Page 68

136 STAT. 1884 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(ii) who has incurred such costs, as so determined, in the year that are equal to or exceed such threshold for the year, 80 percent of the negotiated price of such drug. ‘‘(B) PHASE-IN FOR CERTAIN DRUGS DISPENSED TO LIS BENEFICIARIES.— ‘‘(i) IN GENERAL.—In the case of an applicable drug of a specified manufacturer (as defined in clause (ii)) that is marketed as of the date of enactment of this subparagraph and dispensed for an applicable bene- ficiary who is a subsidy eligible individual (as defined in section 1860D–14(a)(3)), the term ‘discounted price’ means the specified LIS percent (as defined in clause (iii)) of the negotiated price of the applicable drug of the manufacturer. ‘‘(ii) SPECIFIED MANUFACTURER.— ‘‘(I) IN GENERAL.—In this subparagraph, sub- ject to subclause (II), the term ‘specified manufac- turer’ means a manufacturer of an applicable drug for which, in 2021— ‘‘(aa) the manufacturer had a coverage gap discount agreement under section 1860D–14A; ‘‘(bb) the total expenditures for all of the specified drugs of the manufacturer covered by such agreement or agreements for such year and covered under this part during such year represented less than 1.0 percent of the total expenditures under this part for all cov- ered Part D drugs during such year; and ‘‘(cc) the total expenditures for all of the specified drugs of the manufacturer that are single source drugs and biological products for which payment may be made under part B during such year represented less than 1.0 percent of the total expenditures under part B for all drugs or biological products for which payment may be made under such part during such year. ‘‘(II) SPECIFIED DRUGS.— ‘‘(aa) IN GENERAL.—For purposes of this clause, the term ‘specified drug’ means, with respect to a specified manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or proc- essed by the manufacturer. ‘‘(bb) AGGREGATION RULE.—All persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 shall be treated as one manufac- turer for purposes of this subparagraph. For purposes of making a determination pursuant to the previous sentence, an agreement under this section shall require that a manufacturer provide and attest to such information as specified by the Secretary as necessary. ‘‘(III) LIMITATION.—The term ‘specified manu- facturer’ shall not include a manufacturer Time periods. Effective dates. Determination. Requirement. Attestation. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00068 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw