[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2406 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2406

To amend title XVIII of the Social Security Act to improve oversight of 
      formulary development and management under Medicare part D.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 20, 2023

  Mr. Carper (for himself and Mr. Grassley) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to improve oversight of 
      formulary development and management under Medicare part D.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``PBM Oversight Act of 2023''.

SEC. 2. RESOLVING CONFLICTS OF INTEREST AND IMPROVING OVERSIGHT OF P&T 
              COMMITTEE OVERRIDES.

    (a) In General.--Section 1860D-4(b)(3) of the Social Security Act 
(42 U.S.C. 1395w-104(b)(3)) is amended--
            (1) in subparagraph (A)(ii)(I), by inserting the following 
        before the semicolon: ``(and, for 2025 and each subsequent 
        year, any pharmacy benefit manager)''; and
            (2) by adding at the end the following new subparagraph:
                    ``(J) Reporting on additional committees with 
                formulary decision making authority.--
                            ``(i) In general.--For 2026 and each 
                        subsequent plan year, a PDP sponsor shall 
                        submit to the Secretary the following 
                        information, if applicable, with respect to 
                        each prescription drug plan offered by the PDP 
                        sponsor:
                                    ``(I) The name and a description of 
                                the role and composition of any 
                                committee, entity, or individual within 
                                or affiliated with the PDP sponsor (or 
                                a pharmacy benefit manager, acting 
                                under contract with such sponsor) that 
                                has the authority to make a coverage, 
                                formulary placement, or utilization 
                                management decision (as defined in 
                                clause (ii)(I)), other than the 
                                pharmacy and therapeutic committee 
                                described in subparagraph (A).
                                    ``(II) A list of drugs for which a 
                                committee, entity, or individual 
                                described in subclause (I) made a 
                                coverage, formulary placement, or 
                                utilization management decision (as so 
                                defined) and the corresponding initial 
                                recommendation (as defined in clause 
                                (ii)(II)) made by the pharmacy and 
                                therapeutic committee.
                                    ``(III) A brief justification for 
                                each decision described in subclause 
                                (II).
                            ``(ii) Definitions.--In this subparagraph:
                                    ``(I) Coverage, formulary 
                                placement, or utilization management 
                                decision.--The term `coverage, 
                                formulary placement, or utilization 
                                management decision' means a decision 
                                by a committee, entity, or individual 
                                described in clause (i)(I) that 
                                modifies, adjusts, reverses, or 
                                otherwise alters (such as by 
                                substituting the formulary inclusion of 
                                one covered part D drug for another or 
                                by substituting a more general initial 
                                recommendation for a more specific 
                                decision) an initial recommendation by 
                                the pharmacy and therapeutic committee.
                                    ``(II) Initial recommendation.--The 
                                term `initial recommendation' means 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 beneficiary 
                access to covered part D drugs.
            (2) Report.--Not later than January 1, 2029, the 
        Comptroller General shall submit to Congress a report 
        containing the results of the study conducted under paragraph 
        (1), together with any recommendations for such legislation and 
        administrative action as the Comptroller General determines 
        appropriate.
            (3) Definitions.--In this subsection:
                    (A) Comptroller general.--The term ``Comptroller 
                General'' means the Comptroller General of the United 
                States.
                    (B) Other terms.--The terms ``covered part D 
                drug'', ``MA-PD plan'', and ``prescription drug plan'' 
                have the meaning given those terms in section 1860D-41 
                of the Social Security Act (42 U.S.C. 1395w-151).
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