HR842-119

1. Short title This Act may be cited as the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.

2. Medicare coverage of multi-cancer early detection screening tests Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended— in subsection (s)(2)— by striking the semicolon at the end of subparagraph (JJ) and inserting ; and; and by adding at the end the following new subparagraph: multi-cancer early detection screening tests (as defined in subsection (nnn)); by adding at the end the following new subsection: The term multi-cancer early detection screening test means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites 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; is— a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or a test based on samples of biological material that provides results comparable to those obtained with a test described in clause (i), as determined by the Secretary; and the Secretary determines is— reasonable and necessary for the prevention or early detection of an illness or disability; and appropriate for individuals entitled to benefits under part A or enrolled under part B. In making determinations under paragraph (1)(C) regarding the coverage of a new test, the Secretary shall use the process for making national coverage determinations (as defined in section 1869(f)(1)(B)) under this title. Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection: The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is— with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test covered pursuant to section 1861(pp)(1)(D); and with respect to such a test furnished on or after January 1, 2031, equal to the lesser of— the amount described in subparagraph (A); or the payment amount determined for such test under section 1834A. No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if— as of January 1 of such year, such individual has attained the age specified in subparagraph (B) for such year; or such a test was furnished to the individual during the previous 11 months. For purposes of subparagraph (A)(i), the age specified in this subparagraph is— for 2028, 68 years of age; and for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year. In the case of a multi-cancer early detection screening test that is recommended with a grade of A or B by the United States Preventive Services Task Force, beginning on the date on which coverage for such test is provided pursuant to section 1861(ddd)(1), the preceding provisions of this subsection shall not apply. Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended— in subsection (a)— in paragraph (1)(D)(i)(I), by striking section 1834(d)(1) and inserting subsection (d)(1) or (aa) of section 1834; and in paragraph (2)(D)(i)(I), by striking section 1834(d)(1) and inserting subsection (d)(1) or (aa) of section 1834; and in subsection (h), by striking section 1834(d)(1) and inserting subsections (d)(1) and (aa) of section 1834. Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended— in paragraph (1)— in subparagraph (O), by striking and at the end; in subparagraph (P), by striking the semicolon at the end and inserting , and; and by adding at the end the following new subparagraph: in the case of multi-cancer early detection screening tests (as defined in section 1861(nnn)), which are not reasonable and necessary for the concurrent detection of multiple cancer types across multiple organ sites; in paragraph (7), by striking or (P) and inserting (P), or (Q). Nothing in this section, including the amendments made by this section, shall be construed— in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B of title XVIII of the Social Security Act for other cancer screening tests covered under such title, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test. (KK)multi-cancer early detection screening tests (as defined in subsection (nnn));; and (nnn)Multi-Cancer early detection screening tests(1)In generalThe term multi-cancer early detection screening test means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2028, that—(A)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;(B)is—(i)a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or(ii)a test based on samples of biological material that provides results comparable to those obtained with a test described in clause (i), as determined by the Secretary; and(C)the Secretary determines is—(i)reasonable and necessary for the prevention or early detection of an illness or disability; and(ii)appropriate for individuals entitled to benefits under part A or enrolled under part B.(2)NCD processIn making determinations under paragraph (1)(C) regarding the coverage of a new test, the Secretary shall use the process for making national coverage determinations (as defined in section 1869(f)(1)(B)) under this title.. (aa)Payment and standards for multi-Cancer early detection screening tests(1)Payment amountThe payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is—(A)with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test covered pursuant to section 1861(pp)(1)(D); and(B)with respect to such a test furnished on or after January 1, 2031, equal to the lesser of—(i)the amount described in subparagraph (A); or(ii)the payment amount determined for such test under section 1834A.(2)Limitations(A)In generalNo payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if—(i)as of January 1 of such year, such individual has attained the age specified in subparagraph (B) for such year; or(ii)such a test was furnished to the individual during the previous 11 months.(B)Age specifiedFor purposes of subparagraph (A)(i), the age specified in this subparagraph is—(i)for 2028, 68 years of age; and(ii)for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.(3)Standards following USPSTF ratingIn the case of a multi-cancer early detection screening test that is recommended with a grade of A or B by the United States Preventive Services Task Force, beginning on the date on which coverage for such test is provided pursuant to section 1861(ddd)(1), the preceding provisions of this subsection shall not apply.. (Q)in the case of multi-cancer early detection screening tests (as defined in section 1861(nnn)), which are not reasonable and necessary for the concurrent detection of multiple cancer types across multiple organ sites;; and