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136 STAT. 1883 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(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 a covered part D 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; and ‘‘(C) has incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for covered part D drugs in the year that exceed the annual deductible specified in section 1860D–2(b)(1). ‘‘(2) APPLICABLE DRUG.—The term ‘applicable drug’, with respect to an applicable beneficiary— ‘‘(A) means a covered part D drug— ‘‘(i) approved under a new drug application under section 505(c) 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; and ‘‘(ii)(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 prescription drug plan or MA–PD plan that the applicable beneficiary 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 avail- able 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; and ‘‘(B) does not include a selected drug (as referred to under section 1192(c)) during a price applicability period (as defined in section 1191(b)(2)) with respect to such drug. ‘‘(3) APPLICABLE NUMBER OF CALENDAR DAYS.—The term ‘applicable number of calendar days’ means— ‘‘(A) with respect to claims for reimbursement sub- mitted electronically, 14 days; and ‘‘(B) with respect to claims for reimbursement sub- mitted otherwise, 30 days. ‘‘(4) DISCOUNTED PRICE.— ‘‘(A) IN GENERAL.—The term ‘discounted price’ means, subject to subparagraphs (B) and (C), with respect to an applicable drug of a manufacturer dispensed during a year to an applicable beneficiary— ‘‘(i) who has not incurred costs, as determined in accordance with section 1860D–2(b)(4)(C), for cov- ered part D drugs in the year that are equal to or exceed the annual out-of-pocket threshold specified in section 1860D–2(b)(4)(B)(i) for the year, 90 percent of the negotiated price of such drug; and VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00067 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw