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136 STAT. 1848 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(ii) for which there is a change in status to that of an extended-monopoly drug. ‘‘(C) CHANGE OF STATUS TO A LONG-MONOPOLY DRUG.— A selected drug that— ‘‘(i) is not a long-monopoly drug; and ‘‘(ii) for which there is a change in status to that of a long-monopoly drug. ‘‘(D) MATERIAL CHANGES.—A selected drug for which the Secretary determines there has been a material change of any of the factors described in paragraph (1) or (2) of subsection (e). ‘‘(3) SELECTION OF DRUGS FOR RENEGOTIATION.—For each year (beginning with 2028), the Secretary shall select among renegotiation-eligible drugs for renegotiation as follows: ‘‘(A) ALL EXTENDED-MONOPOLY NEGOTIATION-ELIGIBLE DRUGS.—The Secretary shall select all renegotiation-eligible drugs described in paragraph (2)(B). ‘‘(B) ALL LONG-MONOPOLY NEGOTIATION-ELIGIBLE DRUGS.—The Secretary shall select all renegotiation-eligible drugs described in paragraph (2)(C). ‘‘(C) REMAINING DRUGS.—Among the remaining renego- tiation-eligible drugs described in subparagraphs (A) and (D) of paragraph (2), the Secretary shall select renegoti- ation-eligible drugs for which the Secretary expects renego- tiation is likely to result in a significant change in the maximum fair price otherwise negotiated. ‘‘(4) RENEGOTIATION PROCESS.— ‘‘(A) IN GENERAL.—The Secretary shall specify the process for renegotiation of maximum fair prices with the manufacturer of a renegotiation-eligible drug selected for renegotiation under this subsection. ‘‘(B) CONSISTENT WITH NEGOTIATION PROCESS.—The process specified under subparagraph (A) shall, to the extent practicable, be consistent with the methodology and process established under subsection (b) and in accordance with subsections (c), (d), and (e), and for purposes of applying subsections (c)(1)(A) and (d), the reference to the first initial price applicability year of the price applicability period with respect to such drug shall be treated as the first initial price applicability year of such period for which the maximum fair price established pursuant to such renegotiation applies, including for applying subsection (c)(3)(B) in the case of renegotiation-eligible drugs described in paragraph (3)(A) of this subsection and subsection (c)(3)(C) in the case of renegotiation-eligible drugs described in paragraph (3)(B) of this subsection. ‘‘(5) CLARIFICATION.—A renegotiation-eligible drug for which the Secretary makes a determination described in section 1192(c)(1) before or during the period of renegotiation shall not be subject to the renegotiation process under this section. ‘‘(g) CLARIFICATION.—The maximum fair price for a selected drug described in subparagraph (A) or (B) of paragraph (1) shall take effect no later than the first day of the first calendar quarter that begins after the date described in subparagraph (A) or (B), as applicable. Effective date. Effective date. Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00032 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw