[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3561 Introduced in House (IH)]

<DOC>






118th CONGRESS
  1st Session
                                H. R. 3561

   To promote hospital and insurer price transparency, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 22, 2023

Mrs. Rodgers of Washington (for herself and Mr. Pallone) introduced the 
   following bill; which was referred to the Committee on Energy and 
  Commerce, and in addition to the Committees on Ways and Means, and 
Education and the Workforce, for a period to be subsequently determined 
 by the Speaker, in each case for consideration of such provisions as 
        fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
   To promote hospital and insurer price transparency, and for other 
                               purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Promoting Access to Treatments and 
Increasing Extremely Needed Transparency Act of 2023'' or the ``PATIENT 
Act of 2023''.

         TITLE I--INCREASING PRICE TRANSPARENCY TO LOWER COSTS

SEC. 101. PRICE TRANSPARENCY REQUIREMENTS.

    (a) In General.--Section 2718(e) of the Public Health Service Act 
(42 U.S.C. 300gg-18(e)) is amended--
            (1) by striking ``Each hospital'' and inserting the 
        following:
            ``(1) In general.--Each hospital'';
            (2) by inserting ``, without subscription and free of 
        charge, in a single machine-readable file,'' after ``a list'';
            (3) by inserting ``and a list, in plain language and 
        without subscription and free of charge, in a consumer-friendly 
        format, of the hospital's standard charges for as many of the 
        70 Centers for Medicare & Medicaid Services-specified shoppable 
        services that are provided by the hospital, and as many 
        additional hospital-selected shoppable services (or all such 
        additional services, if such hospital provides fewer than 300 
        shoppable services) as may be necessary for a combined total of 
        at least 300 shoppable services'' after ``Social Security 
        Act''; and
            (4) by adding at the end the following: ``Such lists shall 
        be updated not less frequently than annually. Beginning January 
        1, 2024, each hospital shall include in its lists of standard 
        charges, along with such additional information as the 
        Secretary may require with respect to such charges for purposes 
        of promoting public awareness of hospital pricing in advance of 
        receiving a hospital item or service, the following:
                    ``(A) A plain language description of each item or 
                service included on such list, including, as 
                applicable, the Healthcare Common Procedure Coding 
                System (HCPCS) code, the Diagnosis Related Group (DRG), 
                the National Drug Code (NDC), or other payer identifier 
                used or approved by the Centers for Medicare & Medicaid 
                Services for such item or service.
                    ``(B) The gross charge, expressed as a dollar 
                amount, for each such item or service, when provided 
                in, as applicable, the hospital inpatient setting and 
                outpatient department setting.
                    ``(C) Any current payer-specific negotiated 
                charges, clearly associated with the name of the third 
                party payer and plan and expressed as a dollar amount, 
                that applies to each such item or service when provided 
                in, as applicable, the hospital inpatient setting and 
                outpatient department setting.
                    ``(D) The de-identified maximum and minimum 
                negotiated charges for each such item or service.
                    ``(E) The discounted cash price, expressed as a 
                dollar amount, for each such item or service when 
                provided in, as applicable, the hospital inpatient 
                setting and outpatient department setting. If the 
                discounted cash price is a percentage of another value 
                provided, the calculated value must be entered as a 
                dollar amount. If the discounted cash price equates to 
                the gross charge, the gross charge shall be re-entered 
                to indicate that no cash discount is available.
            ``(2) Deemed compliance with shoppable services requirement 
        for certain years.--With respect to a year before 2025, a 
        hospital shall be deemed to meet the requirement of paragraph 
        (1) that such hospital make available a list of standard 
        charges for shoppable services if the hospital maintains an 
        internet-based price estimator tool that meets the following 
        requirements:
                    ``(A) The tool provides estimates for as many of 
                the 70 Centers for Medicare & Medicaid Services 
                specified shoppable services that are provided by the 
                hospital, and as many additional hospital-selected 
                shoppable services (or all such additional services, if 
                such hospital provides fewer than 300 shoppable 
                services) as may be necessary for a combined total of 
                at least 300 shoppable services.
                    ``(B) The tool allows health care consumers to, at 
                the time they use the tool, obtain an estimate of the 
                amount they will be obligated to pay the hospital for 
                the shoppable service.
                    ``(C) The tool is prominently displayed on the 
                hospital's website and easily accessible to the public, 
                without subscription, fee, or having to submit personal 
                identifying information, and searchable by service 
                description, billing code, and payer.
        The Secretary may not deem the establishment of an internet-
        based price estimator tool that meets the requirements of this 
        paragraph to constitute compliance with the requirement of 
        paragraph (1) that such hospital make available a list of 
        standard charges for shoppable services for 2025 or a 
        subsequent year.
            ``(3) Uniform method and format.--Not later than January 1, 
        2025, the Secretary shall implement a standard, uniform method 
        and format for hospitals to use in order to satisfy the 
        requirements of this subsection for disclosing directly to the 
        public charge and price information. Such method and format may 
        be similar to any template established by the Centers for 
        Medicare & Medicaid Services as of the date of the enactment of 
        this paragraph for reporting such information under this 
        subsection and shall meet such standards as determined 
        appropriate by the Secretary.
            ``(4) Monitoring of pricing information.--The Secretary, in 
        consultation with the Inspector General of the Department of 
        Health and Human Services, shall, through notice and comment 
        rulemaking, establish a process to regularly monitor the 
        accuracy and validity of pricing information displayed by each 
        hospital pursuant to paragraph (1).
            ``(5) Definitions.--Notwithstanding any other provision of 
        law, for the purpose of paragraphs (1) and (2):
                    ``(A) De-identified maximum negotiated charge.--The 
                term `de-identified maximum negotiated charge' means 
                the highest charge that a hospital has negotiated with 
                all third party payers for an item or service.
                    ``(B) De-identified minimum negotiated charge.--The 
                term `de-identified minimum negotiated charge' means 
                the lowest charge that a hospital has negotiated with 
                all third party payers for an item or service.
                    ``(C) Discounted cash price.--The term `discounted 
                cash price' means the charge that applies to an 
                individual who pays cash, or cash equivalent, for a 
                hospital item or service. Hospitals that do not offer 
                self-pay discounts may display the hospital's 
                undiscounted gross charges as found in the hospital 
                chargemaster.
                    ``(D) Gross charge.--The term `gross charge' means 
                the charge for an individual item or service that is 
                reflected on a hospital's chargemaster, absent any 
                discounts.
                    ``(E) Payer-specific negotiated charge.--The term 
                `payer-specific negotiated charge' means the charge 
                that a hospital has negotiated with a third party payer 
                for an item or service.
                    ``(F) Shoppable service.--The term `shoppable 
                service' means a service that can be scheduled by a 
                health care consumer in advance.
                    ``(G) Third party payer.--The term `third party 
                payer' means an entity that is, by statute, contract, 
                or agreement, legally responsible for payment of a 
                claim for a health care item or service.
            ``(6) Enforcement.--
                    ``(A) In general.--In the case of a hospital that 
                fails to comply with this subsection--
                            ``(i) the Secretary shall notify such 
                        hospital of such failure not later than 30 days 
                        after the date on which the Secretary 
                        determines such failure exists; and
                            ``(ii) not later than 45 days after the 
                        date of such notification, the hospital shall 
                        complete a corrective action plan to comply 
                        with such requirements.
                    ``(B) Civil monetary penalty.--
                            ``(i) In general.--In addition to any other 
                        enforcement actions or penalties that may apply 
                        under subsection (b)(3) or another provision of 
                        law, a hospital that has received a 
                        notification under subparagraph (A)(i) and 
                        fails to satisfy the requirement under 
                        subparagraph (A)(ii) or otherwise comply with 
                        the requirements of this subsection by the date 
                        that is 90 days after such notification shall 
                        be subject to a civil monetary penalty of an 
                        amount--
                                    ``(I) in the case the hospital 
                                provides not more than 30 beds (as 
                                determined under section 
                                180.90(c)(2)(ii)(D) of title 45, Code 
                                of Federal Regulations, as in effect on 
                                the date of the enactment of this 
                                paragraph), not to exceed $300 per day 
                                that the violation is ongoing as 
                                determined by the Secretary; and
                                    ``(II) in the case the hospital 
                                provides more than 30 beds (as so 
                                determined), equal to--
                                            ``(aa) subject to item 
                                        (bb), $10 per bed per day that 
                                        the violation is ongoing as 
                                        determined by the Secretary, 
                                        but for violations occurring 
                                        before January 1, 2024, not to 
                                        exceed $5,500 per each such 
                                        day; or
                                            ``(bb) in the case such 
                                        hospital has failed to satisfy 
                                        the requirement under 
                                        subparagraph (A)(ii) or 
                                        otherwise comply with the 
                                        requirements of this subsection 
                                        for any continuous 1-year 
                                        period beginning on or after 
                                        January 1, 2024, and the amount 
                                        otherwise imposed under item 
                                        (aa) for such failure for such 
                                        period would be less than 
                                        $5,000,000, an amount not less 
                                        than $5,000,000.
                            ``(ii) Increase authority.--In applying 
                        this subparagraph with respect to violations 
                        occurring in 2025 or a subsequent year, the 
                        Secretary may through notice and comment 
                        rulemaking increase any dollar amount applied 
                        under this subparagraph by an amount specified 
                        by the Secretary.
                            ``(iii) Application of certain 
                        provisions.--The provisions of section 1128A of 
                        the Social Security Act (other than subsections 
                        (a) and (b) of such section) shall apply to a 
                        civil monetary penalty imposed under clause (i) 
                        in the same manner as such provisions apply to 
                        a civil monetary penalty imposed under 
                        subsection (a) of such section.''.
    (b) Publication of List of Hospitals.--
            (1) List of hospitals.--Beginning not later than 90 days 
        after the date of enactment of this Act, the Secretary of 
        Health and Human Services (referred to in this section as the 
        ``Secretary'') shall establish and maintain a publicly 
        available list on the website of the Centers for Medicare & 
        Medicaid Services of each hospital with respect to which the 
        Secretary has conducted a review of such hospital's compliance 
        with the provisions of section 2718(e) of the Public Health 
        Service Act (42 U.S.C. 300gg-18(e)). Such list shall include, 
        with respect to each such hospital that was noncompliant with 
        such provisions, a specification as to whether such hospital--
                    (A) has been issued a civil monetary penalty;
                    (B) has received a warning notice; or
                    (C) has submitted a corrective action plan.
            (2) Additions and updates.--In the case of a hospital not 
        included on the list described in paragraph (1) as of the date 
        of the establishment of such list and that is subject to a 
        review of such hospital's compliance with the provisions 
        described in such paragraph after such date, the Secretary 
        shall add such hospital to such list, along with the 
        specifications described in such paragraph, not later than 1 
        business day after such review occurs. The Secretary shall 
        update such specifications with respect to any hospital 
        included on such list--
                    (A) not later than 1 business day after any 
                subsequent review of such hospital's compliance with 
                such provisions; and
                    (B) not later than 1 business day after any 
                penalty, notice, or request described in paragraph (1) 
                is made with respect to such hospital.
            (3) FOIA requests.--Any penalty, notice, or request 
        described in paragraph (1) shall be subject to public 
        disclosure, in full and without redaction, under section 552 of 
        title 21, United States Code, notwithstanding any exemptions or 
        exclusions otherwise available under such section 552.
            (4) Reports to congress.--Not later than 1 year after the 
        date of enactment of this Act and each year thereafter, the 
        Secretary of Health and Human Services shall submit to 
        Congress, and make publicly available, a report that contains 
        information regarding complaints of alleged violations of law 
        and enforcement activities by the Secretary under the hospital 
        price transparency rule implementing section 2718(e) of the 
        Public Health Service Act (42 U.S.C. 300gg-18(e)). Such report 
        shall be made available to the public on the website of the 
        Centers for Medicare & Medicaid Services. Each such report 
        shall include, with respect to the year involved--
                    (A) the number of compliance and enforcement 
                inquiries opened by the Secretary pursuant to such 
                section;
                    (B) the number of notices of noncompliance issued 
                by the Secretary based on such inquiries;
                    (C) the identity of each hospital entity that 
                received a notice of noncompliance and the nature of 
                the failure giving rise to the Secretary's 
                determination of noncompliance;
                    (D) the amount of civil monetary penalty assessed 
                against the hospital entity;
                    (E) whether the hospital entity subsequently 
                corrected the noncompliance; and
                    (F) an analysis of factors contributing to 
                increasing health care costs.
            (5) GAO report.--Not later than 1 year after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to the Committee on Energy and Commerce of 
        the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report on the 
        compliance and enforcement with the hospital price transparency 
        rule implementing section 2718(e) of the Public Health Service 
        Act (42 U.S.C. 300gg-18(e)). The report shall include 
        recommendations related to--
                    (A) improving price transparency to patients, 
                employers, and the public; and
                    (B) increased civil monetary penalty amounts to 
                ensure compliance.
            (6) Request for information.--Not later than January 1, 
        2025, the Secretary of Health and Human Services shall issue a 
        public request for information as to the best method through 
        which hospitals may be required to publish quality data (such 
        as data required to be reported under the Medicare Hospital 
        Compare program) alongside data required to be reported under 
        section 2718(e) of the Public Health Service Act (42 U.S.C. 
        300gg-18(e)).
    (c) Ensuring Accessibility Through Implementation.--In implementing 
the amendments made by this section, the Secretary of Health and Human 
Services shall through rulemaking ensure that a hospital submitting 
charges and information pursuant to such amendments takes reasonable 
steps (as specified by the Secretary) to ensure the accessibility of 
such charges and information to individuals with limited English 
proficiency. Such steps may include the hospital's provision of 
interpretation services or the hospital's provision of translations of 
charges and information.

SEC. 102. STRENGTHENING HEALTH INSURER TRANSPARENCY REQUIREMENTS.

    (a) Transparency in Coverage.--Section 1311(e)(3)(C) of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)(C)) is 
amended--
            (1) by striking ``The Exchange'' and inserting the 
        following:
                            ``(i) In general.--The Exchange'';
            (2) in clause (i), as inserted by paragraph (1)--
                    (A) by striking ``participating provider'' and 
                inserting ``provider'';
                    (B) by inserting ``shall include the information 
                specified in clause (ii) and'' after ``such 
                information'';
                    (C) by striking ``an Internet website'' and 
                inserting ``a self-service tool that meets the 
                requirements of clause (iii)''; and
                    (D) by striking ``and such other'' and all that 
                follows through the period and inserting ``or, at the 
                option such individual, through a paper or phone 
                disclosure (as selected by such individual and provided 
                at no cost to such individual) that meets such 
                requirements as the Secretary may specify.''; and
            (3) by adding at the end the following new clauses:
                            ``(ii) Specified information.--For purposes 
                        of clause (i), the information specified in 
                        this clause is, with respect to an item or 
                        service for which benefits are available under 
                        a health plan furnished by a health care 
                        provider, the following:
                                    ``(I) If such provider is a 
                                participating provider with respect to 
                                such item or service, the in-network 
                                rate (as defined in subparagraph (F)) 
                                for such item or service.
                                    ``(II) If such provider is not 
                                described in subclause (I), the maximum 
                                allowed amount for such item or 
                                service.
                                    ``(III) The amount of cost sharing 
                                (including deductibles, copayments, and 
                                coinsurance) that the individual will 
                                incur for such item or service (which, 
                                in the case such item or service is to 
                                be furnished by a provider described in 
                                subclause (II), shall be calculated 
                                using the maximum amount described in 
                                such subclause).
                                    ``(IV) The amount the individual 
                                has already accumulated with respect to 
                                any deductible or out of pocket maximum 
                                under the plan (broken down, in the 
                                case separate deductibles or maximums 
                                apply to separate individuals enrolled 
                                in the plan, by such separate 
                                deductibles or maximums, in addition to 
                                any cumulative deductible or maximum).
                                    ``(V) In the case such plan imposes 
                                any frequency or volume limitations 
                                with respect to such item or service 
                                (excluding medical necessity 
                                determinations), the amount that such 
                                individual has accrued towards such 
                                limitation with respect to such item or 
                                service.
                                    ``(VI) Any prior authorization, 
                                concurrent review, step therapy, fail 
                                first, or similar requirements 
                                applicable to coverage of such item or 
                                service under such plan.
                            ``(iii) Self-service tool.--For purposes of 
                        clause (i), a self-service tool established by 
                        a health plan meets the requirements of this 
                        clause if such tool--
                                    ``(I) is based on an internet 
                                website;
                                    ``(II) provides for real-time 
                                responses to requests described in such 
                                clause;
                                    ``(III) is updated in a manner such 
                                that information provided through such 
                                tool is timely and accurate;
                                    ``(IV) allows such a request to be 
                                made with respect to an item or service 
                                furnished by--
                                            ``(aa) a specific provider 
                                        that is a participating 
                                        provider with respect to such 
                                        item or service;
                                            ``(bb) all providers that 
                                        are participating providers 
                                        with respect to such plan and 
                                        such item or service; or
                                            ``(cc) a provider that is 
                                        not described in item (bb); and
                                    ``(V) provides that such a request 
                                may be made with respect to an item or 
                                service through use of the billing code 
                                for such item or service or through use 
                                of a descriptive term for such item or 
                                service.
                        The Secretary may require such tool, as a 
                        condition of complying with subclause (V), to 
                        link multiple billing codes to a single 
                        descriptive term if the Secretary determines 
                        that the billing codes to be so linked 
                        correspond to items and services.''.
    (b) Disclosure of Additional Information.--Section 1311(e)(3) of 
the Patient Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)) 
is amended by adding at the end the following new subparagraphs:
                    ``(E) Rate and payment information.--
                            ``(i) In general.--Not later than January 
                        1, 2025, and every 3 months thereafter, each 
                        health plan shall submit to the Exchange, the 
                        Secretary, the State insurance commissioner, 
                        and make available to the public, the rate and 
                        payment information described in clause (ii) in 
                        accordance with clause (iii).
                            ``(ii) Rate and payment information 
                        described.--For purposes of clause (i), the 
                        rate and payment information described in this 
                        clause is, with respect to a health plan, the 
                        following:
                                    ``(I) With respect to each item or 
                                service for which benefits are 
                                available under such plan, the in-
                                network rate in effect as of the date 
                                of the submission of such information 
                                with each provider (identified by 
                                national provider identifier) that is a 
                                participating provider with respect to 
                                such item or service, other than such a 
                                rate in effect with a provider that, 
                                during the 1-year period ending on such 
                                date, submitted fewer than 10 claims 
                                for such item or service to such plan.
                                    ``(II) With respect to each drug 
                                (identified by national drug code) for 
                                which benefits are available under such 
                                plan, the average amount paid by such 
                                plan (net of rebates, discounts, and 
                                price concessions) for such drug 
                                dispensed or administered during the 
                                90-day period beginning 180 days before 
                                such date of submission to each 
                                provider that was a participating 
                                provider with respect to such drug, 
                                broken down by each such provider 
                                (identified by national provider 
                                identifier), other than such an amount 
                                paid to a provider that, during such 
                                period, submitted fewer than 20 claims 
                                for such drug to such plan.
                                    ``(III) With respect to each item 
                                or service for which benefits are 
                                available under such plan, the amount 
                                billed, and the amount allowed by the 
                                plan, for each such item or service 
                                furnished during the 90-day period 
                                specified in subclause (II) by a 
                                provider that was not a participating 
                                provider with respect to such item or 
                                service, broken down by each such 
                                provider (identified by national 
                                provider identifier), other than items 
                                and services with respect to which 
                                fewer than 20 claims for such item or 
                                service were submitted to such plan 
                                during such period.
                            ``(iii) Manner of submission.--Rate and 
                        payment information required to be submitted 
                        and made available under this subparagraph 
                        shall be so submitted and so made available in 
                        3 separate machine-readable files corresponding 
                        to the information described in each of 
                        subclauses (I) through (III) of clause (ii) 
                        that meet such requirements as specified by the 
                        Secretary through rulemaking. Such requirements 
                        shall ensure that such files are limited to an 
                        appropriate size, are made available in a 
                        widely-available format that allows for 
                        information contained in such files to be 
                        compared across health plans, and are 
                        accessible to individuals at no cost and 
                        without the need to establish a user account or 
                        provider other credentials.
                            ``(iv) User guide.--Each health plan shall 
                        make available to the public instructions 
                        written in plain language explaining how 
                        individuals may search for information 
                        described in clause (ii) in files submitted in 
                        accordance with clause (iii).
                    ``(F) Definitions.--In this paragraph:
                            ``(i) Participating provider.--The term 
                        `participating provider' has the meaning given 
                        such term in section 2799A-1 of the Public 
                        Health Service Act.
                            ``(ii) In-network rate.--The term `in-
                        network rate' means, with respect to a health 
                        plan and an item or service furnished by a 
                        provider that is a participating provider with 
                        respect to such plan and item or service, the 
                        contracted rate in effect between such plan and 
                        such provider for such item or service.''.
    (c) Reports.--
            (1) Compliance.--Not later than January 1, 2025, the 
        Comptroller General of the United States shall submit to 
        Congress a report containing--
                    (A) an analysis of health plan compliance with the 
                amendments made by this section;
                    (B) an analysis of enforcement of such amendments 
                by the Secretaries of Health and Human Services, Labor, 
                and the Treasury;
                    (C) recommendations relating to improving such 
                enforcement; and
                    (D) recommendations relating to improving public 
                disclosure, and public awareness, of information 
                required to be made available by such plans pursuant to 
                such amendments.
            (2) Prices.--Not later than January 1, 2028, the 
        Comptroller General of the United States shall submit to 
        Congress a report containing an assessment of differences in 
        negotiated prices (and any trends in such prices) in the 
        private market between--
                    (A) rural and urban areas;
                    (B) the individual, small group, and large group 
                markets;
                    (C) consolidated and nonconsolidated health care 
                provider areas (as specified by the Secretary);
                    (D) nonprofit and for-profit hospitals;
                    (E) nonprofit and for-profit insurers; and
                    (F) insurers serving local or regional areas and 
                insurers serving multistate or national areas.
    (d) Ensuring Accessibility Through Implementation.--In implementing 
the amendments made by this section, the Secretary shall through 
rulemaking ensure that any entity making available information pursuant 
to such amendments takes reasonable steps (as specified by the 
Secretary) to ensure the accessibility of such to individuals with 
limited English proficiency. Such steps may include the entity's 
provision of interpretation services or of translations of such 
information.
    (e) Effective Date.--
            (1) In general.--The amendments made by subsection (a) 
        shall apply beginning January 1, 2025.
            (2) Continued applicability of rules for previous years.--
        Nothing in the amendments made by this section may be construed 
        as affecting the applicability of the rule entitled 
        ``Transparency in Coverage'' published by the Department of the 
        Treasury, the Department of Labor, and the Department of Health 
        and Human Services on November 12, 2020 (85 Fed. Reg. 72158) 
        before January 1, 2025.

SEC. 103. REQUIRING A SEPARATE IDENTIFICATION NUMBER AND AN ATTESTATION 
              FOR EACH OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER.

    Section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)) is 
amended by adding at the end the following new paragraph:
            ``(23) Use of unique health identifiers; attestation.--
                    ``(A) In general.--No payment may be made under 
                this subsection (or under an applicable payment system 
                pursuant to paragraph (21)) for items and services 
                furnished on or after January 1, 2026, by an off-campus 
                outpatient department of a provider (as defined in 
                subparagraph (C)) unless--
                            ``(i) such department has obtained, and 
                        such items and services are billed under, a 
                        standard unique health identifier for health 
                        care providers (as described in section 
                        1173(b)) that is separate from such identifier 
                        for such provider; and
                            ``(ii) such provider has submitted to the 
                        Secretary, during the 2-year period ending on 
                        the date such items and services are so 
                        furnished, an attestation that such department 
                        is compliant with the requirements described in 
                        section 413.65 of title 42, Code of Federal 
                        Regulations (or a successor regulation).
                    ``(B) Process for submission and review.--Not later 
                than 1 year after the date of enactment of this 
                paragraph, the Secretary shall, through notice and 
                comment rulemaking, establish a process for each 
                provider with an off-campus outpatient department of a 
                provider to submit an attestation pursuant to 
                subparagraph (A)(ii), and for the Secretary to review 
                each such attestation and determine, through site 
                visits or through remote audits (as determined 
                appropriate by the Secretary), whether such department 
                is compliant with the requirements described in such 
                subparagraph.
                    ``(C) Off-campus outpatient department of a 
                provider defined.--For purposes of this paragraph, the 
                term `off-campus outpatient department of a provider' 
                means a department of a provider (as defined in section 
                413.65 of title 42, Code of Federal Regulations, or any 
                successor regulation) that is not located--
                            ``(i) on the campus (as defined in such 
                        section) of such provider; or
                            ``(ii) within the distance (described in 
                        such definition of campus) from a remote 
                        location of a hospital facility (as defined in 
                        such section).''.

SEC. 104. MANDATORY REPORTING WITH RESPECT TO CERTAIN HEALTH-RELATED 
              OWNERSHIP INFORMATION.

    Part A of title XI of the Social Security Act (42 U.S.C. 1301 et 
seq.) is amended by adding at the end the following new section:

``SEC. 1150D. MANDATORY REPORTING WITH RESPECT TO CERTAIN HEALTH-
              RELATED OWNERSHIP INFORMATION.

    ``(a) Mandatory Reporting With Respect Certain Health-Related 
Ownership Information.--
            ``(1) Initial report.--Not later than January 1, 2025 (or 
        in the case of a specified entity formed after January 1, 2025, 
        within 60 days of becoming a specified entity), each specified 
        entity (as defined in subsection (f)(5)) shall submit to the 
        Secretary, in a form and manner specified by the Secretary, a 
        report containing the following information:
                    ``(A) Data on mergers, acquisitions, and changes in 
                ownership with respect to such specified entity for the 
                previous 1-year period.
                    ``(B) In the case that a specified entity is, or 
                includes, a hospital, the additional information 
                described in subsection (b).
                    ``(C) As applicable, the name, address, and 
                business structure of the parent company of such 
                specified entity (including the tax status of such 
                parent company), as of the date of the submission of 
                this report.
                    ``(D) Any other information with respect to 
                ownership of a specified entity, as determined by the 
                Secretary.
            ``(2) Subsequent reports.--Not later than 1 year after 
        submitting the report under paragraph (1), and annually 
        thereafter, each specified entity shall submit to the Secretary 
        an updated report, including--
                    ``(A)(i) data on mergers, acquisitions, and changes 
                in ownership with respect to such entities for the 
                previous 1-year period; and
                            ``(ii) any other information with respect 
                        to ownership of a specified entity, as 
                        determined by the Secretary; and
                    ``(B) in the case that a specified entity is, or 
                includes, a hospital, the additional information 
                described in subsection (b).
    ``(b) Additional Information Submitted by Certain Specified 
Entities.--For purposes of paragraphs (1)(B) and (2)(B) of subsection 
(a), with respect to a specified entity that is, or includes, a 
hospital, the information described in this subsection is the following 
information with respect to the previous 1-year period:
            ``(1) The business structure of the specified entity, 
        including the business type and the tax status of such entity.
            ``(2) The average debt-to-earnings ratio of the specified 
        entity.
            ``(3) The average amount of debt incurred--
                    ``(A) by the hospital; and
                    ``(B) by the entire specified entity.
            ``(4) Information with respect to real estate leases and 
        purchases for property used, or intended to be used, to furnish 
        or otherwise support the provision of health care services.
            ``(5) In the case of a non-profit hospital, a subsidiary of 
        a non-profit hospital, or a 501(c)(3) entity that shares common 
        ownership with a non-profit hospital, capital gains investments 
        (disaggregated by the type of investment) and any taxes paid on 
        such gains from such investments.
            ``(6) As applicable, information with respect to the parent 
        company of such specified entity.
    ``(c) Public Reporting.--Not later than January 1, 2027, and 
annually thereafter, the Secretary shall post on a publicly available 
website of the Department of Health and Human Services a report with 
respect to the previous 1-year period, including--
            ``(1) the number of specified entities reporting for such 
        year, disaggregated by the business structure of each specified 
        entity;
            ``(2) the number of owners of each specified entity;
            ``(3) any change in ownership for each specified entity;
            ``(4) any change in the tax status of a specified entity;
            ``(5) an analysis of trends in horizontal and vertical 
        consolidation, disaggregated by business structure and provider 
        type; and
            ``(6) as applicable, the name, address, and business 
        structure of the parent company of such specified entity 
        (including the business type and the tax status of such parent 
        company).
    ``(d) Audits.--The Secretary shall conduct an annual audit 
consisting of a random sample of specified entities to verify 
compliance with the requirements of this section and the accuracy of 
information submitted pursuant to this section.
    ``(e) Penalty for Failure To Report.--If a specified entity fails 
to provide a complete report under subsection (a), or submits a report 
containing false information, such entity shall be subject to a civil 
monetary penalty of not more than $5,000,000 for each such report not 
provided or containing false information. Such penalty shall be imposed 
and collected in the same manner as civil money penalties under 
subsection (a) of section 1128A are imposed and collected under that 
section.
    ``(f) Inapplicability of Paperwork Reduction Act.--Chapter 35 of 
title 44, United States Code, shall not apply to collections of 
information made under this section.
    ``(g) Definitions.--In this section:
            ``(1) Health plan.--The term `health plan' has the meaning 
        given such term in section 1128C(c).
            ``(2) Hospital.--The term `hospital' has the meaning given 
        such term in section 1861(e).
            ``(3) Independent freestanding emergency department.--The 
        term `independent freestanding emergency department' has the 
        meaning given such term in section 2799A-1(a)(3)(D) of the 
        Public Health Service Act.
            ``(4) Private equity company.--The term `private equity 
        company' means a publicly-traded or non-publicly traded company 
        that collects capital investments from individuals or entities 
        and purchases an ownership share of a provider of services (as 
        defined in section 1861(u)).
            ``(5) Specified entity.--The term `specified entity' 
        means--
                    ``(A) a hospital;
                    ``(B) a physician-owned physician practice with 
                more than 25 physicians for a year;
                    ``(C) a physician practice owned by a hospital, a 
                health plan, a private equity company, or a venture 
                capital firm;
                    ``(D) an ambulatory surgical center meeting the 
                standards specified under section 1832(a)(2)(F)(i); or
                    ``(E) an independent freestanding emergency 
                department.
            ``(6) Venture capital fund.--The term `venture capital 
        fund' has the meaning given such term in section 275.203(l)-1 
        of title 17, Code of Federal Regulations.''.

SEC. 105. INCREASING PRICE TRANSPARENCY OF CLINICAL DIAGNOSTIC 
              LABORATORY TESTS UNDER THE MEDICARE PROGRAM.

    Section 1846 of the Social Security Act (42 U.S.C. 1395w-2) is 
amended--
            (1) in the header, by inserting ``and additional 
        requirements'' after ``sanctions''; and
            (2) by adding at the end the following new subsection:
    ``(c) Price Transparency Requirement.--
            ``(1) In general.--Beginning January 1, 2025, each provider 
        of services or supplier that is available to furnish any 
        specified clinical diagnostic laboratory test under this title 
        shall--
                    ``(A) make publicly available on an internet 
                website the information described in paragraph (2) with 
                respect to each such specified clinical diagnostic 
                laboratory test that such provider or supplier is so 
                available to furnish; and
                    ``(B) ensure that such information is updated not 
                less frequently than annually.
            ``(2) Information described.--For purposes of paragraph 
        (1), the information described in this paragraph is, with 
        respect to a provider of services or supplier and a specified 
        clinical diagnostic laboratory test, the following:
                    ``(A) The discounted cash price for such test (or, 
                if no such price exists, the gross charge for such 
                test).
                    ``(B) The deidentified minimum negotiated rate in 
                effect between such provider or supplier and any group 
                health plan or group or individual health insurance 
                coverage for such test.
                    ``(C) The deidentified maximum negotiated rate in 
                effect between such provider or supplier and any such 
                plan or coverage for such test.
            ``(3) Inclusion of ancillary services.--Any price or rate 
        for a specified clinical diagnostic laboratory test available 
        to be furnished by a provider of services or supplier made 
        publicly available in accordance with paragraph (1) shall 
        include the price or rate (as applicable) for any ancillary 
        item or service (such as specimen collection services) that 
        would normally be furnished by such provider or supplier as 
        part of such test, as specified by the Secretary.
            ``(4) Enforcement.--
                    ``(A) In general.--In the case that the Secretary 
                determines that a provider of services or supplier is 
                not in compliance with paragraph (1)--
                            ``(i) not later than 30 days after such 
                        determination, the Secretary shall notify such 
                        provider or supplier of such determination;
                            ``(ii) not later than 90 days after such 
                        notification is sent, such provider or supplier 
                        shall complete a corrective action plan to 
                        comply with such paragraph and submit such plan 
                        to the Secretary; and
                            ``(iii) if such provider or supplier 
                        continues to fail to comply with such paragraph 
                        after the date that is 90 days after such 
                        notification is sent, the Secretary may impose 
                        a civil monetary penalty in an amount not to 
                        exceed $300 for each day (beginning with the 
                        date that is 91 days after such notification 
                        was sent) during which such failure is ongoing.
                    ``(B) Application of certain provisions.--The 
                provisions of section 1128A (other than subsections (a) 
                and (b) of such section) shall apply to a civil 
                monetary penalty imposed under this paragraph in the 
                same manner as such provisions apply to a civil 
                monetary penalty imposed under subsection (a) of such 
                section.
            ``(5) Definitions.--In this subsection:
                    ``(A) Group health plan; group health insurance 
                coverage; individual health insurance coverage.--The 
                terms `group health plan', `group health insurance 
                coverage', and `individual health insurance coverage' 
                have the meaning given such terms in section 2791 of 
                the Public Health Service Act.
                    ``(B) Specified clinical diagnostic laboratory 
                test.--the term `specified clinical diagnostic 
                laboratory test' means a clinical diagnostic laboratory 
                test that is included on the list of shoppable services 
                specified by the Centers for Medicare & Medicaid 
                Services (as described in section 180.60 of title 42, 
                Code of Federal Regulations (or a successor 
                regulation)).''.

SEC. 106. PROMOTING TRANSPARENCY OF COMMON OWNERSHIP INTERESTS UNDER 
              PARTS C AND D OF THE MEDICARE PROGRAM.

    (a) Medicare Advantage.--Section 1857(e) of the Social Security Act 
(42 U.S.C. 1395w-27(e)) is amended by adding at the end the following 
new paragraph:
            ``(6) Required disclosure of certain information relating 
        to health care provider ownership.--
                    ``(A) In general.--For plan years beginning on or 
                after January 1, 2025, a contract under this section 
                with an MA organization shall require the organization 
                to report to the Secretary, not later than 1 year after 
                the last day of such plan year, the information 
                described in subparagraph (B) with respect to such plan 
                year.
                    ``(B) Information described.--For purposes of 
                subparagraph (A), the information described in this 
                subparagraph is, with respect to an MA organization and 
                a plan year, the following:
                            ``(i) The number of items and services 
                        furnished during such plan year by each 
                        specified provider (as defined in subparagraph 
                        (C)) for which payment was made by such 
                        organization.
                            ``(ii) The number of items and services 
                        furnished during such plan year by providers of 
                        services or suppliers not described in clause 
                        (i) for which payment was made by such 
                        organization.
                            ``(iii) The average per-enrollee number of 
                        qualifying diagnoses (as defined in 
                        subparagraph (C)) made during such plan year by 
                        specified providers (including through chart 
                        reviews and health risk assessments) with 
                        respect to individuals enrolled under an MA 
                        plan offered by such organization, broken down 
                        by site of service of such providers, as 
                        specified by the Secretary.
                            ``(iv) The average per-enrollee number of 
                        qualifying diagnoses made during such plan year 
                        by providers of services and suppliers not 
                        described in clause (iii) (including through 
                        such reviews and assessments) with respect to 
                        such individuals, broken down by site of 
                        service of such providers.
                            ``(v) The average risk score (as calculated 
                        under the methodology described in subparagraph 
                        (C)(i)) for such an individual for such plan 
                        year who received items and services from a 
                        specified provider during such plan year.
                            ``(vi) The average risk score for such an 
                        individual for such plan year who did not 
                        receive items and services from a specified 
                        provider during such plan year.
                            ``(vii) The average risk score for such an 
                        individual for such plan year who received a 
                        health risk assessment from an assessment 
                        entity that was a specified assessment entity 
                        during such plan year.
                            ``(viii) The average risk score for such an 
                        individual for such plan year who received a 
                        health risk assessment from an assessment 
                        entity that was not a specified assessment 
                        entity during such plan year.
                            ``(ix) The number of prior authorization 
                        requests for an item or service submitted to 
                        such organization during such plan year, the 
                        number of such requests that were approved, the 
                        number of such requests that were denied, and 
                        the number of such denied requests that were 
                        subsequently appealed and then approved, broken 
                        down by whether the entity proposing to furnish 
                        such item or service was a specified provider 
                        or not a specified provider.
                            ``(x) The total amount of incentive-based 
                        payments made to, and the total amount of 
                        shared losses recoupments collected from, 
                        specified providers during such plan year.
                            ``(xi) The total amount of incentive-based 
                        payments made to, and the total amount of 
                        shared losses recoupments collected from, 
                        providers of services and suppliers not 
                        described in clause (x) during such plan year.
                            ``(xii) The allowed amount, and the amount 
                        of cost sharing imposed, with respect to each 
                        item and service furnished during such plan 
                        year by specified providers paid by such 
                        organization.
                            ``(xiii) The allowed amount, and the amount 
                        of cost sharing imposed, with respect to each 
                        item and service furnished during such plan 
                        year by providers of services and suppliers not 
                        described in clause (xii) paid by such 
                        organization.
                            ``(xiv) For each MA plan offered by such 
                        organization during such plan year--
                                    ``(I) the total amount of payments 
                                made under section 1853(a)(1) to such 
                                organization for coverage of 
                                individuals under such plan, and the 
                                total amount of payments made by such 
                                individuals to such organization for 
                                coverage under such plan;
                                    ``(II) the total amount expended 
                                under such plan as payment for items 
                                and services furnished by each 
                                specified provider during such year;
                                    ``(III) the total amount expended 
                                under such plan as payment for items 
                                and services furnished by providers of 
                                services or suppliers not described in 
                                subclause (II) during such year;
                                    ``(IV) the medical loss ratio under 
                                such plan with respect to individuals 
                                furnished an item or service from a 
                                specified provider during such year; 
                                and
                                    ``(V) the medical loss ratio under 
                                such plan with respect to individuals 
                                not described in subclause (IV).
                    ``(C) Definitions.--In this paragraph:
                            ``(i) Assessment entity.--The term 
                        `assessment entity' means an entity with a 
                        focus on furnishing in-home medical 
                        assessments, as specified by the Secretary.
                            ``(ii) Qualifying diagnosis.--The term 
                        `qualifying diagnosis' means, with respect to 
                        an individual, a diagnosis that is taken into 
                        account in calculating a risk score for such 
                        individual under the risk adjustment 
                        methodology established by the Secretary 
                        pursuant to section 1853(a)(3).
                            ``(iii) Specified assessment entity.--The 
                        term `specified assessment entity' means, with 
                        respect to an MA organization and a plan year, 
                        an assessment entity with respect to which such 
                        organization (or any person with an ownership 
                        or control interest (as defined in section 
                        1124(a)(3)) in such organization) is a person 
                        with an ownership or control interest (as so 
                        defined).
                            ``(iv) Specified provider.--The term 
                        `specified provider' means, with respect to an 
                        MA organization and a plan year, a provider of 
                        services or supplier with respect to which such 
                        organization (or any person with an ownership 
                        or control interest (as defined in section 
                        1124(a)(3)) in such organization) is a person 
                        with an ownership or control interest (as so 
                        defined).
                    ``(D) Nonapplication of paperwork reduction act.--
                Chapter 35 of title 44, United States Code, shall not 
                apply to information collected under this paragraph.''.
    (b) Pharmacy Benefit Manager and Pharmacy Information.--Section 
1860D-12(b) of the Social Security Act (42 U.S.C. 1395w-112(b)) is 
amended by adding at the end the following new paragraphs:
            ``(9) Provision of information relating to pharmacy 
        ownership.--
                    ``(A) In general.--For plan years beginning on or 
                after January 1, 2025, a contract entered into under 
                this part with a PDP sponsor shall require the sponsor 
                to report to the Secretary, not later than 1 year after 
                the last day of such plan year, the information 
                described in subparagraph (B) with respect to such plan 
                year.
                    ``(B) Information described.--For purposes of 
                subparagraph (A), the information described in this 
                subparagraph is, for each prescription drug plan 
                offered by a PDP sponsor for a plan year, the 
                following:
                            ``(i) The negotiated price for each covered 
                        part D drug for which benefits are available 
                        under such plan for each network pharmacy 
                        (including an identification of whether each 
                        such pharmacy is a specified pharmacy).
                            ``(ii) The average per-drug amount of 
                        direct and indirect remuneration paid by 
                        specified pharmacies for such covered part D 
                        drugs dispensed during such plan year under 
                        such plan.
                            ``(iii) The average per-drug amount of 
                        direct and indirect remuneration paid by 
                        pharmacies not described in clause (ii) for 
                        such covered part D drugs dispensed during such 
                        plan year under such plan.
                    ``(C) Definitions.--In this paragraph:
                            ``(i) Direct and indirect remuneration.--
                        The term `direct and indirect remuneration' has 
                        the meaning given such term in section 423.308 
                        of title 42, Code of Federal Regulations (or 
                        any successor regulation).
                            ``(ii) Network pharmacy.--The term `network 
                        pharmacy' has the meaning given such term in 
                        section 423.100 of title 42, Code of Federal 
                        Regulations (or any successor regulation).
                            ``(iii) Negotiated price.--The `negotiated 
                        price' for a covered part D drug shall take 
                        into account all negotiated price concessions, 
                        such as discounts, direct or indirect 
                        subsidies, rebates, and direct or indirect 
                        remunerations, for such drug, and include any 
                        dispensing fee for such drug.
                            ``(iv) Specified pharmacy.--The term 
                        `specified pharmacy' means, with respect to an 
                        PDP sponsor and a plan year, a pharmacy with 
                        respect to which such sponsor (or any person 
                        with an ownership or control interest (as 
                        defined in section 1124(a)(3)) in such sponsor) 
                        is a person with an ownership or control 
                        interest (as so defined).
                    ``(D) Nonapplication of paperwork reduction act.--
                Chapter 35 of title 44, United States Code, shall not 
                apply to information collected under this paragraph.
            ``(10) Provision of information by pharmacy benefit 
        managers.--
                    ``(A) In general.--For plan years beginning on or 
                after January 1, 2025, a contract entered into under 
                this part with a PDP sponsor shall prohibit such 
                sponsor from entering into a contract with a specified 
                pharmacy benefit manager for purposes of performing any 
                service with respect to covered part D drugs dispensed 
                under any prescription drug plan offered by such 
                sponsor for such plan year unless such manager agrees 
                to report to the Secretary, not later than 1 year after 
                the last day of such plan year, the information 
                described in subparagraph (B) with respect to each 
                prescription drug plan for which such manager is 
                providing any such service during such plan year, 
                regardless of the sponsor of such plan.
                    ``(B) Information described.--For purposes of 
                subparagraph (A), the information described in this 
                subparagraph is, with respect to a pharmacy benefit 
                manager performing services under a prescription drug 
                plan for a plan year, the following:
                            ``(i) With respect to the total amount of 
                        pharmacy and manufacturer rebates collected by 
                        such manager (or collected on behalf of such 
                        plan by any other entity with a contract in 
                        effect with such manager for such collection) 
                        for all covered part D drugs dispensed under 
                        such plan during such plan year--
                                    ``(I) the total amount of such 
                                rebates passed through to the PDP 
                                sponsor of such plan; and
                                    ``(II) the total amount of such 
                                rebates retained by such manager or 
                                such other entities.
                            ``(ii) The total amount paid by such 
                        manager to pharmacies for drugs furnished under 
                        such plan during such plan year.
                            ``(iii) The total amount of payments made 
                        by such sponsor to such manager as 
                        reimbursement for such manager's payments 
                        described in clause (ii).
                            ``(iv) The total amount of payments made by 
                        such sponsor to such manager as fees for 
                        services furnished by such manager with respect 
                        to such plan for such plan year (not including 
                        payments described in clause (iii)).
                            ``(v) The total amount of administrative 
                        costs incurred by such manager for furnishing 
                        such services under such plan for such plan 
                        year.
                            ``(vi) A specification as to whether such 
                        manager is a specified pharmacy benefit manager 
                        with respect to the PDP sponsor of such plan.
                    ``(C) Definition.--In this paragraph, the term 
                `specified pharmacy benefit manager' means, with 
                respect to an PDP sponsor and a plan year, a pharmacy 
                benefit manager with respect to which such sponsor (or 
                any person with an ownership or control interest (as 
                defined in section 1124(a)(3)) in such sponsor) is a 
                person with an ownership or control interest (as so 
                defined).''.
    (c) Encounter Data.--Section 1859 of the Social Security Act (42 
U.S.C. 1395w-28) is amended by adding at the end the following new 
subsection:
    ``(j) Inclusion of Certain Information in Encounter Data.--
            ``(1) In general.--In the case of any encounter data 
        submitted by a Medicare Advantage plan with respect to an item 
        or service furnished to an individual under such plan during a 
        plan year beginning on or after January 1, 2025, the Secretary 
        shall require that such data include--
                    ``(A) the allowed amount for such item or service;
                    ``(B) the amount of cost sharing (including 
                deductibles, copayments, and coinsurance) imposed for 
                such item or service;
                    ``(C) in the case such individual was furnished, 
                during such plan year before such item or service was 
                so furnished, an at-home health risk assessment from a 
                specified assessment entity, an indicator that such 
                individual was so furnished such an assessment by such 
                an entity; and
                    ``(D) in the case such individual was furnished, 
                during such plan year before such item or service was 
                so furnished, an at-home health risk assessment from an 
                assessment entity not described in subparagraph (C), an 
                indicator (distinct from the indicator described in 
                such subparagraph) that such individual was so 
                furnished such an assessment by such an entity.
            ``(2) Definitions.--For purposes of this subsection, the 
        terms `assessment entity' and `specified assessment entity' 
        have the meaning given such terms in section 1857(e)(6).''.
    (d) MedPAC Report.--Not later than December 31, 2027, and every 2 
years thereafter, the Medicare Payment Advisory Commission shall submit 
to Congress a report on the effects of vertical integration in the 
health care sector on the Medicare program. Such report shall include 
an analysis of the effects of entities such as health care providers, 
pharmacies, PDP sponsors, Medicare Advantage organizations, and 
pharmacy benefit managers that were previously under separate ownership 
from one another coming under common ownership.
    (e) Publication.--Not later than January 1, 2027, the Secretary of 
Health and Human Services shall establish a process under which 
information submitted to the Secretary pursuant to the amendments made 
by subsections (a) and (b) is publicly disclosed. Such process shall 
ensure that any information so disclosed does not identify a specific 
drug manufacturer, provider of services or supplier, pharmacy, pharmacy 
benefit manager, or any price charged with respect to a particular 
drug.

SEC. 107. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.

    (a) PHSA.--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 PHARMACY BENEFITS MANAGER SERVICES.

    ``(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 or subsidiary providing pharmacy 
benefits management services on behalf of such a plan or issuer shall 
not enter into a contract with a drug manufacturer, distributor, 
wholesaler, subcontractor, rebate aggregator, or any associated third 
party that limits the disclosure of information to plan sponsors in 
such a manner that prevents the plan or issuer, or an entity or 
subsidiary providing pharmacy benefits management services on behalf of 
a plan or issuer, from making the reports described in subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after 
        January 1, 2025, not less frequently than annually, a health 
        insurance issuer offering group health insurance coverage or an 
        entity providing pharmacy benefits management services on 
        behalf of a group health plan or an issuer providing group 
        health insurance coverage shall submit to the plan sponsor (as 
        defined in section 3(16)(B) of the Employee Retirement Income 
        Security Act of 1974) of such group health plan or health 
        insurance coverage a report in accordance with this subsection 
        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 or health insurance 
        coverage--
                    ``(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 or coverage;
                    ``(B) a list of each drug covered by such plan, 
                issuer, or entity providing pharmacy benefits 
                management services that was dispensed during the 
                reporting period, including, with respect to each such 
                drug during the reporting period--
                            ``(i) the brand name, chemical entity, and 
                        National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom the drug was filled 
                        during the plan year, the total number of 
                        prescription fills for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the plan year, including 
                        whether the dispensing channel was by retail, 
                        mail order, or specialty pharmacy;
                            ``(iii) the wholesale acquisition cost, 
                        listed as cost per days supply and cost per 
                        pill, or in the case of a drug in another form, 
                        per dose;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and
                            ``(v) for any drug for which gross spending 
                        of the group health plan or health insurance 
                        coverage exceeded $10,000 during the reporting 
                        period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic category or class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic category or 
                                class as such drug; and
                                    ``(II) the rationale for preferred 
                                formulary placement of such drug in 
                                that therapeutic category or class, if 
                                applicable;
                    ``(C) a list of each therapeutic category or class 
                of drugs that were dispensed under the health plan or 
                health insurance coverage during the reporting period, 
                and, with respect to each such therapeutic category or 
                class of drugs, during the reporting period--
                            ``(i) total gross spending by the plan, 
                        before manufacturer rebates, fees, or other 
                        manufacturer remuneration;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that category or class;
                            ``(iii) if applicable to that category or 
                        class, a description of the formulary tiers and 
                        utilization mechanisms (such as prior 
                        authorization or step therapy) employed for 
                        drugs in that category or class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries, including 
                        participant and beneficiary spending through 
                        copayments, coinsurance, and deductibles; and
                            ``(v) for each therapeutic category or 
                        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, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--
                                            ``(aa) that has been paid, 
                                        or is to be paid, by drug 
                                        manufacturers for claims 
                                        incurred during the reporting 
                                        period; or
                                            ``(bb) that is related to 
                                        utilization of drugs, in such 
                                        therapeutic category or class;
                                    ``(II) the total net spending, 
                                after deducting rebates, price 
                                concessions, alternative discounts or 
                                other remuneration from drug 
                                manufacturers, by the health plan or 
                                health insurance coverage on that 
                                category or class of drugs; and
                                    ``(III) the net price per course of 
                                treatment or single fill, such as a 30-
                                day supply or 90-day supply, incurred 
                                by the health plan or health insurance 
                                coverage and its participants and 
                                beneficiaries, after manufacturer 
                                rebates, fees, and other remuneration 
                                for drugs dispensed within such 
                                therapeutic category or class during 
                                the reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan or coverage during the reporting period, 
                before rebates and other manufacturer fees or 
                remuneration;
                    ``(E) total amount received, or expected to be 
                received, by the health plan or health insurance 
                coverage in drug manufacturer rebates, fees, 
                alternative discounts, and all other remuneration 
                received from the manufacturer or any third party, 
                other than the plan sponsor, related to utilization of 
                drug or drug spending under that health plan or health 
                insurance coverage during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the health plan or health insurance coverage during 
                the reporting period; and
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of remuneration to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's or health 
                insurance issuer's business to the pharmacy benefits 
                manager.
            ``(2) Privacy requirements.--Health insurance issuers 
        offering group health insurance coverage and entities providing 
        pharmacy benefits management services on behalf of a group 
        health plan shall provide information under paragraph (1) in a 
        manner consistent with the privacy, security, and breach 
        notification regulations promulgated under section 264(c) of 
        the Health Insurance Portability and Accountability Act of 
        1996, and shall restrict the use and disclosure of such 
        information according to such privacy regulations.
            ``(3) Disclosure and redisclosure.--
                    ``(A) Limitation to business associates.--A group 
                health plan receiving a report under paragraph (1) may 
                disclose such information only to business associates 
                of such plan as defined in section 160.103 of title 45, 
                Code of Federal Regulations (or successor regulations).
                    ``(B) Clarification regarding public disclosure of 
                information.--Nothing in this section prevents a health 
                insurance issuer offering group health insurance 
                coverage or an entity providing pharmacy benefits 
                management services on behalf of a group health plan 
                from placing reasonable restrictions on the public 
                disclosure of the information contained in a report 
                described in paragraph (1), except that such issuer or 
                entity may not restrict disclosure of such report to 
                the Department of Health and Human Services, the 
                Department of Labor, the Department of the Treasury, 
                the Comptroller General of the United States, or 
                applicable State agencies.
                    ``(C) Limited form of report.--The Secretary shall 
                define through rulemaking a limited form of the report 
                under paragraph (1) required of plan sponsors who are 
                drug manufacturers, drug wholesalers, or other direct 
                participants in the drug supply chain, in order to 
                prevent anti-competitive behavior.
            ``(4) Report to gao.--A health insurance issuer offering 
        group health insurance coverage or an entity providing pharmacy 
        benefits management services on behalf of a group health plan 
        shall submit to the Comptroller General of the United States 
        each of the first 4 reports submitted to a plan sponsor under 
        paragraph (1) with respect to such coverage or plan, and other 
        such reports as requested, in accordance with the privacy 
        requirements under paragraph (2), the disclosure and 
        redisclosure standards under paragraph (3), the standards 
        specified pursuant to paragraph (5), and such other information 
        that the Comptroller General determines necessary to carry out 
        the study under section 2(d) of the Pharmacy Benefits Manager 
        Accountability Act.
            ``(5) Standard format.--Not later than June 1, 2023, the 
        Secretary shall specify through rulemaking standards for health 
        insurance issuers and entities required to submit reports under 
        paragraph (4) to submit such reports in a standard format.
    ``(c) Enforcement.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Labor and the Secretary of the Treasury, shall 
        enforce this section.
            ``(2) Failure to provide timely information.--A health 
        insurance issuer or an entity providing pharmacy benefits 
        management services that violates subsection (a) or fails to 
        provide information required under subsection (b) 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 health insurance issuer or 
        entity providing pharmacy benefits management services 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.
    ``(d) 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.
    ``(e) Definition.--In this section, the term `wholesale acquisition 
cost' has the meaning given such term in section 1847A(c)(6)(B) of the 
Social Security Act.''; and
            (2) in section 2723 (42 U.S.C. 300gg-22)--
                    (A) in subsection (a)--
                            (i) in paragraph (1), by inserting ``(other 
                        than subsections (a) and (b) of section 2799A-
                        11)'' after ``part D''; and
                            (ii) in paragraph (2), by inserting 
                        ``(other than subsections (a) and (b) of 
                        section 2799A-11)'' after ``part D''; and
                    (B) in subsection (b)--
                            (i) in paragraph (1), by inserting ``(other 
                        than subsections (a) and (b) of section 2799A-
                        11)'' after ``part D'';
                            (ii) in paragraph (2)(A), by inserting 
                        ``(other than subsections (a) and (b) of 
                        section 2799A-11)'' after ``part D''; and
                            (iii) in paragraph (2)(C)(ii), by inserting 
                        ``(other than subsections (a) and (b) of 
                        section 2799A-11)'' after ``part D''.
    (b) ERISA.--
            (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 PHARMACY BENEFITS MANAGER SERVICES.

    ``(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 
or subsidiary providing pharmacy benefits management services on behalf 
of such a plan or issuer shall not enter into a contract with a drug 
manufacturer, distributor, wholesaler, subcontractor, rebate 
aggregator, or any associated third party that limits the disclosure of 
information to plan sponsors in such a manner that prevents the plan or 
issuer, or an entity or subsidiary providing pharmacy benefits 
management services on behalf of a plan or issuer, from making the 
reports described in subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after 
        January 1, 2025, not less frequently than annually, a health 
        insurance issuer offering group health insurance coverage or an 
        entity providing pharmacy benefits management services on 
        behalf of a group health plan or an issuer providing group 
        health insurance coverage shall submit to the plan sponsor (as 
        defined in section 3(16)(B)) of such group health plan or group 
        health insurance coverage a report in accordance with this 
        subsection 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 or health 
        insurance coverage--
                    ``(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 or coverage;
                    ``(B) a list of each drug covered by such plan, 
                issuer, or entity providing pharmacy benefits 
                management services that was dispensed during the 
                reporting period, including, with respect to each such 
                drug during the reporting period--
                            ``(i) the brand name, chemical entity, and 
                        National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom the drug was filled 
                        during the plan year, the total number of 
                        prescription fills for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the plan year, including 
                        whether the dispensing channel was by retail, 
                        mail order, or specialty pharmacy;
                            ``(iii) the wholesale acquisition cost, 
                        listed as cost per days supply and cost per 
                        pill, or in the case of a drug in another form, 
                        per dose;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and
                            ``(v) for any drug for which gross spending 
                        of the group health plan or health insurance 
                        coverage exceeded $10,000 during the reporting 
                        period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic category or class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic category or 
                                class as such drug; and
                                    ``(II) the rationale for preferred 
                                formulary placement of such drug in 
                                that therapeutic category or class, if 
                                applicable;
                    ``(C) a list of each therapeutic category or class 
                of drugs that were dispensed under the health plan or 
                health insurance coverage during the reporting period, 
                and, with respect to each such therapeutic category or 
                class of drugs, during the reporting period--
                            ``(i) total gross spending by the plan, 
                        before manufacturer rebates, fees, or other 
                        manufacturer remuneration;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that category or class;
                            ``(iii) if applicable to that category or 
                        class, a description of the formulary tiers and 
                        utilization mechanisms (such as prior 
                        authorization or step therapy) employed for 
                        drugs in that category or class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries, including 
                        participant and beneficiary spending through 
                        copayments, coinsurance, and deductibles; and
                            ``(v) for each therapeutic category or 
                        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, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--
                                            ``(aa) that has been paid, 
                                        or is to be paid, by drug 
                                        manufacturers for claims 
                                        incurred during the reporting 
                                        period; or
                                            ``(bb) that is related to 
                                        utilization of drugs, in such 
                                        therapeutic category or class;
                                    ``(II) the total net spending, 
                                after deducting rebates, price 
                                concessions, alternative discounts or 
                                other remuneration from drug 
                                manufacturers, by the health plan or 
                                health insurance coverage on that 
                                category or class of drugs; and
                                    ``(III) the net price per course of 
                                treatment or single fill, such as a 30-
                                day supply or 90-day supply, incurred 
                                by the health plan or health insurance 
                                coverage and its participants and 
                                beneficiaries, after manufacturer 
                                rebates, fees, and other remuneration 
                                for drugs dispensed within such 
                                therapeutic category or class during 
                                the reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan or coverage during the reporting period, 
                before rebates and other manufacturer fees or 
                remuneration;
                    ``(E) total amount received, or expected to be 
                received, by the health plan or health insurance 
                coverage in drug manufacturer rebates, fees, 
                alternative discounts, and all other remuneration 
                received from the manufacturer or any third party, 
                other than the plan sponsor, related to utilization of 
                drug or drug spending under that health plan or health 
                insurance coverage during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the health plan or health insurance coverage during 
                the reporting period; and
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of remuneration to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's or health 
                insurance issuer's business to the pharmacy benefits 
                manager.
            ``(2) Privacy requirements.--Health insurance issuers 
        offering group health insurance coverage and entities providing 
        pharmacy benefits management services on behalf of a group 
        health plan shall provide information under paragraph (1) in a 
        manner consistent with the privacy, security, and breach 
        notification regulations promulgated under section 264(c) of 
        the Health Insurance Portability and Accountability Act of 
        1996, and shall restrict the use and disclosure of such 
        information according to such privacy regulations.
            ``(3) Disclosure and redisclosure.--
                    ``(A) Limitation to business associates.--A group 
                health plan receiving a report under paragraph (1) may 
                disclose such information only to business associates 
                of such plan as defined in section 160.103 of title 45, 
                Code of Federal Regulations (or successor regulations).
                    ``(B) Clarification regarding public disclosure of 
                information.--Nothing in this section prevents a health 
                insurance issuer offering group health insurance 
                coverage or an entity providing pharmacy benefits 
                management services on behalf of a group health plan 
                from placing reasonable restrictions on the public 
                disclosure of the information contained in a report 
                described in paragraph (1), except that such issuer or 
                entity may not restrict disclosure of such report to 
                the Department of Health and Human Services, the 
                Department of Labor, the Department of the Treasury, 
                the Comptroller General of the United States, or 
                applicable State agencies.
                    ``(C) Limited form of report.--The Secretary shall 
                define through rulemaking a limited form of the report 
                under paragraph (1) required of plan sponsors who are 
                drug manufacturers, drug wholesalers, or other direct 
                participants in the drug supply chain, in order to 
                prevent anti-competitive behavior.
            ``(4) Report to gao.--A health insurance issuer offering 
        group health insurance coverage or an entity providing pharmacy 
        benefits management services on behalf of a group health plan 
        shall submit to the Comptroller General of the United States 
        each of the first 4 reports submitted to a plan sponsor under 
        paragraph (1) with respect to such coverage or plan, and other 
        such reports as requested, in accordance with the privacy 
        requirements under paragraph (2), the disclosure and 
        redisclosure standards under paragraph (3), the standards 
        specified pursuant to paragraph (5), and such other information 
        that the Comptroller General determines necessary to carry out 
        the study under section 2(d) of the Pharmacy Benefits Manager 
        Accountability Act.
            ``(5) Standard format.--Not later than June 1, 2023, the 
        Secretary shall specify through rulemaking standards for health 
        insurance issuers and entities required to submit reports under 
        paragraph (4) to submit such reports in a standard format.
    ``(c) 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.
    ``(d) Definition.--In this section, the term `wholesale acquisition 
cost' has the meaning given such term in section 1847A(c)(6)(B) of the 
Social Security Act.''; and
                    (B) in section 502 (29 U.S.C. 1132)--
                            (i) in subsection (a)--
                                    (I) in paragraph (6), by striking 
                                ``or (9)'' and inserting ``(9), or 
                                (13)'';
                                    (II) in paragraph (10), by striking 
                                at the end ``or'';
                                    (III) in paragraph (11), at the end 
                                by striking the period and inserting 
                                ``; or''; and
                                    (IV) by adding at the end the 
                                following new paragraph:
            ``(12) by the Secretary, in consultation with the Secretary 
        of Health and Human Services, and the Secretary of the 
        Treasury, to enforce section 726.'';
                            (ii) in subsection (b)(3), by inserting 
                        ``and subsections (a)(12) and (c)(13)'' before 
                        ``, the Secretary is not''; and
                            (iii) in subsection (c), by adding at the 
                        end the following new paragraph:
            ``(13) Secretarial enforcement authority relating to 
        oversight of pharmacy benefits manager services.--
                    ``(A) Failure to provide timely information.--The 
                Secretary, in consultation with the Secretary of Health 
                and Human Services and the Secretary of the Treasury, 
                may impose a penalty against any health insurance 
                issuer or entity providing pharmacy benefits management 
                services that violates section 726(a) or fails to 
                provide information required under section 726(b) in 
                the amount of $10,000 for each day during which such 
                violation continues or such information is not 
                disclosed or reported.
                    ``(B) False information.--The Secretary, in 
                consultation with the Secretary of Health and Human 
                Services and the Secretary of the Treasury, may impose 
                a penalty against a health insurance issuer or entity 
                providing pharmacy benefits management services that 
                knowingly provides false information under section 726 
                in an amount not to exceed $100,000 for each item of 
                false information. Such penalty shall be in addition to 
                other penalties as may be prescribed by law.
                    ``(C) Waivers.--The Secretary may waive penalties 
                under subparagraph (A), or extend the period of time 
                for compliance with a requirement of section 726, for 
                an entity in violation of such section that has made a 
                good-faith effort to comply with such section.''.
            (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 pharmacy benefits manager services.''.
    (c) IRC.--
            (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 PHARMACY BENEFITS MANAGER SERVICES.

    ``(a) In General.--For plan years beginning on or after January 1, 
2025, a group health plan or an entity or subsidiary providing pharmacy 
benefits management services on behalf of such a plan shall not enter 
into a contract with a drug manufacturer, distributor, wholesaler, 
subcontractor, rebate aggregator, or any associated third party that 
limits the disclosure of information to plan sponsors in such a manner 
that prevents the plan, or an entity or subsidiary providing pharmacy 
benefits management services on behalf of a plan, from making the 
reports described in subsection (b).
    ``(b) Reports.--
            ``(1) In general.--For plan years beginning on or after 
        January 1, 2025, not less frequently than annually, an entity 
        providing pharmacy benefits management services on behalf of a 
        group health plan shall submit to the plan sponsor (as defined 
        in section 3(16)(B) of the Employee Retirement Income Security 
        Act of 1974) of such group health plan a report in accordance 
        with this subsection 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--
                    ``(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;
                    ``(B) a list of each drug covered by such plan or 
                entity providing pharmacy benefits management services 
                that was dispensed during the reporting period, 
                including, with respect to each such drug during the 
                reporting period--
                            ``(i) the brand name, chemical entity, and 
                        National Drug Code;
                            ``(ii) the number of participants and 
                        beneficiaries for whom the drug was filled 
                        during the plan year, the total number of 
                        prescription fills for the drug (including 
                        original prescriptions and refills), and the 
                        total number of dosage units of the drug 
                        dispensed across the plan year, including 
                        whether the dispensing channel was by retail, 
                        mail order, or specialty pharmacy;
                            ``(iii) the wholesale acquisition cost, 
                        listed as cost per days supply and cost per 
                        pill, or in the case of a drug in another form, 
                        per dose;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries on such drug, 
                        including participant and beneficiary spending 
                        through copayments, coinsurance, and 
                        deductibles; and
                            ``(v) for any drug for which gross spending 
                        of the group health plan exceeded $10,000 
                        during the reporting period--
                                    ``(I) a list of all other drugs in 
                                the same therapeutic category or class, 
                                including brand name drugs and 
                                biological products and generic drugs 
                                or biosimilar biological products that 
                                are in the same therapeutic category or 
                                class as such drug; and
                                    ``(II) the rationale for preferred 
                                formulary placement of such drug in 
                                that therapeutic category or class, if 
                                applicable;
                    ``(C) a list of each therapeutic category or class 
                of drugs that were dispensed under the health plan 
                during the reporting period, and, with respect to each 
                such therapeutic category or class of drugs, during the 
                reporting period--
                            ``(i) total gross spending by the plan, 
                        before manufacturer rebates, fees, or other 
                        manufacturer remuneration;
                            ``(ii) the number of participants and 
                        beneficiaries who filled a prescription for a 
                        drug in that category or class;
                            ``(iii) if applicable to that category or 
                        class, a description of the formulary tiers and 
                        utilization mechanisms (such as prior 
                        authorization or step therapy) employed for 
                        drugs in that category or class;
                            ``(iv) the total out-of-pocket spending by 
                        participants and beneficiaries, including 
                        participant and beneficiary spending through 
                        copayments, coinsurance, and deductibles; and
                            ``(v) for each therapeutic category or 
                        class under which 3 or more drugs are included 
                        on the formulary of such plan--
                                    ``(I) the amount received, or 
                                expected to be received, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--
                                            ``(aa) that has been paid, 
                                        or is to be paid, by drug 
                                        manufacturers for claims 
                                        incurred during the reporting 
                                        period; or
                                            ``(bb) that is related to 
                                        utilization of drugs, in such 
                                        therapeutic category or class;
                                    ``(II) the total net spending, 
                                after deducting rebates, price 
                                concessions, alternative discounts or 
                                other remuneration from drug 
                                manufacturers, by the health plan on 
                                that category or class of drugs; and
                                    ``(III) the net price per course of 
                                treatment or single fill, such as a 30-
                                day supply or 90-day supply, incurred 
                                by the health plan and its participants 
                                and beneficiaries, after manufacturer 
                                rebates, fees, and other remuneration 
                                for drugs dispensed within such 
                                therapeutic category or class during 
                                the reporting period;
                    ``(D) total gross spending on prescription drugs by 
                the plan during the reporting period, before rebates 
                and other manufacturer fees or remuneration;
                    ``(E) total amount received, or expected to be 
                received, by the health plan in drug manufacturer 
                rebates, fees, alternative discounts, and all other 
                remuneration received from the manufacturer or any 
                third party, other than the plan sponsor, related to 
                utilization of drug or drug spending under that health 
                plan during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the health plan during the reporting period; and
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of remuneration to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's business 
                to the pharmacy benefits manager.
            ``(2) Privacy requirements.--Entities providing pharmacy 
        benefits management services on behalf of a group health plan 
        shall provide information under paragraph (1) in a manner 
        consistent with the privacy, security, and breach notification 
        regulations promulgated under section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996, and shall 
        restrict the use and disclosure of such information according 
        to such privacy regulations.
            ``(3) Disclosure and redisclosure.--
                    ``(A) Limitation to business associates.--A group 
                health plan receiving a report under paragraph (1) may 
                disclose such information only to business associates 
                of such plan as defined in section 160.103 of title 45, 
                Code of Federal Regulations (or successor regulations).
                    ``(B) Clarification regarding public disclosure of 
                information.--Nothing in this section prevents an 
                entity providing pharmacy benefits management services 
                on behalf of a group health plan from placing 
                reasonable restrictions on the public disclosure of the 
                information contained in a report described in 
                paragraph (1), except that such entity may not restrict 
                disclosure of such report to the Department of Health 
                and Human Services, the Department of Labor, the 
                Department of the Treasury, the Comptroller General of 
                the United States, or applicable State agencies.
                    ``(C) Limited form of report.--The Secretary shall 
                define through rulemaking a limited form of the report 
                under paragraph (1) required of plan sponsors who are 
                drug manufacturers, drug wholesalers, or other direct 
                participants in the drug supply chain, in order to 
                prevent anti-competitive behavior.
            ``(4) Report to gao.--An entity providing pharmacy benefits 
        management services on behalf of a group health plan shall 
        submit to the Comptroller General of the United States each of 
        the first 4 reports submitted to a plan sponsor under paragraph 
        (1) with respect to such plan, and other such reports as 
        requested, in accordance with the privacy requirements under 
        paragraph (2), the disclosure and redisclosure standards under 
        paragraph (3), the standards specified pursuant to paragraph 
        (5), and such other information that the Comptroller General 
        determines necessary to carry out the study under section 2(d) 
        of the Pharmacy Benefits Manager Accountability Act.
            ``(5) Standard format.--Not later than June 1, 2023, the 
        Secretary shall specify through rulemaking standards for 
        entities required to submit reports under paragraph (4) to 
        submit such reports in a standard format.
    ``(c) Enforcement.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Labor and the Secretary of Health and Human 
        Services, shall enforce this section.
            ``(2) Failure to provide timely information.--An entity 
        providing pharmacy benefits management services that violates 
        subsection (a) or fails to provide information required under 
        subsection (b) 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.--An entity providing pharmacy 
        benefits management services 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.
    ``(d) 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.
    ``(e) Definition.--In this section, the term `wholesale acquisition 
cost' has the meaning given such term in section 1847A(c)(6)(B) of the 
Social Security Act.''.
            (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 pharmacy benefits manager services.''.
    (d) GAO Study.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to Congress a report on--
                    (A) pharmacy networks of group health plans, health 
                insurance issuers, and entities providing pharmacy 
                benefits 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 benefits management services or pharmacy 
                benefits administrative services under group health 
                plan or group or individual health insurance coverage;
                    (B) as it relates to pharmacy networks that include 
                pharmacies under common ownership described in 
                subparagraph (A)--
                            (i) whether such networks are designed to 
                        encourage enrollees 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 
                        enrollees disproportionately more in the 
                        aggregate or for specific services or drugs 
                        compared to other network pharmacies;
                    (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 benefits management services, the 
                prevalence of electing such different network pricing 
                arrangements;
                    (D) pharmacy network design parameters that 
                encourage enrollees 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) the degree to which mail order, specialty, or 
                retail pharmacies that dispense prescription drugs to 
                an enrollee 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 benefits 
                management services or pharmacy benefits 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 enrollees 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 benefits management services.
            (2) Requirement.--The Comptroller General of the United 
        States shall ensure that the report under paragraph (1) does 
        not contain information that would allow a reader to identify a 
        specific plan or entity providing pharmacy benefits management 
        services or otherwise contain 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).

 TITLE II--SUPPORTING PATIENTS, HEALTH CARE WORKERS, COMMUNITY HEALTH 
                         CENTERS, AND HOSPITALS

SEC. 201. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL HEALTH 
              SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE 
              GME PROGRAMS.

    (a) Teaching Health Centers That Operate Graduate Medical Education 
Programs.--Section 340H(g) of the Public Health Service Act (42 U.S.C. 
256h(g)) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(1) In general.--To carry out this section, there are 
        appropriated such sums as may be necessary, not to exceed--
                    ``(A) $230,000,000, for the period of fiscal years 
                2011 through 2015;
                    ``(B) $60,000,000 for each of fiscal years 2016 and 
                2017;
                    ``(C) $126,500,000 for each of fiscal years 2018 
                through 2023;
                    ``(D) $175,000,000 for each of fiscal years 2024 
                and 2025;
                    ``(E) $225,000,000 for each of fiscal years 2026 
                and 2027; and
                    ``(F) $275,000,000 for each of fiscal years 2028 
                and 2029.''; and
            (2) by adding at the end the following:
            ``(3) Availability.--The amounts made available under 
        paragraph (1) shall remain available until expended.''.
    (b) Extension for Community Health Centers.--Section 10503(b)(1)(F) 
of the Patient Protection and Affordable Care Act (42 U.S.C. 254b-
2(b)(1)(F)) is amended--
            (1) by striking ``and'' before ``$4,000,000,000'' and 
        inserting a comma; and
            (2) by inserting ``, and $4,200,000,000 for each of fiscal 
        years 2024 and 2025'' before the semicolon.
    (c) Extension for the National Health Service Corps.--Section 
10503(b)(2) of the Patient Protection and Affordable Care Act (42 
U.S.C. 254b-2(b)(2)) is amended--
            (1) in subparagraph (G), by striking ``and'' at the end;
            (2) in subparagraph (H), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(I) $350,000,000 for each of fiscal years 2024 
                and 2025.''.
    (d) Application of Provisions.--Amounts appropriated pursuant to 
the amendments made by this section shall be subject to the 
requirements contained in Public Law 117-328 for funds for programs 
authorized under sections 330 through 340 of the Public Health Service 
Act.
    (e) Conforming Amendment.--Paragraph (4) of section 3014(h) of 
title 18, United States Code, is amended by striking ``and section 
301(d) of division BB of the Consolidated Appropriations Act, 2021.'' 
and inserting ``section 301(d) of division BB of the Consolidated 
Appropriations Act, 2021, and section 201(d) of the PATIENT Act of 
2023''.

SEC. 202. EXTENSION OF SPECIAL DIABETES PROGRAMS.

    (a) Extension of Special Diabetes Programs for Type I Diabetes.--
Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c-
2(b)(2)) is amended--
            (1) in subparagraph (C), by striking ``and'' at the end;
            (2) in subparagraph (D), by striking the period and 
        inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(E) $170,000,000 for each of fiscal years 2024 
                and 2025.''.
    (b) Extending Funding for Special Diabetes Programs for Indians.--
Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c-
3(c)(2)) is amended--
            (1) in subparagraph (C), by striking ``and'' at the end;
            (2) in subparagraph (D), by striking the period and 
        inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(E) $170,000,000 for each of fiscal years 2024 
                and 2025.''.

SEC. 203. DELAYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL PAYMENT 
              REDUCTIONS UNDER THE MEDICAID PROGRAM.

    Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C.1396r-
4(f)(7)(A)) is amended--
            (1) in clause (i), in the matter preceding subclause (I), 
        by striking ``2024'' and inserting ``2026''; and
            (2) in clause (ii), by striking ``2024'' and inserting 
        ``2026''.

SEC. 204. MEDICAID IMPROVEMENT FUND.

    Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w-
1(b)(3)(A)) is amended by striking ``$7,000,000,000'' and inserting 
``$0''.

                 TITLE III--REDUCING HEALTH CARE COSTS

SEC. 301. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.

    (a) In General.--Section 505(j)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the 
following:
    ``(H)(i) Upon request (in controlled correspondence or an analogous 
process) by a person that has submitted or intends to submit an 
abbreviated application under this subsection for a drug that is 
required by regulation to contain one or more of the same inactive 
ingredients in the same concentrations as the listed drug referred to, 
or for which the Secretary determines there is a scientific 
justification for an approach that is in vitro in whole or in part to 
be used to demonstrate bioequivalence for a drug if such a drug 
contains one or more of the same inactive ingredients in the same 
concentrations as the listed drug, the Secretary shall inform the 
person whether such drug is qualitatively and quantitatively the same 
as the listed drug. The Secretary may also provide such information to 
such a person on the Secretary's own initiative during the review of an 
abbreviated application under this subsection for such drug.
    ``(ii) Notwithstanding section 301(j), if the Secretary determines 
that such drug is not qualitatively or quantitatively the same as the 
listed drug, the Secretary shall identify and disclose to the person--
            ``(I) the ingredient or ingredients that cause such drug 
        not to be qualitatively or quantitatively the same as the 
        listed drug; and
            ``(II) for any ingredient for which there is an identified 
        quantitative deviation, whether the quantity or proportion of 
        any ingredient in such drug is greater than or less than the 
        quantity or proportion of such ingredient in the listed drug.
    ``(iii) If the Secretary determines that such drug is qualitatively 
and quantitatively the same as the listed drug, the Secretary shall not 
change or rescind such determination after the submission of an 
abbreviated application for such drug under this subsection unless--
            ``(I) the formulation of the listed drug has been changed 
        and the Secretary has determined that the prior listed drug 
        formulation was withdrawn for reasons of safety or 
        effectiveness; or
            ``(II) the Secretary makes a written determination that the 
        prior determination must be changed because an error has been 
        identified.
    ``(iv) If the Secretary makes a written determination described in 
clause (iii)(II), the Secretary shall provide notice and a copy of the 
written determination to the person making the request under clause 
(i).
    ``(v) The disclosures required by this subparagraph are disclosures 
authorized by law, including for purposes of section 1905 of title 18, 
United States Code.''.
    (b) Guidance.--
            (1) In general.--Not later than one year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance, or update guidance, 
        describing how the Secretary will determine whether a drug is 
        qualitatively and quantitatively the same as the listed drug 
        (as such terms are used in section 505(j)(3)(H) of the Federal 
        Food, Drug, and Cosmetic Act, as added by subsection (a)), 
        including with respect to assessing pH adjusters.
            (2) Process.--In issuing guidance under this subsection, 
        the Secretary of Health and Human Services shall--
                    (A) publish draft guidance;
                    (B) provide a period of at least 60 days for 
                comment on the draft guidance; and
                    (C) after considering any comments received and not 
                later than one year after the close of the comment 
                period on the draft guidance, publish final guidance.
    (c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), applies beginning on the 
date of enactment of this Act, irrespective of the date on which the 
guidance required by subsection (b) is finalized.

SEC. 302. PARITY IN MEDICARE PAYMENTS FOR HOSPITAL OUTPATIENT 
              DEPARTMENT SERVICES FURNISHED OFF-CAMPUS.

    (a) In General.--Section 1833(t)(16) of the Social Security Act (42 
U.S.C. 1395l(t)(16)) is amended by adding at the end the following new 
subparagraph:
                    ``(H) Parity in fee schedule amount for certain 
                services furnished by an off-campus outpatient 
                department of a provider.--
                            ``(i) In general.--Subject to clause (iii), 
                        in the case of specified OPD services (as 
                        defined in clause (iv)) that are furnished 
                        during 2025 or a subsequent year by an off-
                        campus outpatient department of a provider (as 
                        defined in clause (iv)), there shall be 
                        substituted for the amount otherwise determined 
                        under this subsection for such service and year 
                        an amount equal to the payment amount that 
                        would have been payable under the applicable 
                        payment system under this part (other than 
                        under this subsection) had such services been 
                        furnished by such a department subject to such 
                        payment system pursuant to paragraph (21)(C).
                            ``(ii) Not budget neutral implementation.--
                        In making any budget neutrality adjustments 
                        under this subsection for 2025 or a subsequent 
                        year, the Secretary shall not take into account 
                        the reduced expenditures that result from the 
                        application of this subparagraph.
                            ``(iii) Transition.--The Secretary shall 
                        provide for a 4-year phase-in of the 
                        application of clause (i), with clause (i) 
                        being fully applicable for specified OPD 
                        services beginning with 2028.
                            ``(iv) Definitions.--For purposes of this 
                        subparagraph:
                                    ``(I) Designated ambulatory payment 
                                classification group.--The term 
                                `designated ambulatory payment 
                                classification group' means an 
                                ambulatory payment classification group 
                                for drug administration services.
                                    ``(II) Specified opd services 
                                defined.--The term `specified OPD 
                                services' means covered OPD services 
                                included in a designated ambulatory 
                                payment classification group.
                                    ``(III) Off-campus outpatient 
                                department of a provider defined.--The 
                                term `off-campus outpatient department 
                                of a provider' means a department of a 
                                provider (as defined in section 
                                413.65(a)(2) of title 42, Code of 
                                Federal Regulations) that is not 
                                located--
                                            ``(aa) on the campus (as 
                                        such term is defined in such 
                                        section 413.65(a)(2)) of such 
                                        provider; or
                                            ``(bb) within the distance 
                                        (described in such definition 
                                        of campus) from a remote 
                                        location of a hospital facility 
                                        (as defined in such section 
                                        413.65(a)(2)).''.
    (b) Implementation.--Section 1833(t)(12) of the Social Security Act 
(42 U.S.C. 1395l(t)(12)) is amended--
            (1) in subparagraph (D), by striking ``and'' at the end;
            (2) in subparagraph (E), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(F) the determination of any payment amount under 
                paragraph (16)(H), including the transition under 
                clause (iii) of such paragraph.''.

SEC. 303. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE 
              SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.

    (a) Pharmacy Price Reimbursement Requirements.--
            (1) In general.--Section 1927(e) of the Social Security Act 
        (42 U.S.C. 1396r-8(e)) is amended by adding at the end the 
        following:
            ``(6) Pharmacy price reimbursement required.--A contract 
        between the State and a managed care entity (or subcontractor 
        of a managed care entity that manages the pharmacy benefit for 
        such entity (in this section referred to as a `PBM'), or other 
        specified entity (as such terms are defined in section 
        1903(m)(9)(D)) that includes provisions making the managed care 
        entity responsible for coverage of covered outpatient drugs 
        dispensed to individuals enrolled with the entity, shall 
        require that payment for such drugs and related administrative 
        services (as applicable), including payments made by a PBM on 
        behalf of the State or entity, is based on a pass-through 
        pricing model under which--
                    ``(A) any payment made by the entity or the PBM (as 
                applicable) for such a drug--
                            ``(i) is limited to--
                                    ``(I) ingredient cost; and
                                    ``(II) a professional dispensing 
                                fee that is not less than the 
                                professional dispensing fee that the 
                                State plan or waiver would pay if the 
                                plan or waiver was making the payment 
                                directly;
                            ``(ii) is passed through in its entirety by 
                        the entity or PBM to the pharmacy or provider 
                        that dispenses the drug; and
                            ``(iii) is made in a manner that is 
                        consistent with sections 447.502, 447.512, 
                        447.514, and 447.518 of title 42, Code of 
                        Federal Regulations (or any successor 
                        regulation) as if such requirements applied 
                        directly to the entity or the PBM;
                    ``(B) payment to the entity or the PBM (as 
                applicable) for administrative services performed by 
                the entity or PBM is limited to an administrative fee 
                that covers the reasonable cost of providing such 
                services;
                    ``(C) the entity or the PBM (as applicable) shall 
                make available to the State, and the Secretary upon 
                request, all costs and payments related to covered 
                outpatient drugs and accompanying administrative 
                services incurred, received, or made by the entity or 
                the PBM, including ingredient costs, professional 
                dispensing fees, administrative fees, post-sale and 
                post-invoice fees, discounts, or related adjustments 
                such as direct and indirect remuneration fees, and any 
                and all other remuneration; and
                    ``(D) any form of spread pricing whereby any amount 
                charged or claimed by the entity or the PBM (as 
                applicable) is in excess of the amount paid to the 
                pharmacies on behalf of the entity, including any post-
                sale or post-invoice fees, discounts, or related 
                adjustments such as direct and indirect remuneration 
                fees or assessments (after allowing for a reasonable 
                administrative fee as described in subparagraph (B)) is 
                not allowable for purposes of claiming Federal matching 
                payments under this title.''.
            (2) Conforming amendments.--Section 1903(m)(2)(A)(xiii) of 
        such Act (42 U.S.C. 1396b(m)(2)(A)(xiii)) is amended--
                    (A) by striking ``and (III)'' and inserting 
                ``(III)'';
                    (B) by inserting before the period at the end the 
                following: ``, and (IV) the pharmacy benefit provided 
                by the entity (or pharmacy benefit manager on behalf of 
                the entity under a contract), the other specified 
                entity (as defined in paragraph (9)(D)), or by another 
                arrangement between the entity and the pharmacy benefit 
                manager, shall comply with the requirements of section 
                1927(e)(6)''; and
                    (C) by moving the left margin 2 ems to the left.
            (3) Effective date.--The amendments made by this subsection 
        apply to contracts between States and managed care entities, or 
        other specified entities, that have an initial effective date 
        or are renewed on or after the date that is 18 months after the 
        date of enactment of this Act.
    (b) Ensuring Accurate Payments to Pharmacies Under Medicaid.--
            (1) In general.--Section 1927(f) of the Social Security Act 
        (42 U.S.C. 1396r-8(f)) is amended--
                    (A) by striking ``and'' after the semicolon at the 
                end of paragraph (1)(A)(i) and all that precedes it 
                through ``(1)'' and inserting the following:
            ``(1) Determining pharmacy actual acquisition costs.--The 
        Secretary shall conduct a survey of retail community pharmacy 
        drug prices to determine the national average drug acquisition 
        cost as follows:
                    ``(A) Use of vendor.--The Secretary may contract 
                services for--
                            ``(i) with respect to retail community 
                        pharmacies, the determination of retail survey 
                        prices of the national average drug acquisition 
                        cost for covered outpatient drugs based on a 
                        monthly survey of such pharmacies; and'';
                    (B) by adding at the end of paragraph (1) the 
                following:
                    ``(F) Survey reporting.--A State shall require that 
                any retail community pharmacy in the State that 
                receives any payment, reimbursement, administrative 
                fee, discount, or rebate related to the dispensing of 
                covered outpatient drugs to individuals receiving 
                benefits under this title, regardless of whether such 
                payment, reimbursement, administrative fee, discount, 
                or rebate is received from the State or a managed care 
                entity directly or from a pharmacy benefit manager or 
                other specified entity (as defined in section 
                1903(m)(9)(D)) that has a contract with the State or a 
                managed care entity, shall respond to surveys of retail 
                prices conducted under this subsection.
                    ``(G) Survey information.--Information on national 
                drug acquisition prices obtained under this paragraph 
                shall be made publicly available in a timely manner 
                following the collection of such information and shall 
                include at least the following:
                            ``(i) The monthly response rate to the 
                        survey including a list of pharmacies not in 
                        compliance with subparagraph (F).
                            ``(ii) The sampling frame and number of 
                        pharmacies sampled monthly.
                            ``(iii) Information on price concessions to 
                        the pharmacy, including discounts, rebates, and 
                        other price concessions, to the extent that 
                        such information is available during the survey 
                        period.
                    ``(H) Report on specialty pharmacies.--Not later 
                than 1 year after the date that this subparagraph takes 
                effect, the Secretary shall submit to Congress a report 
                examining specialty drug coverage and reimbursement 
                under this title, including--
                            ``(i) a description of how State Medicaid 
                        programs define specialty drugs and specialty 
                        pharmacies;
                            ``(ii) the amount State Medicaid programs 
                        pay for specialty drugs;
                            ``(iii) how States and managed care 
                        entities determine payment for specialty drugs;
                            ``(iv) the settings in which specialty 
                        drugs are dispensed to individuals receiving 
                        benefits under this title (such as retail 
                        community pharmacies or specialty pharmacies);
                            ``(v) the extent to which speciality drugs 
                        (as defined by the respective States) are 
                        captured in the national average drug 
                        acquisition cost survey (or through another 
                        process);
                            ``(vi) examples of specialty drug 
                        dispensing fees to support the services 
                        associated with dispensing such specialty 
                        drugs; and
                            ``(vii) recommendations as to whether 
                        specialty pharmacies should be included in the 
                        survey of retail prices to ensure national 
                        average drug acquisition costs capture drugs 
                        sold at specialty pharmacies, and how such 
                        specialty pharmacies should be defined.
                    ``(I) Enforcement.--At the discretion of the 
                Secretary, the Secretary may enforce non-compliance 
                with this paragraph by a pharmacy through the 
                establishment of penalties or the suspension of 
                payments under this title, in full or in part, until 
                compliance with this paragraph has been completed.''; 
                and
                    (C) in paragraph (2)--
                            (i) in subparagraph (A), by inserting 
                        ``(including payment rates under Medicaid 
                        managed care plans)'' after ``under this 
                        title''; and
                            (ii) in subparagraph (B), by inserting ``, 
                        and the basis for such dispensing fees'' before 
                        the semicolon at the end.
            (2) Effective date.--The amendments made by this subsection 
        take effect on the first day of the first quarter that begins 
        on or after the date that is 18 months after the date of 
        enactment of this Act.
                                 <all>