H.R. 6130: Alzheimer’s Screening and Prevention Act of 2025

This bill, known as the Alzheimer’s Screening and Prevention Act of 2025 (or ASAP Act), proposes changes to Medicare that would expand coverage for early detection tests related to Alzheimer's disease and other dementias. The purpose of the bill is to facilitate the detection of Alzheimer's and related conditions at earlier stages, potentially improving treatment and care options.

Key Provisions of the Bill

1. Medicare Coverage Expansion

The bill seeks to amend the Social Security Act to include coverage for specific early detection screening tests for Alzheimer's disease and related dementias. This includes:

• Tests that are performed on or after January 1, 2028.
• Screening tests that are cleared, classified, or approved under the Federal Food, Drug, and Cosmetic Act.
• Blood-based tests that can identify pre-symptomatic and early-stage Alzheimer's disease.

2. Definition of Early Detection Tests

The bill clearly defines what constitutes an "Alzheimer’s disease and related dementias early detection screening test." Such tests include:

• Genomic sequencing blood or blood product tests.
• Other equivalent tests such as:
• Single-analyte tests
• Blood tests analyzing cell-free nucleic acids
• Multiplex panel tests
• Whole genome sequencing
• Protein expression tests
• Whole exome and whole transcriptome tests
• Medical imaging based on various biospecimens, including blood and urine.

3. Payment Adjustments

The bill calls for adjustments to the payment provisions related to Medicare coverage. It specifies that the costs for these early detection screening tests will be included under Medicare, ensuring providers are compensated for administering such tests.

Implementation Timeline

The expanded coverage for these screening tests would not take effect until the specified date of January 1, 2028, providing time for the necessary regulatory and administrative changes to be made.

Relevant Companies

• AGEF - Companies engaged in developing blood tests or diagnostic tools for Alzheimer’s and other dementias may see an increase in demand for their products as a result of this bill.
• ABT - Abbott Laboratories produces diagnostic tests and could be significantly involved in developing or providing blood-based Alzheimer’s screening tests.
• SNY - Sanofi has initiatives in CNS-related therapies and diagnostics, which could benefit from the increased focus on early detection of Alzheimer’s disease facilitated by this legislation.