```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5393 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5393

    To amend title XVIII of the Social Security Act to ensure fair 
 assessment of pharmacy performance and quality under Medicare part D, 
                        and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           September 12, 2023

  Mr. Griffith (for himself and Mr. Carter of Georgia) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committee on Ways and Means, for a 
 period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 A BILL

 
    To amend title XVIII of the Social Security Act to ensure fair 
 assessment of pharmacy performance and quality under 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. ENSURING FAIR ASSESSMENT OF PHARMACY PERFORMANCE AND QUALITY 
              UNDER MEDICARE PART D.

    (a) Standardized Pharmacy Performance Measures.--Section 1860D-2 of 
the Social Security Act (42 U.S.C. 1395w-102) is amended by adding at 
the end the following new subsection:
    ``(f) Application of Standardized Pharmacy Performance Measures.--
            ``(1) Measures.--For plan years beginning on or after 
        January 1, 2025, a PDP sponsor offering a prescription drug 
        plan and an MA organization offering an MA-PD plan shall, for 
        purposes of incentive payments, price concessions, or any fees 
        or other remuneration paid or charged to a pharmacy based on 
        performance measures, only use measures that are--
                    ``(A) established or adopted by the Secretary under 
                paragraph (2) and included on the list described in 
                subparagraph (B) of such paragraph; and
                    ``(B) relevant to the performance of such pharmacy 
                based on the type of pharmacy (including retail, mail 
                order, specialty, long-term care, and home infusion or 
                other types of pharmacies), drugs dispensed, and 
                pharmacy services used to dispense and manage drugs.
            ``(2) Standardized pharmacy performance measures.--
                    ``(A) Measures.--
                            ``(i) In general .--Notwithstanding any 
                        other provision of law, the Secretary shall 
                        establish (or adopt pursuant to clause (iii)) 
                        standardized pharmacy performance measures to 
                        be used by a PDP sponsor offering a 
                        prescription drug plan and an MA organization 
                        offering an MA-PD plan for the purpose of 
                        determining incentive payments, price 
                        concessions, or fees described in paragraph 
                        (1).
                            ``(ii) Requirements.--The measures under 
                        clause (i) shall focus on pharmacy performance 
                        and quality of care based on the type of 
                        pharmacy, as determined by the Secretary. Such 
                        measures shall be evidence-based, feasible, 
                        appropriate and reasonable. The Secretary may 
                        rely on data and information collected from 
                        relevant stakeholders to make determinations 
                        about whether a measure satisfies the 
                        requirements of this clause.
                            ``(iii) Adoption of measure.--In lieu of 
                        establishing some or all of the measures under 
                        this paragraph, the Secretary may adopt 
                        measures and measure performance criteria that 
                        are endorsed by 1 or more multi-stakeholder 
                        consensus organizations (such as the Pharmacy 
                        Quality Alliance), that has participation from 
                        pharmacies (including retail and specialty 
                        pharmacies not owned or affiliated with a plan, 
                        pharmacy benefit manager, or other pharmacy), 
                        health plans, pharmacy benefit managers, and 
                        the Centers for Medicare & Medicaid Services. 
                        Any measure adopted under this clause shall be 
                        deemed to meet the requirements under clause 
                        (ii).
                    ``(B) Maintenance of list.--
                            ``(i) In general.--The Secretary shall 
                        maintain, and publish on a publicly available 
                        internet website, a list of measures 
                        established or adopted under this paragraph. 
                        Such list shall initially be published no later 
                        than June 1, 2024.
                            ``(ii) Update.--The Secretary shall 
                        periodically evaluate measures, measure 
                        criteria, and how measures are applied by type 
                        of pharmacy and update the measures on the list 
                        under clause (i) to ensure such measures meet 
                        the requirements under subparagraph (A)(ii).
            ``(3) OIG reports on pharmacy performance measures.--
                    ``(A) OIG study.--The Office of the Inspector 
                General of the Department of Health and Human Services 
                (in this paragraph referred to as the `Inspector 
                General') shall conduct a study of the use of 
                performance measures and other quality-related 
                mechanisms in network pharmacy agreements and other 
                relevant contracting arrangements among PDP sponsors 
                offering a prescription drug plan, MA organizations 
                offering a MA-PD plan, pharmacy benefit managers acting 
                on behalf of such sponsors and organizations, and 
                network pharmacies. Such study may include audits, 
                reviews of relevant enforcement actions, consultation 
                with relevant stakeholders, and other activities 
                determined appropriate by the Inspector General, 
                consistent with other provisions of law. Such study 
                shall, to the extent feasible, include analysis of--
                            ``(i) oversight and enforcement activities 
                        undertaken with respect to current statutory 
                        and regulatory requirements related to network 
                        pharmacy agreements, including under sections 
                        423.505(b)(18) and 423.505(i) of title 42 of 
                        the Code of Federal Regulations (or any 
                        successor regulation) and under section 1860D-
                        4(b)(1)(A);
                            ``(ii) penalties or other corrective 
                        actions imposed with respect to the 
                        requirements described in clause (i);
                            ``(iii) the prevalence of the application 
                        of performance measures in network pharmacy 
                        agreements, and the manner in which such 
                        measures are applied, including variation based 
                        on the type of pharmacy, the type of drug 
                        dispensed, and the services required to manage 
                        and dispense such drug;
                            ``(iv) the extent to which the performance 
                        measures and related criteria applied under 
                        network agreements vary among similar types of 
                        pharmacies within a single network, and the 
                        extent to which the application of such 
                        measures or criteria differ between 
                        pharmacies--
                                    ``(I) affiliated with a pharmacy 
                                benefit manager, a PDP sponsor offering 
                                a prescription drug plan, or an MA 
                                organization offering a MA-PD plan; and
                                    ``(II) those not affiliated with an 
                                entity described in subclause (I);
                            ``(v) patterns and trends in the 
                        performance measures applied under pharmacy 
                        network agreements, including if the measure is 
                        being used in accordance with published measure 
                        specifications which have been validated and 
                        tested, if the measure is being used according 
                        to licensing agreements with measure stewards, 
                        and the level of attribution and attribution 
                        criteria;
                            ``(vi) the extent to which performance 
                        measures result in incentive payments, fees, 
                        price concessions, or other forms of 
                        remuneration between pharmacies and PDP 
                        sponsors or MA organizations (or pharmacy 
                        benefit managers acting on their behalf), 
                        including an analysis of which measures most 
                        often result in incentive payments to 
                        pharmacies (and the general amount of such 
                        payments) and which measures most often result 
                        in remuneration paid by pharmacies to other 
                        entities (and the general amount of such 
                        payments);
                            ``(vii) variation in the type of 
                        remuneration (as described in clause (vi) 
                        resulting from the application of performance 
                        measures, including between different types of 
                        pharmacies, different types of drugs dispensed, 
                        and affiliation status of pharmacies (as 
                        described in clause (iv));
                            ``(viii) when, in what manner, different 
                        types of pharmacies receive notice of the 
                        application of performance measures, the 
                        measures that will be utilized, the performance 
                        criteria that will be applied, and the data and 
                        methodologies that will be used to evaluate 
                        performance; and
                            ``(ix) the extent to which the Centers for 
                        Medicare & Medicaid Services has implemented 
                        the pharmacy performance reporting requirements 
                        of section 423.514(a)(5) of title 42, Code of 
                        Federal Regulations, the extent to which PDP 
                        sponsors or MA organizations (or pharmacy 
                        benefit managers acting on their behalf) comply 
                        with such provision, and the extent to which 
                        the Centers for Medicare & Medicaid Services 
                        has sought enforcement.
                    ``(B) OIG reports.--
                            ``(i) Report on initial findings.--Not 
                        later than December 31, 2024, the Inspector 
                        General shall submit a report to Congress 
                        outlining, to the extent practicable, a status 
                        update on the study under subparagraph (A), 
                        together with initial findings with respect to 
                        the issues included under such study. Such 
                        report may include an analysis of barriers to 
                        accessing any of the information required under 
                        such study, along with recommendations for 
                        addressing such barriers. Such report may also 
                        include recommendations for the effective 
                        implementation of the requirements enacted 
                        under this subsection as well as existing 
                        regulations, including section 423.514(a)(5) of 
                        title 42, Code of Federal Regulations, along 
                        with other recommendations, as determined 
                        appropriate by the Inspector General.
                            ``(ii) Interim report.--Not later than July 
                        31, 2025, the Inspector General shall submit to 
                        Congress an interim report on the study under 
                        subparagraph (A), including additional 
                        recommendations for the implementation of the 
                        requirements enacted under this subsection as 
                        well as under existing regulations, including 
                        section 423.514(a)(5) of title 42, Code of 
                        Federal Regulations.
                            ``(iii) Final report.--Not later than 
                        December 31, 2025, the Inspector General shall 
                        submit to Congress a final report on the study 
                        under subparagraph (A), together with 
                        additional recommendations, as determined 
                        appropriate by the Inspector General.
            ``(4) Nonapplication of paperwork reduction act.--Chapter 
        35 of title 44, United States Code, shall not apply to any data 
        collection undertaken by the Secretary under this paragraph.''.
    (b) Funding.--In addition to amounts otherwise available, there is 
appropriated to the Centers for Medicare & Medicaid Services Program 
Management Account, out of any money in the Treasury not otherwise 
appropriated, $4,000,000 for fiscal year 2025, to remain available 
until expended, to carry out the amendment made by subsection (a).

SEC. 2. PROMOTING TRANSPARENCY FOR PHARMACIES UNDER MEDICARE PART D.

    (a) Transparency for Pharmacies.--Section 1860D-2(f) of the Social 
Security Act (42 U.S.C. 1395w-102(f)), as added by section 3, is 
amended by adding at the end the following new paragraph:
            ``(3) Transparency for pharmacies.--
                    ``(A) In general.--For plan years beginning on or 
                after January 1, 2025, a PDP sponsor offering a 
                prescription drug plan and an MA organization offering 
                an MA-PD plan, with respect to payment made by such PDP 
                sponsor or such MA organization to a pharmacy for a 
                covered part D drug dispensed by such pharmacy during a 
                plan year, shall promptly furnish, upon receiving a 
                claim for a covered Part D drug from a pharmacy, to 
                such pharmacy information related to such claim, such 
                as the Network Reimbursement ID, fees, pharmacy price 
                concessions, discounts, incentives, or any other forms 
                of remuneration that affect payment and pricing of the 
                claim.
                    ``(B) Standardized format.--The PDP sponsor and the 
                MA organization shall furnish the information described 
                in subparagraph (A) in a standardized format (as 
                specified by the Secretary) that includes all fields 
                needed to price the claim for a covered part D drug 
                dispensed by such pharmacy.
                    ``(C) Implementation.--The Secretary shall 
                implement this paragraph by program instruction or 
                other forms of program guidance.''.
    (b) Funding.--In addition to amounts otherwise available, there is 
appropriated to the Centers for Medicare & Medicaid Services Program 
Management Account, out of any money in the Treasury not otherwise 
appropriated, $2,000,000 for fiscal year 2025, to remain available 
until expended, to carry out the amendment made by subsection (a).
                                 <all>
```