S892-118

1. Short title This Act may be cited as the Colorectal Cancer Detection Act.

2. Medicare coverage for FDA-approved qualifying colorectal cancer screening blood-based tests Section 1861(pp) of the Social Security Act (42 U.S.C. 1395x(pp)) is amended— in paragraph (1)— by redesignating subparagraph (D) as subparagraph (E); and by inserting after subparagraph (C) the following new subparagraph: Qualifying colorectal cancer screening blood-based test. by adding at the end the following new paragraph: The term qualifying colorectal cancer screening blood-based test means a screening blood-based test for the early detection of colorectal cancer that is 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. Section 1834(d) of the Social Security Act (42 U.S.C. 1395m(d)) is amended— by amending clause (ii) of paragraph (1)(B) to read as follows: if the test is performed within the 11 months after a previous screening fecal-occult blood test or a previous qualifying colorectal cancer screening blood-based test. 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; by amending subparagraph (E) of paragraph (3) to read as follows: No payment may be made under this part for a colorectal cancer screening test consisting of a screening colonoscopy— 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; for individuals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy; or 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. by adding at the end the following new paragraph: The payment amount for colorectal cancer screening tests consisting of qualifying colorectal cancer screening blood-based tests shall be established by the Secretary in accordance with section 1833(h) and section 1834A, as applicable. 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. 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. (D)Qualifying colorectal cancer screening blood-based test.; and (3)The term qualifying colorectal cancer screening blood-based test means a screening blood-based test for the early detection of colorectal cancer that is 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.. (ii)if the test is performed within the 11 months after a previous screening fecal-occult blood test or a previous qualifying colorectal cancer screening blood-based test.; (E)Frequency limitNo 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)Qualifying colorectal cancer screening blood-based tests(A)Payment amountThe payment amount for colorectal cancer screening tests consisting of qualifying colorectal cancer screening blood-based tests shall be established by the Secretary in accordance with section 1833(h) and section 1834A, as applicable.(B)Frequency limitParagraph (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..