Donald Payne, Sr., Colorectal Cancer Detection Act of 2021

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 02:39 Jun 30, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2149.IS S2149 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 2149 IS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Donald Payne, Sr., 2 Colorectal Cancer Detection Act of 2021’’. 3 SEC. 2. MEDICARE COVERAGE FOR FDA-APPROVED QUALI- 4 FYING COLORECTAL CANCER SCREENING 5 BLOOD-BASED TESTS. 6 (a) IN GENERAL.—Section 1861(pp) of the Social Se- 7 curity Act (42 U.S.C. 1395x(pp)) is amended— 8 (1) in paragraph (1)— 9 (A) by redesignating subparagraph (D) as 10 subparagraph (E); and 11 (B) by inserting after subparagraph (C) 12 the following new subparagraph: 13 ‘‘(D) Qualifying colorectal cancer screening 14 blood-based test.’’; and 15 (2) by adding at the end the following new 16 paragraph: 17 ‘‘(3) The term ‘qualifying colorectal cancer screening 18 blood-based test’ means, with respect to a year, a screen- 19 ing blood-based test for the early detection of colorectal 20 cancer furnished in the year that was marketed or used, 21 as applicable, in accordance with the relevant provisions 22 of section 353 of the Public Health Service Act or the 23 Federal Food, Drug, and Cosmetic Act more than 6 24 months before the beginning of the year.’’. 25 VerDate Sep 11 2014 02:39 Jun 30, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2149.IS S2149 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 2149 IS (b) FREQUENCY LIMITS FOR COLORECTAL CANCER 1 SCREENING TESTS AND PAYMENT AMOUNT FOR QUALI- 2 FYING COLORECTAL CANCER SCREENING BLOOD-BASED 3 TESTS.—Section 1834(d) of the Social Security Act (42 4 U.S.C. 1395m(d)) is amended— 5 (1) by amending clause (ii) of paragraph (1)(B) 6 to read as follows: 7 ‘‘(ii) if the test is performed within— 8 ‘‘(I) the 11 months after a pre- 9 vious screening fecal-occult blood test 10 or a previous qualifying colorectal 11 cancer screening blood-based test; 12 ‘‘(II) the 35 months after a pre- 13 vious screening flexible sigmoidoscopy 14 or a previous screening colonoscopy 15 with adenoma findings; 16 ‘‘(III) the 59 months after a pre- 17 vious screening colonoscopy with small 18 polyp findings; or 19 ‘‘(IV) the 119 months after a 20 previous screening colonoscopy with- 21 out adenoma findings or small polyp 22 findings.’’; 23 (2) in paragraph (2)(E)(ii), by inserting ‘‘or 24 within the 35 months after a previous screening 25 VerDate Sep 11 2014 02:39 Jun 30, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2149.IS S2149 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 2149 IS fecal-occult blood test or previous qualifying 1 colorectal cancer screening blood-based test’’ after 2 ‘‘sigmoidoscopy’’; 3 (3) by amending subparagraph (E) of para- 4 graph (3) to read as follows: 5 ‘‘(E) FREQUENCY LIMIT.—No payment 6 may be made under this part for a colorectal 7 cancer screening test consisting of a screening 8 colonoscopy— 9 ‘‘(i) if the procedure is performed 10 within the 11 months after a previous 11 screening fecal-occult blood test or previous 12 qualifying colorectal cancer screening 13 blood-based test; 14 ‘‘(ii) for individuals at high risk for 15 colorectal cancer if the procedure is per- 16 formed within the 23 months after a pre- 17 vious screening colonoscopy; or 18 ‘‘(iii) for individuals not at high risk 19 for colorectal cancer if the procedure is 20 performed within the 119 months after a 21 previous screening colonoscopy or within 22 the 47 months after a previous screening 23 flexible sigmoidoscopy.’’; and 24 VerDate Sep 11 2014 02:39 Jun 30, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2149.IS S2149 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 2149 IS (4) by adding at the end the following new 1 paragraph: 2 ‘‘(4) QUALIFYING COLORECTAL CANCER 3 SCREENING BLOOD-BASED TESTS.— 4 ‘‘(A) PAYMENT AMOUNT.—The payment 5 amount for colorectal cancer screening tests 6 consisting of qualifying colorectal cancer screen- 7 ing blood-based tests shall be established by the 8 Secretary. 9 ‘‘(B) FREQUENCY LIMIT.—Paragraph 10 (1)(B) shall apply to colorectal cancer screening 11 tests consisting of qualifying colorectal cancer 12 screening blood-based tests in the same manner 13 as such paragraph applies to colorectal cancer 14 screening tests consisting of fecal-occult blood 15 tests.’’. 16 (c) EFFECTIVE DATE.—The amendments made by 17 this section shall apply to colorectal cancer screening tests 18 furnished in a year beginning more than 6 months after 19 the date of the enactment of this Act. 20 Æ VerDate Sep 11 2014 02:39 Jun 30, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S2149.IS S2149 pbinns on DSKJLVW7X2PROD with BILLS