II 

117TH CONGRESS 

1ST SESSION S. 2149 

To amend title XVIII of the Social Security Act to provide coverage under 

the Medicare program for FDA-approved qualifying colorectal cancer 

screening blood-based tests, to increase participation in colorectal cancer 

screening in under-screened communities of color, to offset the COVID– 

19 pandemic driven declines in colorectal cancer screening, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 21, 2021 

Mr. HEINRICH (for himself, Mr. WICKER, and Mr. PADILLA) 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 

coverage under the Medicare program for FDA-approved 

qualifying colorectal cancer screening blood-based tests, 

to increase participation in colorectal cancer screening 

in under-screened communities of color, to offset the 

COVID–19 pandemic driven declines in colorectal cancer 

screening, and for other purposes. 

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


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•S 2149 IS

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Donald Payne, Sr., 

3 Colorectal Cancer Detection Act of 2021’’. 

4 SEC. 2. MEDICARE COVERAGE FOR FDA-APPROVED QUALI5 FYING COLORECTAL CANCER SCREENING 

6 BLOOD-BASED TESTS. 

7 (a) IN GENERAL.—Section 1861(pp) of the Social Se8 curity Act (42 U.S.C. 1395x(pp)) is amended— 

9 (1) in paragraph (1)— 

10 (A) by redesignating subparagraph (D) as 

11 subparagraph (E); and 

12 (B) by inserting after subparagraph (C) 

13 the following new subparagraph: 

14 ‘‘(D) Qualifying colorectal cancer screening 

15 blood-based test.’’; and 

16 (2) by adding at the end the following new 

17 paragraph: 

18 ‘‘(3) The term ‘qualifying colorectal cancer screening 

19 blood-based test’ means, with respect to a year, a screen20 ing blood-based test for the early detection of colorectal 

21 cancer furnished in the year that was marketed or used, 

22 as applicable, in accordance with the relevant provisions 

23 of section 353 of the Public Health Service Act or the 

24 Federal Food, Drug, and Cosmetic Act more than 6 

25 months before the beginning of the year.’’. 


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•S 2149 IS

1 (b) FREQUENCY LIMITS FOR COLORECTAL CANCER

2 SCREENING TESTS AND PAYMENT AMOUNT FOR QUALI3 FYING COLORECTAL CANCER SCREENING BLOOD-BASED

4 TESTS.—Section 1834(d) of the Social Security Act (42 

5 U.S.C. 1395m(d)) is amended— 

6 (1) by amending clause (ii) of paragraph (1)(B) 

7 to read as follows: 

8 ‘‘(ii) if the test is performed within— 

9 ‘‘(I) the 11 months after a pre10 vious screening fecal-occult blood test 

11 or a previous qualifying colorectal 

12 cancer screening blood-based test; 

13 ‘‘(II) the 35 months after a pre14 vious screening flexible sigmoidoscopy 

15 or a previous screening colonoscopy 

16 with adenoma findings; 

17 ‘‘(III) the 59 months after a pre18 vious screening colonoscopy with small 

19 polyp findings; or 

20 ‘‘(IV) the 119 months after a 

21 previous screening colonoscopy with22 out adenoma findings or small polyp 

23 findings.’’; 

24 (2) in paragraph (2)(E)(ii), by inserting ‘‘or 

25 within the 35 months after a previous screening 


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•S 2149 IS

1 fecal-occult blood test or previous qualifying 

2 colorectal cancer screening blood-based test’’ after 

3 ‘‘sigmoidoscopy’’; 

4 (3) by amending subparagraph (E) of para5 graph (3) to read as follows: 

6 ‘‘(E) FREQUENCY LIMIT.—No payment 

7 may be made under this part for a colorectal 

8 cancer screening test consisting of a screening 

9 colonoscopy— 

10 ‘‘(i) if the procedure is performed 

11 within the 11 months after a previous 

12 screening fecal-occult blood test or previous 

13 qualifying colorectal cancer screening 

14 blood-based test; 

15 ‘‘(ii) for individuals at high risk for 

16 colorectal cancer if the procedure is per17 formed within the 23 months after a pre18 vious screening colonoscopy; or 

19 ‘‘(iii) for individuals not at high risk 

20 for colorectal cancer if the procedure is 

21 performed within the 119 months after a 

22 previous screening colonoscopy or within 

23 the 47 months after a previous screening 

24 flexible sigmoidoscopy.’’; and 


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•S 2149 IS

1 (4) by adding at the end the following new 

2 paragraph: 

3 ‘‘(4) QUALIFYING COLORECTAL CANCER

4 SCREENING BLOOD-BASED TESTS.— 

5 ‘‘(A) PAYMENT AMOUNT.—The payment 

6 amount for colorectal cancer screening tests 

7 consisting of qualifying colorectal cancer screen8 ing blood-based tests shall be established by the 

9 Secretary. 

10 ‘‘(B) FREQUENCY LIMIT.—Paragraph 

11 (1)(B) shall apply to colorectal cancer screening 

12 tests consisting of qualifying colorectal cancer 

13 screening blood-based tests in the same manner 

14 as such paragraph applies to colorectal cancer 

15 screening tests consisting of fecal-occult blood 

16 tests.’’. 

17 (c) EFFECTIVE DATE.—The amendments made by 

18 this section shall apply to colorectal cancer screening tests 

19 furnished in a year beginning more than 6 months after 

20 the date of the enactment of this Act. 

Æ 


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