Alzheimer's Screening and Prevention Act
A BILL
To amend title XVIII of the Social Security Act to provide for Medicare coverage of blood-based dementia screening tests.
Sec. 2 Medicare coverage of Alzheimer’s disease and related dementias early detection screening tests
“(KK) Alzheimer’s disease and related dementias early detection screening tests (as defined in subsection (nnn));”
“(nnn) Alzheimer’s disease and related dementias early detection screening tests—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—
“(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).”