IIB 

116TH CONGRESS 

2D SESSION H. R. 1570 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 10, 2020 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend title XVIII of the Social Security Act to waive 

coinsurance under Medicare for colorectal cancer screening tests, regardless of whether therapeutic intervention 

is required during the screening, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Removing Barriers to 

3 Colorectal Cancer Screening Act of 2020’’. 

4 SEC. 2. WAIVING MEDICARE COINSURANCE FOR CERTAIN 

5 COLORECTAL CANCER SCREENING TESTS. 

6 (a) IN GENERAL.—Section 1833(a) of the Social Se7 curity Act (42 U.S.C. 1395l(a)) is amended— 

8 (1) in the second sentence, by striking ‘‘section 

9 1834(0)’’ and inserting ‘‘section 1834(o)’’; 

10 (2) by moving such second sentence 2 ems to 

11 the left; and 

12 (3) by inserting the following third sentence fol13 lowing such second sentence: ‘‘For services furnished 

14 on or after January 1, 2022, paragraph (1)(Y) shall 

15 apply with respect to a colorectal cancer screening 

16 test regardless of the code that is billed for the es17 tablishment of a diagnosis as a result of the test, or 

18 for the removal of tissue or other matter or other 

19 procedure that is furnished in connection with, as a 

20 result of, and in the same clinical encounter as the 

21 screening test.’’. 

22 (b) SPECIAL COINSURANCE RULE FOR CERTAIN

23 TESTS.—Section 1833 of the Social Security Act (42 

24 U.S.C. 1395l) is amended— 


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1 (1) in subsection (a)(1)(Y), by inserting ‘‘sub2 ject to subsection (dd),’’ before ‘‘with respect to’’; 

3 and 

4 (2) by adding at the end the following new sub5 section: 

6 ‘‘(dd) SPECIAL COINSURANCE RULE FOR CERTAIN

7 COLORECTAL CANCER SCREENING TESTS.— 

8 ‘‘(1) IN GENERAL.—In the case of a colorectal 

9 cancer screening test to which paragraph (1)(Y) of 

10 subsection (a) would not apply but for the third sen11 tence of such subsection that is furnished during a 

12 year beginning on or after January 1, 2022, and be13 fore January 1, 2030, the amount paid shall be 

14 equal to the specified percent (as defined in para15 graph (2)) for such year of the lesser of the actual 

16 charge for the service or the amount determined 

17 under the fee schedule that applies to such test 

18 under this part (or, in the case such test is a cov19 ered OPD service (as defined in subsection 

20 (t)(1)(B)), the amount determined under subsection 

21 (t)). 

22 ‘‘(2) SPECIFIED PERCENT DEFINED.—For pur23 poses of paragraph (1), the term ‘specified percent’ 

24 means— 

25 ‘‘(A) for 2022 and 2023, 80 percent; 


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1 ‘‘(B) for 2024 and 2025, 85 percent; 

2 ‘‘(C) for 2026 and 2027, 90 percent; and 

3 ‘‘(D) for 2028 and 2029, 95 percent.’’. 

4 (c) CONFORMING AMENDMENTS.—Paragraphs (2) 

5 and (3) of section 1834(d) of the Social Security Act (42 

6 U.S.C. 1395m(d)) are each amended— 

7 (1) in subparagraph (C)(ii), in the matter pre8 ceding subclause (I), by striking ‘‘Notwithstanding’’ 

9 and inserting ‘‘Subject to section 1833(a)(1)(Y), but 

10 notwithstanding’’; and 

11 (2) in subparagraph (D), by striking ‘‘If dur12 ing’’ and inserting ‘‘Subject to section 

13 1833(a)(1)(Y), if during’’. 

14 SEC. 3. REQUIRING CERTAIN MANUFACTURERS TO REPORT 

15 DRUG PRICING INFORMATION WITH RE16 SPECT TO DRUGS UNDER THE MEDICARE 

17 PROGRAM. 

18 (a) IN GENERAL.—Section 1847A of the Social Secu19 rity Act (42 U.S.C. 1395w–3a) is amended— 

20 (1) in subsection (b)— 

21 (A) in paragraph (2)(A), by inserting ‘‘or 

22 subsection (f)(2), as applicable’’ before the pe23 riod at the end; 

24 (B) in paragraph (3), in the matter pre25 ceding subparagraph (A), by inserting ‘‘or subVerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570

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1 section (f)(2), as applicable,’’ before ‘‘deter2 mined by’’; and 

3 (C) in paragraph (6)(A), in the matter 

4 preceding clause (i), by inserting ‘‘or subsection 

5 (f)(2), as applicable,’’ before ‘‘determined by’’; 

6 and 

7 (2) in subsection (f)— 

8 (A) by striking ‘‘For requirements’’ and 

9 inserting the following: 

10 ‘‘(1) IN GENERAL.—For requirements’’; and 

11 (B) by adding at the end the following new 

12 paragraph: 

13 ‘‘(2) MANUFACTURERS WITHOUT A REBATE

14 AGREEMENT UNDER TITLE XIX.— 

15 ‘‘(A) IN GENERAL.—If the manufacturer 

16 of a drug or biological described in subpara17 graph (C), (E), or (G) of section 1842(o)(1) or 

18 in section 1881(b)(14)(B) that is payable under 

19 this part has not entered into and does not 

20 have in effect a rebate agreement described in 

21 subsection (b) of section 1927, for calendar 

22 quarters beginning with the second calendar 

23 quarter beginning on or after the date of the 

24 enactment of this paragraph, such manufac25 turer shall report to the Secretary the informaVerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570

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1 tion described in subsection (b)(3)(A)(iii) of 

2 such section 1927 with respect to such drug or 

3 biological in a time and manner specified by the 

4 Secretary. For purposes of applying this para5 graph, a drug or biological described in the pre6 vious sentence includes items, services, supplies, 

7 and products that are payable under this part 

8 as a drug or biological. 

9 ‘‘(B) AUDIT.—Information reported under 

10 subparagraph (A) is subject to audit by the In11 spector General of the Department of Health 

12 and Human Services. 

13 ‘‘(C) VERIFICATION.—The Secretary may 

14 survey wholesalers and manufacturers that di15 rectly distribute drugs described in subpara16 graph (A), when necessary, to verify manufac17 turer prices and manufacturer’s average sales 

18 prices (including wholesale acquisition cost) if 

19 required to make payment reported under sub20 paragraph (A). The Secretary may impose a 

21 civil monetary penalty in an amount not to ex22 ceed $100,000 on a wholesaler, manufacturer, 

23 or direct seller, if the wholesaler, manufacturer, 

24 or direct seller of such a drug refuses a request 

25 for information about charges or prices by the 


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1 Secretary in connection with a survey under 

2 this subparagraph or knowingly provides false 

3 information. The provisions of section 1128A 

4 (other than subsections (a) (with respect to 

5 amounts of penalties or additional assessments) 

6 and (b)) shall apply to a civil money penalty 

7 under this subparagraph in the same manner as 

8 such provisions apply to a penalty or proceeding 

9 under section 1128A(a). 

10 ‘‘(D) CONFIDENTIALITY.—Notwith11 standing any other provision of law, information 

12 disclosed by manufacturers or wholesalers 

13 under this paragraph (other than the wholesale 

14 acquisition cost for purposes of carrying out 

15 this section) is confidential and shall not be dis16 closed by the Secretary in a form which dis17 closes the identity of a specific manufacturer or 

18 wholesaler or prices charged for drugs by such 

19 manufacturer or wholesaler, except— 

20 ‘‘(i) as the Secretary determines to be 

21 necessary to carry out this section (includ22 ing the determination and implementation 

23 of the payment amount), or to carry out 

24 section 1847B; 


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1 ‘‘(ii) to permit the Comptroller Gen2 eral of the United States to review the in3 formation provided; and 

4 ‘‘(iii) to permit the Director of the 

5 Congressional Budget Office to review the 

6 information provided.’’. 

7 (b) ENFORCEMENT.—Section 1847A of such Act (42 

8 U.S.C. 1395w–3a) is further amended— 

9 (1) in subsection (d)(4)— 

10 (A) in subparagraph (A), by striking ‘‘IN

11 GENERAL’’ and inserting ‘‘MISREPRESENTA12 TION’’; 

13 (B) in subparagraph (B), by striking ‘‘sub14 paragraph (B)’’ and inserting ‘‘subparagraph 

15 (A), (B), or (C)’’; 

16 (C) by redesignating subparagraph (B) as 

17 subparagraph (D); and 

18 (D) by inserting after subparagraph (A) 

19 the following new subparagraphs: 

20 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR21 MATION.—If the Secretary determines that a 

22 manufacturer described in subsection (f)(2) has 

23 failed to report on information described in sec24 tion 1927(b)(3)(A)(iii) with respect to a drug or 

25 biological in accordance with such subsection, 


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1 the Secretary shall apply a civil money penalty 

2 in an amount of $10,000 for each day the man3 ufacturer has failed to report such information 

4 and such amount shall be paid to the Treasury. 

5 ‘‘(C) FALSE INFORMATION.—Any manu6 facturer required to submit information under 

7 subsection (f)(2) that knowingly provides false 

8 information is subject to a civil money penalty 

9 in an amount not to exceed $100,000 for each 

10 item of false information. Such civil money pen11 alties are in addition to other penalties as may 

12 be prescribed by law.’’; and 

13 (2) in subsection (c)(6)(A), by striking the pe14 riod at the end and inserting ‘‘, except that, for pur15 poses of subsection (f)(2), the Secretary may, if the 

16 Secretary determines appropriate, exclude repack17 agers of a drug or biological from such term.’’. 

18 (c) MANUFACTURERS WITH A REBATE AGREE19 MENT.— 

20 (1) IN GENERAL.—Section 1927(b)(3)(A) of the 

21 Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is 

22 amended by adding at the end the following new 

23 sentence: ‘‘For purposes of applying clause (iii), a 

24 drug or biological described in the flush matter fol25 lowing such clause includes items, services, supplies, 


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1 and products that are payable under this part as a 

2 drug or biological.’’. 

3 (2) TECHNICAL AMENDMENT.—Section 

4 1927(b)(3)(A)(iii) of the Social Security Act (42 

5 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended by striking 

6 ‘‘section 1881(b)(13)(A)(ii)’’ and inserting ‘‘section 

7 1881(b)(14)(B)’’. 

8 (d) REPORT.—Not later than January 1, 2023, the 

9 Inspector General of the Department of Health and 

10 Human Services shall assess and submit to Congress a 

11 report on the accuracy of average sales price information 

12 submitted by manufacturers under section 1847A of the 

13 Social Security Act (42 U.S.C. 1395w–3a). Such report 

14 shall include any recommendations on how to improve the 

15 accuracy of such information. 

16 SEC. 4. DETERMINATION OF BUDGETARY EFFECTS. 

17 The budgetary effects of this Act, for the purpose of 

18 complying with the Statutory Pay-As-You-Go Act of 2010, 

19 shall be determined by reference to the latest statement 

20 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

21 Act, submitted for printing in the Congressional Record 

22 by the Chairman of the House Budget Committee, proVerDate Sep 11 2014 02:00 Dec 11, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.RFS H1570

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1 vided that such statement has been submitted prior to the 

2 vote on passage. 

Passed the House of Representatives December 9, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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