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136 STAT. 1849 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES. ‘‘(a) IN GENERAL.—With respect to an initial price applicability year and a selected drug with respect to such year— ‘‘(1) not later than November 30 of the year that is 2 years prior to such initial price applicability year, the Secretary shall publish the maximum fair price for such drug negotiated with the manufacturer of such drug under this part; and ‘‘(2) not later than March 1 of the year prior to such initial price applicability year, the Secretary shall publish, sub- ject to section 1193(c), the explanation for the maximum fair price with respect to the factors as applied under section 1194(e) for such drug described in paragraph (1). ‘‘(b) UPDATES.— ‘‘(1) SUBSEQUENT YEAR MAXIMUM FAIR PRICES.—For a selected drug, for each year subsequent to the first initial price applicability year of the price applicability period with respect to such drug, with respect to which an agreement for such drug is in effect under section 1193, not later than November 30 of the year that is 2 years prior to such subse- quent year, the Secretary shall publish the maximum fair price applicable to such drug and year, which shall be— ‘‘(A) subject to subparagraph (B), the amount equal to the maximum fair price published for such drug for the previous year, increased by the annual percentage increase in the consumer price index for all urban con- sumers (all items; United States city average) for the 12- month period ending with the July immediately preceding such November 30; or ‘‘(B) in the case the maximum fair price for such drug was renegotiated, for the first year for which such price as so renegotiated applies, such renegotiated maximum fair price. ‘‘(2) PRICES NEGOTIATED AFTER DEADLINE.—In the case of a selected drug with respect to an initial price applicability year for which the maximum fair price is determined under this part after the date of publication under this section, the Secretary shall publish such maximum fair price by not later than 30 days after the date such maximum price is so deter- mined. ‘‘SEC. 1196. ADMINISTRATIVE DUTIES AND COMPLIANCE MONITORING. ‘‘(a) ADMINISTRATIVE DUTIES.—For purposes of section 1191(a)(4), the administrative duties described in this section are the following: ‘‘(1) The establishment of procedures to ensure that the maximum fair price for a selected drug is applied before— ‘‘(A) any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of maximum fair price eligible individuals; and ‘‘(B) any other discounts. ‘‘(2) The establishment of procedures to compute and apply the maximum fair price across different strengths and dosage forms of a selected drug and not based on the specific formula- tion or package size or package type of such drug. 42 USC 1320f–5. Determination. Deadlines. Time periods. 42 USC 1320f–4. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00033 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw