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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1339 Reported in Senate (RS)]

<DOC>

                                                       Calendar No. 113
118th CONGRESS
  1st Session
                                S. 1339

 To provide for increased oversight of entities that provide pharmacy 
benefit management services on behalf of group health plans and health 
                          insurance coverage.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 27, 2023

 Mr. Sanders (for himself, Mr. Cassidy, Mrs. Murray, Mr. Marshall, and 
  Mr. Braun) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                             June 22, 2023

               Reported by Mr. Sanders, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
 To provide for increased oversight of entities that provide pharmacy 
benefit management services on behalf of group health plans and health 
                          insurance coverage.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Pharmacy Benefit Manager 
Reform Act''.</DELETED>

<DELETED>SEC. 2. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT 
              MANAGEMENT SERVICES.</DELETED>

<DELETED>    (a) PHSA.--Title XXVII of the Public Health Service Act 
(42 U.S.C. 300gg et seq.) is amended--</DELETED>
        <DELETED>    (1) in part D (42 U.S.C. 300gg-111 et seq.), by 
        adding at the end the following new section:</DELETED>

<DELETED>``SEC. 2799A-11. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY 
              BENEFIT MANAGEMENT SERVICES.</DELETED>

<DELETED>    ``(a) In General.--For plan years beginning on or after 
January 1, 2025, a group health plan or health insurance issuer 
offering group health insurance coverage or an entity providing 
pharmacy benefit management services on behalf of such a plan or issuer 
shall not enter into a contract with an applicable entity that limits 
the disclosure of information to plan sponsors in such a manner that 
prevents the plan or issuer, or an entity providing pharmacy benefit 
management services on behalf of a plan or issuer, from making the 
reports described in subsection (b).</DELETED>
<DELETED>    ``(b) Reports.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, not less frequently than annually, an 
        entity providing pharmacy benefit management services on behalf 
        of a covered group health plan shall submit to the plan sponsor 
        of such covered group health plan a report in accordance with 
        this subsection and make such report available to the plan 
        sponsor in a machine-readable format and, as the Secretary, the 
        Secretary of Labor, and the Secretary of the Treasury may 
        determine, other formats. Each such report shall include, with 
        respect to the covered group health plan--</DELETED>
                <DELETED>    ``(A) as applicable, information collected 
                from drug manufacturers by such issuer or entity on the 
                total amount of copayment assistance dollars paid, or 
                copayment cards applied, that were funded by the drug 
                manufacturer with respect to the participants and 
                beneficiaries in such plan;</DELETED>
                <DELETED>    ``(B) a list of each drug covered by such 
                plan or entity providing pharmacy benefit management 
                services that was billed during the reporting period, 
                including, with respect to each such drug during the 
                reporting period--</DELETED>
                        <DELETED>    ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug 
                        Code;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries for whom the drug was billed 
                        during the reporting period, the total number 
                        of prescription claims for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the reporting 
                        period;</DELETED>
                        <DELETED>    ``(iii) for each claim or dosage 
                        unit described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;</DELETED>
                        <DELETED>    ``(iv) the wholesale acquisition 
                        cost, listed as cost per days supply, cost per 
                        dosage unit, and cost per typical course of 
                        treatment (as applicable);</DELETED>
                        <DELETED>    ``(v) the total out-of-pocket 
                        spending by participants and beneficiaries on 
                        such drug after application of any benefits 
                        under the plan or coverage, including 
                        participant and beneficiary spending through 
                        copayments, coinsurance, and deductibles, but 
                        not including any amounts spent by participants 
                        and beneficiaries on drugs not covered under 
                        the plan or coverage or for which no claim is 
                        submitted to the plan or coverage; 
                        and</DELETED>
                        <DELETED>    ``(vi) for any drug for which 
                        gross spending by the plan exceeded $10,000 and 
                        that is one of the 50 prescription drugs for 
                        which the group health plan spent the most on 
                        prescription drug benefits during the reporting 
                        period--</DELETED>
                                <DELETED>    ``(I) a list of all other 
                                drugs in the same therapeutic class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic class as 
                                such drug; and</DELETED>
                                <DELETED>    ``(II) if applicable, the 
                                rationale for preferred formulary 
                                placement of such drug in that 
                                therapeutic class, selected from a list 
                                of standard rationales established by 
                                the Secretary;</DELETED>
                <DELETED>    ``(C) a list of each therapeutic class of 
                drugs that were dispensed under the health plan during 
                the reporting period, and, with respect to each such 
                therapeutic class of drugs, during the reporting 
                period--</DELETED>
                        <DELETED>    ``(i) total gross spending by the 
                        plan, before rebates, fees, alternative 
                        discounts, or other remuneration;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries who filled a prescription for 
                        a drug in that class;</DELETED>
                        <DELETED>    ``(iii) if applicable to that 
                        class, a description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;</DELETED>
                        <DELETED>    ``(iv) the total out-of-pocket 
                        spending by participants and beneficiaries, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and</DELETED>
                        <DELETED>    ``(v) for each therapeutic class 
                        under which 3 or more drugs are included on the 
                        formulary of such plan--</DELETED>
                                <DELETED>    ``(I) the amount received, 
                                or expected to be received, by such 
                                entity, from an applicable entity, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration that--</DELETED>
                                        <DELETED>    ``(aa) has been 
                                        paid, or will be paid, by such 
                                        an applicable entity for claims 
                                        incurred during the reporting 
                                        period; or</DELETED>
                                        <DELETED>    ``(bb) is related 
                                        to utilization of drugs or drug 
                                        spending;</DELETED>
                                <DELETED>    ``(II) the total net 
                                spending by the health plan on that 
                                class of drugs; and</DELETED>
                                <DELETED>    ``(III) the net price per 
                                typical course of treatment or 30-day 
                                supply incurred by the health plan and 
                                its participants and beneficiaries, 
                                after rebates, fees, alternative 
                                discounts, or other remuneration 
                                provided by an applicable entity, for 
                                drugs dispensed within such therapeutic 
                                class during the reporting 
                                period;</DELETED>
                <DELETED>    ``(D) total gross spending on prescription 
                drugs by the plan during the reporting period, before 
                rebates, fees, alternative discounts, or other 
                remuneration provided by an applicable 
                entity;</DELETED>
                <DELETED>    ``(E) the total amount received, or 
                expected to be received, by the health plan, from an 
                applicable entity, in rebates, fees, alternative 
                discounts, and other remuneration received from any 
                such entities, related to utilization of drug or drug 
                spending under that health plan during the reporting 
                period;</DELETED>
                <DELETED>    ``(F) the total net spending on 
                prescription drugs by the health plan during the 
                reporting period;</DELETED>
                <DELETED>    ``(G) amounts paid directly or indirectly 
                in rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA) of the 
                Employee Retirement Income Security Act of 1974) to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's business 
                to the pharmacy benefit manager; and</DELETED>
                <DELETED>    ``(H) a summary document that includes 
                such information described in subparagraphs (A) through 
                (G) as the Secretary determines useful for plan 
                sponsors for purposes of selecting pharmacy benefit 
                management services, such as an estimated net price to 
                plan sponsor and participant or beneficiary, a cost per 
                claim, the fee structure or reimbursement model, and 
                estimated cost per participant or 
                beneficiary.</DELETED>
        <DELETED>    ``(2) Supplementary reporting for intra-company 
        prescription drug transactions.--</DELETED>
                <DELETED>    ``(A) In general.--A health insurance 
                issuer offering covered group health insurance coverage 
                or an entity providing pharmacy benefit management 
                services under a covered group health plan or covered 
                group health insurance coverage shall submit, together 
                with the report under paragraph (1), a supplementary 
                report every 6 months to the plan sponsor that 
                includes--</DELETED>
                        <DELETED>    ``(i) an explanation of any 
                        benefit design parameters that encourage or 
                        require participants and beneficiaries in the 
                        plan or coverage to fill prescriptions at mail 
                        order, specialty, or retail pharmacies that are 
                        wholly or partially-owned by that issuer or 
                        entity providing pharmacy benefit management 
                        services under such plan or coverage, including 
                        mandatory mail and specialty home delivery 
                        programs, retail and mail auto-refill programs, 
                        and copayment incentives funded by an entity 
                        providing pharmacy benefit management 
                        services;</DELETED>
                        <DELETED>    ``(ii) the percentage of total 
                        prescriptions charged to the plan, coverage, or 
                        participants and beneficiaries in the plan or 
                        coverage, that were dispensed by mail order, 
                        specialty, or retail pharmacies that are wholly 
                        or partially-owned by the issuer or entity 
                        providing pharmacy benefit management services; 
                        and</DELETED>
                        <DELETED>    ``(iii) a list of all drugs 
                        dispensed by such wholly or partially-owned 
                        pharmacy and charged to the plan or coverage, 
                        or participants and beneficiaries of the plan 
                        or coverage, during the applicable quarter, 
                        and, with respect to each drug--</DELETED>
                                <DELETED>    ``(I) the amounts charged, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, with respect to 
                                participants and beneficiaries in the 
                                plan or coverage, including amounts 
                                charged to the plan or coverage and 
                                amounts charged to the participants and 
                                beneficiaries;</DELETED>
                                <DELETED>    ``(II) the median amount 
                                charged to the plan or coverage, per 
                                dosage unit, per course of treatment, 
                                per 30-day supply, and per 90-day 
                                supply, including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the issuer or entity 
                                and that are included in the pharmacy 
                                network of that plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(III) the interquartile 
                                range of the costs, per dosage unit, 
                                per course of treatment, per 30-day 
                                supply, and per 90-day supply, 
                                including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the issuer or entity 
                                and that are included in the pharmacy 
                                network of that plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(IV) the lowest cost, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, for such drug, including 
                                amounts charged to the plan or issuer 
                                and participants and beneficiaries, 
                                that is available from any pharmacy 
                                included in the network of the plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(V) the net acquisition 
                                cost per dosage unit and for a 30 day-
                                supply, and the acquisition cost per 
                                typical course of treatment, if the 
                                drug is subject to a maximum price 
                                discount; and</DELETED>
                                <DELETED>    ``(VI) other information 
                                with respect to the cost of the drug, 
                                as determined by the Secretary, such as 
                                average sales price, wholesale 
                                acquisition cost, and national average 
                                drug acquisition cost per dosage unit, 
                                per typical course of treatment, or per 
                                30-day supply, for such drug, including 
                                amounts charged to the plan or issuer 
                                and participants and beneficiaries 
                                among all pharmacies included in the 
                                network of the plan or 
                                coverage.</DELETED>
                <DELETED>    ``(B) Plans and coverage offered by small 
                employers.--A health insurance issuer offering covered 
                group health insurance coverage that is not covered 
                group health insurance coverage or an entity providing 
                pharmacy benefit management services under a group 
                health plan that is not a covered group health plan or 
                under group health insurance coverage that is not 
                covered group health insurance coverage that conducts 
                transactions with a wholly or partially-owned pharmacy 
                shall submit, together with the report under paragraph 
                (1), a supplementary report every 6 months to the plan 
                sponsor that includes the information described in 
                clauses (i) and (ii) of subparagraph (A).</DELETED>
        <DELETED>    ``(3) Privacy requirements.--</DELETED>
                <DELETED>    ``(A) Relationship to hipaa regulations.--
                Nothing in this section shall be construed to modify 
                the requirements for the creation, receipt, 
                maintenance, or transmission of protected health 
                information under the privacy, security, breach 
                notification, and enforcement regulations in parts 160 
                and 164 of title 45, Code of Federal Regulations (or 
                successor regulations).</DELETED>
                <DELETED>    ``(B) Requirement.--A report submitted 
                under paragraph (1) or (2) shall contain only summary 
                health information, as defined in section 164.504(a) of 
                title 45, Code of Federal Regulations (or successor 
                regulations).</DELETED>
                <DELETED>    ``(C) Clarification regarding certain 
                disclosures of information.--</DELETED>
                        <DELETED>    ``(i) Reasonable restrictions.--
                        Nothing in this section prevents a health 
                        insurance issuer offering group health 
                        insurance coverage or an entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan or group health 
                        insurance coverage from placing reasonable 
                        restrictions on the public disclosure of the 
                        information contained in a report under 
                        paragraph (1) or (2).</DELETED>
                        <DELETED>    ``(ii) Limitations.--A health 
                        insurance issuer offering group health 
                        insurance coverage or an entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan or group health 
                        insurance coverage may not restrict disclosure 
                        of such reports to the Department of Health and 
                        Human Services, the Department of Labor, the 
                        Department of the Treasury, or any other 
                        Federal agency responsible for enforcement 
                        activities under this section for purposes of 
                        enforcement under this section or other 
                        applicable law, or to the Comptroller General 
                        of the United States in accordance with 
                        paragraph (6).</DELETED>
        <DELETED>    ``(4) Use and disclosure by plan sponsors.--
        </DELETED>
                <DELETED>    ``(A) Prohibition.--A plan sponsor may 
                not--</DELETED>
                        <DELETED>    ``(i) fail or refuse to hire, or 
                        discharge, any employee, or otherwise 
                        discriminate against any employee with respect 
                        to the compensation, terms, conditions, or 
                        privileges of employment of the employee, 
                        because of information submitted under 
                        paragraph (1) or (2) attributed to the employee 
                        or a dependent of the employee; or</DELETED>
                        <DELETED>    ``(ii) limit, segregate, or 
                        classify the employees of the employer in any 
                        way that would deprive or tend to deprive any 
                        employee of employment opportunities or 
                        otherwise adversely affect the status of the 
                        employee as an employee, because of information 
                        submitted under paragraph (1) or (2) attributed 
                        to the employee or a dependent of the 
                        employee.</DELETED>
                <DELETED>    ``(B) Disclosure and redisclosure.--A plan 
                sponsor shall not disclose the information received 
                under paragraph (1) or (2) except--</DELETED>
                        <DELETED>    ``(i) to an occupational or other 
                        health researcher if the research is conducted 
                        in compliance with the regulations and 
                        protections provided for under part 46 of title 
                        45, Code of Federal Regulations (or successor 
                        regulations);</DELETED>
                        <DELETED>    ``(ii) in response to an order of 
                        a court, except that the plan sponsor may 
                        disclose only the information expressly 
                        authorized by such order;</DELETED>
                        <DELETED>    ``(iii) to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or other 
                        Federal agency responsible for enforcement 
                        activities under this section; or</DELETED>
                        <DELETED>    ``(iv) to a contractor or agent 
                        for purposes of health plan administration, if 
                        such contractor or agent agrees, in writing, to 
                        abide by the same use and disclosure 
                        restrictions as the plan sponsor.</DELETED>
                <DELETED>    ``(C) Relationship to hipaa regulations.--
                With respect to the regulations promulgated by the 
                Secretary of Health and Human Services under part C of 
                title XI of the Social Security Act and section 264 of 
                the Health Insurance Portability and Accountability Act 
                of 1996, subparagraph (B) does not prohibit a covered 
                entity (as defined for purposes of such regulations) 
                from any use or disclosure of health information that 
                is authorized for the covered entity under such 
                regulations. The previous sentence does not affect the 
                authority of such Secretary to modify such 
                regulations.</DELETED>
                <DELETED>    ``(D) Enforcement.--</DELETED>
                        <DELETED>    ``(i) In general.--The powers, 
                        procedures, and remedies provided in section 
                        207 of the Genetic Information 
                        Nondiscrimination Act to a person alleging a 
                        violation of title II of such Act shall be the 
                        powers, procedures, and remedies this 
                        subparagraph provides for any person alleging a 
                        violation of this paragraph.</DELETED>
                        <DELETED>    ``(ii) Prohibition against 
                        retaliation.--No person shall discriminate 
                        against any individual because such individual 
                        has opposed any act or practice made unlawful 
                        by this paragraph or because such individual 
                        made a charge, testified, assisted, or 
                        participated in any manner in an investigation, 
                        proceeding, or hearing under this paragraph. 
                        The remedies and procedures otherwise provided 
                        for under this subparagraph shall be available 
                        to aggrieved individuals with respect to 
                        violations of this clause.</DELETED>
        <DELETED>    ``(5) Additional reporting.--</DELETED>
                <DELETED>    ``(A) Reporting with respect to group 
                health plans offered by small employers.--For plan 
                years beginning on or after January 1, 2025, not less 
                frequently than annually, an entity providing pharmacy 
                benefit management services on behalf of a group health 
                plan that is not a covered group health plan shall 
                submit to the plan sponsor of such group health plan a 
                report in accordance with this paragraph, and make such 
                report available to the plan sponsor in a machine-
                readable format, and such other formats as the 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of the Treasury may determine. Each 
                such report shall include, with respect to the 
                applicable group health plan, the information described 
                in subparagraphs (A), (D), (E), (F), (G), and (H) of 
                paragraph (1).</DELETED>
                <DELETED>    ``(B) Opt-in for group health insurance 
                coverage.--</DELETED>
                        <DELETED>    ``(i) In general.--A plan sponsor 
                        may, on an annual basis, beginning with plan 
                        years beginning on or after January 1, 2025, 
                        elect to require a health insurance issuer 
                        offering group health insurance coverage to 
                        submit to such plan sponsor a report in 
                        accordance with this subsection.</DELETED>
                        <DELETED>    ``(ii) Contents of reports.--
                        </DELETED>
                                <DELETED>    ``(I) Covered group health 
                                insurance coverage.--In the case of an 
                                issuer that offers covered group health 
                                insurance coverage, a report provided 
                                pursuant to clause (i) shall include, 
                                with respect to the applicable covered 
                                group health insurance coverage, the 
                                information required under paragraph 
                                (1) for covered group health 
                                plans.</DELETED>
                                <DELETED>    ``(II) Other group health 
                                insurance coverage.--In the case of an 
                                issuer that offers group health 
                                insurance coverage that is not covered 
                                group health insurance, a report 
                                provided pursuant to clause (i) shall 
                                include, with respect to the applicable 
                                group health insurance coverage, the 
                                information described in subparagraphs 
                                (A), (D), (E), (F), and (G) of 
                                paragraph (1).</DELETED>
                        <DELETED>    ``(iii) Application.--For purposes 
                        of reports submitted in accordance with this 
                        subparagraph, paragraph (1) shall be applied by 
                        substituting `group health insurance coverage' 
                        or `health insurance issuer', as applicable, 
                        for `group health plan', `group plan', and 
                        `plan' where such terms appear in such 
                        paragraph.</DELETED>
                        <DELETED>    ``(iv) Required reporting for all 
                        group health insurance coverage.--Each health 
                        insurance issuer of health insurance coverage 
                        shall annually submit the information described 
                        in paragraph (1)(H), regardless of whether the 
                        plan sponsor made the election described in 
                        clause (i) for the applicable year.</DELETED>
        <DELETED>    ``(6) Submissions to gao.--A health insurance 
        issuer offering group health insurance coverage or an entity 
        providing pharmacy benefit management services on behalf of a 
        group health plan shall submit to the Comptroller General of 
        the United States each of the first 2 reports submitted to a 
        plan sponsor under paragraph (1) or (5) with respect to such 
        coverage or plan, and other such reports as requested, in 
        accordance with the privacy requirements under paragraph (3), 
        and such other information that the Comptroller General 
        determines necessary to carry out the study under section 2(f) 
        of the Pharmacy Benefit Manager Reform Act.</DELETED>
        <DELETED>    ``(7) Standard formats.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than June 1, 
                2024, the Secretary, the Secretary of Labor, and the 
                Secretary of the Treasury shall specify, through 
                rulemaking, standard formats for health insurance 
                issuers and entities providing pharmacy benefit 
                management services to submit reports required under 
                this subsection.</DELETED>
                <DELETED>    ``(B) Limited form of report.--The 
                Secretary, the Secretary of Labor, and the Secretary of 
                the Treasury shall define through rulemaking a limited 
                form of the reports under paragraphs (1) and (2) 
                required to be submitted to plan sponsors who also are 
                drug manufacturers, drug wholesalers, entities 
                providing pharmacy benefit management services, or 
                other direct participants in the drug supply chain, in 
                order to prevent anti-competitive behavior.</DELETED>
<DELETED>    ``(c) Limitations on Spread Pricing.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, a group health plan or health insurance 
        issuer offering group or individual health insurance coverage 
        shall not charge participants and beneficiaries, and an entity 
        providing pharmacy benefit management services under such a 
        plan or coverage shall not charge the plan, issuer, or 
        participants and beneficiaries, a price for a prescription drug 
        that exceeds the price paid to the pharmacy for such drug, 
        excluding penalties paid by the pharmacy (as described in 
        paragraph (2)) to such plan, issuer, or entity.</DELETED>
        <DELETED>    ``(2) Rule of construction.--For purposes of 
        paragraph (1), penalties paid by pharmacies include only the 
        following:</DELETED>
                <DELETED>    ``(A) A penalty paid if an original claim 
                for a prescription drug was submitted fraudulently by 
                the pharmacy to the plan, issuer, or entity.</DELETED>
                <DELETED>    ``(B) A penalty paid if the original claim 
                payment made by the plan, issuer, or entity to the 
                pharmacy was inconsistent with the reimbursement terms 
                in any contract between the pharmacy and the plan, 
                issuer, or entity.</DELETED>
                <DELETED>    ``(C) A penalty paid if the pharmacist 
                services billed to the plan, issuer, or entity were not 
                rendered by the pharmacy.</DELETED>
<DELETED>    ``(d) Full Rebate Pass-Through to Plan.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, a third-party administrator of a group 
        health plan, a health insurance issuer offering group health 
        insurance coverage, or an entity providing pharmacy benefit 
        management services under such health plan or health insurance 
        coverage shall--</DELETED>
                <DELETED>    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                from any applicable entity that are related to 
                utilization of drugs under such health plan or health 
                insurance coverage, to the group health plan; 
                and</DELETED>
                <DELETED>    ``(B) ensure that any contract entered 
                into by such third-party administrator, health 
                insurance issuer, or entity providing pharmacy benefit 
                management services with an applicable entity remit 100 
                percent of rebates, fees, alternative discounts, and 
                other remuneration received to the third-party 
                administrator, health insurance issuer, or entity 
                providing pharmacy benefit management 
                services.</DELETED>
        <DELETED>    ``(2) Form and manner of remittance.--Such 
        rebates, fees, alternative discounts, and other remuneration 
        shall be--</DELETED>
                <DELETED>    ``(A) remitted to the group health plan or 
                group health insurance coverage in a timely fashion 
                after the period for which such rebates, fees, 
                alternative discounts, or other remuneration is 
                calculated, and in no case later than 90 days after the 
                end of such period;</DELETED>
                <DELETED>    ``(B) fully disclosed and enumerated to 
                the group health plan sponsor, as described in 
                paragraphs (1) and (4) of subsection (b);</DELETED>
                <DELETED>    ``(C) available for audit by the plan 
                sponsor, or a third-party designated by a plan sponsor 
                not less than once per plan year; and</DELETED>
                <DELETED>    ``(D) returned to the issuer or entity 
                providing pharmaceutical benefit management services by 
                the group health plan if audits by such issuer or 
                entity indicate that the amounts received are incorrect 
                after such amounts have been paid to the group health 
                plan.</DELETED>
        <DELETED>    ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan, a health insurance issuer 
        offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services under such 
        health plan or health insurance coverage shall make rebate 
        contracts with rebate aggregators or drug manufacturers 
        available for audit by such plan sponsor or designated third-
        party, subject to confidentiality agreements to prevent re-
        disclosure of such contracts.</DELETED>
        <DELETED>    ``(4) Auditors.--The applicable plan sponsor may 
        select an auditor for purposes of carrying out audits under 
        paragraphs (2)(C) and (3).</DELETED>
        <DELETED>    ``(5) Rule of construction.--Nothing in this 
        subsection shall be construed to prohibit payments to entities 
        offering pharmacy benefit management services for bona fide 
        services using a fee structure not contemplated by this 
        subsection, provided that such fees are transparent to group 
        health plans and health insurance issuers.</DELETED>
<DELETED>    ``(e) Enforcement.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in consultation 
        with the Secretary of Labor and the Secretary of the Treasury, 
        shall enforce this section.</DELETED>
        <DELETED>    ``(2) Failure to provide timely information.--A 
        health insurance issuer or an entity providing pharmacy benefit 
        management services that violates subsection (a) or fails to 
        provide information required under subsection (b); a group 
        health plan, health insurance issuer, or entity providing 
        pharmacy benefit management services that violates subsection 
        (c); or a third-party administrator of a group health plan, a 
        health insurance issuer offering group health insurance 
        coverage, or an entity providing pharmacy benefit management 
        services that violates subsection (d) shall be subject to a 
        civil monetary penalty in the amount of $10,000 for each day 
        during which such violation continues or such information is 
        not disclosed or reported.</DELETED>
        <DELETED>    ``(3) False information.--A health insurance 
        issuer, entity providing pharmacy benefit management services, 
        or drug manufacturer that knowingly provides false information 
        under this section shall be subject to a civil money penalty in 
        an amount not to exceed $100,000 for each item of false 
        information. Such civil money penalty shall be in addition to 
        other penalties as may be prescribed by law.</DELETED>
        <DELETED>    ``(4) Procedure.--The provisions of section 1128A 
        of the Social Security Act, other than subsections (a) and (b) 
        and the first sentence of subsection (c)(1) of such section 
        shall apply to civil monetary penalties under this subsection 
        in the same manner as such provisions apply to a penalty or 
        proceeding under section 1128A of the Social Security 
        Act.</DELETED>
        <DELETED>    ``(5) Waivers.--The Secretary may waive penalties 
        under paragraph (2), or extend the period of time for 
        compliance with a requirement of this section, for an entity in 
        violation of this section that has made a good-faith effort to 
        comply with this section.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to permit a health insurance issuer, group health plan, or 
other entity to restrict disclosure to, or otherwise limit the access 
of, the Department of Health and Human Services to a report described 
in subsection (b)(1) or information related to compliance with 
subsection (a) by such issuer, plan, or entity.</DELETED>
<DELETED>    ``(g) Definitions.--In this section--</DELETED>
        <DELETED>    ``(1) the term `applicable entity' means--
        </DELETED>
                <DELETED>    ``(A) a drug manufacturer, distributor, 
                wholesaler, rebate aggregator (or other purchasing 
                entity designed to aggregate rebates), group purchasing 
                organization, or associated third party;</DELETED>
                <DELETED>    ``(B) any subsidiary, parent, affiliate, 
                or subcontractor of a group health plan, health 
                insurance issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); 
                or</DELETED>
                <DELETED>    ``(C) such other entity as the Secretary, 
                the Secretary of Labor, and the Secretary of the 
                Treasury may specify through rulemaking;</DELETED>
        <DELETED>    ``(2) the term `covered group health insurance 
        coverage' means health insurance coverage offered in connection 
        with a group health plan maintained by a large 
        employer;</DELETED>
        <DELETED>    ``(3) the term `covered group health plan' means a 
        group health plan maintained by a large employer;</DELETED>
        <DELETED>    ``(4) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated before the application of manufacturer rebates, 
        fees, alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(5) the term `large employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 50 employees on business days during the preceding 
        calendar year and who employs at least 1 employee on the first 
        day of the plan year;</DELETED>
        <DELETED>    ``(6) the term `net spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated after the application of manufacturer rebates, fees, 
        alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(7) the term `plan sponsor' has the meaning 
        given such term in section 3(16)(B) of the Employee Retirement 
        Income Security Act of 1974;</DELETED>
        <DELETED>    ``(8) the term `remuneration' has the meaning 
        given such term by the Secretary, the Secretary of Labor, and 
        the Secretary of the Treasury, through notice and comment 
        rulemaking;</DELETED>
        <DELETED>    ``(9) the term `small employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 1 but not more than 49 employees on business days during 
        the preceding calendar year and who employs at least 1 employee 
        on the first day of the plan year; and</DELETED>
        <DELETED>    ``(10) the term `wholesale acquisition cost' has 
        the meaning given such term in section 1847A(c)(6)(B) of the 
        Social Security Act.''; and</DELETED>
        <DELETED>    (2) in section 2723 (42 U.S.C. 300gg-22)--
        </DELETED>
                <DELETED>    (A) in subsection (a)--</DELETED>
                        <DELETED>    (i) in paragraph (1), by inserting 
                        ``(other than section 2799A-11)'' after ``part 
                        D''; and</DELETED>
                        <DELETED>    (ii) in paragraph (2), by 
                        inserting ``(other than section 2799A-11)'' 
                        after ``part D'';</DELETED>
                <DELETED>    (B) in subsection (b)--</DELETED>
                        <DELETED>    (i) in paragraph (1), by inserting 
                        ``(other than section 2799A-11)'' after ``part 
                        D'';</DELETED>
                        <DELETED>    (ii) in paragraph (2)(A), by 
                        inserting ``(other than section 2799A-11)'' 
                        after ``part D''; and</DELETED>
                        <DELETED>    (iii) in paragraph (2)(C)(ii), by 
                        inserting ``(other than section 2799A-11)'' 
                        after ``part D''.</DELETED>
<DELETED>    (b) ERISA.--</DELETED>
        <DELETED>    (1) In general.--Subtitle B of title I of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 1021 
        et seq.) is amended--</DELETED>
                <DELETED>    (A) in subpart B of part 7 (29 U.S.C. 1185 
                et seq.), by adding at the end the following:</DELETED>

<DELETED>``SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY 
              BENEFIT MANAGEMENT SERVICES.</DELETED>

<DELETED>    ``(a) In General.--For plan years beginning on or after 
January 1, 2025, a group health plan (or health insurance issuer 
offering group health insurance coverage in connection with such a 
plan) or an entity providing pharmacy benefit management services on 
behalf of such a plan or issuer shall not enter into a contract with an 
applicable entity that limits the disclosure of information to plan 
sponsors in such a manner that prevents the plan or issuer, or an 
entity providing pharmacy benefit management services on behalf of a 
plan or issuer, from making the reports described in subsection 
(b).</DELETED>
<DELETED>    ``(b) Reports.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, not less frequently than annually, an 
        entity providing pharmacy benefit management services on behalf 
        of a covered group health plan shall submit to the plan sponsor 
        of such covered group health plan a report in accordance with 
        this subsection and make such report available to the plan 
        sponsor in a machine-readable format and, as the Secretary may 
        determine, other formats. Each such report shall include, with 
        respect to the covered group health plan--</DELETED>
                <DELETED>    ``(A) as applicable, information collected 
                from drug manufacturers by such issuer or entity on the 
                total amount of copayment assistance dollars paid, or 
                copayment cards applied, that were funded by the drug 
                manufacturer with respect to the participants and 
                beneficiaries in such plan;</DELETED>
                <DELETED>    ``(B) a list of each drug covered by such 
                plan or entity providing pharmacy benefit management 
                services that was billed during the reporting period, 
                including, with respect to each such drug during the 
                reporting period--</DELETED>
                        <DELETED>    ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug 
                        Code;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries for whom the drug was billed 
                        during the reporting period, the total number 
                        of prescription claims for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the reporting 
                        period;</DELETED>
                        <DELETED>    ``(iii) for each claim or dosage 
                        unit described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;</DELETED>
                        <DELETED>    ``(iv) the wholesale acquisition 
                        cost, listed as cost per days supply, cost per 
                        dosage unit, and cost per typical course of 
                        treatment (as applicable);</DELETED>
                        <DELETED>    ``(v) the total out-of-pocket 
                        spending by participants and beneficiaries on 
                        such drug after application of any benefits 
                        under the plan or coverage, including 
                        participant and beneficiary spending through 
                        copayments, coinsurance, and deductibles, but 
                        not including any amounts spent by participants 
                        and beneficiaries on drugs not covered under 
                        the plan or coverage or for which no claim is 
                        submitted to the plan or coverage; 
                        and</DELETED>
                        <DELETED>    ``(vi) for any drug for which 
                        gross spending by the plan exceeded $10,000 and 
                        that is one of the 50 prescription drugs for 
                        which the group health plan spent the most on 
                        prescription drug benefits during the reporting 
                        period--</DELETED>
                                <DELETED>    ``(I) a list of all other 
                                drugs in the same therapeutic class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic class as 
                                such drug; and</DELETED>
                                <DELETED>    ``(II) if applicable, the 
                                rationale for preferred formulary 
                                placement of such drug in that 
                                therapeutic class, selected from a list 
                                of standard rationales established by 
                                the Secretary;</DELETED>
                <DELETED>    ``(C) a list of each therapeutic class of 
                drugs that were dispensed under the health plan during 
                the reporting period, and, with respect to each such 
                therapeutic class of drugs, during the reporting 
                period--</DELETED>
                        <DELETED>    ``(i) total gross spending by the 
                        plan, before rebates, fees, alternative 
                        discounts, or other remuneration;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries who filled a prescription for 
                        a drug in that class;</DELETED>
                        <DELETED>    ``(iii) if applicable to that 
                        class, a description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;</DELETED>
                        <DELETED>    ``(iv) the total out-of-pocket 
                        spending by participants and beneficiaries, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and</DELETED>
                        <DELETED>    ``(v) for each therapeutic class 
                        under which 3 or more drugs are included on the 
                        formulary of such plan--</DELETED>
                                <DELETED>    ``(I) the amount received, 
                                or expected to be received, by such 
                                entity, from an applicable entity, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration that--</DELETED>
                                        <DELETED>    ``(aa) has been 
                                        paid, or will be paid, by such 
                                        an applicable entity for claims 
                                        incurred during the reporting 
                                        period; or</DELETED>
                                        <DELETED>    ``(bb) is related 
                                        to utilization of drugs or drug 
                                        spending;</DELETED>
                                <DELETED>    ``(II) the total net 
                                spending by the health plan on that 
                                class of drugs; and</DELETED>
                                <DELETED>    ``(III) the net price per 
                                typical course of treatment or 30-day 
                                supply incurred by the health plan and 
                                its participants and beneficiaries, 
                                after rebates, fees, alternative 
                                discounts, or other remuneration 
                                provided by an applicable entity, for 
                                drugs dispensed within such therapeutic 
                                class during the reporting 
                                period;</DELETED>
                <DELETED>    ``(D) total gross spending on prescription 
                drugs by the plan during the reporting period, before 
                rebates, fees, alternative discounts, or other 
                remuneration provided by an applicable 
                entity;</DELETED>
                <DELETED>    ``(E) the total amount received, or 
                expected to be received, by the health plan, from an 
                applicable entity, in rebates, fees, alternative 
                discounts, and other remuneration received from any 
                such entities, related to utilization of drug or drug 
                spending under that health plan during the reporting 
                period;</DELETED>
                <DELETED>    ``(F) the total net spending on 
                prescription drugs by the health plan during the 
                reporting period;</DELETED>
                <DELETED>    ``(G) amounts paid directly or indirectly 
                in rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA)) to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's business 
                to the pharmacy benefit manager; and</DELETED>
                <DELETED>    ``(H) a summary document that includes 
                such information described in subparagraphs (A) through 
                (G) as the Secretary determines useful for plan 
                sponsors for purposes of selecting pharmacy benefit 
                management services, such as an estimated net price to 
                plan sponsor and participant or beneficiary, a cost per 
                claim, the fee structure or reimbursement model, and 
                estimated cost per participant or 
                beneficiary.</DELETED>
        <DELETED>    ``(2) Supplementary reporting for intra-company 
        prescription drug transactions.--</DELETED>
                <DELETED>    ``(A) In general.--A health insurance 
                issuer offering covered group health insurance coverage 
                or an entity providing pharmacy benefit management 
                services under a covered group health plan or covered 
                group health insurance coverage shall submit, together 
                with the report under paragraph (1), a supplementary 
                report every 6 months to the plan sponsor that 
                includes--</DELETED>
                        <DELETED>    ``(i) an explanation of any 
                        benefit design parameters that encourage or 
                        require participants and beneficiaries in the 
                        plan or coverage to fill prescriptions at mail 
                        order, specialty, or retail pharmacies that are 
                        wholly or partially-owned by that issuer or 
                        entity providing pharmacy benefit management 
                        services under such plan or coverage, including 
                        mandatory mail and specialty home delivery 
                        programs, retail and mail auto-refill programs, 
                        and copayment incentives funded by an entity 
                        providing pharmacy benefit management 
                        services;</DELETED>
                        <DELETED>    ``(ii) the percentage of total 
                        prescriptions charged to the plan, coverage, or 
                        participants and beneficiaries in the plan or 
                        coverage, that were dispensed by mail order, 
                        specialty, or retail pharmacies that are wholly 
                        or partially-owned by the issuer or entity 
                        providing pharmacy benefit management services; 
                        and</DELETED>
                        <DELETED>    ``(iii) a list of all drugs 
                        dispensed by such wholly or partially-owned 
                        pharmacy and charged to the plan or coverage, 
                        or participants and beneficiaries of the plan 
                        or coverage, during the applicable quarter, 
                        and, with respect to each drug--</DELETED>
                                <DELETED>    ``(I) the amounts charged, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, with respect to 
                                participants and beneficiaries in the 
                                plan or coverage, including amounts 
                                charged to the plan or coverage and 
                                amounts charged to the participants and 
                                beneficiaries;</DELETED>
                                <DELETED>    ``(II) the median amount 
                                charged to the plan or coverage, per 
                                dosage unit, per course of treatment, 
                                per 30-day supply, and per 90-day 
                                supply, including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the issuer or entity 
                                and that are included in the pharmacy 
                                network of that plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(III) the interquartile 
                                range of the costs, per dosage unit, 
                                per course of treatment, per 30-day 
                                supply, and per 90-day supply, 
                                including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the issuer or entity 
                                and that are included in the pharmacy 
                                network of that plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(IV) the lowest cost, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, for such drug, including 
                                amounts charged to the plan or issuer 
                                and participants and beneficiaries, 
                                that is available from any pharmacy 
                                included in the network of the plan or 
                                coverage;</DELETED>
                                <DELETED>    ``(V) the net acquisition 
                                cost per dosage unit and for a 30 day-
                                supply, and the acquisition cost per 
                                typical course of treatment, if the 
                                drug is subject to a maximum price 
                                discount; and</DELETED>
                                <DELETED>    ``(VI) other information 
                                with respect to the cost of the drug, 
                                as determined by the Secretary, such as 
                                average sales price, wholesale 
                                acquisition cost, and national average 
                                drug acquisition cost per dosage unit, 
                                per typical course of treatment, or per 
                                30-day supply, for such drug, including 
                                amounts charged to the plan or issuer 
                                and participants and beneficiaries 
                                among all pharmacies included in the 
                                network of the plan or 
                                coverage.</DELETED>
                <DELETED>    ``(B) Plans and coverage offered by small 
                employers.--A health insurance issuer offering covered 
                group health insurance coverage that is not covered 
                group health insurance coverage or an entity providing 
                pharmacy benefit management services under a group 
                health plan that is not a covered group health plan or 
                under group health insurance coverage that is not 
                covered group health insurance coverage that conducts 
                transactions with a wholly or partially-owned pharmacy 
                shall submit, together with the report under paragraph 
                (1), a supplementary report every 6 months to the plan 
                sponsor that includes the information described in 
                clauses (i) and (ii) of subparagraph (A).</DELETED>
        <DELETED>    ``(3) Privacy requirements.--</DELETED>
                <DELETED>    ``(A) Relationship to hipaa regulations.--
                Nothing in this section shall be construed to modify 
                the requirements for the creation, receipt, 
                maintenance, or transmission of protected health 
                information under the privacy, security, breach 
                notification, and enforcement regulations in parts 160 
                and 164 of title 45, Code of Federal Regulations (or 
                successor regulations).</DELETED>
                <DELETED>    ``(B) Requirement.--A report submitted 
                under paragraph (1) or (2) shall contain only summary 
                health information, as defined in section 164.504(a) of 
                title 45, Code of Federal Regulations (or successor 
                regulations).</DELETED>
                <DELETED>    ``(C) Clarification regarding certain 
                disclosures of information.--</DELETED>
                        <DELETED>    ``(i) Reasonable restrictions.--
                        Nothing in this section prevents a health 
                        insurance issuer offering group health 
                        insurance coverage or an entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan or group health 
                        insurance coverage from placing reasonable 
                        restrictions on the public disclosure of the 
                        information contained in a report under 
                        paragraph (1) or (2).</DELETED>
                        <DELETED>    ``(ii) Limitations.--A health 
                        insurance issuer offering group health 
                        insurance coverage or an entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan or group health 
                        insurance coverage may not restrict disclosure 
                        of such reports to the Department of Health and 
                        Human Services, the Department of Labor, the 
                        Department of the Treasury, or any other 
                        Federal agency responsible for enforcement 
                        activities under this section for purposes of 
                        enforcement under this section or other 
                        applicable law, or to the Comptroller General 
                        of the United States in accordance with 
                        paragraph (6).</DELETED>
        <DELETED>    ``(4) Use and disclosure by plan sponsors.--
        </DELETED>
                <DELETED>    ``(A) Prohibition.--A plan sponsor may 
                not--</DELETED>
                        <DELETED>    ``(i) fail or refuse to hire, or 
                        discharge, any employee, or otherwise 
                        discriminate against any employee with respect 
                        to the compensation, terms, conditions, or 
                        privileges of employment of the employee, 
                        because of information submitted under 
                        paragraph (1) or (2) attributed to the employee 
                        or a dependent of the employee; or</DELETED>
                        <DELETED>    ``(ii) limit, segregate, or 
                        classify the employees of the employer in any 
                        way that would deprive or tend to deprive any 
                        employee of employment opportunities or 
                        otherwise adversely affect the status of the 
                        employee as an employee, because of information 
                        submitted under paragraph (1) or (2) attributed 
                        to the employee or a dependent of the 
                        employee.</DELETED>
                <DELETED>    ``(B) Disclosure and redisclosure.--A plan 
                sponsor shall not disclose the information received 
                under paragraph (1) or (2) except--</DELETED>
                        <DELETED>    ``(i) to an occupational or other 
                        health researcher if the research is conducted 
                        in compliance with the regulations and 
                        protections provided for under part 46 of title 
                        45, Code of Federal Regulations (or successor 
                        regulations);</DELETED>
                        <DELETED>    ``(ii) in response to an order of 
                        a court, except that the plan sponsor may 
                        disclose only the information expressly 
                        authorized by such order;</DELETED>
                        <DELETED>    ``(iii) to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or other 
                        Federal agency responsible for enforcement 
                        activities under this section; or</DELETED>
                        <DELETED>    ``(iv) to a contractor or agent 
                        for purposes of health plan administration, if 
                        such contractor or agent agrees, in writing, to 
                        abide by the same use and disclosure 
                        restrictions as the plan sponsor.</DELETED>
                <DELETED>    ``(C) Relationship to hipaa regulations.--
                With respect to the regulations promulgated by the 
                Secretary of Health and Human Services under part C of 
                title XI of the Social Security Act (42 U.S.C. 1320d et 
                seq.) and section 264 of the Health Insurance 
                Portability and Accountability Act of 1996 (42 U.S.C. 
                1320d-2), subparagraph (B) does not prohibit a covered 
                entity (as defined for purposes of such regulations) 
                from any use or disclosure of health information that 
                is authorized for the covered entity under such 
                regulations. The previous sentence does not affect the 
                authority of such Secretary to modify such 
                regulations.</DELETED>
                <DELETED>    ``(D) Enforcement.--</DELETED>
                        <DELETED>    ``(i) In general.--The powers, 
                        procedures, and remedies provided in section 
                        207 of the Genetic Information 
                        Nondiscrimination Act (42 U.S.C. 2000ff-6) to a 
                        person alleging a violation of title II of such 
                        Act shall be the powers, procedures, and 
                        remedies this subparagraph provides for any 
                        person alleging a violation of this 
                        paragraph.</DELETED>
                        <DELETED>    ``(ii) Prohibition against 
                        retaliation.--No person shall discriminate 
                        against any individual because such individual 
                        has opposed any act or practice made unlawful 
                        by this paragraph or because such individual 
                        made a charge, testified, assisted, or 
                        participated in any manner in an investigation, 
                        proceeding, or hearing under this paragraph. 
                        The remedies and procedures otherwise provided 
                        for under this subparagraph shall be available 
                        to aggrieved individuals with respect to 
                        violations of this clause.</DELETED>
        <DELETED>    ``(5) Additional reporting.--</DELETED>
                <DELETED>    ``(A) Reporting with respect to group 
                health plans offered by small employers.--For plan 
                years beginning on or after January 1, 2025, not less 
                frequently than annually, an entity providing pharmacy 
                benefit management services on behalf of a group health 
                plan that is not a covered group health plan shall 
                submit to the plan sponsor of such group health plan a 
                report in accordance with this paragraph, and make such 
                report available to the plan sponsor in a machine-
                readable format, and such other formats as the 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of Labor may determine. Each such 
                report shall include, with respect to the applicable 
                group health plan, the information described in 
                subparagraphs (A), (D), (E), (F), (G), and (H) of 
                paragraph (1).</DELETED>
                <DELETED>    ``(B) Opt-in for group health insurance 
                coverage.--</DELETED>
                        <DELETED>    ``(i) In general.--A plan sponsor 
                        may, on an annual basis, beginning with plan 
                        years beginning on or after January 1, 2025, 
                        elect to require a health insurance issuer 
                        offering group health insurance coverage to 
                        submit to such plan sponsor a report in 
                        accordance with this subsection.</DELETED>
                        <DELETED>    ``(ii) Contents of reports.--
                        </DELETED>
                                <DELETED>    ``(I) Covered group health 
                                insurance coverage.--In the case of an 
                                issuer that offers covered group health 
                                insurance coverage, a report provided 
                                pursuant to clause (i) shall include, 
                                with respect to the applicable covered 
                                group health insurance coverage, the 
                                information required under paragraph 
                                (1) for covered group health 
                                plans.</DELETED>
                                <DELETED>    ``(II) Other group health 
                                insurance coverage.--In the case of an 
                                issuer that offers group health 
                                insurance coverage that is not covered 
                                group health insurance, a report 
                                provided pursuant to clause (i) shall 
                                include, with respect to the applicable 
                                group health insurance coverage, the 
                                information described in subparagraphs 
                                (A), (D), (E), (F), and (G) of 
                                paragraph (1).</DELETED>
                        <DELETED>    ``(iii) Application.--For purposes 
                        of reports submitted in accordance with this 
                        subparagraph, paragraph (1) shall be applied by 
                        substituting `group health insurance coverage' 
                        or `health insurance issuer', as applicable, 
                        for `group health plan', `group plan', and 
                        `plan' where such terms appear in such 
                        paragraph.</DELETED>
                        <DELETED>    ``(iv) Required reporting for all 
                        group health insurance coverage.--Each health 
                        insurance issuer of health insurance coverage 
                        shall annually submit the information described 
                        in paragraph (1)(H), regardless of whether the 
                        plan sponsor made the election described in 
                        clause (i) for the applicable year.</DELETED>
        <DELETED>    ``(6) Submissions to gao.--A health insurance 
        issuer offering group health insurance coverage or an entity 
        providing pharmacy benefit management services on behalf of a 
        group health plan shall submit to the Comptroller General of 
        the United States each of the first 2 reports submitted to a 
        plan sponsor under paragraph (1) or (5) with respect to such 
        coverage or plan, and other such reports as requested, in 
        accordance with the privacy requirements under paragraph (3), 
        and such other information that the Comptroller General 
        determines necessary to carry out the study under section 2(f) 
        of the Pharmacy Benefit Manager Reform Act.</DELETED>
        <DELETED>    ``(7) Standard formats.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than June 1, 
                2024, the Secretary, the Secretary of Health and Human 
                Services, and the Secretary of the Treasury shall 
                specify, through rulemaking, standard formats for 
                health insurance issuers and entities providing 
                pharmacy benefit management services to submit reports 
                required under this subsection.</DELETED>
                <DELETED>    ``(B) Limited form of report.--The 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of the Treasury shall define through 
                rulemaking a limited form of the reports under 
                paragraphs (1) and (2) required to be submitted to plan 
                sponsors who also are drug manufacturers, drug 
                wholesalers, entities providing pharmacy benefit 
                management services, or other direct participants in 
                the drug supply chain, in order to prevent anti-
                competitive behavior.</DELETED>
<DELETED>    ``(c) Limitations on Spread Pricing.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, a group health plan or health insurance 
        issuer offering group health insurance coverage shall not 
        charge participants and beneficiaries, and an entity providing 
        pharmacy benefit management services under such a plan or 
        coverage shall not charge the plan, issuer, or participants and 
        beneficiaries, a price for a prescription drug that exceeds the 
        price paid to the pharmacy for such drug, excluding penalties 
        paid by the pharmacy (as described in paragraph (2)) to such 
        plan, issuer, or entity.</DELETED>
        <DELETED>    ``(2) Rule of construction.--For purposes of 
        paragraph (1), penalties paid by pharmacies include only the 
        following:</DELETED>
                <DELETED>    ``(A) A penalty paid if an original claim 
                for a prescription drug was submitted fraudulently by 
                the pharmacy to the plan, issuer, or entity.</DELETED>
                <DELETED>    ``(B) A penalty paid if the original claim 
                payment made by the plan, issuer, or entity to the 
                pharmacy was inconsistent with the reimbursement terms 
                in any contract between the pharmacy and the plan, 
                issuer, or entity.</DELETED>
                <DELETED>    ``(C) A penalty paid if the pharmacist 
                services billed to the plan, issuer, or entity were not 
                rendered by the pharmacy.</DELETED>
<DELETED>    ``(d) Full Rebate Pass-Through to Plan.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, a third-party administrator of a group 
        health plan, a health insurance issuer offering group health 
        insurance coverage, or an entity providing pharmacy benefit 
        management services under such health plan or health insurance 
        coverage shall--</DELETED>
                <DELETED>    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other applicable 
                remuneration received from any applicable entity that 
                are related to utilization of drugs under such health 
                plan or health insurance coverage, to the group health 
                plan; and</DELETED>
                <DELETED>    ``(B) ensure that any contract entered 
                into by such third-party administrator, health 
                insurance issuer, or entity providing pharmacy benefit 
                management services with an applicable entity remit 100 
                percent of rebates, fees, alternative discounts, and 
                other remuneration received to the third-party 
                administrator, health insurance issuer, or entity 
                providing pharmacy benefit management 
                services.</DELETED>
        <DELETED>    ``(2) Form and manner of remittance.--Such 
        rebates, fees, alternative discounts, and other remuneration 
        shall be--</DELETED>
                <DELETED>    ``(A) remitted to the group health plan or 
                group health insurance coverage in a timely fashion 
                after the period for which such rebates, fees, 
                alternative discounts, or other remuneration is 
                calculated, and in no case later than 90 days after the 
                end of such period;</DELETED>
                <DELETED>    ``(B) fully disclosed and enumerated to 
                the group health plan sponsor, as described in 
                paragraphs (1) and (4) of subsection (b);</DELETED>
                <DELETED>    ``(C) available for audit by the plan 
                sponsor, or a third-party designated by a plan sponsor 
                not less than once per plan year; and</DELETED>
                <DELETED>    ``(D) returned to the issuer or entity 
                providing pharmaceutical benefit management services by 
                the group health plan if audits by such issuer or 
                entity indicate that the amounts received are incorrect 
                after such amounts have been paid to the group health 
                plan.</DELETED>
        <DELETED>    ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan, a health insurance issuer 
        offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services under such 
        health plan or health insurance coverage shall make rebate 
        contracts with rebate aggregators or drug manufacturers 
        available for audit by such plan sponsor or designated third-
        party, subject to confidentiality agreements to prevent re-
        disclosure of such contracts.</DELETED>
        <DELETED>    ``(4) Auditors.--The applicable plan sponsor may 
        select an auditor for purposes of carrying out audits under 
        paragraphs (2)(C) and (3).</DELETED>
        <DELETED>    ``(5) Rule of construction.--Nothing in this 
        subsection shall be construed to prohibit payments to entities 
        offering pharmacy benefit management services for bona fide 
        services using a fee structure not contemplated by this 
        subsection, provided that such fees are transparent to group 
        health plans and health insurance issuers.</DELETED>
<DELETED>    ``(e) Enforcement.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in consultation 
        with the Secretary of Health and Human Services and the 
        Secretary of the Treasury, shall enforce this 
        section.</DELETED>
        <DELETED>    ``(2) Failure to provide timely information.--A 
        health insurance issuer or an entity providing pharmacy benefit 
        management services that violates subsection (a) or fails to 
        provide information required under subsection (b); a group 
        health plan, health insurance issuer, or entity providing 
        pharmacy benefit management services that violates subsection 
        (c); or a third-party administrator of a group health plan, a 
        health insurance issuer offering group health insurance 
        coverage, or an entity providing pharmacy benefit management 
        services that violates subsection (d) shall be subject to a 
        civil monetary penalty in the amount of $10,000 for each day 
        during which such violation continues or such information is 
        not disclosed or reported.</DELETED>
        <DELETED>    ``(3) False information.--A health insurance 
        issuer, entity providing pharmacy benefit management services, 
        or drug manufacturer that knowingly provides false information 
        under this section shall be subject to a civil money penalty in 
        an amount not to exceed $100,000 for each item of false 
        information. Such civil money penalty shall be in addition to 
        other penalties as may be prescribed by law.</DELETED>
        <DELETED>    ``(4) Procedure.--The provisions of section 1128A 
        of the Social Security Act, other than subsections (a) and (b) 
        and the first sentence of subsection (c)(1) of such section 
        shall apply to civil monetary penalties under this subsection 
        in the same manner as such provisions apply to a penalty or 
        proceeding under section 1128A of the Social Security 
        Act.</DELETED>
        <DELETED>    ``(5) Waivers.--The Secretary may waive penalties 
        under paragraph (2), or extend the period of time for 
        compliance with a requirement of this section, for an entity in 
        violation of this section that has made a good-faith effort to 
        comply with this section.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to permit a health insurance issuer, group health plan, or 
other entity to restrict disclosure to, or otherwise limit the access 
of, the Department of Labor to a report described in subsection (b)(1) 
or information related to compliance with subsection (a) by such 
issuer, plan, or entity.</DELETED>
<DELETED>    ``(g) Definitions.--In this section--</DELETED>
        <DELETED>    ``(1) the term `applicable entity' means--
        </DELETED>
                <DELETED>    ``(A) a drug manufacturer, distributor, 
                wholesaler, rebate aggregator (or other purchasing 
                entity designed to aggregate rebates), group purchasing 
                organization, or associated third party;</DELETED>
                <DELETED>    ``(B) any subsidiary, parent, affiliate, 
                or subcontractor of a group health plan, health 
                insurance issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); 
                or</DELETED>
                <DELETED>    ``(C) such other entity as the Secretary, 
                the Secretary of Health and Human Services, and the 
                Secretary of the Treasury may specify through 
                rulemaking;</DELETED>
        <DELETED>    ``(2) the term `covered group health insurance 
        coverage' means health insurance coverage offered in connection 
        with a group health plan maintained by a large 
        employer;</DELETED>
        <DELETED>    ``(3) the term `covered group health plan' means a 
        group health plan maintained by a large employer;</DELETED>
        <DELETED>    ``(4) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated before the application of manufacturer rebates, 
        fees, alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(5) the term `large employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 50 employees on business days during the preceding 
        calendar year and who employs at least 1 employee on the first 
        day of the plan year;</DELETED>
        <DELETED>    ``(6) the term `net spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated after the application of manufacturer rebates, fees, 
        alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(7) the term `plan sponsor' has the meaning 
        given such term in section 3(16)(B);</DELETED>
        <DELETED>    ``(8) the term `remuneration' has the meaning 
        given such term by the Secretary, the Secretary of Health and 
        Human Services, and the Secretary of the Treasury, through 
        notice and comment rulemaking;</DELETED>
        <DELETED>    ``(9) the term `small employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 1 but not more than 49 employees on business days during 
        the preceding calendar year and who employs at least 1 employee 
        on the first day of the plan year; and</DELETED>
        <DELETED>    ``(10) the term `wholesale acquisition cost' has 
        the meaning given such term in section 1847A(c)(6)(B) of the 
        Social Security Act (42 U.S.C. 1395w-3a(c)(6)(B)).''; 
        and</DELETED>
                <DELETED>    (B) in section 502(b)(3) (29 U.S.C. 
                1132(b)(3)), by inserting ``(other than section 726)'' 
                after ``part 7''.</DELETED>
        <DELETED>    (2) Clerical amendment.--The table of contents in 
        section 1 of the Employee Retirement Income Security Act of 
        1974 (29 U.S.C. 1001 et seq.) is amended by inserting after the 
        item relating to section 725 the following new item:</DELETED>

<DELETED>``Sec. 726. Oversight of entities that provide pharmacy 
                            benefit management services.''.
<DELETED>    (c) Internal Revenue Code.--</DELETED>
        <DELETED>    (1) In general.--Subchapter B of chapter 100 of 
        the Internal Revenue Code of 1986 is amended by adding at the 
        end the following:</DELETED>

<DELETED>``SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY 
              BENEFIT MANAGEMENT SERVICES.</DELETED>

<DELETED>    ``(a) In General.--For plan years beginning on or after 
January 1, 2025, a group health plan or an entity providing pharmacy 
benefit management services on behalf of such a plan shall not enter 
into a contract with an applicable entity that limits the disclosure of 
information to plan sponsors in such a manner that prevents the plan, 
or an entity providing pharmacy benefit management services on behalf 
of a plan, from making the reports described in subsection 
(b).</DELETED>
<DELETED>    ``(b) Reports.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, not less frequently than annually, an 
        entity providing pharmacy benefit management services on behalf 
        of a covered group health plan shall submit to the plan sponsor 
        of such covered group health plan a report in accordance with 
        this subsection and make such report available to the plan 
        sponsor in a machine-readable format and, as the Secretary may 
        determine, other formats. Each such report shall include, with 
        respect to the covered group health plan--</DELETED>
                <DELETED>    ``(A) as applicable, information collected 
                from drug manufacturers by such entity on the total 
                amount of copayment assistance dollars paid, or 
                copayment cards applied, that were funded by the drug 
                manufacturer with respect to the participants and 
                beneficiaries in such plan;</DELETED>
                <DELETED>    ``(B) a list of each drug covered by such 
                plan or entity providing pharmacy benefit management 
                services that was billed during the reporting period, 
                including, with respect to each such drug during the 
                reporting period--</DELETED>
                        <DELETED>    ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug 
                        Code;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries for whom the drug was billed 
                        during the reporting period, the total number 
                        of prescription claims for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the reporting 
                        period;</DELETED>
                        <DELETED>    ``(iii) for each claim or dosage 
                        unit described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;</DELETED>
                        <DELETED>    ``(iv) the wholesale acquisition 
                        cost, listed as cost per days supply, cost per 
                        dosage unit, and cost per typical course of 
                        treatment (as applicable);</DELETED>
                        <DELETED>    ``(v) the total out-of-pocket 
                        spending by participants and beneficiaries on 
                        such drug after application of any benefits 
                        under the plan, including participant and 
                        beneficiary spending through copayments, 
                        coinsurance, and deductibles, but not including 
                        any amounts spent by participants and 
                        beneficiaries on drugs not covered under the 
                        plan or for which no claim is submitted to the 
                        plan; and</DELETED>
                        <DELETED>    ``(vi) for any drug for which 
                        gross spending by the plan exceeded $10,000 and 
                        that is one of the 50 prescription drugs for 
                        which the group health plan spent the most on 
                        prescription drug benefits during the reporting 
                        period--</DELETED>
                                <DELETED>    ``(I) a list of all other 
                                drugs in the same therapeutic class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic class as 
                                such drug; and</DELETED>
                                <DELETED>    ``(II) if applicable, the 
                                rationale for preferred formulary 
                                placement of such drug in that 
                                therapeutic class, selected from a list 
                                of standard rationales established by 
                                the Secretary;</DELETED>
                <DELETED>    ``(C) a list of each therapeutic class of 
                drugs that were dispensed under the health plan during 
                the reporting period, and, with respect to each such 
                therapeutic class of drugs, during the reporting 
                period--</DELETED>
                        <DELETED>    ``(i) total gross spending by the 
                        plan, before rebates, fees, alternative 
                        discounts, or other remuneration;</DELETED>
                        <DELETED>    ``(ii) the number of participants 
                        and beneficiaries who filled a prescription for 
                        a drug in that class;</DELETED>
                        <DELETED>    ``(iii) if applicable to that 
                        class, a description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;</DELETED>
                        <DELETED>    ``(iv) the total out-of-pocket 
                        spending by participants and beneficiaries, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and</DELETED>
                        <DELETED>    ``(v) for each therapeutic class 
                        under which 3 or more drugs are included on the 
                        formulary of such plan--</DELETED>
                                <DELETED>    ``(I) the amount received, 
                                or expected to be received, by such 
                                entity, from an applicable entity, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration that--</DELETED>
                                        <DELETED>    ``(aa) has been 
                                        paid, or will be paid, by such 
                                        an applicable entity for claims 
                                        incurred during the reporting 
                                        period; or</DELETED>
                                        <DELETED>    ``(bb) is related 
                                        to utilization of drugs or drug 
                                        spending;</DELETED>
                                <DELETED>    ``(II) the total net 
                                spending by the health plan on that 
                                class of drugs; and</DELETED>
                                <DELETED>    ``(III) the net price per 
                                typical course of treatment or 30-day 
                                supply incurred by the health plan and 
                                its participants and beneficiaries, 
                                after rebates, fees, alternative 
                                discounts, or other remuneration 
                                provided by an applicable entity, for 
                                drugs dispensed within such therapeutic 
                                class during the reporting 
                                period;</DELETED>
                <DELETED>    ``(D) total gross spending on prescription 
                drugs by the plan during the reporting period, before 
                rebates, fees, alternative discounts, or other 
                remuneration provided by an applicable 
                entity;</DELETED>
                <DELETED>    ``(E) the total amount received, or 
                expected to be received, by the health plan, from an 
                applicable entity, in rebates, fees, alternative 
                discounts, and other remuneration received from any 
                such entities, related to utilization of drug or drug 
                spending under that health plan during the reporting 
                period;</DELETED>
                <DELETED>    ``(F) the total net spending on 
                prescription drugs by the health plan during the 
                reporting period;</DELETED>
                <DELETED>    ``(G) amounts paid directly or indirectly 
                in rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA) of the 
                Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1108(b)(2)(B)(ii)(dd)(A))) to brokers, 
                consultants, advisors, or any other individual or firm 
                who referred the group health plan's business to the 
                pharmacy benefit manager; and</DELETED>
                <DELETED>    ``(H) a summary document that includes 
                such information described in subparagraphs (A) through 
                (G) as the Secretary determines useful for plan 
                sponsors for purposes of selecting pharmacy benefit 
                management services, such as an estimated net price to 
                plan sponsor and participant or beneficiary, a cost per 
                claim, the fee structure or reimbursement model, and 
                estimated cost per participant or 
                beneficiary.</DELETED>
        <DELETED>    ``(2) Supplementary reporting for intra-company 
        prescription drug transactions.--</DELETED>
                <DELETED>    ``(A) In general.--An entity providing 
                pharmacy benefit management services under a covered 
                group health plan shall submit, together with the 
                report under paragraph (1), a supplementary report 
                every 6 months to the plan sponsor that includes--
                </DELETED>
                        <DELETED>    ``(i) an explanation of any 
                        benefit design parameters that encourage or 
                        require participants and beneficiaries in the 
                        plan to fill prescriptions at mail order, 
                        specialty, or retail pharmacies that are wholly 
                        or partially-owned by that entity providing 
                        pharmacy benefit management services under such 
                        plan, including mandatory mail and specialty 
                        home delivery programs, retail and mail auto-
                        refill programs, and copayment incentives 
                        funded by an entity providing pharmacy benefit 
                        management services;</DELETED>
                        <DELETED>    ``(ii) the percentage of total 
                        prescriptions charged to the plan or 
                        participants and beneficiaries in the plan, 
                        that were dispensed by mail order, specialty, 
                        or retail pharmacies that are wholly or 
                        partially-owned by the entity providing 
                        pharmacy benefit management services; 
                        and</DELETED>
                        <DELETED>    ``(iii) a list of all drugs 
                        dispensed by such wholly or partially-owned 
                        pharmacy and charged to the plan, or 
                        participants and beneficiaries of the plan, 
                        during the applicable quarter, and, with 
                        respect to each drug--</DELETED>
                                <DELETED>    ``(I) the amounts charged, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, with respect to 
                                participants and beneficiaries in the 
                                plan, including amounts charged to the 
                                plan and amounts charged to the 
                                participants and 
                                beneficiaries;</DELETED>
                                <DELETED>    ``(II) the median amount 
                                charged to the plan, per dosage unit, 
                                per course of treatment, per 30-day 
                                supply, and per 90-day supply, 
                                including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the entity and that 
                                are included in the pharmacy network of 
                                that plan;</DELETED>
                                <DELETED>    ``(III) the interquartile 
                                range of the costs, per dosage unit, 
                                per course of treatment, per 30-day 
                                supply, and per 90-day supply, 
                                including amounts paid by the 
                                participants and beneficiaries, when 
                                the same drug is dispensed by other 
                                pharmacies that are not wholly or 
                                partially-owned by the entity and that 
                                are included in the pharmacy network of 
                                that plan;</DELETED>
                                <DELETED>    ``(IV) the lowest cost, 
                                per dosage unit, per course of 
                                treatment, per 30-day supply, and per 
                                90-day supply, for such drug, including 
                                amounts charged to the plan and 
                                participants and beneficiaries, that is 
                                available from any pharmacy included in 
                                the network of the plan;</DELETED>
                                <DELETED>    ``(V) the net acquisition 
                                cost per dosage unit and for a 30 day-
                                supply, and the acquisition cost per 
                                typical course of treatment, if the 
                                drug is subject to a maximum price 
                                discount; and</DELETED>
                                <DELETED>    ``(VI) other information 
                                with respect to the cost of the drug, 
                                as determined by the Secretary, such as 
                                average sales price, wholesale 
                                acquisition cost, and national average 
                                drug acquisition cost per dosage unit, 
                                per typical course of treatment, or per 
                                30-day supply, for such drug, including 
                                amounts charged to the plan and 
                                participants and beneficiaries among 
                                all pharmacies included in the network 
                                of the plan.</DELETED>
                <DELETED>    ``(B) Plans offered by small employers.--
                An entity providing pharmacy benefit management 
                services under a group health plan that is not a 
                covered group health plan that conducts transactions 
                with a wholly or partially-owned pharmacy shall submit, 
                together with the report under paragraph (1), a 
                supplementary report every 6 months to the plan sponsor 
                that includes the information described in clauses (i) 
                and (ii) of subparagraph (A).</DELETED>
        <DELETED>    ``(3) Privacy requirements.--</DELETED>
                <DELETED>    ``(A) Relationship to hipaa regulations.--
                Nothing in this section shall be construed to modify 
                the requirements for the creation, receipt, 
                maintenance, or transmission of protected health 
                information under the privacy, security, breach 
                notification, and enforcement regulations in parts 160 
                and 164 of title 45, Code of Federal Regulations (or 
                successor regulations).</DELETED>
                <DELETED>    ``(B) Requirement.--A report submitted 
                under paragraph (1) or (2) shall contain only summary 
                health information, as defined in section 164.504(a) of 
                title 45, Code of Federal Regulations (or successor 
                regulations).</DELETED>
                <DELETED>    ``(C) Clarification regarding certain 
                disclosures of information.--</DELETED>
                        <DELETED>    ``(i) Reasonable restrictions.--
                        Nothing in this section prevents an entity 
                        providing pharmacy benefit management services 
                        on behalf of a group health plan from placing 
                        reasonable restrictions on the public 
                        disclosure of the information contained in a 
                        report under paragraph (1) or (2).</DELETED>
                        <DELETED>    ``(ii) Limitations.--An entity 
                        providing pharmacy benefit management services 
                        on behalf of a group health plan or group 
                        health insurance coverage may not restrict 
                        disclosure of such reports to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or any 
                        other Federal agency responsible for 
                        enforcement activities under this section for 
                        purposes of enforcement under this section or 
                        other applicable law, or to the Comptroller 
                        General of the United States in accordance with 
                        paragraph (6).</DELETED>
        <DELETED>    ``(4) Use and disclosure by plan sponsors.--
        </DELETED>
                <DELETED>    ``(A) Prohibition.--A plan sponsor may 
                not--</DELETED>
                        <DELETED>    ``(i) fail or refuse to hire, or 
                        discharge, any employee, or otherwise 
                        discriminate against any employee with respect 
                        to the compensation, terms, conditions, or 
                        privileges of employment of the employee, 
                        because of information submitted under 
                        paragraph (1) or (2) attributed to the employee 
                        or a dependent of the employee; or</DELETED>
                        <DELETED>    ``(ii) limit, segregate, or 
                        classify the employees of the employer in any 
                        way that would deprive or tend to deprive any 
                        employee of employment opportunities or 
                        otherwise adversely affect the status of the 
                        employee as an employee, because of information 
                        submitted under paragraph (1) or (2) attributed 
                        to the employee or a dependent of the 
                        employee.</DELETED>
                <DELETED>    ``(B) Disclosure and redisclosure.--A plan 
                sponsor shall not disclose the information received 
                under paragraph (1) or (2) except--</DELETED>
                        <DELETED>    ``(i) to an occupational or other 
                        health researcher if the research is conducted 
                        in compliance with the regulations and 
                        protections provided for under part 46 of title 
                        45, Code of Federal Regulations (or successor 
                        regulations);</DELETED>
                        <DELETED>    ``(ii) in response to an order of 
                        a court, except that the plan sponsor may 
                        disclose only the information expressly 
                        authorized by such order;</DELETED>
                        <DELETED>    ``(iii) to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or other 
                        Federal agency responsible for enforcement 
                        activities under this section; or</DELETED>
                        <DELETED>    ``(iv) to a contractor or agent 
                        for purposes of health plan administration, if 
                        such contractor or agent agrees, in writing, to 
                        abide by the same use and disclosure 
                        restrictions as the plan sponsor.</DELETED>
                <DELETED>    ``(C) Relationship to hipaa regulations.--
                With respect to the regulations promulgated by the 
                Secretary of Health and Human Services under part C of 
                title XI of the Social Security Act (42 U.S.C. 1320d et 
                seq.) and section 264 of the Health Insurance 
                Portability and Accountability Act of 1996 (42 U.S.C. 
                1320d-2), subparagraph (B) does not prohibit a covered 
                entity (as defined for purposes of such regulations) 
                from any use or disclosure of health information that 
                is authorized for the covered entity under such 
                regulations. The previous sentence does not affect the 
                authority of such Secretary to modify such 
                regulations.</DELETED>
                <DELETED>    ``(D) Enforcement.--</DELETED>
                        <DELETED>    ``(i) In general.--The powers, 
                        procedures, and remedies provided in section 
                        207 of the Genetic Information 
                        Nondiscrimination Act (42 U.S.C. 2000ff-6) to a 
                        person alleging a violation of title II of such 
                        Act shall be the powers, procedures, and 
                        remedies this subparagraph provides for any 
                        person alleging a violation of this 
                        paragraph.</DELETED>
                        <DELETED>    ``(ii) Prohibition against 
                        retaliation.--No person shall discriminate 
                        against any individual because such individual 
                        has opposed any act or practice made unlawful 
                        by this paragraph or because such individual 
                        made a charge, testified, assisted, or 
                        participated in any manner in an investigation, 
                        proceeding, or hearing under this paragraph. 
                        The remedies and procedures otherwise provided 
                        for under this subparagraph shall be available 
                        to aggrieved individuals with respect to 
                        violations of this clause.</DELETED>
        <DELETED>    ``(5) Reporting with respect to group health plans 
        offered by small employers.--For plan years beginning on or 
        after January 1, 2025, not less frequently than annually, an 
        entity providing pharmacy benefit management services on behalf 
        of a group health plan that is not a covered group health plan 
        shall submit to the plan sponsor of such group health plan a 
        report in accordance with this paragraph, and make such report 
        available to the plan sponsor in a machine-readable format. 
        Each such report shall include, with respect to the applicable 
        group health plan, the information described in subparagraphs 
        (A), (D), (E), (F), (G), and (H) of paragraph (1).</DELETED>
        <DELETED>    ``(6) Submissions to gao.--An entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan shall submit to the Comptroller General of the 
        United States each of the first 2 reports submitted to a plan 
        sponsor under paragraph (1) or (5) with respect to such plan, 
        and other such reports as requested, in accordance with the 
        privacy requirements under paragraph (3), and such other 
        information that the Comptroller General determines necessary 
        to carry out the study under section 2(f) of the Pharmacy 
        Benefit Manager Reform Act.</DELETED>
        <DELETED>    ``(7) Standard formats.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than June 1, 
                2024, the Secretary, the Secretary of Health and Human 
                Services, and the Secretary of Labor shall specify, 
                through rulemaking, standard formats for health 
                insurance issuers and entities providing pharmacy 
                benefit management services to submit reports required 
                under this subsection.</DELETED>
                <DELETED>    ``(B) Limited form of report.--The 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of Labor shall define through 
                rulemaking a limited form of the reports under 
                paragraphs (1) and (2) required to be submitted to plan 
                sponsors who also are drug manufacturers, drug 
                wholesalers, entities providing pharmacy benefit 
                management services, or other direct participants in 
                the drug supply chain, in order to prevent anti-
                competitive behavior.</DELETED>
<DELETED>    ``(c) Limitations on Spread Pricing.--</DELETED>
        <DELETED>    ``(1) In general.--A group health plan shall not 
        charge participants and beneficiaries, and an entity providing 
        pharmacy benefit management services under such a plan shall 
        not charge the plan or participants and beneficiaries, a price 
        for a prescription drug that exceeds the price paid to the 
        pharmacy for such drug, excluding penalties paid by the 
        pharmacy (as described in paragraph (2)) to such plan or 
        entity.</DELETED>
        <DELETED>    ``(2) Rule of construction.--For purposes of 
        paragraph (1), penalties paid by pharmacies include only the 
        following:</DELETED>
                <DELETED>    ``(A) A penalty paid if an original claim 
                for a prescription drug was submitted fraudulently by 
                the pharmacy to the plan or entity.</DELETED>
                <DELETED>    ``(B) A penalty paid if the original claim 
                payment made by the plan, issuer, or entity to the 
                pharmacy was inconsistent with the reimbursement terms 
                in any contract between the pharmacy and the plan or 
                entity.</DELETED>
                <DELETED>    ``(C) A penalty paid if the pharmacist 
                services billed to the plan or entity were not rendered 
                by the pharmacy.</DELETED>
<DELETED>    ``(d) Full Rebate Pass-Through to Plan.--</DELETED>
        <DELETED>    ``(1) In general.--For plan years beginning on or 
        after January 1, 2025, a third-party administrator of a group 
        health plan or an entity providing pharmacy benefit management 
        services under such health plan shall--</DELETED>
                <DELETED>    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                from any applicable entity that are related to 
                utilization of drugs under such health plan, to the 
                group health plan; and</DELETED>
                <DELETED>    ``(B) ensure that any contract entered 
                into by such third-party administrator or entity 
                providing pharmacy benefit management services with an 
                applicable entity remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                to the third-party administrator or entity providing 
                pharmacy benefit management services.</DELETED>
        <DELETED>    ``(2) Form and manner of remittance.--Such 
        rebates, fees, alternative discounts, and other remuneration 
        shall be--</DELETED>
                <DELETED>    ``(A) remitted to the group health plan in 
                a timely fashion after the period for which such 
                rebates, fees, alternative discounts, or other 
                remuneration is calculated, and in no case later than 
                90 days after the end of such period;</DELETED>
                <DELETED>    ``(B) fully disclosed and enumerated to 
                the group health plan sponsor, as described in 
                paragraphs (1) and (4) of subsection (b);</DELETED>
                <DELETED>    ``(C) available for audit by the plan 
                sponsor, or a third-party designated by a plan sponsor 
                not less than once per plan year; and</DELETED>
                <DELETED>    ``(D) returned to the issuer or entity 
                providing pharmaceutical benefit management services by 
                the group health plan if audits by such entity indicate 
                that the amounts received are incorrect after such 
                amounts have been paid to the group health 
                plan.</DELETED>
        <DELETED>    ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services under such health plan 
        shall make rebate contracts with rebate aggregators or drug 
        manufacturers available for audit by such plan sponsor or 
        designated third-party, subject to confidentiality agreements 
        to prevent re-disclosure of such contracts.</DELETED>
        <DELETED>    ``(4) Auditors.--The applicable plan sponsor may 
        select an auditor for purposes of carrying out audits under 
        paragraphs (2)(C) and (3).</DELETED>
        <DELETED>    ``(5) Rule of construction.--Nothing in this 
        subsection shall be construed to prohibit payments to entities 
        offering pharmacy benefit management services for bona fide 
        services using a fee structure not contemplated by this 
        subsection, provided that such fees are transparent to group 
        health plans.</DELETED>
<DELETED>    ``(e) Enforcement.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in consultation 
        with the Secretary of Labor and the Secretary of Health and 
        Human Services, shall enforce this section.</DELETED>
        <DELETED>    ``(2) Failure to provide timely information.--A 
        health insurance issuer or an entity providing pharmacy benefit 
        management services that violates subsection (a) or fails to 
        provide information required under subsection (b); a group 
        health plan or entity providing pharmacy benefit management 
        services that violates subsection (c); or a third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services that violates subsection 
        (d) shall be subject to a civil monetary penalty in the amount 
        of $10,000 for each day during which such violation continues 
        or such information is not disclosed or reported.</DELETED>
        <DELETED>    ``(3) False information.--An entity providing 
        pharmacy benefit management services, or drug manufacturer that 
        knowingly provides false information under this section shall 
        be subject to a civil money penalty in an amount not to exceed 
        $100,000 for each item of false information. Such civil money 
        penalty shall be in addition to other penalties as may be 
        prescribed by law.</DELETED>
        <DELETED>    ``(4) Procedure.--The provisions of section 1128A 
        of the Social Security Act, other than subsections (a) and (b) 
        and the first sentence of subsection (c)(1) of such section 
        shall apply to civil monetary penalties under this subsection 
        in the same manner as such provisions apply to a penalty or 
        proceeding under section 1128A of the Social Security 
        Act.</DELETED>
        <DELETED>    ``(5) Waivers.--The Secretary may waive penalties 
        under paragraph (2), or extend the period of time for 
        compliance with a requirement of this section, for an entity in 
        violation of this section that has made a good-faith effort to 
        comply with this section.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to permit a group health plan or other entity to restrict 
disclosure to, or otherwise limit the access of, the Department of the 
Treasury to a report described in subsection (b)(1) or information 
related to compliance with subsection (a) by such plan or 
entity.</DELETED>
<DELETED>    ``(g) Definitions.--In this section--</DELETED>
        <DELETED>    ``(1) the term `applicable entity' means--
        </DELETED>
                <DELETED>    ``(A) a drug manufacturer, distributor, 
                wholesaler, rebate aggregator (or other purchasing 
                entity designed to aggregate rebates), group purchasing 
                organization, or associated third party;</DELETED>
                <DELETED>    ``(B) any subsidiary, parent, affiliate, 
                or subcontractor of a group health plan, health 
                insurance issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); 
                or</DELETED>
                <DELETED>    ``(C) such other entity as the Secretary, 
                the Secretary of Health and Human Services, and the 
                Secretary of Labor may specify through 
                rulemaking;</DELETED>
        <DELETED>    ``(2) the term `covered group health insurance 
        coverage' means health insurance coverage offered in connection 
        with a group health plan maintained by a large 
        employer;</DELETED>
        <DELETED>    ``(3) the term `covered group health plan' means a 
        group health plan maintained by a large employer;</DELETED>
        <DELETED>    ``(4) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated before the application of manufacturer rebates, 
        fees, alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(5) the term `large employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 50 employees on business days during the preceding 
        calendar year and who employs at least 1 employee on the first 
        day of the plan year;</DELETED>
        <DELETED>    ``(6) the term `net spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated after the application of manufacturer rebates, fees, 
        alternative discounts, or other remuneration;</DELETED>
        <DELETED>    ``(7) the term `plan sponsor' has the meaning 
        given such term in section 3(16)(B) of the Employee Retirement 
        Income Security Act of 1974 (29 U.S.C. 1002(16)(B));</DELETED>
        <DELETED>    ``(8) the term `remuneration' has the meaning 
        given such term by the Secretary, the Secretary of Labor, and 
        the Secretary of Health and Human Services, through notice and 
        comment rulemaking;</DELETED>
        <DELETED>    ``(9) the term `small employer' means, in 
        connection with a group health plan with respect to a calendar 
        year and a plan year, an employer who employed an average of at 
        least 1 but not more than 49 employees on business days during 
        the preceding calendar year and who employs at least 1 employee 
        on the first day of the plan year; and</DELETED>
        <DELETED>    ``(10) the term `wholesale acquisition cost' has 
        the meaning given such term in section 1847A(c)(6)(B) of the 
        Social Security Act (42 U.S.C. 1395w-3a(c)(6)(B)).''.</DELETED>
        <DELETED>    (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of the Internal Revenue Code of 
        1986 is amended by adding at the end the following new 
        item:</DELETED>

<DELETED>``Sec. 9826. Oversight of entities that provide pharmacy 
                            benefit management services.''.
<DELETED>    (d) Funding.--</DELETED>
        <DELETED>    (1) For purposes of carrying out the amendments 
        made by subsection (a), there are appropriated to the Centers 
        for Medicare & Medicaid Services, out of amounts in the 
        Treasury not otherwise appropriated, $80,000,000 for fiscal 
        year 2024.</DELETED>
        <DELETED>    (2) For purposes of carrying out the amendments 
        made by subsection (b), there are appropriated to the 
        Department of Labor, out of amounts in the Treasury not 
        otherwise appropriated, $43,750,000 for fiscal year 
        2024.</DELETED>
<DELETED>    (e) ASPE Study.--The Assistant Secretary for Planning and 
Evaluation of the Department of Health and Human Services shall conduct 
or commission a study on how the United States health care market would 
be impacted by potential regulatory changes disallowing manufacturer 
rebates in the manner and to the extent allowed on the date of 
enactment of this Act, with a focus on the impact to stakeholders in 
the commercial insurance market, and, not later than 1 year after the 
date of enactment of this Act, submit a report to Congress on the 
results of such study. Such study and report shall consider the 
following:</DELETED>
        <DELETED>    (1) The impact on the impact of making no such 
        regulatory changes, as well as potential behavioral changes by 
        plan sponsors, members, and pharmaceutical manufacturers, such 
        as tighter formularies, changes to price concessions, changes 
        in utilization, if such regulatory changes are made.</DELETED>
        <DELETED>    (2) The mechanics needed in the pharmaceutical 
        supply chain (whether existing or not) to move a manufacturer 
        rebate to the point of sale.</DELETED>
        <DELETED>    (3) The feasibility of a partial point-of-sale 
        manufacturer rebate versus a full point-of-sale manufacturer 
        rebate.</DELETED>
        <DELETED>    (4) The impact on patient out-of-pocket costs, 
        premiums, and other cost-sharing.</DELETED>
        <DELETED>    (5) Possible behavioral changes by other third 
        parties in the pharmaceutical supply chain including drug 
        manufacturer, distributor, wholesaler, rebate aggregators, 
        pharmacy services administrative organizations, or group 
        purchasing organizations.</DELETED>
        <DELETED>    (6) Behavioral changes between entities that 
        contract with pharmaceutical manufacturers and pharmaceutical 
        supply chain.</DELETED>
        <DELETED>    (7) Alternative price negotiation mechanisms, 
        including the impact of the Act of June 19, 1936 (commonly 
        known as the ``Robinson-Patman Act''; 49 Stat. 1526, chapter 
        592; 15 U.S.C. 13a et seq.), and the amendments made by that 
        Act, on drug pricing negotiations.</DELETED>
        <DELETED>    (8) The impact on pharmacies, including pharmacy 
        rebates, pharmacy fees, and dispensing channels.</DELETED>
<DELETED>    (f) GAO Study.--</DELETED>
        <DELETED>    (1) In general.--Not later than January 1, 2029, 
        the Comptroller General of the United States shall report to 
        Congress on--</DELETED>
                <DELETED>    (A) pharmacy networks of group health 
                plans, health insurance issuers, and entities providing 
                pharmacy benefit management services under such group 
                health plan or group or individual health insurance 
                coverage, including networks that have pharmacies that 
                are under common ownership (in whole or part) with 
                group health plans, health insurance issuers, or 
                entities providing pharmacy benefit management services 
                or pharmacy benefit administrative services under group 
                health plan or group or individual health insurance 
                coverage;</DELETED>
                <DELETED>    (B) as it relates to pharmacy networks 
                that include pharmacies under common ownership 
                described in subparagraph (A)--</DELETED>
                        <DELETED>    (i) whether such networks are 
                        designed to encourage participants and 
                        beneficiaries of a plan or coverage to use such 
                        pharmacies over other network pharmacies for 
                        specific services or drugs, and if so, the 
                        reasons the networks give for encouraging use 
                        of such pharmacies; and</DELETED>
                        <DELETED>    (ii) whether such pharmacies are 
                        used by participants and beneficiaries 
                        disproportionately more in the aggregate or for 
                        specific services or drugs compared to other 
                        network pharmacies;</DELETED>
                <DELETED>    (C) whether group health plans and health 
                insurance issuers offering group or individual health 
                insurance coverage have options to elect different 
                network pricing arrangements in the marketplace with 
                entities that provide pharmacy benefit management 
                services, the prevalence of electing such different 
                network pricing arrangements;</DELETED>
                <DELETED>    (D) pharmacy network design parameters 
                that encourage participants and beneficiaries in the 
                plan or coverage to fill prescriptions at mail order, 
                specialty, or retail pharmacies that are wholly or 
                partially-owned by that issuer or entity; and</DELETED>
                <DELETED>    (E) the degree to which mail order, 
                specialty, or retail pharmacies that dispense 
                prescription drugs to participants and beneficiaries in 
                a group health plan or health insurance coverage that 
                are under common ownership (in whole or part) with 
                group health plans, health insurance issuers, or 
                entities providing pharmacy benefit management services 
                or pharmacy benefit administrative services under group 
                health plan or group or individual health insurance 
                coverage receive reimbursement that is greater than the 
                median price charged to the group health plan or health 
                insurance issuer when the same drug is dispensed to 
                participants and beneficiaries in the plan or coverage 
                by other pharmacies included in the pharmacy network of 
                that plan, issuer, or entity that are not wholly or 
                partially owned by the health insurance issuer or 
                entity providing pharmacy benefit management 
                services.</DELETED>
        <DELETED>    (2) Requirement.--In carrying out paragraph (1), 
        the Comptroller General of the United States shall not 
        disclose--</DELETED>
                <DELETED>    (A) information that would allow for 
                identification of a specific individual, plan sponsor, 
                health insurance issuer, plan, or entity providing 
                pharmacy benefit management services; or</DELETED>
                <DELETED>    (B) commercial or financial information 
                that is privileged or confidential.</DELETED>
        <DELETED>    (3) Definitions.--In this subsection, the terms 
        ``group health plan'', ``health insurance coverage'', and 
        ``health insurance issuer'' have the meanings given such terms 
        in section 2791 of the Public Health Service Act (42 U.S.C. 
        300gg-91).</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmacy Benefit Manager Reform 
Act''.

SEC. 2. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT MANAGEMENT 
              SERVICES.

    (a) Public Health Service Act.--Title XXVII of the Public Health 
Service Act (42 U.S.C. 300gg et seq.) is amended--
            (1) in part D (42 U.S.C. 300gg-111 et seq.), by adding at 
        the end the following new section:

``SEC. 2799A-11. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT 
              MANAGEMENT SERVICES.

    ``(a) In General.--For plan years beginning on or after the date 
that is 30 months after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, a group health plan or health insurance issuer 
offering group health insurance coverage or an entity providing 
pharmacy benefit management services on behalf of such a plan or issuer 
shall not enter into a contract with an applicable entity unless such 
applicable entity agrees to--
            ``(1) not limit the disclosure of information to plan 
        sponsors in such a manner that prevents the plan or issuer, or 
        an entity providing pharmacy benefit management services on 
        behalf of a plan or issuer, from making the reports described 
        in subsection (b); and
            ``(2) provide the group health plan or health insurance 
        issuer offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services on behalf of a 
        plan or issuer, relevant information necessary to make the 
        reports described in subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, not less frequently than 
        annually, an entity providing pharmacy benefit management 
        services on behalf of a covered group health plan or group 
        health insurance coverage (regardless of whether such coverage 
        is covered group health insurance coverage as defined in 
        subsection (g)(3)) shall submit to the plan sponsor of such 
        covered group health plan or issuer of such health insurance 
        coverage a report in accordance with this subsection and make 
        such report available to the plan sponsor or issuer in plain 
        language, in a machine-readable format, and, as the Secretary, 
        the Secretary of Labor, and the Secretary of the Treasury may 
        determine, other formats. Each such report shall include, with 
        respect to the covered group health plan or health insurance 
        coverage--
                    ``(A) as applicable, information collected from 
                drug manufacturers by such entity on the total amount 
                of copayment assistance dollars paid, or copayment 
                cards applied, that were funded by such drug 
                manufacturers with respect to the participants and 
                beneficiaries in such plan or coverage;
                    ``(B) a list of each drug covered by the plan, 
                coverage, or entity providing pharmacy benefit 
                management services for which a claim was filed during 
                the reporting period, including, with respect to each 
                such drug during the reporting period--
                            ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom a claim for the drug was 
                        filed during the reporting period, the total 
                        number of prescription claims for the drug 
                        (including original prescriptions and refills), 
                        and the total number of dosage units of the 
                        drug for which a claim was filed across the 
                        reporting period;
                            ``(iii) for each claim or dosage unit 
                        described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;
                            ``(iv) the wholesale acquisition cost, 
                        listed as cost per days' supply and cost per 
                        dosage unit;
                            ``(v) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug 
                        after application of any benefits under the 
                        plan or coverage--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                coverage or for which no claim is 
                                submitted to the plan or coverage; and
                            ``(vi) for each of the 50 prescription 
                        drugs with the highest gross spending under the 
                        group health plan or health insurance coverage 
                        during the reporting period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic class (as defined 
                                by the Secretary, the Secretary of 
                                Labor, and the Secretary of the 
                                Treasury), including brand name drugs 
                                and biological products and generic 
                                drugs or biosimilar biological products 
                                that are in the same therapeutic class 
                                as such drug;
                                    ``(II) if applicable, the rationale 
                                for preferred formulary placement of 
                                such drug in that therapeutic class, 
                                selected from a list of standard 
                                rationales established by the 
                                Secretary, the Secretary of Labor, and 
                                the Secretary of the Treasury, in 
                                consultation with stakeholders; and
                                    ``(III) any change in formulary 
                                placement compared to the prior plan 
                                year;
                    ``(C) a list of each therapeutic class of drugs for 
                which a claim was filed under the group health plan or 
                health insurance coverage during the reporting period, 
                and, with respect to each such therapeutic class (as 
                defined as described in subparagraph (B)(vi)(I)) of 
                drugs, during the reporting period--
                            ``(i) total gross spending by the plan or 
                        by the issuer offering such coverage;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that class;
                            ``(iii) if applicable to that class, a 
                        description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on drugs in such 
                        therapeutic class, after application of any 
                        benefits under the plan or coverage--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                coverage or for which no claim is 
                                submitted to the plan or issuer; and
                            ``(v) for each therapeutic class under 
                        which 3 or more drugs are included on the 
                        formulary of such plan or coverage--
                                    ``(I) the amount received, or 
                                expected to be received, by such 
                                entity, from applicable entities, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration--
                                            ``(aa) for claims incurred 
                                        during the reporting period; or
                                            ``(bb) that is related to 
                                        utilization of drugs or drug 
                                        spending;
                                    ``(II) the total net spending by 
                                the plan or by the issuer with respect 
                                to such coverage on that class of 
                                drugs; and
                                    ``(III) the average net spending 
                                per 30-day supply and per 90-day supply 
                                by the plan or by the issuer with 
                                respect to such coverage and its 
                                participants and beneficiaries, among 
                                all drugs within the therapeutic class 
                                for which a claim was filed during the 
                                reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan or by the issuer with respect to such coverage 
                during the reporting period;
                    ``(E) the total amount received, or expected to be 
                received, by the group health plan or health insurance 
                issuer, from applicable entities, in rebates, fees, 
                alternative discounts, and other remuneration received 
                from such entities, related to utilization of drugs or 
                drug spending under that group health plan or health 
                insurance coverage during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the group health plan or health insurance issuer 
                with respect to the coverage during the reporting 
                period;
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA) of the 
                Employee Retirement Income Security Act of 1974) to 
                brokers, consultants, advisors, or any other individual 
                or firm for--
                            ``(i) referral of the group health plan's 
                        or health insurance issuer's business to the 
                        pharmacy benefit manager;
                            ``(ii) consideration of the entity 
                        providing pharmacy benefit management services 
                        by the group health plan or health insurance 
                        issuer; or
                            ``(iii) the retention of the entity by the 
                        group health plan or health insurance issuer;
                    ``(H)(i) an explanation of any benefit design 
                parameters that encourage or require participants and 
                beneficiaries in the plan or coverage to fill 
                prescriptions at mail order, specialty, or retail 
                pharmacies that are affiliated with or under common 
                ownership with the entity providing pharmacy benefit 
                management services on behalf of such plan or coverage, 
                including mandatory mail and specialty home delivery 
                programs, retail and mail auto-refill programs, and 
                cost-sharing assistance incentives funded by an entity 
                providing pharmacy benefit management services;
                    ``(ii) the percentage of total prescriptions 
                charged to the plan, issuer, or participants and 
                beneficiaries in the plan or coverage, that were 
                dispensed by mail order, specialty, or retail 
                pharmacies that are affiliated with or under common 
                ownership with the entity providing pharmacy benefit 
                management services; and
                    ``(iii) a list of all drugs dispensed by such 
                affiliated pharmacy or pharmacy under common ownership 
                and charged to the plan, issuer, or participants and 
                beneficiaries of the plan or coverage, during the 
                applicable period, and, with respect to each drug--
                            ``(I)(aa) the amount charged, per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        with respect to participants and beneficiaries 
                        in the plan or coverage, to the plan or issuer; 
                        and
                            ``(bb) the amount charged, per dosage unit, 
                        per 30-day supply, and per 90-day supply to 
                        participants and beneficiaries;
                            ``(II) the median amount charged to the 
                        plan or issuer, per dosage unit, per 30-day 
                        supply, and per 90-day supply, including 
                        amounts paid by the participants and 
                        beneficiaries, when the same drug is dispensed 
                        by other pharmacies that are not affiliated 
                        with or under common ownership with the entity 
                        and that are included in the pharmacy network 
                        of that plan or coverage;
                            ``(III) the interquartile range of the 
                        costs, per dosage unit, per 30-day supply, and 
                        per 90-day supply, including amounts paid by 
                        the participants and beneficiaries, when the 
                        same drug is dispensed by other pharmacies that 
                        are not affiliated with or under common 
                        ownership with the entity and that are included 
                        in the pharmacy network of that plan or 
                        coverage;
                            ``(IV) the lowest cost, per dosage unit, 
                        per 30-day supply, and per 90-day supply, for 
                        such drug, including amounts charged to the 
                        plan and participants and beneficiaries, that 
                        is available from any pharmacy included in the 
                        network of the plan or coverage;
                            ``(V) the net acquisition cost per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        if the drug is subject to a maximum price 
                        discount; and
                            ``(VI) other information with respect to 
                        the cost of the drug, as determined by the 
                        Secretary, the Secretary of Labor, and the 
                        Secretary of the Treasury, such as average 
                        sales price, wholesale acquisition cost, and 
                        national average drug acquisition cost per 
                        dosage unit or per 30-day supply, for such 
                        drug, including amounts charged to the plan or 
                        issuer and participants and beneficiaries among 
                        all pharmacies included in the network of the 
                        plan or coverage;
                    ``(I) a summary document for plan sponsors or 
                issuers that includes the information described in 
                subparagraphs (A) through (H) that the Secretary, the 
                Secretary of Labor, and the Secretary of the Treasury 
                determine useful to plan sponsors and health insurance 
                issuers for purposes of selecting pharmacy benefit 
                management services, such as an estimated net price to 
                plan sponsor and participant or beneficiary, a cost per 
                claim, the fee structure or reimbursement model, and 
                estimated cost per participant or beneficiary; and
                    ``(J) a summary document for participants or 
                beneficiaries, which shall be made available to 
                participants or beneficiaries upon request to the plan 
                sponsor, that contains the information described in 
                subparagraphs (D) through (G) that the Secretary, the 
                Secretary of Labor, and the Secretary of the Treasury 
                determine useful to participants or beneficiaries in 
                better understanding their plan or benefits, except 
                that such summary document for participants or 
                beneficiaries shall contain only aggregate information.
            ``(2) Regulations.--Not later than 2 years after the date 
        of enactment of the Pharmacy Benefit Manager Reform Act, the 
        Secretary, the Secretary of Labor, and the Secretary of the 
        Treasury shall, through notice and comment rulemaking, 
        promulgate final regulations to implement the requirements of 
        this subsection. In promulgating such regulations, the 
        Secretary, the Secretary of Labor, and the Secretary of the 
        Treasury shall, to the extent practicable, align the reporting 
        requirements under this subsection with the reporting 
        requirements under section 2799A-10.
            ``(3) Additional reporting.--
                    ``(A) Reporting with respect to group health plans 
                offered by small employers.--For plan years beginning 
                on or after the date that is 30 months after the date 
                of enactment of the Pharmacy Benefit Manager Reform 
                Act, not less frequently than annually, an entity 
                providing pharmacy benefit management services on 
                behalf of a group health plan that is not a covered 
                group health plan shall submit to the plan sponsor of 
                such group health plan a report in accordance with this 
                paragraph, and make such report available to the plan 
                sponsor in a machine-readable format, and such other 
                formats as the Secretary, the Secretary of Labor, and 
                the Secretary of the Treasury may specify. Each such 
                report shall include, with respect to the applicable 
                group health plan--
                            ``(i) the information described in 
                        subparagraphs (D), (E), (F), and (G) of 
                        paragraph (1);
                            ``(ii) as applicable, information collected 
                        from drug manufacturers by such plan on the 
                        total amount of copayment assistance dollars 
                        paid, or copayment cards applied, that were 
                        funded by applicable drug manufacturers with 
                        respect to the participants and beneficiaries 
                        in such plan, except that such information 
                        shall not identify any drug manufacturer; and
                            ``(iii) a summary document that includes 
                        the information described in clauses (i) and 
                        (ii) that the Secretary, the Secretary of 
                        Labor, and the Secretary of the Treasury 
                        determine useful for plan sponsors for purposes 
                        of selecting pharmacy benefit management 
                        services, provided that such summary documents 
                        include only aggregate information.
                    ``(B) Opt-in for group health insurance coverage.--
                            ``(i) In general.--A plan sponsor of group 
                        health insurance coverage offered in connection 
                        with a group health plan may, on an annual 
                        basis, for plan years beginning on or after the 
                        date that is 30 months after the date of 
                        enactment of the Pharmacy Benefit Manager 
                        Reform Act, elect to require an entity 
                        providing pharmacy benefit management services 
                        on behalf of a health insurance issuer offering 
                        group health insurance coverage to submit to 
                        such plan sponsor a report in accordance with 
                        this subsection.
                            ``(ii) Contents of reports.--
                                    ``(I) Covered group health 
                                insurance coverage.--In the case of an 
                                entity providing pharmacy benefit 
                                management services on behalf of an 
                                issuer that offers covered group health 
                                insurance coverage, a report provided 
                                pursuant to clause (i) shall include, 
                                with respect to the applicable covered 
                                group health insurance coverage, the 
                                information required under paragraph 
                                (1) for covered group health plans.
                                    ``(II) Other group health insurance 
                                coverage.--In the case of an entity 
                                providing pharmacy benefit management 
                                services on behalf of an issuer that 
                                offers group health insurance coverage 
                                that is not covered group health 
                                insurance, a report provided pursuant 
                                to clause (i) shall include, with 
                                respect to the applicable group health 
                                insurance coverage--
                                            ``(aa) the information 
                                        described in subparagraphs (D), 
                                        (E), (F), and (G) of paragraph 
                                        (1); and
                                            ``(bb) as applicable, 
                                        information collected from drug 
                                        manufacturers by such issuer or 
                                        entity on the total amount of 
                                        copayment assistance dollars 
                                        paid, or copayment cards 
                                        applied, that were funded by 
                                        applicable drug manufacturers 
                                        with respect to the 
                                        participants and beneficiaries 
                                        in such plan, except that such 
                                        information shall not identify 
                                        any drug manufacturer.
                            ``(iii) Required reporting for covered 
                        group health insurance coverage.--Each health 
                        insurance issuer that offers covered group 
                        health insurance coverage shall annually submit 
                        to the plan sponsor the information described 
                        in paragraph (1)(I), regardless of whether the 
                        plan sponsor made the election described in 
                        clause (i) for the applicable year.
                            ``(iv) Required reporting for other group 
                        health insurance coverage.--Each health 
                        insurance issuer that offers group health 
                        insurance coverage that is not covered group 
                        health insurance shall annually submit a 
                        summary document that includes such information 
                        described in items (aa) and (bb) of clause 
                        (ii)(II) as the Secretary and the Secretary of 
                        Labor determine useful for plan sponsors for 
                        purposes of selecting pharmacy benefit 
                        management services, provided that such summary 
                        documents include only aggregate information.
            ``(4) Privacy requirements.--
                    ``(A) Relationship to hipaa regulations.--Nothing 
                in this section shall be construed to modify the 
                requirements for the creation, receipt, maintenance, or 
                transmission of protected health information under the 
                HIPAA privacy regulations, as defined in section 
                1180(b)(3) of the Social Security Act.
                    ``(B) Requirement.--A report submitted under 
                paragraph (1) or (3) shall contain only summary health 
                information, as defined in section 164.504(a) of title 
                45, Code of Federal Regulations (or successor 
                regulations).
                    ``(C) Clarification regarding certain disclosures 
                of information.--
                            ``(i) Reasonable restrictions.--Nothing in 
                        this section prevents a health insurance issuer 
                        offering group health insurance coverage or an 
                        entity providing pharmacy benefit management 
                        services on behalf of a group health plan or 
                        health insurance issuer offering group health 
                        insurance coverage from placing reasonable 
                        restrictions (as the Secretary, the Secretary 
                        of Labor, and the Secretary of the Treasury may 
                        determine) on the public disclosure of the 
                        information contained in a report under 
                        paragraph (1) or (3).
                            ``(ii) Limitations.--A health insurance 
                        issuer offering group health insurance coverage 
                        or an entity providing pharmacy benefit 
                        management services on behalf of a group health 
                        plan or health insurance issuer offering group 
                        health insurance coverage may not restrict 
                        disclosure of such reports to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or any 
                        other Federal agency responsible for 
                        enforcement activities under this section for 
                        purposes of enforcement under this section or 
                        other applicable law, or to the Comptroller 
                        General of the United States in accordance with 
                        paragraph (6).
            ``(5) Use and disclosure by plan sponsors.--
                    ``(A) Prohibition.--A plan sponsor may not--
                            ``(i) fail or refuse to hire, or discharge, 
                        any employee, or otherwise discriminate against 
                        any employee with respect to the compensation, 
                        terms, conditions, or privileges of employment 
                        of the employee, because of information 
                        submitted under paragraph (1) or (3) attributed 
                        to the employee or a dependent of the employee; 
                        or
                            ``(ii) limit, segregate, or classify the 
                        employees of the employer in any way that would 
                        deprive or tend to deprive any employee of 
                        employment opportunities or otherwise adversely 
                        affect the status of the employee as an 
                        employee, because of information submitted 
                        under paragraph (1) or (3) attributed to the 
                        employee or a dependent of the employee.
                    ``(B) Disclosure and redisclosure.--A plan sponsor 
                shall not disclose the information received under 
                paragraph (1) or (3) except--
                            ``(i) to an occupational or other health 
                        researcher if the research is conducted in 
                        compliance with the regulations and protections 
                        provided for under part 46 of title 45, Code of 
                        Federal Regulations (or successor regulations);
                            ``(ii) in response to an order of a court, 
                        except that the plan sponsor may disclose only 
                        the information expressly authorized by such 
                        order;
                            ``(iii) to the Department of Health and 
                        Human Services, the Department of Labor, the 
                        Department of the Treasury, or other Federal 
                        agency responsible for enforcement activities 
                        under this section; or
                            ``(iv) to a contractor or agent for 
                        purposes of health plan administration, if such 
                        contractor or agent agrees, in writing, and as 
                        a term of the contract, to abide by the same 
                        use and disclosure restrictions as the plan 
                        sponsor.
                    ``(C) Relationship to hipaa regulations.--With 
                respect to the HIPAA privacy regulations, as defined in 
                section 1180(b)(3) of the Social Security Act, 
                subparagraph (B) does not prohibit a covered entity (as 
                defined for purposes of such regulations promulgated 
                under section 264 of the Health Insurance Portability 
                and Accountability Act of 1996) from any use or 
                disclosure of health information that is authorized for 
                the covered entity under such regulations. The previous 
                sentence does not affect the authority of such 
                Secretary to modify such regulations.
                    ``(D) Written notice.--Plan sponsors of group 
                health plans and group health insurance coverage shall 
                provide to each employee written notice informing the 
                employee of the requirement for health insurance 
                issuers or entities providing pharmacy benefit 
                management services on behalf of the plan or coverage 
                to submit reports to plan sponsors under paragraphs (1) 
                and (3), as applicable, which may include incorporating 
                such notification in plan documents provided to the 
                employee, an employee handbook provided to the 
                employee, or individual notification.
                    ``(E) Enforcement.--
                            ``(i) In general.--The powers, procedures, 
                        and remedies provided in section 207 of the 
                        Genetic Information Nondiscrimination Act to a 
                        person alleging a violation of title II of such 
                        Act shall be the powers, procedures, and 
                        remedies this subparagraph provides for any 
                        person alleging a violation of this paragraph.
                            ``(ii) Prohibition against retaliation.--No 
                        person shall discriminate against any 
                        individual because such individual has opposed 
                        any act or practice made unlawful by this 
                        paragraph or because such individual made a 
                        charge, testified, assisted, or participated in 
                        any manner in an investigation, proceeding, or 
                        hearing under this paragraph. The remedies and 
                        procedures otherwise provided for under this 
                        subparagraph shall be available to aggrieved 
                        individuals with respect to violations of this 
                        clause.
            ``(6) Submissions to gao.--A health insurance issuer 
        offering group health insurance coverage or an entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan shall submit, upon request, to the Comptroller 
        General of the United States each of the first 2 reports 
        submitted to a plan sponsor under paragraph (1) or (3) with 
        respect to such coverage or plan, and other such reports as 
        requested, in accordance with the privacy requirements under 
        paragraph (4), and such other information that the Comptroller 
        General determines necessary to carry out the study under 
        section 2(f) of the Pharmacy Benefit Manager Reform Act.
            ``(7) Standard formats.--
                    ``(A) In general.--Not later than June 1, 2024, the 
                Secretary, the Secretary of Labor, and the Secretary of 
                the Treasury shall specify, through rulemaking, 
                standard formats for entities providing pharmacy 
                benefit management services to submit reports required 
                under this subsection. Such secretaries may provide for 
                separate standard formats for reports to plan sponsors 
                of group health plans and reports to plan sponsors of 
                group health insurance coverage offered in connection 
                with a group health plan.
                    ``(B) Form of report.--The Secretary, the Secretary 
                of Labor, and the Secretary of the Treasury shall 
                define through rulemaking a form of the reports under 
                paragraphs (1) and (3) required to be submitted to plan 
                sponsors who also are drug manufacturers, drug 
                wholesalers, entities providing pharmacy benefit 
                management services, or other direct participants in 
                the drug supply chain, in the case that such 
                secretaries determine that changes to the standard 
                format are necessary to prevent anticompetitive 
                behavior.
    ``(c) Limitations on Spread Pricing.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a group health plan or 
        health insurance issuer offering group or individual health 
        insurance coverage shall ensure that the amount required to be 
        paid by a participant, beneficiary, or enrollee for a 
        prescription drug covered under the plan or coverage, and a 
        third-party administrator or an entity providing pharmacy 
        benefit management services on behalf of such a plan or 
        coverage shall ensure that the total amount required to be paid 
        by the plan or issuer and participant, beneficiary, or enrollee 
        for a prescription drug covered under the plan or coverage, 
        does not exceed the price paid to the pharmacy, excluding 
        penalties paid by the pharmacy (as described in paragraph (2)) 
        to such plan, issuer, or entity.
            ``(2) Rule of construction.--For purposes of paragraph (1), 
        penalties paid by pharmacies include only the following:
                    ``(A) A penalty paid if an original claim for a 
                prescription drug was submitted fraudulently by the 
                pharmacy to the plan, issuer, or entity.
                    ``(B) A penalty paid if the original claim payment 
                made by the plan, issuer, or entity to the pharmacy was 
                inconsistent with the reimbursement terms in any 
                contract between the pharmacy and the plan, issuer, or 
                entity.
                    ``(C) A penalty paid if the pharmacist services for 
                which a claim was filed with the plan, issuer, or 
                entity were not rendered by the pharmacy.
    ``(d) Full Rebate Pass-through to Plan or Health Insurance 
Issuer.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan or health insurance issuer offering group health 
        insurance coverage shall--
                    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                from any applicable entity that are related to 
                utilization of drugs under such group health plan or 
                health insurance coverage, to the group health plan or 
                health insurance issuer offering group health insurance 
                coverage; and
                    ``(B) ensure that any contract entered into, by 
                such third-party administrator or entity providing 
                pharmacy benefit management services on behalf of such 
                a plan or coverage, with rebate aggregators (or other 
                purchasing entity designed to aggregate rebates), 
                applicable group purchasing organizations, or any 
                subsidiary, parent, affiliate, or subcontractor of the 
                plan, entity, rebate aggregator (or other purchasing 
                entity designed to aggregate rebates), or applicable 
                group purchasing organization remit 100 percent of 
                rebates, fees, alternative discounts, and other 
                remuneration received that are related to utilization 
                of drugs under such group health plan or health 
                insurance coverage, to the third-party administrator or 
                entity providing pharmacy benefit management services.
            ``(2) Form and manner of remittance.--With respect to such 
        rebates, fees, alternative discounts, and other remuneration--
                    ``(A) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(A) shall be--
                            ``(i) remitted--
                                    ``(I) on a quarterly basis, to the 
                                group health plan or the group health 
                                insurance issuer, not later than 90 
                                days after the end of each quarter; or
                                    ``(II) in the case of an 
                                underpayment in a remittance for a 
                                prior quarter, as soon as practicable, 
                                but not later than 90 days after notice 
                                of the underpayment is first given;
                            ``(ii) fully disclosed and enumerated to 
                        the group health plan or health insurance 
                        issuer, as described in paragraphs (1) and (3) 
                        of subsection (b); and
                            ``(iii) returned to the issuer or entity 
                        providing pharmacy benefit management services 
                        on behalf of the group health plan if an audit 
                        by a plan sponsor, or a third party designated 
                        by a plan sponsor, indicates that the amounts 
                        received are incorrect after such amounts have 
                        been paid to the group health plan or health 
                        insurance issuer;
                    ``(B) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(B) shall be 
                remitted in accordance with such procedures as the 
                Secretary, Secretary of Labor, and Secretary of the 
                Treasury establish; and
                    ``(C) the records of such rebates, fees, 
                alternative discounts, and other remuneration shall be 
                available for audit by the plan sponsor, issuer, or a 
                third party designated by a plan sponsor, not less than 
                once per plan year.
            ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan, a health insurance issuer 
        offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services on behalf of 
        such group health plan or health insurance coverage shall make 
        rebate contracts with rebate aggregators or drug manufacturers 
        available for audit by the plan sponsor or designated third 
        party, subject to reasonable restrictions (as determined by the 
        Secretary, the Secretary of Labor, and the Secretary of the 
        Treasury) on confidentiality to prevent re-disclosure of such 
        contracts.
            ``(4) Auditors.--Audits carried out under paragraphs (2)(C) 
        and (3) shall be performed by an auditor selected by the 
        applicable plan sponsor.
            ``(5) Rule of construction.--Nothing in this subsection 
        shall be construed to--
                    ``(A) prohibit payments to entities offering 
                pharmacy benefit management services for bona fide 
                services using a fee structure not described in this 
                subsection, provided that such fees are transparent to 
                group health plans and health insurance issuers;
                    ``(B) require a third-party administrator of a 
                group health plan or an entity providing pharmacy 
                benefit management services on behalf of a group health 
                plan or health insurance issuer offering health 
                insurance coverage to remit bona fide service fees to 
                group health plans or health insurance issuers; or
                    ``(C) limit the ability of a group health plan or 
                health insurance issuer to pass through rebates, fees, 
                alternative discounts, and other remuneration to the 
                participant or beneficiary.
    ``(e) Enforcement.--
            ``(1) In general.--The Secretary shall enforce this 
        section.
            ``(2) Violations.--A group health plan, a health insurance 
        issuer, or an entity providing pharmacy benefit management 
        services that violates subsection (a); an entity providing 
        pharmacy benefit management services that fails to provide 
        information required under subsection (b); a group health plan, 
        health insurance issuer, or entity providing pharmacy benefit 
        management services that violates subsection (c); or a third-
        party administrator of a group health plan, a health insurance 
        issuer, or an entity providing pharmacy benefit management 
        services that violates subsection (d) shall be subject to a 
        civil monetary penalty in the amount of $10,000 for each day 
        during which such violation continues or such information is 
        not disclosed or reported.
            ``(3) False information.--A group health plan, a health 
        insurance issuer, an entity providing pharmacy benefit 
        management services, or a third-party administrator that 
        knowingly provides false information under this section shall 
        be subject to a civil money penalty in an amount not to exceed 
        $100,000 for each item of false information. Such civil money 
        penalty shall be in addition to other penalties as may be 
        prescribed by law.
            ``(4) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsection (a) and (b) and the 
        first sentence of subsection (c)(1) of such section shall apply 
        to civil monetary penalties under this subsection in the same 
        manner as such provisions apply to a penalty or proceeding 
        under section 1128A of the Social Security Act.
            ``(5) Waivers.--The Secretary may waive penalties under 
        paragraph (2), or extend the period of time for compliance with 
        a requirement of this section, for an entity in violation of 
        this section that has made a good-faith effort to comply with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to permit a health insurance issuer, group health plan, 
entity providing pharmacy benefit management services on behalf of a 
group health plan or health insurance issuer, or other entity to 
restrict disclosure to, or otherwise limit the access of, the Secretary 
of Health and Human Services, the Secretary of Labor, or the Secretary 
of the Treasury to a report described in subsection (b)(1) or 
information related to compliance with subsections (a), (b), (c), or 
(d) by such issuer, plan, or entity.
    ``(g) Definitions.--In this section--
            ``(1) the term `applicable entity' means--
                    ``(A) an applicable group purchasing organization, 
                drug manufacturer, distributor, wholesaler, rebate 
                aggregator (or other purchasing entity designed to 
                aggregate rebates), or associated third party;
                    ``(B) any subsidiary, parent, affiliate, or 
                subcontractor of a group health plan, health insurance 
                issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); or
                    ``(C) such other entity as the Secretary, the 
                Secretary of Labor, and the Secretary of the Treasury 
                may specify through rulemaking;
            ``(2) the term `applicable group purchasing organization' 
        means a group purchasing organization that is affiliated with 
        or under common ownership with an entity providing pharmacy 
        benefit management services;
            ``(3) the term `covered group health insurance coverage' 
        means health insurance coverage offered in connection with a 
        group health plan maintained by a large employer;
            ``(4) the term `covered group health plan' means a group 
        health plan maintained by a large employer;
            ``(5) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated before the application of rebates, fees, alternative 
        discounts, or other remuneration;
            ``(6) the term `large employer' means, in connection with a 
        group health plan with respect to a calendar year and a plan 
        year, an employer who employed an average of at least 50 
        employees on business days during the preceding calendar year 
        and who employs at least 1 employee on the first day of the 
        plan year;
            ``(7) the term `net spending', with respect to prescription 
        drug benefits under a group health plan or health insurance 
        coverage, means the amount spent by a group health plan or 
        health insurance issuer on prescription drug benefits, 
        calculated after the application of rebates, fees, alternative 
        discounts, or other remuneration;
            ``(8) the term `plan sponsor' has the meaning given such 
        term in section 3(16)(B) of the Employee Retirement Income 
        Security Act of 1974;
            ``(9) the term `remuneration' has the meaning given such 
        term by the Secretary, the Secretary of Labor, and the 
        Secretary of the Treasury, through rulemaking, which shall be 
        reevaluated by such secretaries every 5 years; and
            ``(10) the term `wholesale acquisition cost' has the 
        meaning given such term in section 1847A(c)(6)(B) of the Social 
        Security Act.'';
            (2) in section 2723 (42 U.S.C. 300gg-22)--
                    (A) in subsection (a)--
                            (i) in paragraph (1), by inserting ``(other 
                        than section 2799A-11)'' after ``part D''; and
                            (ii) in paragraph (2), by inserting 
                        ``(other than section 2799A-11)'' after ``part 
                        D'';
                    (B) in subsection (b)--
                            (i) in paragraph (1), by inserting ``(other 
                        than section 2799A-11)'' after ``part D'';
                            (ii) in paragraph (2)(A), by inserting 
                        ``(other than section 2799A-11)'' after ``part 
                        D''; and
                            (iii) in paragraph (2)(C)(ii), by inserting 
                        ``(other than section 2799A-11)'' after ``part 
                        D''; and
            (3) in section 2799A-10 (42 U.S.C. 300gg-120), by adding at 
        the end the following:
    ``(d) Entities Providing Pharmacy Benefit Management Services.--
Beginning 2 years after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, entities providing pharmacy benefit management 
services shall report to plan sponsors of group health plans or group 
health insurance coverage information required under paragraphs (4), 
(5), (6), (7)(A)(iii), and (7)(B) of subsection (a).''.
    (b) Employee Retirement Income Security Act of 1974.--
            (1) In general.--Subtitle B of title I of the Employee 
        Retirement Income Security Act of 1974 (29 U.S.C. 1021 et seq.) 
        is amended--
                    (A) in subpart B of part 7 (29 U.S.C. 1185 et 
                seq.), by adding at the end the following:

``SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT 
              MANAGEMENT SERVICES.

    ``(a) In General.--For plan years beginning on or after the date 
that is 30 months after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, a group health plan (or health insurance issuer 
offering group health insurance coverage in connection with such a 
plan) or an entity providing pharmacy benefit management services on 
behalf of such a plan or issuer shall not enter into a contract with an 
applicable entity unless such applicable entity agrees to--
            ``(1) not limit the disclosure of information to plan 
        sponsors in such a manner that prevents the plan or issuer, or 
        an entity providing pharmacy benefit management services on 
        behalf of a plan or issuer, from making the reports described 
        in subsection (b); and
            ``(2) provide the group health plan or health insurance 
        issuer offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services on behalf of a 
        plan or issuer, relevant information necessary to make the 
        reports described in subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, not less frequently than 
        annually, an entity providing pharmacy benefit management 
        services on behalf of a covered group health plan or group 
        health insurance coverage (regardless of whether such coverage 
        is covered group health insurance coverage as defined in 
        subsection (g)(3)) shall submit to the plan sponsor of such 
        covered group health plan or issuer of such health insurance 
        coverage a report in accordance with this subsection and make 
        such report available to the plan sponsor or issuer in plain 
        language, in a machine-readable format, and, as the Secretary, 
        the Secretary of Health and Human Services, and the Secretary 
        of the Treasury may determine, other formats. Each such report 
        shall include, with respect to the covered group health plan or 
        health insurance coverage--
                    ``(A) as applicable, information collected from 
                drug manufacturers by such entity on the total amount 
                of copayment assistance dollars paid, or copayment 
                cards applied, that were funded by such drug 
                manufacturers with respect to the participants and 
                beneficiaries in such plan or coverage;
                    ``(B) a list of each drug covered by the plan, 
                coverage, or entity providing pharmacy benefit 
                management services for which a claim was filed during 
                the reporting period, including, with respect to each 
                such drug during the reporting period--
                            ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom a claim for the drug was 
                        filed during the reporting period, the total 
                        number of prescription claims for the drug 
                        (including original prescriptions and refills), 
                        and the total number of dosage units of the 
                        drug for which a claim was filed across the 
                        reporting period;
                            ``(iii) for each claim or dosage unit 
                        described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;
                            ``(iv) the wholesale acquisition cost, 
                        listed as cost per days' supply and cost per 
                        dosage unit;
                            ``(v) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug 
                        after application of any benefits under the 
                        plan or coverage--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                coverage or for which no claim is 
                                submitted to the plan or coverage; and
                            ``(vi) for each of the 50 prescription 
                        drugs with the highest gross spending under the 
                        group health plan or health insurance coverage 
                        during the reporting period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic class (as defined 
                                by the Secretary, the Secretary of 
                                Health and Human Services, and the 
                                Secretary of the Treasury), including 
                                brand name drugs and biological 
                                products and generic drugs or 
                                biosimilar biological products that are 
                                in the same therapeutic class as such 
                                drug;
                                    ``(II) if applicable, the rationale 
                                for preferred formulary placement of 
                                such drug in that therapeutic class, 
                                selected from a list of standard 
                                rationales established by the 
                                Secretary, the Secretary of Health and 
                                Human Services, and the Secretary of 
                                the Treasury, in consultation with 
                                stakeholders; and
                                    ``(III) any change in formulary 
                                placement compared to the prior plan 
                                year;
                    ``(C) a list of each therapeutic class (as defined 
                as described in subparagraph (B)(vi)(I)) of drugs for 
                which a claim was filed under the group health plan or 
                health insurance coverage during the reporting period, 
                and, with respect to each such therapeutic class of 
                drugs, during the reporting period--
                            ``(i) total gross spending by the plan or 
                        by the issuer offering such coverage;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that class;
                            ``(iii) if applicable to that class, a 
                        description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on drugs in such 
                        therapeutic class, after application of any 
                        benefits under the plan or coverage--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                coverage or for which no claim is 
                                submitted to the plan or issuer; and
                            ``(v) for each therapeutic class under 
                        which 3 or more drugs are included on the 
                        formulary of such plan or coverage--
                                    ``(I) the amount received, or 
                                expected to be received, by such 
                                entity, from applicable entities, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration--
                                            ``(aa) for claims incurred 
                                        during the reporting period; or
                                            ``(bb) that is related to 
                                        utilization of drugs or drug 
                                        spending;
                                    ``(II) the total net spending by 
                                the plan or by the issuer with respect 
                                to such coverage on that class of 
                                drugs; and
                                    ``(III) the average net spending 
                                per 30-day supply and per 90-day supply 
                                by the plan or by the issuer with 
                                respect to such coverage and its 
                                participants and beneficiaries, among 
                                all drugs within the therapeutic class 
                                for which a claim was filed during the 
                                reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan or coverage during the reporting period;
                    ``(E) the total amount received, or expected to be 
                received, by the group health plan or health insurance 
                issuer, from applicable entities, in rebates, fees, 
                alternative discounts, and other remuneration received 
                from such entities, related to utilization of drugs or 
                drug spending under that group health plan or health 
                insurance coverage during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the group health plan or health insurance issuer 
                with respect to the coverage during the reporting 
                period;
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA)) to 
                brokers, consultants, advisors, or any other individual 
                or firm for--
                            ``(i) referral of the group health plan's 
                        or health insurance issuer's business to the 
                        pharmacy benefit manager;
                            ``(ii) consideration of the entity 
                        providing pharmacy benefit management services 
                        by the group health plan or health insurance 
                        issuer; or
                            ``(iii) the retention of the entity by the 
                        group health plan or health insurance issuer;
                    ``(H)(i) an explanation of any benefit design 
                parameters that encourage or require participants and 
                beneficiaries in the plan or coverage to fill 
                prescriptions at mail order, specialty, or retail 
                pharmacies that are affiliated with or under common 
                ownership with the entity providing pharmacy benefit 
                management services on behalf of such plan or coverage, 
                including mandatory mail and specialty home delivery 
                programs, retail and mail auto-refill programs, and 
                cost-sharing assistance incentives funded by an entity 
                providing pharmacy benefit management services;
                    ``(ii) the percentage of total prescriptions 
                charged to the plan, issuer, or participants and 
                beneficiaries in the plan or coverage, that were 
                dispensed by mail order, specialty, or retail 
                pharmacies that are affiliated with or under common 
                ownership with the entity providing pharmacy benefit 
                management services; and
                    ``(iii) a list of all drugs dispensed by such 
                affiliated pharmacy or pharmacy under common ownership 
                and charged to the plan, issuer, or participants and 
                beneficiaries of the plan or coverage, during the 
                applicable period, and, with respect to each drug--
                            ``(I)(aa) the amount charged, per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        with respect to participants and beneficiaries 
                        in the plan or coverage, to the plan or issuer; 
                        and
                            ``(bb) the amount charged, per dosage unit, 
                        per 30-day supply, and per 90-day supply to 
                        participants and beneficiaries;
                            ``(II) the median amount charged to the 
                        plan or issuer, per dosage unit, per 30-day 
                        supply, and per 90-day supply, including 
                        amounts paid by the participants and 
                        beneficiaries, when the same drug is dispensed 
                        by other pharmacies that are not affiliated 
                        with or under common ownership with the entity 
                        and that are included in the pharmacy network 
                        of that plan or coverage;
                            ``(III) the interquartile range of the 
                        costs, per dosage unit, per 30-day supply, and 
                        per 90-day supply, including amounts paid by 
                        the participants and beneficiaries, when the 
                        same drug is dispensed by other pharmacies that 
                        are not affiliated with or under common 
                        ownership with the entity and that are included 
                        in the pharmacy network of that plan or 
                        coverage;
                            ``(IV) the lowest cost, per dosage unit, 
                        per 30-day supply, and per 90-day supply, for 
                        such drug, including amounts charged to the 
                        plan and participants and beneficiaries, that 
                        is available from any pharmacy included in the 
                        network of the plan or coverage;
                            ``(V) the net acquisition cost per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        if the drug is subject to a maximum price 
                        discount; and
                            ``(VI) other information with respect to 
                        the cost of the drug, as determined by the 
                        Secretary, the Secretary of Health and Human 
                        Services, and the Secretary of the Treasury, 
                        such as average sales price, wholesale 
                        acquisition cost, and national average drug 
                        acquisition cost per dosage unit or per 30-day 
                        supply, for such drug, including amounts 
                        charged to the plan or issuer and participants 
                        and beneficiaries among all pharmacies included 
                        in the network of the plan or coverage;
                    ``(I) a summary document for plan sponsors or 
                issuers that includes the information described in 
                subparagraphs (A) through (H) that the Secretary, the 
                Secretary of Health and Human Services, and the 
                Secretary of the Treasury determine useful to plan 
                sponsors and health insurance issuers for purposes of 
                selecting pharmacy benefit management services, such as 
                an estimated net price to plan sponsor and participant 
                or beneficiary, a cost per claim, the fee structure or 
                reimbursement model, and estimated cost per participant 
                or beneficiary; and
                    ``(J) a summary document for participants or 
                beneficiaries, which shall be made available to 
                participants or beneficiaries upon request to the plan 
                sponsor, that contains the information described in 
                subparagraphs (D) through (G) that the Secretary, the 
                Secretary of Health and Human Services, and the 
                Secretary of the Treasury determine useful to 
                participants or beneficiaries in better understanding 
                their plan or benefits, except that such summary 
                document for participants or beneficiaries shall 
                contain only aggregate information.
            ``(2) Regulations.--Not later than 2 years after the date 
        of enactment of the Pharmacy Benefit Manager Reform Act, the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of the Treasury shall, through notice and comment 
        rulemaking, promulgate final regulations to implement the 
        requirements of this subsection. In promulgating such 
        regulations, the Secretary, the Secretary of Health and Human 
        Services, and the Secretary of the Treasury shall, to the 
        extent practicable, align the reporting requirements under this 
        subsection with the reporting requirements under section 725.
            ``(3) Additional reporting.--
                    ``(A) Reporting with respect to group health plans 
                offered by small employers.--For plan years beginning 
                on or after the date that is 30 months after the date 
                of enactment of the Pharmacy Benefit Manager Reform 
                Act, not less frequently than annually, an entity 
                providing pharmacy benefit management services on 
                behalf of a group health plan that is not a covered 
                group health plan shall submit to the plan sponsor of 
                such group health plan a report in accordance with this 
                paragraph, and make such report available to the plan 
                sponsor in a machine-readable format, and such other 
                formats as the Secretary, the Secretary of Health and 
                Human Services, and the Secretary of the Treasury may 
                specify. Each such report shall include, with respect 
                to the applicable group health plan--
                            ``(i) the information described in 
                        subparagraphs (D), (E), (F), and (G) of 
                        paragraph (1);
                            ``(ii) as applicable, information collected 
                        from drug manufacturers by such plan on the 
                        total amount of copayment assistance dollars 
                        paid, or copayment cards applied, that were 
                        funded by applicable drug manufacturers with 
                        respect to the participants and beneficiaries 
                        in such plan, except that such information 
                        shall not identify any drug manufacturer; and
                            ``(iii) a summary document that includes 
                        the information described in clauses (i) and 
                        (ii) that the Secretary, the Secretary of 
                        Health and Human Services, and the Secretary of 
                        the Treasury determine useful to plan sponsors 
                        for purposes of selecting pharmacy benefit 
                        management services, provided that such summary 
                        documents include only aggregate information.
                    ``(B) Opt-in for group health insurance coverage.--
                            ``(i) In general.--A plan sponsor of group 
                        health insurance coverage offered in connection 
                        with a group health plan may, on an annual 
                        basis, for plan years beginning on or after the 
                        date that is 30 months after the date of 
                        enactment of the Pharmacy Benefit Manager 
                        Reform Act, elect to require an entity 
                        providing pharmacy benefit management services 
                        on behalf of a health insurance issuer offering 
                        group health insurance coverage to submit to 
                        such plan sponsor a report in accordance with 
                        this subsection.
                            ``(ii) Contents of reports.--
                                    ``(I) Covered group health 
                                insurance coverage.--In the case of an 
                                entity providing pharmacy benefit 
                                management services on behalf of an 
                                issuer that offers covered group health 
                                insurance coverage, a report provided 
                                pursuant to clause (i) shall include, 
                                with respect to the applicable covered 
                                group health insurance coverage, the 
                                information required under paragraph 
                                (1) for covered group health plans.
                                    ``(II) Other group health insurance 
                                coverage.--In the case of an entity 
                                providing pharmacy benefit management 
                                services on behalf of an issuer that 
                                offers group health insurance coverage 
                                that is not covered group health 
                                insurance, a report provided pursuant 
                                to clause (i) shall include, with 
                                respect to the applicable group health 
                                insurance coverage--
                                            ``(aa) the information 
                                        described in subparagraphs (D), 
                                        (E), (F), and (G) of paragraph 
                                        (1); and
                                            ``(bb) as applicable, 
                                        information collected from drug 
                                        manufacturers by such issuer or 
                                        entity on the total amount of 
                                        copayment assistance dollars 
                                        paid, or copayment cards 
                                        applied, that were funded by 
                                        applicable drug manufacturers 
                                        with respect to the 
                                        participants and beneficiaries 
                                        in such plan, except that such 
                                        information shall not identify 
                                        any drug manufacturer.
                            ``(iii) Required reporting for covered 
                        group health insurance coverage.--Each health 
                        insurance issuer that offers covered group 
                        health insurance coverage shall annually submit 
                        to the plan sponsor the information described 
                        in paragraph (1)(I), regardless of whether the 
                        plan sponsor made the election described in 
                        clause (i) for the applicable year.
                            ``(iv) Required reporting for other group 
                        health insurance coverage.--Each health 
                        insurance issuer that offers group health 
                        insurance coverage that is not covered group 
                        health insurance shall annually submit a 
                        summary document that includes such information 
                        described in items (aa) and (bb) of clause 
                        (ii)(II) as the Secretary and the Secretary of 
                        Health and Human Services determine useful for 
                        plan sponsors for purposes of selecting 
                        pharmacy benefit management services, provided 
                        that such summary documents include only 
                        aggregate information.
            ``(4) Privacy requirements.--
                    ``(A) Relationship to hipaa regulations.--Nothing 
                in this section shall be construed to modify the 
                requirements for the creation, receipt, maintenance, or 
                transmission of protected health information under the 
                HIPAA privacy regulations, as defined in section 
                1180(b)(3) of the Social Security Act (42 U.S.C. 1320d-
                9(b)(3)).
                    ``(B) Requirement.--A report submitted under 
                paragraph (1) or (3) shall contain only summary health 
                information, as defined in section 164.504(a) of title 
                45, Code of Federal Regulations (or successor 
                regulations).
                    ``(C) Clarification regarding certain disclosures 
                of information.--
                            ``(i) Reasonable restrictions.--Nothing in 
                        this section prevents a health insurance issuer 
                        offering group health insurance coverage or an 
                        entity providing pharmacy benefit management 
                        services on behalf of a group health plan or 
                        health insurance issuer offering group health 
                        insurance coverage from placing reasonable 
                        restrictions (as the Secretary, the Secretary 
                        of Health and Human Services, and the Secretary 
                        of the Treasury may determine) on the public 
                        disclosure of the information contained in a 
                        report under paragraph (1) or (3).
                            ``(ii) Limitations.--A health insurance 
                        issuer offering group health insurance coverage 
                        or an entity providing pharmacy benefit 
                        management services on behalf of a group health 
                        plan or health insurance issuer offering group 
                        health insurance coverage may not restrict 
                        disclosure of such reports to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or any 
                        other Federal agency responsible for 
                        enforcement activities under this section for 
                        purposes of enforcement under this section or 
                        other applicable law, or to the Comptroller 
                        General of the United States in accordance with 
                        paragraph (6).
            ``(5) Use and disclosure by plan sponsors.--
                    ``(A) Prohibition.--A plan sponsor may not--
                            ``(i) fail or refuse to hire, or discharge, 
                        any employee, or otherwise discriminate against 
                        any employee with respect to the compensation, 
                        terms, conditions, or privileges of employment 
                        of the employee, because of information 
                        submitted under paragraph (1) or (3) attributed 
                        to the employee or a dependent of the employee; 
                        or
                            ``(ii) limit, segregate, or classify the 
                        employees of the employer in any way that would 
                        deprive or tend to deprive any employee of 
                        employment opportunities or otherwise adversely 
                        affect the status of the employee as an 
                        employee, because of information submitted 
                        under paragraph (1) or (3) attributed to the 
                        employee or a dependent of the employee.
                    ``(B) Disclosure and redisclosure.--A plan sponsor 
                shall not disclose the information received under 
                paragraph (1) or (3) except--
                            ``(i) to an occupational or other health 
                        researcher if the research is conducted in 
                        compliance with the regulations and protections 
                        provided for under part 46 of title 45, Code of 
                        Federal Regulations (or successor regulations);
                            ``(ii) in response to an order of a court, 
                        except that the plan sponsor may disclose only 
                        the information expressly authorized by such 
                        order;
                            ``(iii) to the Department of Health and 
                        Human Services, the Department of Labor, the 
                        Department of the Treasury, or other Federal 
                        agency responsible for enforcement activities 
                        under this section; or
                            ``(iv) to a contractor or agent for 
                        purposes of health plan administration, if such 
                        contractor or agent agrees, in writing, and as 
                        a term of the contract, to abide by the same 
                        use and disclosure restrictions as the plan 
                        sponsor.
                    ``(C) Relationship to hipaa regulations.--With 
                respect to HIPAA privacy regulations, as defined in 
                section 1180(b)(3) of the Social Security Act (42 
                U.S.C. 1320d-9(b)(3)), subparagraph (B) does not 
                prohibit a covered entity (as defined for purposes of 
                such regulations promulgated under section 264 of the 
                Health Insurance Portability and Accountability Act of 
                1996 (42 U.S.C. 1320d-2)) from any use or disclosure of 
                health information that is authorized for the covered 
                entity under such regulations. The previous sentence 
                does not affect the authority of such Secretary to 
                modify such regulations.
                    ``(D) Written notice.--Plan sponsors of group 
                health plans and group health insurance coverage shall 
                provide to each employee written notice informing the 
                employee of the requirement for health insurance 
                issuers or entities providing pharmacy benefit 
                management services on behalf of the plan or coverage 
                to submit reports to plan sponsors under paragraphs (1) 
                and (3), as applicable, which may include incorporating 
                such notification in plan documents provided to the 
                employee, an employee handbook provided to the 
                employee, or individual notification.
                    ``(E) Enforcement.--
                            ``(i) In general.--The powers, procedures, 
                        and remedies provided in section 207 of the 
                        Genetic Information Nondiscrimination Act (42 
                        U.S.C. 2000ff-6) to a person alleging a 
                        violation of title II of such Act shall be the 
                        powers, procedures, and remedies this 
                        subparagraph provides for any person alleging a 
                        violation of this paragraph.
                            ``(ii) Prohibition against retaliation.--No 
                        person shall discriminate against any 
                        individual because such individual has opposed 
                        any act or practice made unlawful by this 
                        paragraph or because such individual made a 
                        charge, testified, assisted, or participated in 
                        any manner in an investigation, proceeding, or 
                        hearing under this paragraph. The remedies and 
                        procedures otherwise provided for under this 
                        subparagraph shall be available to aggrieved 
                        individuals with respect to violations of this 
                        clause.
            ``(6) Submissions to gao.--A health insurance issuer 
        offering group health insurance coverage or an entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan shall submit, upon request, to the Comptroller 
        General of the United States each of the first 2 reports 
        submitted to a plan sponsor under paragraph (1) or (3) with 
        respect to such coverage or plan, and other such reports as 
        requested, in accordance with the privacy requirements under 
        paragraph (4), and such other information that the Comptroller 
        General determines necessary to carry out the study under 
        section 2(f) of the Pharmacy Benefit Manager Reform Act.
            ``(7) Standard formats.--
                    ``(A) In general.--Not later than June 1, 2024, the 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of the Treasury shall specify, 
                through rulemaking, standard formats for entities 
                providing pharmacy benefit management services to 
                submit reports required under this subsection. Such 
                secretaries may provide for separate standard formats 
                for reports to plan sponsors of group health plans and 
                reports to plan sponsors of group health insurance 
                coverage offered in connection with a group health 
                plan.
                    ``(B) Form of report.--The Secretary, the Secretary 
                of Health and Human Services, and the Secretary of the 
                Treasury shall define through rulemaking a form of the 
                reports under paragraphs (1) and (3) required to be 
                submitted to plan sponsors who also are drug 
                manufacturers, drug wholesalers, entities providing 
                pharmacy benefit management services, or other direct 
                participants in the drug supply chain, in the case that 
                such secretaries determine that changes to the standard 
                format are necessary to prevent anticompetitive 
                behavior.
    ``(c) Limitations on Spread Pricing.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a group health plan or 
        health insurance issuer offering group health insurance 
        coverage shall ensure that the amount required to be paid by a 
        participant or beneficiary for a prescription drug covered 
        under the plan or coverage, and a third-party administrator or 
        an entity providing pharmacy benefit management services on 
        behalf of such a plan or coverage shall ensure that the total 
        amount required to be paid by the plan or issuer and 
        participant or beneficiary for a prescription drug covered 
        under the plan or coverage, does not exceed the price paid to 
        the pharmacy, excluding penalties paid by the pharmacy (as 
        described in paragraph (2)) to such plan, issuer, or entity.
            ``(2) Rule of construction.--For purposes of paragraph (1), 
        penalties paid by pharmacies include only the following:
                    ``(A) A penalty paid if an original claim for a 
                prescription drug was submitted fraudulently by the 
                pharmacy to the plan, issuer, or entity.
                    ``(B) A penalty paid if the original claim payment 
                made by the plan, issuer, or entity to the pharmacy was 
                inconsistent with the reimbursement terms in any 
                contract between the pharmacy and the plan, issuer, or 
                entity.
                    ``(C) A penalty paid if the pharmacist services for 
                which a claim was filed with the plan, issuer, or 
                entity were not rendered by the pharmacy.
    ``(d) Full Rebate Pass-through to Plan or Health Insurance 
Issuer.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan or health insurance issuer offering group health 
        insurance coverage shall--
                    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                from any applicable entity that are related to 
                utilization of drugs under such group health plan or 
                health insurance coverage, to the group health plan or 
                health insurance issuer offering group health insurance 
                coverage; and
                    ``(B) ensure that any contract entered into, by 
                such third-party administrator or entity providing 
                pharmacy benefit management services on behalf of such 
                a plan or coverage, with rebate aggregators (or other 
                purchasing entity designed to aggregate rebates), 
                applicable group purchasing organizations, or any 
                subsidiary, parent, affiliate, or subcontractor of the 
                plan, entity, rebate aggregator (or other purchasing 
                entity designed to aggregate rebates), or applicable 
                group purchasing organization remit 100 percent of 
                rebates, fees, alternative discounts, and other 
                remuneration received that are related to utilization 
                of drugs under such group health plan or health 
                insurance coverage, to the third-party administrator or 
                entity providing pharmacy benefit management services.
            ``(2) Form and manner of remittance.--With respect to such 
        rebates, fees, alternative discounts, and other remuneration--
                    ``(A) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(A) shall be--
                            ``(i) remitted--
                                    ``(I) on a quarterly basis, to the 
                                group health plan or the group health 
                                insurance issuer, not later than 90 
                                days after the end of each quarter; or
                                    ``(II) in the case of an 
                                underpayment in a remittance for a 
                                prior quarter, as soon as practicable, 
                                but not later than 90 days after notice 
                                of the underpayment is first given;
                            ``(ii) fully disclosed and enumerated to 
                        the group health plan or health insurance 
                        issuer, as described in paragraphs (1) and (3) 
                        of subsection (b); and
                            ``(iii) returned to the issuer or entity 
                        providing pharmacy benefit management services 
                        on behalf of the group health plan if an audit 
                        by a plan sponsor, or a third party designated 
                        by a plan sponsor, indicates that the amounts 
                        received are incorrect after such amounts have 
                        been paid to the group health plan or health 
                        insurance issuer;
                    ``(B) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(B) shall be 
                remitted in accordance with such procedures as the 
                Secretary, Secretary of Health and Human Services, and 
                Secretary of the Treasury establish; and
                    ``(C) the records of such rebates, fees, 
                alternative discounts, and other remuneration shall be 
                available for audit by the plan sponsor, issuer, or a 
                third party designated by a plan sponsor, not less than 
                once per plan year.
            ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan, a health insurance issuer 
        offering group health insurance coverage, or an entity 
        providing pharmacy benefit management services on behalf of 
        such group health plan or health insurance coverage shall make 
        rebate contracts with rebate aggregators or drug manufacturers 
        available for audit by the plan sponsor or designated third 
        party, subject to reasonable restrictions (as determined by the 
        Secretary, the Secretary of Health and Human Services, and the 
        Secretary of the Treasury) on confidentiality to prevent re-
        disclosure of such contracts.
            ``(4) Auditors.--Audits carried out under paragraphs (2)(C) 
        and (3) shall be performed by an auditor selected by the 
        applicable plan sponsor.
            ``(5) Rule of construction.--Nothing in this subsection 
        shall be construed to--
                    ``(A) prohibit payments to entities offering 
                pharmacy benefit management services for bona fide 
                services using a fee structure not described in this 
                subsection, provided that such fees are transparent to 
                group health plans and health insurance issuers;
                    ``(B) require a third-party administrator of a 
                group health plan or an entity providing pharmacy 
                benefit management services on behalf of a group health 
                plan or health insurance issuer offering group health 
                insurance coverage to remit bona fide service fees to 
                the group health plans or health insurance issuers; or
                    ``(C) limit the ability of a group health plan or 
                health insurance issuer to pass through rebates, fees, 
                alternative discounts, and other remuneration to the 
                participant or beneficiary.
    ``(e) Enforcement.--
            ``(1) In general.--The Secretary shall enforce this 
        section.
            ``(2) Violations.--A group health plan, a health insurance 
        issuer, or an entity providing pharmacy benefit management 
        services that violates subsection (a); an entity providing 
        pharmacy benefit management services that fails to provide 
        information required under subsection (b); a group health plan, 
        health insurance issuer, or entity providing pharmacy benefit 
        management services that violates subsection (c); or a third-
        party administrator of a group health plan, a health insurance 
        issuer, or an entity providing pharmacy benefit management 
        services that violates subsection (d) shall be subject to a 
        civil monetary penalty in the amount of $10,000 for each day 
        during which such violation continues or such information is 
        not disclosed or reported.
            ``(3) False information.--A group health plan, a health 
        insurance issuer, an entity providing pharmacy benefit 
        management services, or a third-party administrator that 
        knowingly provides false information under this section shall 
        be subject to a civil money penalty in an amount not to exceed 
        $100,000 for each item of false information. Such civil money 
        penalty shall be in addition to other penalties as may be 
        prescribed by law.
            ``(4) Procedure.--The Secretary shall impose civil monetary 
        penalties under this subsection in the same manner and 
        according to the same procedures as the Secretary imposes civil 
        monetary penalties as described in section 502(c)(10).
            ``(5) Waivers.--The Secretary may waive penalties under 
        paragraph (2), or extend the period of time for compliance with 
        a requirement of this section, for an entity in violation of 
        this section that has made a good-faith effort to comply with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to permit a health insurance issuer, group health plan, 
entity providing pharmacy benefit management services on behalf of a 
group health plan or health insurance issuer, or other entity to 
restrict disclosure to, or otherwise limit the access of, the Secretary 
of Labor, the Secretary of Health and Human Services, or the Secretary 
of the Treasury to a report described in subsection (b)(1) or 
information related to compliance with subsections (a), (b), (c), or 
(d) by such issuer, plan, or entity.
    ``(g) Definitions.--In this section--
            ``(1) the term `applicable entity' means--
                    ``(A) an applicable group purchasing organization, 
                drug manufacturer, distributor, wholesaler, rebate 
                aggregator (or other purchasing entity designed to 
                aggregate rebates), or associated third party;
                    ``(B) any subsidiary, parent, affiliate, or 
                subcontractor of a group health plan, health insurance 
                issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); or
                    ``(C) such other entity as the Secretary, the 
                Secretary of Health and Human Services, and the 
                Secretary of the Treasury may specify through 
                rulemaking;
            ``(2) the term `applicable group purchasing organization' 
        means a group purchasing organization that is affiliated with 
        or under common ownership with an entity providing pharmacy 
        benefit management services;
            ``(3) the term `covered group health insurance coverage' 
        means health insurance coverage offered in connection with a 
        group health plan maintained by a large employer;
            ``(4) the term `covered group health plan' means a group 
        health plan maintained by a large employer;
            ``(5) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan or health 
        insurance coverage, means the amount spent by a group health 
        plan or health insurance issuer on prescription drug benefits, 
        calculated before the application of rebates, fees, alternative 
        discounts, or other remuneration;
            ``(6) the term `large employer' means, in connection with a 
        group health plan with respect to a calendar year and a plan 
        year, an employer who employed an average of at least 50 
        employees on business days during the preceding calendar year 
        and who employs at least 1 employee on the first day of the 
        plan year;
            ``(7) the term `net spending', with respect to prescription 
        drug benefits under a group health plan or health insurance 
        coverage, means the amount spent by a group health plan or 
        health insurance issuer on prescription drug benefits, 
        calculated after the application of rebates, fees, alternative 
        discounts, or other remuneration;
            ``(8) the term `plan sponsor' has the meaning given such 
        term in section 3(16)(B);
            ``(9) the term `remuneration' has the meaning given such 
        term by the Secretary, the Secretary of Health and Human 
        Services, and the Secretary of the Treasury, through 
        rulemaking, which shall be reevaluated by such secretaries 
        every 5 years; and
            ``(10) the term `wholesale acquisition cost' has the 
        meaning given such term in section 1847A(c)(6)(B) of the Social 
        Security Act (42 U.S.C. 1395w-3a(c)(6)(B)).''; and
                    (B) in section 502(b)(3) (29 U.S.C. 1132(b)(3)), by 
                inserting ``(other than section 726)'' after ``part 
                7''.
            (2) Clerical amendment.--The table of contents in section 1 
        of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1001 et seq.) is amended by inserting after the item 
        relating to section 725 the following new item:

``Sec. 726. Oversight of entities that provide pharmacy benefit 
                            management services.''.
            (3) Additional reporting requirement.--Section 725 of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 
        1185n) is amended by adding at the end the following:
    ``(d) Entities Providing Pharmacy Benefit Management Services.--
Beginning 2 years after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, entities providing pharmacy benefit management 
services shall report to plan sponsors of group health plans 
information required under paragraphs (4), (5), (6), (7)(A)(iii), and 
(7)(B) of subsection (a).''.
    (c) Internal Revenue Code of 1986.--
            (1) In general.--Subchapter B of chapter 100 of the 
        Internal Revenue Code of 1986 is amended by adding at the end 
        the following:

``SEC. 9826. OVERSIGHT OF ENTITIES THAT PROVIDE PHARMACY BENEFIT 
              MANAGEMENT SERVICES.

    ``(a) In General.--For plan years beginning on or after the date 
that is 30 months after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, a group health plan or an entity providing pharmacy 
benefit management services on behalf of such a plan shall not enter 
into a contract with an applicable entity unless such applicable entity 
agrees to--
            ``(1) not limit the disclosure of information to plan 
        sponsors in such a manner that prevents the plan, or an entity 
        providing pharmacy benefit management services on behalf of a 
        plan, from making the reports described in subsection (b); and
            ``(2) provide the group health plan or an entity providing 
        pharmacy benefit management services on behalf of a plan, 
        relevant information necessary to make the reports described in 
        subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, not less frequently than 
        annually, an entity providing pharmacy benefit management 
        services on behalf of a covered group health plan shall submit 
        to the plan sponsor of such covered group health plan a report 
        in accordance with this subsection and make such report 
        available to the plan sponsor in plain language, in a machine-
        readable format, and, as the Secretary, the Secretary of Labor, 
        and the Secretary of Health and Human Services may determine, 
        other formats. Each such report shall include, with respect to 
        the covered group health plan--
                    ``(A) as applicable, information collected from 
                drug manufacturers by such entity on the total amount 
                of copayment assistance dollars paid, or copayment 
                cards applied, that were funded by such drug 
                manufacturers with respect to the participants and 
                beneficiaries in such plan;
                    ``(B) a list of each drug covered by the plan or 
                entity providing pharmacy benefit management services 
                for which a claim was filed during the reporting 
                period, including, with respect to each such drug 
                during the reporting period--
                            ``(i) the brand name, generic or 
                        nonproprietary name, and National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom a claim for the drug was 
                        filed during the reporting period, the total 
                        number of prescription claims for the drug 
                        (including original prescriptions and refills), 
                        and the total number of dosage units of the 
                        drug for which a claim was filed across the 
                        reporting period;
                            ``(iii) for each claim or dosage unit 
                        described in clause (ii), the type of 
                        dispensing channel used, such as retail, mail 
                        order, or specialty pharmacy;
                            ``(iv) the wholesale acquisition cost, 
                        listed as cost per days' supply and cost per 
                        dosage unit;
                            ``(v) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug 
                        after application of any benefits under the 
                        plan--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                for which no claim is submitted to the 
                                plan; and
                            ``(vi) for each of the 50 prescription 
                        drugs with the highest gross spending under the 
                        group health plan during the reporting period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic class (as defined 
                                by the Secretary, the Secretary of 
                                Labor, and the Secretary of Health and 
                                Human Services), including brand name 
                                drugs and biological products and 
                                generic drugs or biosimilar biological 
                                products that are in the same 
                                therapeutic class as such drug;
                                    ``(II) if applicable, the rationale 
                                for preferred formulary placement of 
                                such drug in that therapeutic class, 
                                selected from a list of standard 
                                rationales established by the 
                                Secretary, the Secretary of Labor, and 
                                the Secretary of Health and Human 
                                Services, in consultation with 
                                stakeholders; and
                                    ``(III) any change in formulary 
                                placement compared to the prior plan 
                                year;
                    ``(C) a list of each therapeutic class (as defined 
                as described in subparagraph (B)(vi)(I)) of drugs for 
                which a claim was filed under the group health plan 
                during the reporting period, and, with respect to each 
                such therapeutic class of drugs, during the reporting 
                period--
                            ``(i) total gross spending by the plan;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that class;
                            ``(iii) if applicable to that class, a 
                        description of the formulary tiers and 
                        utilization management mechanisms (such as 
                        prior authorization or step therapy) employed 
                        for drugs in that class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on drugs in such 
                        therapeutic class, after application of any 
                        benefits under the plan--
                                    ``(I) including copayments, 
                                coinsurance, and deductibles; and
                                    ``(II) not including any amounts 
                                spent by participants and beneficiaries 
                                on drugs not covered under the plan or 
                                for which no claim is submitted to the 
                                plan; and
                            ``(v) for each therapeutic class under 
                        which 3 or more drugs are included on the 
                        formulary of such plan--
                                    ``(I) the amount received, or 
                                expected to be received, by such 
                                entity, from applicable entities, in 
                                rebates, fees, alternative discounts, 
                                or other remuneration--
                                            ``(aa) for claims incurred 
                                        during the reporting period; or
                                            ``(bb) that is related to 
                                        utilization of drugs or drug 
                                        spending;
                                    ``(II) the total net spending by 
                                the plan on that class of drugs; and
                                    ``(III) the average net spending 
                                per 30-day supply and per 90-day supply 
                                by the plan and its participants and 
                                beneficiaries, among all drugs within 
                                the therapeutic class for which a claim 
                                was filed during the reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan during the reporting period;
                    ``(E) the total amount received, or expected to be 
                received, by the group health plan, from applicable 
                entities, in rebates, fees, alternative discounts, and 
                other remuneration received from such entities, related 
                to utilization of drugs or drug spending under that 
                group health plan during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the group health plan during the reporting period;
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of compensation (as 
                defined in section 408(b)(2)(B)(ii)(dd)(AA) of the 
                Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1108(b)(2)(B)(ii)(dd)(A))) to brokers, 
                consultants, advisors, or any other individual or firm 
                for--
                            ``(i) referral of the group health plan's 
                        business to the pharmacy benefit manager;
                            ``(ii) consideration of the entity 
                        providing pharmacy benefit management services 
                        by the group health plan; or
                            ``(iii) the retention of the entity by the 
                        group health plan;
                    ``(H)(i) an explanation of any benefit design 
                parameters that encourage or require participants and 
                beneficiaries in the plan to fill prescriptions at mail 
                order, specialty, or retail pharmacies that are 
                affiliated with or under common ownership with the 
                entity providing pharmacy benefit management services 
                on behalf of such plan, including mandatory mail and 
                specialty home delivery programs, retail and mail auto-
                refill programs, and cost-sharing assistance incentives 
                funded by an entity providing pharmacy benefit 
                management services;
                    ``(ii) the percentage of total prescriptions 
                charged to the plan or participants and beneficiaries 
                in the plan, that were dispensed by mail order, 
                specialty, or retail pharmacies that are affiliated 
                with or under common ownership with the entity 
                providing pharmacy benefit management services; and
                    ``(iii) a list of all drugs dispensed by such 
                affiliated pharmacy or pharmacy under common ownership 
                and charged to the plan, or participants and 
                beneficiaries of the plan, during the applicable 
                period, and, with respect to each drug--
                            ``(I)(aa) the amount charged, per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        with respect to participants and beneficiaries 
                        in the plan, to the plan; and
                            ``(bb) the amount charged, per dosage unit, 
                        per 30-day supply, and per 90-day supply to 
                        participants and beneficiaries;
                            ``(II) the median amount charged to the 
                        plan, per dosage unit, per 30-day supply, and 
                        per 90-day supply, including amounts paid by 
                        the participants and beneficiaries, when the 
                        same drug is dispensed by other pharmacies that 
                        are not affiliated with or under common 
                        ownership with the entity and that are included 
                        in the pharmacy network of that plan;
                            ``(III) the interquartile range of the 
                        costs, per dosage unit, per 30-day supply, and 
                        per 90-day supply, including amounts paid by 
                        the participants and beneficiaries, when the 
                        same drug is dispensed by other pharmacies that 
                        are not affiliated with or under common 
                        ownership with the entity and that are included 
                        in the pharmacy network of that plan;
                            ``(IV) the lowest cost, per dosage unit, 
                        per 30-day supply, and per 90-day supply, for 
                        such drug, including amounts charged to the 
                        plan and participants and beneficiaries, that 
                        is available from any pharmacy included in the 
                        network of the plan;
                            ``(V) the net acquisition cost per dosage 
                        unit, per 30-day supply, and per 90-day supply, 
                        if the drug is subject to a maximum price 
                        discount; and
                            ``(VI) other information with respect to 
                        the cost of the drug, as determined by the 
                        Secretary, the Secretary of Labor, and the 
                        Secretary of Health and Human Services, such as 
                        average sales price, wholesale acquisition 
                        cost, and national average drug acquisition 
                        cost per dosage unit or per 30-day supply, for 
                        such drug, including amounts charged to the 
                        plan and participants and beneficiaries among 
                        all pharmacies included in the network of the 
                        plan;
                    ``(I) a summary document for plan sponsors that 
                includes the information described in subparagraphs (A) 
                through (H) that the Secretary, the Secretary of Labor, 
                and the Secretary of Health and Human Services 
                determine useful to plan sponsors for purposes of 
                selecting pharmacy benefit management services, such as 
                an estimated net price to plan sponsor and participant 
                or beneficiary, a cost per claim, the fee structure or 
                reimbursement model, and estimated cost per participant 
                or beneficiary; and
                    ``(J) a summary document for participants or 
                beneficiaries, which shall be made available to 
                participants or beneficiaries upon request to the plan 
                sponsor, that contains the information described in 
                subparagraphs (D) through (G) that the Secretary, the 
                Secretary of Labor, and the Secretary of Health and 
                Human Services determine useful to participants or 
                beneficiaries in better understanding their plan or 
                benefits, except that such summary document for 
                participants or beneficiaries shall contain only 
                aggregate information.
            ``(2) Regulations.--Not later than 2 years after the date 
        of enactment of the Pharmacy Benefit Manager Reform Act, the 
        Secretary, the Secretary of Labor, and the Secretary of Health 
        and Human Services shall, through notice and comment 
        rulemaking, promulgate final regulations to implement the 
        requirements of this subsection. In promulgating such 
        regulations, the Secretary, the Secretary of Labor, and the 
        Secretary of Health and Human Services shall, to the extent 
        practicable, align the reporting requirements under this 
        subsection with the reporting requirements under section 9825.
            ``(3) Additional reporting.--For plan years beginning on or 
        after the date that is 30 months after the date of enactment of 
        the Pharmacy Benefit Manager Reform Act, not less frequently 
        than annually, an entity providing pharmacy benefit management 
        services on behalf of a group health plan that is not a covered 
        group health plan shall submit to the plan sponsor of such 
        group health plan a report in accordance with this paragraph, 
        and make such report available to the plan sponsor in a 
        machine-readable format, and such other formats as the 
        Secretary, the Secretary of Labor, and the Secretary of Health 
        and Human Services may specify. Each such report shall include, 
        with respect to the applicable group health plan--
                    ``(A) the information described in subparagraphs 
                (D), (E), (F), and (G) of paragraph (1);
                    ``(B) as applicable, information collected from 
                drug manufacturers by such plan on the total amount of 
                copayment assistance dollars paid, or copayment cards 
                applied, that were funded by applicable drug 
                manufacturers with respect to the participants and 
                beneficiaries in such plan, except that such 
                information shall not identify any drug manufacturer; 
                and
                    ``(C) a summary document that includes that 
                information described in subparagraphs (A) and (B) that 
                the Secretary, the Secretary of Labor, and the 
                Secretary of Health and Human Services determine useful 
                for plan sponsors for purposes of selecting pharmacy 
                benefit management services, provided that such summary 
                documents include only aggregate information.
            ``(4) Privacy requirements.--
                    ``(A) Relationship to hipaa regulations.--Nothing 
                in this section shall be construed to modify the 
                requirements for the creation, receipt, maintenance, or 
                transmission of protected health information under the 
                HIPAA privacy regulations, as defined in section 
                1180(b)(3) of the Social Security Act (42 U.S.C. 1320d-
                9(b)(3)).
                    ``(B) Requirement.--A report submitted under 
                paragraph (1) or (3) shall contain only summary health 
                information, as defined in section 164.504(a) of title 
                45, Code of Federal Regulations (or successor 
                regulations).
                    ``(C) Clarification regarding certain disclosures 
                of information.--
                            ``(i) Reasonable restrictions.--Nothing in 
                        this section prevents an entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan from placing reasonable 
                        restrictions (as the Secretary, the Secretary 
                        of Labor, and the Secretary of Health and Human 
                        Services may determine) on the public 
                        disclosure of the information contained in a 
                        report under paragraph (1) or (3).
                            ``(ii) Limitations.--An entity providing 
                        pharmacy benefit management services on behalf 
                        of a group health plan may not restrict 
                        disclosure of such reports to the Department of 
                        Health and Human Services, the Department of 
                        Labor, the Department of the Treasury, or any 
                        other Federal agency responsible for 
                        enforcement activities under this section for 
                        purposes of enforcement under this section or 
                        other applicable law, or to the Comptroller 
                        General of the United States in accordance with 
                        paragraph (6).
            ``(5) Use and disclosure by plan sponsors.--
                    ``(A) Prohibition.--A plan sponsor may not--
                            ``(i) fail or refuse to hire, or discharge, 
                        any employee, or otherwise discriminate against 
                        any employee with respect to the compensation, 
                        terms, conditions, or privileges of employment 
                        of the employee, because of information 
                        submitted under paragraph (1) or (3) attributed 
                        to the employee or a dependent of the employee; 
                        or
                            ``(ii) limit, segregate, or classify the 
                        employees of the employer in any way that would 
                        deprive or tend to deprive any employee of 
                        employment opportunities or otherwise adversely 
                        affect the status of the employee as an 
                        employee, because of information submitted 
                        under paragraph (1) or (3) attributed to the 
                        employee or a dependent of the employee.
                    ``(B) Disclosure and redisclosure.--A plan sponsor 
                shall not disclose the information received under 
                paragraph (1) or (3) except--
                            ``(i) to an occupational or other health 
                        researcher if the research is conducted in 
                        compliance with the regulations and protections 
                        provided for under part 46 of title 45, Code of 
                        Federal Regulations (or successor regulations);
                            ``(ii) in response to an order of a court, 
                        except that the plan sponsor may disclose only 
                        the information expressly authorized by such 
                        order;
                            ``(iii) to the Department of Health and 
                        Human Services, the Department of Labor, the 
                        Department of the Treasury, or other Federal 
                        agency responsible for enforcement activities 
                        under this section; or
                            ``(iv) to a contractor or agent for 
                        purposes of health plan administration, if such 
                        contractor or agent agrees, in writing, and as 
                        a term of the contract, to abide by the same 
                        use and disclosure restrictions as the plan 
                        sponsor.
                    ``(C) Relationship to hipaa regulations.--With 
                respect to the HIPAA privacy regulations, as defined in 
                section 1180(b)(3) of the Social Security Act (42 
                U.S.C. 1320d-9(b)(3)), subparagraph (B) does not 
                prohibit a covered entity (as defined for purposes of 
                such regulations promulgated under section 264 of the 
                Health Insurance Portability and Accountability Act of 
                1996 (42 U.S.C. 1320d-2)) from any use or disclosure of 
                health information that is authorized for the covered 
                entity under such regulations. The previous sentence 
                does not affect the authority of such Secretary to 
                modify such regulations.
                    ``(D) Written notice.--Plan sponsors of group 
                health plans shall provide to each employee written 
                notice informing the employee of the requirement for 
                entities providing pharmacy benefit management services 
                to submit reports to plan sponsors under paragraphs (1) 
                and (3), as applicable, which may include incorporating 
                such notification in plan documents provided to the 
                employee, an employee handbook provided to the 
                employee, or individual notification.
                    ``(E) Enforcement.--
                            ``(i) In general.--The powers, procedures, 
                        and remedies provided in section 207 of the 
                        Genetic Information Nondiscrimination Act (42 
                        U.S.C. 2000ff-6) to a person alleging a 
                        violation of title II of such Act shall be the 
                        powers, procedures, and remedies this 
                        subparagraph provides for any person alleging a 
                        violation of this paragraph.
                            ``(ii) Prohibition against retaliation.--No 
                        person shall discriminate against any 
                        individual because such individual has opposed 
                        any act or practice made unlawful by this 
                        paragraph or because such individual made a 
                        charge, testified, assisted, or participated in 
                        any manner in an investigation, proceeding, or 
                        hearing under this paragraph. The remedies and 
                        procedures otherwise provided for under this 
                        subparagraph shall be available to aggrieved 
                        individuals with respect to violations of this 
                        clause.
            ``(6) Submissions to gao.--An entity providing pharmacy 
        benefit management services on behalf of a group health plan 
        shall submit, upon request, to the Comptroller General of the 
        United States each of the first 2 reports submitted to a plan 
        sponsor under paragraph (1) or (3) with respect to such plan, 
        and other such reports as requested, in accordance with the 
        privacy requirements under paragraph (4), and such other 
        information that the Comptroller General determines necessary 
        to carry out the study under section 2(f) of the Pharmacy 
        Benefit Manager Reform Act.
            ``(7) Standard formats.--
                    ``(A) In general.--Not later than June 1, 2024, the 
                Secretary, the Secretary of Health and Human Services, 
                and the Secretary of Labor shall specify, through 
                rulemaking, standard formats for entities providing 
                pharmacy benefit management services to submit reports 
                required under this subsection. Such secretaries may 
                provide for separate standard formats for reports to 
                plan sponsors of group health plans and reports to plan 
                sponsors of group health insurance coverage offered in 
                connection with a group health plan.
                    ``(B) Form.--The Secretary, the Secretary of Health 
                and Human Services, and the Secretary of Labor shall 
                define through rulemaking a form of the reports under 
                paragraphs (1) and (3) required to be submitted to plan 
                sponsors who also are drug manufacturers, drug 
                wholesalers, entities providing pharmacy benefit 
                management services, or other direct participants in 
                the drug supply chain, in the case that such 
                secretaries determine that changes to the standard 
                format are necessary to prevent anticompetitive 
                behavior.
    ``(c) Limitations on Spread Pricing.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a group health plan shall 
        ensure that the amount required to be paid by a participant or 
        beneficiary for a prescription drug covered under the plan, and 
        a third-party administrator or an entity providing pharmacy 
        benefit management services on behalf of such a plan shall 
        ensure that the total amount required to be paid by the plan 
        and participant or beneficiary for a prescription drug covered 
        under the plan, does not exceed the price paid to the pharmacy, 
        excluding penalties paid by the pharmacy (as described in 
        paragraph (2)) to such plan or entity.
            ``(2) Rule of construction.--For purposes of paragraph (1), 
        penalties paid by pharmacies include only the following:
                    ``(A) A penalty paid if an original claim for a 
                prescription drug was submitted fraudulently by the 
                pharmacy to the plan or entity.
                    ``(B) A penalty paid if the original claim payment 
                made by the plan or entity to the pharmacy was 
                inconsistent with the reimbursement terms in any 
                contract between the pharmacy and the plan or entity.
                    ``(C) A penalty paid if the pharmacist services for 
                which a claim was filed with the plan or entity were 
                not rendered by the pharmacy.
    ``(d) Full Rebate Pass-through to Plan.--
            ``(1) In general.--For plan years beginning on or after the 
        date that is 30 months after the date of enactment of the 
        Pharmacy Benefit Manager Reform Act, a third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services on behalf of a group 
        health plan shall--
                    ``(A) remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                from any applicable entity that are related to 
                utilization of drugs under such plan, to the group 
                health plan; and
                    ``(B) ensure that any contract entered into, by 
                such third-party administrator or entity providing 
                pharmacy benefit management services on behalf of such 
                a plan, with rebate aggregators (or other purchasing 
                entity designed to aggregate rebates), applicable group 
                purchasing organizations, or any subsidiary, parent, 
                affiliate, or subcontractor of the plan, entity, rebate 
                aggregator (or other purchasing entity designed to 
                aggregate rebates), or applicable group purchasing 
                organization remit 100 percent of rebates, fees, 
                alternative discounts, and other remuneration received 
                that are related to utilization of drugs under such 
                plan, to the third-party administrator or entity 
                providing pharmacy benefit management services.
            ``(2) Form and manner of remittance.--With respect to such 
        rebates, fees, alternative discounts, and other remuneration--
                    ``(A) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(A) shall be--
                            ``(i) remitted--
                                    ``(I) on a quarterly basis, to the 
                                group health plan, not later than 90 
                                days after the end of each quarter; or
                                    ``(II) in the case of an 
                                underpayment in a remittance for a 
                                prior quarter, as soon as practicable, 
                                but not later than 90 days after notice 
                                of the underpayment is first given;
                            ``(ii) fully disclosed and enumerated to 
                        the group health plan, as described in 
                        paragraphs (1) and (3) of subsection (b); and
                            ``(iii) returned to the entity providing 
                        pharmacy benefit management services on behalf 
                        of the group health plan if an audit by a plan 
                        sponsor, or a third party designated by a plan 
                        sponsor, indicates that the amounts received 
                        are incorrect after such amounts have been paid 
                        to the group health plan;
                    ``(B) the rebates, fees, alternative discounts, and 
                other remuneration under paragraph (1)(B) shall be 
                remitted in accordance with such procedures as the 
                Secretary, Secretary of Health and Human Services, and 
                Secretary of Labor establish; and
                    ``(C) the records of such rebates, fees, 
                alternative discounts, and other remuneration shall be 
                available for audit by the plan sponsor, or a third 
                party designated by a plan sponsor, not less than once 
                per plan year.
            ``(3) Audit of rebate contracts.--A third-party 
        administrator of a group health plan or an entity providing 
        pharmacy benefit management services on behalf of such group 
        health plan shall make rebate contracts with rebate aggregators 
        or drug manufacturers available for audit by the plan sponsor 
        or designated third party, subject to reasonable restrictions 
        (as determined by the Secretary, the Secretary of Labor, and 
        the Secretary of Health and Human Services) on confidentiality 
        to prevent re-disclosure of such contracts.
            ``(4) Auditors.--Audits carried out under paragraphs (2)(C) 
        and (3) shall be performed by an auditor selected by the 
        applicable plan sponsor.
            ``(5) Rule of construction.--Nothing in this subsection 
        shall be construed to--
                    ``(A) prohibit payments to entities offering 
                pharmacy benefit management services for bona fide 
                services using a fee structure not described in this 
                subsection, provided that such fees are transparent to 
                group health plans;
                    ``(B) require a third-party administrator of a 
                group health plan or an entity providing pharmacy 
                benefit management services on behalf of a group health 
                plan to remit bona fide service fees to plan sponsors 
                of the group health plan; or
                    ``(C) limit the ability of a group health plan to 
                pass through rebates, fees, alternative discounts, and 
                other remuneration to the participant or beneficiary.
    ``(e) Enforcement.--
            ``(1) In general.--The Secretary shall enforce this 
        section.
            ``(2) Violations.--A group health plan or an entity 
        providing pharmacy benefit management services that violates 
        subsection (a); an entity providing pharmacy benefit management 
        services that fails to provide information required under 
        subsection (b); a group health plan or entity providing 
        pharmacy benefit management services that violates subsection 
        (c); or a third-party administrator of a group health plan or 
        an entity providing pharmacy benefit management services that 
        violates subsection (d) shall be subject to a civil monetary 
        penalty in the amount of $10,000 for each day during which such 
        violation continues or such information is not disclosed or 
        reported.
            ``(3) False information.--A group health plan, an entity 
        providing pharmacy benefit management services, or a third-
        party administrator that knowingly provides false information 
        under this section shall be subject to a civil money penalty in 
        an amount not to exceed $100,000 for each item of false 
        information. Such civil money penalty shall be in addition to 
        other penalties as may be prescribed by law.
            ``(4) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsection (a) and (b) and the 
        first sentence of subsection (c)(1) of such section shall apply 
        to civil monetary penalties under this subsection in the same 
        manner as such provisions apply to a penalty or proceeding 
        under section 1128A of the Social Security Act.
            ``(5) Waivers.--The Secretary may waive penalties under 
        paragraph (2), or extend the period of time for compliance with 
        a requirement of this section, for an entity in violation of 
        this section that has made a good-faith effort to comply with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to permit a group health plan, entity providing pharmacy 
benefit management services on behalf of a group health plan, or other 
entity to restrict disclosure to, or otherwise limit the access of, the 
Secretary of the Treasury to a report described in subsection (b)(1) or 
information related to compliance with subsections (a), (b), (c), or 
(d) by such plan or entity.
    ``(g) Definitions.--In this section--
            ``(1) the term `applicable entity' means--
                    ``(A) an applicable group purchasing organization, 
                drug manufacturer, distributor, wholesaler, rebate 
                aggregator (or other purchasing entity designed to 
                aggregate rebates), or associated third party;
                    ``(B) any subsidiary, parent, affiliate, or 
                subcontractor of a group health plan, health insurance 
                issuer, entity that provides pharmacy benefit 
                management services on behalf of such a plan or issuer, 
                or any entity described in subparagraph (A); or
                    ``(C) such other entity as the Secretary, the 
                Secretary of Health and Human Services, and the 
                Secretary of Labor may specify through rulemaking;
            ``(2) the term `applicable group purchasing organization' 
        means a group purchasing organization that is affiliated with 
        or under common ownership with an entity providing pharmacy 
        benefit management services;
            ``(3) the term `covered group health plan' means a group 
        health plan maintained by a large employer;
            ``(4) the term `gross spending', with respect to 
        prescription drug benefits under a group health plan, means the 
        amount spent by a group health plan on prescription drug 
        benefits, calculated before the application of rebates, fees, 
        alternative discounts, or other remuneration;
            ``(5) the term `large employer' means, in connection with a 
        group health plan with respect to a calendar year and a plan 
        year, an employer who employed an average of at least 50 
        employees on business days during the preceding calendar year 
        and who employs at least 1 employee on the first day of the 
        plan year;
            ``(6) the term `net spending', with respect to prescription 
        drug benefits under a group health plan, means the amount spent 
        by a group health plan on prescription drug benefits, 
        calculated after the application of rebates, fees, alternative 
        discounts, or other remuneration;
            ``(7) the term `plan sponsor' has the meaning given such 
        term in section 3(16)(B) of the Employee Retirement Income 
        Security Act of 1974 (29 U.S.C. 1002(16)(B));
            ``(8) the term `remuneration' has the meaning given such 
        term by the Secretary, the Secretary of Labor, and the 
        Secretary of Health and Human Services, through rulemaking, 
        which shall be reevaluated by such secretaries every 5 years; 
        and
            ``(9) the term `wholesale acquisition cost' has the meaning 
        given such term in section 1847A(c)(6)(B) of the Social 
        Security Act (42 U.S.C. 1395w-3a(c)(6)(B)).''.
            (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of the Internal Revenue Code of 
        1986 is amended by adding at the end the following new item:

``Sec. 9826. Oversight of entities that provide pharmacy benefit 
                            management services.''.
            (3) Additional reporting requirement.--Section 9825 of the 
        Internal Revenue Code of 1986 is amended by adding at the end 
        the following:
    ``(d) Entities Providing Pharmacy Benefit Management Services.--
Beginning 2 years after the date of enactment of the Pharmacy Benefit 
Manager Reform Act, entities providing pharmacy benefit management 
services shall report to plan sponsors of group health plans 
information required under paragraphs (4), (5), (6), (7)(A)(iii), and 
(7)(B) of subsection (a).''.
    (d) Funding.--
            (1) For purposes of carrying out the amendments made by 
        subsection (a) there is appropriated to the Centers for 
        Medicare & Medicaid Services, out of amounts in the Treasury 
        not otherwise appropriated, $40,000,000 for fiscal year 2023, 
        to remain available until expended.
            (2) For purposes of carrying out the amendments made by 
        subsection (b), there is appropriated to the Department of 
        Labor, out of amounts in the Treasury not otherwise 
        appropriated, $4,500,000 for fiscal year 2023, to remain 
        available until expended.
    (e) ASPE Study.--The Assistant Secretary for Planning and 
Evaluation of the Department of Health and Human Services shall conduct 
or commission a study on how the United States health care market would 
be impacted by potential regulatory changes disallowing manufacturer 
rebates in the manner and to the extent allowed on the date of 
enactment of this Act, with a focus on the impact to stakeholders in 
the commercial insurance market, and, not later than 1 year after the 
date of enactment of this Act, submit a report to Congress on the 
results of such study. Such study and report shall consider the 
following:
            (1) The impact of making no such regulatory changes, as 
        well as potential behavioral changes by plan sponsors, members, 
        and pharmaceutical manufacturers, such as tighter formularies, 
        changes to price concessions, or changes in utilization, if 
        such regulatory changes are made.
            (2) The mechanics needed in the pharmaceutical supply chain 
        (whether existing or not) to move a manufacturer rebate to the 
        point of sale.
            (3) The feasibility of a partial point-of-sale manufacturer 
        rebate versus a full point-of-sale manufacturer rebate.
            (4) The impact on patient out-of-pocket costs, premiums, 
        and other cost-sharing.
            (5) Possible behavioral changes by other third parties in 
        the pharmaceutical supply chain including drug manufacturers, 
        distributors, wholesalers, rebate aggregators, pharmacy 
        services administrative organizations, or group purchasing 
        organizations.
            (6) Behavioral changes between entities that contract with 
        pharmaceutical manufacturers and entities that participate in 
        the pharmaceutical supply chain.
            (7) Alternative price negotiation mechanisms, including the 
        impact of the Act of June 19, 1936 (commonly known as the 
        ``Robinson-Patman Act''; 49 Stat. 1526, chapter 592; 15 U.S.C. 
        13a et seq.), and the amendments made by that Act, on drug 
        pricing negotiations.
            (8) The impact on pharmacies, including pharmacy rebates, 
        pharmacy fees, and dispensing channels.
            (9) The impact of manufacturer rebates on getting insulin 
        products to market, and the market dynamics and extent to which 
        biosimilar biological product development and competition could 
        increase, or is increasing, the number of biological products 
        approved and available to patients, including by examining 
        barriers to--
                    (A) placement of biosimilar biological products on 
                health insurance formularies;
                    (B) market entry of insulin products in the United 
                States, as compared to other highly developed nations; 
                and
                    (C) patient and provider education around 
                biosimilar biological products.
    (f) GAO Study.--
            (1) In general.--Not later than January 1, 2029, the 
        Comptroller General of the United States shall report to 
        Congress on--
                    (A) pharmacy networks of a selection of group 
                health plans, health insurance issuers, and entities 
                providing pharmacy benefit management services on 
                behalf of such group health plan or group or individual 
                health insurance coverage, including networks that have 
                pharmacies that are affiliated with or in common 
                ownership with group health plans, health insurance 
                issuers, or entities providing pharmacy benefit 
                management services or pharmacy benefit administrative 
                services under group health plan or group or individual 
                health insurance coverage;
                    (B) as it relates to pharmacy networks that include 
                pharmacies affiliated with or in common ownership with 
                plans, issuers, or entities, as described in 
                subparagraph (A)--
                            (i) whether such networks are designed to 
                        encourage participants and beneficiaries of a 
                        plan or coverage to use such pharmacies over 
                        other network pharmacies for specific services 
                        or drugs, and if so, the reasons the networks 
                        give for encouraging use of such pharmacies; 
                        and
                            (ii) whether such pharmacies are used by 
                        participants and beneficiaries 
                        disproportionately more in the aggregate or for 
                        specific drugs compared to other network 
                        pharmacies;
                    (C) whether group health plans and health insurance 
                issuers offering group health insurance coverage have 
                options to elect different network pricing arrangements 
                in the marketplace with entities that provide pharmacy 
                benefit management services, and the prevalence of 
                electing such different network pricing arrangements 
                among a selection of such plans and issuers;
                    (D) pharmacy network design parameters that 
                encourage participants and beneficiaries in the plan or 
                coverage to fill prescriptions at mail order, 
                specialty, or retail pharmacies that are wholly or 
                partially owned by that issuer or entity; and
                    (E) for a selection of plans and issuers, the 
                degree to which mail order, specialty, or retail 
                pharmacies that dispense prescription drugs to 
                participants and beneficiaries in a group health plan 
                or group health insurance coverage that are affiliated 
                with or in common ownership with group health plans, 
                health insurance issuers, or entities providing 
                pharmacy benefit management services or pharmacy 
                benefit administrative services under a group health 
                plan or group health insurance coverage receive 
                reimbursement that is greater than the median price 
                charged to the group health plan or health insurance 
                issuer when the same drug is dispensed to participants 
                and beneficiaries in the plan or coverage by other 
                pharmacies included in the pharmacy network of that 
                plan or issuer that are not affiliated with or in 
                common ownership with the health insurance issuer or 
                entity providing pharmacy benefit management services.
            (2) Requirement.--In carrying out paragraph (1), the 
        Comptroller General of the United States shall not disclose--
                    (A) information that would allow for identification 
                of a specific individual, plan sponsor, health 
                insurance issuer, group health plan, or entity 
                providing pharmacy benefit management services; or
                    (B) commercial or financial information that is 
                privileged or confidential.
            (3) Definitions.--In this subsection, the terms ``group 
        health plan'', ``health insurance coverage'', and ``health 
        insurance issuer'' have the meanings given such terms in 
        section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
        91).

SEC. 3. REPORTING ON JUSTIFICATION FOR DRUG PRICE INCREASES.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

            ``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND

``SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG PRICE INCREASES.

    ``(a) Definitions.--In this section:
            ``(1) Manufacturer.--The term `manufacturer' means the 
        person--
                    ``(A) that holds the application for a drug 
                approved under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or the license issued under section 
                351 of this Act; or
                    ``(B) who is engaged in manufacturing, preparing, 
                propagating, compounding, processing, packaging, 
                repackaging, or labeling of a prescription drug.
            ``(2) Qualifying drug.--The term `qualifying drug' means 
        any drug that is approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act or 
        licensed under subsection (a) or (k) of section 351 of this 
        Act--
                    ``(A) that has a wholesale acquisition cost of $100 
                or more per month supply, or per a course of treatment 
                that lasts less than a month, and is--
                            ``(i) subject to section 503(b)(1) of the 
                        Federal Food, Drug, and Cosmetic Act;
                            ``(ii) not a vaccine; and
                            ``(iii) not an antibiotic; and
                    ``(B) for which, during the previous calendar year, 
                at least 1 dollar of the total amount of sales was for 
                individuals enrolled under the Medicare program under 
                title XVIII of the Social Security Act (42 U.S.C. 1395 
                et seq.) or under a State Medicaid plan under title XIX 
                of such Act (42 U.S.C. 1396 et seq.) or under a waiver 
                of such plan.
            ``(3) Wholesale acquisition cost.--The term `wholesale 
        acquisition cost' has the meaning given that term in section 
        1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(B)).
    ``(b) Report.--
            ``(1) Report required.--The manufacturer of a qualifying 
        drug shall submit a report to the Secretary for each planned 
        increase in price of a qualifying drug that will result in an 
        increase in the wholesale acquisition cost of that drug that is 
        equal to--
                    ``(A) 10 percent or more over a 12-month period; or
                    ``(B) 25 percent or more over a 36-month period.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary not later than 30 days 
        prior to the effective date of such planned increase in price.
    ``(c) Contents.--A report under subsection (b) shall, at a minimum, 
include--
            ``(1) with respect to the qualifying drug--
                    ``(A) the percentage by which the manufacturer will 
                raise the wholesale acquisition cost of the drug on the 
                planned effective date of such planned increase in 
                price;
                    ``(B) a justification for, and description of, each 
                manufacturer's planned increase in price that will 
                occur during the 12-month period described in 
                subsection (b)(1)(A) or the 36-month period described 
                in subsection (b)(1)(B), as applicable, that shall be 
                accompanied by information to substantiate the basis 
                for the justification and a certification that, to the 
                manufacturer's knowledge and belief, the justification 
                is truthful and nonmisleading and does not describe 
                uses of the drug beyond those listed as an indication 
                or use in its approved labeling;
                    ``(C) the identity of the initial developer of the 
                drug, if applicable;
                    ``(D) a description of the history of the 
                manufacturer's price increases for the drug since the 
                approval of the application for the drug under section 
                505 of the Federal Food, Drug, and Cosmetic Act or the 
                issuance of the license for the drug under section 351, 
                or since the manufacturer acquired such approved 
                application or license, as applicable;
                    ``(E) the current wholesale acquisition cost of the 
                drug;
                    ``(F) the total expenditures of the manufacturer 
                for the 3 years preceding the planned increase in price 
                on--
                            ``(i) materials and manufacturing for such 
                        drug; and
                            ``(ii) acquiring patents and licensing for 
                        such drug;
                    ``(G) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(H) the total expenditures of the manufacturer on 
                research and development, for the 3 years preceding the 
                planned increase in price for such drug, that is 
                necessary to demonstrate that it meets applicable 
                standards for approval under section 505 of the Federal 
                Food, Drug, and Cosmetic Act or licensure under such 
                section 351, as applicable;
                    ``(I) the total expenditures of the manufacturer on 
                research and development for such drug that is pursuing 
                new or expanded indications for such drug through 
                supplemental applications under section 505(b) of the 
                Federal Food, Drug, and Cosmetic Act or section 351(a) 
                of this Act;
                    ``(J) the total expenditures of the manufacturer on 
                research and development for such drug that is carrying 
                out postmarket requirements related to such drug, 
                including those under section 505(o)(3) of the Federal 
                Food, Drug, and Cosmetic Act;
                    ``(K) the total revenue and the net profit 
                generated from the qualifying drug for each calendar 
                year since the approval of the application for the drug 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act or the issuance of the license for the 
                drug under section 351, or since the manufacturer 
                acquired such approved application or license; and
                    ``(L) the total costs associated with marketing and 
                advertising for the qualifying drug;
            ``(2) with respect to the manufacturer--
                    ``(A) the total revenue and the net profit of the 
                manufacturer--
                            ``(i) for the 12-month period preceding the 
                        date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(A);
                            ``(ii) for the 36-month period preceding 
                        the date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(B);
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation--
                            ``(i) for the 12-month period preceding the 
                        date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(A); or
                            ``(ii) for the 36-month period preceding 
                        the date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(B); and
                    ``(C) any additional information the manufacturer 
                chooses to provide related to drug pricing decisions, 
                such as total expenditures on--
                            ``(i) drug research and development; or
                            ``(ii) clinical trials on drugs, conducted 
                        with the intent of using the data to support 
                        approval of an application under section 505(b) 
                        of the Federal Food, Drug, and Cosmetic Act or 
                        section 351(a), but for which such application 
                        was not submitted or filed, or failed to 
                        receive approval by the Food and Drug 
                        Administration; and
            ``(3) such other related information as the Secretary 
        considers appropriate, as specified through notice and comment 
        rulemaking.
    ``(d) Civil Money Penalty.--Any manufacturer of a qualifying drug 
that fails to submit a report for the drug as required by this section, 
or knowingly provides false information, shall be subject to a civil 
money penalty of $100,000 for each day on which the violation 
continues.
    ``(e) Public Posting.--
            ``(1) In general.--Subject to paragraph (3), not later than 
        30 days after the submission of a report under subsection (b), 
        the Secretary shall post the report on the public website of 
        the Department of Health and Human Services, accompanied by 
        language indicating that such public posting does not represent 
        an endorsement or validation of the report's content by the 
        Secretary.
            ``(2) Format.--In developing the format of such report for 
        public posting, the Secretary shall consult stakeholders, 
        including beneficiary groups, and shall seek feedback on the 
        content and format from consumer advocates and readability 
        experts to ensure such public reports are user-friendly to the 
        public and are written in plain language that consumers can 
        readily understand.
            ``(3) Trade secrets and confidential information.--This 
        section does not authorize the disclosure of confidential 
        commercial information or trade secrets.''.

``SEC. 399OO-1. USE OF CIVIL PENALTY AMOUNTS.

    ``The Secretary shall, without further appropriation, collect civil 
penalties under section 399OO and use the funds derived from such civil 
penalties, in addition to any other amounts available to the Secretary, 
to carry out activities described in this part and to improve consumer 
and provider information about drug value and drug price transparency.

``SEC. 399OO-2. ANNUAL REPORT TO CONGRESS.

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
submit to Congress, and post on the public website of the Department of 
Health and Human Services in a way that is easy to find, use, and 
understand, an annual report--
            ``(1) summarizing the information reported pursuant to 
        section 399OO; and
            ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to section 399OO.
    ``(b) Trade Secrets and Confidential Information.-- This section 
does not authorize the disclosure of confidential commercial 
information or trade secrets.''.

SEC. 4. STUDY ON FIDUCIARY DUTIES OF PHARMACY BENEFIT MANAGERS.

    (a) In General.--The Secretary of Labor shall conduct, and submit 
to Congress a report describing the results of, a study on the impacts 
of a change in policy described in subsection (b).
    (b) Policy Described.--Under a policy referred to in subsection 
(a)--
            (1) an entity providing pharmacy benefit management 
        services would be considered a fiduciary within the meaning of 
        section 3(21) of the Employee Retirement Income Security Act of 
        1974 (29 U.S.C. 1002(21)) with respect to a group health plan 
        or group health insurance coverage; and
            (2) such an entity would--
                    (A) be subject to the responsibilities, 
                obligations, and duties imposed on fiduciaries under 
                part 4 of subtitle B of title I of such Act (29 U.S.C. 
                1101 et seq.); and
                    (B) make the required fiduciary disclosure under 
                section 408(b)(2)(B)(iii) of such Act (29 U.S.C. 
                1108(b)(2)(B)(iii)) with respect to the pharmacy 
                benefit management services provided to the plan or 
                coverage.
    (c) Definition of Pharmacy Benefit Management Services.--In this 
section, the term ``pharmacy benefit management services'' means 
services related to--
            (1) negotiating prices with respect to prescription drugs 
        on behalf of a group health plan or health insurance issuer 
        offering group health insurance coverage; and
            (2) managing the prescription drug benefits provided by 
        such plan or coverage, including designing and implementing a 
        drug formulary, the processing and payment of claims for 
        prescription drugs, the performance of drug utilization review, 
        the processing of drug prior authorization requests, the 
        adjudication of appeals or grievances related to the 
        prescription drug benefit, contracting with network pharmacies, 
        controlling the cost of covered prescription drugs, or the 
        provision of related services.

SEC. 5. CLARIFICATION OF REQUIREMENT TO DISCLOSE DIRECT AND INDIRECT 
              COMPENSATION FOR BROKERS AND CONSULTANTS TO EMPLOYER-
              SPONSORED HEALTH PLANS.

    (a) In General.--Section 408(b)(2)(B)(ii)(I)(bb) of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 
1108(b)(2)(B)(ii)(I)(bb)) is amended by adding at the end the 
following:
            ``(CC) Pharmacy benefit management services provided by 
        pharmacy benefit managers or other service providers and 
        related services provided by third-party administrators (or 
        other entities providing such services) for which the covered 
        service provider, an affiliate, or a subcontractor reasonably 
        expects to receive indirect compensation or direct compensation 
        described in item (dd).''.
    (b) Regulations.--Not later than 18 months after the date of 
enactment of this Act, the Secretary of Labor shall promulgate 
regulations, through notice and comment rulemaking, clarifying the 
requirements of section 408(b)(2)(B) of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)) with respect to covered 
service providers providing services described in subitem (CC) of 
subclause (I)(bb) of such section, as amended by subsection (a). Such 
regulations shall apply with respect to any plan year that begins on or 
after the date that is 6 months after such regulations are promulgated.
    (c) Sense of Congress.--It is the sense of Congress that the 
amendment made by subsection (a) clarifies the existing requirement of 
covered service providers with respect to services described in section 
408(b)(2)(B)(ii)(I)(bb)(BB) of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1108(b)(2)(B)(ii)(I)(bb)(BB)) that were in 
effect since the application date described in section 202(e) of the No 
Surprises Act (Public Law 116-260; 29 U.S.C. 1108 note), and does not 
impose any additional requirement under section 408(b)(2)(B) of such 
Act.

SEC. 6. STUDY ON NALOXONE ACCESS.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on actions that may be taken to ensure appropriate 
access and affordability of naloxone for individuals seeking to 
purchase naloxone. Such study shall address what is known about--
            (1) coverage of naloxone (in any available form), including 
        whether naloxone can be covered as an over-the-counter drug 
        under a group health plan or group or individual health 
        insurance coverage (as such terms are defined in section 2791 
        of the Public Health Service Act (42 U.S.C. 300gg-91));
            (2) the out-of-pocket cost to consumers purchasing 
        naloxone--
                    (A) with a prescription, with and without coverage 
                under any such plan or coverage; and
                    (B) over the counter, with and without coverage 
                under any such plan or coverage; and
            (3) other factors impacting coverage, including barriers in 
        covering naloxone as an over-the-counter drug, the relative net 
        costs of naloxone when purchased over the counter without 
        insurance coverage compared to when purchased with a 
        prescription and covered under a group health plan or health 
        insurance coverage, and the availability of naloxone purchased 
        and distributed through public health entities.
    (b) Report.--Not later than 2 years after the date of the enactment 
of this Act, the Comptroller General of the United States shall submit 
to Congress a report that contains the findings of the study conducted 
under subsection (a).

SEC. 7. PROHIBITION ON BLOCKING CONSUMER DECISION-SUPPORT TOOLS.

    (a) PHSA.--Part D of title XXVII of the Public Health Service Act 
(42 U.S.C. 300gg-111 et seq.), as amended by section 2, is further 
amended by adding at the end the following:

``SEC. 2799A-12. PROHIBITION ON BLOCKING CONSUMER DECISION-SUPPORT 
              TOOLS.

    ``(a) In General.--A group health plan or a health insurance issuer 
offering group or individual health insurance coverage shall not enter 
into a contract with an entity that provides pharmacy benefit 
management services with respect to such plan or coverage if such 
contract includes any terms, conditions, or costs that would prevent or 
restrict a covered third party from accessing or using information, for 
purposes of the consumer decision-support tool, relevant to the 
operability, implementation, and utilization of the consumer-decision 
support tool regarding prescription drug benefits under the plan or 
coverage that are administered by the entity providing pharmacy benefit 
management services in contract with the plan or issuer.
    ``(b) Definitions.--In this section:
            ``(1) Consumer decision-support tool.--The term `consumer 
        decision-support tool' means a tool designed to inform 
        enrollees in a group health plan or health insurance coverage 
        about all costs to the enrollee for prescription drugs covered 
        by the plan or coverage, including out-of-pocket, copayment, 
        and coinsurance responsibility, as well as means for reducing 
        the cost to the enrollee, such as manufacturer copayment 
        assistance, purchasing at the cash price, and purchasing 
        through mail order pharmacy benefits.
            ``(2) Covered third party.--The term `covered third party' 
        means a third party that is in contract, as a business 
        associate (as defined in section 160.103 of title 45, Code of 
        Federal Regulations (or successor regulations)), with a group 
        health plan or a health insurance issuer offering group or 
        individual health insurance coverage to provide a consumer 
        decision-support tool.
    ``(c) Rules of Construction Regarding Privacy.--
            ``(1) Nothing in this section shall be construed to alter 
        existing obligations of a covered entity or business associate 
        under the privacy, security, and breach notification 
        regulations in parts 160 and 164 of title 45, Code of Federal 
        Regulations (or successor regulations).
            ``(2) Nothing in this section shall be construed to require 
        a group health plan, a health insurance issuer offering group 
        or individual health insurance coverage, or an entity providing 
        pharmacy benefit management services to share protected health 
        information, as defined in section 160.103 of title 45, Code of 
        Federal Regulations (or successor regulations), with a covered 
        third party.''.
    (b) ERISA.--
            (1) In general.--Subpart B of part 7 of subtitle B of title 
        I of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1185 et seq.), as amended by section 2, is further 
        amended by adding at the end the following:

``SEC. 727. PROHIBITION ON BLOCKING CONSUMER DECISION-SUPPORT TOOLS.

    ``(a) In General.--A group health plan or a health insurance issuer 
offering group health insurance coverage shall not enter into a 
contract with an entity that provides pharmacy benefit management 
services with respect to such plan or coverage if such contract 
includes any terms, conditions, or costs that would prevent or restrict 
a covered third party from accessing or using information, for purposes 
of the consumer decision-support tool, relevant to the operability, 
implementation, and utilization of the consumer-decision support tool 
regarding prescription drug benefits under the plan or coverage that 
are administered by the entity providing pharmacy benefit management 
services in contract with the plan or issuer.
    ``(b) Definitions.--In this section:
            ``(1) Consumer decision-support tool.--The term `consumer 
        decision-support tool' means a tool designed to inform 
        participants and beneficiaries in a group health plan or health 
        insurance coverage about all costs to the participant or 
        beneficiary for prescription drugs covered by the plan or 
        coverage, including out-of-pocket, copayment, and coinsurance 
        responsibility, as well as means for reducing the cost to the 
        participant or beneficiary, such as manufacturer copayment 
        assistance, purchasing at the cash price, and purchasing 
        through mail order pharmacy benefits.
            ``(2) Covered third party.--The term `covered third party' 
        means a third party that is in contract, as a business 
        associate (as defined in section 160.103 of title 45, Code of 
        Federal Regulations (or successor regulations)), with a group 
        health plan or a health insurance issuer offering group health 
        insurance coverage to provide a consumer decision-support tool.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to alter 
        existing obligations of a covered entity or business associate 
        under the privacy, security, and breach notification 
        regulations in parts 160 and 164 of title 45, Code of Federal 
        Regulations (or successor regulations).
            ``(2) Nothing in this section shall be construed to require 
        a group health plan, a health insurance issuer offering group 
        health insurance coverage, or an entity providing pharmacy 
        benefit management services to share protected health 
        information, as defined in section 160.103 of title 45, Code of 
        Federal Regulations (or successor regulations), with a covered 
        third party.''.
            (2) Clerical amendment.--The table of contents in section 1 
        of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1001 et seq.), as amended by section 2, is further 
        amended by inserting after the item relating to section 726 the 
        following:

``Sec. 727. Prohibition on blocking consumer decision-support tools.''.
    (c) Internal Revenue Code.--
            (1) In general.--Subchapter B of chapter 100 of the 
        Internal Revenue Code of 1986, as amended by section 2, is 
        further amended by adding at the end the following new section:

``SEC. 9827. PROHIBITION ON BLOCKING CONSUMER DECISION-SUPPORT TOOLS.

    ``(a) In General.--A group health plan offering group health 
insurance coverage shall not enter into a contract with an entity that 
provides pharmacy benefit management services with respect to such plan 
if such contract includes any terms, conditions, or costs that would 
prevent or restrict a covered third party from accessing or using 
information, for purposes of the consumer decision-support tool, 
relevant to the operability, implementation, and utilization of the 
consumer-decision support tool regarding prescription drug benefits 
under the plan that are administered by the entity providing pharmacy 
benefit management services in contract with the plan.
    ``(b) Definitions.--In this section:
            ``(1) Consumer decision-support tool.--The term `consumer 
        decision-support tool' means a tool designed to inform 
        participants and beneficiaries in a group health plan about all 
        costs to the participant or beneficiary for prescription drugs 
        covered by the plan, including out-of-pocket, copayment, and 
        coinsurance responsibility, as well as means for reducing the 
        cost to the participant or beneficiary, such as manufacturer 
        copayment assistance, purchasing at the cash price, and 
        purchasing through mail order pharmacy benefits.
            ``(2) Covered third party.--The term `covered third party' 
        means a third party that is in contract, as a business 
        associate (as defined in section 160.103 of title 45, Code of 
        Federal Regulations (or successor regulations)), with a group 
        health plan or a health insurance issuer offering group health 
        insurance coverage to provide a consumer decision-support tool.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to alter 
        existing obligations of a covered entity or business associate 
        under the privacy, security, and breach notification 
        regulations in parts 160 and 164 of title 45, Code of Federal 
        Regulations (or successor regulations).
            ``(2) Nothing in this section shall be construed to require 
        a group health plan or an entity providing pharmacy benefit 
        management services to share protected health information, as 
        defined in section 160.103 of title 45, Code of Federal 
        Regulations (or successor regulations), with a covered third 
        party.''.
            (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of such Code, as amended by section 
        2, is further amended by adding at the end the following new 
        item:

``Sec. 9827. Prohibition on blocking consumer decision-support 
                            tools.''.
    (d) Application.--The amendments made by subsections (a), (b), and 
(c) shall apply with respect to plan years beginning on or after the 
date that is 2 years after the date of enactment of this Act.
    (e) Regulations.--The Secretary of Health and Human Services, the 
Secretary of Labor, and the Secretary of the Treasury shall jointly 
promulgate regulations to carry out the amendments made by subsections 
(a), (b), and (c), and shall issue draft regulations not later than 1 
year after the date of enactment of this Act.

SEC. 8. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND COST 
              INFORMATION.

    (a) In General.--Part A of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg et seq.) is amended by inserting after section 
2715A the following:

``SEC. 2715B. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND COST 
              INFORMATION.

    ``(a) In General.--A group health plan or a health insurance issuer 
offering group or individual health insurance coverage shall make 
available for access, exchange, and use without special effort, through 
application programming interfaces (or successor technology or 
standards), consistent with standards and implementation specifications 
adopted under section 3004, the information described in subsection 
(b), in the manner described in subsection (b), as applicable, and 
otherwise consistent with this section.
    ``(b) Electronic Information.--The following electronic information 
is required to be made available, as the Secretary may specify:
            ``(1) Historical claims, provider encounter, and payment 
        data for each enrollee, which--
                    ``(A) may include adjudicated medical and 
                prescription drug claims and equivalent encounters, 
                including all data elements contained in such 
                transactions--
                            ``(i) that were adjudicated by the group 
                        health plan or health insurance issuer during 
                        the previous 5 years or the enrollee's entire 
                        period of enrollment in the applicable plan or 
                        coverage if such period is less than the 
                        previous 5 years;
                            ``(ii) that involve benefits managed by any 
                        third party, such as a pharmacy benefits 
                        manager or radiology benefits manager that 
                        manages benefits or adjudicates claims on 
                        behalf of the plan or coverage; and
                            ``(iii) from any other group health plan or 
                        health insurance coverage offered by the same 
                        insurance issuer, in which the same enrollee 
                        was enrolled during the previous 5 years; and
                    ``(B) shall be available to an enrollee or former 
                enrollee, the enrollee's providers, and any third-party 
                applications or services authorized by the enrollee--
                            ``(i) through the application programming 
                        interfaces (or successor technology or 
                        standards) consistent with standards and 
                        specifications adopted under section 3004, in a 
                        single, longitudinal format that is easy to 
                        understand, secure, and that may update 
                        automatically;
                            ``(ii) as soon as practicable, and in no 
                        case later than the period of time determined 
                        by the Secretary, after the claim is 
                        adjudicated or the data is received by the 
                        group health plan or health insurance issuer; 
                        and
                            ``(iii) for a period of 5 years after the 
                        end date of the enrollee's enrollment in the 
                        plan or in any coverage offered by the health 
                        insurance issuer.
            ``(2) Identifying directory information for all in-network 
        providers, including facilities and practitioners, that 
        participate in the plan or coverage, which shall--
                    ``(A) include--
                            ``(i) the national provider identifier for 
                        in-network facilities and practitioners; and
                            ``(ii) the name, address, phone number, and 
                        specialty for each such facility and 
                        practitioner, within a timeframe determined by 
                        the Secretary, from when the plan or coverage 
                        receives provider directory information or 
                        updates from that facility or practitioner;
                    ``(B) be capable of returning the information 
                necessary to establish a list of participating in-
                network facilities and practitioners, in a given 
                specialty or at a particular facility type, within a 
                specified geographic radius; and
                    ``(C) be capable of returning the network status, 
                when presented with identifiers for a given enrollee 
                and facility or practitioner.
            ``(3) Estimated enrollee out-of-pocket costs, including 
        costs expected to be incurred through a deductible, co-payment, 
        coinsurance, or other form of cost-sharing, for--
                    ``(A) a designated set of common services or 
                episodes of care, to be established by the Secretary 
                through rulemaking, including, at a minimum--
                            ``(i) in the case of services provided by a 
                        hospital, the 100 most common diagnosis-related 
                        groups, as used in the Medicare Inpatient 
                        Prospective Patient System (or successor 
                        episode-based reimbursement methodology) at 
                        that hospital, based on claims data adjudicated 
                        by the group health plan or health insurance 
                        issuer;
                            ``(ii) in the case of services provided in 
                        an out-patient setting, including radiology, 
                        lab tests, and out-patient surgical procedures, 
                        any service rendered by the facility or 
                        practitioner, and reimbursed by the group 
                        health plan or health insurance issuer; and
                            ``(iii) in the case of post-acute care, 
                        including home health providers, skilled 
                        nursing facilities, inpatient rehabilitation 
                        facilities, and long-term care hospitals, the 
                        patient out-of-pocket costs for an episode of 
                        care, as the Secretary may determine, which 
                        permits users to reasonably compare costs 
                        across different facility and service types; 
                        and
                    ``(B) all prescription drugs currently included on 
                any tier of the formulary of the plan or coverage.
    ``(c) Availability and Access.--Subject to all applicable Federal 
and State privacy, security, and breach notification laws, and within a 
timeframe determined by the Secretary, the application programming 
interfaces (or successor technology or standards), including all data 
required to be made available through such interfaces, shall--
            ``(1) be made available by the applicable group health plan 
        or health insurance issuer, at no charge, to--
                    ``(A) enrollees and prospective enrollees in the 
                group health plan or health insurance coverage;
                    ``(B) third parties authorized by the enrollee;
                    ``(C) facilities and practitioners who are under 
                contract with the plan or coverage; and
                    ``(D) business associates of such facilities and 
                practitioners, as defined in section 160.103 of title 
                45, Code of Federal Regulations (or any successor 
                regulations);
            ``(2) be available to enrollees in the group health plan or 
        health insurance coverage, and to third-party applications or 
        services facilitating such access by enrollees, during the 
        enrollment process and for a minimum of 5 years after the end 
        date of the enrollee's enrollment in the plan or in any 
        coverage offered by the health insurance issuer;
            ``(3) permit persistent access by third-party applications 
        or services authorized by the enrollee, for a reasonable period 
        of time;
            ``(4) employ the applicable content, vocabulary, and 
        technical standards, as determined by the Secretary pursuant to 
        title XXX; and
            ``(5) employ security and authentication standards, as the 
        Secretary determines appropriate.
    ``(d) Denial or Discontinuance of Access.--A group health plan or 
health insurance issuer offering group or individual health insurance 
coverage may deny access or discontinue access of the application 
programming interfaces (or successor technology or standards) to third-
party applications or services on the basis of reasonable privacy or 
security concerns, as determined by the Secretary, including at the 
request of the enrollee.
    ``(e) Notification.--When obtaining enrollee authorization to share 
information with a third party under this section, a group health plan 
or a health insurance issuer offering group or individual health 
insurance coverage shall include a notification for the enrollee that 
information shared with a third party that is not a covered entity or 
business associate is not subject to the privacy, security, or breach 
notification rules under parts 160 and 164 of title 45, Code of Federal 
Regulations (or successor regulations).
    ``(f) Rule of Construction Regarding Privacy.--Nothing in this 
section shall be construed to alter existing obligations of a covered 
entity or business associate under the privacy, security, and breach 
notification rules promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act or section 13402 of the 
HITECH Act, or to alter the Secretary's existing authority to modify 
such rules, under part 2 of title 42, Code of Federal Regulations (or 
successor regulations), under section 444 of the General Education 
Provisions Act (20 U.S.C. 1232g) (commonly referred to as the `Family 
Educational Rights and Privacy Act of 1974'), under the amendments made 
by the Genetic Information Nondiscrimination Act, or under State 
privacy law.''.
    (b) Effective Date.--Section 2715B of the Public Health Service 
Act, as added by subsection (a), shall take effect 18 months after the 
date of enactment of this Act.

SEC. 9. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY 
              PROTOCOLS.

    (a) Short Title.--This section may be cited as the ``Safe Step 
Act''.
    (b) Required Exceptions Process for Medication Step Therapy 
Protocols.--The Employee Retirement Income Security Act of 1974 is 
amended by inserting after section 713 of such Act (29 U.S.C. 1185b) 
the following new section:

``SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY 
              PROTOCOLS.

    ``(a) In General.--In the case of a group health plan or health 
insurance issuer offering coverage offered in connection with such a 
plan that provides coverage of a prescription drug pursuant to a 
medication step therapy protocol, the plan or issuer shall--
            ``(1) implement a clear, prompt, and transparent process 
        for a participant or beneficiary (or the prescribing health 
        care provider (referred to in this section as the `prescriber') 
        on behalf of the participant or beneficiary) to request an 
        exception to such medication step therapy protocol, pursuant to 
        subsection (b); and
            ``(2) where the participant or beneficiary or prescriber's 
        request for an exception to the medication step therapy 
        protocols satisfies the criteria and requirements of subsection 
        (b), cover the requested drug in accordance with the terms 
        established by the plan or coverage for patient cost-sharing 
        rates or amounts at the beginning of the plan year.
    ``(b) Circumstances for Exception Approval.--The circumstances 
requiring an exception to a medication step therapy protocol, pursuant 
to a request under subsection (a), are any of the following:
            ``(1) Any treatments otherwise required under the protocol, 
        or treatments in the same pharmacological class or having the 
        same mechanism of action, including treatments provided prior 
        to the effective date of the participant's or beneficiary's 
        coverage under the plan or coverage, have been ineffective in 
        the treatment of the disease or condition of the participant or 
        beneficiary, when prescribed consistent with clinical 
        indications, clinical guidelines, or other peer-reviewed 
        evidence, based on the prescribing health care professional's 
        judgement or relevant information provided by the participant 
        or beneficiary (including the medical records of the 
        participant or beneficiary).
            ``(2) Delay of effective treatment would lead to severe or 
        irreversible consequences, or worsen disease progression or a 
        comorbidity and the treatment otherwise required under the 
        protocol is reasonably expected by the prescriber to be 
        ineffective based upon the documented physical or mental 
        characteristics of the participant or beneficiary and the known 
        characteristics of such treatment.
            ``(3) Any treatments otherwise required under the protocol 
        are contraindicated for the participant or beneficiary or have 
        caused, or are likely to cause, based on clinical, peer-
        reviewed evidence, an adverse reaction or other physical or 
        mental harm to the participant or beneficiary.
            ``(4) Any treatment otherwise required under the protocol 
        has prevented, will prevent, or is likely to prevent a 
        participant or beneficiary from achieving or maintaining 
        reasonable and safe functional ability in performing 
        occupational responsibilities or activities of daily living (as 
        defined in section 441.505 of title 42, Code of Federal 
        Regulations (or successor regulations)).
            ``(5) The participant or beneficiary is stable for his or 
        her disease or condition on the prescription drug or drugs 
        selected by the prescriber and has previously received approval 
        for coverage of the relevant drug or drugs for the disease or 
        condition by any public or private health plan.
            ``(6) Other circumstances, as determined by the Secretary.
    ``(c) Requirement of a Clear Process.--
            ``(1) In general.--The process required by subsection (a) 
        shall--
                    ``(A) provide the prescriber or participant or 
                beneficiary an opportunity to present such prescriber's 
                clinical rationale and relevant medical information for 
                the group health plan or health insurance issuer to 
                evaluate such request for exception;
                    ``(B) develop and use a standard form and 
                instructions for the request of an exception under 
                subsection (b), available in paper and electronic 
                forms, and allow for submission of such form by paper 
                and electronic means;
                    ``(C) provide both paper and electronic means for 
                the submission of requests for additional information;
                    ``(D) clearly set forth all required information 
                and the specific criteria that will be used to 
                determine whether an exception is warranted, which may 
                require disclosure of--
                            ``(i) the medical history or other health 
                        records of the participant or beneficiary 
                        demonstrating that the participant or 
                        beneficiary seeking an exception--
                                    ``(I) has tried other drugs 
                                included in the drug therapy class 
                                without success; or
                                    ``(II) has taken the requested drug 
                                for a clinically appropriate amount of 
                                time to establish stability, in 
                                relation to the condition being treated 
                                and prescription guidelines given by 
                                the prescribing physician; or
                            ``(ii) other clinical information that may 
                        be relevant to conducting the exception review;
                    ``(E) not require the submission of any information 
                or supporting documentation beyond what is strictly 
                necessary (as determined by the Secretary) to determine 
                whether a circumstance listed in subsection (b) exists;
                    ``(F) clearly outline conditions under which an 
                exception request warrants expedited resolution from 
                the group health plan or health insurance issuer, 
                pursuant to subsection (d)(2); and
                    ``(G) allow a representative of a participant or 
                beneficiary, which may include a designated third-party 
                advocate, to act on behalf of the participant or 
                beneficiary.
            ``(2) Availability of process information.--The group 
        health plan or health insurance issuer shall make information 
        regarding the process required under subsection (a) readily 
        available in the relevant plan materials, including the summary 
        of benefits and, if available, on the website of the group 
        health plan or health insurance issuer. Such information shall 
        include--
                    ``(A) the requirements for requesting an exception 
                to a medication step therapy protocol pursuant to this 
                section; and
                    ``(B) any forms, supporting information, and 
                contact information, as appropriate.
    ``(d) Timing for Determination of Exception.--The process required 
under subsection (a)(1) shall provide for the disposition of requests 
received under such paragraph in accordance with the following:
            ``(1) Subject to paragraph (2), not later than 72 hours 
        after receiving an initial exception request, the plan or 
        issuer shall respond to the participant or beneficiary and, if 
        applicable, the requesting prescriber with either a 
        determination of exception eligibility or a request for 
        additional required information strictly necessary to make a 
        determination of whether the conditions specified in subsection 
        (b) are met. The plan or issuer shall respond to the 
        participant or beneficiary and, if applicable, the requesting 
        prescriber, with a determination of exception eligibility no 
        later than 72 hours after receipt of the additional required 
        information.
            ``(2) In the case of a request under circumstances in which 
        the applicable medication step therapy protocol may seriously 
        jeopardize the life or health of the participant or 
        beneficiary, may jeopardize the ability of the participant or 
        beneficiary to regain maximum function, or may subject the 
        participant or beneficiary to severe pain that cannot be 
        adequately managed without the treatment that is the subject of 
        the request, the plan or issuer shall conduct a review of the 
        request and respond to the participant or beneficiary and, if 
        applicable, the requesting prescriber, with either a 
        determination of exception eligibility or a request for 
        additional required information strictly necessary to make a 
        determination of whether the conditions specified in subsection 
        (b) are met, in accordance with the following:
                    ``(A) If the plan or issuer can make a 
                determination of exception eligibility without 
                additional information, such determination shall be 
                made on an expedited basis, and no later than 24 hours 
                after receipt of such request.
                    ``(B) If the plan or issuer requires additional 
                information before making a determination of exception 
                eligibility, the plan or issuer shall respond to the 
                participant or beneficiary and, if applicable, the 
                requesting prescriber, with a request for such 
                information within 24 hours of the request for a 
                determination, and shall respond with a determination 
                of exception eligibility as quickly as the condition or 
                disease requires, and no later than 24 hours after 
                receipt of the additional required information.
    ``(e) Duration of a Grant.--If an exception to a medication step 
therapy protocol is granted under this section to a participant or 
beneficiary, coverage for the requested drug shall remain in effect 
with respect to such participant or beneficiary for not less than one 
year.
    ``(f) Medication Step Therapy Protocol.--In this section, the term 
`medication step therapy protocol' means a drug therapy utilization 
management protocol or program under which a group health plan or 
health insurance issuer offering group health insurance coverage of 
prescription drugs requires a participant or beneficiary to try an 
alternative preferred prescription drug or drugs before the plan or 
health insurance issuer approves coverage for the non-preferred drug 
therapy prescribed.
    ``(g) Clarification.--This section shall apply with respect to any 
group health plan or health insurance coverage offered in connection 
with such a plan that provides coverage of a prescription drug pursuant 
to a policy that meets the definition of the term `medication step 
therapy protocol' in subsection (f), regardless of whether such policy 
is described by such group health plan or health insurance coverage as 
a step therapy protocol.
    ``(h) Reporting.--
            ``(1) Reporting to the secretary.--Not later than 3 years 
        after the date of enactment of the Safe Step Act and not later 
        than October 1 of each year thereafter, each group health plan 
        and health insurance issuer offering group health insurance 
        coverage shall report to the Secretary, in such manner as the 
        Secretary shall require, the following:
                    ``(A) The number of step therapy exception requests 
                received for each exception circumstance described in 
                paragraphs (1) through (6) of subsection (b), and the 
                numbers of such requests for each such circumstance 
                that were--
                            ``(i) approved;
                            ``(ii) deemed approved under subsection 
                        (d)(3) due to the failure of the plan or issuer 
                        to timely respond;
                            ``(iii) denied, and the reasons for the 
                        denials;
                            ``(iv) initially denied and appealed; and
                            ``(v) initially denied and then 
                        subsequently reversed by internal appeals or 
                        external reviews.
                    ``(B) The number of times a plan or issuer 
                requested additional information in response to a step 
                therapy exception request, by exception circumstance 
                described in paragraphs (1) through (6) of subsection 
                (b).
                    ``(C) The number of exception requests submitted by 
                participants or beneficiaries, and the number of 
                exception requests submitted by prescribers, by medical 
                specialty.
                    ``(D) The medical conditions for which participants 
                and beneficiaries were granted exceptions due to the 
                likelihood that switching from a prescription drug will 
                likely cause an adverse reaction by, or physical or 
                mental harm to, the participant or beneficiary, as 
                described in subsection (b)(3).
                    ``(E) The entities responsible for providing 
                pharmacy benefit management services for the group 
                health plan or health insurance coverage.
            ``(2) Information.--A group health plan or health insurance 
        issuer offering group health insurance coverage shall not enter 
        into a contract with a third-party administrator or an entity 
        providing pharmacy benefit management services on behalf of the 
        plan or coverage that prevents the plan or issuer from 
        obtaining from the third-party administrator or the entity 
        providing pharmacy benefit management services any information 
        needed for the plan or issuer to comply with the reporting 
        requirements under paragraph (1).
            ``(3) Reports to congress.--Not later than 3 years after 
        the date of enactment of the Safe Step Act, and not later than 
        October 1 of each year thereafter, the Secretary shall submit 
        to Congress, and make publicly available, a report that 
        contains a summary and analysis of the information reported 
        under paragraph (1), including an analysis of, with respect to 
        requests for exceptions under this section, approvals, and 
        denials, including the reasons for denials; appeals and 
        external reviews; and trends, if any, in exception requests by 
        medical specialty or medical condition.''.
    (c) Clerical Amendment.--The table of contents in section 1 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et 
seq.) is amended by inserting after the item relating to section 713 
the following new items:

``Sec. 713A. Required exceptions process for medication step therapy 
                            protocols.''.
    (d) Effective Date.--
            (1) In general.--The amendment made by subsection (b) 
        applies with respect to plan years beginning with the first 
        plan year that begins at least 6 months after the date of the 
        enactment of this Act.
            (2) Regulations.--Not later than 6 months after the date of 
        the enactment of this Act, the Secretary of Labor shall issue 
        final regulations, through notice and comment rulemaking, to 
        implement the provisions of section 713A of the Employee 
        Retirement Income Security Act of 1974, as added by subsection 
        (b).
                                                       Calendar No. 113

118th CONGRESS

  1st Session

                                S. 1339

_______________________________________________________________________

                                 A BILL

 To provide for increased oversight of entities that provide pharmacy 
benefit management services on behalf of group health plans and health 
                          insurance coverage.

_______________________________________________________________________

                             June 22, 2023

                       Reported with an amendment
```