; or (B) who is responsible for setting the price 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 per month supply or per a course of treatment that lasts less than a month and is— (i) (I) subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act; or (II) commonly administered by hospitals (as determined by the Secretary); (ii) not designated as a drug for a rare disease or condition under section 526 of the Federal Food, Drug, and Cosmetic Act; and (iii) not designated by the Secretary as 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 for each price increase of a qualifying drug that will result in an increase in the wholesale acquisition cost of that drug that is equal to— (A) 10 percent or more over a 12-month period