Title: Strengthening Average Sales Price Reporting Act of 2019
Policy area: Health

Summary:
Strengthening Average Sales Price Reporting Act of 2019
This bill requires certain manufacturers of drugs that are covered under Medicare medical services to report pricing information to the Centers for Medicare & Medicaid Services. Specifically, manufacturers of such drugs that do not have rebate agreements under the Medicaid Drug Rebate Program must report similar information as is required under the program, including average sales price, total units, and wholesale acquisition cost. Manufacturers that fail to comply or that report false information are subject to civil penalties.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2051 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2051

     To amend XVIII of the Social Security Act to require certain 
manufacturers to report drug pricing information with respect to drugs 
                      under the Medicare program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                June 28 (legislative day, June 27), 2019

Mr. Menendez (for himself and Mr. Young) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
     To amend XVIII of the Social Security Act to require certain 
manufacturers to report drug pricing information with respect to drugs 
                      under the Medicare program.

    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 ``Strengthening Average Sales Price 
Reporting Act of 2019''.

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 
                an applicable drug or biological 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 applicable 
                drug or biological in a time and manner specified by 
                the Secretary.
                    ``(B) Definition of applicable drug or 
                biological.--In this paragraph, the term `applicable 
                drug or biological' means--
                            ``(i) a drug or biological described in--
                                    ``(I) subparagraph (C), (E), or (G) 
                                of section 1842(o)(1); or
                                    ``(II) clause (ii) or (iii) of 
                                section 1881(b)(14)(B); and
                            ``(ii) an item for which payment is 
                        established under this section.
                    ``(C) Audit.--Information reported under 
                subparagraph (A) is subject to audit by the Inspector 
                General of the Department of Health and Human Services.
                    ``(D) Verification.--The Secretary may survey 
                wholesalers and manufacturers that directly distribute 
                an applicable drug or biological, 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).
                    ``(E) 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 an applicable drug or 
                biological 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.--Section 1847A 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 an applicable 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 an applicable drug or 
        biological from such term.''.
    (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.
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