; or (ii) require changes, as necessary, in the covered part D drugs included on formularies of PDP sponsors of prescription drug plans (including changes, as necessary, in the preferred or tiered cost-sharing status of such a drug) to take into account negotiations carried out by the Secretary pursuant to paragraph (1), regardless of whether such a covered part D drug is the subject of such negotiations. (B) Required inclusion of drugs in all therapeutic categories A formulary established and applied under subparagraph (A)(i) shall include at least two covered part D drugs in each category and class of covered part D drugs as described in section 423.120(b)(2)(i) of title 42, Code of Federal Regulations (as in effect on January 1, 2017). (C) Application of development and revision requirements and required inclusion of all drugs in certain categories and classes The requirements described in subparagraphs (A) and (B) of section 1860D–4(b)(3) (relating to development and revision requirements of the formulary) and subparagraph (G) of such section (relating to required inclusion of all drugs in certain categories and classes) shall apply to a formulary established and applied under subparagraph (A)(i) of this paragraph. (3) Plan flexibility to negotiate greater discounts Nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan, or an organization offering an MA–PD plan, from obtaining a discount or reduction of the price for a covered part D drug below the price negotiated under paragraph (1), if applicable, including through the use of preferred or tiered cost-sharing status. (4) Ensuring beneficiary access to needed drugs Beginning with plan year 2019, Each PDP sponsor of a prescription drug plan and organization offering an MA–PD plan shall have in place a process under which an enrollee in the plan may request coverage under the plan for a covered part D drug that is not on the formulary, or is subject to utilization management controls, such as tiered pricing, prior