; or (B) who is responsible for setting the wholesale acquisition cost for the drug. (2) Qualifying drug The term qualifying drug means any drug that is approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under subsection (a) or (k) of section 351 of this Act— (A) that has a wholesale acquisition cost of $100 or more, adjusted for inflation occurring after the date of enactment of this section, for a month’s supply or a typical course of treatment that lasts less than a month, and is— (i) subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act; (ii) administered or otherwise dispensed to treat a disease or condition affecting more than 200,000 persons in the United States; and (iii) not a vaccine; and (B) for which, during the previous calendar year, at least 1 dollar of the total amount of sales were for individuals enrolled under the Medicare program under title XVIII or under a State Medicaid plan under title XIX or under a waiver of such plan. (3) Wholesale acquisition cost The term wholesale acquisition cost has the meaning given that term in section 1847A(c)(6)(B). (b) Report (1) Report required The manufacturer of a qualifying drug shall submit a report to the Secretary— (A) for each increase in the price of a qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to— (i) 10 percent or more within a single calendar year beginning on or after January 1, 2019; or (ii) 25 percent or more within three consecutive calendar years for which the first such calendar year begins on or after January 1, 2019