Sec. 204. Ensuring the accuracy of manufacturer price and drug product information under the Medicaid drug rebate program

779 words·~4 min read·/bill/116/hr/19/ih/section-204

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Subparagraph

(B)of section 1927(b)(3) of the Social Security Act ( 42 U.S.C. 1396r–8(b)(3) ) is amended to read as follows: The Secretary shall conduct ongoing audits of the price and drug product information reported by manufacturers under subparagraph

(A)for the most recently ended rebate period to ensure the accuracy and timeliness of such information. In conducting such audits, the Secretary may employ evaluations, surveys, statistical sampling, predictive analytics and other relevant tools and methods. In addition to the audits required under clause (i), the Secretary may survey wholesalers and manufacturers (including manufacturers that directly distribute their covered outpatient drugs (in this subparagraph referred to as direct sellers )), when necessary, to verify manufacturer prices and manufacturer’s average sales prices (including wholesale acquisition cost) to make payment reported under subparagraph (A). In addition to other penalties as may be prescribed by law, including under subparagraph

(C)of this paragraph, the Secretary may impose a civil monetary penalty in an amount not to exceed $185,000 on an annual basis 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 an audit or 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 clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). The Secretary shall, not later than 18 months after date of enactment of this subparagraph, submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate regarding additional regulatory or statutory changes that may be required in order to ensure accurate and timely reporting and oversight of manufacturer price and drug product information, including whether changes should be made to reasonable assumption requirements to ensure such assumptions are reasonable and accurate or whether another methodology for ensuring accurate and timely reporting of price and drug product information should be considered to ensure the integrity of the drug rebate program under this section. The Secretary shall, on at least an annual basis, submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate summarizing the results of the audits and surveys conducted under this subparagraph during the period that is the subject of the report. Each report submitted under subclause

(II)shall, with respect to the period that is the subject of the report, include summaries of— error rates in the price, drug product, and other relevant information supplied by manufacturers under subparagraph (A); the timeliness with which manufacturers, wholesalers, and direct sellers provide information required under subparagraph

(A)or under clause

(i)or

(ii)of this subparagraph; the number of manufacturers, wholesalers, and direct sellers and drug products audited under this subparagraph; the types of price and drug product information reviewed under the audits conducted under this subparagraph; the tools and methodologies employed in such audits; the findings of such audits, including which manufacturers, if any, were penalized under this subparagraph; and such other relevant information as the Secretary shall deem appropriate. In preparing a report required under subclause (II), the Secretary shall redact such proprietary information as the Secretary determines appropriate to prevent disclosure of, and to safeguard, such information. Out of any funds in the Treasury not otherwise appropriated, there is appropriated to the Secretary $2,000,000 for fiscal year 2020 and each fiscal year thereafter to carry out this subparagraph. . The amendments made by this subsection shall take effect on the first day of the first fiscal quarter that begins after the date of enactment of this Act. Section 1927(b)(3)(C)(i) of the Social Security Act ( 42 U.S.C. 1396r–8(b)(3)(C)(i) ) is amended by striking 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 inserting , for each covered outpatient drug with respect to which such information is not provided, $50,000 for the first day that such information is not provided on a timely basis and $19,000 for each subsequent day that such information is not provided . Section 1927(b)(3)(C)(ii) of the Social Security Act ( 42 U.S.C. 1396r–8(b)(3)(C)(ii) ) is amended by striking $100,000 and inserting $500,000 . The amendments made by this subsection shall take effect on the first day of the first fiscal quarter that begins after the date of enactment of this Act.

Connections3 off-index

3 references not yet in our index

42 USC 1396r–8(b)(3)
42 USC 1396r–8(b)(3)(C)(i)
42 USC 1396r–8(b)(3)(C)(ii)

Citation graph

cites case law

Sec. 204

Ensuring the accuracy of manufacturer price and drug product information under the Medicaid drug rebate program

Cite42 USC 1396r–8(b)(3)

Cite42 USC 1396r–8(b)(3)(C)(i)

Cite42 USC 1396r–8(b)(3)(C)(ii)

Cites 3Cited by 0 across 0 sources