HR6130

The ASAP Act, HR6130, mandates Medicare coverage for blood-based dementia screening tests for the detection of pre-symptomatic and early-stage Alzheimer's disease and related dementias, effective January 1, 2028. This coverage applies to tests cleared, classified, or approved by the FDA, including genomic sequencing blood tests, single-analyte tests, blood analysis of cell-free nucleic acids, multiplex panel tests, whole genome sequencing, protein expression, whole exome, whole transcriptome, and medical imaging based on various biospecimens. This legislative action establishes a new, guaranteed revenue stream for diagnostic companies in a previously underserved market. The money trail for this legislation is direct: Medicare will pay for these FDA-approved tests. This creates a new total addressable market (TAM) for diagnostic companies. The Centers for Medicare & Medicaid Services (CMS) will establish payment rates for these tests, ensuring reimbursement for providers. Companies with existing infrastructure for blood-based diagnostics and those actively developing or commercializing FDA-approved Alzheimer's blood tests are positioned to capture this new market. This includes large reference laboratories and specialized diagnostic developers. Historically, similar expansions of Medicare coverage for specific diagnostic tests have led to significant revenue growth for the companies involved. For example, when Medicare expanded coverage for certain cancer screening tests, companies like Exact Sciences ($EXAS) saw substantial increases in test volumes and revenue. While direct historical precedent for blood-based dementia screening is limited due to the novelty of the technology, the expansion of coverage for other diagnostic categories has consistently driven market adoption and financial gains for test providers. The passage of the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015, which reformed physician payment, also highlighted the government's ability to shape healthcare markets through reimbursement policy. Specific winners include large diagnostic laboratories with the infrastructure to process high volumes of blood tests, such as LabCorp ($LH) and Quest Diagnostics ($DGX). Companies specializing in diagnostic test development and commercialization for neurological conditions, particularly those with FDA-approved or late-stage Alzheimer's blood tests, also stand to gain. QuidelOrtho ($QDEL) and Revvity ($RVTY) are examples of companies with relevant diagnostic platforms. The bill's broad definition of covered tests allows for various technological approaches, benefiting a range of innovators. There are no direct losers from this bill, as it expands coverage rather than restricting it. What happens next is that the bill, if passed, will become law. The effective date of January 1, 2028, provides a clear timeline for diagnostic companies to finalize FDA approvals and scale their operations. CMS will then establish the specific reimbursement codes and payment rates for these tests. The bill's sponsorship by Representative Buchanan (R-FL) with 54 cosponsors indicates moderate legislative momentum, particularly given its referral to two key committees, Energy and Commerce and Ways and Means, which have jurisdiction over Medicare policy.