II 

115TH CONGRESS 

2D SESSION S. 2523 

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, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2018 

Mrs. CAPITO (for herself and Mr. HEINRICH) 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, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Colorectal Cancer De5 tection Act of 2018’’. 


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•S 2523 IS

1 SEC. 2. MEDICARE COVERAGE FOR FDA-APPROVED QUALI2 FYING COLORECTAL CANCER SCREENING 

3 BLOOD-BASED TESTS. 

4 (a) IN GENERAL.—Section 1861(pp) of the Social Se5 curity Act (42 U.S.C. 1395x(pp)) is amended— 

6 (1) in paragraph (1)— 

7 (A) by redesignating subparagraph (D) as 

8 subparagraph (E); and 

9 (B) by inserting after subparagraph (C) 

10 the following new subparagraph: 

11 ‘‘(D) Qualifying colorectal cancer screening 

12 blood-based test.’’; and 

13 (2) by adding at the end the following new 

14 paragraph: 

15 ‘‘(3) The term ‘qualifying colorectal cancer screening 

16 blood-based test’ means, with respect to a year, a screen17 ing blood-based test for the early detection of colorectal 

18 cancer furnished in the year that was marketed or used, 

19 as applicable, in accordance with the relevant provisions 

20 of section 353 of the Public Health Service Act or the 

21 Federal Food, Drug, and Cosmetic Act more than 6 

22 months before the beginning of the year.’’. 

23 (b) FREQUENCY LIMITS FOR COLORECTAL CANCER

24 SCREENING TESTS AND PAYMENT AMOUNT FOR QUALI25 FYING COLORECTAL CANCER SCREENING BLOOD-BASED


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•S 2523 IS

1 TESTS.—Section 1834(d) of the Social Security Act (42 

2 U.S.C. 1395m(d)) is amended— 

3 (1) by amending clause (ii) of paragraph (1)(B) 

4 to read as follows: 

5 ‘‘(ii) if the test is performed within— 

6 ‘‘(I) the 11 months after a pre7 vious screening fecal-occult blood test 

8 or a previous qualifying colorectal 

9 cancer screening blood-based test; 

10 ‘‘(II) the 35 months after a pre11 vious screening flexible sigmoidoscopy 

12 or a previous screening colonoscopy 

13 with adenoma findings; 

14 ‘‘(III) the 59 months after a pre15 vious screening colonoscopy with small 

16 polyp findings; or 

17 ‘‘(IV) the 119 months after a 

18 previous screening colonoscopy with19 out adenoma findings or small polyp 

20 findings.’’; 

21 (2) in paragraph (2)(E)(ii), by inserting ‘‘or 

22 within the 35 months after a previous screening 

23 fecal-occult blood test or previous qualifying 

24 colorectal cancer screening blood-based test’’ after 

25 ‘‘sigmoidoscopy’’; 


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•S 2523 IS

1 (3) by amending subparagraph (E) of para2 graph (3) to read as follows: 

3 ‘‘(E) FREQUENCY LIMIT.—No payment 

4 may be made under this part for a colorectal 

5 cancer screening test consisting of a screening 

6 colonoscopy— 

7 ‘‘(i) if the procedure is performed 

8 within the 119 months after a previous 

9 screening fecal-occult blood test or previous 

10 qualifying colorectal cancer screening 

11 blood-based test; 

12 ‘‘(ii) for individuals at high risk for 

13 colorectal cancer if the procedure is per14 formed within the 23 months after a pre15 vious screening colonoscopy; or 

16 ‘‘(iii) for individuals not at high risk 

17 for colorectal cancer if the procedure is 

18 performed within the 119 months after a 

19 previous screening colonoscopy or within 

20 the 47 months after a previous screening 

21 flexible sigmoidoscopy.’’; and 

22 (4) by adding at the end the following new 

23 paragraph: 

24 ‘‘(4) QUALIFYING COLORECTAL CANCER

25 SCREENING BLOOD-BASED TESTS.— 


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•S 2523 IS

1 ‘‘(A) PAYMENT AMOUNT.—The payment 

2 amount for colorectal cancer screening tests 

3 consisting of qualifying colorectal cancer screen4 ing blood-based tests shall be established by the 

5 Secretary based on a crosswalk to payment 

6 amounts for tests for the diagnosis of inherited 

7 colorectal cancer by methylation methods. 

8 ‘‘(B) FREQUENCY LIMIT.—Paragraph 

9 (1)(B) shall apply to colorectal cancer screening 

10 tests consisting of qualifying colorectal cancer 

11 screening blood-based tests in the same manner 

12 as such paragraph applies to colorectal cancer 

13 screening tests consisting of fecal-occult blood 

14 tests.’’. 

15 (c) EFFECTIVE DATE.—The amendments made by 

16 this section shall apply to colorectal cancer screening tests 

17 furnished in a year beginning more than 6 months after 

18 the date of the enactment of this Act. 

Æ 


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