124 STAT. 465 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(2) LIMITATION.— ‘‘(A) IN GENERAL.—Subject to subparagraph (B), in pro- viding for such implementation, the Secretary shall not receive or distribute any funds of a manufacturer under the program. ‘‘(B) EXCEPTION.—The limitation under subparagraph (A) shall not apply to the Secretary with respect to drugs dispensed during the period beginning on July 1, 2010, and ending on December 31, 2010, but only if the Secretary determines that the exception to such limitation under this subparagraph is necessary in order for the Secretary to begin implementation of this section and provide applicable beneficiaries timely access to discounted prices during such period. ‘‘(3) CONTRACT WITH THIRD PARTIES.—The Secretary shall enter into a contract with 1 or more third parties to administer the requirements established by the Secretary in order to carry out this section. At a minimum, the contract with a third party under the preceding sentence shall require that the third party— ‘‘(A) receive and transmit information between the Sec- retary, manufacturers, and other individuals or entities the Secretary determines appropriate; ‘‘(B) receive, distribute, or facilitate the distribution of funds of manufacturers to appropriate individuals or entities in order to meet the obligations of manufacturers under agreements under this section; ‘‘(C) provide adequate and timely information to manu- facturers, consistent with the agreement with the manufac- turer under this section, as necessary for the manufacturer to fulfill its obligations under this section; and ‘‘(D) permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used by the third party to determine discounts for applicable drugs of the manufacturer under the program. ‘‘(4) PERFORMANCE REQUIREMENTS.—The Secretary shall establish performance requirements for a third party with a contract under paragraph (3) and safeguards to protect the independence and integrity of the activities carried out by the third party under the program under this section. ‘‘(5) IMPLEMENTATION.—The Secretary may implement the program under this section by program instruction or otherwise. ‘‘(6) ADMINISTRATION.—Chapter 35 of title 44, United States Code, shall not apply to the program under this section. ‘‘(e) ENFORCEMENT.— ‘‘(1) AUDITS.—Each manufacturer with an agreement in effect under this section shall be subject to periodic audit by the Secretary. ‘‘(2) CIVIL MONEY PENALTY.— ‘‘(A) IN GENERAL.—The Secretary shall impose a civil money penalty on a manufacturer that fails to provide applicable beneficiaries discounts for applicable drugs of the manufacturer in accordance with such agreement for each such failure in an amount the Secretary determines is commensurate with the sum of— Determination. Time period. Determination.
