Title: Medicaid Drug Rebate Accountability Act
Policy area: Health

Summary:
Medicaid Drug Rebate Accountability Act
This bill requires drug manufacturers with Medicaid rebate agreements for covered outpatient drugs to correct any misclassifications of such drugs within a specified time period, and establishes civil penalties for failures to do so.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5712 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 5712

 To amend title XIX of the Social Security Act to compel manufacturers 
  to correct inaccurate classification data reported to the Medicaid 
                rebate program, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 8, 2018

Mr. Schrader (for himself and Mr. Welch) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend title XIX of the Social Security Act to compel manufacturers 
  to correct inaccurate classification data reported to the Medicaid 
                rebate 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 ``Medicaid Drug Rebate Accountability 
Act''.

SEC. 2. AUTHORITY TO COMPEL MANUFACTURERS TO CORRECT INACCURATE 
              CLASSIFICATION DATA REPORTED TO MEDICAID REBATE PROGRAM.

    Section 1927(b)(3) of the Social Security Act (42 U.S.C. 1396r-
8(b)(3)) is amended by adding at the end the following new 
subparagraph:
                    ``(E) Remedy with respect to inaccurate 
                classification data.--
                            ``(i) Correction of inaccurate 
                        classification data.--In the case that the 
                        Secretary determines that drug classification 
                        data reported on or after September 30, 2018, 
                        by a manufacturer under this paragraph, with 
                        respect to a covered outpatient drug of such 
                        manufacturer, provides an inaccurate 
                        classification for such drug, the Secretary 
                        shall require such manufacturer to correct, 
                        within a 30-day period, the classification for 
                        such drug.
                            ``(ii) Civil monetary penalty.--In the case 
                        of a manufacturer who fails to correct the 
                        classification of a covered outpatient drug 
                        within a 30-day period pursuant to clause (i), 
                        the Secretary shall, beginning the day after 
                        the end of such 30-day period, require such 
                        manufacturer to pay a civil monetary penalty of 
                        $100,000 per day until the date on which the 
                        manufacturer corrects such classification.
                            ``(iii) Classification defined.--For 
                        purposes of this subparagraph, the term 
                        `classification' means identification or 
                        designation as one of the following:
                                    ``(I) A single source drug.
                                    ``(II) An innovator multiple source 
                                drug.
                                    ``(III) A noninnovator multiple 
                                source drug.''.
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