; or (II) commonly administered by hospitals (as determined by the Secretary); and (ii) 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) United States median household income The term United States median household income means median household income for the United States as published by the Census Bureau for the most recent year for which data is available. (4) 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 if, with respect to the qualifying drug— (A) there is an increase in the price of the qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to— (i) 10 percent or more over a 12-month period beginning on or after January 1, 2024; or (ii) 25 percent or more over a 36-month period beginning on or after January 1, 2024