; and (ii) had an increase in the wholesale acquisition cost of the drug, with respect to determinations made— (I) during 2019, of at least 15 percent since the date of the enactment of this section; (II) during 2020, of at least 15 percent in the preceding 12 months or of at least 20 percent in the preceding 2 years; (III) during 2021, of at least 15 percent in the preceding 12 months or of at least 30 percent in the preceding 3 years; (IV) during 2022, of at least 15 percent in the preceding 12 months or of at least 40 percent in the preceding 4 years; or (V) on or after January 1, 2023, of at least 15 percent in the preceding 12 months or of at least 50 percent in the preceding 5 years. (2) Special rule For purposes of applying paragraph (1), the Secretary may substitute for each percentage described in subparagraph (A) or (B) of such paragraph (other than the percentile described subparagraph (B)(i) of such paragraph) a percentage within a de minimis range specified by the Secretary below the percentage so described. (3) Manufacturer The term manufacturer has the meaning given that term in section 581(10) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360eee(10) ). (4) Wholesale acquisition cost The term wholesale acquisition cost has the meaning given that term in section 1847A(c)(6)(B). (c) Justification described The justification described in this subsection is all relevant information and supporting documentation necessary to justify the increase in the wholesale acquisition cost of the applicable drug of the manufacturer, which may include the following: (1) The individual factors that have contributed to the increase in the wholesale acquisition cost. (2) An explanation of the role of each factor in contributing to such increase. (3) Total expenditures of the manufacturer on— (A) materials and manufacturing for such drug; (B) acquiring patents and licensing for each drug of the manufacturer