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136 STAT. 1852 PUBLIC LAW 117–169—AUG. 16, 2022 (i) by redesignating subclause (VII) as subclause (VIII); and (ii) by inserting after subclause (VI) the following subclause: ‘‘(VII) A drug or biological product that is a selected drug (as referred to in section 1192(c)).’’. (C) EXCEPTION TO PART D NON-INTERFERENCE.—Section 1860D–11(i) of the Social Security Act (42 U.S.C. 1395w– 111(i)) is amended— (i) in paragraph (1), by striking ‘‘and’’ at the end; (ii) in paragraph (2), by striking ‘‘or institute a price structure for the reimbursement of covered part D drugs.’’ and inserting ‘‘, except as provided under section 1860D–4(b)(3)(l); and’’; and (iii) by adding at the end the following new para- graph: ‘‘(3) may not institute a price structure for the reimburse- ment of covered part D drugs, except as provided under part E of title XI.’’. (D) APPLICATION AS NEGOTIATED PRICE UNDER PART D.—Section 1860D–2(d)(1) of the Social Security Act (42 U.S.C. 1395w–102(d)(1)) is amended— (i) in subparagraph (B), by inserting ‘‘, subject to subparagraph (D),’’ after ‘‘negotiated prices’’; and (ii) by adding at the end the following new subparagraph: ‘‘(D) APPLICATION OF MAXIMUM FAIR PRICE FOR SELECTED DRUGS.—In applying this section, in the case of a covered part D drug that is a selected drug (as referred to in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), the negotiated prices used for payment (as described in this subsection) shall be no greater than the maximum fair price (as defined in section 1191(c)(3)) for such drug and for each year during such period plus any dispensing fees for such drug.’’. (E) COVERAGE OF SELECTED DRUGS.—Section 1860D– 4(b)(3) of the Social Security Act (42 U.S.C. 1395w– 104(b)(3)) is amended by adding at the end the following new subparagraph: ‘‘(I) REQUIRED INCLUSION OF SELECTED DRUGS.— ‘‘(i) IN GENERAL.—For 2026 and each subsequent year, the PDP sponsor offering a prescription drug plan shall include each covered part D drug that is a selected drug under section 1192 for which a max- imum fair price (as defined in section 1191(c)(3)) is in effect with respect to the year. ‘‘(ii) CLARIFICATION.—Nothing in clause (i) shall be construed as prohibiting a PDP sponsor from removing such a selected drug from a formulary if such removal would be permitted under section 423.120(b)(5)(iv) of title 42, Code of Federal Regula- tions (or any successor regulation).’’. (F) INFORMATION FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS REQUIRED.— (i) PRESCRIPTION DRUG PLANS.—Section 1860D– 12(b) of the Social Security Act (42 U.S.C. 1395w– Time periods. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00036 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw