; (B) provide a period of at least 60 days for comment on the draft guidance; and (C) after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance. (c) Applicability Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized. 202. Improving transparency and preventing the use of abusive spread pricing and related practices in Medicaid (a) Spread pricing (1) In general Section 1927(e) of the Social Security Act ( 42 U.S.C. 1396r–8(e) ) is amended by adding at the end the following: (6) Pharmacy price reimbursement required (A) In general A contract between the State and a pharmacy benefit manager (in this paragraph referred to as a PBM ), or a contract between the State and a designated entity (as defined in subparagraph (C)) that includes provisions making the designated entity responsible for the administration of medical assistance consisting of covered outpatient drugs for individuals enrolled with the designated entity, shall require that payment for such drugs and related administrative services (as applicable), including payments made by a PBM on behalf of the State or designated entity, is based on a pharmacy price reimbursement model under which— (i) any payment made by the designated entity or the PBM (as applicable) for such a drug— (I) is limited to— (aa) ingredient cost; and (bb) a professional dispensing fee that is not less than the professional dispensing fee that the State plan or waiver would pay if the plan or waiver was making the payment directly; (II) is passed through in its entirety by the designated entity or PBM to the pharmacy or provider that dispenses the drug and is not retroactively denied or reduced except as permitted or required under Federal or State law or regulation