On Wednesday, April 26, 2023, the Health Subcommittee of the House Energy and Commerce Committee held a hearing to discuss bipartisan ideas to lower healthcare costs. Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure served as the witness and gave testimony.
During the hearing, Members of Congress from both sides of the aisle asked Administrator Brooks-LaSure about the Medicare program’s lack of coverage for FDA-approved disease-modifying treatments for beneficiaries with mild cognitive impairment or mild Alzheimer’s disease. Chair of the Subcommittee Representative Brett Guthrie (R-KY) and Ranking Member Anna Eshoo (D-CA) both expressed serious concerns that CMS was not doing their duty to protect Alzheimer’s patients, with Chair Guthrie asking if CMS needs further clarity from Congress as to the definition of “reasonable and necessary.”
Ranking Member Eshoo and Representative Nanette Barragan (D-CA) asked pointed questions about the nature of the coverage and whether the Administrator was aware of any efforts being made to develop registries in the case that Leqembi, which was awarded “accelerated approval” in January 2023, receives traditional approval from the FDA in July. Administrator Brooks-LaSure was not aware of any registries being developed.
Research from the Alliance has shown that registries often take a year or more to establish, meaning that there would be significant delay for patient access to treatment even after the drug’s consideration for traditional FDA approval in July if CMS mandates registry participation as a requirement for coverage.
Additionally, representatives Griffith (R-VA), Barragan, Joyce (R-PA), Blunt-Rochester (D-DE) and Buschon (R-IN) noted their support for Medicare providing coverage for Alzheimer’s therapeutics and for CMS to stop differentiating between accelerated and traditional FDA approval. After Administrator Brooks-LaSure said CMS considers accelerated approval to be in a “different category” than a traditional approval, Chair Guthrie and Congressman Bucshon noted that Congress and the FDA consider Accelerated Approval to be a full approval.
Overall, there was significant bipartisan support for full Medicare coverage of Alzheimer’s treatments and emphasis from members that coverage must begin as soon as possible. The Alliance has been happy to work with Chair McMorris Rodgers, Ranking Member Eshoo, and Congresswoman Barragan on these important issues and applauds their vital efforts on behalf of individuals with Alzheimer’s and their families.