Medicare Multi-Cancer Early Detection Screening Coverage Act of 2020

II 116TH CONGRESS 2D SESSION S. 5051 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests. 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medicare Multi-Cancer 4 Early Detection Screening Coverage Act of 2020’’. 5 SEC. 2. PURPOSE. 6 The purpose of this Act is to create a covered benefit 7 for multi-cancer early detection screening tests to ensure 8 Medicare beneficiary access to these tests without unnec- 9 VerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S5051.IS S5051 kjohnson on DSK79L0C42PROD with BILLS 2 •S 5051 IS essary delay once approved under the Federal Food, Drug, 1 and Cosmetic Act. 2 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 3 DETECTION SCREENING TESTS. 4 (a) COVERAGE.—Section 1861 of the Social Security 5 Act (42 U.S.C. 1395x) is amended— 6 (1) in subsection (s)(2)— 7 (A) by striking ‘‘and’’ at the end of sub- 8 paragraph (GG); 9 (B) by striking the period at the end of 10 subparagraph (HH) and inserting ‘‘; and’’; and 11 (C) by adding at the end the following new 12 subparagraph: 13 ‘‘(II) multi-cancer early detection screening 14 tests (as defined in subsection (kkk));’’; and 15 (2) by adding at the end the following new sub- 16 section: 17 ‘‘(kkk) MULTI-CANCER EARLY DETECTION SCREEN- 18 ING TESTS.—The term ‘multi-cancer early detection 19 screening test’ means any of the following tests, approved 20 or cleared by the Food and Drug Administration, fur- 21 nished to an individual for the purpose of early detection 22 of cancer across many cancer types (as categorized in the 23 Annual Report to the Nation on the Status of Cancer 24 issued by the National Cancer Institute): 25 VerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5051.IS S5051 kjohnson on DSK79L0C42PROD with BILLS 3 •S 5051 IS ‘‘(1) A genomic sequencing blood or blood prod- 1 uct test that includes the analysis of cell-free nucleic 2 acids. 3 ‘‘(2) Such other equivalent tests (which are 4 based on urine or other sample of biological mate- 5 rial) as the Secretary determines appropriate.’’. 6 (b) PAYMENT AND FREQUENCY LIMIT.— 7 (1) PAYMENT UNDER FEE SCHEDULE.—Section 8 1833(h) of the Social Security Act (42 U.S.C. 9 1395l(h)) is amended— 10 (A) in paragraph (1)(A), by inserting after 11 ‘‘(including’’ the following: ‘‘multi-cancer early 12 detection screening tests under section 13 1861(kkk) and including’’; and 14 (B) by adding at the end the following new 15 paragraph: 16 ‘‘(10) No payment may be made under this 17 part for a multi-cancer early detection screening test 18 (as defined in section 1861(kkk)) for an individual 19 if such a test was furnished to the individual during 20 the previous 11 months.’’. 21 (2) CONFORMING AMENDMENT.—Section 22 1862(a) of the Social Security Act (42 U.S.C. 23 1395y(a)) is amended— 24 (A) in paragraph (1)— 25 VerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S5051.IS S5051 kjohnson on DSK79L0C42PROD with BILLS 4 •S 5051 IS (i) in subparagraph (O), by striking 1 ‘‘and’’ at the end; 2 (ii) in subparagraph (P), by striking 3 the semicolon at the end and inserting ‘‘, 4 and’’; and 5 (iii) by adding at the end the fol- 6 lowing new subparagraph: 7 ‘‘(Q) in the case of multi-cancer early de- 8 tection screening tests (as defined in section 9 1861(kkk)), which are performed more fre- 10 quently than is covered under section 11 1833(h)(10);’’; and 12 (B) in paragraph (7), by striking ‘‘or (P)’’ 13 and inserting ‘‘(P), or (Q)’’. 14 (c) RULE OF CONSTRUCTION RELATING TO OTHER 15 CANCER SCREENING TESTS.—Nothing in this section, in- 16 cluding the amendments made by this section, shall be 17 construed— 18 (1) in the case of an individual who undergoes 19 a multi-cancer early detection screening test, to af- 20 fect coverage under part B for other cancer screen- 21 ing tests covered under this title, such as screening 22 tests for breast, cervical, colorectal, lung, or prostate 23 cancer; or 24 VerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S5051.IS S5051 kjohnson on DSK79L0C42PROD with BILLS 5 •S 5051 IS (2) in the case of an individual who undergoes 1 another cancer screening test, to affect coverage for 2 a multi-cancer early detection screening test or the 3 use of such a test as a diagnostic or confirmatory 4 test for a result of the other cancer screening test. 5 Æ VerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S5051.IS S5051 kjohnson on DSK79L0C42PROD with BILLS