Page:United States Statutes at Large Volume 104 Part 2.djvu/553

 PUBLIC LAW 101-508—NOV. 5, 1990 104 STAT. 1388-145 pended under the State plan in the quarter for medical assistance for purposes of section 1903(a)(1). " (2) STATE PROVISION OF INFORMATION. — "(A) STATE RESPONSIBILITY. —Each State agency under this title shall report to each manufacturer not later than 60 days after the end of each calendar quarter and in a form consistent with a standard reporting format established by the Secretary, information on the total number of dosage units of each covered outpatient drug dispensed under the plan during the quarter, and shall promptly transmit a copy of such report to the Secretary. "(B) AUDITS.— A manufacturer may audit the information provided (or required to be provided) under subparagraph (A). Adjustments to rebates shall be made to the extent that information indicates that utilization was greater or less than the amount previously specified. "(3) MANUFACTURER PROVISION OF PRICE INFORMATION. — "(A) IN GENERAL.—Each manufacturer with an agreement in effect under this section shall report to the Secretary— "(i) not later than 30 days after the last day of each quarter (beginning on or after January 1, 1991), on the average manufacturer price (as defined in subsection (k)(l)) and, (for single source drugs and innovator multiple source drugs), the manufacturer's best price (as defined in subsection (c)(2)(B)) for covered outpatient drugs for the quarter, and "(ii) not later than 30 days after the date of entering into an agreement under this section on the average manufacturer price (as defined in subsection (k)(l)) as of October 1, 1990 ^^ for each of the manufacturer's covered outpatient drugs. " (B) VERIFICATION SURVEYS OF AVERAGE MANUFACTURER PRICE.— The Secretary may survey wholesalers and manufacturers that directly distribute their covered outpatient drugs, when necessary, to verify manufacturer prices 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 a covered outpatient 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). "(C) PENALTIES. — " (i) FAILURE TO PROVIDE TIMELY INFORMATION. — In the case of a manufacturer with an agreement under this section that fails to provide information required under subparagraph (A) on a timely basis, the amount of the penalty shall be increased by $10,000 for each day in which such information has not been provided and such amount shall be paid to the Treasury, and, if such " So in original. Probably should be "1990,".

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