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136 STAT. 1843 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS. ‘‘(a) IN GENERAL.—For purposes of this part, under an agree- ment under section 1193 between the Secretary and a manufacturer of a selected drug (or selected drugs), with respect to the period for which such agreement is in effect and in accordance with sub- sections (b), (c), and (d), the Secretary and the manufacturer— ‘‘(1) shall during the negotiation period with respect to such drug, in accordance with this section, negotiate a max- imum fair price for such drug for the purpose described in section 1193(a)(1); and ‘‘(2) renegotiate, in accordance with the process specified pursuant to subsection (f), such maximum fair price for such drug for the purpose described in section 1193(a)(2) if such drug is a renegotiation-eligible drug under such subsection. ‘‘(b) NEGOTIATION PROCESS REQUIREMENTS.— ‘‘(1) METHODOLOGY AND PROCESS.—The Secretary shall develop and use a consistent methodology and process, in accordance with paragraph (2), for negotiations under sub- section (a) that aims to achieve the lowest maximum fair price for each selected drug. ‘‘(2) SPECIFIC ELEMENTS OF NEGOTIATION PROCESS.—As part of the negotiation process under this section, with respect to a selected drug and the negotiation period with respect to the initial price applicability year with respect to such drug, the following shall apply: ‘‘(A) SUBMISSION OF INFORMATION.—Not later than March 1 of the year of the selected drug publication date, with respect to the selected drug, the manufacturer of the drug shall submit to the Secretary, in accordance with section 1193(a)(4), the information described in such sec- tion. ‘‘(B) INITIAL OFFER BY SECRETARY.—Not later than the June 1 following the selected drug publication date, the Secretary shall provide the manufacturer of the selected drug with a written initial offer that contains the Sec- retary’s proposal for the maximum fair price of the drug and a concise justification based on the factors described in section 1194(e) that were used in developing such offer. ‘‘(C) RESPONSE TO INITIAL OFFER.— ‘‘(i) IN GENERAL.—Not later than 30 days after the date of receipt of an initial offer under subpara- graph (B), the manufacturer shall either accept such offer or propose a counteroffer to such offer. ‘‘(ii) COUNTEROFFER REQUIREMENTS.—If a manu- facturer proposes a counteroffer, such counteroffer— ‘‘(I) shall be in writing; and ‘‘(II) shall be justified based on the factors described in subsection (e). ‘‘(D) RESPONSE TO COUNTEROFFER.—After receiving a counteroffer under subparagraph (C), the Secretary shall respond in writing to such counteroffer. ‘‘(E) DEADLINE.—All negotiations between the Sec- retary and the manufacturer of the selected drug shall end prior to the first day of November following the selected drug publication date, with respect to the initial price applicability year. Proposal. Proposal. Applicability. Deadlines. 42 USC 1320f–3. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00027 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw