Lawmakers relentlessly demand comprehensive information on Medicare coverage

Two Democratic lawmakers are urging Medicare to provide comprehensive information on its plans to cover treatments for Alzheimer’s disease in seniors. They claim that Medicare has not adequately addressed basic questions regarding the logistics of its coverage plan. Rep. Anna Eshoo, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan have expressed concerns over the lack of clarity concerning how seniors will access these new treatments. They conveyed their concerns to Chiquita Brooks-LaSure, the head of the Centers for Medicare and Medicaid Services (CMS), via a letter.

Medicare has committed to covering Alzheimer’s antibody treatments on the same day they receive full approval from the Food and Drug Administration (FDA). These treatments will be covered under Part B of the program, which typically covers treatments that cannot be self-administered by seniors, such as infusions. The coverage for Eisai and Biogen’s antibody-infusion treatment, known as Leqembi, may become available as early as this summer, pending FDA approval on July 6. While Leqembi has shown promise in reducing cognitive decline, it also carries the risk of brain swelling and bleeding.

However, Medicare intends to require patients to visit doctors who participate in a registry that collects real-world data on the effectiveness of the drug. Eshoo and Barragan are concerned that this registry could pose a barrier to care.

Last week, Brooks-LaSure announced that CMS would facilitate the establishment of a national registry to simplify the process of doctors and clinicians entering the necessary data on patients receiving the drug. However, Eshoo and Barragan have pointed out that CMS has not provided any details on how this registry will function. They have also raised concerns about its availability, the required data, and how patients can find participating doctors.

The lawmakers emphasized the need for immediate answers to these questions, asserting that Congress, doctors, and patients deserve clarity. They also urged Medicare to ensure that the registry does not create disparities in access to the drug for certain racial and ethnic groups, as well as individuals in rural areas. Additionally, Eshoo and Barragan urged Medicare to consider eliminating the registry requirement altogether, stressing the importance of clear and transparent standards for coverage of FDA-approved treatments for life-threatening diseases with unmet medical needs. They urged CMS not to let the demand for additional evidence generation become a barrier to patient care.