```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2087 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 2087

  To amend title XVIII of the Social Security Act to require certain 
manufacturers to report drug pricing information with respect to drugs 
          under the Medicare program, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 4, 2019

  Mr. Doggett (for himself and Mr. Buchanan) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
  in addition to the Committee on Ways and Means, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL

 
  To amend title XVIII of the Social Security Act to require certain 
manufacturers to report drug pricing information with respect to drugs 
          under the Medicare program, 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 ``Drug Price Transparency Act''.

SEC. 2. 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.--In the case of a manufacturer of 
                a drug or biological described in subparagraph (C), 
                (E), or (G) of section 1842(o)(1) or in clause (ii) or 
                (iii) of section 1881(b)(14)(B) that does not have a 
                rebate agreement in effect under section 1927, for 
                calendar quarters beginning on or after January 1, 
                2020, 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.
                    ``(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 to 
                        review the information provided; and
                            ``(iii) to permit the Director of the 
                        Congressional Budget Office to review the 
                        information provided.''.
    (b) Enforcement.--
            (1) In general.--Section 1847A such Act (42 U.S.C. 1395w-
        3a) is further amended--
                    (A) in subsection (d)(4)--
                            (i) in subparagraph (A), by striking ``In 
                        general'' and inserting ``Misrepresentation'';
                            (ii) in subparagraph (B), by striking 
                        ``subparagraph (B)'' and inserting 
                        ``subparagraph (A), (B), or (C)'';
                            (iii) by redesignating subparagraph (B) as 
                        subparagraph (D); and
                            (iv) 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 $25,000 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
                    (B) 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.''.
            (2) Conforming existing manufacturer reporting penalties.--
        Section 1927(b)(3)(C)(i) of such Act (42 U.S.C. 1396r-
        8(b)(3)(C)(i)) is amended by inserting ``(or, for such failures 
        occurring on or after January 1, 2020, $25,000)'' after 
        ``$10,000''.
    (c) Report.--Not later than January 1, 2021, 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.
                                 <all>
```