a coverage, formulary placement, or utilization management decision recommended by the pharmacy and therapeutic committee prior to the review, adoption, or modification of such a recommendation by a committee, entity, or individual described in clause (i)(I). For purposes of this subparagraph, such initial recommendation shall be considered to be separate and distinct from the final review and approval of the formulary design and components by such pharmacy and therapeutic committee, as required under section 423.120 of title 42, Code of Federal Regulations (or any successor regulation). (iii) Non-application of paperwork reduction act Chapter 35 of title 44, United States Code, shall not apply to information required for purposes of carrying out this subparagraph. . (b) Implementation Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendments made by subsection (a) by program instruction or otherwise. (c) GAO study and report (1) Study The Comptroller General shall conduct a study on the use of committees, entities, or individuals described in clause (i)(I) of section 1860D–4(b)(3)(J) of the Social Security Act, as added by subsection (a), in the development and review of formularies under part D of title XVIII of the Social Security Act. Such study shall include an analysis of the following: (A) The prevalence of such committees, entities, or individuals. (B) The number, type, and characteristics of drugs for which a committee, entity, or individual described in such clause (i)(I) made a coverage, formulary placement, or utilization management decision (as defined in clause (ii)(I) of such section 1860D–4(b)(3)(J)). (C) Trends in the justifications provided under clause (i)(III) of such section 1860D–4(b)(3)(J). (D) Trends in the application of utilization management tools (such as prior authorization, step therapy, and quantity limits) and formulary exclusions under prescription drug plans and MA–PD plans and the impact such tools and exclusions have on