; Drug Value Fund 399OO. Reporting on explanation for drug price increases (a) Definitions In this section: (1) Manufacturer The term manufacturer means the person— (A) that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; 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 of the Social Security Act ( 42 U.S.C. 1395 et seq.) or under a State Medicaid plan under title XIX of such Act ( 42 U.S.C. 1396 et seq.) 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) of the Social Security Act (42 U.S.C. 1395w–3a(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