[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2052 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2052

To amend title XVIII of the Social Security Act to enforce any willing 
pharmacy requirements and establish safeguards to ensure patient access 
       to pharmacies in Medicare part D, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 20, 2023

  Mr. Tester (for himself, Mrs. Capito, Mr. Brown, and Mr. Lankford) 
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 enforce any willing 
pharmacy requirements and establish safeguards to ensure patient access 
       to pharmacies in Medicare part D, and for other purposes.

    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 ``Protect Patient Access to Pharmacies 
Act''.

SEC. 2. ESTABLISHING SAFEGUARDS TO ENSURE FAIR MARKET COMPETITION FOR 
              PHARMACIES IN MEDICARE PART D.

    Section 1860D-4(b)(1)(C) of the Social Security Act (42 U.S.C. 
1395w-104(b)(1)(C)) is amended by adding at the end the following new 
clauses:
                            ``(v) Enforcing any willing provider 
                        requirements to support patient choice of 
                        pharmacy.--Not later than September 30, 2024, 
                        the Secretary shall require that total payment 
                        (including dispensing fees) by a PDP sponsor 
                        offering a prescription drug plan or MA 
                        organization offering an MA-PD plan for each 
                        covered part D drug dispensed to an enrollee by 
                        a network pharmacy (including specialty 
                        pharmacies (as defined under section 1860D-
                        2(d)(4)(E))), net of any and all price 
                        concessions, discounts, fees of any type, 
                        incentive payments, or any other form of 
                        remuneration, ensures that at a minimum, such 
                        payment covers such pharmacy's costs to acquire 
                        and to dispense each covered part D drug so 
                        that such pharmacy may have the option to 
                        participate as a network provider, which shall 
                        include the ability to acquire and dispense 
                        covered part D drugs and provide pharmacy 
                        services necessary for dispensing such drugs. 
                        In carrying out this clause, the Secretary 
                        shall--
                                    ``(I) utilize pharmacy acquisition 
                                cost data on each type of pharmacy for 
                                each covered part D drug (excluding 
                                drugs purchased under section 340B of 
                                the Public Health Service Act) and cost 
                                to dispense data from each type of 
                                pharmacy (including pharmacies not 
                                otherwise owned, controlled, or 
                                affiliated with any other pharmacy, 
                                plan, or pharmacy benefit manager);
                                    ``(II) establish payment parameters 
                                for each covered part D drug that 
                                considers how the drug is dispensed and 
                                what pharmacy services are provided by 
                                each type of pharmacy to support drug 
                                management with the individual for whom 
                                the drug is dispensed; and
                                    ``(III) establish an appeal process 
                                in which the pharmacy may appeal 
                                payment, in writing and with supporting 
                                documentation, to the Medicare 
                                Pharmaceutical and Technology Ombudsman 
                                within 60 days following notification 
                                of the payment or any adjustment of 
                                such payment of such a drug, if a 
                                network pharmacy believes that the 
                                amount a PDP offering a prescription 
                                drug plan or an MA organization 
                                offering an MA-PD plan has paid for 
                                such drug is below the pharmacy's 
                                lowest actual acquisition and 
                                dispensing costs of such drug.
                            ``(vi) Utilization of pharmacy acquisition 
                        cost data.--With respect to the requirement 
                        under clause (v)(I) for the Secretary to 
                        utilize pharmacy acquisition cost data--
                                    ``(I) the Secretary shall utilize 
                                pharmacy acquisition cost data 
                                described in section 1927(f), relating 
                                to a survey of retail prices; and
                                    ``(II) for each covered part D drug 
                                not included in the survey described in 
                                section 1927(f), the Secretary shall 
                                amend the survey or establish a 
                                survey.''.

SEC. 3. ENSURING FAIR ASSESSMENT OF PHARMACY PERFORMANCE AND QUALITY.

    Section 1860D-2(d) of the Social Security Act (42 U.S.C. 1395w-
102(d)) is amended--
            (1) in paragraph (1)(B), by striking ``For purposes'' and 
        inserting ``Subject to paragraph (4), for purposes''; and
            (2) by adding at the end the following new paragraph:
            ``(4) Application of pharmacy performance measures.--
                    ``(A) Evaluation of pharmacy performance 
                measures.--Not later than 6 months after the date of 
                enactment of this Act, and annually thereafter, the 
                Secretary shall complete an evaluation of the 
                performance measures used by PDP sponsors offering 
                prescription drug plans and MA organizations offering 
                MA-PD plans to assess pharmacy price concessions or any 
                other fees based on performance, as established in 
                network pharmacy agreements. Each such evaluation shall 
                (to the extent practicable) include at least 5 years of 
                retrospective information to examine the following:
                            ``(i) How measures are being applied to 
                        pharmacies, including whether such measures are 
                        applied based on the type of pharmacy 
                        (including specialty pharmacy), drugs 
                        dispensed, and pharmacy services used to 
                        dispense and manage drugs.
                            ``(ii) Whether, with respect to each such 
                        measure, such measure results in anything of 
                        value including any fees, pharmacy price 
                        concessions, discounts, or incentives, 
                        transferred to or received from a pharmacy by a 
                        PDP sponsor offering a prescription drug plan 
                        or MA organization offering an MA-PD plan after 
                        the point-of-sale of a drug, broken down by 
                        type of pharmacy and the drug dispensed.
                            ``(iii) The extent to which each measure is 
                        applied across prescription drug plans offered 
                        by a PDP sponsor and MA-PD plans offered by an 
                        MA organization and if such application is 
                        uniform.
                            ``(iv) How measures are applied and if they 
                        are uniformly applied to all in-network types 
                        of pharmacies or only certain pharmacies within 
                        a network.
                            ``(v) How and when pharmacies are provided 
                        notice of measures, as well as methods and 
                        actual data calculations used to evaluate 
                        performance, and evaluation outcomes by type of 
                        pharmacy.
                            ``(vi) How pharmacy performance is 
                        evaluated using such measures and the extent to 
                        which the goals or targets are--
                                    ``(I) achievable at scale;
                                    ``(II) structured to improve 
                                patient outcomes; and
                                    ``(III) reasonable in the context 
                                of industry data regarding baseline 
                                patient behavior, such as improved 
                                patient outcomes and measure 
                                performance.
                    ``(B) Application of standardized pharmacy 
                performance measures.--For plan years beginning on or 
                after January 1, 2025, a PDP sponsor offering a 
                prescription drug plan or an MA organization offering 
                an MA-PD plan that makes incentive payments to a 
                pharmacy, or receives price concessions or any other 
                remuneration paid by a pharmacy, based on measures of 
                the performance or quality of work of the pharmacy, 
                shall, for the purposes of such incentive payments and 
                price concessions or fees with respect to covered part 
                D drugs dispensed by such pharmacy, only use measures--
                            ``(i) on the most recently updated list 
                        maintained by the Secretary under subparagraph 
                        (C), as listed under clause (ii) of such 
                        subparagraph; and
                            ``(ii) that are relevant to the performance 
                        of such pharmacy based on the type of pharmacy, 
                        drugs dispensed, and pharmacy services used to 
                        dispense and manage drugs.
                    ``(C) Standardized pharmacy performance measures.--
                            ``(i) In general.--Notwithstanding any 
                        other provision of law, the Secretary shall, 
                        taking into account evaluations under 
                        subparagraph (A), establish or adopt from one 
                        or more multi-stakeholder, neutral, consensus-
                        based measure development organizations 
                        representing all types of pharmacies (including 
                        pharmacies not otherwise owned, controlled, or 
                        affiliated with any other pharmacy, plan, or 
                        pharmacy benefit manager) standardized pharmacy 
                        quality measures and performance criteria, such 
                        as cut points, or any type of payment to be 
                        used by a PDP sponsor offering a prescription 
                        drug plan and an MA organization offering an 
                        MA-PD plan for the purposes of determining 
                        incentive payments and price concessions or 
                        fees described in subparagraph (B). Such 
                        measures shall be evidence-based, feasible, 
                        appropriate, and achievable based on industry 
                        data, and focus on pharmacy performance and 
                        quality of care, as determined by the 
                        Secretary, that the pharmacy can impact based 
                        on covered part D drugs the pharmacy dispenses 
                        and manages.
                            ``(ii) Maintenance of list.--The Secretary 
                        shall maintain a single list of measures 
                        established or adopted under this subparagraph. 
                        Such measures shall be evaluated and such list 
                        updated on an ongoing basis through stakeholder 
                        consensus organizations representing all types 
                        of pharmacies as referenced in clause (i) to 
                        ensure the measures on such list are evidence-
                        based, feasible, appropriate, and achievable. 
                        Such list shall be published on a public 
                        website not later than January 1, 2024, and 
                        updated thereafter as appropriate as determined 
                        by the Secretary.
                    ``(D) Transparency to pharmacy.--For plan years 
                beginning on or after January 1, 2025, the Secretary 
                shall establish a uniform process under which a PDP 
                sponsor offering a prescription drug plan and an MA 
                organization offering an MA-PD plan shall promptly 
                disclose, upon receiving a claim for a covered part D 
                drug from a pharmacy, to such pharmacy all pricing 
                components related to such claim, including the Network 
                Reimbursement ID used to price the claim, any service 
                fees and other fees, pharmacy price concessions, 
                discounts, incentives or anything else of value to or 
                from the pharmacy.
                    ``(E) Specialty pharmacy.--For purposes of this 
                subparagraph and section 1860D-4(b)(1)(C), not later 
                than December 31, 2024, the Secretary shall define the 
                term `specialty pharmacy' in consultation with all 
                relevant stakeholders.
                    ``(F) Definitions.--For purposes of this 
                subparagraph:
                            ``(i) Affiliated.--The term `affiliated' 
                        means, with respect to a pharmacy, a PDP 
                        sponsor offering a prescription drug plan, or 
                        an MA organization offering an MA-PD plan, that 
                        the pharmacy, PDP sponsor, or MA organization--
                                    ``(I) is directly or indirectly 
                                through one or more intermediaries 
                                wholly or partially owned by, 
                                controlled by, or is under common 
                                ownership of such pharmacy, PDP 
                                sponsor, or MA organization; or
                                    ``(II) has a financial interest in 
                                such pharmacy, PDP sponsor, or MA 
                                organization.
                            ``(ii) Type of pharmacy.--The term `type of 
                        pharmacy' means any type of pharmacy licensed 
                        by a State, including a retail pharmacy, 
                        specialty pharmacy, and any other type of 
                        pharmacy specified by the Secretary.''.

SEC. 4. ENCOURAGING USE OF PHARMACY PERFORMANCE MEASURES THROUGH 
              QUALITY RATINGS.

    Section 1853(o)(4)(A) of the Social Security Act (42 U.S.C. 1395w-
23(o)(4)(A)) is amended--
            (1) by striking ``determination.--The quality'' and 
        inserting determination.--
                            ``(i) In general.--Subject to clause (ii), 
                        the quality''; and
            (2) by adding at the end the following new clause:
                            ``(ii) Encouraging use of pharmacy 
                        performance measures.--
                                    ``(I) In general.--In the case of a 
                                plan described in subclause (II), with 
                                respect to the determination of quality 
                                ratings on or after January 1, 2024, 
                                the Secretary shall provide for an 
                                increase in the quality rating 
                                otherwise determined under clause (i) 
                                in a manner determined appropriate by 
                                the Secretary.
                                    ``(II) Plan described.--For 
                                purposes of subclause (I), a plan 
                                described in this subclause is a 
                                prescription drug plan offered by a PDP 
                                sponsor or an MA-PD plan offered by an 
                                MA organization that makes incentive 
                                payments to a pharmacy, or receives 
                                price concessions or any other 
                                remuneration paid by a pharmacy, based 
                                on measures of the performance or 
                                quality of work of the pharmacy.''.
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