Donald Payne Sr. Colorectal Cancer Detection Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 1655 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 HOUSE OF REPRESENTATIVES MARCH 8, 2021 Mr. PAYNE (for himself, Mr. FITZPATRICK, Ms. SPANBERGER, Mr. MCEACHIN, Mr. GARAMENDI, Ms. SEWELL, Mr. DANNY K. DAVIS of Illi- nois, Mr. HASTINGS, Ms. LEE of California, Mr. TORRES of New York, Ms. BASS, Ms. PRESSLEY, Mr. THOMPSON of Mississippi, Mr. PERRY, Mr. MEEKS, Ms. STRICKLAND, Mr. BUTTERFIELD, Mr. LAWSON of Flor- ida, Mrs. WATSON COLEMAN, Ms. JOHNSON of Texas, Mr. RASKIN, Ms. ADAMS, Ms. CLARKE of New York, Ms. WILSON of Florida, Mr. TRONE, Mrs. MCBATH, Mr. SIRES, Mr. RUSH, Ms. NORTON, Ms. KELLY of Illi- nois, Mr. JOHNSON of Georgia, Mr. RODNEY DAVIS of Illinois, Mr. BROWN, Mr. BISHOP of Georgia, Mr. CARSON, Mr. GREEN of Texas, Mr. MCKINLEY, Mr. JEFFRIES, Ms. PLASKETT, Mrs. BEATTY, Ms. BLUNT ROCHESTER, Mr. CLEAVER, Ms. MCCOLLUM, Mr. VEASEY, Ms. WIL- LIAMS of Georgia, Mr. ALLRED, and Mrs. DEMINGS) introduced the fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on Ways and Means, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee concerned 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, VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1655 IH 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Donald Payne Sr. 4 Colorectal Cancer Detection Act of 2021’’. 5 SEC. 2. MEDICARE COVERAGE FOR FDA-APPROVED QUALI- 6 FYING COLORECTAL CANCER SCREENING 7 BLOOD-BASED TESTS. 8 (a) IN GENERAL.—Section 1861(pp) of the Social Se- 9 curity Act (42 U.S.C. 1395x(pp)) is amended— 10 (1) in paragraph (1)— 11 (A) by redesignating subparagraph (D) as 12 subparagraph (E); and 13 (B) by inserting after subparagraph (C) 14 the following new subparagraph: 15 ‘‘(D) Qualifying colorectal cancer screening 16 blood-based test.’’; and 17 (2) by adding at the end the following new 18 paragraph: 19 ‘‘(3) The term ‘qualifying colorectal cancer screening 20 blood-based test’ means, with respect to a year, a screen- 21 ing blood-based test for the early detection of colorectal 22 VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1655 IH cancer furnished in the year that was marketed or used, 1 as applicable, in accordance with the relevant provisions 2 of section 353 of the Public Health Service Act or the 3 Federal Food, Drug, and Cosmetic Act more than 6 4 months before the beginning of the year.’’. 5 (b) FREQUENCY LIMITS FOR COLORECTAL CANCER 6 SCREENING TESTS AND PAYMENT AMOUNT FOR QUALI- 7 FYING COLORECTAL CANCER SCREENING BLOOD-BASED 8 TESTS.—Section 1834(d) of the Social Security Act (42 9 U.S.C. 1395m(d)) is amended— 10 (1) by amending clause (ii) of paragraph (1)(B) 11 to read as follows: 12 ‘‘(ii) if the test is performed within— 13 ‘‘(I) the 11 months after a pre- 14 vious screening fecal-occult blood test 15 or a previous qualifying colorectal 16 cancer screening blood-based test; 17 ‘‘(II) the 35 months after a pre- 18 vious screening flexible sigmoidoscopy 19 or a previous screening colonoscopy 20 with adenoma findings; 21 ‘‘(III) the 59 months after a pre- 22 vious screening colonoscopy with small 23 polyp findings; or 24 VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1655 IH ‘‘(IV) the 119 months after a 1 previous screening colonoscopy with- 2 out adenoma findings or small polyp 3 findings.’’; 4 (2) in paragraph (2)(E)(ii), by inserting ‘‘or 5 within the 35 months after a previous screening 6 fecal-occult blood test or previous qualifying 7 colorectal cancer screening blood-based test’’ after 8 ‘‘sigmoidoscopy’’; 9 (3) by amending subparagraph (E) of para- 10 graph (3) to read as follows: 11 ‘‘(E) FREQUENCY LIMIT.—No payment 12 may be made under this part for a colorectal 13 cancer screening test consisting of a screening 14 colonoscopy— 15 ‘‘(i) if the procedure is performed 16 within the 11 months after a previous 17 screening fecal-occult blood test or previous 18 qualifying colorectal cancer screening 19 blood-based test; 20 ‘‘(ii) for individuals at high risk for 21 colorectal cancer if the procedure is per- 22 formed within the 23 months after a pre- 23 vious screening colonoscopy; or 24 VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 1655 IH ‘‘(iii) for individuals not at high risk 1 for colorectal cancer if the procedure is 2 performed within the 119 months after a 3 previous screening colonoscopy or within 4 the 47 months after a previous screening 5 flexible sigmoidoscopy.’’; and 6 (4) by adding at the end the following new 7 paragraph: 8 ‘‘(4) QUALIFYING COLORECTAL CANCER 9 SCREENING BLOOD-BASED TESTS.— 10 ‘‘(A) PAYMENT AMOUNT.—The payment 11 amount for colorectal cancer screening tests 12 consisting of qualifying colorectal cancer screen- 13 ing blood-based tests shall be established by the 14 Secretary. 15 ‘‘(B) FREQUENCY LIMIT.—Paragraph 16 (1)(B) shall apply to colorectal cancer screening 17 tests consisting of qualifying colorectal cancer 18 screening blood-based tests in the same manner 19 as such paragraph applies to colorectal cancer 20 screening tests consisting of fecal-occult blood 21 tests.’’. 22 (c) EFFECTIVE DATE.—The amendments made by 23 this section shall apply to colorectal cancer screening tests 24 VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 1655 IH furnished in a year beginning more than 6 months after 1 the date of the enactment of this Act. 2 Æ VerDate Sep 11 2014 18:45 May 07, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H1655.IH H1655 pamtmann on DSKBC07HB2PROD with BILLS