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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1895 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  1st Session
                                S. 1895

                      To lower health care costs.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             June 19, 2019

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

_______________________________________________________________________

                                 A BILL

 
                      To lower health care costs.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Lower Health Care 
Costs Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
                 TITLE I--ENDING SURPRISE MEDICAL BILLS

Sec. 101. Protecting patients against out-of-network deductibles in 
                            emergencies.
Sec. 102. Protection against surprise bills.
Sec. 103. Benchmark for payment.
Sec. 104. Effective date.
Sec. 105. Ending surprise air ambulance bills.
Sec. 106. Report.
          TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS

Sec. 201. Biological product patent transparency.
Sec. 202. Orange book modernization.
Sec. 203. Ensuring timely access to generics.
Sec. 204. Protecting access to biological products.
Sec. 205. Preventing blocking of generic drugs.
Sec. 206. Education on biological products.
Sec. 207. Biological product innovation.
Sec. 208. Clarifying the meaning of new chemical entity.
Sec. 209. Streamlining the transition of biological products.
Sec. 210. Orphan drug clarification.
Sec. 211. Prompt approval of drugs related to safety information.
Sec. 212. Conditions of use for biosimilar biological products.
Sec. 213. Modernizing the labeling of certain generic drugs.
            TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE

Sec. 301. Increasing transparency by removing gag clauses on price and 
                            quality information.
Sec. 302. Banning anticompetitive terms in facility and insurance 
                            contracts that limit access to higher 
                            quality, lower cost care.
Sec. 303. Designation of a nongovernmental, nonprofit transparency 
                            organization to lower Americans' health 
                            care costs.
Sec. 304. Protecting patients and improving the accuracy of provider 
                            directory information.
Sec. 305. Timely bills for patients.
Sec. 306. Health plan oversight of pharmacy benefit manager services.
Sec. 307. Government Accountability Office study on profit- and 
                            revenue-sharing in health care.
Sec. 308. Disclosure of direct and indirect compensation for brokers 
                            and consultants to employer-sponsored 
                            health plans and enrollees in plans on the 
                            individual market.
Sec. 309. Ensuring enrollee access to cost-sharing information.
Sec. 310. Strengthening parity in mental health and substance use 
                            disorder benefits.
Sec. 311. Technical amendments.
Sec. 312. Third-party administrators.
                   TITLE IV--IMPROVING PUBLIC HEALTH

Sec. 401. Improving awareness of disease prevention.
Sec. 402. Grants to address vaccine-preventable diseases.
Sec. 403. Guide on evidence-based strategies for public health 
                            department obesity prevention programs.
Sec. 404. Expanding capacity for health outcomes.
Sec. 405. Public health data system modernization.
Sec. 406. Innovation for maternal health.
Sec. 407. Training for health care providers.
Sec. 408. Study on training to reduce and prevent discrimination.
Sec. 409. Perinatal quality collaboratives.
Sec. 410. Integrated services for pregnant and postpartum women.
Sec. 411. Extension for community health centers, the National Health 
                            Service Corps, and teaching health centers 
                            that operate GME programs.
Sec. 412. Other programs.
         TITLE V--IMPROVING THE EXCHANGE OF HEALTH INFORMATION

Sec. 501. Requirement to provide health claims, network, and cost 
                            information.
Sec. 502. Recognition of security practices.
Sec. 503. GAO study on the privacy and security risks of electronic 
                            transmission of individually identifiable 
                            health information to and from entities not 
                            covered by the Health Insurance Portability 
                            and Accountability Act.
Sec. 504. Technical corrections.

                 TITLE I--ENDING SURPRISE MEDICAL BILLS

SEC. 101. PROTECTING PATIENTS AGAINST OUT-OF-NETWORK DEDUCTIBLES IN 
              EMERGENCIES.

    Section 2719A(b) of the Public Health Service Act (42 U.S.C. 300gg-
19a) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A), by 
                inserting ``or a freestanding emergency room'' after 
                ``hospital''; and
                    (B) in subparagraph (C)--
                            (i) in clause (ii)(I), by inserting ``or 
                        emergency room'' after ``emergency 
                        department''; and
                            (ii) in subparagraph (C)(ii)(II), by 
                        adding, ``a deductible,'' after ``(expressed 
                        as''; and
            (2) in paragraph (2)(B)--
                    (A) in clause (i)--
                            (i) by inserting ``or freestanding 
                        emergency room'' after ``hospital''; and
                            (ii) by inserting ``or emergency room'' 
                        after ``emergency department''; and
                    (B) in clause (ii), by inserting ``or emergency 
                room'' after ``hospital''.

SEC. 102. PROTECTION AGAINST SURPRISE BILLS.

    (a) PHSA.--Section 2719A of the Public Health Service Act (42 
U.S.C. 300gg-19a) is amended by adding at the end the following:
    ``(e) Coverage of Certain Out-of-Network Services.--
            ``(1) In general.--Subject to subsection (h), in the case 
        of an enrollee in a group health plan or group or individual 
        health insurance coverage who receives out-of-network, 
        ancillary, non-emergency services at an in-network facility, 
        including any referrals for diagnostic services--
                    ``(A) the cost-sharing requirement (expressed as a 
                copayment amount, coinsurance rate, or deductible) with 
                respect to such services shall be the same requirement 
                that would apply if such services were provided by an 
                in-network practitioner, and any coinsurance or 
                deductible shall be based on in-network rates; and
                    ``(B) such cost-sharing amounts shall be counted 
                towards the in-network deductible and in-network out-
                of-pocket maximum amount under the plan or coverage for 
                the plan year.
            ``(2) Definition.--For purposes of this subsection, the 
        term `facility' has the meaning given the term `health care 
        facility' in section 2729A(c).
    ``(f) Coverage of Out-of-Network Services for Enrollees Admitted 
After Emergency Services.--
            ``(1) Notice and consent.--Subject to subsection (h), in 
        the case of an enrollee in a group health plan or group or 
        individual health insurance coverage who receives emergency 
        services, or maternal care for a woman in labor, in the 
        emergency department of an out-of-network facility and has been 
        stabilized (within the meaning of subsection (b)(2)(C)), if the 
        patient is subsequently admitted to the out-of-network facility 
        for care, the cost-sharing requirement (expressed as a 
        copayment amount, coinsurance rate, or deductible) with respect 
        to any out-of-network services is the same requirement that 
        would apply if such services were provided by a participating 
        provider, unless the enrollee, once stable and in a condition 
        to receive such information, including having sufficient mental 
        capacity--
                    ``(A) has been provided by the facility, prior to 
                the provision of any post-stabilization, out-of-network 
                service at such facility, with--
                            ``(i) paper and electronic notification 
                        that the practitioner or facility is an out-of-
                        network health care provider and the out-of-
                        network rate of the provider, as applicable, 
                        and the option to affirmatively consent to 
                        receiving services from such practitioner or 
                        facility; and
                            ``(ii) the estimated amount that such 
                        provider may charge the participant, 
                        beneficiary, or enrollee for such items and 
                        services involved;
                    ``(B) has been provided by the plan or coverage, 
                prior to the provision of any post-stabilization, out-
                of-network service at such facility, with--
                            ``(i) paper and electronic notification 
                        that the practitioner or facility is an out-of-
                        network health care provider and the out-of-
                        network rate of the provider, as applicable, 
                        and the option to affirmatively consent to 
                        receiving services from such practitioner or 
                        facility;
                            ``(ii) a list of in-network practitioners 
                        or facilities that could provide the same 
                        services, and an option for a referral to such 
                        providers; and
                            ``(iii) information about whether prior 
                        authorization or other care management 
                        limitations may be required in advance of 
                        receiving in-network care at the facility; and
                    ``(C) has acknowledged that the out-of-network 
                treatment may not be covered or may be covered at an 
                out-of-network cost-sharing amount, requiring higher 
                cost-sharing obligations of the enrollee than if the 
                service were provided at an in-network facility, and 
                has assumed, in writing, full responsibility of out-of-
                pocket costs associated with services furnished after 
                the enrollee has been stabilized, from the out-of-
                network practitioner or facility, as applicable.
            ``(2) Requirements of notice.--The notice under paragraph 
        (1) shall be in a format determined by the Secretary to give a 
        reasonable layperson clear comprehension of the terms of the 
        agreement, including all possible financial responsibilities, 
        including the requirements that the notice--
                    ``(A) does not exceed one page in length;
                    ``(B) is readily identifiable for its purpose and 
                as a contract of consent;
                    ``(C) clearly states that consent is optional;
                    ``(D) includes an estimate of the amount that such 
                provider will charge the participant, beneficiary, or 
                enrollee for such items and services involved; and
                    ``(E) be available in the 15 most common languages 
                in the facility's geographic area, with the facility 
                making a good faith effort to provide oral notice in 
                the enrollee's primary language if it is not one of 
                such 15 languages.
    ``(g) Prohibition on Billing More Than an In-Network Rate Under 
Certain Circumstances.--
            ``(1) In general.--A facility or practitioner furnishing--
                    ``(A) emergency services, as defined in subsection 
                (b)(2), regardless of the State in which the patient 
                resides;
                    ``(B) services at an in-network facility described 
                in subsection (e); or
                    ``(C) out-of-network services furnished after the 
                enrollee has been stabilized (within the meaning of 
                subsection (b)(2)(C)), where the notice and option for 
                referral required under subsection (f)(1) have not been 
                provided to the enrollee and the assumption of 
                responsibility for out-of-pocket costs under subsection 
                (f)(2) has not been obtained,
        may not bill an enrollee in a group health plan or group or 
        individual health insurance coverage for amounts beyond the 
        cost-sharing amount that would apply under subsection 
        (b)(1)(C)(ii)(II), (e), or (f), as applicable.
            ``(2) Notice.--A facility furnishing services described in 
        paragraph (1) shall provide enrollees in a group health plan or 
        group or individual health insurance coverage with a one-page 
        notice, in 16-point font, upon intake at the emergency room or 
        being admitted at the facility of the prohibition on balance 
        billing under paragraph (1) and who to contact for recourse if 
        they are sent a balance bill in violation of such paragraph. 
        The facility shall be responsible for obtaining the signature 
        from the enrollee on such notice. The Secretary shall issue 
        regulations within 6 months of the date of enactment of the 
        Lower Health Care Costs Act on the requirements for the notice 
        under this paragraph.
            ``(3) Enforcement.--
                    ``(A) In general.--Subject to subparagraph (B), a 
                facility or practitioner that violates a requirement 
                under paragraph (1) shall be subject to a civil 
                monetary penalty of not more than $10,000 for each act 
                constituting such violation.
                    ``(B) Procedure.--The provisions of section 1128A 
                of the Social Security Act, other than subsections (a) 
                and (b) and the first sentence of subsection (c)(1) of 
                such section, shall apply to civil money 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.
                    ``(C) Safe harbor.--The Secretary shall waive the 
                penalties described under subparagraph (A) with respect 
                to a facility or, practitioner who unknowingly violates 
                paragraph (1) with respect to an enrollee, if such 
                facility or practitioner, within 30 days of the 
                violation, withdraws the bill that was in violation of 
                paragraph (1), and, as applicable, reimburses the group 
                health plan, health insurance issuer, or enrollee, as 
                applicable, in an amount equal to the amount billed in 
                violation of paragraph (1), plus interest, at an 
                interest rate determined by the Secretary.
    ``(h) Maintaining State Surprise Billing Protections.--
            ``(1) In general.--Notwithstanding section 514 of the 
        Employee Retirement Income Security Act of 1974, except with 
        respect to self-insured group health plans, nothing in this 
        section shall prevent a State from establishing or continuing 
        in effect an alternate method under State law for determining 
        the appropriate compensation for services described in 
        subsection (b), (e), or (f).
            ``(2) Additional application.--In the case of group health 
        plans or health insurance coverage in the individual or group 
        market offered in a State that has not enacted an alternate 
        method described in paragraph (1), such as arbitration or a 
        benchmark, or for services described in subsection (b), (e), or 
        (f) that are not covered by such State's alternate method 
        described in paragraph (1), the provisions of this section 
        shall apply.
            ``(3) Self-insured plans.--Subsections (b), (e), and (f) 
        shall apply to a self-insured group health plan that is not 
        subject to State insurance regulation.''.
    (b) Coverage Under Federal Employees Health Benefits Program.--
Section 8904 of title 5, United States Code, is amended by adding at 
the end the following:
    ``(c) Any health benefits plan offered under this chapter shall be 
treated as a group health plan or group or individual health insurance 
coverage for purposes of subsections (e) through (g) of section 2719A 
of the Public Health Service Act (42 U.S.C. 300gg-19a) (except for 
paragraph (3) of such subsection (g)).''.

SEC. 103. BENCHMARK FOR PAYMENT.

    (a) In General.--Subpart II of part A of title XXVII of the Public 
Health Service Act (42 U.S.C. 300gg-11 et seq.) is amended by adding at 
the end the following:

``SEC. 2729A. BENCHMARK FOR PAYMENT.

    ``(a) Establishment of Benchmark.--A group health plan or health 
insurance issuer offering group or individual health insurance coverage 
shall pay facilities or practitioners furnishing services for which 
such facilities and practitioners are prohibited from billing enrollees 
under section 2719A(g), the median in-network rate, using a methodology 
determined under subsection (b) for the same or similar services 
offered by the group health plan or health insurance issuer in that 
geographic region.
    ``(b) Median In-Network Rate.--
            ``(1) In general.--For purposes of this section, the term 
        `median in-network rate' means, with respect to health care 
        services covered by a group health plan or group or individual 
        health insurance coverage, the median negotiated rate under the 
        applicable plan or coverage recognized under the plan or 
        coverage as the total maximum payment for the service minus the 
        in-network cost-sharing for such service under the plan or 
        coverage, for the same or a similar service that is provided by 
        a provider in the same or similar specialty and in the 
        geographic region in which the service is furnished.
            ``(2) Rulemaking.--Not later than 1 year after the date of 
        enactment of the Lower Health Care Costs Act, the Secretary 
        shall, through rulemaking, determine the methodology a group 
        health plan or health insurance issuer is required to use to 
        determine the median in-network rate described in paragraph 
        (1), differentiating by business line, the information the plan 
        or issuer shall share with the nonparticipating provider 
        involved when making such a determination, and the geographic 
        regions applied for purposes of this subparagraph. Such 
        rulemaking shall take into account payments that are made by 
        health insurance issuers that are not on a fee-for-service 
        basis.
            ``(3) Certain insurers.--If a group health plan or health 
        insurance issuer offering group or individual health insurance 
        coverage does not have sufficient information to calculate a 
        median in-network rate for this service or provider type, or 
        amount of, claims for services (as determined by the applicable 
        State authority, in the case of health insurance coverage, or 
        by the Secretary of Labor, in the case of a self-insured group 
        health plan) covered under the list of out-of-network services 
        set by the State authority or Secretary of Labor, as 
        applicable, in a particular geographic area, such plan or 
        issuer shall demonstrate that it will use a database free of 
        conflicts of interest that has sufficient information 
        reflecting allowed amounts paid to individual health care 
        providers for relevant services provided in the applicable 
        geographic region, and that such plan or issuer will use that 
        database to determine a median in-network rate. The group 
        health plan or health insurance issuer shall cover the cost of 
        accessing the database.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall prevent a group health plan or health insurance issuer 
        from establishing separate calculations of a median in-network 
        rate under paragraph (1) for services delivered in nonhospital 
        facilities, including freestanding emergency rooms.
    ``(c) Facility.--For purposes of this section, the term `health 
care facility' includes hospitals, hospital outpatient departments, 
critical access hospitals, ambulatory surgery centers, laboratories, 
radiology clinics, and any other facility that provides services that 
are covered under a group health plan or health insurance coverage, 
including settings of care subject to section 2719A(b).''.
    (b) Non-Federal Governmental Plans.--Section 2722(a)(2)(E) of the 
Public Health Service Act (42 U.S.C. 300gg-21(a)(2)(E)) is amended by 
inserting ``, except that such election shall be available with respect 
to section 2729A'' before the period.

SEC. 104. EFFECTIVE DATE.

    The amendments made by sections 101, 102, and 103 shall take effect 
beginning in the second plan year that begins after the date of 
enactment of this Act.

SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS.

    (a) In General.--Part A of title XXVII of the Public Health Service 
Act is amended by inserting after section 2719A (42 U.S.C. 300gg-19a) 
the following:

``SEC. 2719B. ENDING SURPRISE AIR AMBULANCE BILLS.

    ``(a) In General.--In the case of an enrollee in a group health 
plan or group or individual health insurance coverage who receives air 
ambulance services from an out-of-network provider--
            ``(1) the cost-sharing requirement (expressed as a 
        copayment amount, coinsurance rate, or deductible) with respect 
        to such services shall be the same requirement that would apply 
        if such services were provided by an in-network practitioner, 
        and any coinsurance or deductible shall be based on in-network 
        rates; and
            ``(2) such cost-sharing amounts shall be counted towards 
        the in-network deductible and in-network out-of-pocket maximum 
        amount under the plan or coverage for the plan year.
    ``(b) Payment Rate.--A group health plan or health insurance issuer 
shall pay for air ambulance services for purposes of subsection (a) at 
the median in-network as defined in subsection (c).
    ``(c) Median In-Network Rate.--
            ``(1) In general.--For purposes of this section, the term 
        `median in-network rate' means, with respect to air ambulance 
        services covered by a group health plan or group or individual 
        health insurance coverage, the median negotiated rate under the 
        applicable plan or coverage recognized under the plan or 
        coverage as the total maximum payment for the service, minus 
        the in-network cost-sharing for such service under the plan or 
        coverage, for the same or a similar service that is provided by 
        a provider in the same or similar specialty, and in the 
        geographic region in which the service is furnished.
            ``(2) Rulemaking.--Not later than 6 months after the date 
        of enactment of the Lower Health Care Costs Act, the Secretary 
        shall, through rulemaking, determine the methodology a group 
        health plan or health insurance issuer is required to use to 
        determine the median in-network rate described in paragraph 
        (1), the information the plan or issuer shall share with the 
        non-participating provider involved when making such a 
        determination, and the geographic regions applied for purposes 
        of this subsection. Such rulemaking shall take into account 
        payments that are made by issuers that are not on a fee-for-
        service basis.
            ``(3) Certain insurers.--If a group health plan or health 
        insurance issuer offering group or individual health insurance 
        coverage does not have sufficient information to calculate a 
        median in-network rate for this service or provider type, or 
        amount of, claims for services (as determined by the applicable 
        State authority, in the case of health insurance coverage, or 
        by the Secretary of Labor, in the case of a self-insured group 
        health plan) covered under the list of out-of-network services 
        set by the State authority or Secretary of Labor, as 
        applicable, in a particular geographic area, such plan or 
        issuer shall demonstrate that it will use a database free of 
        conflicts of interest that has sufficient information 
        reflecting allowed amounts paid to individual health care 
        providers for relevant services provided in the applicable 
        geographic region, and that such plan or issuer will use that 
        database to determine a median in-network rate. The group 
        health plan or health insurance issuer shall cover the cost of 
        accessing the database.
            ``(4) Clarification.--For purposes of this subsection, the 
        Secretary may define geographic regions that are different from 
        the geographic regions identified for purposes of section 
        2729A(b) to ensure that an adequate number of air ambulance 
        services are in-network in each geographic region so that a 
        median in-network rate for air ambulance services may be 
        calculated for each such region.
    ``(d) Cost-Sharing Limitation.--An air ambulance service provider 
may not bill an enrollee in a group health plan or group or individual 
health insurance coverage for amounts beyond the cost-sharing amount 
that applies under subsection (a).
    ``(e) Enforcement.--
            ``(1) In general.--Subject to paragraph (2), an air 
        ambulance service provider that violates subsection (d) shall 
        be subject to a civil monetary penalty of not more than $10,000 
        for each act constituting such violation.
            ``(2) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsections (a) and (b) and the 
        first sentence of subsection (c)(1) of such section, shall 
        apply to civil money 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.
            ``(3) Safe harbor.--The Secretary shall waive the penalties 
        described under paragraph (1) with respect to an air ambulance 
        service provider who unknowingly violates subsection (d) with 
        respect to an enrollee, if such air ambulance service provider 
        within 30 days of the violation, withdraws the bill that was in 
        violation of subsection (d), and, as applicable, reimburses the 
        group health plan, health insurance issuer, or enrollee, as 
        applicable, in an amount equal to the amount billed in 
        violation of subsection (d), plus interest, at an interest rate 
        determined by the Secretary.''.
    (b) Effective Date.--Section 2719B of the Public Health Service 
Act, as added by subsection (a), shall take effect on the date that is 
1 year after the date of enactment of this Act.

SEC. 106. REPORT.

    Not later than 1 year after the effective date described in section 
104, and annually for the following 4 years, the Secretary of Health 
and Human Services, in consultation with the Federal Trade Commission 
and the Attorney General, shall--
            (1) conduct a study on--
                    (A) the effects of the amendments made by sections 
                101, 102, and 103, including any patterns of vertical 
                or horizontal integration of health care facilities, 
                providers, group health plans, or health insurance 
                issuers;
                    (B) the effects of the amendments made by sections 
                101, 102, and 103 on overall health care costs; and
                    (C) recommendations for effective enforcement of 
                2729A as added by section 103, including potential 
                challenges to addressing anti-competitive consolidation 
                by health care facilities, providers, group health 
                plans, or health insurance issuers; and
            (2) submit a report on such study to the Committee on 
        Health, Education, Labor, and Pensions, the Committee on 
        Commerce, Science, and Transportation, the Committee on 
        Finance, and the Committee on the Judiciary of the Senate and 
        the Committee on Education and Labor, the Committee on Energy 
        and Commerce, the Committee on Ways and Means, and the 
        Committee on the Judiciary of the House of Representatives.

          TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS

SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended by adding at the end the following:
    ``(o) Additional Requirements With Respect to Patents.--
            ``(1) Approved application holder listing requirements.--
                    ``(A) In general.--Beginning on the date of 
                enactment of the Lower Health Care Costs Act, within 60 
                days of approval of an application under subsection (a) 
                or (k), the holder of such approved application shall 
                submit to the Secretary a list of each patent required 
                to be disclosed (as described in paragraph (3)).
                    ``(B) Previously approved or licensed biological 
                products.--
                            ``(i) Products licensed under section 351 
                        of the phsa.--Not later than 30 days after the 
                        date of enactment of the Lower Health Care 
                        Costs Act, the holder of a biological product 
                        license that was approved under subsection (a) 
                        or (k) before the date of enactment of such Act 
                        shall submit to the Secretary a list of each 
                        patent required to be disclosed (as described 
                        in paragraph (3)).
                            ``(ii) Products approved under section 505 
                        of the ffdca.--Not later than 30 days after 
                        March 23, 2020, the holder of an approved 
                        application for a biological product under 
                        section 505 of the Federal Food, Drug, and 
                        Cosmetic Act that is deemed to be a license for 
                        the biological product under this section on 
                        March 23, 2020, shall submit to the Secretary a 
                        list of each patent required to be disclosed 
                        (as described in paragraph (3)).
                    ``(C) Updates.--The holder of a biological product 
                license that is the subject of an application under 
                subsection (a) or (k) shall submit to the Secretary a 
                list that includes--
                            ``(i) any patent not previously required to 
                        be disclosed (as described in paragraph (3)) 
                        under subparagraph (A) or (B), as applicable, 
                        within 30 days of the earlier of--
                                    ``(I) the date of issuance of such 
                                patent by the United States Patent and 
                                Trademark Office; or
                                    ``(II) the date of approval of a 
                                supplemental application for the 
                                biological product; and
                            ``(ii) any patent, or any claim with 
                        respect to a patent, included on the list 
                        pursuant to this paragraph, that the Patent 
                        Trial and Appeal Board of the United States 
                        Patent and Trademark Office determines in a 
                        decision to be invalid or unenforceable, within 
                        30 days of such decision.
            ``(2) Publication of information.--
                    ``(A) In general.--Within 1 year of the date of 
                enactment of the Lower Health Care Costs Act, the 
                Secretary shall publish and make available to the 
                public a single, easily searchable, list that 
                includes--
                            ``(i) the official and proprietary name of 
                        each biological product licensed under 
                        subsection (a) or (k), and of each biological 
                        product application approved under section 505 
                        of the Federal Food, Drug, and Cosmetic Act and 
                        deemed to be a license for the biological 
                        product under this section on March 23, 2020;
                            ``(ii) with respect to each biological 
                        product described in clause (i), each patent 
                        submitted in accordance with paragraph (1);
                            ``(iii) the date of approval and 
                        application number for each such biological 
                        product;
                            ``(iv) the marketing status, dosage form, 
                        route of administration, strength, and, if 
                        applicable, reference product, for each such 
                        biological product;
                            ``(v) the licensure status for each such 
                        biological product, including whether the 
                        license at the time of listing is approved, 
                        withdrawn, or revoked;
                            ``(vi) with respect to each such biological 
                        product, any period of any exclusivity under 
                        paragraph (6), (7)(A), or (7)(B) of subsection 
                        (k) of this section or section 527 of the 
                        Federal Food, Drug, and Cosmetic Act, and any 
                        extension of such period in accordance with 
                        subsection (m) of this section, for which the 
                        Secretary has determined such biological 
                        product to be eligible, and the date on which 
                        such exclusivity expires;
                            ``(vii) information regarding any 
                        determination of biosimilarity or 
                        interchangeability for each such biological 
                        product; and
                            ``(viii) information regarding approved 
                        indications for each such biological product, 
                        in such manner as the Secretary determines 
                        appropriate.
                    ``(B) Updates.--Every 30 days after the publication 
                of the first list under subparagraph (A), the Secretary 
                shall revise the list to include--
                            ``(i)(I) each biological product licensed 
                        under subsection (a) or (k) during the 30-day 
                        period; and
                            ``(II) with respect to each biological 
                        product described in subclause (I), the 
                        information described in clauses (i) through 
                        (viii) of subparagraph (A); and
                            ``(ii) any updates to information 
                        previously published in accordance with 
                        subparagraph (A).
                    ``(C) Noncompliance.--Beginning 18 months after the 
                date of enactment of the Lower Health Care Costs Act, 
                the Secretary, in consultation with the Director of the 
                United States Patent and Trademark Office, shall 
                publish and make available to the public a list of any 
                holders of biological product licenses, and the 
                corresponding biological product or products, that 
                failed to submit information as required under 
                paragraph (1), including any updates required under 
                paragraph (1)(C), in such manner and format as the 
                Secretary determines appropriate. If information 
                required under paragraph (1) is submitted following 
                publication of such list, the Secretary shall remove 
                such holders of such biological product licenses from 
                the public list in a reasonable period of time.
            ``(3) Patents required to be disclosed.--In this section, a 
        `patent required to be disclosed' is any patent for which the 
        holder of a biological product license approved under 
        subsection (a) or (k), or a biological product application 
        approved under section 505 of the Federal Food, Drug, and 
        Cosmetic Act and deemed to be a license for a biological 
        product under this section on March 23, 2020, believes a claim 
        of patent infringement could reasonably be asserted by the 
        holder, or by a patent owner that has granted an exclusive 
        license to the holder with respect to the biological product 
        that is the subject of such license, if a person not licensed 
        by the holder engaged in the making, using, offering to sell, 
        selling, or importing into the United States of the biological 
        product that is the subject of such license.''.
    (b) Disclosure of Patents.--Section 351(l)(3)(A)(i) of the Public 
Health Service Act (42 U.S.C. 262(l)(3)(A)(i)) is amended by inserting 
``included in the list provided by the reference product sponsor under 
subsection (o)(1)'' after ``a list of patents''.
    (c) Review and Report on Noncompliance.--Not later than 30 months 
after the date of enactment of this Act, the Secretary shall--
            (1) solicit public comments regarding appropriate remedies, 
        in addition to the publication of the list under subsection 
        (o)(2)(C) of section 351 of the Public Health Service Act (42 
        U.S.C. 262), as added by subsection (a), with respect to 
        holders of biological product licenses who fail to timely 
        submit information as required under subsection (o)(1) of such 
        section 351, including any updates required under subparagraph 
        (C) of such subsection (o)(1); and
            (2) submit to Congress an evaluation of comments received 
        under paragraph (1) and the recommendations of the Secretary 
        concerning appropriate remedies.
    (d) Regulations.--The Secretary of Health and Human Services may 
promulgate regulations to carry out subsection (o) of section 351 of 
the Public Health Service Act (42 U.S.C. 262), as added by subsection 
(a).
    (e) Rule of Construction.--Nothing in this Act, including an 
amendment made by this Act, shall be construed to require or allow the 
Secretary of Health and Human Services to delay the licensing of a 
biological product under section 351 of the Public Health Service Act 
(42 U.S.C. 262).

SEC. 202. ORANGE BOOK MODERNIZATION.

    (a) Submission of Patent Information for Brand Name Drugs.--
            (1) In general.--Paragraph (1) of section 505(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is 
        amended to read as follows:
    ``(b)(1)(A) Any person may file with the Secretary an application 
with respect to any drug subject to the provisions of subsection (a). 
Such persons shall submit to the Secretary as part of the application--
            ``(i) full reports of investigations which have been made 
        to show whether or not such drug is safe for use and whether 
        such drug is effective in use;
            ``(ii) a full list of the articles used as components of 
        such drug;
            ``(iii) a full statement of the composition of such drug;
            ``(iv) a full description of the methods used in, and the 
        facilities and controls used for, the manufacture, processing, 
        and packing of such drug;
            ``(v) such samples of such drug and of the articles used as 
        components thereof as the Secretary may require;
            ``(vi) specimens of the labeling proposed to be used for 
        such drug;
            ``(vii) any assessments required under section 505B; and
            ``(viii) the patent number and expiration date, of each 
        patent for which a claim of patent infringement could 
        reasonably be asserted if a person not licensed by the owner 
        engaged in the manufacture, use, or sale of the drug, and 
        that--
                    ``(I) claims the drug for which the applicant 
                submitted the application and is a drug substance 
                patent or a drug product patent; or
                    ``(II) claims the method of using the drug for 
                which approval is sought or has been granted in the 
                application.
    ``(B) If an application is filed under this subsection for a drug, 
and a patent of the type described in subparagraph (A)(viii) that 
claims such drug or a method of using such drug is issued after the 
filing date but before approval of the application, the applicant shall 
amend the application to include such patent information.
    ``(C) Upon approval of the application, the Secretary shall publish 
the information submitted under subparagraph (A)(viii).''.
            (2) Guidance.--The Secretary of Health and Human Services 
        shall, in consultation with the Director of the National 
        Institutes of Health and with representatives of the drug 
        manufacturing industry, review and develop guidance, as 
        appropriate, on the inclusion of women and minorities in 
        clinical trials required under subsection (b)(1)(A)(i) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355), as amended by paragraph (1).
    (b) Conforming Changes to Requirements for Subsequent Submission of 
Patent Information.--Section 505(c)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) is amended--
            (1) by inserting before the first sentence the following: 
        ``Not later than 30 days after the date of approval of an 
        application under subsection (b), the holder of the approved 
        application shall file with the Secretary the patent number and 
        the expiration date of any patent described in subclause (I) or 
        (II) of subsection (b)(1)(A)(viii), except that a patent that 
        claims a method of using such drug shall be filed only if 
        approval for such use has been granted in the application. The 
        holder of the approved application shall file with the 
        Secretary the patent number and the expiration date of any 
        patent described in subclause (I) or (II) of subsection 
        (b)(1)(A)(viii) that is issued after the date of approval of 
        the application, not later than 30 days of the date of issuance 
        of the patent, except that a patent that claims a method of 
        using such drug shall be filed only if approval for such use 
        has been granted in the application.'';
            (2) by inserting after ``the patent number and the 
        expiration date of any patent which'' the following: ``fulfills 
        the criteria in subsection (b) and'';
            (3) by inserting after the third sentence (as amended by 
        paragraph (1)) the following: ``Patent information that is not 
        the type of patent information required by subsection 
        (b)(1)(A)(viii) shall not be submitted under this paragraph.''; 
        and
            (4) by inserting after ``could not file patent information 
        under subsection (b) because no patent'' the following: ``of 
        the type required to be submitted in subsection (b)''.
    (c) Listing of Exclusivities.--Subparagraph (A) of section 
505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)) is amended by adding at the end the following:
    ``(iv) For each drug included on the list, the Secretary shall 
specify any exclusivity period that is applicable, for which the 
Secretary has determined the expiration date, and for which such period 
has not yet expired under--
            ``(I) clause (ii), (iii), or (iv) of subsection (c)(3)(E) 
        of this section;
            ``(II) clause (iv) or (v) of paragraph (5)(B) of this 
        subsection;
            ``(III) clause (ii), (iii), or (iv) of paragraph (5)(F) of 
        this subsection;
            ``(IV) section 505A;
            ``(V) section 505E;
            ``(VI) section 527(a); or
            ``(VII) section 505(u)''.
    (d) Orange Book Updates With Respect to Invalidated Patents.--
            (1) In general.--
                    (A) Amendments.--Section 505(j)(7)(A) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)(7)(A)), as amended by subsection (c), is further 
                amended by adding at the end the following:
            ``(v) In the case of a listed drug for which the list under 
        clause (i) includes a patent or patent claim for the drug, or a 
        patent or a patent claim for the use of such drug, and where 
        the Under Secretary of Commerce for Intellectual Property and 
        Director of the United States Patent and Trademark Office has 
        canceled any claim of the patent relating to such drug or such 
        use pursuant to a decision by the Patent Trial and Appeal Board 
        in an inter partes review conducted under chapter 31 of title 
        35, United States Code, or a post-grant review conducted under 
        chapter 32 of that title, and from which no appeal has been 
        taken, or can be taken, the holder of the applicable approved 
        application shall notify the Secretary, in writing, within 14 
        days of such cancellation, and, if the patent has been deemed 
        wholly inoperative or invalid, or if a patent claim has been 
        canceled, the revisions required under clause (iii) shall 
        include striking the patent or information regarding such 
        patent claim from the list with respect to such drug.''.
                    (B) Application.--The amendment made by 
                subparagraph (A) shall not apply with respect to any 
                determination with respect to a patent or patent claim 
                that is made prior to the date of enactment of this 
                Act.
            (2) No effect on first applicant exclusivity period.--
        Section 505(j)(5)(B)(iv)(I) is amended by adding at the end the 
        following: ``This subclause shall apply even if a patent is 
        stricken from the list under paragraph (7)(A), pursuant to 
        paragraph (7)(A)(v), provided that, at the time that the first 
        applicant submitted an application under this subsection 
        containing a certification described in paragraph 
        (2)(A)(vii)(IV), the patent that was the subject of such 
        certification was included in such list with respect to the 
        listed drug.''.

SEC. 203. ENSURING TIMELY ACCESS TO GENERICS.

    Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(q)(1)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)(i), by inserting ``, 
                10.31,'' after ``10.30'';
                    (B) in subparagraph (E)--
                            (i) by striking ``application and'' and 
                        inserting ``application or'';
                            (ii) by striking ``If the Secretary'' and 
                        inserting the following:
                            ``(i) In general.--If the Secretary''; and
                            (iii) by striking the second sentence and 
                        inserting the following:
                            ``(ii) Primary purpose of delaying.--
                                    ``(I) In general.--For purposes of 
                                this subparagraph, a petition or 
                                supplement to a petition may be 
                                considered to be submitted with the 
                                primary purpose of delaying an 
                                application under subsection (b)(2) or 
                                (j) of this section or section 351(k) 
                                of the Public Health Service Act, if 
                                the petitioner has the purpose of 
                                setting aside, delaying, rescinding, 
                                withdrawing, or preventing submission, 
                                review, or the approval of such an 
                                application.
                                    ``(II) Factors.--In determining 
                                whether a petition was submitted with 
                                the primary purpose of delaying an 
                                application, the Secretary may consider 
                                the following factors:
                                            ``(aa) Whether the petition 
                                        was submitted in accordance 
                                        with paragraph (2)(B), based on 
                                        when the petitioner knew or 
                                        reasonably should have known 
                                        the relevant information relied 
                                        upon to form the basis of such 
                                        petition.
                                            ``(bb) Whether the 
                                        petitioner has submitted 
                                        multiple or serial petitions 
                                        raising issues that reasonably 
                                        could have been known to the 
                                        petitioner at the time of 
                                        submission of the earlier 
                                        petition or petitions.
                                            ``(cc) Whether the petition 
                                        was submitted close in time to 
                                        a known, first date upon which 
                                        an application under subsection 
                                        (b)(2) or (j) of this section 
                                        or section 351(k) of the Public 
                                        Health Service Act could be 
                                        approved.
                                            ``(dd) Whether the petition 
                                        was submitted without any 
                                        relevant data or information in 
                                        support of the scientific 
                                        positions forming the basis of 
                                        such petition.
                                            ``(ee) Whether the petition 
                                        raises the same or 
                                        substantially similar issues as 
                                        a prior petition to which the 
                                        Secretary has responded 
                                        substantively already, 
                                        including if the subsequent 
                                        submission follows such 
                                        response from the Secretary 
                                        closely in time.
                                            ``(ff) Whether the petition 
                                        requests changing the 
                                        applicable standards that other 
                                        applicants are required to 
                                        meet, including requesting 
                                        testing, data, or labeling 
                                        standards that are more onerous 
                                        or rigorous than the standards 
                                        applicable to the listed drug, 
                                        reference product, or 
                                        petitioner's version of the 
                                        same drug.
                                            ``(gg) The petitioner's 
                                        record of submitting petitions 
                                        to the Food and Drug 
                                        Administration that have been 
                                        determined by the Secretary to 
                                        have been submitted with the 
                                        primary purpose of delay.
                                            ``(hh) Other relevant and 
                                        appropriate factors, which the 
                                        Secretary shall describe in 
                                        guidance.
                                    ``(III) Guidance.--The Secretary 
                                may issue or update guidance, as 
                                appropriate, to describe factors the 
                                Secretary considers in accordance with 
                                subclause (II).'';
                    (C) by adding at the end the following:
                            ``(iii) Referral to the federal trade 
                        commission.--The Secretary shall establish 
                        procedures for referring to the Federal Trade 
                        Commission any petition or supplement to a 
                        petition that the Secretary determines was 
                        submitted with the primary purpose of delaying 
                        approval of an application. Such procedures 
                        shall include notification to the petitioner 
                        and an opportunity for judicial review after 
                        the issuance of an order by the Federal Trade 
                        Commission.'';
                    (D) by striking subparagraph (F);
                    (E) by redesignating subparagraphs (G) through (I) 
                as subparagraphs (F) through (H), respectively; and
                    (F) in subparagraph (H), as so redesignated, by 
                striking ``submission of this petition'' and inserting 
                ``submission of this document'';
            (2) in paragraph (2)--
                    (A) by redesignating subparagraphs (A) through (C) 
                as subparagraphs (C) through (E), respectively;
                    (B) by inserting before subparagraph (C), as so 
                redesignated, the following:
                    ``(A) In general.--A person shall submit a petition 
                to the Secretary under paragraph (1) before filing a 
                civil action in which the person seeks to set aside, 
                delay, rescind, withdraw, or prevent submission, 
                review, or approval of an application submitted under 
                subsection (b)(2) or (j) of this section or section 
                351(k) of the Public Health Service Act. Such petition 
                and any supplement to such a petition shall describe 
                all information and arguments that form the basis of 
                the relief requested in any civil action described in 
                the previous sentence.
                    ``(B) Timely submission of citizen petition.--A 
                petition and any supplement to a petition shall be 
                submitted within 60 days after the person knew, or 
                reasonably should have known, the information that 
                forms the basis of the request made in the petition or 
                supplement.'';
                    (C) in subparagraph (C), as so redesignated, by--
                            (i) in the heading, striking ``within 150 
                        days'';
                            (ii) in clause (i), striking ``during the 
                        150-day period referred to in paragraph 
                        (1)(F),''; and
                            (iii) amending clause (ii) to read as 
                        follows:
                            ``(ii) on or after the date that is 151 
                        days after the date of submission of the 
                        petition, the Secretary approves or has 
                        approved the application that is the subject of 
                        the petition without having made such a final 
                        decision.'';
                    (D) by amending subparagraph (D), as so 
                redesignated, to read as follows:
                    ``(D) Dismissal of certain civil actions.--
                            ``(i) Petition.--If a person files a civil 
                        action against the Secretary in which a person 
                        seeks to set aside, delay, rescind, withdraw, 
                        or prevent submission, review, or approval of 
                        an application submitted under subsection 
                        (b)(2) or (j) of this section or section 351(k) 
                        of the Public Health Service Act without 
                        complying with the requirements of subparagraph 
                        (A), the court shall dismiss without prejudice 
                        the action for failure to exhaust 
                        administrative remedies.
                            ``(ii) Timeliness.--If a person files a 
                        civil action against the Secretary in which a 
                        person seeks to set aside, delay, rescind, 
                        withdraw, or prevent submission, review, or 
                        approval of an application submitted under 
                        subsection (b)(2) or (j) of this section or 
                        section 351(k) of the Public Health Service Act 
                        without complying with the requirements of 
                        subparagraph (B), the court shall dismiss with 
                        prejudice the action for failure to timely file 
                        a petition.
                            ``(iii) Final response.--If a civil action 
                        is filed against the Secretary with respect to 
                        any issue raised in a petition timely filed 
                        under paragraph (1) in which the petitioner 
                        requests that the Secretary take any form of 
                        action that could, if taken, set aside, delay, 
                        rescind, withdraw, or prevent submission, 
                        review, or approval of an application submitted 
                        under subsection (b)(2) or (j) of this section 
                        or section 351(k) of the Public Health Service 
                        Act before the Secretary has issued a final 
                        response to any such petition submitted, the 
                        court shall dismiss without prejudice the 
                        action for failure to exhaust administrative 
                        remedies.''; and
                    (E) in subparagraph (E), as so redesignated--
                            (i) in clause (ii), by striking ``, if 
                        issued''; and
                            (ii) in clause (iii), by striking ``final 
                        agency action as defined under subparagraph 
                        (2)(A)'' and inserting ``the final response to 
                        the petitioner''; and
            (3) in paragraph (4)--
                    (A) by striking ``Exceptions'' and all that follows 
                through ``This subsection does'' and inserting 
                ``Exceptions--This subsection does'';
                    (B) by striking subparagraph (B); and
                    (C) by redesignating clauses (i) and (ii) as 
                subparagraphs (A) and (B), respectively, and adjusting 
                the margins accordingly.

SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS.

    Section 351(k)(7) of the Public Health Service Act (42 U.S.C. 
262(k)(7)) is amended by adding at the end the following:
                    ``(D) Deemed licenses.--
                            ``(i) No additional exclusivity through 
                        deeming.--An approved application that is 
                        deemed to be a license for a biological product 
                        under this section pursuant to section 
                        7002(e)(4) of the Biologics Price Competition 
                        and Innovation Act of 2009 shall not be treated 
                        as having been first licensed under subsection 
                        (a) for purposes of subparagraphs (A) and (B).
                            ``(ii) Limitation on exclusivity.--
                        Subparagraph (C) shall apply to any reference 
                        product, without regard to whether--
                                    ``(I) such product was first 
                                licensed under subsection (a); or
                                    ``(II) the approved application for 
                                such product was deemed to be a license 
                                for a biological product as described 
                                in clause (i).
                            ``(iii) Applicability.--Any unexpired 
                        period of exclusivity under section 527 or 
                        section 505A(c)(1)(A)(ii) of the Federal Food, 
                        Drug, and Cosmetic Act with respect to a 
                        biological product shall continue to apply to 
                        such biological product after an approved 
                        application for the biological product is 
                        deemed to be a license for the biological 
                        product as described in clause (i).''.

SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS.

    Section 505(j)(5)(B)(iv)(I) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)(B)(iv)(I)) is amended--
            (1) by striking ``180 days after the date'' and inserting 
        ``180 days after the earlier of the following:
                            ``(aa) The date''; and
            (2) by adding at the end the following:
                            ``(bb) The date on which all of the 
                        following conditions are first met:
                                    ``(AA) An application for the drug 
                                submitted by an applicant other than a 
                                first applicant could receive approval, 
                                if no first applicant were eligible for 
                                180-day exclusivity under this clause.
                                    ``(BB) Thirty-three months have 
                                passed since the date of submission of 
                                an application for the drug by one 
                                first applicant, if there is only one 
                                first applicant, or, in the case of 
                                more than one first applicant, 33 
                                months have passed since the date of 
                                submission of all such applications.
                                    ``(CC) Approval of an application 
                                for the drug submitted by at least one 
                                first applicant would not be precluded 
                                under clause (iii).
                                    ``(DD) No application for the drug 
                                submitted by any first applicant is 
                                approved at the time the conditions 
                                under subitems (AA), (BB), and (CC) are 
                                all met, regardless of whether such an 
                                application is subsequently 
                                approved.''.

SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS.

    Subpart 1 of part F of title III of the Public Health Service Act 
(42 U.S.C. 262 et seq.) is amended by adding at the end the following:

``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.

    ``(a) Internet Website.--
            ``(1) In general.--The Secretary may establish, maintain, 
        and operate an internet website to provide educational 
        materials for health care providers, patients, and caregivers, 
        regarding the meaning of the terms, and the standards for 
        review and licensing of, biological products, including 
        biosimilar biological products and interchangeable biosimilar 
        biological products.
            ``(2) Content.--Educational materials provided under 
        paragraph (1) may include explanations of--
                    ``(A) key statutory and regulatory terms, including 
                `biosimilar' and `interchangeable', and clarification 
                regarding the appropriate use of interchangeable 
                biosimilar biological products;
                    ``(B) information related to development programs 
                for biological products, including biosimilar 
                biological products and interchangeable biosimilar 
                biological products and relevant clinical 
                considerations for prescribers, which may include, as 
                appropriate and applicable, information related to the 
                comparability of such biological products;
                    ``(C) the process for reporting adverse events for 
                biological products, including biosimilar biological 
                products and interchangeable biosimilar biological 
                products; and
                    ``(D) the relationship between biosimilar 
                biological products and interchangeable biosimilar 
                biological products licensed under section 351(k) and 
                reference products (as defined in section 351(i)), 
                including the standards for review and licensing of 
                each such type of biological product.
            ``(3) Format.--The educational materials provided under 
        paragraph (1) may be--
                    ``(A) in formats such as webinars, continuing 
                medical education modules, videos, fact sheets, 
                infographics, stakeholder toolkits, or other formats as 
                appropriate and applicable; and
                    ``(B) tailored for the unique needs of health care 
                providers, patients, caregivers, and other audiences, 
                as the Secretary determines appropriate.
            ``(4) Other information.--In addition to the information 
        described in paragraph (2), the internet website established 
        under paragraph (1) shall include the following information, as 
        a single, searchable database:
                    ``(A) The action package of each biological product 
                licensed under subsection (a) or (k), within 30 days of 
                licensure, or, in the case of a biological product 
                licensed before the date of enactment of the Lower 
                Health Care Costs Act, not later than 1 year after such 
                date of enactment.
                    ``(B) The summary review of each biological product 
                licensed under subsection (a) or (k), within 7 days of 
                licensure, except where such materials require 
                redaction by the Secretary, or, in the case of a 
                biological product licensed before the date of 
                enactment of the Lower Health Care Costs Act, not later 
                than 1 year after such date of enactment.
            ``(5) Confidential and trade secret information.--This 
        subsection does not authorize the disclosure of any trade 
        secret, confidential commercial or financial information, or 
        other matter described in section 552(b) of title 5.
    ``(b) Continuing Medical Education.--The Secretary shall advance 
education and awareness among health care providers regarding 
biological products, including biosimilar biological products and 
interchangeable biosimilar biological products, as appropriate, 
including by developing or improving continuing medical education 
programs that advance the education of such providers on the 
prescribing of, and relevant clinical considerations with respect to 
biological products, including biosimilar biological products and 
interchangeable biosimilar biological products.''.

SEC. 207. BIOLOGICAL PRODUCT INNOVATION.

    Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) 
is amended--
            (1) by striking ``except that a product'' and inserting 
        ``except that--
            ``(1) a product'';
            (2) by striking ``Act.'' and inserting ``Act; and''; and
            (3) by adding at the end the following:
            ``(2) no requirement under such Act regarding an official 
        compendium (as defined in section 201(j) of such Act), or other 
        reference in such Act to an official compendium (as so 
        defined), shall apply with respect to a biological product 
        subject to regulation under this section.''.

SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended--
            (1) in section 505 (21 U.S.C. 355)--
                    (A) in subsection (c)(3)(E)--
                            (i) in clause (ii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))''; and
                            (ii) in clause (iii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))'';
                    (B) in subsection (j)(5)(F)--
                            (i) in clause (ii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))''; and
                            (ii) in clause (iii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))'';
                    (C) in subsection (l)(2)(A)(i), by striking 
                ``active ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active moiety (as 
                defined by the Secretary in section 314.3 of title 21, 
                Code of Federal Regulations (or any successor 
                regulations))'';
                    (D) in subsection (s), in the matter preceding 
                paragraph (1), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))''; 
                and
                    (E) in subsection (u)(1), in the matter preceding 
                subparagraph (A)--
                            (i) by striking ``active ingredient 
                        (including any ester or salt of the active 
                        ingredient)'' and inserting ``active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations))''; and
                            (ii) by striking ``same active ingredient'' 
                        and inserting ``same active moiety'';
            (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F))--
                    (A) in clause (i), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))'';
                    (B) in clause (ii), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))''; 
                and
                    (C) in clause (v), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))'';
            (3) in section 524(a)(4)(C) (21 U.S.C. 360n(a)(4)(C)), by 
        striking ``active ingredient (including any ester or salt of 
        the active ingredient)'' and inserting ``active moiety (as 
        defined by the Secretary in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations))'';
            (4) in section 529(a)(4)(A)(ii) (21 U.S.C. 
        360ff(a)(4)(A)(ii)), by striking ``active ingredient (including 
        any ester or salt of the active ingredient)'' and inserting 
        ``active moiety (as defined by the Secretary in section 314.3 
        of title 21, Code of Federal Regulations (or any successor 
        regulations))''; and
            (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb-
        4a(a)(4)(D)), by striking ``active ingredient (including any 
        ester or salt of the active ingredient)'' and inserting 
        ``active moiety (as defined by the Secretary in section 314.3 
        of title 21, Code of Federal Regulations (or any successor 
        regulations))''.

SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL PRODUCTS.

    Section 7002(e)(4) of the Biologics Price Competition and 
Innovation Act of 2009 (Public Law 111-148) is amended by adding at the 
end the following: ``With respect to an application for a biological 
product under section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) with a filing date that is not later than September 23, 
2019, the Secretary shall continue to review and approve such 
application under section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355), even if such review and approval process continues 
after March 23, 2020. Effective on the later of March 23, 2020, or the 
date of approval of such application under such section 505, such 
approved application shall be deemed to be a license for the biological 
product under section 351 of the Public Health Service Act.''.

SEC. 210. ORPHAN DRUG CLARIFICATION.

    Section 527(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360cc(c)) is amended by adding at the end the following:
            ``(3) Applicability.--This subsection applies to any drug 
        designated under section 526 that was approved under section 
        505 of this Act or licensed under section 351 of the Public 
        Health Service Act after the date of enactment of the FDA 
        Reauthorization Act of 2017, regardless of the date of on which 
        such drug was designated under section 526.''.

SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO SAFETY INFORMATION.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(z) Prompt Approval of Drugs When Safety Information Is Added to 
Labeling.--
            ``(1) General rule.--A drug for which an application has 
        been submitted or approved under subsection (b)(2) or (j) shall 
        not be considered ineligible for approval under this section or 
        misbranded under section 502 on the basis that the labeling of 
        the drug omits safety information, including contraindications, 
        warnings, precautions, dosing, administration, or other 
        information pertaining to safety, when the omitted safety 
        information is protected by exclusivity under clause (iii) or 
        (iv) of subsection (j)(5)(F), clause (iii) or (iv) of 
        subsection (c)(3)(E), or section 527(a), or by an extension of 
        such exclusivity under section 505A or 505E.
            ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
        subsection (j)(5)(F), clauses (iii) and (iv) of subsection 
        (c)(3)(E), or section 527, the Secretary shall require that the 
        labeling of a drug approved pursuant to an application 
        submitted under subsection (b)(2) or (j) that omits safety 
        information described in paragraph (1) include a statement of 
        any appropriate safety information that the Secretary considers 
        necessary to assure safe use.
            ``(3) Availability and scope of exclusivity.--This 
        subsection does not affect--
                    ``(A) the availability or scope of exclusivity or 
                an extension of exclusivity described in subparagraph 
                (A) or (B) of section 505A(o)(3);
                    ``(B) the question of the eligibility for approval 
                under this section of any application described in 
                subsection (b)(2) or (j) that omits any other aspect of 
                labeling protected by exclusivity under--
                            ``(i) clause (iii) or (iv) of subsection 
                        (j)(5)(F);
                            ``(ii) clause (iii) or (iv) of subsection 
                        (c)(3)(E); or
                            ``(iii) section 527(a); or
                    ``(C) except as expressly provided in paragraphs 
                (1) and (2), the operation of this section or section 
                527.''.

SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

    Section 351(k)(2)(A)(iii) of the Public Health Service Act (42 
U.S.C. 262(k)(2)(A)(iii)) is amended--
            (1) in subclause (I), by striking ``; and'' and inserting a 
        semicolon;
            (2) in subclause (II), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
                                    ``(III) may include information to 
                                show that the conditions of use 
                                prescribed, recommended, or suggested 
                                in the labeling proposed for the 
                                biological product have been previously 
                                approved for the reference product.''.

SEC. 213. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 503C the following:

``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN DRUGS.

    ``(a) Definitions.--For purposes of this section:
            ``(1) The term `covered drug' means a drug approved under 
        section 505(c)--
                    ``(A) for which there are no unexpired patents 
                included in the list under section 505(j)(7) and no 
                unexpired period of market exclusivity;
                    ``(B) for which the approval of the application has 
                been withdrawn for reasons other than safety or 
                effectiveness; and
                    ``(C) for which, with respect to the labeling--
                            ``(i) new scientific evidence is available 
                        regarding the conditions of use of the drug;
                            ``(ii) there is a relevant accepted use in 
                        clinical practice that is not reflected in the 
                        approved labeling; or
                            ``(iii) the labeling of such drug does not 
                        reflect current legal and regulatory 
                        requirements.
            ``(2) The term `period of market exclusivity', with respect 
        to a drug approved under section 505(c), means any period of 
        market exclusivity under clause (ii), (iii), or (iv) of section 
        505(c)(3)(E), clause (ii), (iii), or (iv) of section 
        505(j)(5)(F), or section 505A, 505E, or 527.
            ``(3) The term `generic version' means a drug approved 
        under section 505(j) whose reference drug is a covered drug.
            ``(4) The term `relevant accepted use' means a use for a 
        drug in clinical practice that is supported by scientific 
        evidence that appears to the Secretary to meet the standards 
        for approval under section 505.
            ``(5) The term `selected drug' means a covered drug for 
        which the Secretary has determined through the process under 
        subsection (c) that the labeling should be changed.
    ``(b) Identification of Covered Drugs.--The Secretary may identify 
covered drugs for which labeling updates would provide a public health 
benefit. To assist in identifying covered drugs, the Secretary may do 
one or both of the following:
            ``(1) Enter into cooperative agreements or contracts with 
        public or private entities to review the available scientific 
        evidence concerning such drugs.
            ``(2) Seek public input concerning such drugs, including 
        input on whether there is a relevant accepted use in clinical 
        practice that is not reflected in the approved labeling of such 
        drugs or whether new scientific evidence is available regarding 
        the conditions of use for such drug, by--
                    ``(A) holding one or more public meetings;
                    ``(B) opening a public docket for the submission of 
                public comments; or
                    ``(C) other means, as the Secretary determines 
                appropriate.
    ``(c) Selection of Drugs for Updating.--If the Secretary 
determines, with respect to a covered drug, that the available 
scientific evidence meets the standards under section 505 for adding or 
modifying information to the labeling or providing supplemental 
information to the labeling regarding the use of the covered drug, the 
Secretary may initiate the process under subsection (d).
    ``(d) Initiation of the Process of Updating.--If the Secretary 
determines that labeling changes are appropriate for a selected drug 
pursuant to subsection (c), the Secretary shall provide notice to the 
holders of approved applications for a generic version of such drug 
that--
            ``(1) summarizes the findings supporting the determination 
        of the Secretary that the available scientific evidence meets 
        the standards under section 505 for adding or modifying 
        information or providing supplemental information to the 
        labeling of the covered drug pursuant to subsection (c);
            ``(2) provides a clear statement regarding the additional, 
        modified, or supplemental information for such labeling, 
        according to the determination by the Secretary (including, as 
        applicable, modifications to add the relevant accepted use to 
        the labeling of the drug as an additional indication for the 
        drug); and
            ``(3) states whether the statement under paragraph (2) 
        applies to the selected drug as a class of covered drugs or 
        only as to a specific drug product.
    ``(e) Response to Notification.--Within 30 days of receipt of 
notification provided by the Secretary pursuant to subsection (d), the 
holder of an approved application for a generic version of the selected 
drug shall--
            ``(1) agree to change the approved labeling to reflect the 
        additional, modified, or supplemental information the Secretary 
        has determined to be appropriate; or
            ``(2) notify the Secretary that the holder of the approved 
        application does not believe that the requested labeling 
        changes are warranted and submit a statement detailing the 
        reasons why such changes are not warranted.
    ``(f) Review of Application Holder's Response.--
            ``(1) In general.--Upon receipt of the application holder's 
        response, the Secretary shall promptly review each statement 
        received under subsection (e)(2) and determine which labeling 
        changes pursuant to the Secretary's notice under subsection (d) 
        are appropriate, if any. If the Secretary disagrees with the 
        reasons why such labeling changes are not warranted, the 
        Secretary shall provide opportunity for discussions with the 
        application holders to reach agreement on whether the labeling 
        for the covered drug should be updated to reflect current 
        scientific evidence, and if so, the content of such labeling 
        changes.
            ``(2) Changes to labeling.--After considering all responses 
        from the holder of an approved application under paragraph (1) 
        or (2) of subsection (e), and any discussion under paragraph 
        (1), the Secretary may order such holder to make the labeling 
        changes the Secretary determines are appropriate. Such holder 
        of an approved application shall--
                    ``(A) update its paper labeling for the drug at the 
                next printing of that labeling;
                    ``(B) update any electronic labeling for the drug 
                within 30 days; and
                    ``(C) submit the revised labeling through the form, 
                `Supplement--Changes Being Effected'.
    ``(g) Violation.--If the holder of an approved application for the 
generic version of the selected drug does not comply with the 
requirements of subsection (f)(2), such generic version of the selected 
drug shall be deemed to be misbranded under section 502.
    ``(h) Limitations; Generic Drugs.--
            ``(1) In general.--With respect to any labeling change 
        required under this section, the generic version shall be 
        deemed to have the same conditions of use and the same labeling 
        as a reference drug for purposes of clauses (i) and (v) of 
        section 505(j)(2)(A). Any labeling change so required shall not 
        have any legal effect for the applicant that is different than 
        the legal effect that would have resulted if a supplemental 
        application had been submitted and approved to conform the 
        labeling of the generic version to a change in the labeling of 
        the reference drug.
            ``(2) Supplemental applications.--Changes to labeling made 
        in accordance with this paragraph shall not be eligible for an 
        exclusivity period under this Act.
    ``(i) Drug Product Classes.--In the case of a selected drug for 
which the labeling changes ordered by the Secretary under subsection 
(d)(2) are required for a class of covered drugs, such labeling changes 
shall be made for generic versions of such drug in that class.
    ``(j) Rules of Construction.--
            ``(1) Approval standards.--This section shall not be 
        construed as altering the applicability of the standards for 
        approval of an application under section 505. No order shall be 
        issued under this subsection unless the evidence supporting the 
        changed labeling meets the standards for approval applicable to 
        any change to labeling under section 505.
            ``(2) Removal of information.--Nothing in this section 
        shall be construed to give the Secretary additional authority 
        to remove approved indications for drugs, other than the 
        authority to remove certain indications from the labels of 
        certain covered drugs, as described in this section.
    ``(k) Reports.--Not later than 4 years after the date of the 
enactment of the Lower Health Care Costs Act and every 4 years 
thereafter, the Secretary shall prepare and submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives, a report that--
            ``(1) describes the actions of the Secretary under this 
        section, including--
                    ``(A) the number of covered drugs and description 
                of the types of drugs the Secretary has selected for 
                labeling changes and the rationale for such recommended 
                changes; and
                    ``(B) the number of times the Secretary entered 
                into discussions concerning a disagreement with an 
                application holder or holders and a summary of the 
                decision regarding a labeling change, if any; and
            ``(2) includes any recommendations of the Secretary for 
        modifying the program under this section.''.

            TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE

SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON PRICE AND 
              QUALITY INFORMATION.

    Subpart II of part A of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg-11 et seq.), as amended by section 103, is amended 
by adding at the end the following:

``SEC. 2729B. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON PRICE 
              AND QUALITY INFORMATION.

    ``(a) Increasing Price and Quality Transparency for Plan Sponsors 
and Consumers.--
            ``(1) Group health plans.--A group health plan or a health 
        insurance issuer offering group health insurance coverage may 
        not enter into an agreement with a health care provider, 
        network or association of providers, third-party administrator, 
        or other service provider offering access to a network of 
        providers that would directly or indirectly restrict a group 
        health plan or health insurance issuer from--
                    ``(A) providing provider-specific cost or quality 
                of care information, through a consumer engagement tool 
                or any other means, to referring providers, the plan 
                sponsor, enrollees, or eligible enrollees of the plan 
                or coverage;
                    ``(B) electronically accessing de-identified claims 
                and encounter data for each enrollee in the plan or 
                coverage, upon request and consistent with the privacy 
                regulations promulgated pursuant to section 264(c) of 
                the Health Insurance Portability and Accountability 
                Act, the amendments to this Act made by the Genetic 
                Information Nondiscrimination Act of 2008, and the 
                Americans with Disabilities Act of 1990, with respect 
                to the applicable health plan or health insurance 
                coverage, including, on a per claim basis--
                            ``(i) financial information, such as the 
                        allowed amount, or any other claim-related 
                        financial obligations included in the provider 
                        contract;
                            ``(ii) provider information, including name 
                        and clinical designation;
                            ``(iii) service codes; or
                            ``(iv) any other data element normally 
                        included in claim or encounter transactions 
                        when received by a plan or issuer; or
                    ``(C) sharing data described in subparagraph (A) or 
                (B) with a business associate as defined in section 
                160.103 of title 45, Code of Federal Regulations (or 
                successor regulations), consistent with the privacy 
                regulations promulgated pursuant to section 264(c) of 
                the Health Insurance Portability and Accountability 
                Act, the amendments to this Act made by the Genetic 
                Information Nondiscrimination Act of 2008, and the 
                Americans with Disabilities Act of 1990.
            ``(2) Individual health insurance coverage.--A health 
        insurance issuer offering individual health insurance coverage 
        may not enter into an agreement with a health care provider, 
        network or association of providers, or other service provider 
        offering access to a network of providers that would, directly 
        or indirectly restrict the health insurance issuer from--
                    ``(A) providing provider-specific price or quality 
                of care information, through a consumer engagement tool 
                or any other means, to referring providers or the plan 
                sponsor, enrollees, or eligible enrollees of the plan 
                or coverage; or
                    ``(B) sharing data described in subparagraph (A) 
                with a business associate as defined in section 160.103 
                of title 45, Code of Federal Regulations (or successor 
                regulations), consistent with the privacy regulations 
                promulgated pursuant to section 264(c) of the Health 
                Insurance Portability and Accountability Act, the 
                amendments to this Act made by the Genetic Information 
                Nondiscrimination Act of 2008, and the Americans with 
                Disabilities Act of 1990, for plan design, plan 
                administration, and plan, financial, legal, and quality 
                improvement activities.
            ``(3) Clarification regarding public disclosure of 
        information.--Nothing in paragraph (1)(A) or (2)(A) prevents a 
        health care provider, network or association of providers, or 
        other service provider from placing reasonable restrictions on 
        the public disclosure of the information described in such 
        paragraphs (1) and (2).
            ``(4) Attestation.--A group health plan or a health 
        insurance issuer offering group or individual health insurance 
        coverage shall annually submit to, as applicable, the 
        applicable authority described in section 2723 or the Secretary 
        of Labor, an attestation that such plan or issuer is in 
        compliance with the requirements of this subsection.
            ``(5) Rule of construction.--Nothing in this section shall 
        be construed to otherwise limit group health plan or plan 
        sponsor access to data currently permitted under the privacy 
        regulations promulgated pursuant to section 264(c) of the 
        Health Insurance Portability and Accountability Act, the 
        amendments to this Act made by the Genetic Information 
        Nondiscrimination Act of 2008, and the Americans with 
        Disabilities Act of 1990.''.

SEC. 302. BANNING ANTICOMPETITIVE TERMS IN FACILITY AND INSURANCE 
              CONTRACTS THAT LIMIT ACCESS TO HIGHER QUALITY, LOWER COST 
              CARE.

    (a) In General.--Section 2729B of the Public Health Service Act, as 
added by section 301, is amended by adding at the end the following:
    ``(b) Protecting Health Plans Network Design Flexibility.--
            ``(1) In general.--A group health plan or a health 
        insurance issuer offering group or individual health insurance 
        coverage shall not enter into an agreement with a provider, 
        network or association of providers, or other service provider 
        offering access to a network of service providers if such 
        agreement, directly or indirectly--
                    ``(A) restricts the group health plan or health 
                insurance issuer from--
                            ``(i) directing or steering enrollees to 
                        other health care providers; or
                            ``(ii) offering incentives to encourage 
                        enrollees to utilize specific health care 
                        providers;
                    ``(B) requires the group health plan or health 
                insurance issuer to enter into any additional contract 
                with an affiliate of the provider as a condition of 
                entering into a contract with such provider;
                    ``(C) requires the group health plan or health 
                insurance issuer to agree to payment rates or other 
                terms for any affiliate not party to the contract of 
                the provider involved; or
                    ``(D) restricts other group health plans or health 
                insurance issuers not party to the contract, from 
                paying a lower rate for items or services than the 
                contracting plan or issuer pays for such items or 
                services.
            ``(2) Additional requirement for self-insured plans.--A 
        self-insured group health plan shall not enter into an 
        agreement with a provider, network or association of providers, 
        third-party administrator, or other service provider offering 
        access to a network of providers if such agreement, directly or 
        indirectly requires the group health plan to certify, attest, 
        or otherwise confirm in writing that the group health plan is 
        bound by the terms of the contract between the service provider 
        and a third-party administrator that the group health plan is 
        not party to and is not allowed to review.
            ``(3) Exception for certain group model issuers.--Paragraph 
        (1)(A) shall not apply to a group health plan or a health 
        insurance issuer offering group or individual health insurance 
        coverage with respect to a health maintenance organization (as 
        defined in section 2791(b)(3)) if such health maintenance 
        organization operates primarily through exclusive contracts 
        with multi-specialty physician groups, nor to any arrangement 
        between such a health maintenance organization and its 
        affiliates.
            ``(4) Attestation.--A group health plan or a health 
        insurance issuer offering group or individual health insurance 
        coverage shall annually submit to, as applicable, the 
        applicable authority described in section 2723 or the Secretary 
        of Labor, an attestation that such plan or issuer is in 
        compliance with the requirements of this subsection.
    ``(c) Maintenance of Existing HIPAA, GINA, and ADA Protections.--
Nothing in this section shall modify, reduce, or eliminate the existing 
privacy protections and standards provided by reason of State and 
Federal law, including the requirements of parts 160 and 164 of title 
45, Code of Federal Regulations (or any successor regulations).
    ``(d) Regulations.--The Secretary, in coordination with the 
Secretary of Labor and the Secretary of the Treasury, not later than 1 
year after the date of enactment of the Lower Health Care Costs Act, 
shall promulgate regulations to carry out this section.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed to limit network design or cost or quality initiatives by a 
group health plan or health insurance issuer, including accountable 
care organizations, exclusive provider organizations, networks that 
tier providers by cost or quality or steer enrollees to centers of 
excellence, or other pay-for-performance programs.''.
    (b) Effective Date.--Section 2729B of the Public Health Service Act 
(as added by section 301 and amended by subsection (a)) shall apply 
with respect to any contract entered into after the date of enactment 
of this Act. With respect to an applicable contract that is in effect 
on the date of enactment of this Act, such section 2729B shall apply on 
the earlier of the date of renewal of such contract or 3 years after 
such date of enactment.

SEC. 303. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT TRANSPARENCY 
              ORGANIZATION TO LOWER AMERICANS' HEALTH CARE COSTS.

    (a) In General.--Subpart C of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191 et 
seq.) is amended by adding at the end the following:

``SEC. 735. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT TRANSPARENCY 
              ORGANIZATION TO LOWER AMERICANS' HEALTH CARE COSTS.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Health and Human Services, not later than 6 months after 
the date of enactment of the Lower Health Care Costs Act, shall have in 
effect a contract with a nonprofit entity to support the establishment 
and maintenance of a database that receives and utilizes health care 
claims information and related information and issues reports that are 
available to the public and authorized users, and are submitted to the 
Department of Labor.
    ``(b) Requirements.--
            ``(1) In general.--The database established under 
        subsection (a) shall--
                    ``(A) improve transparency by using de-identified 
                health care data to--
                            ``(i) inform patients about the cost, 
                        quality, and value of their care;
                            ``(ii) assist providers and hospitals, as 
                        they work with patients, to make informed 
                        choices about care;
                            ``(iii) enable providers, hospitals, and 
                        communities to improve services and outcomes 
                        for patients by benchmarking their performance 
                        against that of other providers, hospitals, and 
                        communities;
                            ``(iv) enable purchasers, including 
                        employers, employee organizations, and health 
                        plans, to develop value-based purchasing 
                        models, improve quality, and reduce the cost of 
                        health care and insurance coverage for 
                        enrollees;
                            ``(v) enable employers and employee 
                        organizations to evaluate network design and 
                        construction, and the cost of care for 
                        enrollees;
                            ``(vi) facilitate State-led initiatives to 
                        lower health care costs and improve quality; 
                        and
                            ``(vii) promote competition based on 
                        quality and cost;
                    ``(B) collect medical claims, prescription drug 
                claims, and remittance data consistent with the 
                protections and requirements of subsection (d);
                    ``(C) be established in such a manner that allows 
                the data collected pursuant to subparagraph (B) to be 
                shared with any State all-payer claims database or 
                regional database operated with authorization from 
                States, at cost, using a standardized format, if such 
                State or regional database also submits claims data to 
                the database established under this section; and
                    ``(D) be available to--
                            ``(i) the Director of the Congressional 
                        Budget Office, the Comptroller General of the 
                        United States, the Executive Director of the 
                        Medicare Payment Advisory Commission, and the 
                        Executive Director of the Medicaid and CHIP 
                        Payment Advisory Commission, upon request, 
                        subject to the privacy and security 
                        requirements of authorized users under 
                        subsection (e)(2); and
                            ``(ii) authorized users, including 
                        employers, employee organizations, providers, 
                        researchers, and policymakers, subject to 
                        subsection (e).
            ``(2) Privacy and security.--The entity receiving a 
        contract under subsection (a) shall--
                    ``(A) be subject to the breach notification rule 
                under subpart D of part 164 of title 45, Code of 
                Federal Regulations (or any successor regulations), the 
                security rule under part 160 and subparts A and C of 
                part 164 of title 45, Code of Federal Regulations (or 
                any successor regulations), and the privacy rule under 
                part 160 and subparts A and E of part 164 of title 45, 
                Code of Federal Regulations (or any successor 
                regulations); and
                    ``(B) consistent with the requirements and 
                prohibitions in the regulations promulgated under 
                section 264(c) of the Health Insurance Portability and 
                Accountability Act of 1996--
                            ``(i) ensure that the database under 
                        subsection (a) is capable of--
                                    ``(I) receiving data under 
                                subsection (d);
                                    ``(II) providing data access to 
                                authorized users; and
                                    ``(III) storing data on secure 
                                servers in a manner that is consistent 
                                with the privacy, security, and breach 
                                notification requirements under section 
                                13402 of the HITECH Act and under the 
                                regulations promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability Act of 
                                1996;
                            ``(ii) not disclose to the public any 
                        individually identifiable health information or 
                        proprietary financial information;
                            ``(iii) strictly limit staff access to the 
                        data to staff with appropriate training, 
                        clearance, and background checks and require 
                        regular privacy and security training;
                            ``(iv) maintain effective security 
                        standards for transferring data or making data 
                        available to authorized users;
                            ``(v) develop a process for providing 
                        access to data to authorized users, in a secure 
                        manner that maintains privacy and 
                        confidentiality of data;
                            ``(vi) adhere to current best security 
                        practices with respect to the management and 
                        use of such data for health services research, 
                        in accordance with applicable Federal privacy 
                        law; and
                            ``(vii) report on the security methods of 
                        the entity to the Secretary, the Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate, and the Committee on Education and 
                        Labor of the House of Representatives.
            ``(3) Consultation.--
                    ``(A) Advisory committee.--Not later than 180 days 
                after the date of enactment of the Lower Health Care 
                Costs Act, the Secretary shall convene an Advisory 
                Committee (referred to in this section as the 
                `Committee'), consisting of 11 members, to advise the 
                Secretary, the contracting entity, and Congress on the 
                establishment, operations, and use of the database 
                established under this section.
                    ``(B) Membership.--
                            ``(i) Appointment.--In accordance with 
                        clause (ii), the Secretary, in consultation 
                        with the Secretary of Health and Human 
                        Services, and the Comptroller General of the 
                        United States shall, not later than 1 year 
                        after the date of enactment of the Lower Health 
                        Care Costs Act, appoint members to the 
                        Committee who have distinguished themselves in 
                        the fields of health services research, health 
                        economics, health informatics, or the 
                        governance of State all-payer claims databases, 
                        or who represent organizations likely to submit 
                        data to or use the database, including 
                        patients, employers, or employee organizations 
                        that sponsor group health plans, health care 
                        providers, health insurance issuers, and third-
                        party administrators of group health plans. 
                        Such members shall serve 3-year terms on a 
                        staggered basis. Vacancies on the Committee 
                        shall be filled by appointment consistent with 
                        this subsection not later than 3 months after 
                        the vacancy arises.
                            ``(ii) Composition.--In accordance with 
                        clause (i)--
                                    ``(I) the Secretary, in 
                                consultation with the Secretary of 
                                Health and Human Services, shall 
                                appoint to the Committee--
                                            ``(aa) 1 member selected by 
                                        the Secretary, in coordination 
                                        with the Secretary of Health 
                                        and Human Services, to serve as 
                                        the chair of the Committee;
                                            ``(bb) the Assistant 
                                        Secretary for Planning and 
                                        Evaluation of the Department of 
                                        Health and Human Services;
                                            ``(cc) 1 representative of 
                                        the Centers for Medicare & 
                                        Medicaid Services;
                                            ``(dd) 1 representative of 
                                        the Agency for Health Research 
                                        and Quality;
                                            ``(ee) 1 representative of 
                                        the Office for Civil Rights of 
                                        the Department of Health and 
                                        Human Services with expertise 
                                        in data privacy and security; 
                                        and
                                            ``(ff) 1 representative of 
                                        the National Center for Health 
                                        Statistics; and
                                    ``(II) the Comptroller General of 
                                the United States shall appoint to the 
                                Committee--
                                            ``(aa) 1 representative of 
                                        an employer that sponsors a 
                                        group health plan;
                                            ``(bb) 1 representative of 
                                        an employee organization that 
                                        sponsors a group health plan;
                                            ``(cc) 1 academic 
                                        researcher with expertise in 
                                        health economics or health 
                                        services research;
                                            ``(dd) 1 patient advocate; 
                                        and
                                            ``(ee) 2 additional 
                                        members.
                    ``(C) Duties.--The Committee shall--
                            ``(i) assist and advise the Secretary on 
                        the management of the contract under subsection 
                        (a);
                            ``(ii) assist and advise the entity 
                        receiving the contract under subsection (a) in 
                        establishing--
                                    ``(I) the scope and format of the 
                                data to be submitted under subsection 
                                (d);
                                    ``(II) the appropriate uses of data 
                                by authorized users, including 
                                developing standards for the approval 
                                of requests by organizations to access 
                                and use the data; and
                                    ``(III) the appropriate formats and 
                                methods for making reports and analyses 
                                based on the database to the public;
                            ``(iii) conduct an annual review of whether 
                        data was used according to the appropriate uses 
                        as described in clause (ii)(II), and advise the 
                        designated entity on using the data for 
                        authorized purposes;
                            ``(iv) report, as appropriate, to the 
                        Secretary and Congress on the operation of the 
                        database and opportunities to better achieve 
                        the objectives of this section;
                            ``(v) establish additional restrictions on 
                        researchers who receive compensation from 
                        entities described in subsection (e)(2)(B)(ii), 
                        in order to protect proprietary financial 
                        information; and
                            ``(vi) establish objectives for research 
                        and public reporting.
            ``(4) State requirements.--A State may require health 
        insurance issuers and other payers to submit claims data to the 
        database established under this section, provided that such 
        data is submitted in a form and manner established by the 
        Secretary, and pursuant to subsection (d)(4)(B).
            ``(5) Sanctions.--The Secretary shall take appropriate 
        action to sanction users who attempt to re-identify data 
        accessed pursuant to paragraph (1)(D).
    ``(c) Contract Requirements.--
            ``(1) Competitive procedures.--The Secretary shall enter 
        into the contract under subsection (a) using full and open 
        competition procedures pursuant to chapter 33 of title 41, 
        United States Code.
            ``(2) Eligible entities.--To be eligible to enter into a 
        contract described in subsection (a), an entity shall--
                    ``(A) be a private nonprofit entity governed by a 
                board that includes representatives of the academic 
                research community and individuals with expertise in 
                employer-sponsored insurance, research using health 
                care claims data and actuarial analysis;
                    ``(B) conduct its business in an open and 
                transparent manner that provides the opportunity for 
                public comment on its activities; and
                    ``(C) agree to maintain an active certification as 
                a qualified entity under section 1874(e) of the Social 
                Security Act (or any successor program) throughout the 
                contract period.
            ``(3) Considerations.--In awarding the contract under 
        subsection (a), the Secretary shall consider an entity's 
        experience in--
                    ``(A) health care claims data collection, 
                aggregation, quality assurance, analysis, and security;
                    ``(B) supporting academic research on health costs, 
                spending, and utilization for and by privately insured 
                patients;
                    ``(C) working with large health insurance issuers 
                and third-party administrators to assemble a national 
                claims database;
                    ``(D) effectively collaborating with and engaging 
                stakeholders to develop reports;
                    ``(E) meeting budgets and timelines, including in 
                connection with report generation; and
                    ``(F) facilitating the creation of, or supporting, 
                State all-payer claims databases.
            ``(4) Contract term.--A contract awarded under this section 
        shall be for a period of 5 years, and may be renewed after a 
        subsequent competitive bidding process under this section.
            ``(5) Transition of contract.--If the Secretary, following 
        a competitive process at the end of the contract period, 
        selects a new entity to maintain the database, all data shall 
        be transferred to the new entity according to a schedule and 
        process to be determined by the Secretary. Upon termination of 
        a contract, no entity may keep data held by the database or 
        disclose such data to any entity other than the entity so 
        designated by the Secretary. The Secretary shall include 
        enforcement terms in any contract with an organization chosen 
        under this section, to ensure the timely transfer of all data 
        to a new entity in the event of contract termination.
    ``(d) Receiving Health Information.--
            ``(1) Requirements.--
                    ``(A) In general.--An applicable self-insured group 
                health plan shall, through its health insurance issuer, 
                third-party administrator, pharmacy benefit manager, or 
                other entity designated by the group health plan, 
                electronically submit all claims data with respect to 
                the plan, pursuant to subparagraph (B).
                    ``(B) Scope of information and format of 
                submission.--The entity awarded the contract under 
                subsection (a), in consultation with the Committee 
                described in subsection (b)(3), and pursuant to the 
                privacy and security requirements of subsection (b)(2), 
                shall--
                            ``(i) specify the data elements required to 
                        be submitted under subparagraph (A), which 
                        shall include all data related to transactions 
                        described in subparagraphs (A) and (E) of 
                        section 1173(a)(2) of the Social Security Act, 
                        including all data elements normally present in 
                        such transactions when adjudicated, and 
                        enrollment information;
                            ``(ii) specify the form and manner for such 
                        submissions, and the historical period to be 
                        included in the initial submission; and
                            ``(iii) offer an automated submission 
                        option to minimize administrative burdens for 
                        entities required to submit data.
                    ``(C) De-identification of data.--The entity 
                awarded the contract under subsection (a) shall--
                            ``(i) establish a process under which data 
                        is de-identified in accordance with section 
                        164.514(a) of title 45, Code of Federal 
                        Regulations (or any successor regulations), 
                        while retaining the ability to link data 
                        longitudinally for the purposes of research on 
                        cost and quality, and the ability to complete 
                        risk adjustment and geographic analysis;
                            ``(ii) ensure that any third-party 
                        subcontractors who perform the de-
                        identification process described in clause (i) 
                        retain the minimum necessary information to 
                        perform such a process, and adhere to effective 
                        security and encryption practices in data 
                        storage and transmission;
                            ``(iii) store claims and other data 
                        collected under this subsection only in de-
                        identified form, in accordance with section 
                        164.514(a) of title 45, Code of Federal 
                        Regulations (or any successor regulations); and
                            ``(iv) ensure that data is encrypted, in 
                        accordance with the regulations promulgated 
                        under section 264(c) of the Health Insurance 
                        Portability and Accountability Act of 1996.
            ``(2) Applicable self-insured group health plan.--For 
        purposes of paragraph (1), a self-insured group health plan is 
        an applicable self-insured group health plan if such plan is 
        self-administered, or is administered by a health insurance 
        issuer or third-party administrator that meets one or both of 
        the following criteria:
                    ``(A) Administers health benefits for more than 
                50,000 enrollees.
                    ``(B) Is one of the 5 largest administrators or 
                issuers of self-insured group health plans in a State 
                in which such administrator operates, as measured by 
                the number of enrollees.
            ``(3) Issuers and third-party administrators.--In the case 
        of a health insurance issuer or third-party administrator that 
        is required under this subsection to submit claims data with 
        respect to an applicable self-insured group health plan, such 
        issuer or administrator shall submit claims data with respect 
        to all self-insured group health plans that the issuer or 
        administrator administers, including such plans that are not 
        applicable self-insured group health plans, as described in 
        paragraph (2).
            ``(4) Receiving other information.--
                    ``(A) Medicare data.--The entity awarded the 
                contract under subsection (a) shall maintain active 
                certification as a qualified entity pursuant to section 
                1874(e) of the Social Security Act for the term of the 
                contract awarded under subsection (a).
                    ``(B) State data.--The entity awarded the contract 
                under subsection (a) shall collect data from State all-
                payer claims databases that seek access to the database 
                established under this section.
            ``(5) Availability of data.--An entity required to submit 
        data under this subsection may not place any restrictions on 
        the use of such data by authorized users.
    ``(e) Uses of Information.--
            ``(1) In general.--The entity awarded the contract under 
        subsection (a) shall make the database available to users who 
        are authorized under this subsection, at cost, and reports and 
        analyses based on the data available to the public with no 
        charge.
            ``(2) Authorization of users.--
                    ``(A) In general.--An entity may request 
                authorization by the entity awarded the contract under 
                subsection (a) for access to the database in accordance 
                with this paragraph.
                    ``(B) Application.--An entity desiring 
                authorization under this paragraph shall submit to the 
                entity awarded the contract an application for such 
                access, which shall include--
                            ``(i) in the case of an entity requesting 
                        access for research purposes--
                                    ``(I) a description of the uses and 
                                methodologies for evaluating health 
                                system performance using such data; and
                                    ``(II) documentation of approval of 
                                the research by an institutional review 
                                board, if applicable for a particular 
                                plan of research; or
                            ``(ii) in the case of an entity such as an 
                        employer, health insurance issuer, third-party 
                        administrator, or health care provider, 
                        requesting access for the purpose of quality 
                        improvement or cost-containment, a description 
                        of the intended uses for such data.
                    ``(C) Requirements.--
                            ``(i) Research.--Upon approval of an 
                        application for research purposes under 
                        subparagraph (B)(i), the authorized user shall 
                        enter into a data use and confidentiality 
                        agreement with the entity awarded the contract 
                        under subsection (a), which shall include a 
                        prohibition on attempts to reidentify and 
                        disclose protected health information and 
                        proprietary financial information.
                            ``(ii) Quality improvement and cost-
                        containment.--In consultation with the 
                        Committee described in subsection (b)(3), the 
                        Secretary shall, through rulemaking, establish 
                        the form and manner in which authorized users 
                        described in subparagraph (B)(ii) may access 
                        data. Data provided to such authorized users 
                        shall be provided in a form and manner such 
                        that users may not obtain individually 
                        identifiable price information with respect to 
                        direct competitors. Upon approval, such 
                        authorized user shall enter into a data use and 
                        confidentiality agreement with the entity.
                            ``(iii) Customized reports.--Employers and 
                        employer organizations may request customized 
                        reports from the entity awarded the contract 
                        under subsection (a), at cost, subject to the 
                        requirements of this section with respect to 
                        privacy, security, and proprietary financial 
                        information.
                            ``(iv) Non-customized reports.--The entity 
                        awarded the contract under subsection (a), in 
                        consultation with the Committee, shall make 
                        available to all authorized users aggregate 
                        data sets, free of charge.
    ``(f) Funding.--
            ``(1) Initial funding.--There are authorized to be 
        appropriated, and there are appropriated, out of monies in the 
        Treasury not otherwise appropriated, $20,000,000 for fiscal 
        year 2020, for the implementation of the initial contract and 
        establishment of the database under this section.
            ``(2) Ongoing funding.--There are authorized to be 
        appropriated $15,000,000 for each of fiscal years 2021 through 
        2025, for purposes of carrying out this section (other than the 
        grant program under subsection (h)).
    ``(g) Annual Report.--
            ``(1) Submission.--Not later than March 1, 2021, and March 
        1 of each year thereafter, the entity receiving the contract 
        under subsection (a) shall submit to Congress, the Secretary of 
        Labor, and the Secretary of Health and Human Services, and 
        publish online for access by the general public, a report 
        containing a description of--
                    ``(A) trends in the price, utilization, and total 
                spending on health care services, including a 
                geographic analysis of differences in such trends;
                    ``(B) limitations in the data set;
                    ``(C) progress towards the objectives of this 
                section; and
                    ``(D) the performance by the entity of the duties 
                required under such contract.
            ``(2) Public reports and research.--The entity receiving a 
        contract under subsection (a) shall, in coordination with 
        authorized users, make analyses and research available to the 
        public on an ongoing basis to promote the objectives of this 
        section.
    ``(h) Grants to States.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Health and Human Services, may award grants to 
        States for the purpose of establishing and maintaining State 
        all-payer claims databases that improve transparency of data in 
        order to meet the goals of subsection (a)(1).
            ``(2) Requirement.--To be eligible to receive the funding 
        under paragraph (1), a State shall submit data to the database 
        as described in subsection (b)(1)(C), using the format 
        described in subsection (d)(1).
            ``(3) Funding.--There is authorized to be appropriated 
        $100,000,000 for the period of fiscal years 2020 through 2029 
        for the purpose of awarding grants to States under this 
        subsection.
    ``(i) Exemption From Public Disclosure.--
            ``(1) In general.--Claims data provided to the database, 
        and the database itself shall not be considered public records 
        and shall be exempt from public disclosure requirements.
            ``(2) Restrictions on uses for certain proceedings.--Data 
        disclosed to authorized users shall not be subject to discovery 
        or admission as public information, or evidence in judicial or 
        administrative proceedings without consent of the affected 
        parties.
    ``(j) Definitions.--
            ``(1) Protected health information.--The term `protected 
        health information' has the meaning given such term in section 
        160.103 of title 45, Code of Federal Regulations (or any 
        successor regulations).
            ``(2) Proprietary financial information.--The term 
        `proprietary financial information' means data that would 
        disclose the terms of a specific contract between an individual 
        health care provider or facility and a specific group health 
        plan, Medicaid managed care organization or other managed care 
        entity, or health insurance issuer offering group or individual 
        coverage.
    ``(k) Rule of Construction.--Nothing in this section shall be 
construed to affect or modify enforcement of the privacy, security, or 
breach notification rules promulgated under section 264(c) of the 
Health Insurance Portability and Accountability Act of 1996 (or 
successor regulations).''.
    (b) GAO Report.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study on--
                    (A) the performance of the entity awarded a 
                contract under section 735(a) of the Employee 
                Retirement Income Security Act of 1974, as added by 
                subsection (a), under such contract;
                    (B) the privacy and security of the information 
                reported to the entity; and
                    (C) the costs incurred by such entity in performing 
                such duties.
            (2) Reports.--Not later than 2 years after the effective 
        date of the first contract entered into under section 735(a) of 
        the Employee Retirement Income Security Act of 1974, as added 
        by subsection (a), and again not later than 4 years after such 
        effective date, the Comptroller General of the United States 
        shall submit to Congress a report containing the results of the 
        study conducted under paragraph (1), together with 
        recommendations for such legislation and administrative action 
        as the Comptroller General determines appropriate.
    (c) Clerical Amendment.--The table of contents in section 1 of the 
Employee Retirement Income Security Act of 1974 is amended by inserting 
after the item relating to section 734 the following new item:

``Sec. 735. Designation of a nongovernmental, nonprofit transparency 
                            organization to lower Americans' health 
                            care costs.''.

SEC. 304. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF PROVIDER 
              DIRECTORY INFORMATION.

    Subpart II of part A of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg-11 et seq.), as amended by sections 301 and 302, 
is further amended by adding at the end the following:

``SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF 
              PROVIDER DIRECTORY INFORMATION.

    ``(a) Network Status of Providers.--
            ``(1) In general.--Beginning on the date that is one year 
        after the date of enactment of this section, a group health 
        plan or a health insurance issuer offering group or individual 
        health insurance coverage shall--
                    ``(A) establish business processes to ensure that 
                all enrollees in such plan or coverage receive proof of 
                a health care provider's network status--
                            ``(i) through a written electronic 
                        communication from the plan or issuer to the 
                        enrollee, as soon as practicable and not later 
                        than 1 business day after a telephone inquiry 
                        is made by such enrollee for such information; 
                        and
                            ``(ii) in real-time through an online 
                        health care provider directory search tool 
                        maintained by the plan or issuer; and
                    ``(B) include in any print directory a disclosure 
                that the information included in the directory is 
                accurate as of the date of the last data update and 
                that enrollees or prospective enrollees should consult 
                the group health plan or issuer's electronic provider 
                directory on its website or call a specified customer 
                service telephone number to obtain the most current 
                provider directory information.
            ``(2) Group health plan and health insurance issuer 
        business processes.--Beginning on the date that is one year 
        after the date of enactment of the Lower Health Care Costs Act, 
        a group health plan or a health insurance issuer offering group 
        or individual health insurance coverage shall establish 
        business processes to--
                    ``(A) verify and update, at least once every 90 
                days, the provider directory information for all 
                providers included in the online health care provider 
                directory search tool described in paragraph 
                (1)(A)(ii); and
                    ``(B) remove any provider from such online 
                directory search tool if such provider has not verified 
                the directory information within the previous 6 months 
                or the plan or issuer has been unable to verify the 
                provider's network participation.
    ``(b) Cost-Sharing Limitations.--
            ``(1) In general.--A group health plan or a health 
        insurance issuer offering group or individual health insurance 
        coverage shall not apply, and shall ensure that no provider 
        applies cost-sharing to an enrollee for treatment or services 
        provided by a health care provider in excess of the normal 
        cost-sharing applied for in-network care (including any balance 
        bill issued by the health care provider involved), if such 
        enrollee, or health care provider referring such enrollee, 
        demonstrates (based on the electronic information described in 
        subsection (a)(1)(A)(i) or a copy of the online provider 
        directory described in subsection (a)(1)(A)(ii) on the date the 
        enrollee attempted to obtain the provider's network status) 
        that the enrollee relied on the information described in 
        subsection (a)(1), if the provider's network status or 
        directory information on such directory was incorrect at the 
        time the treatment or services involved was provided.
            ``(2) Refunds to enrollees.--If a health care provider 
        submits a bill to an enrollee in violation of paragraph (1), 
        and the enrollee pays such bill, the provider shall reimburse 
        the enrollee for the full amount paid by the enrollee in excess 
        of the in-network cost-sharing amount for the treatment or 
        services involved, plus interest, at an interest rate 
        determined by the Secretary.
    ``(c) Provider Business Processes.--A health care provider shall 
have in place business processes to ensure the timely provision of 
provider directory information to a group health plan or a health 
insurance issuer offering group or individual health insurance coverage 
to support compliance by such plans or issuers with subsection (a)(1). 
Such providers shall submit provider directory information to a plan or 
issuers, at a minimum--
            ``(1) when the provider begins a network agreement with a 
        plan or with an issuer with respect to certain coverage;
            ``(2) when the provider terminates a network agreement with 
        a plan or with an issuer with respect to certain coverage;
            ``(3) when there are material changes to the content of 
        provider directory information described in subsection (a)(1); 
        and
            ``(4) every 90 days throughout the duration of the network 
        agreement with a plan or issuer.
    ``(d) Enforcement.--
            ``(1) In general.--Subject to paragraph (2), a health care 
        provider that violates a requirement under subsection (c) or 
        takes actions that prevent a group health plan or health 
        insurance issuer from complying with subsection (a)(1) or (b) 
        shall be subject to a civil monetary penalty of not more than 
        $10,000 for each act constituting such violation.
            ``(2) Safe harbor.--The Secretary may waive the penalty 
        described under paragraph (1) with respect to a health care 
        provider that unknowingly violates subsection (b)(1) with 
        respect to an enrollee if such provider rescinds the bill 
        involved and, if applicable, reimburses the enrollee within 30 
        days of the date on which the provider billed the enrollee in 
        violation of such subsection.
            ``(3) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsections (a) and (b) and the 
        first sentence of subsection (c)(1) of such section, shall 
        apply to civil money 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.
    ``(e) Savings Clause.--Nothing in this section shall prohibit a 
provider from requiring in the terms of a contract, or contract 
termination, with a group health plan or health insurance issuer--
            ``(1) that the plan or issuer remove, at the time of 
        termination of such contract, the provider from a directory of 
        the plan or issuer described in subsection (a)(1); or
            ``(2) that the plan or issuer bear financial 
        responsibility, including under subsection (b), for providing 
        inaccurate network status information to an enrollee.
    ``(f) Definition.--For purposes of this section, the term `provider 
directory information' includes the names, addresses, specialty, and 
telephone numbers of individual health care providers, and the names, 
addresses, and telephone numbers of each medical group, clinic, or 
facility contracted to participate in any of the networks of the group 
health plan or health insurance coverage involved.
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed to preempt any provision of State law relating to health care 
provider directories or network adequacy.''.

SEC. 305. TIMELY BILLS FOR PATIENTS.

    (a) In General.--
            (1) Amendment.--Part P of title III of the Public Health 
        Service Act (42 U.S.C. 280g et seq.) is amended by adding at 
        the end the following:

``SEC. 399V-7. TIMELY BILLS FOR PATIENTS.

    ``(a) In General.--The Secretary shall require--
            ``(1) health care facilities, or in the case of 
        practitioners providing services outside of such a facility, 
        practitioners, to provide to patients a list of services 
        rendered during the visit to such facility or practitioner, 
        and, in the case of a facility, the name of the provider for 
        each such service, upon discharge or by postal or electronic 
        communication as soon as practicable and not later than 5 
        calendar days after discharge; and
            ``(2) health care facilities and practitioners to send all 
        adjudicated bills to the patient as soon as practicable, but 
        not later than 45 calendar days after discharge.
    ``(b) Payment After Billing.--No patient may be required to pay a 
bill for health care services any earlier than 30 calendar days after 
receipt of a bill for such services.
    ``(c) Effect of Violation.--
            ``(1) Notification and refund requirements.--
                    ``(A) Provider lists.--If a facility or 
                practitioner fails to provide a patient a list as 
                required under subsection (a)(1), such facility or 
                practitioner shall report such failure to the 
                Secretary.
                    ``(B) Billing.--If a facility or practitioner bills 
                a patient after the 45-calendar-day period described in 
                subsection (a)(2), such facility or practitioner 
                shall--
                            ``(i) report such bill to the Secretary; 
                        and
                            ``(ii) refund the patient for the full 
                        amount paid in response to such bill with 
                        interest, at a rate determined by the 
                        Secretary.
            ``(2) Civil monetary penalties.--
                    ``(A) In general.--The Secretary may impose civil 
                monetary penalties of up to $10,000 a day on any 
                facility or practitioner that--
                            ``(i) fails to provide a list required 
                        under subsection (a)(1) more than 10 times, 
                        beginning on the date of such tenth failure;
                            ``(ii) submits more than 10 bills outside 
                        of the period described in subsection (a)(2), 
                        beginning on the date on which such facility or 
                        practitioner sends the tenth such bill;
                            ``(iii) fails to report to the Secretary 
                        any failure to provide lists as required under 
                        paragraph (1)(A), beginning on the date that is 
                        45 calendar days after discharge; or
                            ``(iv) fails to send any bill as required 
                        under subsection (a)(2), beginning on the date 
                        that is 45 calendar days after the date of 
                        discharge or visit, as applicable.
                    ``(B) Procedure.--The provisions of section 1128A 
                of the Social Security Act, other than subsections (a) 
                and (b) and the first sentence of subsection (c)(1) of 
                such section, shall apply to civil money 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.
            ``(3) Safe harbor.--The Secretary may exempt a practitioner 
        or facility from the penalties under paragraph (2)(A) or extend 
        the period of time specified under subsection (a)(2) for 
        compliance with such subsection if a practitioner or facility--
                    ``(A) makes a good faith attempt to send a bill 
                within 30 days but is unable to do so because of an 
                incorrect address; or
                    ``(B) experiences extenuating circumstances (as 
                defined by the Secretary), such as a hurricane or 
                cyberattack, that may reasonably delay delivery of a 
                timely bill.''.
            (2) Rulemaking.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall promulgate final 
        regulations to define the term ``extenuating circumstance'' for 
        purposes of section 399V-7(c)(3)(B) of the Public Health 
        Service Act, as added by paragraph (1).
    (b) Group Health Plan and Health Insurance Issuer Requirements.--
Subpart II of part A of title XXVII of the Public Health Service Act 
(42 U.S.C. 300gg-11), as amended by section 304, is further amended by 
adding to the end the following:

``SEC. 2729D. TIMELY BILLS FOR PATIENTS.

    ``(a) In General.--A group health plan or health insurance issuer 
offering group or individual health insurance coverage shall have in 
place business practices with respect to in-network facilities and 
practitioners to ensure that claims are adjudicated in order to 
facilitate facility and practitioner compliance with the requirements 
under section 399V-7(a).
    ``(b) Clarification.--Nothing in subsection (a) prohibits a 
provider and a group health plan or health insurance issuer from 
establishing in a contract the timeline for submission by either party 
to the other party of billing information, adjudication, sending of 
remittance information, or any other coordination required between the 
provider and the plan or issuer necessary for meeting the deadline 
described in section 399V-7(a)(2).''.
    (c) Effective Date.--The amendments made by subsections (a) and (b) 
shall take effect 6 months after the date of enactment of this Act.

SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.

    Subpart II of part A of title XXVII of the Public Health Service 
Act (42 U.S.C. 300gg-11 et seq.), as amended by section 305, is further 
amended by adding at the end the following:

``SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER 
              SERVICES.

    ``(a) In General.--A group health plan or health insurance issuer 
offering group or individual health insurance coverage or an entity or 
subsidiary providing pharmacy benefits management services 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 coverage, or an entity or 
subsidiary providing pharmacy benefits management services on behalf of 
a plan or coverage from making the reports described in subsection (b).
    ``(b) Reports to Group Plan Sponsors.--
            ``(1) In general.--Beginning with the first plan year that 
        begins after the date of enactment of the Lower Health Care 
        Costs Act, not less frequently than once per plan quarter, 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 
        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) 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 enrollees in such plan or coverage;
                    ``(B) a list of each covered drug 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 enrollees 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 
                        enrollees on such drug, including enrollee 
                        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 available 
                                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; and
                                    ``(II) the rationale for preferred 
                                formulary placement of a particular 
                                drug or drugs in that therapeutic 
                                category or class;
                    ``(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 enrollees 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 
                        enrollees, including enrollee spending through 
                        copayments, coinsurance, and deductibles; and
                            ``(v) for each therapeutic category or 
                        class under which three or more drugs are 
                        marketed and available--
                                    ``(I) the amount received, or 
                                expected to be received, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--
                                            ``(aa) 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 by 
                                the health plan or health insurance 
                                coverage on that category or class of 
                                drugs; and
                                    ``(III) the net price per dosage 
                                unit or course of treatment incurred by 
                                the health plan or health insurance 
                                coverage and its enrollees, 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 
                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 benefit 
                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 
        (or successor regulations), 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).
    ``(c) Limitations on Spread Pricing.--
            ``(1) Prescription drug transactions with pharmacies 
        independent of the issuer or pharmacy benefits manager.--If the 
        pharmacy that dispenses a prescription drug to an enrollee in a 
        group health plan or group or individual health insurance 
        coverage is not wholly or partially owned by such plan, such 
        issuer, or an entity providing pharmacy benefit management 
        services under such plan or coverage, such plan, issuer, or 
        entity shall not charge the plan, issuer, or enrollee a price 
        for such prescription drug that exceeds the price paid to the 
        pharmacy, excluding penalties paid by pharmacies to such plan, 
        issuer, or entity.
            ``(2) Intra-company prescription drug transactions.--If the 
        mail order, specialty, or retail pharmacy that dispenses a 
        prescription drug to an enrollee in a group health plan or 
        health insurance coverage is wholly or partially owned by such 
        health insurance issuer or an entity providing pharmacy benefit 
        management services under a group health plan or group or 
        individual health insurance coverage, the price charged for 
        such drug by such pharmacy to such group health plan or health 
        insurance issuer offering group or individual health insurance 
        coverage may not exceed the lesser of--
                    ``(A) the wholesale acquisition cost of the drug 
                paid by the pharmacy, plus clearly documented 
                dispensing costs, including pharmacy profit; or
                    ``(B) 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 
                similarly situated pharmacies not wholly or partially 
                owned by the health insurance issuer or entity 
                providing pharmacy benefits management services, as 
                described in paragraph (1).
            ``(3) Supplementary reporting for intra-company 
        prescription drug transactions.--A health insurance issuer of 
        group health insurance coverage or an entity providing pharmacy 
        benefits management services under a group health plan or group 
        health insurance coverage that conducts transactions with a 
        wholly or partially owned pharmacy, as described in paragraph 
        (2), shall submit, together with the report under subsection 
        (b), a supplementary quarterly report to the plan sponsor that 
        includes--
                    ``(A) an explanation of any benefit 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;
                    ``(B) the percentage of total prescriptions charged 
                to the plan, coverage, or enrollees in the plan or 
                coverage, that were dispensed by mail order, specialty, 
                or retail pharmacies that are wholly or partially owned 
                by the issuer or entity providing pharmacy benefits 
                management services; and
                    ``(C) a list of all drugs dispensed by such wholly 
                or partially owned pharmacy and charged to the plan or 
                coverage, or enrollees of the plan or coverage, during 
                the applicable quarter, and, with respect to each 
                drug--
                            ``(i) the amount charged per dosage unit or 
                        course of treatment with respect to enrollees 
                        in the plan or coverage, including amounts 
                        charged to the plan or coverage and amounts 
                        charged to the enrollee;
                            ``(ii) the median amount charged to the 
                        plan or coverage, per dosage unit or course of 
                        treatment, and including amounts paid by the 
                        enrollee, when the same drug is dispensed by 
                        other pharmacies that are not wholly or 
                        partially owned by the issuer or entity and 
                        that are included in the pharmacy network of 
                        that plan or coverage;
                            ``(iii) the interquartile range of the 
                        costs, per dosage unit or course of treatment, 
                        and including amounts paid by the enrollee, 
                        when the same drug is dispensed by other 
                        pharmacies that are not wholly or partially 
                        owned by the issuer or entity and that are 
                        included in the pharmacy network of that plan 
                        or coverage; and
                            ``(iv) the lowest cost per dosage unit or 
                        course of treatment, for such drug, including 
                        amounts charged to the plan or issuer and 
                        enrollee, that is available from any pharmacy 
                        included in the network of the plan or 
                        coverage.
    ``(d) Full Rebate Pass-Through to Plan.--
            ``(1) In general.--A pharmacy benefits manager, a third-
        party administrator of a group health plan, a health insurance 
        issuer offering group health insurance coverage, or an entity 
        providing pharmacy benefits management services under such 
        health plan or health insurance coverage shall remit 100 
        percent of rebates, fees, alternative discounts, and all other 
        remuneration received from a pharmaceutical manufacturer, 
        distributor or any other third party, that are related to 
        utilization of drugs under such health plan or health insurance 
        coverage, to the group health plan.
            ``(2) Form and manner of remittance.--Such rebates, fees, 
        alternative discounts, and other remuneration shall be--
                    ``(A) remitted to the group health plan in a timely 
                fashion after the period for which such rebates, fees, 
                or other remuneration is calculated, and in no case 
                later than 90 days after the end of such period;
                    ``(B) fully disclosed and enumerated to the group 
                health plan sponsor, as described in (b)(1); and
                    ``(C) available for audit by the plan sponsor, or a 
                third-party designated by a plan sponsor no less than 
                once per plan year.
    ``(e) Enforcement.--
            ``(1) Failure to provide timely information.--A health 
        insurance issuer or an entity providing pharmacy benefit 
        management services that violates subsection (a), fails to 
        provide information required under subsection (b), engages in 
        spread pricing as defined in subsection (c), or fails to comply 
        with the requirements of subsection (d), or a drug manufacturer 
        that fails to provide information under subsection (b)(1)(A), 
        in a timely manner 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.
            ``(2) False information.--A health insurance issuer, entity 
        providing pharmacy benefit management services, or drug 
        manufacturer that knowingly provides false information under 
        this section shall be subject to a civil money penalty in an 
        amount not to exceed $100,000 for each item of false 
        information. Such civil money penalty shall be in addition to 
        other penalties as may be prescribed by law.
            ``(3) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsections (a) and (b) and the 
        first sentence of subsection (c)(1) of such section shall apply 
        to civil monetary penalties under this subsection in the same 
        manner as such provisions apply to a penalty or proceeding 
        under section 1128A of the Social Security Act.
    ``(f) Definitions.--In this section--
            ``(1) the term `similarly situated pharmacy' means, with 
        respect to a particular pharmacy, another pharmacy that is 
        approximately the same size (as measured by the number of 
        prescription drugs dispensed), and that serves patients in the 
        same geographical area, whether through physical locations or 
        mail order; and
            ``(2) the term `wholesale acquisition cost' has the meaning 
        given such term in section 1847A(c)(6)(B) of the Social 
        Security Act.''.

SEC. 307. GOVERNMENT ACCOUNTABILITY OFFICE STUDY ON PROFIT- AND 
              REVENUE-SHARING IN HEALTH CARE.

    (a) Study.--Not later than 1 year after the date of enactment of 
this Act, the Comptroller General of the United States shall conduct a 
study to--
            (1) describe what is known about profit- and revenue-
        sharing relationships in the commercial health care markets, 
        including those relationships that--
                    (A) involve one or more--
                            (i) physician groups that practice within a 
                        hospital included in the profit- or revenue-
                        sharing relationship, or refer patients to such 
                        hospital;
                            (ii) laboratory, radiology, or pharmacy 
                        services that are delivered to privately 
                        insured patients of such hospital;
                            (iii) surgical services;
                            (iv) hospitals or group purchasing 
                        organizations; or
                            (v) rehabilitation or physical therapy 
                        facilities or services; and
                    (B) include revenue- or profit-sharing whether 
                through a joint venture, management or professional 
                services agreement, or other form of gain-sharing 
                contract;
            (2) describe Federal oversight of such relationships, 
        including authorities of the Department of Health and Human 
        Services and the Federal Trade Commission to review such 
        relationships and their potential to increase costs for 
        patients, and identify limitations in such oversight; and
            (3) as appropriate, make recommendations to improve Federal 
        oversight of such relationships.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Comptroller General of the United States shall prepare 
and submit a report on the study conducted under subsection (a) to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Education and Labor and the Committee on Energy and 
Commerce of the House of Representatives.

SEC. 308. DISCLOSURE OF DIRECT AND INDIRECT COMPENSATION FOR BROKERS 
              AND CONSULTANTS TO EMPLOYER-SPONSORED HEALTH PLANS AND 
              ENROLLEES IN PLANS ON THE INDIVIDUAL MARKET.

    (a) Group Health Plans.--Section 408(b)(2) of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)) is 
amended--
            (1) by striking ``(2) Contracting or making'' and inserting 
        ``(2)(A) Contracting or making''; and
            (2) by adding at the end the following:
            ``(B)(i) No contract or arrangement for services between a 
        covered plan and a covered service provider, and no extension 
        or renewal of such a contract or arrangement, is reasonable 
        within the meaning of this paragraph unless the requirements of 
        this clause are met.
            ``(ii)(I) For purposes of this subparagraph:
                    ``(aa) The term `covered plan' means a group health 
                plan as defined section 733(a).
                    ``(bb) The term `covered service provider' means a 
                service provider that enters into a contract or 
                arrangement with the covered plan and reasonably 
                expects $1,000 (or such amount as the Secretary may 
                establish in regulations to account for inflation since 
                the date of enactment of the Lower Health Care Costs 
                Act, as appropriate) or more in compensation, direct or 
                indirect, to be received in connection with providing 
                one or more of the following services, pursuant to the 
                contract or arrangement, regardless of whether such 
                services will be performed, or such compensation 
                received, by the covered service provider, an 
                affiliate, or a subcontractor:
                            ``(AA) Brokerage services, for which the 
                        covered service provider, an affiliate, or a 
                        subcontractor reasonably expects to receive 
                        indirect compensation or direct compensation 
                        described in item (dd), provided to a covered 
                        plan with respect to selection of insurance 
                        products (including vision and dental), 
                        recordkeeping services, medical management 
                        vendor, benefits administration (including 
                        vision and dental), stop-loss insurance, 
                        pharmacy benefit management services, wellness 
                        services, transparency tools and vendors, group 
                        purchasing organization preferred vendor 
                        panels, disease management vendors and 
                        products, compliance services, employee 
                        assistance programs, or third-party 
                        administration services.
                            ``(BB) Consulting, for which the covered 
                        service provider, an affiliate, or a 
                        subcontractor reasonably expects to receive 
                        indirect compensation or direct compensation 
                        described in item (dd), related to the 
                        development or implementation of plan design, 
                        insurance or insurance product selection 
                        (including vision and dental), recordkeeping, 
                        medical management, benefits administration 
                        selection (including vision and dental), stop-
                        loss insurance, pharmacy benefit management 
                        services, wellness design and management 
                        services, transparency tools, group purchasing 
                        organization agreements and services, 
                        participation in and services from preferred 
                        vendor panels, disease management, compliance 
                        services, employee assistance programs, or 
                        third-party administration services.
                    ``(cc) The term `affiliate', with respect to a 
                covered service provider, means an entity that directly 
                or indirectly (through one or more intermediaries) 
                controls, is controlled by, or is under common control 
                with, such provider, or is an officer, director, or 
                employee of, or partner in, such provider.
                    ``(dd)(AA) The term `compensation' means anything 
                of monetary value, but does not include non-monetary 
                compensation valued at $250 (or such amount as the 
                Secretary may establish in regulations to account for 
                inflation since the date of enactment of the Lower 
                Health Care Costs Act, as appropriate) or less, in the 
                aggregate, during the term of the contract or 
                arrangement.
                    ``(BB) The term `direct compensation' means 
                compensation received directly from a covered plan.
                    ``(CC) The term `indirect compensation' means 
                compensation received from any source other than the 
                covered plan, the plan sponsor, the covered service 
                provider, or an affiliate. Compensation received from a 
                subcontractor is indirect compensation, unless it is 
                received in connection with services performed under a 
                contract or arrangement with a subcontractor.
                    ``(ee) The term `responsible plan fiduciary' means 
                a fiduciary with authority to cause the covered plan to 
                enter into, or extend or renew, the contract or 
                arrangement.
                    ``(ff) The term `subcontractor' means any person or 
                entity (or an affiliate of such person or entity) that 
                is not an affiliate of the covered service provider and 
                that, pursuant to a contract or arrangement with the 
                covered service provider or an affiliate, reasonably 
                expects to receive $1,000 (or such amount as the 
                Secretary may establish in regulations to account for 
                inflation since the date of enactment of the Lower 
                Health Care Costs Act, as appropriate) or more in 
                compensation for performing one or more services 
                described in item (bb) under a contract or arrangement 
                with the covered plan.
            ``(II) For purposes of this subparagraph, a description of 
        compensation or cost may be expressed as a monetary amount, 
        formula, or a per capita charge for each enrollee or, if the 
        compensation or cost cannot reasonably be expressed in such 
        terms, by any other reasonable method, including a disclosure 
        that additional compensation may be earned but may not be 
        calculated at the time of contract if such a disclosure 
        includes a description of the circumstances under which the 
        additional compensation may be earned and a reasonable and good 
        faith estimate if the covered service provider cannot otherwise 
        readily describe compensation or cost and explains the 
        methodology and assumptions used to prepare such estimate. Any 
        such description shall contain sufficient information to permit 
        evaluation of the reasonableness of the compensation or cost.
            ``(III) No person or entity is a `covered service provider' 
        within the meaning of subclause (I)(bb) solely on the basis of 
        providing services as an affiliate or a subcontractor that is 
        performing one or more of the services described in subitem 
        (AA) or (BB) of such subclause under the contract or 
        arrangement with the covered plan.
            ``(iii) A covered service provider shall disclose to a 
        responsible plan fiduciary, in writing, the following:
                    ``(I) A description of the services to be provided 
                to the covered plan pursuant to the contract or 
                arrangement.
                    ``(II) If applicable, a statement that the covered 
                service provider, an affiliate, or a subcontractor will 
                provide, or reasonably expects to provide, services 
                pursuant to the contract or arrangement directly to the 
                covered plan as a fiduciary (within the meaning of 
                section 3(21)).
                    ``(III) A description of all direct compensation, 
                either in the aggregate or by service, that the covered 
                service provider, an affiliate, or a subcontractor 
                reasonably expects to receive in connection with the 
                services described in subclause (I).
                    ``(IV)(aa) A description of all indirect 
                compensation that the covered service provider, an 
                affiliate, or a subcontractor reasonably expects to 
                receive in connection with the services described in 
                subclause (I)--
                            ``(AA) including compensation from a vendor 
                        to a brokerage firm based on a structure of 
                        incentives not solely related to the contract 
                        with the covered plan; and
                            ``(BB) not including compensation received 
                        by an employee from an employer on account of 
                        work performed by the employee.
                    ``(bb) A description of the arrangement between the 
                payer and the covered service provider, an affiliate, 
                or a subcontractor, as applicable, pursuant to which 
                such indirect compensation is paid.
                    ``(cc) Identification of the services for which the 
                indirect compensation will be received, if applicable.
                    ``(dd) Identification of the payer of the indirect 
                compensation.
                    ``(V) A description of any compensation that will 
                be paid among the covered service provider, an 
                affiliate, or a subcontractor, in connection with the 
                services described in subclause (I) if such 
                compensation is set on a transaction basis (such as 
                commissions, finder's fees, or other similar incentive 
                compensation based on business placed or retained), 
                including identification of the services for which such 
                compensation will be paid and identification of the 
                payers and recipients of such compensation (including 
                the status of a payer or recipient as an affiliate or a 
                subcontractor), regardless of whether such compensation 
                also is disclosed pursuant to subclause (III) or (IV).
                    ``(VI) A description of any compensation that the 
                covered service provider, an affiliate, or a 
                subcontractor reasonably expects to receive in 
                connection with termination of the contract or 
                arrangement, and how any prepaid amounts will be 
                calculated and refunded upon such termination.
            ``(iv) A covered service provider shall disclose to a 
        responsible plan fiduciary, in writing a description of the 
        manner in which the compensation described in clause (iii), as 
        applicable, will be received.
            ``(v)(I) A covered service provider shall disclose the 
        information required under clauses (iii) and (iv) to the 
        responsible plan fiduciary not later than the date that is 
        reasonably in advance of the date on which the contract or 
        arrangement is entered into, and extended or renewed.
            ``(II) A covered service provider shall disclose any change 
        to the information required under clauses (iii) and (iv) as 
        soon as practicable, but not later than 60 days from the date 
        on which the covered service provider is informed of such 
        change, unless such disclosure is precluded due to 
        extraordinary circumstances beyond the covered service 
        provider's control, in which case the information shall be 
        disclosed as soon as practicable.
            ``(vi)(I) Upon the written request of the responsible plan 
        fiduciary or covered plan administrator, a covered service 
        provider shall furnish any other information relating to the 
        compensation received in connection with the contract or 
        arrangement that is required for the covered plan to comply 
        with the reporting and disclosure requirements under this Act.
            ``(II) The covered service provider shall disclose the 
        information required under clause (iii)(I) reasonably in 
        advance of the date upon which such responsible plan fiduciary 
        or covered plan administrator states that it is required to 
        comply with the applicable reporting or disclosure requirement, 
        unless such disclosure is precluded due to extraordinary 
        circumstances beyond the covered service provider's control, in 
        which case the information shall be disclosed as soon as 
        practicable.
            ``(vii) No contract or arrangement will fail to be 
        reasonable under this subparagraph solely because the covered 
        service provider, acting in good faith and with reasonable 
        diligence, makes an error or omission in disclosing the 
        information required pursuant to clause (iii) (or a change to 
        such information disclosed pursuant to clause (v)(II)) or 
        clause (vi), provided that the covered service provider 
        discloses the correct information to the responsible plan 
        fiduciary as soon as practicable, but not later than 30 days 
        from the date on which the covered service provider knows of 
        such error or omission.
            ``(viii)(I) Pursuant to subsection (a), subparagraphs (C) 
        and (D) of section 406(a)(1) shall not apply to a responsible 
        plan fiduciary, notwithstanding any failure by a covered 
        service provider to disclose information required under clause 
        (iii), if the following conditions are met:
                    ``(aa) The responsible plan fiduciary did not know 
                that the covered service provider failed or would fail 
                to make required disclosures and reasonably believed 
                that the covered service provider disclosed the 
                information required to be disclosed.
                    ``(bb) The responsible plan fiduciary, upon 
                discovering that the covered service provider failed to 
                disclose the required information, requests in writing 
                that the covered service provider furnish such 
                information.
                    ``(cc) If the covered service provider fails to 
                comply with a written request described in subclause 
                (II) within 90 days of the request, the responsible 
                plan fiduciary notifies the Secretary of the covered 
                service provider's failure, in accordance with 
                subclauses (II) and (III).
            ``(II) A notice described in subclause (I)(cc) shall 
        contain--
                    ``(aa) the name of the covered plan;
                    ``(bb) the plan number used for the annual report 
                on the covered plan;
                    ``(cc) the plan sponsor's name, address, and 
                employer identification number;
                    ``(dd) the name, address, and telephone number of 
                the responsible plan fiduciary;
                    ``(ee) the name, address, phone number, and, if 
                known, employer identification number of the covered 
                service provider;
                    ``(ff) a description of the services provided to 
                the covered plan;
                    ``(gg) a description of the information that the 
                covered service provider failed to disclose;
                    ``(hh) the date on which such information was 
                requested in writing from the covered service provider; 
                and
                    ``(ii) a statement as to whether the covered 
                service provider continues to provide services to the 
                plan.
            ``(III) A notice described in subclause (I)(cc) shall be 
        filed with the Department not later than 30 days following the 
        earlier of--
                    ``(aa) the covered service provider's refusal to 
                furnish the information requested by the written 
                request described in subclause (I)(bb); or
                    ``(bb) 90 days after the written request referred 
                to in subclause (I)(cc) is made.
            ``(IV) If the covered service provider fails to comply with 
        the written request under subclause (I)(bb) within 90 days of 
        such request, the responsible plan fiduciary shall determine 
        whether to terminate or continue the contract or arrangement 
        under section 404. If the requested information relates to 
        future services and is not disclosed promptly after the end of 
        the 90-day period, the responsible plan fiduciary shall 
        terminate the contract or arrangement as expeditiously as 
        possible, consistent with such duty of prudence.
            ``(ix) Nothing in this subparagraph shall be construed to 
        supersede any provision of State law that governs disclosures 
        by parties that provide the services described in this section, 
        except to the extent that such law prevents the application of 
        a requirement of this section.''.
    (b) Applicability of Existing Regulations.--Nothing in the 
amendments made by subsection (a) shall be construed to affect the 
applicability of section 2550.408b-2 of title 29, Code of Federal 
Regulations (or any successor regulations), with respect to any 
applicable entity other than a covered plan or a covered service 
provider (as defined in section 408(b)(2)(B)(ii) of the Employee 
Retirement Income Security Act of 1974, as amended by subsection (a)).
    (c) Individual Market Coverage.--Subpart 1 of part B of title XVII 
of the Public Health Service Act (42 U.S.C. 300gg-41 et seq.) is 
amended by adding at the end the following:

``SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL MARKET COVERAGE.

    ``(a) In General.--A health insurance issuer offering individual 
health insurance coverage shall make disclosures to enrollees in such 
coverage, as described in subsection (b), and reports to the Secretary, 
as described in subsection (c), regarding direct or indirect 
compensation provided to an agent or broker associated with enrolling 
individuals in such coverage.
    ``(b) Disclosure.--A health insurance issuer described in 
subsection (a) shall disclose to an enrollee the amount of direct or 
indirect compensation provided to an agent or broker for services 
provided by such agent or broker associated with plan selection and 
enrollment. Such disclosure shall be--
            ``(1) made prior to the individual finalizing plan 
        selection; and
            ``(2) included on any documentation confirming the 
        individual's enrollment.
    ``(c) Reporting.--A health insurance issuer described in subsection 
(a) shall report to the Secretary any direct or indirect compensation 
provided to an agent or broker associated with enrolling individuals in 
such coverage.
    ``(d) Rulemaking.--Not later than 1 year after the date of 
enactment of the Lower Health Care Costs Act, the Secretary shall 
finalize, through notice-and-comment rulemaking, the form and manner in 
which issuers described in subsection (a) are required to make the 
disclosures described in subsection (b) and the reports described in 
subsection (c).''.
    (d) Transition Rule.--No contract executed prior to the effective 
date described in subsection (e) by a group health plan subject to the 
requirements of section 408(b)(2)(B) of the Employee Retirement Income 
Security Act of 1974 (as amended by subsection (a)) or by a health 
insurance issuer subject to the requirements of section 2746 of the 
Public Health Service Act (as added by subsection (c)) shall be subject 
to the requirements of such section 408(b)(2)(B) or such section 2746, 
as applicable.
    (e) Effective Date.--The amendments made by subsections (a) and (c) 
shall take effect 2 years after the date of enactment of this Act.

SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING INFORMATION.

    (a) In General.--Subpart II of part A of title XXVII of the Public 
Health Service Act (42 U.S.C. 300gg-11 et seq.), as amended by section 
306, is further amended by adding at the end the following:

``SEC. 2729F. PROVISION OF COST-SHARING INFORMATION.

    ``(a) Provider Disclosures.--A provider that is in-network with 
respect to a group health plan or a health insurance issuer offering 
group or individual health insurance coverage shall provide to an 
enrollee in the plan or coverage who submits a request for the 
information described in paragraph (1) or (2), together with accurate 
and complete information about the enrollee's coverage under the 
applicable plan or coverage--
            ``(1) as soon as practicable and not later than 2 business 
        days after the enrollee requests such information, a good faith 
        estimate of the expected enrollee cost-sharing for the 
        provision of a particular health care service (including any 
        service that is reasonably expected to be provided in 
        conjunction with such specific service); and
            ``(2) as soon as practicable and not later than 2 business 
        days after an enrollee requests such information, the contact 
        information for any ancillary providers for a scheduled health 
        care service.
    ``(b) Insurer Disclosures.--A group health plan or a health 
insurance issuer offering group or individual health insurance coverage 
shall provide an enrollee in the plan or coverage with a good faith 
estimate of the enrollee's cost-sharing (including deductibles, 
copayments, and coinsurance) for which the enrollee would be 
responsible for paying with respect to a specific health care service 
(including any service that is reasonably expected to be provided in 
conjunction with such specific service), as soon as practicable and not 
later than 2 business days after receiving a request for such 
information by an enrollee.
    ``(c) Enforcement.--
            ``(1) In general.--Subject to paragraph (2), a health care 
        provider that violates a requirement under subsection (a) shall 
        be subject to a civil monetary penalty of not more than $10,000 
        for each act constituting such violation.
            ``(2) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsections (a) and (b) and the 
        first sentence of subsection (c)(1) of such section, shall 
        apply to civil money 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.''.
    (b) Effective Date.--Section 2729G of the Public Health Service 
Act, as added by subsection (a), shall apply with respect to plan years 
beginning on or after January 1, 2021.

SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH AND SUBSTANCE USE 
              DISORDER BENEFITS.

    Section 2726 of the Public Health Service Act (42 U.S.C. 300gg-26) 
is amended--
            (1) in subsection (a), by adding at the end the following:
            ``(8) Compliance requirements.--
                    ``(A) Nonquantitative treatment limitation (nqtl) 
                requirements.--In the case of a group health plan or a 
                health insurance issuer offering group or individual 
                health insurance coverage that provides both medical 
                and surgical benefits and mental health or substance 
                use disorder benefits, the plan or coverage shall 
                perform comparative analyses about the design and 
                application of nonquantitative treatment limitations 
                (referred to in this paragraph as the `NQTL') in 
                accordance with the following process, and make 
                available to the Secretary upon request within 60 days 
                beginning January 1, 2020, and within 30 days beginning 
                January 1, 2021, the following information:
                            ``(i) The specific plan or coverage 
                        language regarding the NQTL, that applies to 
                        such plan or coverage, and a description of all 
                        mental health or substance use disorder and 
                        medical/surgical services to which it applies 
                        in each respective benefits classification.
                            ``(ii) The factors used to determine that 
                        an NQTL will apply to mental health or 
                        substance use disorder benefits and medical/
                        surgical benefits.
                            ``(iii) The evidentiary standard (both 
                        identified and deidentified) for the factors 
                        identified in clause (ii) and any other 
                        evidence relied upon to design and apply the 
                        NQTL to mental health or substance use disorder 
                        benefits and medical/surgical benefits.
                            ``(iv) The comparative analyses 
                        demonstrating that the processes and strategies 
                        used to design the NQTL, as written and in 
                        operation, and the as written processes and 
                        strategies used to apply the NQTL for mental 
                        health or substance use disorder benefits are 
                        comparable to, and are applied no more 
                        stringently than, the processes and strategies 
                        used to design the NQTL, as written and in 
                        operation, and the as written processes and 
                        strategies used to apply the NQTL to medical/
                        surgical benefits.
                            ``(v) A disclosure of the specific findings 
                        and conclusions reached by the plan or coverage 
                        that the results of the analyses described in 
                        this subparagraph indicate that the plan or 
                        coverage is in compliance with this section.
                    ``(B) Secretary request process.--
                            ``(i) Submission upon complaint.--The 
                        Secretary shall request that a group health 
                        plan or a health insurance issuer offering 
                        group or individual health insurance coverage 
                        submit the comparative analyses described in 
                        subparagraph (A) if the Secretary has received 
                        any complaints from plan participants or 
                        participating providers about such a plan or 
                        coverage that involve mental health or 
                        substance use disorder benefits.
                            ``(ii) Random submissions.--The Secretary 
                        shall request the comparative analyses 
                        described in subparagraph (A) from no fewer 
                        than 50 plans or coverages selected at random, 
                        annually, and such plans or coverages shall 
                        not--
                                    ``(I) be the same plans or 
                                coverages for which the comparative 
                                analyses are requested under clause 
                                (i);
                                    ``(II) be the same plan or coverage 
                                being investigated by the Department 
                                regarding NQTLs or that has been 
                                investigated by the Department 
                                regarding NQTLs within the last 5 
                                years; and
                                    ``(III) be the same plan or 
                                coverage that has been selected under 
                                clause (i) or (ii) within the last 5 
                                years.
                            ``(iii) Additional information.--In 
                        instances in which the Secretary has concluded 
                        that the plan or coverage has not submitted 
                        sufficient information for the Secretary to 
                        review the comparative analyses described in 
                        subparagraph (A), as requested under clauses 
                        (i) and (ii), the Secretary shall specify to 
                        the plan or coverage the information the plan 
                        or coverage must submit to be responsive to the 
                        request under clauses (i) and (ii) for the 
                        Secretary to review the comparative analyses 
                        described in subparagraph (A) for compliance 
                        with this section.
                            ``(iv) Required action.--In instances in 
                        which the Secretary has reviewed the 
                        comparative analyses described in subparagraph 
                        (A), as requested under clauses (i) and (ii), 
                        and determined that the plan or coverage is not 
                        in compliance with this section, the Secretary 
                        shall specify to the plan or coverage the 
                        actions the plan or coverage must take to be in 
                        compliance with this section. Documents or 
                        communications produced in connection with the 
                        Secretary's recommendations to the plan or 
                        coverage shall not be subject to disclosure 
                        pursuant to section 552 of title 5, United 
                        States Code.
                            ``(v) Report.--Not later than 1 year after 
                        the date of enactment of this paragraph, and 
                        annually thereafter, the Secretary shall submit 
                        to the Committee on Education and Labor of the 
                        House of Representatives and the Committee on 
                        Health, Education, Labor, and Pensions of the 
                        Senate a report that contains--
                                    ``(I) each of the comparative 
                                analyses requested under clauses (i) 
                                and (ii), except that the identity of 
                                each plan or coverage and any 
                                contracted entity of a plan or coverage 
                                shall be redacted;
                                    ``(II) the Secretary's conclusions 
                                as to whether each plan or coverage 
                                submitted sufficient information for 
                                the Secretary to review the comparative 
                                analyses requested under clauses (i) 
                                and (ii) for compliance with this 
                                section;
                                    ``(III) for each plan or coverage 
                                that did submit sufficient information 
                                for the Secretary to review the 
                                comparative analyses requested under 
                                clause (i), the Secretary's conclusions 
                                as to whether and why the plan or 
                                coverage is in compliance with this 
                                section;
                                    ``(IV) the Secretary's 
                                specifications described in clause 
                                (iii) for each plan or coverage that 
                                the Secretary determined did not submit 
                                sufficient information for the 
                                Secretary to review the comparative 
                                analyses requested under clauses (i) 
                                and (ii) for compliance with this 
                                section; and
                                    ``(V) the Secretary's 
                                specifications described in clause (iv) 
                                of the actions each plan or coverage 
                                that the Secretary determined is not in 
                                compliance with this section must take 
                                to be in compliance with this section, 
                                including the reason why the Secretary 
                                determined the plan or coverage is not 
                                in compliance.
                    ``(C) Compliance program guidance document update 
                process.--
                            ``(i) In general.--The Secretary shall 
                        include select instances of noncompliance that 
                        the Secretary discovers upon reviewing the 
                        comparative analyses requested under clauses 
                        (i) and (ii) of subparagraph (B) in the 
                        compliance program guidance document described 
                        in section 2726(a)(6), as it is updated every 2 
                        years, except that all instances shall be 
                        deidentified and such instances shall not 
                        disclose any protected health information or 
                        individually identifiable information.
                            ``(ii) Guidance and regulations.--Not later 
                        than 18 months after the date of enactment of 
                        this paragraph, the Secretary shall finalize 
                        any draft or interim guidance and regulations 
                        relating to mental health parity under this 
                        section.
                            ``(iii) State.--Any instances of 
                        noncompliance the Secretary discovers upon 
                        reviewing the comparative analyses requested 
                        under clauses (i) and (ii) of subparagraph (B) 
                        shall be shared with a State for coverage 
                        offered by a health insurance issuer in the 
                        group market, in accordance with section 
                        2726(a)(6)(B)(iii)(II).''.

SEC. 311. TECHNICAL AMENDMENTS.

    (a) ERISA.--Section 715 of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1185d) is amended--
            (1) in subsection (a)(1), by striking ``(as amended by the 
        Patient Protection and Affordable Care Act)'' and inserting 
        ``(including any subsequent amendments to such part)''; and
            (2) in subsection (b)--
                    (A) by striking ``(as amended by the Patient 
                Protection and Affordable Care Act)'' and inserting 
                ``(including any subsequent amendments to such part)''; 
                and
                    (B) by striking ``(as so amended)''.
    (b) IRC.--Section 9815 of the Internal Revenue Code of 1986 is 
amended--
            (1) in subsection (a)(1), by striking ``(as amended by the 
        Patient Protection and Affordable Care Act)'' and inserting 
        ``(including any subsequent amendments to such part)''; and
            (2) in subsection (b)--
                    (A) by striking ``(as amended by the Patient 
                Protection and Affordable Care Act)'' and inserting 
                ``(including any subsequent amendments to such part)''; 
                and
                    (B) by striking ``(as so amended)''.
    (c) Applicability.--The amendments made by subsections (a) and (b) 
shall take effect as though included in the enactment of the Patient 
Protection and Affordable Care Act (Public Law 111-148).

SEC. 312. THIRD-PARTY ADMINISTRATORS.

    Any obligation on a third-party administrator under this Act 
(including the amendments made by this Act) shall not affect any other 
direct or indirect requirement under any other provision of Federal law 
that applies to third-party administrators offering services to group 
health plans.

                   TITLE IV--IMPROVING PUBLIC HEALTH

SEC. 401. IMPROVING AWARENESS OF DISEASE PREVENTION.

    The Public Health Service Act is amended by striking section 313 of 
such Act (42 U.S.C. 245) and inserting the following:

``SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF 
              VACCINATIONS.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in coordination with 
other offices and agencies, as appropriate, shall award competitive 
grants to one or more public or private entities to carry out a 
national, evidence-based campaign to increase awareness and knowledge 
of the safety and effectiveness of vaccines for the prevention and 
control of diseases, combat misinformation about vaccines, and 
disseminate scientific and evidence-based vaccine-related information, 
with the goal of increasing rates of vaccination across all ages, as 
applicable, particularly in communities with low rates of vaccination, 
to reduce and eliminate vaccine-preventable diseases.
    ``(b) Consultation.--In carrying out the campaign under this 
section, the Secretary shall consult with appropriate public health and 
medical experts, including the National Academy of Medicine and medical 
and public health associations and nonprofit organizations, in the 
development, implementation, and evaluation of the evidence-based 
public awareness campaign.
    ``(c) Requirements.--The campaign under this section shall--
            ``(1) be a national, evidence-based initiative;
            ``(2) include the development of resources for communities 
        with low rates of vaccination, including culturally and 
        linguistically appropriate resources, as applicable;
            ``(3) include the dissemination of vaccine information and 
        communication resources to public health departments, health 
        care providers, and health care facilities, including such 
        providers and facilities that provide prenatal and pediatric 
        care;
            ``(4) be complementary to, and coordinated with, any other 
        Federal, State, or local efforts, as appropriate; and
            ``(5) assess the effectiveness of communication strategies 
        to increase rates of vaccination.
    ``(d) Additional Activities.--The campaign under this section may--
            ``(1) include the use of television, radio, the internet, 
        and other media and telecommunications technologies;
            ``(2) be focused to address specific needs of communities 
        and populations with low rates of vaccination; and
            ``(3) include the dissemination of scientific and evidence-
        based vaccine-related information, such as--
                    ``(A) advancements in evidence-based research 
                related to diseases that may be prevented by vaccines 
                and vaccine development;
                    ``(B) information on vaccinations for individuals 
                and communities, including individuals for whom 
                vaccines are not recommended by the Advisory Committee 
                for Immunization Practices, and the effects of low 
                vaccination rates within a community on such 
                individuals;
                    ``(C) information on diseases that may be prevented 
                by vaccines; and
                    ``(D) information on vaccine safety and the systems 
                in place to monitor vaccine safety.
    ``(e) Evaluation.--The Secretary shall--
            ``(1) establish benchmarks and metrics to quantitatively 
        measure and evaluate the awareness campaign under this section;
            ``(2) conduct qualitative assessments regarding the 
        awareness campaign under this section; and
            ``(3) prepare and submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives an 
        evaluation of the awareness campaign under this section.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section and section 317(k) such sums as 
may be necessary for fiscal years 2020 through 2024.''.

SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE DISEASES.

    Section 317(k)(1) of the Public Health Service Act (42 U.S.C. 
247b(k)(1)) is amended--
            (1) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;
            (2) in subparagraph (D), by striking the period and 
        inserting a semicolon; and
            (3) by adding at the end the following:
            ``(E) planning, implementation, and evaluation of 
        activities to address vaccine-preventable diseases, including 
        activities to--
                    ``(i) identify communities at high risk of 
                outbreaks related to vaccine-preventable diseases, 
                including through improved data collection and 
                analysis;
                    ``(ii) pilot innovative approaches to improve 
                vaccination rates in communities and among populations 
                with low rates of vaccination;
                    ``(iii) reduce barriers to accessing vaccines and 
                evidence-based information about the health effects of 
                vaccines;
                    ``(iv) partner with community organizations and 
                health care providers to develop and deliver evidence-
                based interventions, including culturally and 
                linguistically appropriate interventions, to increase 
                vaccination rates;
                    ``(v) improve delivery of evidence-based vaccine-
                related information to parents and others; and
                    ``(vi) improve the ability of State, local, tribal, 
                and territorial public health departments to engage 
                communities at high risk for outbreaks related to 
                vaccine-preventable diseases; and
            ``(F) research related to strategies for improving 
        awareness of scientific and evidence-based vaccine-related 
        information, including for communities with low rates of 
        vaccination, in order to understand barriers to vaccination, 
        improve vaccination rates, and assess the public health 
        outcomes of such strategies.''.

SEC. 403. GUIDE ON EVIDENCE-BASED STRATEGIES FOR PUBLIC HEALTH 
              DEPARTMENT OBESITY PREVENTION PROGRAMS.

    (a) Development and Dissemination of an Evidence-Based Strategies 
Guide.--The Secretary of Health and Human Services (referred to in this 
section as the ``Secretary''), acting through the Director of the 
Centers for Disease Control and Prevention, not later than 2 years 
after the date of enactment of this Act, shall--
            (1) develop a guide on evidence-based strategies for State, 
        territorial, and local health departments to use to build and 
        maintain effective obesity prevention and reduction programs, 
        and, in consultation with stakeholders that have expertise in 
        Tribal health, a guide on such evidence-based strategies with 
        respect to Indian Tribes and Tribal organizations for such 
        Indian Tribes and Tribal organizations to use for such purpose, 
        both of which guides shall--
                    (A) describe an integrated program structure for 
                implementing interventions proven to be effective in 
                preventing and reducing the incidence of obesity; and
                    (B) recommend--
                            (i) optimal resources, including staffing 
                        and infrastructure, for promoting nutrition and 
                        obesity prevention and reduction; and
                            (ii) strategies for effective obesity 
                        prevention programs for State and local health 
                        departments, Indian Tribes, and Tribal 
                        organizations, including strategies related 
                        to--
                                    (I) the application of evidence-
                                based and evidence-informed practices 
                                to prevent and reduce obesity rates;
                                    (II) the development, 
                                implementation, and evaluation of 
                                obesity prevention and reduction 
                                strategies for specific communities and 
                                populations;
                                    (III) demonstrated knowledge of 
                                obesity prevention practices that 
                                reduce associated preventable diseases, 
                                health conditions, death, and health 
                                care costs;
                                    (IV) best practices for the 
                                coordination of efforts to prevent and 
                                reduce obesity and related chronic 
                                diseases;
                                    (V) addressing the underlying risk 
                                factors and social determinants of 
                                health that impact obesity rates; and
                                    (VI) interdisciplinary coordination 
                                between relevant public health 
                                officials specializing in fields such 
                                as nutrition, physical activity, 
                                epidemiology, communications, and 
                                policy implementation, and 
                                collaboration between public health 
                                officials and community-based 
                                organizations; and
            (2) disseminate the guides and current research, evidence-
        based practices, tools, and educational materials related to 
        obesity prevention, consistent with the guide, to State and 
        local health departments, Indian Tribes, and Tribal 
        organizations.
    (b) Technical Assistance.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall 
provide technical assistance to State and local health departments, 
Indian Tribes, and Tribal organizations to support such health 
departments in implementing the guide developed under subsection 
(a)(1).
    (c) Indian Tribes; Tribal Organizations.--The terms ``Indian 
Tribe'' and ``Tribal organization'' have the meanings given the terms 
``Indian tribe'' and ``tribal organization'', respectively, in section 
4 of the Indian Self-Determination and Education Assistance Act (25 
U.S.C. 5304).

SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES.

    Title III of the Public Health Service Act is amended by inserting 
after section 330M (42 U.S.C. 254c-19) the following:

``SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES.

    ``(a) Definitions.--In this section:
            ``(1) Eligible entity.--The term `eligible entity' means an 
        entity providing health care services in rural areas, frontier 
        areas, health professional shortage areas, or medically 
        underserved areas, or to medically underserved populations or 
        Native Americans, including Indian tribes or tribal 
        organizations.
            ``(2) Health professional shortage area.--The term `health 
        professional shortage area' means a health professional 
        shortage area designated under section 332.
            ``(3) Indian tribe.--The terms `Indian tribe' and `tribal 
        organization' have the meanings given such terms in section 4 
        of the Indian Self-Determination and Education Assistance Act.
            ``(4) Medically underserved population.--The term 
        `medically underserved population' has the meaning given the 
        term in section 330(b)(3).
            ``(5) Native americans.--The term `Native Americans' has 
        the meaning given such term in section 736 and includes Indian 
        tribes and tribal organizations.
            ``(6) Technology-enabled collaborative learning and 
        capacity building model.--The term `technology-enabled 
        collaborative learning and capacity building model' means a 
        distance health education model that connects specialists with 
        multiple other health care professionals through simultaneous 
        interactive videoconferencing for the purpose of facilitating 
        case-based learning, disseminating best practices, and 
        evaluating outcomes.
    ``(b) Program Established.--The Secretary shall, as appropriate, 
award grants to evaluate, develop, and, as appropriate, expand the use 
of technology-enabled collaborative learning and capacity building 
models, to increase access to health care services, such as those to 
address chronic diseases and conditions, mental health, substance use 
disorders, prenatal and maternal health, pediatric care, pain 
management, palliative care, and other specialty care in medically 
underserved areas and for medically underserved populations.
    ``(c) Use of Funds.--
            ``(1) In general.--Grants awarded under subsection (b) 
        shall be used for--
                    ``(A) the development and acquisition of 
                instructional programming, and the training of health 
                care providers and other professionals that provide or 
                assist in the provision of services through such 
                models;
                    ``(B) information collection and evaluation 
                activities to study the impact of such models on 
                patient outcomes and health care providers, and to 
                identify best practices for the expansion and use of 
                such models; or
                    ``(C) other activities consistent with achieving 
                the objectives of the grants awarded under this 
                section, as determined by the Secretary.
            ``(2) Other uses.--In addition to any of the uses under 
        paragraph (1), grants awarded under subsection (b) may be used 
        for--
                    ``(A) equipment to support the use and expansion of 
                technology-enabled collaborative learning and capacity 
                building models, including for hardware and software 
                that enables distance learning, health care provider 
                support, and the secure exchange of electronic health 
                information; or
                    ``(B) support for health care providers and other 
                professionals that provide or assist in the provision 
                of services through such models.
    ``(d) Length of Grants.--Grants awarded under subsection (b) shall 
be for a period of up to 5 years.
    ``(e) Application.--An eligible entity that seeks to receive a 
grant under subsection (b) shall submit to the Secretary an 
application, at such time, in such manner, and containing such 
information as the Secretary may require. Such application criteria 
shall include an assessment of the effect of technology-enabled 
collaborative learning and capacity building models on patient outcomes 
and health care providers.
    ``(f) Technical Assistance.--The Secretary shall provide (either 
directly through the Department of Health and Human Services or by 
contract) technical assistance to eligible entities, including 
recipients of grants under subsection (b), on the development, use, and 
evaluation of technology-enabled collaborative learning and capacity 
building models in order to expand access to health care services 
provided by such entities, including for medically underserved areas 
and to medically underserved populations.
    ``(g) Report by Secretary.--Not later than 4 years after the date 
of enactment of this section, the Secretary shall prepare and submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, and post on the internet website of the Department of 
Health and Human Services, a report including, at minimum--
            ``(1) a description of any new and continuing grants 
        awarded to entities under subsection (b) and the specific 
        purpose and amounts of such grants;
            ``(2) an overview of--
                    ``(A) the evaluations conducted under subsections 
                (b) or (f); and
                    ``(B) technical assistance provided under 
                subsection (f); and
            ``(3) a description of any significant findings or 
        developments in patient outcomes and health care providers and 
        best practices for eligible entities expanding, using, or 
        evaluating technology-enabled collaborative learning and 
        capacity building models.
    ``(h) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2020 through 2024.''.

SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION.

    Subtitle C of title XXVIII of the Public Health Service Act (42 
U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:

``SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZATION GRANTS.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall--
            ``(1) award grants to State, local, Tribal, and territorial 
        public health departments for the expansion and modernization 
        of public health data systems, to assist public health 
        departments in--
                    ``(A) assessing current data infrastructure 
                capabilities and gaps to improve and increase 
                consistency in data collection, storage, analysis, and, 
                as appropriate, to improve dissemination of public 
                health-related information;
                    ``(B) improving secure public health data 
                collection, transmission, exchange, maintenance, and 
                analysis;
                    ``(C) simplifying and supporting reporting by 
                health care providers, as applicable, pursuant to State 
                law, including through the use of health information 
                technology, to State, local, Tribal, and territorial 
                public health departments, including public health 
                officials in multiple jurisdictions within such State, 
                as appropriate;
                    ``(D) enhancing interoperability of public health 
                data systems (including systems created or accessed by 
                public health departments) with health information 
                technology, including certified health information 
                technology;
                    ``(E) supporting earlier disease and health 
                condition detection, such as through near real-time 
                data monitoring, to support rapid public health 
                responses; and
                    ``(F) supporting activities within the applicable 
                jurisdiction related to the expansion and modernization 
                of electronic case reporting;
            ``(2) as appropriate, conduct activities related to the 
        interoperability and improvement of applicable public health 
        data systems used by the Centers for Disease Control and 
        Prevention, and, in coordination with the Office of the 
        National Coordinator for Health Information Technology, the 
        designation of data and technology standards for health 
        information systems of the public health infrastructure with 
        deference given to standards published by standards development 
        organizations and voluntary consensus-based standards bodies; 
        and
            ``(3) develop and utilize public-private partnerships for 
        technical assistance and related implementation support for 
        State, local, Tribal, and territorial public health 
        departments, and the Centers for Disease Control and 
        Prevention, on the expansion and modernization of electronic 
        case reporting and public health data systems, as applicable.
    ``(b) Requirements.--
            ``(1) In general.--The Secretary may not award a grant 
        under subsection (a)(1) unless the applicant supports standards 
        endorsed by the National Coordinator for Health Information 
        Technology pursuant to section 3001(c)(1) or adopted by the 
        Secretary under section 3004.
            ``(2) Waiver.--The Secretary may waive the requirement 
        under paragraph (1) with respect to an applicant if the 
        Secretary determines that the activities under subsection (a) 
        cannot otherwise be carried out within the applicable 
        jurisdiction.
            ``(3) Application.--A State, local, Tribal, or territorial 
        health department applying for a grant under this section shall 
        submit an application to the Secretary at such time and in such 
        manner as the Secretary may require. Such application shall 
        include information describing--
                    ``(A) the activities that will be supported by the 
                grant; and
                    ``(B) how the modernization of such public health 
                data systems will support or impact the public health 
                infrastructure of the health department, including a 
                description of remaining gaps, if any, and the actions 
                needed to address such gaps.
    ``(c) Use of Funds.--An entity receiving a grant under this section 
may use amounts received under such grant for one or both of the 
following:
            ``(1) Carrying out activities described in subsection 
        (a)(1) to support public health data systems (including 
        electronic case reporting), which may include support for, and 
        training of, professionals with expertise in contributing to 
        and using such systems (including public health data 
        scientists).
            ``(2) Developing and disseminating information related to 
        the use and importance of public health data.
    ``(d) Strategy and Implementation Plan.--Not later than 180 days 
after the date of enactment of the Lower Health Care Costs Act, the 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention, shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives, a coordinated 
strategy and an accompanying implementation plan that identifies and 
demonstrates the steps the Secretary will carry out to--
            ``(1) update and improve applicable public health data 
        systems used by the Centers for Disease Control and Prevention; 
        and
            ``(2) carry out the activities described in this section to 
        support the improvement of State, local, Tribal, and 
        territorial public health data systems.
    ``(e) Consultation.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall consult with 
State, local, Tribal, and territorial health departments, professional 
medical and public health associations, associations representing 
hospitals or other health care entities, health information technology 
experts, and other appropriate entities regarding the plan and grant 
program to modernize public health data systems pursuant to this 
section. Such activities may include the provision of technical 
assistance related to the exchange of information by such public health 
data systems used by relevant health care and public health entities at 
the local, State, Federal, Tribal, and territorial levels.
    ``(f) Report to Congress.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall submit a report to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives 
that includes--
            ``(1) a description of any barriers to--
                    ``(A) public health authorities implementing 
                electronic case reporting and interoperable public 
                health data systems; or
                    ``(B) the exchange of information pursuant to 
                electronic case reporting;
            ``(2) an assessment of the potential public health impact 
        of implementing electronic case reporting and interoperable 
        public health data systems; and
            ``(3) a description of the activities carried out pursuant 
        to this section.
    ``(g) Electronic Case Reporting.--In this section, the term 
`electronic case reporting' means the automated identification, 
generation, and bilateral exchange of reports of health events among 
electronic health record or health information technology systems and 
public health authorities.
    ``(h) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for fiscal years 2020 through 2024.''.

SEC. 406. INNOVATION FOR MATERNAL HEALTH.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in consultation 
with experts representing a variety of clinical specialties, State, 
tribal, or local public health officials, researchers, epidemiologists, 
statisticians, and community organizations, shall establish a program 
to award competitive grants to eligible entities for the purpose of--
            (1) identifying, developing, or disseminating best 
        practices to improve maternal health care quality and outcomes, 
        eliminate preventable maternal mortality and severe maternal 
        morbidity, and improve infant health outcomes, which may 
        include--
                    (A) information on evidence-based practices to 
                improve the quality and safety of maternal health care 
                in hospitals and other health care settings of a State 
                or health care system, including by addressing topics 
                commonly associated with health complications or risks 
                related to prenatal care, labor care, birthing, and 
                postpartum care;
                    (B) best practices for improving maternal health 
                care based on data findings and reviews conducted by a 
                State maternal mortality review committee that address 
                topics of relevance to common complications or health 
                risks related to prenatal care, labor care, birthing, 
                and postpartum care; and
                    (C) information on addressing determinants of 
                health that impact maternal health outcomes for women 
                before, during, and after pregnancy;
            (2) collaborating with State maternal mortality review 
        committees to identify issues for the development and 
        implementation of evidence-based practices to improve maternal 
        health outcomes and reduce preventable maternal mortality and 
        severe maternal morbidity;
            (3) providing technical assistance and supporting the 
        implementation of best practices identified in paragraph (1) to 
        entities providing health care services to pregnant and 
        postpartum women; and
            (4) identifying, developing, and evaluating new models of 
        care that improve maternal and infant health outcomes, which 
        may include the integration of community-based services and 
        clinical care.
    (b) Eligible Entities.--To be eligible for a grant under subsection 
(a), an entity shall--
            (1) submit to the Secretary an application at such time, in 
        such manner, and containing such information as the Secretary 
        may require; and
            (2) demonstrate in such application that the entity has a 
        demonstrated expertise in data-driven maternal safety and 
        quality improvement initiatives in the areas of obstetrics and 
        gynecology or maternal health.
    (c) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated such sums as may be necessary 
for each of fiscal years 2020 through 2024.

SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS.

    Title VII of the Public Health Service Act is amended by striking 
section 763 (42 U.S.C. 294p) and inserting the following:

``SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.

    ``(a) Grant Program.--The Secretary shall establish a program to 
award grants to accredited schools of allopathic medicine, osteopathic 
medicine, and nursing, and other health professional training programs 
for the training of health care professionals to reduce and prevent 
discrimination (including training related to implicit biases) in the 
provision of health care services related to prenatal care, labor care, 
birthing, and postpartum care.
    ``(b) Eligibility.--To be eligible for a grant under subsection 
(a), an entity described in such subsection shall submit to the 
Secretary an application at such time, in such manner, and containing 
such information as the Secretary may require.
    ``(c) Reporting Requirement.--Each entity awarded a grant under 
this section shall periodically submit to the Secretary a report on the 
status of activities conducted using the grant, including a description 
of the impact of such training on patient outcomes, as applicable.
    ``(d) Best Practices.--The Secretary may identify and disseminate 
best practices for the training of health care professionals to reduce 
and prevent discrimination (including training related to implicit 
biases) in the provision of health care services related to prenatal 
care, labor care, birthing, and postpartum care.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated such sums as may be necessary 
for each of fiscal years 2020 through 2024.''.

SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT DISCRIMINATION.

    Not later than 2 years after date of enactment of this Act, the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') shall, through a contract with an independent 
research organization, study and make recommendations for accredited 
schools of allopathic medicine, osteopathic medicine, and nursing, and 
other health professional training programs on best practices related 
to training to reduce and prevent discrimination, including training 
related to implicit biases, in the provision of health care services 
related to prenatal care, labor care, birthing, and postpartum care.

SEC. 409. PERINATAL QUALITY COLLABORATIVES.

    Section 317K(a)(2) of the Public Health Service Act (42 U.S.C. 
247b-12(a)(2)) is amended by adding at the end the following:
                    ``(E)(i) The Secretary, acting through the Director 
                of the Centers for Disease Control and Prevention and 
                in coordination with other offices and agencies, as 
                appropriate, shall establish or continue a competitive 
                grant program for the establishment or support of 
                perinatal quality collaboratives to improve perinatal 
                care and perinatal health outcomes for pregnant and 
                postpartum women and their infants. A State or Indian 
                Tribe may use funds received through such grant to--
                            ``(I) support the use of evidence-based or 
                        evidence-informed practices to improve outcomes 
                        for maternal and infant health;
                            ``(II) work with clinical teams; experts; 
                        State, local, and, as appropriate, tribal 
                        public health officials; and stakeholders, 
                        including patients and families, to identify, 
                        develop, or disseminate best practices to 
                        improve perinatal care and outcomes; and
                            ``(III) employ strategies that provide 
                        opportunities for health care professionals and 
                        clinical teams to collaborate across health 
                        care settings and disciplines, including 
                        primary care and mental health, as appropriate, 
                        to improve maternal and infant health outcomes, 
                        which may include the use of data to provide 
                        timely feedback across hospital and clinical 
                        teams to inform responses, and to provide 
                        support and training to hospital and clinical 
                        teams for quality improvement, as appropriate.
                    ``(ii) To be eligible for a grant under clause (i), 
                an entity shall submit to the Secretary an application 
                in such form and manner and containing such information 
                as the Secretary may require.''.

SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.

    (a) Grants.--Title III of the Public Health Service Act is amended 
by inserting after section 330N of such Act, as added by section 404, 
the following:

``SEC. 330O. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM WOMEN.

    ``(a) In General.--The Secretary may award grants for the purpose 
of establishing or operating evidence-based or innovative, evidence-
informed programs to deliver integrated health care services to 
pregnant and postpartum women to optimize the health of women and their 
infants, including to reduce adverse maternal health outcomes, 
pregnancy-related deaths, and related health disparities (including 
such disparities associated with racial and ethnic minority 
populations), and as appropriate, by addressing issues researched under 
subsection (b)(2) of section 317K.
    ``(b) Integrated Services for Pregnant and Postpartum Women.--
            ``(1) Eligibility.--To be eligible to receive a grant under 
        subsection (a), a State or Indian Tribe (as defined in section 
        4 of the Indian Self-Determination and Education Assistance 
        Act) shall work with relevant stakeholders that coordinate care 
        (including coordinating resources and referrals for health care 
        and social services) to develop and carry out the program, 
        including--
                    ``(A) State, tribal, and local agencies responsible 
                for Medicaid, public health, social services, mental 
                health, and substance use disorder treatment and 
                services;
                    ``(B) health care providers who serve pregnant 
                women; and
                    ``(C) community-based health organizations and 
                health workers, including providers of home visiting 
                services and individuals representing communities with 
                disproportionately high rates of maternal mortality and 
                severe maternal morbidity, and including those 
                representing racial and ethnicity minority populations.
            ``(2) Terms.--
                    ``(A) Limitation.--The Secretary may award a grant 
                under subsection (a) to up to 10 States.
                    ``(B) Period.--A grant awarded under subsection (a) 
                shall be made for a period of 5 years.
                    ``(C) Prioritization.--In awarding grants under 
                subsection (a), the Secretary shall prioritize 
                applications from States or Indian Tribes with the 
                highest rates of maternal mortality and severe maternal 
                morbidity, and shall consider health disparities 
                related to maternal mortality and severe maternal 
                morbidity, including such disparities associated with 
                racial and ethnic minority populations.
                    ``(D) Evaluation.--The Secretary shall require 
                grantees to evaluate the outcomes of the programs 
                supported under the grant.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of fiscal years 2020 through 2024.''.
    (b) Report on Grant Outcomes and Dissemination of Best Practices.--
            (1) Report.--Not later than April 1, 2025, the Secretary of 
        Health and Human Services shall submit to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives a report that describes--
                    (A) the outcomes of the activities supported by the 
                grants awarded under the amendments made by this 
                section on maternal and child health;
                    (B) best practices and models of care used by 
                recipients of grants under such amendments; and
                    (C) obstacles identified by recipients of grants 
                under such amendments, and strategies used by such 
                recipients to deliver care, improve maternal and child 
                health, and reduce health disparities.
            (2) Dissemination of best practices.--Not later than 
        October 1, 2025, the Secretary of Health and Human Services 
        shall disseminate information on best practices and models of 
        care used by recipients of grants under the amendments made by 
        this section (including best practices and models of care 
        relating to the reduction of health disparities, including such 
        disparities associated with racial and ethnic minority 
        populations, in rates of maternal mortality and severe maternal 
        morbidity) to relevant stakeholders, which may include health 
        providers, medical schools, nursing schools, relevant State, 
        tribal, and local agencies, and the general public.

SEC. 411. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL HEALTH 
              SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE 
              GME PROGRAMS.

    (a) Community Health Centers Funding.--Section 10503(b)(1)(F) of 
the Patient Protection and Affordable Care Act (42 U.S.C. 254b-
2(b)(1)(F)) is amended by striking ``fiscal year 2019'' and inserting 
``each of fiscal years 2019 through 2024''.
    (b) National Health Service Corps.--Section 10503(b)(2)(F) of the 
Patient Protection and Affordable Care Act (42 U.S.C. 254b-2(b)(2)(F)) 
is amended by striking ``and 2019'' and inserting ``through 2024''.
    (c) Teaching Health Centers That Operate Graduate Medical Education 
Programs.--Section 340H(g)(1) of the Public Health Service Act (42 
U.S.C. 256h(g)(1)) is amended by striking ``and 2019'' and inserting 
``through 2024''.
    (d) Application of Provisions.--Amounts appropriated pursuant to 
this section for each of fiscal years 2019 through 2024 shall be 
subject to the requirements contained in Public Law 115-245 for funds 
for programs authorized under sections 330 through 340 of the Public 
Health Service Act.
    (e) Conforming Amendments.--Paragraph (4) of section 3014(h) of 
title 18, United States Code, as amended by section 50901 of Public Law 
115-123, is amended by striking ``and section 50901(e) of the Advancing 
Chronic Care, Extenders, and Social Services Act'' and inserting ``, 
section 50901(e) of the Advancing Chronic Care, Extenders, and Social 
Services Act, and section 411(d) of the Lower Health Care Costs Act''.

SEC. 412. OTHER PROGRAMS.

    (a) Type I.--Section 330B(b)(2)(D) of the Public Health Service Act 
(42 U.S.C. 254c-2(b)(2)(D)) is amended by striking ``and 2019'' and 
inserting ``through 2024''.
    (b) Indians.--Subparagraph (D) of section 330C(c)(2) of the Public 
Health Service Act (42 U.S.C. 254c-3(c)(2)(D)) is amended by striking 
``and 2019'' and inserting ``through 2024''.

         TITLE V--IMPROVING THE EXCHANGE OF HEALTH INFORMATION

SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND COST 
              INFORMATION.

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

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

    ``(a) In General.--A group health plan or a health insurance issuer 
offering group or individual health insurance coverage shall make 
available for access, exchange, or use without special effort, through 
application programming interfaces (or successor technology or 
standards), the information described in subsection (b), in the manner 
described in subsection (b) and otherwise consistent with this section.
    ``(b) Information.--The following information is required to be 
made available, in such form and manner as the Secretary may specify, 
as described in subsection (a):
            ``(1) Historical claims, provider encounter, and payment 
        data for each enrollee, which shall--
                    ``(A) include adjudicated medical and prescription 
                drug claims and equivalent encounters, including all 
                data elements contained in such transactions--
                            ``(i) that were adjudicated by the group 
                        health plan or health insurance issuer during 
                        the previous 5 years or the enrollee's entire 
                        period of enrollment in the applicable plan or 
                        coverage if such period is less than 5 years;
                            ``(ii) that involve benefits managed by any 
                        third party, such as a pharmacy benefits 
                        manager or radiology benefits manager that 
                        manages benefits or adjudicates claims on 
                        behalf of the plan or coverage; and
                            ``(iii) from any other health plan or 
                        health insurance coverage issued or 
                        administered by the same insurance issuer, in 
                        which the same enrollee was enrolled during the 
                        previous 5 years; and
                    ``(B) be available--
                            ``(i) in a single, longitudinal format that 
                        is easy to understand and secure, and that may 
                        update automatically, including by using the 
                        standards adopted for implementation of section 
                        3001(c)(5)(D)(iv);
                            ``(ii) as soon as practicable, and in no 
                        case later than the period of time determined 
                        by the Secretary, after the claim is 
                        adjudicated or the data is received by the 
                        health plan or health insurance issuer; and
                            ``(iii) to the enrollee, and any providers 
                        or third-party applications or services 
                        authorized by the enrollee, for 5 years after 
                        the end date of the enrollee's enrollment in 
                        the plan or in any coverage offered by the 
                        health insurance issuer.
            ``(2) Identifying directory information for all in-network 
        providers, including facilities and practitioners, that 
        participate in the plan or coverage, which shall--
                    ``(A) include--
                            ``(i) the national provider identifier for 
                        in-network facilities and practitioners; and
                            ``(ii) the name, address, phone number, and 
                        specialty for each such facility and 
                        practitioner, based on the most recent 
                        interaction between the plan or coverage and 
                        that facility or practitioner;
                    ``(B) be capable of returning a list of 
                participating in-network facilities and practitioners, 
                in a given specialty or at a particular facility type, 
                within a specified geographic radius; and
                    ``(C) be capable of returning the network status, 
                when presented with identifiers for a given enrollee 
                and facility or practitioner.
            ``(3) Estimated patient out-of-pocket costs, including 
        costs expected to be incurred through a deductible, copayment, 
        coinsurance, or other form of cost-sharing, for--
                    ``(A) a designated set of common services or 
                episodes of care, to be established by the Secretary 
                through rulemaking, including, at a minimum--
                            ``(i) in the case of services provided by a 
                        hospital, the 100 most common diagnosis-related 
                        groups, as used in the Medicare Inpatient 
                        Prospective Patient System (or successor 
                        episode-based reimbursement methodology) at 
                        that hospital, based on claims data adjudicated 
                        by the group health plan or health insurance 
                        issuer;
                            ``(ii) in the case of services provided in 
                        an outpatient setting, including radiology, lab 
                        tests, and outpatient surgical procedures, any 
                        service rendered by the facility or 
                        practitioner, and reimbursed by the health plan 
                        or health insurance issuer; and
                            ``(iii) in the case of post-acute care, 
                        including home health providers, skilled 
                        nursing facilities, inpatient rehabilitation 
                        facilities, and long-term care hospitals, the 
                        patient out-of-pocket costs for an episode of 
                        care, as the Secretary may determine, which 
                        permits users to reasonably compare costs 
                        across different facility and service types; 
                        and
                    ``(B) all prescription drugs currently included on 
                any tier of the formulary of the plan or coverage.
    ``(c) Availability and Access.--The application programming 
interfaces, including all data required to be made available through 
such interfaces, shall--
            ``(1) be made available by the applicable group health plan 
        or health insurance issuer, at no charge, to--
                    ``(A) enrollees in the group health plan or health 
                insurance coverage;
                    ``(B) third parties authorized by the enrollee;
                    ``(C) facilities and practitioners who are under 
                contract with the plan or coverage; and
                    ``(D) business associates of such facilities and 
                practitioners, as defined in section 160.103 of title 
                45, Code of Federal Regulations (or any successor 
                regulations);
            ``(2) be available to enrollees in the group health plan or 
        health insurance coverage, and to third-party applications or 
        services facilitating such access by enrollees, during the 
        enrollment process and for a minimum of 5 years after the end 
        date of the enrollee's enrollment in the plan or in any 
        coverage offered by the health insurance issuer;
            ``(3) permit persistent access by third-party applications 
        or services authorized by the enrollee, for a reasonable period 
        of time, consistent with current security practices;
            ``(4) employ the applicable content, vocabulary, and 
        technical standards, including, as appropriate, such standards 
        adopted by the Secretary pursuant to title XXX; and
            ``(5) employ security and authentication standards, as the 
        Secretary determines appropriate.
    ``(d) Rule of Construction Regarding Privacy.--Nothing in this 
section shall be construed to alter existing obligations under the 
privacy, security, and breach notification rules promulgated under 
section 264(c) of the Health Insurance Portability and Accountability 
Act (or successor regulations), under part 2 of title 42, Code of 
Federal Regulations (or successor regulations), under section 444 of 
the General Education Provisions Act (20 U.S.C. 1232g) (commonly 
referred to as the `Family Educational Rights and Privacy Act of 
1974'), under the amendments made by the Genetic Information 
Nondiscrimination Act, or under State privacy law.''.
    (b) Effective Date.--Section 2715B of the Public Health Service 
Act, as added by subsection (a), shall take effect 1 year after the 
date of enactment of this Act.

SEC. 502. RECOGNITION OF SECURITY PRACTICES.

    Part 1 of subtitle D of the Health Information Technology for 
Economic and Clinical Health Act (42 U.S.C. 17931 et seq.) is amended 
by adding at the end the following:

``SEC. 13412. RECOGNITION OF SECURITY PRACTICES.

    ``(a) In General.--Consistent with the authority of the Secretary 
under sections 1176 and 1177 of the Social Security Act, when making 
determinations relating to fines under section 13410, decreasing the 
length and extent of an audit under section 13411, or remedies 
otherwise agreed to by the Secretary, the Secretary shall consider 
whether the entity or business associate had, for not less than the 
previous 12 months, recognized security practices in place that may--
            ``(1) mitigate fines under section 13410;
            ``(2) result in the early, favorable termination of an 
        audit under section 13411; and
            ``(3) limit the remedies that would otherwise be agreed to 
        in any agreement between the entity or business associate and 
        the Department of Health and Human Services.
    ``(b) Additional Consideration.--At the election of the entity or 
business associate, the Secretary may provide further consideration to 
an entity or business associate that can adequately demonstrate that 
such recognized security practices were in place, as determined by the 
Secretary.
    ``(c) Definition and Miscellaneous Provisions.--
            ``(1) Recognized security practices.--The term `recognized 
        security practices' means the standards, guidelines, best 
        practices, methodologies, procedures, and processes developed 
        under section 2(c)(15) of the National Institute of Standards 
        and Technology Act, the approaches promulgated under section 
        405(d) of the Cybersecurity Information Sharing Act of 2015, 
        and any other program or processes that are equivalent to such 
        requirements as may be developed through regulations. Such 
        practices shall be determined by the entity or business 
        associate, except where additional consideration is requested 
        under subsection (b).
            ``(2) Limitation.--Nothing in this section shall be 
        construed as providing the Secretary authority to--
                    ``(A) increase fines under section 13410, or the 
                length, extent or quantity of audits under section 
                13411, due to a lack of compliance with the recognized 
                security practices; or
                    ``(B) mandate, direct, or condition the award of 
                any Federal grant, contract, or purchase, on compliance 
                with such recognized security practices.
            ``(3) No liability for nonparticipation.--Nothing in this 
        section shall be construed to subject an entity or business 
        associate to liability for electing not to engage in the 
        recognized security practices defined by this section.
            ``(4) Rule of construction.--Nothing in this section shall 
        be construed to limit the Secretary's authority to enforce the 
        HIPAA Security rule (part 160 of title 45, Code of Federal 
        Regulations, and subparts A and C of part 164 of such title), 
        or to supersede or conflict with an entity or business 
        associate's obligations under the HIPAA Security rule.''.

SEC. 503. GAO STUDY ON THE PRIVACY AND SECURITY RISKS OF ELECTRONIC 
              TRANSMISSION OF INDIVIDUALLY IDENTIFIABLE HEALTH 
              INFORMATION TO AND FROM ENTITIES NOT COVERED BY THE 
              HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States shall conduct 
a study to--
            (1) describe the roles of Federal agencies and the private 
        sector with respect to protecting the privacy and security of 
        individually identifiable health information transmitted 
        electronically to and from entities not covered by the 
        regulations promulgated under section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note);
            (2) identify recent developments regarding the use of 
        application programming interfaces to access individually 
        identifiable health information, and implications for the 
        privacy and security of such information;
            (3) identify practices in the private sector, such as terms 
        and conditions for use, relating to the privacy, disclosure, 
        and secondary uses of individually identifiable health 
        information transmitted electronically to or from entities, 
        selected by an individual, that are not subject to the 
        regulations promulgated under section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996; and
            (4) identify steps the public and private sectors can take 
        to improve the private and secure access to and availability of 
        individually identifiable health information.
    (b) Report.--Not later than 1 year after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
Congress a report concerning the findings of the study conducted under 
subsection (a).

SEC. 504. TECHNICAL CORRECTIONS.

    (a) In General.--Section 3022(b) of the Public Health Service Act 
(42 U.S.C. 300jj-52(b)) is amended by adding at the end the following 
new paragraph:
            ``(4) Application of authorities under inspector general 
        act of 1978.--In carrying out this subsection, the Inspector 
        General shall have the same authorities as provided under 
        section 6 of the Inspector General Act of 1978 (5 U.S.C. 
        App.).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect as if included in the enactment of the 21st Century Cures 
Act (Public Law 114-255).
                                 <all>
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