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 screen-
ing tests, regardless of whether therapeutic intervention 
is required during the screening, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Removing Barriers to 
Colorectal Cancer Screening Act of 2020’’. 
SEC. 2. WAIVING MEDICARE COINSURANCE FOR CERTAIN 
COLORECTAL CANCER SCREENING TESTS. 
(a) IN GENERAL.—Section 1833(a) of the Social Se-
curity Act (42 U.S.C. 1395l(a)) is amended— 
(1) in the second sentence, by striking ‘‘section 
1834(0)’’ and inserting ‘‘section 1834(o)’’; 
(2) by moving such second sentence 2 ems to 
the left; and 
(3) by inserting the following third sentence fol-
lowing such second sentence: ‘‘For services furnished 
on or after January 1, 2022, paragraph (1)(Y) shall 
apply with respect to a colorectal cancer screening 
test regardless of the code that is billed for the es-
tablishment of a diagnosis as a result of the test, or 
for the removal of tissue or other matter or other 
procedure that is furnished in connection with, as a 
result of, and in the same clinical encounter as the 
screening test.’’. 
(b) SPECIAL COINSURANCE RULE
FOR CERTAIN 
TESTS.—Section 1833 of the Social Security Act (42 
U.S.C. 1395l) is amended— 
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(1) in subsection (a)(1)(Y), by inserting ‘‘sub-
ject to subsection (dd),’’ before ‘‘with respect to’’; 
and 
(2) by adding at the end the following new sub-
section: 
‘‘(dd) SPECIAL COINSURANCE RULE FOR CERTAIN 
COLORECTAL CANCER SCREENING TESTS.— 
‘‘(1) IN GENERAL.—In the case of a colorectal 
cancer screening test to which paragraph (1)(Y) of 
subsection (a) would not apply but for the third sen-
tence of such subsection that is furnished during a 
year beginning on or after January 1, 2022, and be-
fore January 1, 2030, the amount paid shall be 
equal to the specified percent (as defined in para-
graph (2)) for such year of the lesser of the actual 
charge for the service or the amount determined 
under the fee schedule that applies to such test 
under this part (or, in the case such test is a cov-
ered OPD service (as defined in subsection 
(t)(1)(B)), the amount determined under subsection 
(t)). 
‘‘(2) SPECIFIED PERCENT DEFINED.—For pur-
poses of paragraph (1), the term ‘specified percent’ 
means— 
‘‘(A) for 2022 and 2023, 80 percent; 
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section (f)(2), as applicable,’’ before ‘‘deter-
mined by’’; and 
(C) in paragraph (6)(A), in the matter 
preceding clause (i), by inserting ‘‘or subsection 
(f)(2), as applicable,’’ before ‘‘determined by’’; 
and 
(2) in subsection (f)— 
(A) by striking ‘‘For requirements’’ and 
inserting the following: 
‘‘(1) IN GENERAL.—For requirements’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(2) MANUFACTURERS
WITHOUT
A
REBATE 
AGREEMENT UNDER TITLE XIX.— 
‘‘(A) IN GENERAL.—If the manufacturer 
of a drug or biological described in subpara-
graph (C), (E), or (G) of section 1842(o)(1) or 
in section 1881(b)(14)(B) that is payable under 
this part has not entered into and does not 
have in effect a rebate agreement described in 
subsection (b) of section 1927, for calendar 
quarters beginning with the second calendar 
quarter beginning on or after the date of the 
enactment of this paragraph, such manufac-
turer shall report to the Secretary the informa-
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tion described in subsection (b)(3)(A)(iii) of 
such section 1927 with respect to such drug or 
biological in a time and manner specified by the 
Secretary. For purposes of applying this para-
graph, a drug or biological described in the pre-
vious sentence includes items, services, supplies, 
and products that are payable under this part 
as a drug or biological. 
‘‘(B) AUDIT.—Information reported under 
subparagraph (A) is subject to audit by the In-
spector General of the Department of Health 
and Human Services. 
‘‘(C) VERIFICATION.—The Secretary may 
survey wholesalers and manufacturers that di-
rectly distribute drugs described in subpara-
graph (A), when necessary, to verify manufac-
turer prices and manufacturer’s average sales 
prices (including wholesale acquisition cost) if 
required to make payment reported under sub-
paragraph (A). The Secretary may impose a 
civil monetary penalty in an amount not to ex-
ceed $100,000 on a wholesaler, manufacturer, 
or direct seller, if the wholesaler, manufacturer, 
or direct seller of such a drug refuses a request 
for information about charges or prices by the 
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Secretary in connection with a survey under 
this subparagraph or knowingly provides false 
information. The provisions of section 1128A 
(other than subsections (a) (with respect to 
amounts of penalties or additional assessments) 
and (b)) shall apply to a civil money penalty 
under this subparagraph in the same manner as 
such provisions apply to a penalty or proceeding 
under section 1128A(a). 
‘‘(D) 
CONFIDENTIALITY.—Notwith-
standing any other provision of law, information 
disclosed by manufacturers or wholesalers 
under this paragraph (other than the wholesale 
acquisition cost for purposes of carrying out 
this section) is confidential and shall not be dis-
closed by the Secretary in a form which dis-
closes the identity of a specific manufacturer or 
wholesaler or prices charged for drugs by such 
manufacturer or wholesaler, except— 
‘‘(i) as the Secretary determines to be 
necessary to carry out this section (includ-
ing the determination and implementation 
of the payment amount), or to carry out 
section 1847B; 
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‘‘(ii) to permit the Comptroller Gen-
eral of the United States to review the in-
formation provided; and 
‘‘(iii) to permit the Director of the 
Congressional Budget Office to review the 
information provided.’’. 
(b) ENFORCEMENT.—Section 1847A of such Act (42 
U.S.C. 1395w–3a) is further amended— 
(1) in subsection (d)(4)— 
(A) in subparagraph (A), by striking ‘‘IN 
GENERAL’’ and inserting ‘‘MISREPRESENTA-
TION’’; 
(B) in subparagraph (B), by striking ‘‘sub-
paragraph (B)’’ and inserting ‘‘subparagraph 
(A), (B), or (C)’’; 
(C) by redesignating subparagraph (B) as 
subparagraph (D); and 
(D) by inserting after subparagraph (A) 
the following new subparagraphs: 
‘‘(B) FAILURE TO PROVIDE TIMELY INFOR-
MATION.—If the Secretary determines that a 
manufacturer described in subsection (f)(2) has 
failed to report on information described in sec-
tion 1927(b)(3)(A)(iii) with respect to a drug or 
biological in accordance with such subsection, 
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the Secretary shall apply a civil money penalty 
in an amount of $10,000 for each day the man-
ufacturer has failed to report such information 
and such amount shall be paid to the Treasury. 
‘‘(C) FALSE
INFORMATION.—Any manu-
facturer required to submit information under 
subsection (f)(2) that knowingly provides false 
information is subject to a civil money penalty 
in an amount not to exceed $100,000 for each 
item of false information. Such civil money pen-
alties are in addition to other penalties as may 
be prescribed by law.’’; and 
(2) in subsection (c)(6)(A), by striking the pe-
riod at the end and inserting ‘‘, except that, for pur-
poses of subsection (f)(2), the Secretary may, if the 
Secretary determines appropriate, exclude repack-
agers of a drug or biological from such term.’’. 
(c) MANUFACTURERS
WITH
A
REBATE
AGREE-
MENT.— 
(1) IN GENERAL.—Section 1927(b)(3)(A) of the 
Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is 
amended by adding at the end the following new 
sentence: ‘‘For purposes of applying clause (iii), a 
drug or biological described in the flush matter fol-
lowing such clause includes items, services, supplies, 
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