ASAP Act
- Bill Number
- H.R. 6130
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-09-16: Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 40 - 0.
- Last Updated
- 2026-10-10T08:05:50Z
AI-Generated Summary
Purpose
The Alzheimer's Screening and Prevention Act of 2025 (H.R. 6130), also known as the ASAP Act, aims to expand Medicare coverage to include early detection screening tests for Alzheimer's disease and related dementias. This legislation seeks to enable earlier identification of these conditions through blood-based and similar tests, potentially improving health outcomes for older adults.
Key Provisions
- Coverage Addition: Amends Section 1861 of the Social Security Act to include "Alzheimer's disease and related dementias early detection screening tests" as a covered Medicare benefit under preventive services (subsection (s)(2)).
- Definition of Covered Tests (new subsection (nnn)):
- Tests must detect pre-symptomatic (before symptoms appear) or early-stage Alzheimer's disease or related dementias.
- Coverage begins on January 1, 2028.
- Tests must be approved, cleared, or classified by the Food and Drug Administration (FDA) through processes like 510(k) clearance (for devices similar to existing ones), de novo classification (for novel low-risk devices), or premarket approval (PMA) for higher-risk devices.
- Eligible test types include:
- Genomic sequencing tests using blood or blood products.
- Equivalent tests, such as single-analyte blood tests (measuring one specific marker), analysis of cell-free nucleic acids in blood, multiplex panel tests (testing multiple markers), whole genome or exome sequencing, protein expression analysis, whole transcriptome tests, or medical imaging based on blood, tissue, urine, or other biospecimens—as determined by the Secretary of Health and Human Services to provide comparable results.
- Payment Mechanism: Amends Section 1833 of the Social Security Act to include payment for these tests under the clinical diagnostic laboratory fee schedule, similar to other lab tests.
Significant Changes to Existing Law
- Expansion of Medicare Benefits: Previously, Medicare covered certain preventive screenings but did not specifically include blood-based or biospecimen-based tests for early dementia detection. This bill adds a new category of covered services, integrating them into existing preventive care and laboratory payment structures without requiring prior authorization or cost-sharing for beneficiaries.
- FDA Integration: Ties coverage directly to FDA regulatory approvals, ensuring only validated, safe tests qualify, which standardizes eligibility beyond current Medicare lab coverage rules.
Potential Impacts
- On Citizens: Medicare beneficiaries, particularly those aged 65 and older at higher risk for dementia, gain access to no-cost early screening tests starting in 2028. This could lead to earlier diagnosis, better management of conditions, and potentially reduced long-term care needs, though it may increase overall healthcare utilization initially.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to update coverage guidelines, implement payment systems, and determine "equivalent" tests, possibly increasing administrative workload and program costs (estimated impacts not specified in the bill). The FDA's role in approvals remains unchanged but gains indirect importance for Medicare eligibility.
- On International Relations: No direct impacts; the bill focuses on domestic U.S. healthcare policy.
Main Stakeholders Affected
- Medicare Beneficiaries: Primary beneficiaries, especially older adults and those with family history of dementia, who will have new access to preventive screenings.
- Healthcare Providers: Doctors and clinics that can now bill Medicare for these tests, potentially increasing their role in early dementia detection.
- Diagnostic and Biotech Companies: Firms developing blood-based or biospecimen tests (e.g., genomic or imaging-based) that meet FDA standards, as coverage could boost demand and market growth.
- Government Entities: CMS for implementation and payment; congressional committees (Energy and Commerce, Ways and Means) for oversight; and the Department of Health and Human Services for test equivalency determinations.
- Advocacy Groups: Organizations focused on Alzheimer's and dementia, such as the Alzheimer's Association, which may support broader access to care.
Notable Legal, Constitutional, or Political Implications
- Legal Implications: Strengthens Medicare's preventive care framework under the Social Security Act by explicitly adding dementia screenings, aligning with broader trends in value-based care (focusing on prevention to lower future costs). It avoids creating new entitlements by fitting within existing payment structures, reducing legal challenges related to unfunded mandates.
- Constitutional Implications: None significant; the bill operates within Congress's enumerated powers to regulate interstate commerce and spend for the general welfare, particularly in healthcare for seniors.
- Political Implications: Bipartisan introduction (by Reps. Buchanan (R) and Tonko (D)) signals potential broad support for addressing the growing dementia crisis (affecting millions of Americans). It could influence future healthcare budgets, with debates over costs versus long-term savings from early intervention, but does not alter broader Medicare financing or eligibility rules.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (230)
Rep. Tonko, Paul [D-NY-20], Rep. Kennedy, Timothy M. [D-NY-26], Rep. Kiggans, Jennifer A. [R-VA-2], Rep. Torres, Ritchie [D-NY-15], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Kelly, Mike [R-PA-16], Rep. Ezell, Mike [R-MS-4], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Kim, Young [R-CA-40], Rep. Malliotakis, Nicole [R-NY-11], Rep. Latimer, George [D-NY-16], Rep. Soto, Darren [D-FL-9], Rep. Neguse, Joe [D-CO-2], Rep. Hayes, Jahana [D-CT-5], Rep. Thompson, Mike [D-CA-4], Rep. Gonzalez, Vicente [D-TX-34], Rep. Subramanyam, Suhas [D-VA-10], Rep. Carson, André [D-IN-7], Rep. Wittman, Robert J. [R-VA-1], Rep. Cole, Tom [R-OK-4], Rep. Balint, Becca [D-VT-At Large], Rep. Gottheimer, Josh [D-NJ-5], Rep. Lawler, Michael [R-NY-17], Rep. Salazar, Maria Elvira [R-FL-27], Rep. Sorensen, Eric [D-IL-17], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Morrison, Kelly [D-MN-3], Rep. Dingell, Debbie [D-MI-6], Rep. Rutherford, John H. [R-FL-5], Rep. Smith, Christopher H. [R-NJ-4], Rep. Craig, Angie [D-MN-2], Rep. Cisneros, Gilbert Ray [D-CA-31], Rep. Davids, Sharice [D-KS-3], Rep. Huizenga, Bill [R-MI-4], Rep. Lieu, Ted [D-CA-36], Rep. Mackenzie, Ryan [R-PA-7], Rep. Tlaib, Rashida [D-MI-12], Rep. Pocan, Mark [D-WI-2], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. LaLota, Nick [R-NY-1], Rep. Ryan, Patrick [D-NY-18], Rep. McDowell, Addison P. [R-NC-6], Rep. Norcross, Donald [D-NJ-1], Rep. McBride, Sarah [D-DE-At Large], Rep. Miller, Carol D. [R-WV-1], Rep. Ciscomani, Juan [R-AZ-6], Rep. Crow, Jason [D-CO-6], Rep. Mullin, Kevin [D-CA-15], Rep. Pfluger, August [R-TX-11] and 180 more
Recent Actions
- 2026-09-16: Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 40 - 0.
- 2026-09-16: Committee Consideration and Mark-up Session Held
- 2025-11-19: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-11-19: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-11-19: Introduced in House
- 2025-11-19: Introduced in House
Bill Versions
- Alzheimer’s Screening and Prevention Act of 2025 — issued 2025-11-19 — PDF (3 pages)