The Medicare program should only cover the controversial new Alzheimer's drug Aduhelm for patients who are participating in approved clinical trials. The number of patients who could use the expensive drug would be limited if the preliminary decision is finalized later this year.
The C.M.S. released a decision on Tuesday stating that coverage should be provided for patients in approved trials. All trials must be done in a hospital setting.
The agency said that Aduhelm and similar drugs for Alzheimer's that are provided outside of these trials are not nationally covered.
The C.M.S. administrator said that the policy was proposed after experts reviewed all relevant publicly available evidence and feedback received from stakeholders.
The future of Aduhelm, which is made by Biogen and is priced at $28,200 a year per patient, is dependent on Medicare's coverage decision. Most of the 1.5 million Americans with the type of condition that the F.D.A. approved the drug to treat are over the age of 65.
The agency is expected to make a final decision about covering the drug by mid-April, after 30 days of public comment.
It is unusual that Medicare is conducting an extensive review of Aduhelm. Health policy experts said that the program almost always pays for F.D.A.-approved drugs for medical conditions on their label.
After months of weak sales, Biogen slashed the price of the drug from $60,000 a year to $30,000 last month. One of the biggest increases in Medicare Part B premiums in history was imposed before Biogen slashed its prices, partly because of the possibility of Aduhelm coverage.
Advocacy groups for Alzheimer's patients urged C.M.S. to lower the premium increase after the price cut by Biogen. On Monday, the secretary for health and human services said that he was instructing C.M.S. to reexamine the premium hike for the Alzheimer's drug, Aduhelm.
Aduhelm was approved by the FDA in June, but it was criticized by many doctors and Alzheimer's experts because of the significant safety risks and unclear benefit to patients.
The F.D.A. worked with Biogen and Aduhelm was approved despite strong objections from some senior F.D.A. officials and the agency's independent advisory committee.
Aduhelm has only been used by a small number of patients, a fraction of the number analysts had expected. Many large American health care systems have refused to offer the drug due to questions about its benefits and risks.
According to Sean Tunis, a former official with C.M.S. who is now a senior fellow at the Center, Medicare officials are supposed to determine coverage based on whether a drug is a "reasonable and necessary" treatment.
Standards for evaluating several similar Alzheimer's drugs will be established by Medicare's decision on Aduhelm.
The F.D.A. acknowledged that there wasn't enough evidence that Aduhelm would help patients. The medication was greenlighted under a program called accelerated approval, which allows authorization of drugs for serious diseases with few treatment options if the drug affects a biological mechanism in a way that is reasonably likely.
The F.D.A. said it was based on the approval of Aduhelm for the reduction of amyloid in the brains of people with Alzheimer's. There is little evidence that reducing amyloid slows cognitive decline. The F.D.A. requires Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit. Aduhelm will be available to patients in the years to come.
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