ASAP Act
Introduced November 20, 2025 · Last action November 20, 2025
Plain English Summary
This bill requires Medicare to cover blood-based screening tests for early-stage Alzheimer's disease and related dementias, starting January 1, 2028. The tests must be FDA-cleared or approved and can include genomic sequencing, protein analysis, cell-free DNA tests, imaging biomarkers, and similar tests that detect pre-symptomatic or early-stage disease. Medicare will pay for these tests under the same process used for other covered screening services.
Who benefits
Medicare beneficiaries aged 65 and older and younger disabled individuals on Medicare; diagnostic laboratory companies and in vitro diagnostics manufacturers producing blood-based biomarker tests (including companies like Eli Lilly subsidiary Lilly Diagnostics, C2N Diagnostics, AC Immune, and similar Alzheimer's biomarker test developers); clinical laboratories and hospital pathology departments that perform or interpret these tests; primary care physicians and neurologists who order these screening tests; medical imaging centers providing biomarker imaging; pharmaceutical companies developing Alzheimer's disease treatments, as earlier detection expands the potential treatment-eligible population
Who pays / loses
Medicare Trust Fund (which covers all Medicare Part B services through beneficiary premiums, general revenue taxation, and payroll taxes); Medicare beneficiaries through increased Part B premiums if aggregate costs exceed projections; healthcare systems and physician practices that absorb costs if reimbursement rates are below their testing and counseling costs; potential financial burden on beneficiaries for counseling and follow-up care if not separately covered; individuals identified as having pre-symptomatic disease who may face anxiety, potential discrimination, or pressure to pursue early treatment before symptom onset
Funding & Lobbying Interests
In vitro diagnostics and laboratory testing companies with financial interest in Medicare coverage of blood-based biomarker tests (Roche Diagnostics, Abbott Diagnostics, Siemens Healthineers, Bio-Rad Laboratories, specialty Alzheimer's biomarker companies); pharmaceutical manufacturers developing anti-amyloid monoclonal antibodies and other dementia treatments (Eli Lilly, Biogen, Eisai, Roche) who benefit from expanded patient identification for treatment eligibility; clinical laboratory associations (American Association for Clinical Laboratory Science, American Clinical Laboratory Association) that represent testing companies; Alzheimer's disease patient advocacy organizations (Alzheimer's Association); neurology and geriatric professional societies. Sponsor Susan Collins represents Maine and has historically received contributions from healthcare and pharmaceutical sectors; no specific donor finance data was provided in the bill submission.
Political Impact
Affected Groups
Medicare beneficiaries aged 65+ (approximately 46 million individuals); younger disabled individuals on Medicare; individuals with family history of Alzheimer's disease or cognitive concerns; racial and ethnic groups with higher Alzheimer's prevalence (particularly Black Americans and Hispanic Americans, who develop Alzheimer's at higher rates); cognitively normal individuals who may be identified as having pre-symptomatic biomarker evidence of disease (estimated at 20-30% of cognitively normal older adults based on research); rural Medicare beneficiaries in areas with limited access to specialized diagnostic testing; lower-income Medicare beneficiaries who may lack resources for follow-up diagnostic workup or treatment if identified as at-risk
Political Subtext
Proponents argue this bill brings Medicare into alignment with clinical evidence that blood-based biomarkers can identify Alzheimer's disease in pre-symptomatic stages, enabling early intervention with recently FDA-approved anti-amyloid monoclonal antibodies (aducanumab, lecanemab, donanemab) that show modest slowing of cognitive decline in early symptomatic disease. They contend early detection saves lives and preserves independence. Critics worry the bill will drive mass screening of asymptomatic older adults, creating unnecessary anxiety and downstream treatment costs without clear evidence that pre-symptomatic treatment improves long-term outcomes or quality of life. They note that the recently approved anti-amyloid therapies carry risks of amyloid-related imaging abnormalities (ARIA), require frequent infusions and MRI monitoring, and show minimal clinical benefit in prevention trials. Non-partisan evidence shows mixed results: the PREVENT-AD trial (healthy at-risk individuals) found lecanemab did not significantly delay cognitive decline in pre-symptomatic biomarker-positive people, though the CLARITY trial showed modest benefit in mild cognitive impairment; long-term health and cost-effectiveness data remain limited. CMS has not yet issued coverage guidance for biomarker-based screening in asymptomatic populations, and cost-effectiveness of population screening remains unestablished.
Real-World Stakes
If passed, Medicare will begin covering blood-based Alzheimer's screening tests on January 1, 2028. Millions of asymptomatic Medicare beneficiaries will gain access to early biomarker testing, likely increasing annual test volume from thousands to hundreds of thousands. This will expand the population identified as having pre-symptomatic disease, increasing demand for follow-up neuropsychological testing, PET imaging, or MRI, and increasing initiation of anti-amyloid monoclonal antibody therapies in individuals without symptoms. Precedent from state and insurance coverage decisions: Aetna and UnitedHealthcare began covering biomarker testing in some populations in 2023-2024; Massachusetts and New York have proposed coverage for screening in high-risk populations. California's Medicaid program began covering lecanemab for mild cognitive impairment in 2024. The Medicare payment will accelerate these trends. Risk: widespread screening and treatment in asymptomatic populations could increase iatrogenic harm (ARIA-related brain microhemorrhages or microinfarcts, which occur in 15-35% of treated individuals in trials), increase healthcare costs without proportionate benefit, and divert resources from symptomatic dementia care and support services that have stronger evidence of improving quality of life. Benefit: earlier identification of at-risk individuals could allow time for lifestyle interventions, cognitive rehabilitation, advance care planning, and enrollment in treatment trials before symptom onset, though long-term benefit remains unproven. The bill imposes no requirements for informed consent standards, genetic counseling, or shared decision-making protocols, leaving those details to CMS regulation after passage.
What's Inside This Bill
Non-obvious provisions not apparent from the headline summary.
Genomic Sequencing Eligibility Without Prior Genetic Counseling Requirement
The bill explicitly includes 'genomic sequencing' as a covered blood-based test for Alzheimer's screening without establishing any requirement for pre-test or post-test genetic counseling, which is standard practice for genomic testing in other Medicare-covered contexts.
AffectsMedicare beneficiaries aged 65+ who may receive genomic sequencing results with significant implications for family members and future health planning without mandatory professional genetic counseling to interpret results or discuss implications.
Incidental Finding Liability Gap
The bill covers tests that 'detect pre-symptomatic or early-stage disease' but does not establish who is responsible for managing or disclosing incidental findings (such as cancer-related biomarkers, cardiovascular risks, or other conditions detected in blood analysis but unrelated to Alzheimer's).
AffectsBeneficiaries and testing providers face unclear liability when blood tests reveal serious unrelated conditions; Medicare may deny coverage for follow-up care on the basis that findings are 'incidental,' while providers may be uncertain about disclosure obligations.
No Exclusion for Asymptomatic Individuals with Contraindicated Medications
The bill mandates coverage for screening asymptomatic individuals but does not exclude those taking medications (such as certain anticoagulants or immunosuppressants) that could be affected by an early Alzheimer's diagnosis or those for whom early intervention is contraindicated.
AffectsBeneficiaries on complex medication regimens may receive positive screening results triggering treatment recommendations that conflict with their existing medical management, without clear clinical guidance on priority or safety protocols.
Biomarker Cutoff Thresholds Determined Unilaterally by CMS
The bill requires coverage of FDA-cleared tests but grants CMS sole authority to determine what biomarker levels qualify as 'pre-symptomatic or early-stage' through the standard coverage process, without requiring independent clinical validation or Congressional notification of threshold changes.
Sponsor
Co-sponsors (48)
RSen. Lankford, James [R-OK]DSen. Booker, Cory A. [D-NJ]RSen. Daines, Steve [R-MT]RSen. Scott, Rick [R-FL]RSen. Rounds, Mike [R-SD]DSen. Coons, Christopher A. [D-DE]RSen. Wicker, Roger F. [R-MS]DSen. Hirono, Mazie K. [D-HI]DSen. Cantwell, Maria [D-WA]DSen. Kim, Andy [D-NJ]DSen. Gallego, Ruben [D-AZ]DSen. Padilla, Alex [D-CA]DSen. Peters, Gary C. [D-MI]RSen. Boozman, John [R-AR]DSen. Whitehouse, Sheldon [D-RI]DSen. Cortez Masto, Catherine [D-NV]RSen. Banks, Jim [R-IN]DSen. Duckworth, Tammy [D-IL]RSen. Tillis, Thomas [R-NC]RSen. Murkowski, Lisa [R-AK]+28 more
Vote Record
No recorded votes.
Campaign Finance — Primary Sponsor
Top contributing industries
Other$89,108.7
Finance$25,041.02
Defense$4,500
501(c)(4) disclosure: Contributions from 501(c)(4) "dark money" organizations are not required to be publicly disclosed and are not reflected in the figures above. Data sourced from FEC public disclosure filings.
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