II 116th CONGRESS 2d Session S. 5051 IN THE SENATE OF THE UNITED STATES December 17, 2020 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 of 2020 . 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 and at the end of subparagraph (GG); (B) by striking the period at the end of subparagraph (HH) and inserting ; and ; and (C) by adding at the end the following new subparagraph: (II) multi-cancer early detection screening tests (as defined in subsection (kkk)); ; and (2) by adding at the end the following new subsection: (kkk) 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, furnished to an individual for the purpose of early detection of cancer across many cancer types (as categorized in the Annual Report to the Nation on the Status of Cancer issued by the National Cancer Institute): (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 urine or other sample of biological material) as the Secretary determines appropriate. . (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(kkk) 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(kkk)) 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 multi-cancer early detection screening tests (as defined in section 1861(kkk)), which are 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 for other cancer screening tests covered under this 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 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.