Lawmakers are pushing for extra data on Medicare protection

Rep. Nanette Barragan (D-CA) speaks alongside U.S. Secretary of Transportation Pete Buttigieg after touring the Ports of Los Angeles and Long Beach during a press conference at the Port of Long Beach January 11, 2022 in Long Beach, California .

Patrick T Fallon | AFP | Getty Images

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

Rep. Anna Eshoo, the senior Democrat on the House Health Subcommittee, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how its insurance plan works.

Lawmakers told Chiquita Brooks-LaSure, director of the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it’s still “very unclear” how seniors will gain access to the new treatments.

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

The federal health program will cover the treatments under Part B of the program for seniors. Part B typically covers treatments that seniors cannot perform at home on their own, such as IV fluids.

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

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

But Medicare will require patients to see a doctor who participates in what’s called a registry, which collects real-world data on how the drug works.

Eshoo and Barragan told Brooks-LaSure that they are concerned the registry could become a barrier to care.

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Brooks-LaSure said last week that CMS will help set up a national registry to make it easier for doctors and clinicians to enter the necessary data about patients taking the drug.

However, lawmakers said CMS has not released details of how the required registry will actually work. The agency has not said when the registry will go live, what data will need to be collected and how patients can find doctors who participate in the system, Eshoo and Barragan said.

“Congress, physicians and patients at least deserve immediate answers to the above questions,” they said.

Medicare must clearly define how the registry will work and ensure the system is not a burden on patients and doctors, they added.

Legislators asked CMS to ensure that the registry does not create disparities in access for Black, Hispanic, Native American, and people living in rural areas.

In addition, Eshoo and Barragan said that Medicare should consider eliminating registration altogether.

“There must be clarity and transparency about the standards for coverage of FDA-approved treatments for fatal diseases with unmet medical needs,” lawmakers said. “Please do not allow CMS’s request for additional evidence generation to be an impediment to patient care.”

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