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136 STAT. 1840 PUBLIC LAW 117–169—AUG. 16, 2022 (B), with respect to an authorized generic drug, in applying the provisions of this part, such authorized generic drug and such listed drug or such product shall be treated as the same qualifying single source drug. ‘‘(B) AUTHORIZED GENERIC DRUG DEFINED.—For pur- poses of this paragraph, the term ‘authorized generic drug’ means— ‘‘(i) in the case of a drug, an authorized generic drug (as such term is defined in section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act); and ‘‘(ii) in the case of a biological product, a product that— ‘‘(I) has been licensed under section 351(a) of such Act; and ‘‘(II) is marketed, sold, or distributed directly or indirectly to retail class of trade under a dif- ferent labeling, packaging (other than repackaging as the reference product in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the reference product. ‘‘(3) EXCLUSIONS.—In this part, the term ‘qualifying single source drug’ does not include any of the following: ‘‘(A) CERTAIN ORPHAN DRUGS.—A drug that is des- ignated as a drug for only one rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act and for which the only approved indication (or indica- tions) is for such disease or condition. ‘‘(B) LOW SPEND MEDICARE DRUGS.—A drug or biological product with respect to which the total expenditures under parts B and D of title XVIII, as determined by the Secretary in accordance with subsection (d)(3)(B)— ‘‘(i) with respect to initial price applicability year 2026, is less than, during the period beginning on June 1, 2022, and ending on May 31, 2023, $200,000,000; ‘‘(ii) with respect to initial price applicability year 2027, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount speci- fied in clause (i) increased by the annual percentage increase in the consumer price index for all urban consumers (all items; United States city average) for the period beginning on June 1, 2023, and ending on September 30, 2024; or ‘‘(iii) with respect to a subsequent initial price applicability year, is less than, during the most recent 12-month period applicable under subparagraphs (A) and (B) of subsection (d)(1) for such year, the dollar amount specified in this subparagraph for the previous initial price applicability year increased by the annual percentage increase in such consumer price index for the 12-month period ending on September 30 of the year prior to the year of the selected drug publication date with respect to such subsequent initial price applicability year. Time periods. Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00024 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw