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136 STAT. 1860 PUBLIC LAW 117–169—AUG. 16, 2022 1927, as reported by such manufacturer to the Secretary pursuant to the agreement under section 1193(a)) for such biological product, with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds ‘‘(bb) in the initial price applicability year that would have applied but for a delay under— ‘‘(AA) paragraph (2)(A), the maximum fair price negotiated under section 1194 for such biological product under such agreement; or ‘‘(BB) paragraph (2)(B)(iii), such max- imum fair price, increased as described in section 1195(b)(1)(A); and ‘‘(II) the number of units dispensed under part D of title XVIII for such covered part D drug during each such calendar quarter of such price applicability period; and ‘‘(ii) in the case of a biological product for which payment may be made under part B of title XVIII, that is the sum of the products of— ‘‘(I) 80 percent of the amount by which— ‘‘(aa) the payment amount for such biological product under section 1847A(b), with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection; exceeds ‘‘(bb) in the initial price applicability year that would have applied but for a delay under— ‘‘(AA) paragraph (2)(A), the maximum fair price negotiated under section 1194 for such biological product under such agreement; or ‘‘(BB) paragraph (2)(B)(iii), such max- imum fair price, increased as described in section 1195(b)(1)(A); and ‘‘(II) the number of units (excluding units that are packaged into the payment amount for an item or service and are not separately payable under such part B) of the billing and payment code of such biological product administered or furnished under such part B during each such calendar quarter of such price applicability period. ‘‘(C) SPECIAL RULE FOR DELAYED BIOLOGICAL PRODUCTS THAT ARE LONG-MONOPOLY DRUGS.— ‘‘(i) IN GENERAL.—In the case of a biological product with respect to which a rebate is required to be paid under this paragraph, if such biological product quali- fies as a long-monopoly drug (as defined in section 1194(c)(5)) at the time of its inclusion on the list pub- lished under subsection (a), in determining the amount of the rebate for such biological product under subpara- graph (B), the amount described in clause (ii) shall Determination. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00044 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw