Lawmakers demand more information on Medicare coverage

Two Democratic lawmakers are asking Medicare to provide more information on how the program will deliver on its promise to cover Alzheimer’s treatments for seniors.

Rep. Anna Eshoo, a Democrat on the House Health Subcommittee, and Rep. Nanette Barragan said Medicare failed to answer basic questions about how its coverage plan worked.

Lawmakers told Chiquita Brooks-LaSure, who directs the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it’s still unclear how seniors will access new treatments.

Medicare has promised to cover antibody treatments for Alzheimer’s the same day the drugs receive full Food and Drug Administration approval.

The federal health program will cover treatment through Part B of the program for the elderly. Part B usually covers treatments that older people cannot administer on their own at home, such as infusions.

Under the policy, seniors could get coverage for Leqembi antibody infusion therapy from Eisai and Biogen as early as this summer. The FDA is expected to issue a decision on Leqembi on July 6.

Leqembi slowed cognitive decline by 27% in a clinical trial, although the treatment also carries risks of brain swelling and bleeding.

But Medicare will require patients to see a doctor who participates in a so-called registry that collects real data on how the drug works.

Eshoo and Barragan told Brooks-LaSure they fear the registry presents a barrier to care.

Brooks-LaSure said last week that CMS will help set up a national registry to allow doctors and clinicians to easily enter required data about patients taking the drug.

But lawmakers said CMS has not released any details about how the required register actually works. The agency did not say when the registry will be operational, what data should be collected and how patients can find doctors who participate in the system, Eshoo and Barragan said.

“At a minimum, Congress, physicians, and patients deserve to have the answers to the above questions immediately,” they said.

Medicare needs to clearly define how the registry works and ensure the system is not burdensome for patients and doctors, they added.

Lawmakers asked CMS to ensure that the registry does not create access disparities for blacks, Hispanics and Native Americans as well as people living in rural areas.

Additionally, Eshoo and Barragan said Medicare should consider removing the requirement from the registry altogether.

“There must be clarity and transparency about the standards for coverage of FDA-approved treatments for life-threatening conditions with unmet medical needs,” the lawmakers said. “Please don’t let CMS’s request for the generation of additional evidence be a barrier to patient care.”