I 115th CONGRESS 2d Session H. R. 5712 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.

1. Short title This Act may be cited as the Medicaid Drug Rebate Accountability Act . 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. .