Page:United States Statutes at Large Volume 124.djvu/853

From Wikisource
Jump to navigation Jump to search
This page needs to be proofread.

124 STAT. 827 PUBLIC LAW 111–148—MAR. 23, 2010 as a prerequisite to initiating administrative dispute resolution proceedings against a covered entity; ‘‘(v) permit the official or body designated under clause (i), at the request of a manufacturer or manufac- turers, to consolidate claims brought by more than one manufacturer against the same covered entity where, in the judgment of such official or body, consoli- dation is appropriate and consistent with the goals of fairness and economy of resources; and ‘‘(vi) include provisions and procedures to permit multiple covered entities to jointly assert claims of overcharges by the same manufacturer for the same drug or drugs in one administrative proceeding, and permit such claims to be asserted on behalf of covered entities by associations or organizations representing the interests of such covered entities and of which the covered entities are members. ‘‘(C) FINALITY OF ADMINISTRATIVE RESOLUTION.—The administrative resolution of a claim or claims under the regulations promulgated under subparagraph (A) shall be a final agency decision and shall be binding upon the parties involved, unless invalidated by an order of a court of competent jurisdiction. ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this subsection, such sums as may be necessary for fiscal year 2010 and each succeeding fiscal year.’’. (b) CONFORMING AMENDMENTS.—Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended— (1) in subsection (a)(1), by adding at the end the following: ‘‘Each such agreement shall require that the manufacturer furnish the Secretary with reports, on a quarterly basis, of the price for each covered drug subject to the agreement that, according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug (referred to in this section as the ‘ceiling price’), and shall require that the manufacturer offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such drug is made available to any other pur- chaser at any price.’’; and (2) in the first sentence of subsection (a)(5)(E), as redesig- nated by section 7101(c), by inserting ‘‘after audit as described in subparagraph (D) and’’ after ‘‘finds,’’. SEC. 7103. GAO STUDY TO MAKE RECOMMENDATIONS ON IMPROVING THE 340B PROGRAM. (a) REPORT.—Not later than 18 months after the date of enact- ment of this Act, the Comptroller General of the United States shall submit to Congress a report that examines whether those individuals served by the covered entities under the program under section 340B of the Public Health Service Act (42 U.S.C. 256b) (referred to in this section as the ‘‘340B program’’) are receiving optimal health care services. (b) RECOMMENDATIONS.—The report under subsection (a) shall include recommendations on the following: Contracts. Reports. Deadlines.