II 117th CONGRESS 1st Session S. 2149 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. Short title This Act may be cited as the Donald Payne, Sr., Colorectal Cancer Detection Act of 2021 . 2. Medicare coverage for FDA-approved qualifying colorectal cancer screening blood-based tests (a) In general Section 1861(pp) of the Social Security 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 screening blood-based test for the early detection of colorectal 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 qualifying 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 previous screening fecal-occult blood test or a previous qualifying colorectal cancer screening blood-based test; (II) the 35 months after a previous screening flexible sigmoidoscopy or a previous screening colonoscopy with adenoma findings; (III) the 59 months after a previous screening colonoscopy with small polyp findings; or (IV) the 119 months after a previous screening colonoscopy without 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 paragraph (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 performed within the 23 months after a previous screening colonoscopy; or (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 screening 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 furnished in a year beginning more than 6 months after the date of the enactment of this Act.