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136 STAT. 1835 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(4) REFERENCE PRODUCT.—The term ‘reference product’ has the meaning given such term in section 351(i) of the Public Health Service Act. ‘‘(5) TOTAL EXPENDITURES.—The term ‘total expenditures’ includes, in the case of expenditures with respect to part D of title XVIII, the total gross covered prescription drug costs (as defined in section 1860D–15(b)(3)). The term ‘total expendi- tures’ excludes, in the case of expenditures with respect to part B of such title, expenditures for a drug or biological product that are bundled or packaged into the payment for another service. ‘‘(6) UNIT.—The term ‘unit’ means, with respect to a drug or biological product, the lowest identifiable amount (such as a capsule or tablet, milligram of molecules, or grams) of the drug or biological product that is dispensed or furnished. ‘‘(d) TIMING FOR INITIAL PRICE APPLICABILITY YEAR 2026.— Notwithstanding the provisions of this part, in the case of initial price applicability year 2026, the following rules shall apply for purposes of implementing the program: ‘‘(1) Subsection (b)(3) shall be applied by substituting ‘Sep- tember 1, 2023’ for ‘, with respect to each initial price applica- bility year, February 1 of the year that begins 2 years prior to such year’. ‘‘(2) Subsection (b)(4) shall be applied— ‘‘(A) in subparagraph (A)(ii), by substituting ‘October 1, 2023’ for ‘February 28 following the selected drug publication date with respect to such selected drug’; and ‘‘(B) in subparagraph (B), by substituting ‘August 1, 2024’ for ‘November 1 of the year that begins 2 years prior to the initial price applicability year’. ‘‘(3) Section 1192 shall be applied— ‘‘(A) in subsection (b)(1)(A), by substituting ‘during the period beginning on June 1, 2022, and ending on May 31, 2023’ for ‘during the most recent period of 12 months prior to the selected drug publication date (but ending not later than October 31 of the year prior to the year of such drug publication date), with respect to such year, for which data are available’; and ‘‘(B) in subsection (d)(1)(A), by substituting ‘during the period beginning on June 1, 2022, and ending on May 31, 2023’ for ‘during the most recent period for which data are available of at least 12 months prior to the selected drug publication date (but ending no later than October 31 of the year prior to the year of such drug publication date), with respect to such year’. ‘‘(4) Section 1193(a) shall be applied by substituting ‘October 1, 2023’ for ‘February 28 following the selected drug publication date with respect to such selected drug’. ‘‘(5) Section 1194(b)(2) shall be applied— ‘‘(A) in subparagraph (A), by substituting ‘October 2, 2023’ for ‘March 1 of the year of the selected drug publica- tion date, with respect to the selected drug’; ‘‘(B) in subparagraph (B), by substituting ‘February 1, 2024’ for ‘the June 1 following the selected drug publica- tion date’; and ‘‘(C) in subparagraph (E), by substituting ‘August 1, 2024’ for ‘the first day of November following the selected Regulations. Applicability. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00019 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw