ASAP Act

Mr. President, I rise to introduce the Alzheimer's Screening and Prevention ASAP Act. This bill would require the Centers for Medicare & Medicaid Services to cover FDA-approved blood-based biomarker tests for Alzheimer's disease, expanding access to earlier and more accurate diagnoses for millions of Americans.

Alzheimer's disease is one of the greatest public health challenges of our time. It currently affects more than 7 million Americans, including an estimated 29,000 individuals in Maine. That number is expected to increase in the coming years as our population ages.

Alzheimer's is also the most expensive disease in America. The cost of caring for people with Alzheimer's and other dementia was an estimated $360 billion in 2024. Total costs are expected to exceed $1 trillion by 2050 unless we take meaningful action.

Early diagnosis of this disease is critical. It allows patients and their families to better plan for the future, access

care and support services, and take advantage of available treatments that are most effective in the early stages. Yet far too many individuals remain undiagnosed until their symptoms become severe.

I have had the privilege of meeting with Mainers from the Alzheimer's Association year after year when they come to Washington. One story stands out to me as an example of the importance of early diagnosis. Ten years ago, Ralph Carmona was diagnosed with mild cognitive impairment resulting from Alzheimer's disease. Because he was diagnosed in the very early stages of disease, Ralph was able to participate in a clinical trial for Leqembi. Leqembi is one of the first disease- modifying therapies approved by the FDA for early treatment of Alzheimer's. Ralph credits this drug with significantly slowing his symptoms. He has even run a marathon since his initial diagnosis.

Recent scientific advances have led to the development of blood-based biomarker tests that can detect Alzheimer's with increasing accuracy. These tests are far less invasive and significantly more affordable than current diagnostic methods, such as PET scans or spinal taps. Earlier this year, FDA approved the first blood test for clinical use. This approval will greatly increase the ability of primary care physicians to diagnose the disease in its very early stages while symptoms are still mild and potentially treatable. The only current treatments available for Alzheimer's disease are approved for patients in the early stages of disease.

An important next step is for CMS to cover this breakthrough. I pushed CMS to cover Leqembi and other early-stage disease-modifying therapies. If the FDA approves a treatment an innovative blood test such as this one, there is no reason why CMS should refuse to cover it.

The ASAP Act would address this gap by requiring CMS to cover FDA- approved blood tests for Alzheimer's once they are deemed safe and effective. The bill also supports the continued development and evaluation of screening practices that reflect the latest in medical science.

As the founder and cochair of the Congressional Alzheimer's Task Force, I have long believed that we must do more to detect Alzheimer's early and expand access to innovations in diagnosis and treatment. I want to thank the Alzheimer's Association for its continued advocacy and for developing this important legislation. Their partnership and dedication to improving the lives of those affected by Alzheimer's have been invaluable.

I look forward to working with my colleagues to ensure swift passage of this bill.

Mr. President, I rise to introduce the Alzheimer's Screening and Prevention ASAP Act. This bill would require the Centers for Medicare & Medicaid Services to cover FDA-approved blood-based biomarker tests for Alzheimer's disease, expanding access to earlier and more accurate diagnoses for millions of Americans.

Alzheimer's disease is one of the greatest public health challenges of our time. It currently affects more than 7 million Americans, including an estimated 29,000 individuals in Maine. That number is expected to increase in the coming years as our population ages.

Alzheimer's is also the most expensive disease in America. The cost of caring for people with Alzheimer's and other dementia was an estimated $360 billion in 2024. Total costs are expected to exceed $1 trillion by 2050 unless we take meaningful action.

Early diagnosis of this disease is critical. It allows patients and their families to better plan for the future, access

care and support services, and take advantage of available treatments that are most effective in the early stages. Yet far too many individuals remain undiagnosed until their symptoms become severe.

I have had the privilege of meeting with Mainers from the Alzheimer's Association year after year when they come to Washington. One story stands out to me as an example of the importance of early diagnosis. Ten years ago, Ralph Carmona was diagnosed with mild cognitive impairment resulting from Alzheimer's disease. Because he was diagnosed in the very early stages of disease, Ralph was able to participate in a clinical trial for Leqembi. Leqembi is one of the first disease- modifying therapies approved by the FDA for early treatment of Alzheimer's. Ralph credits this drug with significantly slowing his symptoms. He has even run a marathon since his initial diagnosis.

Recent scientific advances have led to the development of blood-based biomarker tests that can detect Alzheimer's with increasing accuracy. These tests are far less invasive and significantly more affordable than current diagnostic methods, such as PET scans or spinal taps. Earlier this year, FDA approved the first blood test for clinical use. This approval will greatly increase the ability of primary care physicians to diagnose the disease in its very early stages while symptoms are still mild and potentially treatable. The only current treatments available for Alzheimer's disease are approved for patients in the early stages of disease.

An important next step is for CMS to cover this breakthrough. I pushed CMS to cover Leqembi and other early-stage disease-modifying therapies. If the FDA approves a treatment an innovative blood test such as this one, there is no reason why CMS should refuse to cover it.

The ASAP Act would address this gap by requiring CMS to cover FDA- approved blood tests for Alzheimer's once they are deemed safe and effective. The bill also supports the continued development and evaluation of screening practices that reflect the latest in medical science.

As the founder and cochair of the Congressional Alzheimer's Task Force, I have long believed that we must do more to detect Alzheimer's early and expand access to innovations in diagnosis and treatment. I want to thank the Alzheimer's Association for its continued advocacy and for developing this important legislation. Their partnership and dedication to improving the lives of those affected by Alzheimer's have been invaluable.

I look forward to working with my colleagues to ensure swift passage of this bill.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.