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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1570 Engrossed in House (EH)]

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116th CONGRESS
  2d Session
                                H. R. 1570

_______________________________________________________________________

                                 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.

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

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 Security 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 following 
        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 establishment 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--
            (1) in subsection (a)(1)(Y), by inserting ``subject to 
        subsection (dd),'' before ``with respect to''; and
            (2) by adding at the end the following new subsection:
    ``(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 sentence of such subsection 
        that is furnished during a year beginning on or after January 
        1, 2022, and before January 1, 2030, the amount paid shall be 
        equal to the specified percent (as defined in paragraph (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 covered OPD service (as defined in subsection (t)(1)(B)), 
        the amount determined under subsection (t)).
            ``(2) Specified percent defined.--For purposes of paragraph 
        (1), the term `specified percent' means--
                    ``(A) for 2022 and 2023, 80 percent;
                    ``(B) for 2024 and 2025, 85 percent;
                    ``(C) for 2026 and 2027, 90 percent; and
                    ``(D) for 2028 and 2029, 95 percent.''.
    (c) Conforming Amendments.--Paragraphs (2) and (3) of section 
1834(d) of the Social Security Act (42 U.S.C. 1395m(d)) are each 
amended--
            (1) in subparagraph (C)(ii), in the matter preceding 
        subclause (I), by striking ``Notwithstanding'' and inserting 
        ``Subject to section 1833(a)(1)(Y), but notwithstanding''; and
            (2) in subparagraph (D), by striking ``If during'' and 
        inserting ``Subject to section 1833(a)(1)(Y), if during''.

SEC. 3. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING 
              INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE 
              PROGRAM.

    (a) In General.--Section 1847A of the Social Security Act (42 
U.S.C. 1395w-3a) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (2)(A), by inserting ``or 
                subsection (f)(2), as applicable'' before the period at 
                the end;
                    (B) in paragraph (3), in the matter preceding 
                subparagraph (A), by inserting ``or subsection (f)(2), 
                as applicable,'' before ``determined 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 subparagraph (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 manufacturer shall report to the Secretary the 
                information 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 paragraph, a 
                drug or biological described in the previous 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 Inspector 
                General of the Department of Health and Human Services.
                    ``(C) Verification.--The Secretary may survey 
                wholesalers and manufacturers that directly distribute 
                drugs described in subparagraph (A), when necessary, to 
                verify manufacturer prices and manufacturer's average 
                sales prices (including wholesale acquisition cost) if 
                required to make payment reported under subparagraph 
                (A). The Secretary may impose a civil monetary penalty 
                in an amount not to exceed $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 
                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.--Notwithstanding 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 disclosed by the Secretary in a form which 
                discloses 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 (including 
                        the determination and implementation of the 
                        payment amount), or to carry out section 1847B;
                            ``(ii) to permit the Comptroller General of 
                        the United States to review the information 
                        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 ``Misrepresentation'';
                    (B) in subparagraph (B), by striking ``subparagraph 
                (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 information.--If 
                the Secretary determines that a manufacturer described 
                in subsection (f)(2) has failed to report on 
                information described in section 1927(b)(3)(A)(iii) 
                with respect to a drug or biological in accordance with 
                such subsection, the Secretary shall apply a civil 
                money penalty in an amount of $10,000 for each day the 
                manufacturer has failed to report such information and 
                such amount shall be paid to the Treasury.
                    ``(C) False information.--Any manufacturer 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 
                penalties are in addition to other penalties as may be 
                prescribed by law.''; and
            (2) in subsection (c)(6)(A), by striking the period at the 
        end and inserting ``, except that, for purposes of subsection 
        (f)(2), the Secretary may, if the Secretary determines 
        appropriate, exclude repackagers of a drug or biological from 
        such term.''.
    (c) Manufacturers With a Rebate Agreement.--
            (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 following such clause includes items, services, 
        supplies, and products that are payable under this part as a 
        drug or biological.''.
            (2) Technical amendment.--Section 1927(b)(3)(A)(iii) of the 
        Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is 
        amended by striking ``section 1881(b)(13)(A)(ii)'' and 
        inserting ``section 1881(b)(14)(B)''.
    (d) Report.--Not later than January 1, 2023, the Inspector General 
of the Department of Health and Human Services shall assess and submit 
to Congress a report on the accuracy of average sales price information 
submitted by manufacturers under section 1847A of the Social Security 
Act (42 U.S.C. 1395w-3a). Such report shall include any recommendations 
on how to improve the accuracy of such information.

SEC. 4. DETERMINATION OF BUDGETARY EFFECTS.

    The budgetary effects of this Act, for the purpose of complying 
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by 
reference to the latest statement titled ``Budgetary Effects of PAYGO 
Legislation'' for this Act, submitted for printing in the Congressional 
Record by the Chairman of the House Budget Committee, provided that 
such statement has been submitted prior to the vote on passage.

            Passed the House of Representatives December 9, 2020.

            Attest:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H. R. 1570

_______________________________________________________________________

                                 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.
```