Page:United States Statutes at Large Volume 124.djvu/492

 124 STAT. 466 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(i) the amount that the manufacturer would have paid with respect to such discounts under the agree- ment, which will then be used to pay the discounts which the manufacturer had failed to provide; and ‘‘(ii) 25 percent of such amount. ‘‘(B) APPLICATION.—The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). ‘‘(f) CLARIFICATION REGARDING AVAILABILITY OF OTHER COV- ERED PART D DRUGS.—Nothing in this section shall prevent an applicable beneficiary from purchasing a covered part D drug that is not an applicable drug (including a generic drug or a drug that is not on the formulary of the prescription drug plan or MA– PD plan that the applicable beneficiary is enrolled in). ‘‘(g) DEFINITIONS.—In this section: ‘‘(1) APPLICABLE BENEFICIARY.—The term ‘applicable bene- ficiary’ means an individual who, on the date of dispensing an applicable drug— ‘‘(A) is enrolled in a prescription drug plan or an MA– PD plan; ‘‘(B) is not enrolled in a qualified retiree prescription drug plan; ‘‘(C) is not entitled to an income-related subsidy under section 1860D–14(a); ‘‘(D) is not subject to a reduction in premium subsidy under section 1839(i); and ‘‘(E) who— ‘‘(i) has reached or exceeded the initial coverage limit under section 1860D–2(b)(3) during the year; and ‘‘(ii) has not incurred costs for covered part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B). ‘‘(2) APPLICABLE DRUG.—The term ‘applicable drug’ means, with respect to an applicable beneficiary, a covered part D drug— ‘‘(A) approved under a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or, in the case of a biologic product, licensed under section 351 of the Public Health Service Act (other than a product licensed under subsection (k) of such section 351); and ‘‘(B)(i) if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan uses a formulary, which is on the formulary of the prescrip- tion drug plan or MA–PD plan that the applicable bene- ficiary is enrolled in; ‘‘(ii) if the PDP sponsor of the prescription drug plan or the MA organization offering the MA–PD plan does not use a formulary, for which benefits are available under the prescription drug plan or MA–PD plan that the applicable beneficiary is enrolled in; or ‘‘(iii) is provided through an exception or appeal. ‘‘(3) APPLICABLE NUMBER OF CALENDAR DAYS.—The term ‘applicable number of calendar days’ means—