Medicare needs to reconsider its national coverage decision on FDA-approved Alzheimer’s drug treatments, bipartisan members of the House told Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure on Wednesday.
In April 2022, Medicare announced it would limit its coverage of FDA-approved monoclonal antibody treatments used to treat amyloid plaques in the brains of those with Alzheimer’s disease. The federal government only covers drugs approved under the FDA standard review process, not under the accelerated review program.
During her testimony before the House Committee on Energy and Comerce’s Health Subcommittee on legislative solutions to increase healthcare transparency and competition, Brooks-LaSure was peppered with questions and comments about CMS’ coverage decision, including its rejection of a request to expand its coverage of monoclonal antibody treatments and continue to limit access to a class of Alzheimer’s treatments targeting amyloid, including aducanumab (Aduhelm) and lecanemab (Leqembi).
“Like so many members of Congress on both sides of the aisle pointed out today, accelerated approval is full approval, according to the FDA, and it’s past time for CMS to acknowledge that fact and reverse its unprecedented and unfair decision blocking access to Alzheimer’s treatments,” Robert Egge, Alzheimer’s Association chief public policy officer and executive director of Alzheimer’s Impact Movement, said in a statement.
The FDA approved both aducanumab and lecanemab under an accelerated approval process. But a congressional investigation found the agency broke its own protocols in reviewing and approving aducanumab, and that it acted against the recommendation of an FDA advisory committee against approval.
Subcommittee Chairman Brett Guthrie (R-KY) questioned what is unnecessary and unreasonable about this class of treatments. Rep. Morgan Griffith (R-VA) questioned CMS’ evolving role and the fact that it has positioned itself as a “scientific regulatory body” by denying payment for Alzheimer’s medication.
“This is a progressive disease,” Subcommittee Ranking Member Anna Eschoo (D-CA) said during the hearing. “We know that early intervention with progressive diseases is really essential, so I hope that you will leave this hearing with a new commitment and a new view of how to do this, because you’re not prepared.”
Rep. Nanette Diaz Barragan (D-CA) called it a “bipartisan issue” and said she was concerned by CMS’ decision. Others backing a coverage decision reversal were Reps. Larry Buschon (R-IN), John Joyce (R-PA) and Mariannette Miller-Meeks (R-IA).
Egge said he was disappointed that Brooks-LaSure was unable to answer questions during the hearing about why CMS had determined that those Alzhiemer’s treatments were not “reasonable and necessary.”
“She also failed to explain why CMS has imposed an inconsistent, stricter standard for this class of treatments,” Egge said.
Egge called on CMS to reverse course and ensure full access to FDA-approved Alzheimer’s treatments. Each day that CMS blocks access, he said, more than 2,000 people will transition to a more advanced stage of Alzheimer’s and will no longer be eligible for treatment.
The dialogue during the hearing followed a bipartisan letter — led by Reps. Darin LaHood (R-IL) and Paul Tonko (D-NY) and signed by 72 colleagues — to US Department of Health and Human Services Secretary Xavier Becerra and Brooks-LaSure emphasizing the importance of access to FDA-approved treatments. Sens. Susan Collins (R-ME) and Shelley Moore Capito (R-WV) led a similar bipartisan letter in the Senate that was signed by 20 colleagues.
Last month, lawmakers in a Senate Finance Committee hearing called for the federal government to speed up access to Alzheimer’s treatments after CMS denied the Alzheimer’s Association’s request to reconsider its restrictive national coverage determination policy for monoclonal antibody treatments.
