Lawmakers press for more information on Medicare coverage

Two Democratic lawmakers are calling on Medicare to supply more information on how this system will make good on its promise to cover Alzheimer’s treatments for seniors.

Rep. Anna Eshoo, the rating Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan said Medicare has didn’t answer basic questions on how its coverage plan will work.

The lawmakers told Chiquita Brooks-LaSure, who heads the Centers for Medicare and Medicaid Services (CMS), in a letter Monday that it remains to be “very unclear” how seniors will access the brand new treatments.

Medicare has promised to cover Alzheimer’s antibody treatments on the identical day the medications receive full approval by the Food and Drug Administration.

The federal health program will cover the treatments through Part B of this system for seniors. Part B typically covers treatments that seniors cannot administer at home on their very own, resembling infusions.

Under this policy, seniors could receive coverage for Eisai and Biogen’s antibody-infusion treatment Leqembi as soon as this summer. The FDA is anticipated to make a call on Leqembi July 6.

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

But Medicare would require patients to go to a health care provider who participates in a so-called registry that collects real-world data on how the drug works.

Eshoo and Barragan told Brooks-LaSure that they’re anxious the registry could present a barrier to care.

Brooks-LaSure said last week that CMS will help arrange a national registry to make it easy for doctors and clinicians to enter the required data on patients who’re taking the drug.

However the lawmakers said CMS has published no details about how the required registry will actually work. The agency has not said when the registry might be live, what data have to be collected, and the way patients can find doctors who’re participating within the system, Eshoo and Barragan said.

“At minimum, Congress, doctors, and patients should have the answers to the above questions immediately,” they said.

Medicare needs to obviously define how the registry will work and make sure that the system just isn’t burdensome to patients and doctors, they added.

The lawmakers called on CMS to be certain that the registry doesn’t create disparities in access for Black, Hispanic and Native Americans in addition to people living in rural areas.

What’s more, Eshoo and Barragan said Medicare should consider dropping the registry requirement altogether.

“There must be clarity and transparency in regards to the standards for coverage for FDA-approved treatments for deadly diseases with unmet medical needs,” the lawmakers said. “Please don’t allow CMS’s demand for added evidence generation be a barrier to patient care.”