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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Multi-Cancer 

5 Early Detection Screening Coverage Act of 2020’’. 

6 SEC. 2. PURPOSE. 

7 The purpose of this Act is to create a covered benefit 

8 for multi-cancer early detection screening tests to ensure 

9 Medicare beneficiary access to these tests without unnecVerDate Sep 11 2014 03:58 Jan 09, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S5051.IS S5051

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1 essary delay once approved under the Federal Food, Drug, 

2 and Cosmetic Act. 

3 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 

4 DETECTION SCREENING TESTS. 

5 (a) COVERAGE.—Section 1861 of the Social Security 

6 Act (42 U.S.C. 1395x) is amended— 

7 (1) in subsection (s)(2)— 

8 (A) by striking ‘‘and’’ at the end of sub9 paragraph (GG); 

10 (B) by striking the period at the end of 

11 subparagraph (HH) and inserting ‘‘; and’’; and 

12 (C) by adding at the end the following new 

13 subparagraph: 

14 ‘‘(II) multi-cancer early detection screening 

15 tests (as defined in subsection (kkk));’’; and 

16 (2) by adding at the end the following new sub17 section: 

18 ‘‘(kkk) MULTI-CANCER EARLY DETECTION SCREEN19 ING TESTS.—The term ‘multi-cancer early detection 

20 screening test’ means any of the following tests, approved 

21 or cleared by the Food and Drug Administration, fur22 nished to an individual for the purpose of early detection 

23 of cancer across many cancer types (as categorized in the 

24 Annual Report to the Nation on the Status of Cancer 

25 issued by the National Cancer Institute): 


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1 ‘‘(1) A genomic sequencing blood or blood prod2 uct test that includes the analysis of cell-free nucleic 

3 acids. 

4 ‘‘(2) Such other equivalent tests (which are 

5 based on urine or other sample of biological mate6 rial) as the Secretary determines appropriate.’’. 

7 (b) PAYMENT AND FREQUENCY LIMIT.— 

8 (1) PAYMENT UNDER FEE SCHEDULE.—Section 

9 1833(h) of the Social Security Act (42 U.S.C. 

10 1395l(h)) is amended— 

11 (A) in paragraph (1)(A), by inserting after 

12 ‘‘(including’’ the following: ‘‘multi-cancer early 

13 detection screening tests under section 

14 1861(kkk) and including’’; and 

15 (B) by adding at the end the following new 

16 paragraph: 

17 ‘‘(10) No payment may be made under this 

18 part for a multi-cancer early detection screening test 

19 (as defined in section 1861(kkk)) for an individual 

20 if such a test was furnished to the individual during 

21 the previous 11 months.’’. 

22 (2) CONFORMING AMENDMENT.—Section 

23 1862(a) of the Social Security Act (42 U.S.C. 

24 1395y(a)) is amended— 

25 (A) in paragraph (1)— 


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1 (i) in subparagraph (O), by striking 

2 ‘‘and’’ at the end; 

3 (ii) in subparagraph (P), by striking 

4 the semicolon at the end and inserting ‘‘, 

5 and’’; and 

6 (iii) by adding at the end the fol7 lowing new subparagraph: 

8 ‘‘(Q) in the case of multi-cancer early de9 tection screening tests (as defined in section 

10 1861(kkk)), which are performed more fre11 quently than is covered under section 

12 1833(h)(10);’’; and 

13 (B) in paragraph (7), by striking ‘‘or (P)’’ 

14 and inserting ‘‘(P), or (Q)’’. 

15 (c) RULE OF CONSTRUCTION RELATING TO OTHER

16 CANCER SCREENING TESTS.—Nothing in this section, in17 cluding the amendments made by this section, shall be 

18 construed— 

19 (1) in the case of an individual who undergoes 

20 a multi-cancer early detection screening test, to af21 fect coverage under part B for other cancer screen22 ing tests covered under this title, such as screening 

23 tests for breast, cervical, colorectal, lung, or prostate 

24 cancer; or 


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1 (2) in the case of an individual who undergoes 

2 another cancer screening test, to affect coverage for 

3 a multi-cancer early detection screening test or the 

4 use of such a test as a diagnostic or confirmatory 

5 test for a result of the other cancer screening test. 

Æ 


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