Rep. Nanette Barragan (D-CA) speaks with US Secretary of Transportation Pete Buttigieg after visiting the Ports of Los Angeles and Long Beach during a press conference at the Port of Long Beach on January 11, 2022 in Long Beach, California.
Patrick T. Fallon | AFP | Getty Images
Rep. Anna Eshu, the top Democrat on the House Health Subcommittee, and Rep. Nanette Barragan said Medicare has failed to answer basic questions about how coverage plan will work.
The deputies told Chiquita Brooks-Lasurwho heads the Centers for Medicare and Medicaid Services (CMS), Monday’s letter said it is still “very unclear” how older people will have access to new treatments.
Medicare has promised to cover Alzheimer’s antibody treatments the same day the drugs receive full Food and Drug Administration approval.
The federal health program will cover treatment under the Part B program for the elderly. Part B usually covers treatments that older people cannot do on their own at home, such as infusions.
Under this policy, seniors can receive Eisai and Biogen Leqembi antibody infusion therapy coverage this summer. The FDA is expected to make a decision on Lekambi on July 6th.
Lekambi slowed cognitive decline by 27% in clinical trials, although the treatment also comes with a risk of brain swelling and bleeding.
But Medicare will require patients to visit a doctor who participates in a so-called registry that collects real data about how the drug works.
Ash and Barragan told Brooks-LaSure they were concerned the registry could become a barrier to treatment.
Brooks-LaSure said last week that CMS will help create a national registry to make it easier for doctors and clinicians to enter the necessary data about patients taking the drug.
But lawmakers said the CMS has not released details on how the required registry will actually work. Eshu and Barragan said the agency did not say when the registry would be launched, what data would need to be collected, or how patients could find doctors participating in the system.
“At a minimum, Congress, physicians and patients deserve immediate answers to the above questions,” they said.
They added that Medicare should be clear about how the registry will work and make sure the system is not burdensome for patients and doctors.
Lawmakers called on 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.
What’s more, Eshu and Barragan said Medicare should consider dropping the registration requirement altogether.
“There is a need for clarity and transparency about standards for coverage of FDA-approved treatments for terminal illnesses with unmet medical needs,” the legislators said. “Please don’t let CMS’s demand for additional evidence become a barrier to patient care.”