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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Donald Payne Sr. 
Colorectal Cancer Detection Act of 2021’’. 
SEC. 2. MEDICARE COVERAGE FOR FDA-APPROVED QUALI-
FYING 
COLORECTAL 
CANCER 
SCREENING 
BLOOD-BASED TESTS. 
(a) IN GENERAL.—Section 1861(pp) of the Social Se-
curity Act (42 U.S.C. 1395x(pp)) is amended— 
(1) in paragraph (1)— 
(A) by redesignating subparagraph (D) as 
subparagraph (E); and 
(B) by inserting after subparagraph (C) 
the following new subparagraph: 
‘‘(D) Qualifying colorectal cancer screening 
blood-based test.’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(3) The term ‘qualifying colorectal cancer screening 
blood-based test’ means, with respect to a year, a screen-
ing blood-based test for the early detection of colorectal 
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cancer furnished in the year that was marketed or used, 
as applicable, in accordance with the relevant provisions 
of section 353 of the Public Health Service Act or the 
Federal Food, Drug, and Cosmetic Act more than 6 
months before the beginning of the year.’’. 
(b) FREQUENCY LIMITS FOR COLORECTAL CANCER 
SCREENING TESTS AND PAYMENT AMOUNT FOR QUALI-
FYING COLORECTAL CANCER SCREENING BLOOD-BASED 
TESTS.—Section 1834(d) of the Social Security Act (42 
U.S.C. 1395m(d)) is amended— 
(1) by amending clause (ii) of paragraph (1)(B) 
to read as follows: 
‘‘(ii) if the test is performed within— 
‘‘(I) the 11 months after a pre-
vious screening fecal-occult blood test 
or a previous qualifying colorectal 
cancer screening blood-based test; 
‘‘(II) the 35 months after a pre-
vious screening flexible sigmoidoscopy 
or a previous screening colonoscopy 
with adenoma findings; 
‘‘(III) the 59 months after a pre-
vious screening colonoscopy with small 
polyp findings; or 
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‘‘(IV) the 119 months after a 
previous screening colonoscopy with-
out adenoma findings or small polyp 
findings.’’; 
(2) in paragraph (2)(E)(ii), by inserting ‘‘or 
within the 35 months after a previous screening 
fecal-occult 
blood 
test 
or 
previous 
qualifying 
colorectal cancer screening blood-based test’’ after 
‘‘sigmoidoscopy’’; 
(3) by amending subparagraph (E) of para-
graph (3) to read as follows: 
‘‘(E) FREQUENCY
LIMIT.—No payment 
may be made under this part for a colorectal 
cancer screening test consisting of a screening 
colonoscopy— 
‘‘(i) if the procedure is performed 
within the 11 months after a previous 
screening fecal-occult blood test or previous 
qualifying 
colorectal 
cancer 
screening 
blood-based test; 
‘‘(ii) for individuals at high risk for 
colorectal cancer if the procedure is per-
formed within the 23 months after a pre-
vious screening colonoscopy; or 
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‘‘(iii) for individuals not at high risk 
for colorectal cancer if the procedure is 
performed within the 119 months after a 
previous screening colonoscopy or within 
the 47 months after a previous screening 
flexible sigmoidoscopy.’’; and 
(4) by adding at the end the following new 
paragraph: 
‘‘(4) 
QUALIFYING
COLORECTAL
CANCER 
SCREENING BLOOD-BASED TESTS.— 
‘‘(A) PAYMENT
AMOUNT.—The payment 
amount for colorectal cancer screening tests 
consisting of qualifying colorectal cancer screen-
ing blood-based tests shall be established by the 
Secretary. 
‘‘(B) 
FREQUENCY
LIMIT.—Paragraph 
(1)(B) shall apply to colorectal cancer screening 
tests consisting of qualifying colorectal cancer 
screening blood-based tests in the same manner 
as such paragraph applies to colorectal cancer 
screening tests consisting of fecal-occult blood 
tests.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to colorectal cancer screening tests 
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furnished in a year beginning more than 6 months after 
the date of the enactment of this Act. 
Æ 
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