II 118th CONGRESS 1st Session S. 2085 IN THE SENATE OF THE UNITED STATES June 21, 2023 Mr. Crapo (for himself, Mr. Bennet , Mr. Scott of South Carolina , and Mr. Cardin ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

1. Short title This Act may be cited as the Medicare Multi-Cancer Early Detection Screening Coverage Act . 2. Purpose The purpose of this Act is to create a covered benefit for multi-cancer early detection screening tests to ensure Medicare beneficiary access to these tests without unnecessary delay once approved under the Federal Food, Drug, and Cosmetic Act. 3. Medicare coverage of multi-cancer early detection screening tests (a) Coverage Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended— (1) in subsection (s)(2)— (A) by striking the semicolon at the end of subparagraph (JJ) and inserting ; and ; and (B) by adding at the end the following new subparagraph: (KK) multi-cancer early detection screening tests (as defined in subsection (nnn)); ; and (2) by adding at the end the following new subsection: (nnn) Multi-Cancer early detection screening tests The term multi-cancer early detection screening test means any of the following tests, approved or cleared by the Food and Drug Administration, insofar as the Secretary determines coverage of such tests is appropriate, furnished to an individual for the purpose of earlier detection of cancer across many cancer types (such as described in the National Cancer Institute’s Annual Report to the Nation on the Status of Cancer): (1) A genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids. (2) Such other equivalent tests (which are based on blood, blood products, urine, or other sample of biological material) as the Secretary determines appropriate in providing results comparable to those obtained with a test described in paragraph (1). . (b) Payment and frequency limit (1) Payment under fee schedule Section 1833(h) of the Social Security Act ( 42 U.S.C. 1395l(h) ) is amended— (A) in paragraph (1)(A), by inserting after (including the following: multi-cancer early detection screening tests under section 1861(nnn), and including ; and (B) by adding at the end the following new paragraph: (10) No payment may be made under this part for a multi-cancer early detection screening test (as defined in section 1861(nnn)) for an individual if such a test was furnished to the individual during the previous 11 months. . (2) Conforming amendment Section 1862(a) of the Social Security Act ( 42 U.S.C. 1395y(a) ) is amended— (A) in paragraph (1)— (i) in subparagraph (O), by striking and at the end; (ii) in subparagraph (P), by striking the semicolon at the end and inserting , and ; and (iii) by adding at the end the following new subparagraph: (Q) in the case of a multi-cancer early detection screening test (as defined in section 1861(nnn)), which is performed more frequently than is covered under section 1833(h)(10); ; and (B) in paragraph (7), by striking or (P) and inserting (P), or (Q) . (c) Rule of construction relating to other cancer screening tests Nothing in this section, including the amendments made by this section, shall be construed— (1) 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 (2) 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.