Page:United States Statutes at Large Volume 124.djvu/488

124 STAT. 462 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(2) the Secretary determines that in the period beginning on July 1, 2010, and ending on December 31, 2010, there were extenuating circumstances. ‘‘(d) DEFINITION OF MANUFACTURER.—In this section, the term ‘manufacturer’ has the meaning given such term in section 1860D– 14A(g)(5).’’. (b) MEDICARE COVERAGE GAP DISCOUNT PROGRAM.—Part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101) is amended by inserting after section 1860D–14 the following new section: ‘‘MEDICARE COVERAGE GAP DISCOUNT PROGRAM ‘‘SEC. 1860D–14A. (a) ESTABLISHMENT.—The Secretary shall establish a Medicare coverage gap discount program (in this section referred to as the ‘program’) by not later than July 1, 2010. Under the program, the Secretary shall enter into agreements described in subsection (b) with manufacturers and provide for the perform- ance of the duties described in subsection (c)(1). The Secretary shall establish a model agreement for use under the program by not later than April 1, 2010, in consultation with manufacturers, and allow for comment on such model agreement. ‘‘(b) TERMS OF AGREEMENT.— ‘‘(1) IN GENERAL.— ‘‘(A) AGREEMENT.—An agreement under this section shall require the manufacturer to provide applicable bene- ficiaries access to discounted prices for applicable drugs of the manufacturer. ‘‘(B) PROVISION OF DISCOUNTED PRICES AT THE POINT- OF-SALE.—Except as provided in subsection (c)(1)(A)(iii), such discounted prices shall be provided to the applicable beneficiary at the pharmacy or by the mail order service at the point-of-sale of an applicable drug. ‘‘(C) TIMING OF AGREEMENT.— ‘‘(i) SPECIAL RULE FOR 2010 AND 2011.—In order for an agreement with a manufacturer to be in effect under this section with respect to the period beginning on July 1, 2010, and ending on December 31, 2011, the manufacturer shall enter into such agreement not later than May 1, 2010. ‘‘(ii) 2012 AND SUBSEQUENT YEARS.—In order for an agreement with a manufacturer to be in effect under this section with respect to plan year 2012 or a subse- quent plan year, the manufacturer shall enter into such agreement (or such agreement shall be renewed under paragraph (4)(A)) not later than January 30 of the preceding year. ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each manufacturer with an agreement in effect under this section shall collect and have available appropriate data, as determined by the Secretary, to ensure that it can demonstrate to the Secretary compliance with the requirements under the program. ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR ADMINISTRATION OF PROGRAM.—Each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the Secretary or a third party with a contract under sub- section (d)(3), as applicable, for purposes of administering the Determination. Deadlines. Contracts. Deadlines. 42 USC 1395w–114a. Determination. Time period.