under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensed under section 351(a) of the Public Health Service Act. (II) Lowest branded drug tier The term lowest branded drug tier means the cost-sharing tier of a formulary which includes at least 1 brand drug and provides for the lowest level of cost sharing applicable to any such tier, as determined by the Secretary. (III) Specialty tier The term specialty tier means a cost-sharing tier consisting only of covered part D drugs that have a cost (as defined by the Secretary) which equals or exceeds an applicable cost threshold established by the Secretary for high-cost covered part D drugs to be eligible for inclusion on such cost-sharing tier. . (b) Conforming amendments Section 1860D–2 of the Social Security Act ( 42 U.S.C. 1395w–102 ) is amended— (1) in subsection (b)(2)— (A) in subparagraph (A), by striking and paragraphs (8) and (9) and inserting , paragraphs (8) and (9), and section 1860D–4(b)(3)(K)