Bipartisan members sharply question CMS Administrator why Alzheimer’s drugs aren’t reasonable and necessary

Washington, D.C., April 26, 2023 — Today, the Alzheimer’s Association brought its purple presence again to Capitol Hill, urging access to FDA-approved Alzheimer’s treatments during Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure’s testimony before the House Committee on Energy and Commerce’s Health Subcommittee. Adding to the bipartisan momentum from last month’s budget hearings in the House and Senate, members of Congress from both sides of the aisle urged Administrator Brooks-LaSure to reverse CMS’s unprecedented decision blocking access to Food and Drug Administration (FDA)-approved Alzheimer’s treatments. 

“Thank you to the bipartisan members of Congress for standing up for the Alzheimer’s community today and urgently calling on CMS Administrator Brooks-LaSure to ensure full access to FDA-approved Alzheimer’s treatments,” said Robert Egge, chief public policy officer of the Alzheimer’s Association and Alzheimer’s Impact Movement (AIM) executive director. “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.”

During the hearing, Chairman Brett Guthrie (R-Ky.) spoke about Alzheimer’s and the CMS decision. “[Alzheimer’s has] touched every family, and there's been a lot of attention to a decision by CMS to severely limit access to an entire class of FDA-approved Alzheimer's drug treatments.” Referring to the coverage guidelines for CMS, Guthrie directly asked Administrator Brooks-LaSure about coverage of an Alzheimer’s treatment. “In the case of Leqembi, what is unnecessary and unreasonable about this FDA-approved drug?” 

“It is deeply disappointing that the CMS Administrator was unable to answer many of the members’ questions today, including why CMS has determined Alzheimer’s treatments are not ‘reasonable and necessary,’” said Egge. “She also failed to explain why CMS has imposed an inconsistent, stricter standard for this class of treatments. Requiring a registry will impose barriers to access and exacerbate health inequity. CMS must reverse course and ensure full access to FDA-approved Alzheimer’s treatments.” 

Subcommittee Ranking Member Anna Eshoo (D-Calif.) pointed out the inconsistency between CMS and the Veterans Health Administration on FDA-approved Alzheimer’s treatments, and emphasized that a lack of preparation and guidance from CMS will further limit access to these treatments. “Here’s the thing — if doctors don’t know, if patients don’t know, and Medicare doesn’t really seem to know what this registry entails, how are Medicare patients going to get the drug, potentially beginning in July?” asked Eshoo.

Eshoo went on to describe the real-world impact of the current policy on individuals living with Alzheimer’s throughout the nation. “Let me describe to you two constituents. One is a grandfather and a veteran. He has coverage. He’s been diagnosed. His wife was also diagnosed. She’s not a veteran. How do I, or any of us, explain that to our constituents?” asked Eshoo.

Eshoo concluded by urging Brooks-LaSure to take action. “This is a progressive disease,” Eschoo said. “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. Morgan Griffith (R-Va.) asked about the evolving role of CMS: “When did CMS decide or get authority to operate like a scientific regulatory body when that’s the FDA’s job? And isn’t that what you’re doing? You’ve turned yourself into a regulating body, a scientific regulatory body, by denying paying for the Alzheimer’s medication that this subcommittee and this committee on a bipartisan basis worked hard to make sure it was available to the patients of Alzheimer’s?”

A longtime congressional champion with a personal connection to the disease, Rep. Nanette Diaz Barragán (D-Calif.) also recognized the Alzheimer’s Association advocates and stood with them in support of access to FDA-approved Alzheimer’s treatments. “This is a bipartisan issue,” said Barragán, “and a failure, really, of CMS to provide meaningful coverage for the class of therapies targeting Alzheimer’s disease. CMS’s decision continues to concern me.”

Rep. Larry Buschon (R-Ind.) asked Administrator Brooks-LaSure about the discrepancy between the FDA and CMS on accelerated approval. “Has the FDA told you that accelerated approval is not full approval and should be treated differently?”

Administrator Brooks-LaSure responded: “We have many conversations with the FDA. We consider accelerated approval in a different category.”

“You do, but the FDA does not. I just want to make that clear,” Buschon concluded.

Reps. John Joyce (R-Pa.) and Mariannette Miller-Meeks (R-Iowa) added their support to the calls for access to FDA-approved treatment. “I would like to add my voice to the list of those concerned of what CMS has decided on restricting coverage for anti-amyloid treatment for Alzheimer’s disease,” said Joyce.

“I want to also echo the sentiments — my mother had Alzheimer's, so I appreciate all of you here in purple supporting Alzheimer’s and our support for getting drugs that have been approved through the FDA onto the marketplace and covered,” said Miller-Meeks.

“Thank you to subcommittee members on both sides of the aisle for reaffirming the bipartisan support for access to FDA-approved Alzheimer’s treatments,” said Egge. “Our passionate and dedicated advocates who attended this hearing and those across the nation will relentlessly pursue access to Alzheimer’s treatments, and we will not stop until people have access to the Alzheimer’s treatments they need and deserve.”

Medicare has always covered FDA-approved treatments. Each day CMS blocks access, more than 2,000 people transition to a more advanced stage of Alzheimer’s where they are no longer eligible for treatment.

The broad bipartisan support seen during today’s hearing is just the latest example of the growing momentum and political pressure on CMS to change its policy and stop blocking access to FDA-approved Alzheimer’s treatments. In February, Reps. Darin LaHood (R-Ill.) and Paul Tonko (D-N.Y.) led a letter to Secretary Xavier Becerra and CMS Administrator Brooks-LaSure emphasizing the importance of access to FDA-approved Alzheimer’s treatments, which was signed by 72 of their bipartisan colleagues. Sens. Susan Collins (R-Maine) and Shelley Moore Capito (R-W.Va.) also led a bipartisan letter in the Senate, signed by 20 bipartisan leaders.

Rep. Lisa Blunt-Rochester (D-Del.) recognized the Alzheimer’s Association presence in the hearing room and reiterated the bipartisan support in the fight against Alzheimer’s and other dementia. “This has touched so many of us — whether it’s my grandmother, my mother, one of my good neighbors, that the reason why you wear purple is because this is not a red issue or a blue issue, it’s an American issue. So thank you so much for your advocacy.”