— Congressional Bipartisan Support for Individuals, Families and Treatment on Display —
WASHINGTON, D.C., May 10, 2023 — Today, Tony Gonzales passionately shared his story with Congress, advocating for Centers for Medicare & Medicaid Services (CMS) coverage for Alzheimer’s treatments that are approved by the Food and Drug Administration (FDA). Flanked by a sea of purple -clad advocates and receiving broad bipartisan support, Gonzales, an Alzheimer’s Association Early Stage Advisory Group member and Board of Directors member, testified before the House Ways and Means Health Subcommittee about what access to treatments would mean for him and the Alzheimer’s community.
“When diagnosed, it would’ve given me so much hope to have the opportunity to access treatments that can give me more time — I’d like the chance to make the decision if the treatments are right for me and my family instead of Medicare making that decision for me,” Gonzales shared with the subcommittee.
“Medicare is treating people with mild cognitive impairment (MCI) and Alzheimer’s differently when they apply this restriction to an entire class of drugs — current and future,” Gonzales continued. “This action has a ripple effect as well. Private insurance and health systems follow Medicare’s lead. If Medicare won’t cover, chances are that other insurance won’t either, and health systems won’t make it available. Thus, taking more time away from people including for me and others who aren’t on Medicare.”
“We are grateful to Tony for sharing his story, time and time again, to raise awareness of the impact the unjust CMS decision is having on Americans across the country,” said Robert Egge, chief public policy officer of the Alzheimer’s Association and Alzheimer’s Impact Movement (AIM) executive director. “We need to listen to people living with the disease. They deserve the right to access FDA-approved treatments now, while they still can, if they and their clinician decide it is right for them.”
During the hearing, bipartisan members of the subcommittee thanked Gonzales for sharing his story, expressed their desire for CMS to change its policy for current and future FDA-approved treatments, and confirmed their support for the FDA accelerated approval pathway.
“In fact, just last week, data was released on a third promising Alzheimer’s drug, showing it significantly slows the progression of the disease but it will still be a subject for current restrictive CMS mandates,” Health Subcommittee Chairman Rep. Vern Buchanan (R-Fl.) said. “FDA approval — whether traditional or accelerated — is a full approval, and CMS should not be second guessing the scientists at FDA who granted the approval.”
Ways and Means Committee Chairman Rep. Jason Smith (R-Mo.) discussed the impact the CMS decision will have on communities across the country. “Broadly restricting coverage for Alzheimer's treatments, the first approved in nearly 20 years, is a devastating blow to the patients and caregivers relying on new innovations. Importantly, these restrictions are disproportionately felt by those living in rural America who don't have access to qualifying clinical trials,” he said. “I hope in the light of continued positive data such as the study released last week, CMS will reconsider this decision.”
Rep. Carol Miller (R-W.Va.) also shared concerns about the impact the CMS decision will have on health equity. “I'm concerned that rural patients won't be able to access an entire class of drugs just because of where they live,” she said.
The CMS decision to deny coverage of an FDA-approved drugs may be a sign to come to other people seeking treatment — not just those facing Alzheimer's. Rep. Mike Kelly (R-Penn.) noted that the administration has taken “major steps to devalue the accelerated approval pathway for new drugs coming on to the market.” He went on to warn: “If CMS is successful in expanding the Alzheimer’s precedent to other categories of drugs like cancer drugs, patients will see their access to innovative new lifesaving cures restricted or even cut off altogether.”
“I think I have demonstrated what is meaningful and necessary in my life,” Gonzales said, addressing the members of the subcommittee. “But let me ask you: What is meaningful and necessary in your life? The government should not be having this conversation with me. It should be between a patient and their doctor. Period. That is what I need.”
Rep. Brad Wenstrup (R-Ohio) spoke about the value of treatments for patients, families and society, and the importance of the conversations happening between patients and families. “We don't talk [enough] about the value of productive life because [of] medicine. Doctors sit there everyday with patients in front of them and talk to them — they understand it. The people that wear the white coats, not the ones who write white papers.”
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.
There is mounting bipartisan political support for CMS to change its policy. Last week, 26 bipartisan attorneys general urged President Biden to provide access to Alzheimer's treatments. In April, CMS Administrator Chiquita Brooks La-Sure testified before the House Energy and Commerce Health Subcommittee, where members from both sides of the aisle forcefully called into question why CMS has determined people living with Alzheimer’s should be treated differently. In March, Health and Human Services (HHS) Secretary Xavier Becerra’s budget testimony before the House and the Senate members from both sides of the aisle urged him to reverse this unprecedented decision.
“CMS must immediately reconsider,” Gonzales said. “They must look at the clear evidence now before them, and when they do I trust they will acknowledge that these treatments are absolutely reasonable and necessary for people like me with a terrible, progressive disease and no other treatment options … We are losing time. It is unacceptable.”