "prior authorization" requirements and procedures for patients to appeal drug-coverage decisions.
McClellan said the government would scrutinize all formularies to make sure that they did not discourage enrollment by any group of beneficiaries with high drug costs.
Insurers praised the guidelines.
"They go in the right direction for Medicare beneficiaries," said Alissa Fox, policy director for the Blue Cross and Blue Shield Association.
ON THE WEB
For more information on U.S. Pharmacopeia's recommendations,
go to www.usp.org.