HR6130-119

What This Bill Does

The ASAP Act amends Medicare to cover early detection screening tests for Alzheimer disease and related dementias. Beginning January 1, 2028, the covered tests are used to detect pre-symptomatic or early-stage disease and must be cleared under FDA section 510(k), classified under section 513(f)(2), or approved under section 515 of the Food, Drug, and Cosmetic Act. The bill includes genomic sequencing blood or blood-product tests and other equivalent tests that HHS determines provide comparable results, including single-analyte tests, cell-free nucleic acid blood tests, multiplex panels, whole genome sequencing, protein expression, whole exome, whole transcriptome, and medical imaging based on blood, blood products, tissue, urine, or other biospecimens. It also adds the tests to Medicare clinical laboratory payment coverage.

Who Benefits and How

Medicare beneficiaries at risk for Alzheimer disease or related dementias benefit from covered early detection tests. Patients and families benefit from earlier information for diagnosis, care planning, and treatment conversations. Diagnostic test developers benefit from a Medicare coverage pathway for qualifying early detection tests. Memory disorder clinicians benefit from covered tests that can detect early-stage disease. Clinical laboratories benefit from Medicare payment coverage for qualifying screening tests.

Who Bears the Burden and How

Medicare Part B financing bears the cost of covering qualifying tests. CMS must update coverage, billing, and laboratory payment rules by January 1, 2028. HHS must decide which equivalent tests produce comparable results. Diagnostic manufacturers must obtain FDA clearance, classification, or approval. Providers and laboratories must code, document, and bill the new screening benefit correctly.

Key Provisions

• Adds Medicare coverage for Alzheimer disease and related dementias early detection screening tests.
• Starts coverage for tests furnished on or after January 1, 2028.
• Requires tests to be FDA-cleared, classified, or approved.
• Includes genomic blood tests and comparable biospecimen, protein, genome, transcriptome, and imaging tests.
• Adds the tests to Medicare clinical laboratory payment coverage.