HR6130-119

1. Short title This Act may be cited as the Alzheimer’s Screening and Prevention Act of 2025 or the ASAP Act.

2. Medicare coverage of Alzheimer’s disease and related dementias early detection screening tests Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— in subsection (s)(2)— in subparagraph (JJ), by striking the semicolon at the end and inserting ; and; and by adding at the end the following new subparagraph: Alzheimer’s disease and related dementias early detection screening tests (as defined in subsection (nnn)); by adding at the end the following new subsection: The term Alzheimer’s disease and related dementias early detection screening test means a test furnished to an individual for the detection of the pre-symptomatic and early stage of Alzheimer’s disease or related dementias on or after January 1, 2028, that— is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act; and is— a genomic sequencing blood or blood product test; or such other equivalent test, including a single-analyte test, blood test analysis of cell-free nucleic acids, multiplex panel test, whole genome sequencing, protein expression, whole exome, whole transcriptome, and medical imaging (which are based on blood, blood products, tissue, urine or other biospecimen), as the Secretary determines appropriate in providing results comparable to those obtained with a test described in subparagraph (A). Section 1833(h)(1)(A) of the Social Security Act (42 U.S.C. 1395l(h)(1)(A)) is amended by inserting Alzheimer’s disease and related dementias early detection screening tests under section 1861(nnn) and after including. (KK)Alzheimer’s disease and related dementias early detection screening tests (as defined in subsection (nnn));; and (nnn)Alzheimer’s disease and related dementias early detection screening testsThe term Alzheimer’s disease and related dementias early detection screening test means a test furnished to an individual for the detection of the pre-symptomatic and early stage of Alzheimer’s disease or related dementias on or after January 1, 2028, that—(1)is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act; and(2)is—(A)a genomic sequencing blood or blood product test; or(B)such other equivalent test, including a single-analyte test, blood test analysis of cell-free nucleic acids, multiplex panel test, whole genome sequencing, protein expression, whole exome, whole transcriptome, and medical imaging (which are based on blood, blood products, tissue, urine or other biospecimen), as the Secretary determines appropriate in providing results comparable to those obtained with a test described in subparagraph (A)..