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

<DOC>





                                                       Calendar No. 133
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

                              July 8, 2019

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

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

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

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

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

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

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

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

<DELETED>Sec. 501. Requirement to provide health claims, network, and 
                            cost information.
<DELETED>Sec. 502. Recognition of security practices.
<DELETED>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.
<DELETED>Sec. 504. Technical corrections.

       <DELETED>TITLE I--ENDING SURPRISE MEDICAL BILLS</DELETED>

<DELETED>SEC. 101. PROTECTING PATIENTS AGAINST OUT-OF-NETWORK 
              DEDUCTIBLES IN EMERGENCIES.</DELETED>

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

<DELETED>SEC. 102. PROTECTION AGAINST SURPRISE BILLS.</DELETED>

<DELETED>    (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:</DELETED>
<DELETED>    ``(e) Coverage of Certain Out-of-Network Services.--
</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Definition.--For purposes of this 
        subsection, the term `facility' has the meaning given the term 
        `health care facility' in section 2729A(c).</DELETED>
<DELETED>    ``(f) Coverage of Out-of-Network Services for Enrollees 
Admitted After Emergency Services.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) has been provided by the facility, 
                prior to the provision of any post-stabilization, out-
                of-network service at such facility, with--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) the estimated amount that 
                        such provider may charge the participant, 
                        beneficiary, or enrollee for such items and 
                        services involved;</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) does not exceed one page in 
                length;</DELETED>
                <DELETED>    ``(B) is readily identifiable for its 
                purpose and as a contract of consent;</DELETED>
                <DELETED>    ``(C) clearly states that consent is 
                optional;</DELETED>
                <DELETED>    ``(D) includes an estimate of the amount 
                that such provider will charge the participant, 
                beneficiary, or enrollee for such items and services 
                involved; and</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) Prohibition on Billing More Than an In-Network Rate 
Under Certain Circumstances.--</DELETED>
        <DELETED>    ``(1) In general.--A facility or practitioner 
        furnishing--</DELETED>
                <DELETED>    ``(A) emergency services, as defined in 
                subsection (b)(2), regardless of the State in which the 
                patient resides;</DELETED>
                <DELETED>    ``(B) services at an in-network facility 
                described in subsection (e); or</DELETED>
                <DELETED>    ``(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,</DELETED>
        <DELETED>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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Enforcement.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) Maintaining State Surprise Billing Protections.--
</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(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)).''.</DELETED>

<DELETED>SEC. 103. BENCHMARK FOR PAYMENT.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2729A. BENCHMARK FOR PAYMENT.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Median In-Network Rate.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 104. EFFECTIVE DATE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 105. ENDING SURPRISE AIR AMBULANCE BILLS.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2719B. ENDING SURPRISE AIR AMBULANCE BILLS.</DELETED>

<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(c) Median In-Network Rate.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(e) Enforcement.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 106. REPORT.</DELETED>

<DELETED>    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--</DELETED>
        <DELETED>    (1) conduct a study on--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (B) the effects of the amendments made by 
                sections 101, 102, and 103 on overall health care 
                costs; and</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>

 <DELETED>TITLE II--REDUCING THE PRICES OF PRESCRIPTION DRUGS</DELETED>

<DELETED>SEC. 201. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.</DELETED>

<DELETED>    (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:</DELETED>
<DELETED>    ``(o) Additional Requirements With Respect to Patents.--
</DELETED>
        <DELETED>    ``(1) Approved application holder listing 
        requirements.--</DELETED>
                <DELETED>    ``(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)).</DELETED>
                <DELETED>    ``(B) Previously approved or licensed 
                biological products.--</DELETED>
                        <DELETED>    ``(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)).</DELETED>
                        <DELETED>    ``(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)).</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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--</DELETED>
                                <DELETED>    ``(I) the date of issuance 
                                of such patent by the United States 
                                Patent and Trademark Office; 
                                or</DELETED>
                                <DELETED>    ``(II) the date of 
                                approval of a supplemental application 
                                for the biological product; 
                                and</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Publication of information.--</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(ii) with respect to each 
                        biological product described in clause (i), 
                        each patent submitted in accordance with 
                        paragraph (1);</DELETED>
                        <DELETED>    ``(iii) the date of approval and 
                        application number for each such biological 
                        product;</DELETED>
                        <DELETED>    ``(iv) the marketing status, 
                        dosage form, route of administration, strength, 
                        and, if applicable, reference product, for each 
                        such biological product;</DELETED>
                        <DELETED>    ``(v) the licensure status for 
                        each such biological product, including whether 
                        the license at the time of listing is approved, 
                        withdrawn, or revoked;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(vii) information regarding any 
                        determination of biosimilarity or 
                        interchangeability for each such biological 
                        product; and</DELETED>
                        <DELETED>    ``(viii) information regarding 
                        approved indications for each such biological 
                        product, in such manner as the Secretary 
                        determines appropriate.</DELETED>
                <DELETED>    ``(B) Updates.--Every 30 days after the 
                publication of the first list under subparagraph (A), 
                the Secretary shall revise the list to include--
                </DELETED>
                        <DELETED>    ``(i)(I) each biological product 
                        licensed under subsection (a) or (k) during the 
                        30-day period; and</DELETED>
                        <DELETED>    ``(II) with respect to each 
                        biological product described in subclause (I), 
                        the information described in clauses (i) 
                        through (viii) of subparagraph (A); 
                        and</DELETED>
                        <DELETED>    ``(ii) any updates to information 
                        previously published in accordance with 
                        subparagraph (A).</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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''.</DELETED>
<DELETED>    (c) Review and Report on Noncompliance.--Not later than 30 
months after the date of enactment of this Act, the Secretary shall--
</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) submit to Congress an evaluation of comments 
        received under paragraph (1) and the recommendations of the 
        Secretary concerning appropriate remedies.</DELETED>
<DELETED>    (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).</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 202. ORANGE BOOK MODERNIZATION.</DELETED>

<DELETED>    (a) Submission of Patent Information for Brand Name 
Drugs.--</DELETED>
        <DELETED>    (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:</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(ii) a full list of the articles used as 
        components of such drug;</DELETED>
        <DELETED>    ``(iii) a full statement of the composition of 
        such drug;</DELETED>
        <DELETED>    ``(iv) a full description of the methods used in, 
        and the facilities and controls used for, the manufacture, 
        processing, and packing of such drug;</DELETED>
        <DELETED>    ``(v) such samples of such drug and of the 
        articles used as components thereof as the Secretary may 
        require;</DELETED>
        <DELETED>    ``(vi) specimens of the labeling proposed to be 
        used for such drug;</DELETED>
        <DELETED>    ``(vii) any assessments required under section 
        505B; and</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(I) claims the drug for which the 
                applicant submitted the application and is a drug 
                substance patent or a drug product patent; or</DELETED>
                <DELETED>    ``(II) claims the method of using the drug 
                for which approval is sought or has been granted in the 
                application.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(C) Upon approval of the application, the Secretary 
shall publish the information submitted under subparagraph 
(A)(viii).''.</DELETED>
        <DELETED>    (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).</DELETED>
<DELETED>    (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--
</DELETED>
        <DELETED>    (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.'';</DELETED>
        <DELETED>    (2) by inserting after ``the patent number and the 
        expiration date of any patent which'' the following: ``fulfills 
        the criteria in subsection (b) and'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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)''.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(I) clause (ii), (iii), or (iv) of subsection 
        (c)(3)(E) of this section;</DELETED>
        <DELETED>    ``(II) clause (iv) or (v) of paragraph (5)(B) of 
        this subsection;</DELETED>
        <DELETED>    ``(III) clause (ii), (iii), or (iv) of paragraph 
        (5)(F) of this subsection;</DELETED>
        <DELETED>    ``(IV) section 505A;</DELETED>
        <DELETED>    ``(V) section 505E;</DELETED>
        <DELETED>    ``(VI) section 527(a); or</DELETED>
        <DELETED>    ``(VII) section 505(u)''.</DELETED>
<DELETED>    (d) Orange Book Updates With Respect to Invalidated 
Patents.--</DELETED>
        <DELETED>    (1) In general.--</DELETED>
                <DELETED>    (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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
                <DELETED>    (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.</DELETED>
        <DELETED>    (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.''.</DELETED>

<DELETED>SEC. 203. ENSURING TIMELY ACCESS TO GENERICS.</DELETED>

<DELETED>    Section 505(q) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(q)(1)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (A)(i), by inserting 
                ``, 10.31,'' after ``10.30'';</DELETED>
                <DELETED>    (B) in subparagraph (E)--</DELETED>
                        <DELETED>    (i) by striking ``application 
                        and'' and inserting ``application 
                        or'';</DELETED>
                        <DELETED>    (ii) by striking ``If the 
                        Secretary'' and inserting the 
                        following:</DELETED>
                        <DELETED>    ``(i) In general.--If the 
                        Secretary''; and</DELETED>
                        <DELETED>    (iii) by striking the second 
                        sentence and inserting the following:</DELETED>
                        <DELETED>    ``(ii) Primary purpose of 
                        delaying.--</DELETED>
                                <DELETED>    ``(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.</DELETED>
                                <DELETED>    ``(II) Factors.--In 
                                determining whether a petition was 
                                submitted with the primary purpose of 
                                delaying an application, the Secretary 
                                may consider the following 
                                factors:</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(dd) Whether the 
                                        petition was submitted without 
                                        any relevant data or 
                                        information in support of the 
                                        scientific positions forming 
                                        the basis of such 
                                        petition.</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(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.</DELETED>
                                        <DELETED>    ``(hh) Other 
                                        relevant and appropriate 
                                        factors, which the Secretary 
                                        shall describe in 
                                        guidance.</DELETED>
                                <DELETED>    ``(III) Guidance.--The 
                                Secretary may issue or update guidance, 
                                as appropriate, to describe factors the 
                                Secretary considers in accordance with 
                                subclause (II).'';</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                        <DELETED>    ``(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.'';</DELETED>
                <DELETED>    (D) by striking subparagraph 
                (F);</DELETED>
                <DELETED>    (E) by redesignating subparagraphs (G) 
                through (I) as subparagraphs (F) through (H), 
                respectively; and</DELETED>
                <DELETED>    (F) in subparagraph (H), as so 
                redesignated, by striking ``submission of this 
                petition'' and inserting ``submission of this 
                document'';</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) by redesignating subparagraphs (A) 
                through (C) as subparagraphs (C) through (E), 
                respectively;</DELETED>
                <DELETED>    (B) by inserting before subparagraph (C), 
                as so redesignated, the following:</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.'';</DELETED>
                <DELETED>    (C) in subparagraph (C), as so 
                redesignated, by--</DELETED>
                        <DELETED>    (i) in the heading, striking 
                        ``within 150 days'';</DELETED>
                        <DELETED>    (ii) in clause (i), striking 
                        ``during the 150-day period referred to in 
                        paragraph (1)(F),''; and</DELETED>
                        <DELETED>    (iii) amending clause (ii) to read 
                        as follows:</DELETED>
                        <DELETED>    ``(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.'';</DELETED>
                <DELETED>    (D) by amending subparagraph (D), as so 
                redesignated, to read as follows:</DELETED>
                <DELETED>    ``(D) Dismissal of certain civil 
                actions.--</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    (E) in subparagraph (E), as so 
                redesignated--</DELETED>
                        <DELETED>    (i) in clause (ii), by striking 
                        ``, if issued''; and</DELETED>
                        <DELETED>    (ii) in clause (iii), by striking 
                        ``final agency action as defined under 
                        subparagraph (2)(A)'' and inserting ``the final 
                        response to the petitioner''; and</DELETED>
        <DELETED>    (3) in paragraph (4)--</DELETED>
                <DELETED>    (A) by striking ``Exceptions'' and all 
                that follows through ``This subsection does'' and 
                inserting ``Exceptions--This subsection 
                does'';</DELETED>
                <DELETED>    (B) by striking subparagraph (B); 
                and</DELETED>
                <DELETED>    (C) by redesignating clauses (i) and (ii) 
                as subparagraphs (A) and (B), respectively, and 
                adjusting the margins accordingly.</DELETED>

<DELETED>SEC. 204. PROTECTING ACCESS TO BIOLOGICAL PRODUCTS.</DELETED>

<DELETED>    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:</DELETED>
                <DELETED>    ``(D) Deemed licenses.--</DELETED>
                        <DELETED>    ``(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).</DELETED>
                        <DELETED>    ``(ii) Limitation on 
                        exclusivity.--Subparagraph (C) shall apply to 
                        any reference product, without regard to 
                        whether--</DELETED>
                                <DELETED>    ``(I) such product was 
                                first licensed under subsection (a); 
                                or</DELETED>
                                <DELETED>    ``(II) the approved 
                                application for such product was deemed 
                                to be a license for a biological 
                                product as described in clause 
                                (i).</DELETED>
                        <DELETED>    ``(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).''.</DELETED>

<DELETED>SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS.</DELETED>

<DELETED>    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--</DELETED>
        <DELETED>    (1) by striking ``180 days after the date'' and 
        inserting ``180 days after the earlier of the 
        following:</DELETED>
                        <DELETED>    ``(aa) The date''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
                        <DELETED>    ``(bb) The date on which all of 
                        the following conditions are first 
                        met:</DELETED>
                                <DELETED>    ``(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.</DELETED>
                                <DELETED>    ``(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.</DELETED>
                                <DELETED>    ``(CC) Approval of an 
                                application for the drug submitted by 
                                at least one first applicant would not 
                                be precluded under clause 
                                (iii).</DELETED>
                                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 206. EDUCATION ON BIOLOGICAL PRODUCTS.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 352A. EDUCATION ON BIOLOGICAL PRODUCTS.</DELETED>

<DELETED>    ``(a) Internet Website.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Content.--Educational materials provided 
        under paragraph (1) may include explanations of--</DELETED>
                <DELETED>    ``(A) key statutory and regulatory terms, 
                including `biosimilar' and `interchangeable', and 
                clarification regarding the appropriate use of 
                interchangeable biosimilar biological 
                products;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) the process for reporting adverse 
                events for biological products, including biosimilar 
                biological products and interchangeable biosimilar 
                biological products; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Format.--The educational materials provided 
        under paragraph (1) may be--</DELETED>
                <DELETED>    ``(A) in formats such as webinars, 
                continuing medical education modules, videos, fact 
                sheets, infographics, stakeholder toolkits, or other 
                formats as appropriate and applicable; and</DELETED>
                <DELETED>    ``(B) tailored for the unique needs of 
                health care providers, patients, caregivers, and other 
                audiences, as the Secretary determines 
                appropriate.</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 207. BIOLOGICAL PRODUCT INNOVATION.</DELETED>

<DELETED>    Section 351(j) of the Public Health Service Act (42 U.S.C. 
262(j)) is amended--</DELETED>
        <DELETED>    (1) by striking ``except that a product'' and 
        inserting ``except that--</DELETED>
        <DELETED>    ``(1) a product'';</DELETED>
        <DELETED>    (2) by striking ``Act.'' and inserting ``Act; 
        and''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 208. CLARIFYING THE MEANING OF NEW CHEMICAL 
              ENTITY.</DELETED>

<DELETED>    Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended--</DELETED>
        <DELETED>    (1) in section 505 (21 U.S.C. 355)--</DELETED>
                <DELETED>    (A) in subsection (c)(3)(E)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (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))'';</DELETED>
                <DELETED>    (B) in subsection (j)(5)(F)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (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))'';</DELETED>
                <DELETED>    (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))'';</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (E) in subsection (u)(1), in the matter 
                preceding subparagraph (A)--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (ii) by striking ``same active 
                        ingredient'' and inserting ``same active 
                        moiety'';</DELETED>
        <DELETED>    (2) in section 512(c)(2)(F) (21 U.S.C. 
        360b(c)(2)(F))--</DELETED>
                <DELETED>    (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))'';</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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))'';</DELETED>
        <DELETED>    (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))'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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))''.</DELETED>

<DELETED>SEC. 209. STREAMLINING THE TRANSITION OF BIOLOGICAL 
              PRODUCTS.</DELETED>

<DELETED>    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.''.</DELETED>

<DELETED>SEC. 210. ORPHAN DRUG CLARIFICATION.</DELETED>

<DELETED>    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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 211. PROMPT APPROVAL OF DRUGS RELATED TO SAFETY 
              INFORMATION.</DELETED>

<DELETED>    Section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(z) Prompt Approval of Drugs When Safety Information Is 
Added to Labeling.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Availability and scope of exclusivity.--This 
        subsection does not affect--</DELETED>
                <DELETED>    ``(A) the availability or scope of 
                exclusivity or an extension of exclusivity described in 
                subparagraph (A) or (B) of section 
                505A(o)(3);</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) clause (iii) or (iv) of 
                        subsection (j)(5)(F);</DELETED>
                        <DELETED>    ``(ii) clause (iii) or (iv) of 
                        subsection (c)(3)(E); or</DELETED>
                        <DELETED>    ``(iii) section 527(a); 
                        or</DELETED>
                <DELETED>    ``(C) except as expressly provided in 
                paragraphs (1) and (2), the operation of this section 
                or section 527.''.</DELETED>

<DELETED>SEC. 212. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL 
              PRODUCTS.</DELETED>

<DELETED>    Section 351(k)(2)(A)(iii) of the Public Health Service Act 
(42 U.S.C. 262(k)(2)(A)(iii)) is amended--</DELETED>
        <DELETED>    (1) in subclause (I), by striking ``; and'' and 
        inserting a semicolon;</DELETED>
        <DELETED>    (2) in subclause (II), by striking the period and 
        inserting ``; and''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
                                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 213. MODERNIZING THE LABELING OF CERTAIN GENERIC 
              DRUGS.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN 
              DRUGS.</DELETED>

<DELETED>    ``(a) Definitions.--For purposes of this 
section:</DELETED>
        <DELETED>    ``(1) The term `covered drug' means a drug 
        approved under section 505(c)--</DELETED>
                <DELETED>    ``(A) for which there are no unexpired 
                patents included in the list under section 505(j)(7) 
                and no unexpired period of market 
                exclusivity;</DELETED>
                <DELETED>    ``(B) for which the approval of the 
                application has been withdrawn for reasons other than 
                safety or effectiveness; and</DELETED>
                <DELETED>    ``(C) for which, with respect to the 
                labeling--</DELETED>
                        <DELETED>    ``(i) new scientific evidence is 
                        available regarding the conditions of use of 
                        the drug;</DELETED>
                        <DELETED>    ``(ii) there is a relevant 
                        accepted use in clinical practice that is not 
                        reflected in the approved labeling; 
                        or</DELETED>
                        <DELETED>    ``(iii) the labeling of such drug 
                        does not reflect current legal and regulatory 
                        requirements.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) The term `generic version' means a drug 
        approved under section 505(j) whose reference drug is a covered 
        drug.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) Enter into cooperative agreements or 
        contracts with public or private entities to review the 
        available scientific evidence concerning such drugs.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) holding one or more public 
                meetings;</DELETED>
                <DELETED>    ``(B) opening a public docket for the 
                submission of public comments; or</DELETED>
                <DELETED>    ``(C) other means, as the Secretary 
                determines appropriate.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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);</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) agree to change the approved labeling to 
        reflect the additional, modified, or supplemental information 
        the Secretary has determined to be appropriate; or</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(f) Review of Application Holder's Response.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) update its paper labeling for the 
                drug at the next printing of that labeling;</DELETED>
                <DELETED>    ``(B) update any electronic labeling for 
                the drug within 30 days; and</DELETED>
                <DELETED>    ``(C) submit the revised labeling through 
                the form, `Supplement--Changes Being 
                Effected'.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) Limitations; Generic Drugs.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Supplemental applications.--Changes to 
        labeling made in accordance with this paragraph shall not be 
        eligible for an exclusivity period under this Act.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(j) Rules of Construction.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(1) describes the actions of the Secretary under 
        this section, including--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) includes any recommendations of the 
        Secretary for modifying the program under this 
        section.''.</DELETED>

  <DELETED>TITLE III--IMPROVING TRANSPARENCY IN HEALTH CARE</DELETED>

<DELETED>SEC. 301. INCREASING TRANSPARENCY BY REMOVING GAG CLAUSES ON 
              PRICE AND QUALITY INFORMATION.</DELETED>

<DELETED>    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:</DELETED>

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

<DELETED>    ``(a) Increasing Price and Quality Transparency for Plan 
Sponsors and Consumers.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(i) financial information, such 
                        as the allowed amount, or any other claim-
                        related financial obligations included in the 
                        provider contract;</DELETED>
                        <DELETED>    ``(ii) provider information, 
                        including name and clinical 
                        designation;</DELETED>
                        <DELETED>    ``(iii) service codes; 
                        or</DELETED>
                        <DELETED>    ``(iv) any other data element 
                        normally included in claim or encounter 
                        transactions when received by a plan or issuer; 
                        or</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>

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

<DELETED>    (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:</DELETED>
<DELETED>    ``(b) Protecting Health Plans Network Design 
Flexibility.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) restricts the group health plan or 
                health insurance issuer from--</DELETED>
                        <DELETED>    ``(i) directing or steering 
                        enrollees to other health care providers; 
                        or</DELETED>
                        <DELETED>    ``(ii) offering incentives to 
                        encourage enrollees to utilize specific health 
                        care providers;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

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

<DELETED>    (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:</DELETED>

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

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Requirements.--</DELETED>
        <DELETED>    ``(1) In general.--The database established under 
        subsection (a) shall--</DELETED>
                <DELETED>    ``(A) improve transparency by using de-
                identified health care data to--</DELETED>
                        <DELETED>    ``(i) inform patients about the 
                        cost, quality, and value of their 
                        care;</DELETED>
                        <DELETED>    ``(ii) assist providers and 
                        hospitals, as they work with patients, to make 
                        informed choices about care;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(v) enable employers and 
                        employee organizations to evaluate network 
                        design and construction, and the cost of care 
                        for enrollees;</DELETED>
                        <DELETED>    ``(vi) facilitate State-led 
                        initiatives to lower health care costs and 
                        improve quality; and</DELETED>
                        <DELETED>    ``(vii) promote competition based 
                        on quality and cost;</DELETED>
                <DELETED>    ``(B) collect medical claims, prescription 
                drug claims, and remittance data consistent with the 
                protections and requirements of subsection 
                (d);</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(D) be available to--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) authorized users, including 
                        employers, employee organizations, providers, 
                        researchers, and policymakers, subject to 
                        subsection (e).</DELETED>
        <DELETED>    ``(2) Privacy and security.--The entity receiving 
        a contract under subsection (a) shall--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) ensure that the database 
                        under subsection (a) is capable of--</DELETED>
                                <DELETED>    ``(I) receiving data under 
                                subsection (d);</DELETED>
                                <DELETED>    ``(II) providing data 
                                access to authorized users; 
                                and</DELETED>
                                <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(ii) not disclose to the public 
                        any individually identifiable health 
                        information or proprietary financial 
                        information;</DELETED>
                        <DELETED>    ``(iii) strictly limit staff 
                        access to the data to staff with appropriate 
                        training, clearance, and background checks and 
                        require regular privacy and security 
                        training;</DELETED>
                        <DELETED>    ``(iv) maintain effective security 
                        standards for transferring data or making data 
                        available to authorized users;</DELETED>
                        <DELETED>    ``(v) develop a process for 
                        providing access to data to authorized users, 
                        in a secure manner that maintains privacy and 
                        confidentiality of data;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Consultation.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Membership.--</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(ii) Composition.--In accordance 
                        with clause (i)--</DELETED>
                                <DELETED>    ``(I) the Secretary, in 
                                consultation with the Secretary of 
                                Health and Human Services, shall 
                                appoint to the Committee--</DELETED>
                                        <DELETED>    ``(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;</DELETED>
                                        <DELETED>    ``(bb) the 
                                        Assistant Secretary for 
                                        Planning and Evaluation of the 
                                        Department of Health and Human 
                                        Services;</DELETED>
                                        <DELETED>    ``(cc) 1 
                                        representative of the Centers 
                                        for Medicare & Medicaid 
                                        Services;</DELETED>
                                        <DELETED>    ``(dd) 1 
                                        representative of the Agency 
                                        for Health Research and 
                                        Quality;</DELETED>
                                        <DELETED>    ``(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</DELETED>
                                        <DELETED>    ``(ff) 1 
                                        representative of the National 
                                        Center for Health Statistics; 
                                        and</DELETED>
                                <DELETED>    ``(II) the Comptroller 
                                General of the United States shall 
                                appoint to the Committee--</DELETED>
                                        <DELETED>    ``(aa) 1 
                                        representative of an employer 
                                        that sponsors a group health 
                                        plan;</DELETED>
                                        <DELETED>    ``(bb) 1 
                                        representative of an employee 
                                        organization that sponsors a 
                                        group health plan;</DELETED>
                                        <DELETED>    ``(cc) 1 academic 
                                        researcher with expertise in 
                                        health economics or health 
                                        services research;</DELETED>
                                        <DELETED>    ``(dd) 1 patient 
                                        advocate; and</DELETED>
                                        <DELETED>    ``(ee) 2 
                                        additional members.</DELETED>
                <DELETED>    ``(C) Duties.--The Committee shall--
                </DELETED>
                        <DELETED>    ``(i) assist and advise the 
                        Secretary on the management of the contract 
                        under subsection (a);</DELETED>
                        <DELETED>    ``(ii) assist and advise the 
                        entity receiving the contract under subsection 
                        (a) in establishing--</DELETED>
                                <DELETED>    ``(I) the scope and format 
                                of the data to be submitted under 
                                subsection (d);</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(III) the appropriate 
                                formats and methods for making reports 
                                and analyses based on the database to 
                                the public;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(vi) establish objectives for 
                        research and public reporting.</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(5) Sanctions.--The Secretary shall take 
        appropriate action to sanction users who attempt to re-identify 
        data accessed pursuant to paragraph (1)(D).</DELETED>
<DELETED>    ``(c) Contract Requirements.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Eligible entities.--To be eligible to enter 
        into a contract described in subsection (a), an entity shall--
        </DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) conduct its business in an open and 
                transparent manner that provides the opportunity for 
                public comment on its activities; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Considerations.--In awarding the contract 
        under subsection (a), the Secretary shall consider an entity's 
        experience in--</DELETED>
                <DELETED>    ``(A) health care claims data collection, 
                aggregation, quality assurance, analysis, and 
                security;</DELETED>
                <DELETED>    ``(B) supporting academic research on 
                health costs, spending, and utilization for and by 
                privately insured patients;</DELETED>
                <DELETED>    ``(C) working with large health insurance 
                issuers and third-party administrators to assemble a 
                national claims database;</DELETED>
                <DELETED>    ``(D) effectively collaborating with and 
                engaging stakeholders to develop reports;</DELETED>
                <DELETED>    ``(E) meeting budgets and timelines, 
                including in connection with report generation; 
                and</DELETED>
                <DELETED>    ``(F) facilitating the creation of, or 
                supporting, State all-payer claims databases.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Receiving Health Information.--</DELETED>
        <DELETED>    ``(1) Requirements.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(ii) specify the form and manner 
                        for such submissions, and the historical period 
                        to be included in the initial submission; 
                        and</DELETED>
                        <DELETED>    ``(iii) offer an automated 
                        submission option to minimize administrative 
                        burdens for entities required to submit 
                        data.</DELETED>
                <DELETED>    ``(C) De-identification of data.--The 
                entity awarded the contract under subsection (a) 
                shall--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(A) Administers health benefits for more 
                than 50,000 enrollees.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(4) Receiving other information.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Uses of Information.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Authorization of users.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) in the case of an entity 
                        requesting access for research purposes--
                        </DELETED>
                                <DELETED>    ``(I) a description of the 
                                uses and methodologies for evaluating 
                                health system performance using such 
                                data; and</DELETED>
                                <DELETED>    ``(II) documentation of 
                                approval of the research by an 
                                institutional review board, if 
                                applicable for a particular plan of 
                                research; or</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(C) Requirements.--</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(f) Funding.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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)).</DELETED>
<DELETED>    ``(g) Annual Report.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) trends in the price, utilization, 
                and total spending on health care services, including a 
                geographic analysis of differences in such 
                trends;</DELETED>
                <DELETED>    ``(B) limitations in the data 
                set;</DELETED>
                <DELETED>    ``(C) progress towards the objectives of 
                this section; and</DELETED>
                <DELETED>    ``(D) the performance by the entity of the 
                duties required under such contract.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(h) Grants to States.--</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(i) Exemption From Public Disclosure.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(j) Definitions.--</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (b) GAO Report.--</DELETED>
        <DELETED>    (1) In general.--The Comptroller General of the 
        United States shall conduct a study on--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (B) the privacy and security of the 
                information reported to the entity; and</DELETED>
                <DELETED>    (C) the costs incurred by such entity in 
                performing such duties.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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:</DELETED>

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

<DELETED>SEC. 304. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF 
              PROVIDER DIRECTORY INFORMATION.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 2729C. PROTECTING PATIENTS AND IMPROVING THE ACCURACY 
              OF PROVIDER DIRECTORY INFORMATION.</DELETED>

<DELETED>    ``(a) Network Status of Providers.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) establish business processes to 
                ensure that all enrollees in such plan or coverage 
                receive proof of a health care provider's network 
                status--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) in real-time through an 
                        online health care provider directory search 
                        tool maintained by the plan or issuer; 
                        and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Cost-Sharing Limitations.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) when the provider begins a network agreement 
        with a plan or with an issuer with respect to certain 
        coverage;</DELETED>
        <DELETED>    ``(2) when the provider terminates a network 
        agreement with a plan or with an issuer with respect to certain 
        coverage;</DELETED>
        <DELETED>    ``(3) when there are material changes to the 
        content of provider directory information described in 
        subsection (a)(1); and</DELETED>
        <DELETED>    ``(4) every 90 days throughout the duration of the 
        network agreement with a plan or issuer.</DELETED>
<DELETED>    ``(d) Enforcement.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) that the plan or issuer bear financial 
        responsibility, including under subsection (b), for providing 
        inaccurate network status information to an enrollee.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 305. TIMELY BILLS FOR PATIENTS.</DELETED>

<DELETED>    (a) In General.--</DELETED>
        <DELETED>    (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:</DELETED>

<DELETED>``SEC. 399V-7. TIMELY BILLS FOR PATIENTS.</DELETED>

<DELETED>    ``(a) In General.--The Secretary shall require--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Effect of Violation.--</DELETED>
        <DELETED>    ``(1) Notification and refund requirements.--
        </DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) report such bill to the 
                        Secretary; and</DELETED>
                        <DELETED>    ``(ii) refund the patient for the 
                        full amount paid in response to such bill with 
                        interest, at a rate determined by the 
                        Secretary.</DELETED>
        <DELETED>    ``(2) Civil monetary penalties.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary may 
                impose civil monetary penalties of up to $10,000 a day 
                on any facility or practitioner that--</DELETED>
                        <DELETED>    ``(i) fails to provide a list 
                        required under subsection (a)(1) more than 10 
                        times, beginning on the date of such tenth 
                        failure;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) experiences extenuating 
                circumstances (as defined by the Secretary), such as a 
                hurricane or cyberattack, that may reasonably delay 
                delivery of a timely bill.''.</DELETED>
        <DELETED>    (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).</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2729D. TIMELY BILLS FOR PATIENTS.</DELETED>

<DELETED>    ``(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).</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (c) Effective Date.--The amendments made by subsections 
(a) and (b) shall take effect 6 months after the date of enactment of 
this Act.</DELETED>

<DELETED>SEC. 306. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT MANAGER 
              SERVICES.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY BENEFIT 
              MANAGER SERVICES.</DELETED>

<DELETED>    ``(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).</DELETED>
<DELETED>    ``(b) Reports to Group Plan Sponsors.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) a list of each covered drug 
                dispensed during the reporting period, including, with 
                respect to each such drug during the reporting period--
                </DELETED>
                        <DELETED>    ``(i) the brand name, chemical 
                        entity, and National Drug Code;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(iv) the total out-of-pocket 
                        spending by enrollees on such drug, including 
                        enrollee spending through copayments, 
                        coinsurance, and deductibles; and</DELETED>
                        <DELETED>    ``(v) for any drug for which gross 
                        spending of the group health plan or health 
                        insurance coverage exceeded $10,000 during the 
                        reporting period--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(II) the rationale for 
                                preferred formulary placement of a 
                                particular drug or drugs in that 
                                therapeutic category or 
                                class;</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) total gross spending by the 
                        plan, before manufacturer rebates, fees, or 
                        other manufacturer remuneration;</DELETED>
                        <DELETED>    ``(ii) the number of enrollees who 
                        filled a prescription for a drug in that 
                        category or class;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(iv) the total out-of-pocket 
                        spending by enrollees, including enrollee 
                        spending through copayments, coinsurance, and 
                        deductibles; and</DELETED>
                        <DELETED>    ``(v) for each therapeutic 
                        category or class under which three or more 
                        drugs are marketed and available--</DELETED>
                                <DELETED>    ``(I) the amount received, 
                                or expected to be received, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--</DELETED>
                                        <DELETED>    ``(aa) to be paid 
                                        by drug manufacturers for 
                                        claims incurred during the 
                                        reporting period; or</DELETED>
                                        <DELETED>    ``(bb) that is 
                                        related to utilization of 
                                        drugs, in such therapeutic 
                                        category or class;</DELETED>
                                <DELETED>    ``(II) the total net 
                                spending by the health plan or health 
                                insurance coverage on that category or 
                                class of drugs; and</DELETED>
                                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(D) total gross spending on prescription 
                drugs by the plan or coverage during the reporting 
                period, before rebates and other manufacturer fees or 
                remuneration;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(F) the total net spending on 
                prescription drugs by the health plan or health 
                insurance coverage during the reporting period; 
                and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Disclosure and redisclosure.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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).</DELETED>
<DELETED>    ``(c) Limitations on Spread Pricing.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) the wholesale acquisition cost of 
                the drug paid by the pharmacy, plus clearly documented 
                dispensing costs, including pharmacy profit; 
                or</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Full Rebate Pass-Through to Plan.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Form and manner of remittance.--Such 
        rebates, fees, alternative discounts, and other remuneration 
        shall be--</DELETED>
                <DELETED>    ``(A) remitted to the group health plan in 
                a timely fashion after the period for which such 
                rebates, fees, or other remuneration is calculated, and 
                in no case later than 90 days after the end of such 
                period;</DELETED>
                <DELETED>    ``(B) fully disclosed and enumerated to 
                the group health plan sponsor, as described in (b)(1); 
                and</DELETED>
                <DELETED>    ``(C) available for audit by the plan 
                sponsor, or a third-party designated by a plan sponsor 
                no less than once per plan year.</DELETED>
<DELETED>    ``(e) Enforcement.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(f) Definitions.--In this section--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) the term `wholesale acquisition cost' has 
        the meaning given such term in section 1847A(c)(6)(B) of the 
        Social Security Act.''.</DELETED>

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

<DELETED>    (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--</DELETED>
        <DELETED>    (1) describe what is known about profit- and 
        revenue-sharing relationships in the commercial health care 
        markets, including those relationships that--</DELETED>
                <DELETED>    (A) involve one or more--</DELETED>
                        <DELETED>    (i) physician groups that practice 
                        within a hospital included in the profit- or 
                        revenue-sharing relationship, or refer patients 
                        to such hospital;</DELETED>
                        <DELETED>    (ii) laboratory, radiology, or 
                        pharmacy services that are delivered to 
                        privately insured patients of such 
                        hospital;</DELETED>
                        <DELETED>    (iii) surgical services;</DELETED>
                        <DELETED>    (iv) hospitals or group purchasing 
                        organizations; or</DELETED>
                        <DELETED>    (v) rehabilitation or physical 
                        therapy facilities or services; and</DELETED>
                <DELETED>    (B) include revenue- or profit-sharing 
                whether through a joint venture, management or 
                professional services agreement, or other form of gain-
                sharing contract;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (3) as appropriate, make recommendations to 
        improve Federal oversight of such relationships.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>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.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (1) by striking ``(2) Contracting or making'' and 
        inserting ``(2)(A) Contracting or making''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(ii)(I) For purposes of this 
        subparagraph:</DELETED>
                <DELETED>    ``(aa) The term `covered plan' means a 
                group health plan as defined section 733(a).</DELETED>
                <DELETED>    ``(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:</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(BB) The term `direct compensation' 
                means compensation received directly from a covered 
                plan.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(iii) A covered service provider shall disclose 
        to a responsible plan fiduciary, in writing, the 
        following:</DELETED>
                <DELETED>    ``(I) A description of the services to be 
                provided to the covered plan pursuant to the contract 
                or arrangement.</DELETED>
                <DELETED>    ``(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)).</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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)--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(BB) not including compensation 
                        received by an employee from an employer on 
                        account of work performed by the 
                        employee.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(cc) Identification of the services for 
                which the indirect compensation will be received, if 
                applicable.</DELETED>
                <DELETED>    ``(dd) Identification of the payer of the 
                indirect compensation.</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(II) A notice described in subclause (I)(cc) 
        shall contain--</DELETED>
                <DELETED>    ``(aa) the name of the covered 
                plan;</DELETED>
                <DELETED>    ``(bb) the plan number used for the annual 
                report on the covered plan;</DELETED>
                <DELETED>    ``(cc) the plan sponsor's name, address, 
                and employer identification number;</DELETED>
                <DELETED>    ``(dd) the name, address, and telephone 
                number of the responsible plan fiduciary;</DELETED>
                <DELETED>    ``(ee) the name, address, phone number, 
                and, if known, employer identification number of the 
                covered service provider;</DELETED>
                <DELETED>    ``(ff) a description of the services 
                provided to the covered plan;</DELETED>
                <DELETED>    ``(gg) a description of the information 
                that the covered service provider failed to 
                disclose;</DELETED>
                <DELETED>    ``(hh) the date on which such information 
                was requested in writing from the covered service 
                provider; and</DELETED>
                <DELETED>    ``(ii) a statement as to whether the 
                covered service provider continues to provide services 
                to the plan.</DELETED>
        <DELETED>    ``(III) A notice described in subclause (I)(cc) 
        shall be filed with the Department not later than 30 days 
        following the earlier of--</DELETED>
                <DELETED>    ``(aa) the covered service provider's 
                refusal to furnish the information requested by the 
                written request described in subclause (I)(bb); 
                or</DELETED>
                <DELETED>    ``(bb) 90 days after the written request 
                referred to in subclause (I)(cc) is made.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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)).</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2746. DISCLOSURE TO ENROLLEES OF INDIVIDUAL MARKET 
              COVERAGE.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) made prior to the individual finalizing plan 
        selection; and</DELETED>
        <DELETED>    ``(2) included on any documentation confirming the 
        individual's enrollment.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (e) Effective Date.--The amendments made by subsections 
(a) and (c) shall take effect 2 years after the date of enactment of 
this Act.</DELETED>

<DELETED>SEC. 309. ENSURING ENROLLEE ACCESS TO COST-SHARING 
              INFORMATION.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2729F. PROVISION OF COST-SHARING INFORMATION.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Enforcement.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 310. STRENGTHENING PARITY IN MENTAL HEALTH AND SUBSTANCE 
              USE DISORDER BENEFITS.</DELETED>

<DELETED>    Section 2726 of the Public Health Service Act (42 U.S.C. 
300gg-26) is amended--</DELETED>
        <DELETED>    (1) in subsection (a), by adding at the end the 
        following:</DELETED>
        <DELETED>    ``(8) Compliance requirements.--</DELETED>
                <DELETED>    ``(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:</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(ii) The factors used to 
                        determine that an NQTL will apply to mental 
                        health or substance use disorder benefits and 
                        medical/surgical benefits.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Secretary request process.--
                </DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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--</DELETED>
                                <DELETED>    ``(I) be the same plans or 
                                coverages for which the comparative 
                                analyses are requested under clause 
                                (i);</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(III) be the same plan 
                                or coverage that has been selected 
                                under clause (i) or (ii) within the 
                                last 5 years.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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--</DELETED>
                                <DELETED>    ``(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;</DELETED>
                                <DELETED>    ``(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;</DELETED>
                                <DELETED>    ``(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;</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(C) Compliance program guidance document 
                update process.--</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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.</DELETED>
                        <DELETED>    ``(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).''.</DELETED>

<DELETED>SEC. 311. TECHNICAL AMENDMENTS.</DELETED>

<DELETED>    (a) ERISA.--Section 715 of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1185d) is amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) in subsection (b)--</DELETED>
                <DELETED>    (A) by striking ``(as amended by the 
                Patient Protection and Affordable Care Act)'' and 
                inserting ``(including any subsequent amendments to 
                such part)''; and</DELETED>
                <DELETED>    (B) by striking ``(as so 
                amended)''.</DELETED>
<DELETED>    (b) IRC.--Section 9815 of the Internal Revenue Code of 
1986 is amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (2) in subsection (b)--</DELETED>
                <DELETED>    (A) by striking ``(as amended by the 
                Patient Protection and Affordable Care Act)'' and 
                inserting ``(including any subsequent amendments to 
                such part)''; and</DELETED>
                <DELETED>    (B) by striking ``(as so 
                amended)''.</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 312. THIRD-PARTY ADMINISTRATORS.</DELETED>

<DELETED>    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.</DELETED>

          <DELETED>TITLE IV--IMPROVING PUBLIC HEALTH</DELETED>

<DELETED>SEC. 401. IMPROVING AWARENESS OF DISEASE PREVENTION.</DELETED>

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

<DELETED>``SEC. 313. PUBLIC AWARENESS CAMPAIGN ON THE IMPORTANCE OF 
              VACCINATIONS.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Requirements.--The campaign under this section 
shall--</DELETED>
        <DELETED>    ``(1) be a national, evidence-based 
        initiative;</DELETED>
        <DELETED>    ``(2) include the development of resources for 
        communities with low rates of vaccination, including culturally 
        and linguistically appropriate resources, as 
        applicable;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(4) be complementary to, and coordinated with, 
        any other Federal, State, or local efforts, as appropriate; 
        and</DELETED>
        <DELETED>    ``(5) assess the effectiveness of communication 
        strategies to increase rates of vaccination.</DELETED>
<DELETED>    ``(d) Additional Activities.--The campaign under this 
section may--</DELETED>
        <DELETED>    ``(1) include the use of television, radio, the 
        internet, and other media and telecommunications 
        technologies;</DELETED>
        <DELETED>    ``(2) be focused to address specific needs of 
        communities and populations with low rates of vaccination; 
        and</DELETED>
        <DELETED>    ``(3) include the dissemination of scientific and 
        evidence-based vaccine-related information, such as--</DELETED>
                <DELETED>    ``(A) advancements in evidence-based 
                research related to diseases that may be prevented by 
                vaccines and vaccine development;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) information on diseases that may be 
                prevented by vaccines; and</DELETED>
                <DELETED>    ``(D) information on vaccine safety and 
                the systems in place to monitor vaccine 
                safety.</DELETED>
<DELETED>    ``(e) Evaluation.--The Secretary shall--</DELETED>
        <DELETED>    ``(1) establish benchmarks and metrics to 
        quantitatively measure and evaluate the awareness campaign 
        under this section;</DELETED>
        <DELETED>    ``(2) conduct qualitative assessments regarding 
        the awareness campaign under this section; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 402. GRANTS TO ADDRESS VACCINE-PREVENTABLE 
              DISEASES.</DELETED>

<DELETED>    Section 317(k)(1) of the Public Health Service Act (42 
U.S.C. 247b(k)(1)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;</DELETED>
        <DELETED>    (2) in subparagraph (D), by striking the period 
        and inserting a semicolon; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(E) planning, implementation, and evaluation of 
        activities to address vaccine-preventable diseases, including 
        activities to--</DELETED>
                <DELETED>    ``(i) identify communities at high risk of 
                outbreaks related to vaccine-preventable diseases, 
                including through improved data collection and 
                analysis;</DELETED>
                <DELETED>    ``(ii) pilot innovative approaches to 
                improve vaccination rates in communities and among 
                populations with low rates of vaccination;</DELETED>
                <DELETED>    ``(iii) reduce barriers to accessing 
                vaccines and evidence-based information about the 
                health effects of vaccines;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(v) improve delivery of evidence-based 
                vaccine-related information to parents and others; 
                and</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.''.</DELETED>

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

<DELETED>    (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--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) describe an integrated program 
                structure for implementing interventions proven to be 
                effective in preventing and reducing the incidence of 
                obesity; and</DELETED>
                <DELETED>    (B) recommend--</DELETED>
                        <DELETED>    (i) optimal resources, including 
                        staffing and infrastructure, for promoting 
                        nutrition and obesity prevention and reduction; 
                        and</DELETED>
                        <DELETED>    (ii) strategies for effective 
                        obesity prevention programs for State and local 
                        health departments, Indian Tribes, and Tribal 
                        organizations, including strategies related 
                        to--</DELETED>
                                <DELETED>    (I) the application of 
                                evidence-based and evidence-informed 
                                practices to prevent and reduce obesity 
                                rates;</DELETED>
                                <DELETED>    (II) the development, 
                                implementation, and evaluation of 
                                obesity prevention and reduction 
                                strategies for specific communities and 
                                populations;</DELETED>
                                <DELETED>    (III) demonstrated 
                                knowledge of obesity prevention 
                                practices that reduce associated 
                                preventable diseases, health 
                                conditions, death, and health care 
                                costs;</DELETED>
                                <DELETED>    (IV) best practices for 
                                the coordination of efforts to prevent 
                                and reduce obesity and related chronic 
                                diseases;</DELETED>
                                <DELETED>    (V) addressing the 
                                underlying risk factors and social 
                                determinants of health that impact 
                                obesity rates; and</DELETED>
                                <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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).</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 404. EXPANDING CAPACITY FOR HEALTH OUTCOMES.</DELETED>

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

<DELETED>``SEC. 330N. EXPANDING CAPACITY FOR HEALTH OUTCOMES.</DELETED>

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Health professional shortage area.--The term 
        `health professional shortage area' means a health professional 
        shortage area designated under section 332.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Medically underserved population.--The term 
        `medically underserved population' has the meaning given the 
        term in section 330(b)(3).</DELETED>
        <DELETED>    ``(5) Native americans.--The term `Native 
        Americans' has the meaning given such term in section 736 and 
        includes Indian tribes and tribal organizations.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Use of Funds.--</DELETED>
        <DELETED>    ``(1) In general.--Grants awarded under subsection 
        (b) shall be used for--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) other activities consistent with 
                achieving the objectives of the grants awarded under 
                this section, as determined by the Secretary.</DELETED>
        <DELETED>    ``(2) Other uses.--In addition to any of the uses 
        under paragraph (1), grants awarded under subsection (b) may be 
        used for--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) support for health care providers 
                and other professionals that provide or assist in the 
                provision of services through such models.</DELETED>
<DELETED>    ``(d) Length of Grants.--Grants awarded under subsection 
(b) shall be for a period of up to 5 years.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) a description of any new and continuing 
        grants awarded to entities under subsection (b) and the 
        specific purpose and amounts of such grants;</DELETED>
        <DELETED>    ``(2) an overview of--</DELETED>
                <DELETED>    ``(A) the evaluations conducted under 
                subsections (b) or (f); and</DELETED>
                <DELETED>    ``(B) technical assistance provided under 
                subsection (f); and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 405. PUBLIC HEALTH DATA SYSTEM MODERNIZATION.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 2822. PUBLIC HEALTH DATA SYSTEM MODERNIZATION 
              GRANTS.</DELETED>

<DELETED>    ``(a) In General.--The Secretary, acting through the 
Director of the Centers for Disease Control and Prevention, shall--
</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) improving secure public health data 
                collection, transmission, exchange, maintenance, and 
                analysis;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(E) supporting earlier disease and 
                health condition detection, such as through near real-
                time data monitoring, to support rapid public health 
                responses; and</DELETED>
                <DELETED>    ``(F) supporting activities within the 
                applicable jurisdiction related to the expansion and 
                modernization of electronic case reporting;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Requirements.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the activities that will be 
                supported by the grant; and</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(2) Developing and disseminating information 
        related to the use and importance of public health 
        data.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) update and improve applicable public health 
        data systems used by the Centers for Disease Control and 
        Prevention; and</DELETED>
        <DELETED>    ``(2) carry out the activities described in this 
        section to support the improvement of State, local, Tribal, and 
        territorial public health data systems.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) a description of any barriers to--</DELETED>
                <DELETED>    ``(A) public health authorities 
                implementing electronic case reporting and 
                interoperable public health data systems; or</DELETED>
                <DELETED>    ``(B) the exchange of information pursuant 
                to electronic case reporting;</DELETED>
        <DELETED>    ``(2) an assessment of the potential public health 
        impact of implementing electronic case reporting and 
        interoperable public health data systems; and</DELETED>
        <DELETED>    ``(3) a description of the activities carried out 
        pursuant to this section.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 406. INNOVATION FOR MATERNAL HEALTH.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (C) information on addressing determinants 
                of health that impact maternal health outcomes for 
                women before, during, and after pregnancy;</DELETED>
        <DELETED>    (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;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (b) Eligible Entities.--To be eligible for a grant under 
subsection (a), an entity shall--</DELETED>
        <DELETED>    (1) submit to the Secretary an application at such 
        time, in such manner, and containing such information as the 
        Secretary may require; and</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 407. TRAINING FOR HEALTH CARE PROVIDERS.</DELETED>

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

<DELETED>``SEC. 763. TRAINING FOR HEALTH CARE PROVIDERS.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 408. STUDY ON TRAINING TO REDUCE AND PREVENT 
              DISCRIMINATION.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 409. PERINATAL QUALITY COLLABORATIVES.</DELETED>

<DELETED>    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:</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(I) support the use of evidence-
                        based or evidence-informed practices to improve 
                        outcomes for maternal and infant 
                        health;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 410. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM 
              WOMEN.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 330O. INTEGRATED SERVICES FOR PREGNANT AND POSTPARTUM 
              WOMEN.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Integrated Services for Pregnant and Postpartum 
Women.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) State, tribal, and local agencies 
                responsible for Medicaid, public health, social 
                services, mental health, and substance use disorder 
                treatment and services;</DELETED>
                <DELETED>    ``(B) health care providers who serve 
                pregnant women; and</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Terms.--</DELETED>
                <DELETED>    ``(A) Limitation.--The Secretary may award 
                a grant under subsection (a) to up to 10 
                States.</DELETED>
                <DELETED>    ``(B) Period.--A grant awarded under 
                subsection (a) shall be made for a period of 5 
                years.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(D) Evaluation.--The Secretary shall 
                require grantees to evaluate the outcomes of the 
                programs supported under the grant.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Report on Grant Outcomes and Dissemination of Best 
Practices.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) the outcomes of the activities 
                supported by the grants awarded under the amendments 
                made by this section on maternal and child 
                health;</DELETED>
                <DELETED>    (B) best practices and models of care used 
                by recipients of grants under such amendments; 
                and</DELETED>
                <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>

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

<DELETED>    (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''.</DELETED>
<DELETED>    (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''.</DELETED>
<DELETED>    (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''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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''.</DELETED>

<DELETED>SEC. 412. OTHER PROGRAMS.</DELETED>

<DELETED>    (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''.</DELETED>
<DELETED>    (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''.</DELETED>

          <DELETED>TITLE V--IMPROVING THE EXCHANGE OF HEALTH 
                         INFORMATION</DELETED>

<DELETED>SEC. 501. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, AND 
              COST INFORMATION.</DELETED>

<DELETED>    (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:</DELETED>

<DELETED>``SEC. 2715B. REQUIREMENT TO PROVIDE HEALTH CLAIMS, NETWORK, 
              AND COST INFORMATION.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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):</DELETED>
        <DELETED>    ``(1) Historical claims, provider encounter, and 
        payment data for each enrollee, which shall--</DELETED>
                <DELETED>    ``(A) include adjudicated medical and 
                prescription drug claims and equivalent encounters, 
                including all data elements contained in such 
                transactions--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) be available--</DELETED>
                        <DELETED>    ``(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);</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Identifying directory information for all 
        in-network providers, including facilities and practitioners, 
        that participate in the plan or coverage, which shall--
        </DELETED>
                <DELETED>    ``(A) include--</DELETED>
                        <DELETED>    ``(i) the national provider 
                        identifier for in-network facilities and 
                        practitioners; and</DELETED>
                        <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) be capable of returning the network 
                status, when presented with identifiers for a given 
                enrollee and facility or practitioner.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) a designated set of common services 
                or episodes of care, to be established by the Secretary 
                through rulemaking, including, at a minimum--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) all prescription drugs currently 
                included on any tier of the formulary of the plan or 
                coverage.</DELETED>
<DELETED>    ``(c) Availability and Access.--The application 
programming interfaces, including all data required to be made 
available through such interfaces, shall--</DELETED>
        <DELETED>    ``(1) be made available by the applicable group 
        health plan or health insurance issuer, at no charge, to--
        </DELETED>
                <DELETED>    ``(A) enrollees in the group health plan 
                or health insurance coverage;</DELETED>
                <DELETED>    ``(B) third parties authorized by the 
                enrollee;</DELETED>
                <DELETED>    ``(C) facilities and practitioners who are 
                under contract with the plan or coverage; and</DELETED>
                <DELETED>    ``(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);</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(4) employ the applicable content, vocabulary, 
        and technical standards, including, as appropriate, such 
        standards adopted by the Secretary pursuant to title XXX; 
        and</DELETED>
        <DELETED>    ``(5) employ security and authentication 
        standards, as the Secretary determines appropriate.</DELETED>
<DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 502. RECOGNITION OF SECURITY PRACTICES.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 13412. RECOGNITION OF SECURITY PRACTICES.</DELETED>

<DELETED>    ``(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--
</DELETED>
        <DELETED>    ``(1) mitigate fines under section 
        13410;</DELETED>
        <DELETED>    ``(2) result in the early, favorable termination 
        of an audit under section 13411; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Definition and Miscellaneous Provisions.--</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(2) Limitation.--Nothing in this section shall 
        be construed as providing the Secretary authority to--
        </DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) mandate, direct, or condition the 
                award of any Federal grant, contract, or purchase, on 
                compliance with such recognized security 
                practices.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>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.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (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);</DELETED>
        <DELETED>    (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;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 504. TECHNICAL CORRECTIONS.</DELETED>

<DELETED>    (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:</DELETED>
        <DELETED>    ``(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.).''.</DELETED>
<DELETED>    (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).</DELETED>

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.
Sec. 214. Actions for delays of generic drugs and biosimilar biological 
                            products.
Sec. 215. Reducing the price of prescription 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.
Sec. 313. Group health plan reporting requirements.
Sec. 314. Study by Comptroller General of United States.

                   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.
Sec. 413. Native American suicide prevention.
Sec. 414. Minimum age of sale of tobacco products.
Sec. 415. Sale of tobacco products to individuals under the age of 21.

         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.
Sec. 505. Public meeting.

                 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 
                        freestanding 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 freestanding 
                        emergency room'' after ``emergency 
                        department''; and
                    (B) in clause (ii), by inserting ``or freestanding 
                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) Out-of-network Ancillary Services.--
            ``(1) Coverage of services.--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 services at an in-network facility, including 
        any referrals for diagnostic services, and such services would 
        be covered under such plan or coverage if provided in-network--
                    ``(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) amounts paid toward such cost-sharing shall 
                be counted towards the in-network deductible and in-
                network out-of-pocket maximum amount, as applicable, 
                under the plan or coverage for the plan year.
            ``(2) Notice before providing non-emergency services.--
        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, non-emergency services 
        that are not ancillary services, from an out-of-network 
        provider at an in-network facility, and such services would be 
        covered under such plan or coverage if provided in-network, 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, 
        unless, as soon as practicable, and in no case later than 48 
        hours prior to providing non-emergency services that are not 
        ancillary services--
                    ``(A) the in-network facility provides to the 
                enrollee who is scheduled to receive such services 
                notice that--
                            ``(i) is provided in paper or electronic 
                        form (and including electronic notification 
                        whenever practicable);
                            ``(ii) states that such service will be 
                        provided out-of-network;
                            ``(iii) includes the estimated amount that 
                        such practitioner or facility may charge the 
                        enrollee for such services; and
                            ``(iv) provides the option to affirmatively 
                        consent to receiving such services from such 
                        practitioner or facility;
                    ``(B) such enrollee signs such notice consenting to 
                receive such services from an out-of-network provider 
                at an in-network facility, and acknowledging that the 
                out-of-network services 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 by an in-network practitioner or 
                facility; and
                    ``(C) such facility maintains documentation of the 
                enrollee's signature or confirmation of receipt of such 
                information under subparagraph (B) in the enrollee's 
                patient record for 2 years after the date of services.
            ``(3) 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) Protection for enrollees admitted to the hospital for 
        emergency services prior to stabilization.--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 not 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 provided to the enrollee prior to being stable 
        and in a condition to receive information under (2), is the 
        same requirement that would apply as under subsection 
        (b)(2)(C)(ii)(II).
            ``(2) Notice and consent.--
                    ``(A) 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 
                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 an 
                in-network provider, unless the enrollee, once stable 
                and in a condition to receive such information, 
                including having sufficient mental capacity--
                            ``(i) has been provided by the facility, 
                        prior to the provision of any post-
                        stabilization, out-of-network service at such 
                        facility, with--
                                    ``(I) paper or 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 services involved;
                            ``(ii) 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 or electronic 
                                notification (and including electronic 
                                notification whenever practicable) that 
                                the practitioner or facility is an out-
                                of-network health care provider, and 
                                the option to affirmatively consent to 
                                receiving services from such 
                                practitioner or facility;
                                    ``(II) a list of in-network 
                                practitioners or facilities in the 
                                relevant geographic area 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 
                                services at the facility;
                            ``(iii) has acknowledged, in writing, that 
                        the out-of-network services provided after the 
                        individual has been stabilized 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.
                    ``(B) Requirements of notice.--The notice under 
                subparagraph (A) 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--
                            ``(i) does not exceed one page in length;
                            ``(ii) is readily identifiable for its 
                        purpose and as a contract of consent;
                            ``(iii) clearly states that consent to 
                        potential out-of-network charges is optional 
                        and that the enrollee has the choice to 
                        transfer to an in-network facility;
                            ``(iv) includes an estimate of the amount 
                        that such provider will charge the participant, 
                        beneficiary, or enrollee for such services 
                        involved; and
                            ``(v) 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.
                    ``(C) Maintenance of records.--A facility shall 
                maintain documentation of notice given to an enrollee 
                pursuant to this subsection and the enrollee's 
                confirmation of receipt of such information in the 
                enrollee's patient record for 2 years after the date of 
                services.
            ``(3) Rulemaking.--Not later than 6 months after the date 
        of enactment of the Lower Health Care Costs Act, the Secretary 
        shall issue regulations to carry out this subsection, which 
        shall include clarification on how to determine whether an 
        individual is stabilized and the timing of the notice required 
        under this paragraph.
    ``(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) out-of-network services at an in-network 
                facility described in subsection (e)(1);
                    ``(C) out-of-network services at an in-network 
                facility described in subsection (e)(2), where the 
                notice and consent for receiving such services out-of-
                network did not meet the requirement of such 
                subsection;
                    ``(D) services furnished by an out-of-network 
                provider after an enrollee has been admitted to the 
                hospital for emergency services but prior to 
                stabilization, as described in subsection (f)(1); or
                    ``(E) 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 
                receiving care at an alternate facility required under 
                subsection (f)(2) have not been provided to the 
                enrollee and the enrollee did not give consent under 
                subsection (f)(3),
        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)(1), (e)(2), 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.
    ``(h) Maintaining State Surprise Billing Protections.--
            ``(1) In general.--Nothing in this section shall prevent a 
        State from establishing or continuing in effect, with respect 
        to health insurance issuers, facilities, or practitioners, 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 group or individual health insurance coverage offered 
        in a State that has not established 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.
    ``(i) Definitions.--In this section:
            ``(1) In-network.--The term `in-network', with respect to a 
        group health plan or health insurance coverage means a provider 
        that has a contractual relationship with the plan.
            ``(2) Enrollee.--The term `enrollee', with respect to 
        health insurance coverage or a group health plan, includes a 
        participant, dependent, or beneficiary.
            ``(3) Ancillary services.--The term `ancillary services' 
        means non-emergency care that is--
                    ``(A) provided by anesthesiologists, pathologists, 
                emergency medicine providers, intensivists, 
                radiologists, neonatologists, hospitalists, and 
                assistant surgeons, whether the care is provided by a 
                physician or non-physician practitioner;
                    ``(B) a diagnostic service (including radiology and 
                lab services); or
                    ``(C) provided by such other specialty practitioner 
                not typically selected by the patients receiving the 
                care, which the Secretary may add periodically to such 
                definition through rulemaking.''.
    (b) Enforcement of Balance Billing Prohibitions.--Part C of title 
XXVII of the Public Health Service Act (42 U.S.C. 300gg-91 et seq.) is 
amended by adding at the end the following:

``SEC. 2795. ENFORCEMENT OF BALANCE BILLING PROHIBITIONS.

    ``(a) In General.--Subject to subsection (b), a facility or 
practitioner that violates a requirement under section 2719A(g)(1) or 
fails to provide notice or obtain consent as required under subsection 
(e)(2) or (f)(2) 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.--
            ``(1) In general.--The Secretary shall waive the penalties 
        described under subsection (a) with respect to a facility or, 
        practitioner who does not knowingly violate, and should not 
        have reasonably known it violated, section 2719A(g)(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 section 2719A(g)(1), and, as applicable, 
        reimburses the group health plan, health insurance issuer, or 
        enrollee, in an amount equal to the difference between the 
        amount billed and the amount allowed to be billed under section 
        2719A(g)(1), plus interest, at an interest rate determined by 
        the Secretary.
            ``(2) Hardship exemption.--The Secretary may establish a 
        hardship exemption to the penalties under this section.
            ``(3) State enforcement.--The Secretary shall waive 
        penalties under this section with respect to a facility or 
        practitioner that has already been subject to enforcement 
        action under State law for a violation described in subsection 
        (a).''.
    (c) Application to Grandfathered Plans.--Section 1251(a) of the 
Patient Protection and Affordable Care Act (42 U.S.C. 18011(a)) is 
amended by adding at the end the following:
            ``(5) Application of additional provisions.--Subsections 
        (b) through (h) of section 2719A of the Public Health Service 
        Act (42 U.S.C. 300gg-19a) shall apply to grandfathered health 
        plans for plan years beginning with the second plan year that 
        begins after the date of enactment of the Lower Health Care 
        Costs Act.''.
    (d) 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 providers, including facilities and practitioners, furnishing 
services for which such facilities and practitioners are prohibited 
under section 2719A(g) from billing enrollees for amounts beyond the 
cost-sharing amount that would apply under subsection 
(b)(1)(C)(ii)(II), (e), or (f) of section 2719A,the median in-network 
rate for such services provided to enrollees, 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. Such payment shall be made in a timely fashion in 
order to ensure compliance with sections 399V-7 and 2729D.
    ``(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 contracted 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.--
                    ``(A) In general.--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 out-of-network 
                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 health insurance issuers that 
                are not on a fee-for-service basis.
                    ``(B) Geographic regions.--In establishing 
                geographic regions under subparagraph (A), the 
                Secretary shall consider adequate access to services in 
                rural areas and health professional shortage areas, as 
                defined in section 332. The Secretary shall consult 
                with the National Association of Insurance 
                Commissioners in establishing the geographic regions. 
                The Secretary shall update the geographic regions 
                periodically, as appropriate, taking into account the 
                findings of the report under section 106 of the Lower 
                Health Care Costs Act.
            ``(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' or `facility' includes hospitals, hospital outpatient 
departments, critical access hospitals, ambulatory surgery centers, 
laboratories, radiology clinics, freestanding emergency rooms, 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, if such services 
would be covered if provided by an in-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 contracted 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.--
                    ``(A) In general.--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 
                out-of-network 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.
                    ``(B) Geographic regions.--In establishing 
                geographic regions as described in subparagraph (A), 
                the Secretary shall consider adequate access to 
                services in rural areas. The Secretary shall consult 
                with the National Association of Insurance 
                Commissioners in establishing the geographic regions. 
                The Secretary shall update the geographic regions 
                periodically, as appropriate, taking into account the 
                findings of the report under section 106 of the Lower 
                Health Care Costs Act.
            ``(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 a 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, 103, and 105, 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, 103, and 105 on overall health care costs;
                    (C) the effects of the amendments made by sections 
                101, 102, 103, and 105 on access to services, including 
                specialty services, in rural areas and health 
                professional shortage areas as defined in section 332; 
                and
                    (D) recommendations, made in consultation with the 
                Secretary of Labor and the Secretary of the Treasury, 
                for effective enforcement of 2729A of the Public Health 
                Service Act, 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 
                        written decision to cancel as unpatentable, 
                        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, or deemed to 
                        be licensed, under subsection (a) or (k);
                            ``(ii) with respect to each biological 
                        product described in clause (i), each patent 
                        submitted in accordance with paragraph (1);
                            ``(iii) the date of licensure 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 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) 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 owner 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, the applicant shall amend the application to include such 
patent information.''.
            (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(c)(2)) 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 
        is identified as claiming a method of using such drug shall be 
        filed only if the patent claims a method of use approved 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 after 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)(1)(A)(viii)''.
    (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) subsection (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 for such drug, and where the Under 
        Secretary of Commerce for Intellectual Property and Director of 
        the United States Patent and Trademark Office have cancelled 
        any claim of the patent 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 cancelled, 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, as applicable, except that the Secretary shall not remove 
        a patent from the list before the expiration of any 180-day 
        exclusivity period under paragraph (5)(B)(iv) that relies on a 
        certification described in paragraph (2)(A)(vii)(IV) with 
        respect to such patent.''.
                    (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), as amended by section 205, 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)) 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.--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 or 
                                        supplements to 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 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 
                                        the Secretary has determined to 
                                        be 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.
                                    ``(II) 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 by 
                        the Secretary.'';
                    (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--
                            (i) in the heading, by striking ``within 
                        150 days'';
                            (ii) in clause (i), by striking ``during 
                        the 150-day period referred to in paragraph 
                        (1)(F),''; and
                            (iii) by 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 taken final agency 
                        action on the petition within the meaning of 
                        subparagraph (C), the court shall dismiss 
                        without prejudice the action for failure to 
                        exhaust administrative remedies.''; and
                    (E) in clause (iii) of subparagraph (E), as so 
                redesignated, by striking ``as defined under 
                subparagraph (2)(A)'' and inserting ``within the 
                meaning of subparagraph (C)''; 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) Application of limitations on 
                        exclusivity.--Subparagraph (C) shall apply with 
                        respect to a reference product referred to in 
                        such subparagraph that was the subject of an 
                        approved application that was deemed to be a 
                        license pursuant to section 7002(e)(4) of the 
                        Biologics Price Competition and Innovation Act 
                        of 2009.
                            ``(iii) Applicability.--The exclusivity 
                        periods described in section 527, section 
                        505A(b)(1)(A)(ii), and section 
                        505A(c)(1)(A)(ii) of the Federal Food, Drug, 
                        and Cosmetic Act shall continue to apply to a 
                        biological product after an approved 
                        application for the biological product is 
                        deemed to be a license for the biological 
                        product under subsection (a) pursuant to 
                        section 7002(e)(4) of the Biologics Price 
                        Competition and Innovation Act of 2009.''.

SEC. 205. PREVENTING BLOCKING OF GENERIC DRUGS.

    (a) In General.--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, provided no 
                        application submitted by any first applicant is 
                        approved on or before such date:
                                    ``(AA) An application for the drug 
                                submitted by an applicant other than a 
                                first applicant has received tentative 
                                approval and could receive approval, if 
                                no first applicant were eligible for 
                                180-day exclusivity under this clause, 
                                and such applicant has not entered into 
                                an agreement that would prevent 
                                commercial marketing upon approval and 
                                has submitted a notification to the 
                                Secretary documenting that it has not 
                                entered into an agreement that would 
                                prevent commercial marketing.
                                    ``(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).''.
    (b) Information.--Not later than 60 days of the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this subsection as the ``Secretary'') shall publish, as appropriate and 
available, information sufficient to allow applicants to assess whether 
the conditions described in subitems (AA) through (CC) of section 
505(j)(5)(B)(iv)(I)(bb) of the Federal Food, Drug, and Cosmetic Act (as 
amended by subsection (a)) have been or will be satisfied for all 
applications where the exclusivity period under (iv)(I) of section 
505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act (as so 
amended) has not expired, and shall provide updates to reflect the most 
recent information available to the Secretary.

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 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--
                    ``(A) explanations of key statutory and regulatory 
                terms, including `biosimilar' and `interchangeable', 
                and clarification regarding the 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) an explanation of the process for reporting 
                adverse events for biological products, including 
                biosimilar biological products and interchangeable 
                biosimilar biological products; and
                    ``(D) an explanation of 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 Secretary shall continue to 
        publish the following information:
                    ``(A) The action package of each biological product 
                licensed under subsection (a) or (k).
                    ``(B) The summary review of each biological product 
                licensed under subsection (a) or (k).
            ``(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 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.

    (a) In General.--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), by striking ``active 
                ingredient (including any ester or salt of the active 
                ingredient)'' each place it appears 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), by striking ``active 
                ingredient (including any ester or salt of the active 
                ingredient)'' each place it appears 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 amending clause (i) to read as 
                        follows:
                    ``(i) not later than 30 days after the date of 
                approval of such applications--
                            ``(I) for a drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under this 
                        section; or
                            ``(II) for a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act; and''; and
                            (ii) in clause (ii), by inserting "or 
                        biological product" before the period;
                    (D) by amending subsection (s) to read as follows:
    ``(s) Referral to Advisory Committee.--The Secretary shall--
            ``(1) refer a drug or biological product to a Food and Drug 
        Administration advisory committee for review at a meeting of 
        such advisory committee prior to the approval of such drug or 
        biological if it is--
                    ``(A) a drug, no active moiety (as defined by the 
                Secretary in section 314.3 of title 21, Code of Federal 
                Regulations (or any successor regulations)) of which 
                has been approved in any other application under this 
                section; or
                    ``(B) a biological product, no active ingredient of 
                which has been approved in any other application under 
                section 351 of the Public Health Service Act; or
            ``(2) if the Secretary does not refer a drug or biological 
        product described in paragraph (1) to a Food and Drug 
        Administration advisory committee prior to such approval, 
        provide in the action letter on the application for the drug or 
        biological product a summary of the reasons why the Secretary 
        did not refer the drug or biological product to an advisory 
        committee prior to approval.''; 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)), by 
        striking ``active ingredient (including any ester or salt of 
        the active ingredient)'' each place it appears 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) (21 U.S.C. 360n(a)(4)), by 
        amending subparagraph (C) to read as follows:
                    ``(C) is for--
                            ``(i) a human drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under section 
                        505(b)(1); or
                            ``(ii) a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act.'';
            (4) in section 529(a)(4) (21 U.S.C. 21 U.S.C. 360ff(a)(4)), 
        by striking subparagraphs (A) and (B) and inserting the 
        following:
                    ``(A) is for a drug or biological product that is 
                for the prevention or treatment of a rare pediatric 
                disease;
                    ``(B)(i) is for such a drug--
                            ``(I) that contains no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) that has been 
                        previously approved in any other application 
                        under subsection (b)(1), (b)(2), or (j) of 
                        section 505; and
                            ``(II) that is the subject of an 
                        application submitted under section 505(b)(1); 
                        or
                    ``(ii) or is for such a biological product--
                            ``(I) that contains no active ingredient 
                        that has been previously approved in any other 
                        application under section 351(a) or 351(k) of 
                        the Public Health Service Act; and
                            ``(II) that is the subject of an 
                        application submitted under section 351(a) of 
                        the Public Health Service Act;''; and
            (5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by 
        amending subparagraph (D) to read as follows:
                    ``(D) is for--
                            ``(i) a human drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under section 
                        505(b)(1); or
                            ``(ii) a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act.''.
    (b) Technical Corrections.--Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq) is amended--
            (1) in section 505 (21 U.S.C. 355)--
                    (A) in subsection (c)(3)(E), by repealing clause 
                (i); and
                    (B) in subsection (j)(5)(F), by repealing clause 
                (i); and
            (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
        355a(c)(1)(A)(i)), by striking ``(c)(3)(D)'' and inserting 
        ``(c)(3)(E)''.

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 submitted under section 505(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(b)) with a filing date that is not later 
than September 23, 2019, and that does not receive final approval on or 
before March 23, 2020, such application shall be deemed to be withdrawn 
and the Secretary shall refund the fee paid under section 736(a)(1)(B) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)(1)(B)). 
Notwithstanding any such withdrawal of the drug application, the 
Secretary shall consider any previously conducted scientific review and 
accelerate review of any such subsequent application with respect to 
such biological product under section 351 of the Public Health Service 
Act (42 U.S.C. 262). The Secretary shall provide additional assistance 
to the sponsor or manufacturer of such application.''.

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 for which an application 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 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 exclusivity', with respect to a 
        drug approved under section 505(c), means any period of 
        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 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 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.''.

SEC. 214. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL 
              PRODUCTS.

    (a) Definitions.--In this section--
            (1) the term ``commercially reasonable, market-based 
        terms'' means--
                    (A) a nondiscriminatory price for the sale of the 
                covered product at or below, but not greater than, the 
                most recent wholesale acquisition cost for the drug, as 
                defined in section 1847A(c)(6)(B) of the Social 
                Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
                    (B) a schedule for delivery that results in the 
                transfer of the covered product to the eligible product 
                developer consistent with the timing under subsection 
                (b)(2)(A)(iv); and
                    (C) no additional conditions are imposed on the 
                sale of the covered product;
            (2) the term ``covered product''--
                    (A) means--
                            (i) any drug approved under subsection (c) 
                        or (j) of section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355) or 
                        biological product licensed under subsection 
                        (a) or (k) of section 351 of the Public Health 
                        Service Act (42 U.S.C. 262);
                            (ii) any combination of a drug or 
                        biological product described in clause (i); or
                            (iii) when reasonably necessary to support 
                        approval of an application under section 505 of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355), or section 351 of the Public 
                        Health Service Act (42 U.S.C. 262), as 
                        applicable, or otherwise meet the requirements 
                        for approval under either such section, any 
                        product, including any device, that is marketed 
                        or intended for use with such a drug or 
                        biological product; and
                    (B) does not include any drug or biological product 
                that appears on the drug shortage list in effect under 
                section 506E of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 356e), unless--
                            (i) the drug or biological product has been 
                        on the drug shortage list in effect under such 
                        section 506E continuously for more than 6 
                        months; or
                            (ii) the Secretary determines that 
                        inclusion of the drug or biological product as 
                        a covered product is likely to contribute to 
                        alleviating or preventing a shortage.
            (3) the term ``device'' has the meaning given the term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321);
            (4) the term ``eligible product developer'' means a person 
        that seeks to develop a product for approval pursuant to an 
        application for approval under subsection (b)(2) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or for licensing pursuant to an application under 
        section 351(k) of the Public Health Service Act (42 U.S.C. 
        262(k));
            (5) the term ``license holder'' means the holder of an 
        application approved under subsection (c) or (j) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
        the holder of a license under subsection (a) or (k) of section 
        351 of the Public Health Service Act (42 U.S.C. 262) for a 
        covered product;
            (6) the term ``REMS'' means a risk evaluation and 
        mitigation strategy under section 505-1 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355-1);
            (7) the term ``REMS with ETASU'' means a REMS that contains 
        elements to assure safe use under section 505-1(f) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
            (8) the term ``Secretary'' means the Secretary of Health 
        and Human Services;
            (9) the term ``single, shared system of elements to assure 
        safe use'' means a single, shared system of elements to assure 
        safe use under section 505-1(f) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355-1(f)); and
            (10) the term ``sufficient quantities'' means an amount of 
        a covered product that the eligible product developer 
        determines allows it to--
                    (A) conduct testing to support an application 
                under--
                            (i) subsection (b)(2) or (j) of section 505 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355); or
                            (ii) section 351(k) of the Public Health 
                        Service Act (42 U.S.C. 262(k)); and
                    (B) fulfill any regulatory requirements relating to 
                approval of such an application.
    (b) Civil Action for Failure To Provide Sufficient Quantities of a 
Covered Product.--
            (1) In general.--An eligible product developer may bring a 
        civil action against the license holder for a covered product 
        seeking relief under this subsection in an appropriate district 
        court of the United States alleging that the license holder has 
        declined to provide sufficient quantities of the covered 
        product to the eligible product developer on commercially 
        reasonable, market-based terms.
            (2) Elements.--
                    (A) In general.--To prevail in a civil action 
                brought under paragraph (1), an eligible product 
                developer shall prove, by a preponderance of the 
                evidence--
                            (i) that--
                                    (I) the covered product is not 
                                subject to a REMS with ETASU; or
                                    (II) if the covered product is 
                                subject to a REMS with ETASU--
                                            (aa) the eligible product 
                                        developer has obtained a 
                                        covered product authorization 
                                        from the Secretary in 
                                        accordance with subparagraph 
                                        (B); and
                                            (bb) the eligible product 
                                        developer has provided a copy 
                                        of the covered product 
                                        authorization to the license 
                                        holder;
                            (ii) that, as of the date on which the 
                        civil action is filed, the product developer 
                        has not obtained sufficient quantities of the 
                        covered product on commercially reasonable, 
                        market-based terms;
                            (iii) that the eligible product developer 
                        has submitted a written request to purchase 
                        sufficient quantities of the covered product to 
                        the license holder, and such request--
                                    (I) was sent to a named corporate 
                                officer of the license holder;
                                    (II) was made by certified or 
                                registered mail with return receipt 
                                requested;
                                    (III) specified an individual as 
                                the point of contact for the license 
                                holder to direct communications related 
                                to the sale of the covered product to 
                                the eligible product developer and a 
                                means for electronic and written 
                                communications with that individual; 
                                and
                                    (IV) specified an address to which 
                                the covered product was to be shipped 
                                upon reaching an agreement to transfer 
                                the covered product; and
                            (iv) that the license holder has not 
                        delivered to the eligible product developer 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, by 
                                the date that is 31 days after the date 
                                on which the license holder received 
                                the request for the covered product; 
                                and
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, by 31 
                                days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request for the covered 
                                        product; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        subparagraph (B).
                    (B) Authorization for covered product subject to a 
                rems with etasu.--
                            (i) Request.--An eligible product developer 
                        may submit to the Secretary a written request 
                        for the eligible product developer to be 
                        authorized to obtain sufficient quantities of 
                        an individual covered product subject to a REMS 
                        with ETASU.
                            (ii) Authorization.--Not later than 120 
                        days after the date on which a request under 
                        clause (i) is received, the Secretary shall, by 
                        written notice, authorize the eligible product 
                        developer to obtain sufficient quantities of an 
                        individual covered product subject to a REMS 
                        with ETASU for purposes of--
                                    (I) development and testing that 
                                does not involve human clinical trials, 
                                if the eligible product developer has 
                                agreed to comply with any conditions 
                                the Secretary determines necessary; or
                                    (II) development and testing that 
                                involves human clinical trials, if the 
                                eligible product developer has--
                                            (aa)(AA) submitted 
                                        protocols, informed consent 
                                        documents, and informational 
                                        materials for testing that 
                                        include protections that 
                                        provide safety protections 
                                        comparable to those provided by 
                                        the REMS for the covered 
                                        product; or
                                            (BB) otherwise satisfied 
                                        the Secretary that such 
                                        protections will be provided; 
                                        and
                                            (bb) met any other 
                                        requirements the Secretary may 
                                        establish.
                            (iii) Notice.--A covered product 
                        authorization issued under this subparagraph 
                        shall state that the provision of the covered 
                        product by the license holder under the terms 
                        of the authorization will not be a violation of 
                        the REMS for the covered product.
            (3) Affirmative defense.--In a civil action brought under 
        paragraph (1), it shall be an affirmative defense, on which the 
        defendant has the burden of persuasion by a preponderance of 
        the evidence--
                    (A) that, on the date on which the eligible product 
                developer requested to purchase sufficient quantities 
                of the covered product from the license holder--
                            (i) neither the license holder nor any of 
                        its agents, wholesalers, or distributors was 
                        engaged in the manufacturing or commercial 
                        marketing of the covered product; and
                            (ii) neither the license holder nor any of 
                        its agents, wholesalers, or distributors 
                        otherwise had access to inventory of the 
                        covered product to supply to the eligible 
                        product developer on commercially reasonable, 
                        market-based terms;
                    (B) that--
                            (i) the license holder sells the covered 
                        product through agents, distributors, or 
                        wholesalers;
                            (ii) the license holder has placed no 
                        restrictions, explicit or implicit, on its 
                        agents, distributors, or wholesalers to sell 
                        covered products to eligible product 
                        developers; and
                            (iii) the covered product can be purchased 
                        by the eligible product developer in sufficient 
                        quantities on commercially reasonable, market-
                        based terms from the agents, distributors, or 
                        wholesalers of the license holder; or
                    (C) that the license holder made an offer to the 
                individual specified pursuant to paragraph 
                (2)(A)(iii)(III), by a means of communication 
                (electronic, written, or both) specified pursuant to 
                such paragraph, to sell sufficient quantities of the 
                covered product to the eligible product developer at 
                commercially reasonable market-based terms--
                            (i) for a covered product that is not 
                        subject to a REMS with ETASU, by the date that 
                        is 14 days after the date on which the license 
                        holder received the request for the covered 
                        product, and the eligible product developer did 
                        not accept such offer by the date that is 7 
                        days after the date on which the eligible 
                        product developer received such offer from the 
                        license holder; or
                            (ii) for a covered product that is subject 
                        to a REMS with ETASU, by the date that is 20 
                        days after the date on which the license holder 
                        received the request for the covered product, 
                        and the eligible product developer did not 
                        accept such offer by the date that is 10 days 
                        after the date on which the eligible product 
                        developer received such offer from the license 
                        holder.
            (4) Remedies.--
                    (A) In general.--If an eligible product developer 
                prevails in a civil action brought under paragraph (1), 
                the court shall--
                            (i) order the license holder to provide to 
                        the eligible product developer without delay 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms;
                            (ii) award to the eligible product 
                        developer reasonable attorney's fees and costs 
                        of the civil action; and
                            (iii) award to the eligible product 
                        developer a monetary amount sufficient to deter 
                        the license holder from failing to provide 
                        eligible product developers with sufficient 
                        quantities of a covered product on commercially 
                        reasonable, market-based terms, if the court 
                        finds, by a preponderance of the evidence--
                                    (I) that the license holder delayed 
                                providing sufficient quantities of the 
                                covered product to the eligible product 
                                developer without a legitimate business 
                                justification; or
                                    (II) that the license holder failed 
                                to comply with an order issued under 
                                clause (i).
                    (B) Maximum monetary amount.--A monetary amount 
                awarded under subparagraph (A)(iii) shall not be 
                greater than the revenue that the license holder earned 
                on the covered product during the period--
                            (i) beginning on--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, the 
                                date that is 31 days after the date on 
                                which the license holder received the 
                                request; or
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, the date 
                                that is 31 days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        paragraph (2)(B); and
                            (ii) ending on the date on which the 
                        eligible product developer received sufficient 
                        quantities of the covered product.
                    (C) Avoidance of delay.--The court may issue an 
                order under subparagraph (A)(i) before conducting 
                further proceedings that may be necessary to determine 
                whether the eligible product developer is entitled to 
                an award under clause (ii) or (iii) of subparagraph 
                (A), or the amount of any such award.
    (c) Limitation of Liability.--A license holder for a covered 
product shall not be liable for any claim under Federal, State, or 
local law arising out of the failure of an eligible product developer 
to follow adequate safeguards to assure safe use of the covered product 
during development or testing activities described in this section, 
including transportation, handling, use, or disposal of the covered 
product by the eligible product developer.
    (d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the 
following new subsection:
    ``(l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product to an eligible product 
developer (as those terms are defined in section 214(a) of the Lower 
Health Care Costs Act) shall not be considered a violation of the 
requirements of any risk evaluation and mitigation strategy that may be 
in place under this section for such drug.''.
    (e) Rule of Construction.--
            (1) Definition.--In this subsection, the term ``antitrust 
        laws''--
                    (A) has the meaning given the term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12); and
                    (B) includes section 5 of the Federal Trade 
                Commission Act (15 U.S.C. 45) to the extent that such 
                section applies to unfair methods of competition.
            (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of the 
        antitrust laws.
    (f) REMS Approval Process for Subsequent Filers.--Section 505-1 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), as amended 
by subsection (d), is further amended--
            (1) in subsection (g)(4)(B)--
                    (A) in clause (i) by striking ``or'' after the 
                semicolon;
                    (B) in clause (ii) by striking the period at the 
                end and inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) accommodate different, comparable 
                        aspects of the elements to assure safe use for 
                        a drug that is the subject of an application 
                        under section 505(j), and the applicable listed 
                        drug.'';
            (2) in subsection (i)(1), by striking subparagraph (C) and 
        inserting the following:
                    ``(C)(i) Elements to assure safe use, if required 
                under subsection (f) for the listed drug, which, 
                subject to clause (ii), for a drug that is the subject 
                of an application under section 505(j) may use--
                            ``(I) a single, shared system with the 
                        listed drug under subsection (f); or
                            ``(II) a different, comparable aspect of 
                        the elements to assure safe use under 
                        subsection (f).
                    ``(ii) The Secretary may require a drug that is the 
                subject of an application under section 505(j) and the 
                listed drug to use a single, shared system under 
                subsection (f), if the Secretary determines that no 
                different, comparable aspect of the elements to assure 
                safe use could satisfy the requirements of subsection 
                (f).'';
            (3) in subsection (i), by adding at the end the following:
            ``(3) Shared rems.--If the Secretary approves, in 
        accordance with paragraph (1)(C)(i)(II), a different, 
        comparable aspect of the elements to assure safe use under 
        subsection (f) for a drug that is the subject of an abbreviated 
        new drug application under section 505(j), the Secretary may 
        require that such different comparable aspect of the elements 
        to assure safe use can be used with respect to any other drug 
        that is the subject of an application under section 505(j) or 
        505(b) that references the same listed drug.''; and
            (4) by adding at the end the following:
    ``(m) Separate REMS.--When used in this section, the terms 
`different, comparable aspect of the elements to assure safe use' or 
`different, comparable approved risk evaluation and mitigation 
strategies' means a risk evaluation and mitigation strategy for a drug 
that is the subject of an application under section 505(j) that uses 
different methods or operational means than the strategy required under 
subsection (a) for the applicable listed drug, or other application 
under section 505(j) with the same such listed drug, but achieves the 
same level of safety as such strategy.''.
    (g) Rule of Construction.--Nothing in this section, the amendments 
made by this section, or in section 505-1 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355-1), shall be construed as--
            (1) prohibiting a license holder from providing an eligible 
        product developer access to a covered product in the absence of 
        an authorization under this section; or
            (2) in any way negating the applicability of a REMS with 
        ETASU, as otherwise required under such section 505-1, with 
        respect to such covered product.

SEC. 215. REDUCING THE PRICE OF PRESCRIPTION DRUGS.

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

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

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

    ``(a) Definitions.--In this section:
            ``(1) Manufacturer.--The term `manufacturer' means the 
        person--
                    ``(A) that holds the application for a drug 
                approved under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or the license issued under section 
                351 of this Act; or
                    ``(B) who is responsible for setting the price for 
                the drug.
            ``(2) Qualifying drug.--The term `qualifying drug' means 
        any drug that is approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act or 
        licensed under subsection (a) or (k) of section 351 of this 
        Act--
                    ``(A) that has a wholesale acquisition cost of $100 
                or more per month supply, or per a course of treatment 
                that lasts less than a month, and is--
                            ``(i)(I) subject to section 503(b)(1) of 
                        the Federal Food, Drug, and Cosmetic Act; or
                            ``(II) commonly administered by hospitals 
                        (as determined by the Secretary); and
                            ``(ii) not designated by the Secretary as a 
                        vaccine; and
                    ``(B) for which, during the previous calendar year, 
                at least 1 dollar of the total amount of sales were for 
                individuals enrolled under the Medicare program under 
                title XVIII of the Social Security Act (42 U.S.C. 1395 
                et seq.) or under a State Medicaid plan under title XIX 
                of such Act (42 U.S.C. 1396 et seq.) or under a waiver 
                of such plan.
            ``(3) Wholesale acquisition cost.--The term `wholesale 
        acquisition cost' has the meaning given that term in section 
        1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(B)).
    ``(b) Report.--
            ``(1) Report required.--The manufacturer of a qualifying 
        drug shall submit a report to the Secretary for each price 
        increase of a qualifying drug that will result in an increase 
        in the wholesale acquisition cost of that drug that is equal 
        to--
                    ``(A) 10 percent or more over a 12-month period; or
                    ``(B) 25 percent or more over a 36-month period.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary not later than 30 days 
        prior to the planned effective date of such price increase.
    ``(c) Contents.--A report under subsection (b) shall, at a minimum, 
include--
            ``(1) with respect to the qualifying drug--
                    ``(A) the percentage by which the manufacturer will 
                raise the wholesale acquisition cost of the drug on the 
                planned effective date of such price increase;
                    ``(B) a justification for, and description of, each 
                manufacturer's price increase that will occur during 
                the 12-month period described in subsection (b)(1)(A) 
                or the 36-month period described in subsection 
                (b)(1)(B), as applicable;
                    ``(C) the identity of the initial developer of the 
                drug;
                    ``(D) a description of the history of the 
                manufacturer's price increases for the drug since the 
                approval of the application for the drug under section 
                505 of the Federal Food, Drug, and Cosmetic Act or the 
                issuance of the license for the drug under section 351, 
                or since the manufacturer acquired such approved 
                application or license;
                    ``(E) the current list price of the drug;
                    ``(F) the total expenditures of the manufacturer 
                on--
                            ``(i) materials and manufacturing for such 
                        drug; and
                            ``(ii) acquiring patents and licensing for 
                        such drug;
                    ``(G) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(H) the total expenditures of the manufacturer on 
                research and development for such drug that is used 
                for--
                            ``(i) basic and preclinical research;
                            ``(ii) clinical research;
                            ``(iii) new drug development;
                            ``(iv) pursuing new or expanded indications 
                        for such drug through supplemental applications 
                        under section 505 of the Federal Food, Drug, 
                        and Cosmetic Act or section 351 of this Act; 
                        and
                            ``(v) carrying out postmarket requirements 
                        related to such drug, including those under 
                        section 505(o)(3) of the Federal Food, Drug, 
                        and Cosmetic Act;
                    ``(I) the total revenue and the net profit 
                generated from the qualifying drug for each calendar 
                year since the approval of the application for the drug 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act or the issuance of the license for the 
                drug under section 351, or since the manufacturer 
                acquired such approved application or license; and
                    ``(J) the total costs associated with marketing and 
                advertising for the qualifying drug;
            ``(2) with respect to the manufacturer--
                    ``(A) the total revenue and the net profit of the 
                manufacturer--
                            ``(i) for the 12-month period preceding the 
                        date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(A); or
                            ``(ii) for the 36-month period preceding 
                        the date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(B);
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation--
                            ``(i) for the12-month period preceding the 
                        date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(A); or
                            ``(ii) for the 36-month period preceding 
                        the date of the report, in the case of a report 
                        based on an increase described in subsection 
                        (b)(1)(B); and
                    ``(C) any additional information the manufacturer 
                chooses to provide related to drug pricing decisions, 
                such as total expenditures on--
                            ``(i) drug research and development; or
                            ``(ii) clinical trials on drugs that failed 
                        to receive approval by the Food and Drug 
                        Administration; and
            ``(3) such other related information as the Secretary 
        considers appropriate, as specified through notice and comment 
        rulemaking.
    ``(d) Civil Penalty.--Any manufacturer of a qualifying drug that 
fails to submit a report for the drug as required by this section shall 
be subject to a civil penalty of $100,000 for each day on which the 
violation continues.
    ``(e) Public Posting.--
            ``(1) In general.--Subject to paragraph (3), not later than 
        30 days after the submission of a report under subsection (b), 
        the Secretary shall post the report on the public website of 
        the Department of Health and Human Services.
            ``(2) Format.--In developing the format of such report for 
        public posting, the Secretary shall consult stakeholders, 
        including beneficiary groups, and shall seek feedback on the 
        content and format from consumer advocates and readability 
        experts to ensure such public reports are user-friendly to the 
        public and are written in plain language that consumers can 
        readily understand.
            ``(3) Trade secrets and confidential information.--In 
        carrying out this section the Secretary shall enforce current 
        law concerning the protection of confidential commercial 
        information and trade secrets.''.

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

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

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

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
submit to Congress, and post on the public website of the Department of 
Health and Human Services in a way that is easy to find, use, and 
understand, an annual report--
            ``(1) summarizing the information reported pursuant to 
        section 399OO; and
            ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to such section.
    ``(b) Trade Secrets and Confidential Information.--In carrying out 
this section the Secretary shall enforce current law concerning the 
protection of confidential commercial information and trade secrets.''.

            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 Group and Individual Market and Consumers.--
            ``(1) Group health plans.--A group health plan or 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, enrollees, 
                or eligible enrollees of the plan or coverage; or
                    ``(B) sharing, for plan design, plan 
                administration, and plan, financial, legal, and quality 
                improvement activities, 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.
            ``(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, plan 
        sponsor, or health insurance issuer 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; or
                    ``(B) requires the group health plan or health 
                insurance issuer to enter into any additional contract 
                with an affiliate of the provider, such as 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 restrictive contracting terms between the service 
        provider and a third-party administrator that the group health 
        plan is not party to, without a disclosure that such terms 
        exist.
            ``(3) Exception for certain group model issuers.--Paragraph 
        (1)(A) shall not apply to a group health plan or health 
        insurance issuer offering group or individual health insurance 
        coverage with respect to--
                    ``(A) 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; or
                    ``(B) a value-based network arrangement, such as an 
                exclusive provider network, accountable care 
                organization, center of excellence, a provider 
                sponsored health insurance issuer that operates 
                primarily through aligned multi-specialty physician 
                group practices or integrated health systems, or such 
                other similar network arrangements as determined by the 
                Secretary through rulemaking.
            ``(4) Attestation.--A group health plan or 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, 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.
    ``(f) Clarification With Respect to Antitrust Laws.--Compliance 
with this section does not constitute compliance with the antitrust 
laws, as defined in subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12(a)).''.
    (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 on or after the date that is 
18 months 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 title XXVII of the Public Health 
Service Act (42 U.S.C. 300gg-91 et seq.), as amended by section 102, is 
further amended by adding at the end the following:

``SEC. 2796. DESIGNATION OF A NONGOVERNMENTAL, NONPROFIT TRANSPARENCY 
              ORGANIZATION TO LOWER AMERICANS' HEALTH CARE COSTS.

    ``(a) In General.--The Secretary, in consultation with the 
Secretary of Labor, not later than 1 year after the date of enactment 
of the Lower Health Care Costs Act, shall enter into 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 Health and 
Human Services.
    ``(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; breach notifications.--
                    ``(A) Regulations.--
                            ``(i) In general.--The Secretary shall 
                        issue regulations prescribing the extent to 
                        which, and the manner in which, the following 
                        rules (and any successors of such rules) shall 
                        apply to the activities under this section of 
                        an entity receiving a contract under subsection 
                        (a):
                                    ``(I) 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).
                                    ``(II) The Security Rule under part 
                                160 and subparts A and C of part 164 of 
                                such title 45 (or any successor 
                                regulations).
                                    ``(III) The Breach Notification 
                                Rule under part 160 and subparts A and 
                                D of part 164 of such title 45 (or any 
                                successor regulations).
                            ``(ii) Supplemental regulations.--In order 
                        to ensure data privacy and security and the 
                        notification of breaches, the Secretary may 
                        issue such supplemental regulations on the 
                        subjects of the rules listed under clause (i) 
                        as the Secretary determines appropriate to 
                        address differences between the activities 
                        described by this section and the activities 
                        covered by such rules.
                    ``(B) Enforcement.--Section 1176 of Social Security 
                Act shall apply with respect to a violation of this 
                paragraph in the same manner such section 1176 applies 
                to a violation of part C of title XI of the Social 
                Security Act, and the Secretary may include in the 
                regulations promulgated under this section provisions 
                to apply such section to this paragraph.
                    ``(C) Procedure.--
                            ``(i) Timing.--The Secretary shall issue 
                        the initial set of regulations under this 
                        paragraph not later than 1 year after the date 
                        of enactment of the Lower Health Care Costs 
                        Act.
                            ``(ii) Authority to use interim final 
                        procedures.--The Secretary may make such 
                        initial set of regulations effective and final 
                        immediately upon issuance, on an interim basis, 
                        and provide for a period of public comment on 
                        such initial set of regulations after the date 
                        of publication.
                    ``(D) Requirements of entity.--The entity receiving 
                the contract under this section shall--
                            ``(i) not disclose to the public any 
                        individually identifiable health information or 
                        proprietary financial information;
                            ``(ii) strictly limit staff access to the 
                        data to staff with appropriate training, 
                        clearance, and background checks and require 
                        regular privacy and security training;
                            ``(iii) maintain effective security 
                        standards for transferring data or making data 
                        available to authorized users;
                            ``(iv) develop a process for providing 
                        access to data to authorized users, in a secure 
                        manner that maintains privacy and 
                        confidentiality of data; and
                            ``(v) 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
            ``(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 13 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 Labor and the Comptroller 
                        General of the United States shall, not later 
                        than 180 days 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, or 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 
                                Labor, shall appoint to the Committee--
                                            ``(aa) 1 member selected by 
                                        the Secretary, in coordination 
                                        with the Secretary of Labor, to 
                                        serve as the chair of the 
                                        Committee;
                                            ``(bb) the Assistant 
                                        Secretary for Planning and 
                                        Evaluation of the Department of 
                                        Health and Human Services, or a 
                                        designee of such Assistant 
                                        Secretary;
                                            ``(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;
                                            ``(ff) 1 representative of 
                                        the National Center for Health 
                                        Statistics; and
                                            ``(gg) 1 representative of 
                                        the Employee Benefits and 
                                        Security Administration of the 
                                        Department of Labor; 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 consumer advocate; 
                                        and
                                            ``(ee) 2 additional 
                                        members.
                    ``(C) Duties.--The Committee shall--
                            ``(i) 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) best practices with respect 
                                to de-identification of data, as 
                                appropriate;
                                    ``(III) 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
                                    ``(IV) 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 to the entity awarded the contract under this 
        section 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 comply with any requirements imposed 
                under the rulemaking described in subsection (d)(4)(A).
            ``(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, 
        and any associated code or algorithms, to a new entity in the 
        event of contract termination.
    ``(d) Receiving Health Information.--
            ``(1) Requirements.--
                    ``(A) In general.--The Secretary of Labor shall 
                ensure that the applicable self-insured group health 
                plan, through its third-party administrator, pharmacy 
                benefit manager, or other entity designated by the 
                group health plan, as applicable, electronically 
                submits 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 consistent with the de-
                        identification requirements under section 
                        164.514 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 only 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 of title 45, Code of Federal 
                        Regulations (or any successor regulations); and
                            ``(iv) ensure that individually 
                        identifiable data is encrypted, in accordance 
                        with guidance issued by the Secretary under 
                        section 13402(h)(2) of the HITECH Act.
            ``(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 third-party plan 
        administrator that meets 1 or both of the following criteria:
                    ``(A) Administers health, medical, or pharmacy 
                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 aggregate number of enrollees in plans administered 
                by such administrator in such State, as determined by 
                the Secretary.
            ``(3) Third-party administrators.--In the case of a third-
        party administrator that is required under this subsection to 
        submit claims data with respect to an applicable self-insured 
        group health plan, such administrator shall submit claims data 
        with respect to all self-insured group health plans that the 
        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 Secretary, through 
                rulemaking, shall ensure that the data made available 
                to such entity is available to qualified entities under 
                section 1874(e) of the Social Security Act is made 
                available to the entity awarded a contract 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 individually identifiable 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.--On each of the dates described in 
        paragraph (2), the entity receiving the contract under 
        subsection (a) shall submit to Congress, the Secretary of 
        Health and Human Services, and the Secretary of Labor 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) Dates described.--The reports described in paragraph 
        (1) shall be submitted--
                    ``(A) not later than 3 years after the date of 
                enactment of the Lower Health Care Costs Act;
                    ``(B) the later of 1 year after the date that is 3 
                years after such date of enactment or March 1 of the 
                year after the date that is 3 years after such date of 
                enactment; and
                    ``(C) March 1 of each year thereafter.
            ``(3) 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 Labor, 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) Individually identifiable health information.--The 
        term `individually identifiable health information' has the 
        meaning given such term in section 1171(6) of the Social 
        Security Act.
            ``(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 2795(a) of the Public Health 
                Service Act, 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 2795(a) 
        of the Public Health Service Act, 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.

SEC. 304. PROTECTING PATIENTS AND IMPROVING THE ACCURACY OF PROVIDER 
              DIRECTORY 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 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, based on what 
                a plan or issuer knows or could reasonably know--
                            ``(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;
                            ``(ii) through an oral confirmation, 
                        documented by such issuer or coverage, and kept 
                        in the enrollee's file for a minimum of 2 
                        years; and
                            ``(iii) 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)(iii); 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, written information 
        described in subsection (a)(1)(A)(i), the oral confirmation 
        described in subsection (a)(1)(A)(ii), or a copy of the online 
        provider directory described in subsection (a)(1)(A)(iii) 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.''.
    (b) Effective Date.--Section 2729C of the Public Health Service 
Act, as added by subsection (a), shall take effect with respect to plan 
years beginning on or after the date that is 18 months after the date 
of enactment of this Act.

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 end of the visit or by 
        postal or electronic communication as soon as practicable and 
        not later than 5 calendar days after discharge or date of 
        visit; and
            ``(2) health care facilities and practitioners to furnish 
        all adjudicated bills to the patient as soon as practicable, 
        but not later than 45 calendar days after discharge or date of 
        visit.
    ``(b) Payment After Billing.--No patient may be required to pay a 
bill for health care services any earlier than 35 days after the 
postmark date 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 visit; 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 at 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(b), 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 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 every 6 months, 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;
                            ``(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 3 or more drugs are included 
                        on the formulary of such plan or coverage--
                                    ``(I) the amount received, or 
                                expected to be received, from drug 
                                manufacturers in rebates, fees, 
                                alternative discounts, or other 
                                remuneration--
                                            ``(aa) to be paid by drug 
                                        manufacturers for claims 
                                        incurred during the reporting 
                                        period; or
                                            ``(bb) that is related to 
                                        utilization of drugs, in such 
                                        therapeutic category or class;
                                    ``(II) the total net spending, 
                                after deducting rebates, price 
                                concessions, alternative discounts or 
                                other remuneration from drug 
                                manufacturers, by the health plan or 
                                health insurance coverage on that 
                                category or class of drugs; and
                                    ``(III) the net price per course of 
                                treatment or 30-day supply 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, 
                other than the plan sponsor, related to utilization of 
                drug or drug spending under that health plan or health 
                insurance coverage during the reporting period;
                    ``(F) the total net spending on prescription drugs 
                by the health plan or health insurance coverage during 
                the reporting period; and
                    ``(G) amounts paid directly or indirectly in 
                rebates, fees, or any other type of remuneration to 
                brokers, consultants, advisors, or any other individual 
                or firm who referred the group health plan's or health 
                insurance issuer's business to the pharmacy 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), except that such issuer or 
                entity may not restrict disclosure of such report to 
                governmental agencies pursuant to an investigation or 
                enforcement action.
                    ``(C) Limited form of report.--The Secretary shall 
                define through rulemaking a limited form of the report 
                under paragraph (1) required of plan sponsors who are 
                drug manufacturers, drug wholesalers, or other direct 
                participants in the drug supply chain, in order to 
                prevent anti-competitive behavior.
    ``(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, and 
        submits claims to, 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 amount paid to the pharmacy for 
                acquisition of the drug; 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 report every 6 months 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 course of 
                        treatment or 30-day supply 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 course of treatment or 
                        30-day supply, 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 course of treatment or 30-day 
                        supply, 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;
                            ``(iv) the lowest cost per course of 
                        treatment or 30-day supply, 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);
                    ``(C) available for audit by the plan sponsor, or a 
                third-party designated by a plan sponsor no less than 
                once per plan year; and
                    ``(D) returned to the issuer or entity providing 
                pharmaceutical benefit management services by the group 
                health plan if audits by such issuer or entity indicate 
                that the amounts received are incorrect after such 
                amounts have been paid to the group health plan.
            ``(3) Audit of rebate contracts.--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 make rebate contracts with drug manufacturers available 
        for audit by such plan sponsor or designated third-party, 
        subject to confidentiality agreements to prevent re-disclosure 
        of such contracts.
    ``(e) Enforcement.--
            ``(1) In general.--The Secretary, in consultation with the 
        Secretary of Labor and the Secretary of the Treasury, shall 
        enforce this section.
            ``(2) Failure to provide timely information.--A health 
        insurance issuer or an entity providing pharmacy 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.
            ``(3) False information.--A health insurance issuer, entity 
        providing pharmacy benefit management services, or drug 
        manufacturer that knowingly provides false information under 
        this section shall be subject to a civil money penalty in an 
        amount not to exceed $100,000 for each item of false 
        information. Such civil money penalty shall be in addition to 
        other penalties as may be prescribed by law.
            ``(4) Procedure.--The provisions of section 1128A of the 
        Social Security Act, other than subsection (a) and (b) and the 
        first sentence of subsection (c)(1) of such section shall apply 
        to civil monetary penalties under this subsection in the same 
        manner as such provisions apply to a penalty or proceeding 
        under section 1128A of the Social Security Act.
            ``(5) Safe harbor.--The Secretary may waive penalties under 
        paragraph (2), or extend the period of time for compliance with 
        a requirement of this section, for an entity in violation of 
        this section that has made a good-faith effort to comply with 
        this section.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to prohibit payments to entities offering pharmacy benefits 
management services for bona fide services using a fee structure not 
contemplated by this section, provided that such fees are transparent 
to group health plans and health insurance issuers.
    ``(g) 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 sectionb1847A(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 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 clause (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 XXVII 
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 annually report to the Secretary, prior to the beginning of 
open enrollment, 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 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 the date that is 18 months after the date of 
enactment of this Act.

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 and that imposes nonquantitative 
                treatment limitations (referred to in this section as 
                `NQTL') on mental health or substance use disorder 
                benefits, the plan or issuer offering health insurance 
                coverage in connection with such a plan, shall perform 
                comparative analyses of the design and application of 
                NQTLs in accordance with the following process, and 
                make available to the applicable State authority (or, 
                as applicable, to the Secretary of Labor with respect 
                to group health plans or the Secretary of Health and 
                Human Services with respect to health insurance 
                coverage), upon request within 60 days beginning 6 
                months after the date of enactment of the Lower Health 
                Care Costs Act, the following information:
                            ``(i) The specific plan or coverage terms 
                        regarding the NQTL, that applies to such plan 
                        or coverage, and a description of all mental 
                        health or substance use disorder and medical or 
                        surgical benefits to which it applies in each 
                        respective benefits classification.
                            ``(ii) The factors used to determine that 
                        the NQTL will apply to mental health or 
                        substance use disorder benefits and medical or 
                        surgical benefits.
                            ``(iii) The evidentiary standards used for 
                        the factors identified in clause (ii), when 
                        applicable, provided that every factor shall be 
                        defined and any other source or evidence relied 
                        upon to design and apply the NQTL to mental 
                        health or substance use disorder benefits and 
                        medical or surgical benefits.
                            ``(iv) The comparative analyses 
                        demonstrating that the processes, strategies, 
                        evidentiary standards, and other factors used 
                        to design the NQTL, as written, and the 
                        operation processes and strategies as written 
                        and in operation that are 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, strategies, evidentiary standards, 
                        and other factors used to design the NQTL, as 
                        written, and the operation processes and 
                        strategies as written and in operation that are 
                        used to apply the NQTL to medical or 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 request.--With 
                        respect to group health plans or health 
                        insurance coverage for which the Secretary is 
                        enforcing this section in accordance with 
                        section 2723, the Secretary, in consultation 
                        with the Secretary of Labor and the Secretary 
                        of Treasury, 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) for plans that involve 
                        potential violations of this section concerning 
                        NQTLs and any other instances in which the 
                        Secretary determines appropriate. The Secretary 
                        shall request not fewer than 20 such analyses 
                        per year.
                            ``(ii) 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 clause 
                        (i), the Secretary shall specify to the plan or 
                        coverage the information the plan or coverage 
                        must submit to be responsive to the request 
                        under clause (i) for the Secretary to review 
                        the comparative analyses described in 
                        subparagraph(A) for compliance with this 
                        section. Nothing in this paragraph shall 
                        require the Secretary to conclude that a plan 
                        is in compliance with this section solely based 
                        upon the inspection of the comparative analyses 
                        described in subparagraph (A), as requested 
                        under clause (i).
                            ``(iii) Required action.--In instances in 
                        which the Secretary has reviewed the 
                        comparative analyses described in subparagraph 
                        (A), as requested under clause (i), and 
                        determined that the plan or coverage is not in 
                        compliance with this section, the plan or 
                        coverage shall specify to the Secretary the 
                        actions the plan or coverage will 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.
                            ``(iv) 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) a summary of the comparative 
                                analyses requested under clause (i), 
                                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 clause (i) 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 the 
                                disclosure requirements under this 
                                section;
                                    ``(IV) the Secretary's 
                                specifications described in clause (ii) 
                                for each plan or coverage that the 
                                Secretary determined did not submit 
                                sufficient information for the 
                                Secretary to review the comparative 
                                analyses requested under clause (i) for 
                                compliance with this section; and
                                    ``(V) the Secretary's 
                                specifications described in clause 
                                (iii) 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 
                        subparagraph (B)(i) 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.--The Secretary shall share 
                        information on findings of compliance and 
                        noncompliance discovered upon reviewing the 
                        comparative analyses requested under 
                        subparagraph (B)(i) shall be shared with the 
                        State where the group health plan is located or 
                        the State where the health insurance issuer is 
                        licensed to do business 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 Federal law 
that applies to third-party administrators offering services to group 
health plans.

SEC. 313. GROUP HEALTH PLAN REPORTING REQUIREMENTS.

    Part C of title XXVII of the Public Health Service Act (42 U.S.C. 
300gg-91 et seq.), as amended by section 303, is further amended by 
adding at the end the following:

``SEC. 2797. GROUP HEALTH PLAN REPORTING.

    ``(a) In General.--A group health plan or health insurance issuer 
offering group or individual health insurance coverage shall submit to 
the Secretary, not later than March 1 of each year, the following 
information with respect to the health plan in the previous plan year:
            ``(1) The beginning and end dates of the plan year.
            ``(2) The number of enrollees.
            ``(3) Each State in which the plan is offered.
            ``(4) The 50 brand prescription drugs most frequently 
        dispensed by pharmacies for claims paid by the issuer, and the 
        total number of paid claims for each such drug.
            ``(5) The 50 most costly prescription drugs with respect to 
        the plan by total annual spending, and the annual amount spent 
        by the plan for each such drug.
            ``(6) The 50 prescription drugs with the greatest increase 
        in plan expenditures over the plan year preceding the plan year 
        that is the subject of the report, and, for each such drug, the 
        change in amounts expended by the plan in each such plan year.
            ``(7) Total spending on health care services by such group 
        health plan, broken down by--
                    ``(A) the type of costs, including--
                            ``(i) hospital costs;
                            ``(ii) health care provider and clinical 
                        service costs;
                            ``(iii) costs for prescription drugs; and
                            ``(iv) other medical costs; and
                    ``(B) spending on prescription drugs by--
                            ``(i) the health plan; and
                            ``(ii) the enrollees.
            ``(8) The average monthly premium--
                    ``(A) paid by employers on behalf of enrollees; and
                    ``(B) paid by enrollees.
            ``(9) Any impact on premiums by rebates, fees, and any 
        other remuneration paid by drug manufacturers to the plan or 
        its administrators or service providers, with respect to 
        prescription drugs prescribed to enrollees in the plan, 
        including--
                    ``(A) the amounts so paid for each therapeutic 
                class of drugs; and
                    ``(B) the amounts so paid for each of the 25 drugs 
                that yielded the highest amount of rebates and other 
                remuneration under the plan from drug manufacturers 
                during the plan year.
            ``(10) Any reduction in premiums and out-of-pocket costs 
        associated with rebates, fees, or other remuneration described 
        in paragraph (9).
    ``(b) Report.--Not later than 18 months after the date on which the 
first report is required under subsection (a) and biannually 
thereafter, the Secretary, acting through the Assistant Secretary of 
Planning and Evaluation and in coordination with the Inspector General 
of the Department of Health and Human Services, shall make available on 
the internet website of the Department of Health and Human Services a 
report on prescription drug reimbursements under group health plans, 
prescription drug pricing trends, and the role of prescription drug 
costs in contributing to premium increases or decreases under such 
plans, aggregated in such a way as no drug or plan specific information 
will be made public.
    ``(c) Privacy Protections.--No confidential or trade secret 
information submitted to the Secretary under subsection (a) shall be 
included in the report under subsection (b).''.

SEC. 314. STUDY BY COMPTROLLER GENERAL OF UNITED STATES.

    (a) In General.--The Comptroller General of the United States 
(referred to in this section as the ``Comptroller General'') shall, in 
consultation with appropriate stakeholders, conduct a study on the role 
of pharmacy benefit managers.
    (b) Permissible Examination.--In conducting the study required 
under subsection (a), the Comptroller General may examine various 
qualitative and quantitative aspects of the role of pharmacy benefit 
managers, such as the following:
            (1) The role that pharmacy benefit managers play in the 
        pharmaceutical supply chain.
            (2) The state of competition among pharmacy benefit 
        managers, including the market share for the Nation's largest 
        pharmacy benefit managers.
            (3) The use of rebates and fees by pharmacy benefit 
        managers, including--
                    (A) the extent to which rebates are passed on to 
                health plans and whether such rebates are passed on to 
                individuals enrolled in such plans;
                    (B) the extent to which rebates are kept by such 
                pharmacy benefit managers; and
                    (C) the role of any fees charged by such pharmacy 
                benefit managers.
            (4) Whether pharmacy benefit managers structure their 
        formularies in favor of high-rebate prescription drugs over 
        lower-cost, lower-rebate alternatives.
            (5) The average prior authorization approval time for 
        pharmacy benefit managers.
            (6) Factors affecting the use of step therapy by pharmacy 
        benefit managers.
    (c) Report.--Not later than 3 years after the date of enactment of 
this Act, the Comptroller General shall submit to the Secretary of 
Health and Human Services, 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 containing the results of the 
study conducted under subsection (a), including policy recommendations.

                   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, local, or Tribal 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 Committee on 
        Energy and Commerce of the House of Representatives an 
        evaluation of the awareness campaign under this section.
    ``(f) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities described in this 
section.
    ``(g) 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.

    (a) In General.--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.''.
    (b) Supplemental Grant Funds.--Section 330(d)(1) of the Public 
Health Service Act (42 U.S.C. 254b) is amended--
            (1) in subparagraph (F), by striking ``and'' at the end;
            (2) in subparagraph (G), by striking the period and and 
        inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(H) improving access to recommended 
                immunizations.''.

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 Indian Tribes and Tribal 
        organizations, 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, territorial, 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, community-based 
                                organizations, and others, as 
                                appropriate; 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, 
        territorial, 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, territorial, 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 health care 
        professionals, and particularly 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 rural areas, 
frontier areas, health professional shortage areas, or medically 
underserved areas and for medically underserved populations or Native 
Americans, including Indian Tribes and Tribal organizations.
    ``(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) Access to Broadband.--In administering grants under this 
section, the Secretary may coordinate with other agencies to ensure 
that funding opportunities are available to support access to reliable, 
high-speed internet for grantees.
    ``(g) 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 or Native Americans, including 
Indian tribes and Tribal organizations.
    ``(h) Research and Evaluation.--The Secretary, in consultation with 
stakeholders with appropriate expertise in such models, shall develop a 
strategic plan to research and evaluate the evidence for such models. 
The Secretary shall use such plan to inform the activities carried out 
under this section.
    ``(i) 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 (g); 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, including through the activities 
        described in subsection (g).
    ``(j) 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 health information technology 
                certified under section 3001(c)(5);
                    ``(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 uses or agrees to 
        use standards recognized 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 
                interoperable public health data systems and electronic 
                case reporting;
                    ``(B) the exchange of information pursuant to 
                electronic case reporting; or
                    ``(C) reporting by health care providers using such 
                public health data systems, as appropriate, and 
                pursuant to State law;
            ``(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.

    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. INNOVATION FOR MATERNAL HEALTH.

    ``(a) In General.--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 or continue 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 is 
        capable of carrying out 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, conduct a 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, Indian 
                Tribe, or Tribal organization 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 330O of such Act, as added by section 406, 
the following:

``SEC. 330P. 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, Indian Tribe, or Tribal organization 
        (as such terms are 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 and 
                postpartum 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) Period.--A grant awarded under subsection (a) 
                shall be made for a period of 5 years. Any supplemental 
                award made to a grantee under subsection (a) may be 
                made for a period of less than 5 years.
                    ``(B) Preference.--In awarding grants under 
                subsection (a), the Secretary shall--
                            ``(i) give preference to States, Indian 
                        Tribes, and Tribal organizations that have the 
                        highest rates of maternal mortality and severe 
                        maternal morbidity relative to other such 
                        States, Indian Tribes, or Tribal organizations, 
                        respectively; and
                            ``(ii) shall consider health disparities 
                        related to maternal mortality and severe 
                        maternal morbidity, including such disparities 
                        associated with racial and ethnic minority 
                        populations.
                    ``(C) Priority.--In awarding grants under 
                subsection (a), the Secretary shall give priority to 
                applications from up to 15 entities described in 
                subparagraph (B)(i).
                    ``(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 February 1, 2026, 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 August 
        1, 2026, 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.--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''.

SEC. 413. NATIVE AMERICAN SUICIDE PREVENTION.

    Section 520E(b) of the Public Health Service Act (42 U.S.C. 290bb-
36(b) is amended by inserting after paragraph (3) the following:
            ``(4) Consultation.--A State applying for a grant or 
        cooperative agreement under this section shall, in the 
        development and implementation of a statewide early 
        intervention strategy, consult or confer with entities 
        described in paragraph (1)(C) in such State.''.

SEC. 414. MINIMUM AGE OF SALE OF TOBACCO PRODUCTS.

    (a) In General.--Section 906(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387f(d)) is amended--
            (1) in paragraph (3)(A)(ii), by striking ``18 years'' and 
        inserting ``21 years''; and
            (2) by adding at the end the following:
            ``(5) Minimum age of sale.--It shall be unlawful for any 
        retailer to sell a tobacco product to any person younger than 
        21 years of age.''.
    (b) Regulations.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall publish in the 
Federal Register a final rule to update the regulations issued under 
chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387 
et seq.) as appropriate, only to carry out the amendments made by 
subsection (a), including updating the relevant age verification 
requirements under part 1140 of title 21, Code of Federal Regulations 
to require age verification for individuals under the age of 30. Such 
final rule shall--
            (1) take full effect not later than 90 days after the date 
        on which such final rule is published; and
            (2) be deemed to be in compliance with all applicable 
        provisions of chapter 5 of title 5, United States Code and all 
        other provisions of law relating to rulemaking procedures.
    (c) Notification.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall provide written notification 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives regarding the progress of the Department of Health and 
Human Services towards promulgating the final rule under subsection 
(b). If, 180 days after the date of enactment of this Act, such rule 
has not been promulgated in accordance with subsection (b), the 
Secretary shall provide a written notification and a justification for 
the delay in rulemaking to such committees.
    (d) Penalties for Violations.--
            (1) In general.--Section 103(q)(2) of the Family Smoking 
        Prevention and Tobacco Control Act (Public Law 111-31) is 
        amended--
                    (A) in subparagraph (A), in the matter preceding 
                clause (i), by inserting ``section 906(d)(5) or of'' 
                after ``violations of''; and
                    (B) in subparagraph (C), by inserting ``section 
                906(d)(5) or of'' after ``a retailer of''.
            (2) Repeated violations.--Section 303(f)(8) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) is amended 
        by inserting ``section 906(d)(5) or of'' after ``repeated 
        violations of''.
            (3) Misbranded products.--Section 903(a)(7)(B) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387c) is 
        amended by inserting ``section 906(d)(5) or of'' after 
        ``violation of''.

SEC. 415. SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER THE AGE OF 21.

    (a) In General.--Section 1926 of the Public Health Service Act (42 
U.S.C. 300x-26) is amended--
            (1) in the heading--
                    (A) by striking ``state law regarding''; and
                    (B) by striking ``18'' and inserting ``21'';
            (2) by striking subsections (a) and (d);
            (3) by redesignating subsections (b) and (c) as subsections 
        (a) and (b), respectively;
            (4) by amending subsection (a), as so redesignated, to read 
        as follows:
    ``(a) In General.--A funding agreement for a grant under section 
1921 is that the State involved will--
            ``(1) annually conduct random, unannounced inspections to 
        ensure that retailers do not sell tobacco products to 
        individuals under the age of 21; and
            ``(2) annually submit to the Secretary a report 
        describing--
                    ``(A) the activities carried out by the State to 
                ensure that retailers do not sell tobacco products to 
                individuals under the age of 21;
                    ``(B) the extent of success the State has achieved 
                in ensuring that retailers do not sell tobacco products 
                to individuals under the age of 21; and
                    ``(C) the strategies to be utilized by the State to 
                ensure that retailers do not sell tobacco products to 
                individuals under the age of 21 during the fiscal year 
                for which the grant is sought.'';
            (5) in subsection (b), as so redesignated--
                    (A) by striking paragraphs (1), (2), (3), and (4);
                    (B) by striking ``Before making'' and inserting the 
                following:
            ``(1) In general.--Before making'';
                    (C) by striking ``for the first applicable fiscal 
                year or any subsequent fiscal year'';
                    (D) by striking ``subsections (a) and (b)'' and 
                inserting ``subsection (a)'';
                    (E) by striking ``equal to--'' and inserting ``up 
                to 10 percent of the amount determined under section 
                1933 for the State for the applicable fiscal year.''; 
                and
                    (F) by adding at the end the following:
            ``(2) Limitation.--
                    ``(A) In general.--A State shall not have funds 
                withheld pursuant to paragraph (1) if such State for 
                which the Secretary has made a determination of 
                noncompliance under such paragraph--
                            ``(i) certifies to the Secretary by May 1 
                        of the fiscal year for which the funds are 
                        appropriated, consistent with subparagraph (B), 
                        that the State will commit additional State 
                        funds, in accordance with paragraph (1), to 
                        ensure that retailers do not sell tobacco 
                        products to individuals under 21 years of age;
                            ``(ii) agrees to comply with a negotiated 
                        agreement for a corrective action plan that is 
                        approved by the Secretary and carried out in 
                        accordance with guidelines issued by the 
                        Secretary; or
                            ``(iii) is a territory that receives less 
                        than $1,000,000 for a fiscal year under section 
                        1921.
                    ``(B) Certification.--
                            ``(i) In general.--The amount of funds to 
                        be committed by a State pursuant to 
                        subparagraph (A)(i) shall be equal to 1 percent 
                        of such State's substance abuse allocation 
                        determined under section 1933 for each 
                        percentage point by which the State misses the 
                        retailer compliance rate goal established by 
                        the Secretary.
                            ``(ii) State expenditures.--For a fiscal 
                        year in which a State commits funds as 
                        described in clause (i), such State shall 
                        maintain State expenditures for tobacco 
                        prevention programs and for compliance 
                        activities at a level that is not less than the 
                        level of such expenditures maintained by the 
                        State for the preceding fiscal year, plus the 
                        additional funds for tobacco compliance 
                        activities required under clause (i). The State 
                        shall submit a report to the Secretary on all 
                        State obligations of funds for such fiscal year 
                        and all State expenditures for the preceding 
                        fiscal year for tobacco prevention and 
                        compliance activities by program activity by 
                        July 31 of such fiscal year.
                            ``(iii) Discretion.--The Secretary shall 
                        exercise discretion in enforcing the timing of 
                        the State obligation of the additional funds 
                        required by the certification described in 
                        subparagraph (A)(i) as late as July 31 of such 
                        fiscal year.
                    ``(C) Failure to certify.--If a State described in 
                subparagraph (A) fails to certify to the Secretary 
                pursuant to subparagraph (A)(i) or enter into, or 
                comply with, a negotiated agreement under subparagraph 
                (A)(ii), the Secretary may take action pursuant to 
                paragraph (1).''; and
            (6) by adding at the end the following:
    ``(c) Implementation of Reporting Requirements.--
            ``(1) Transition period.--The Secretary shall--
                    ``(A) not withhold amounts under subsection (b) for 
                the 3-year period immediately following the date of 
                enactment of the Lower Health Care Costs Act; and
                    ``(B) use discretion in exercising its authority 
                under subsection (b) during the 2-year period 
                immediately following the 3-year period described in 
                subparagraph (A), to allow for a transition period for 
                implementation of the reporting requirements under 
                subsection (a)(2).
            ``(2) Regulations or guidance.--Not later than 180 days 
        after the date of enactment of the Lower Health Care Costs Act 
        the Secretary shall update regulations under part 96 of title 
        45, Code of Federal Regulations or guidance on the retailer 
        compliance rate goal under subsection (b), the use of funds 
        provided under section 1921 for purposes of meeting the 
        requirements of this section, and reporting requirements under 
        subsection (a)(2).
            ``(3) Coordination.--The Secretary shall ensure the 
        Assistant Secretary for Mental Health and Substance Use 
        coordinates, as appropriate, with the Commissioner of Food and 
        Drugs in providing technical assistance under this section to 
        States, related to ensuring retailers do not sell tobacco 
        products to individuals under the age of 21, that is consistent 
        with applicable regulations issued by the Food and Drug 
        Administration.
    ``(d) Transitional Grants.--
            ``(1) In general.--The Secretary shall award grants under 
        this subsection to each State that receives funding under 
        section 1921 to ensure compliance of each such State with this 
        section.
            ``(2) Use of funds.--A State receiving a grant under this 
        subsection--
                    ``(A) shall use amounts received under such grant 
                for activities to plan for or ensure compliance in the 
                State with subsection (a); and
                    ``(B) in the case of a State for which the 
                Secretary has made a determination under subsection (b) 
                that the State is prepared to meet, or has met, the 
                requirements of subsection (a), may use such funds for 
                tobacco cessation activities, strategies to prevent the 
                use of tobacco products by individuals under the age of 
                21, or allowable uses under section 1921.
            ``(3) Supplement not supplant.--Grants under this 
        subsection shall be used to supplement and not supplant other 
        Federal, State, and local public funds provided for activities 
        under paragraph (2).
            ``(4) Authorization of appropriations.--To carry out this 
        subsection, there are authorized to be appropriated $18,580,790 
        for each of fiscal years 2020 through 2024.
            ``(5) Sunset.--This subsection shall have no force or 
        effect after September 30, 2024.
    ``(e) Technical Assistance.--The Secretary shall provide technical 
assistance to States related to the activities required under this 
section.''.
    (b) Report to Congress.--Not later than 3 years after the date of 
enactment of this Act, the Secretary 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 on the 
status of implementing the requirements of section 1926 of the Public 
Health Service Act (42 U.S.C. 300x-26), as amended by subsection (a), 
and a description of any technical assistance provided under subsection 
(e) of such section, including the number of meetings requested and 
held related to technical assistance.
    (c) Conforming Amendment.--Section 212 of division D of the 
Consolidated Appropriations Act, 2010 (Public Law 111-117) is repealed.

         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, and 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, as the Secretary may specify:
            ``(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 the 
                        previous 5 years;
                            ``(ii) that involve benefits managed by any 
                        third party, such as a pharmacy benefits 
                        manager or radiology benefits manager that 
                        manages benefits or adjudicates claims on 
                        behalf of the plan or coverage; and
                            ``(iii) from any other health plan or 
                        health insurance coverage offered by the same 
                        insurance issuer, in which the same enrollee 
                        was enrolled during the previous 5 years; and
                    ``(B) be available to an enrollee or former 
                enrollee, the enrollee's providers, and any third-party 
                applications or services authorized by the enrollee--
                            ``(i) through the application programming 
                        interfaces (or successor technology or 
                        standards) as required by this paragraph, in a 
                        single, longitudinal format that is easy to 
                        understand, secure, and that may update 
                        automatically;
                            ``(ii) as soon as practicable, and in no 
                        case later than the period of time determined 
                        by the Secretary, after the claim is 
                        adjudicated or the data is received by the 
                        health plan or health insurance issuer; and
                            ``(iii) to the enrollee, former 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 the information 
                necessary to establish a list of participating in-
                network facilities and practitioners, in a given 
                specialty or at a particular facility type, within a 
                specified geographic radius; and
                    ``(C) be capable of returning the network status, 
                when presented with identifiers for a given enrollee 
                and facility or practitioner.
            ``(3) Estimated enrollee out-of-pocket costs, including 
        costs expected to be incurred through a deductible, co-payment, 
        coinsurance, or other form of cost-sharing, for--
                    ``(A) a designated set of common services or 
                episodes of care, to be established by the Secretary 
                through rulemaking, including, at a minimum--
                            ``(i) in the case of services provided by a 
                        hospital, the 100 most common diagnosis-related 
                        groups, as used in the Medicare Inpatient 
                        Prospective Patient System (or successor 
                        episode-based reimbursement methodology) at 
                        that hospital, based on claims data adjudicated 
                        by the group health plan or health insurance 
                        issuer;
                            ``(ii) in the case of services provided in 
                        an out-patient setting, including radiology, 
                        lab tests, and out-patient surgical procedures, 
                        any service rendered by the facility or 
                        practitioner, and reimbursed by the 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.
            ``(4) A list of the categories of providers of ancillary 
        services, as defined in section 2719(A)(i)(3), for which the 
        plan or coverage has no in-network providers.
    ``(c) Availability and Access.--Subject to all applicable Federal 
and State privacy, security, and breach notification laws, 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 and prospective enrollees in the 
                group health plan or health insurance coverage;
                    ``(B) third parties authorized by the enrollee;
                    ``(C) facilities and practitioners who are under 
                contract with the plan or coverage; and
                    ``(D) business associates of such facilities and 
                practitioners, as defined in section 160.103 of title 
                45, Code of Federal Regulations (or any successor 
                regulations);
            ``(2) be available to enrollees in the group health plan or 
        health insurance coverage, and to third-party applications or 
        services facilitating such access by enrollees, during the 
        enrollment process and for a minimum of 5 years after the end 
        date of the enrollee's enrollment in the plan or in any 
        coverage offered by the health insurance issuer;
            ``(3) permit persistent access by third party applications 
        or services authorized by the enrollee, for a reasonable period 
        of time, consistent with the requirements of the HIPAA Security 
        rule (part 160 of title 45 Code of Federal Regulations and 
        subparts A and C of part 164 of such title);
            ``(4) employ the applicable content, vocabulary, and 
        technical standards, as determined by the Secretary pursuant to 
        title XXX; and
            ``(5) employ security and authentication standards, as the 
        Secretary determines appropriate.
    ``(d) Rule of Construction Regarding Privacy.--Nothing in this 
section shall be construed to alter existing obligations of a covered 
entity or business associate under the privacy, security, and breach 
notification rules promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act or section 13402 of the 
HITECH Act, or to alter the Secretary's existing authority to modify 
such rules, under part 2 of title 42, Code of Federal Regulations (or 
successor regulations), under section 444 of the General Education 
Provisions Act (20 U.S.C. 1232g) (commonly referred to as the `Family 
Educational Rights and Privacy Act of 1974'), under the amendments made 
by the Genetic Information Nondiscrimination Act, or under State 
privacy law.''.
    (b) Effective Date.--Section 2715B of the Public Health Service 
Act, as added by subsection (a), shall take effect 18 months after the 
date of enactment of this Act.

SEC. 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 covered entity or business associate has adequately 
demonstrated that it 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) mitigate the remedies that would otherwise be agreed 
        to in any agreement with respect to resolving potential 
        violations of the HIPAA Security rule (part 160 of title 45 
        Code of Federal Regulations and subparts A and C of part 164 of 
        such title) between the covered entity or business associate 
        and the Department of Health and Human Services.
    ``(b) 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 Act of 2015, and other programs and 
        processes that address cybersecurity and that are developed, 
        recognized, or promulgated through regulations under other 
        statutory authorities. Such practices shall be determined by 
        the covered entity or business associate.
            ``(2) Limitation.--Nothing in this section shall be 
        construed as providing the Secretary authority to 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.
            ``(3) No liability for nonparticipation.--Subject to 
        paragraph (4), nothing in this section shall be construed to 
        subject a covered 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).

SEC. 505. PUBLIC MEETING.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
convene a public meeting for purposes of discussing and providing input 
on patient-matching metrics for the purpose of enabling 
interoperability and the exchange of health information across health 
care organizations.
    (b) Experts.--The public meeting under this section may include--
            (1) representatives of relevant Federal agencies (including 
        representatives from the Office of the National Coordinator for 
        Health Information Technology);
            (2) State, local, Tribal, and territorial public health 
        officials;
            (3) stakeholders with expertise in health information 
        exchange;
            (4) stakeholders with expertise in capabilities relevant to 
        patient matching, such as experts in informatics and data 
        analytics;
            (5) stakeholders affected by record-matching (including 
        patients, hospitals, health systems, payers, health information 
        exchanges, and prescription drug monitoring programs); and
            (6) other representatives, as the Secretary determines 
        appropriate.
    (c) Topics.--Such public meeting shall include a discussion of--
            (1) standards and processes for assessing the accuracy of 
        patient-matching algorithms;
            (2) performance metrics for health care providers 
        purchasing patient-matching technology and algorithm 
        developers;
            (3) the development of benchmarks for the accuracy of 
        patient-matching algorithms;
            (4) considerations for State, local, Tribal, and 
        territorial capabilities and infrastructure related to data 
        exchange, interoperability, and matching patient records;
            (5) opportunities for the incorporation of innovative 
        technologies to improve patient matching; and
            (6) privacy and security protections.
                                                       Calendar No. 133

116th CONGRESS

  1st Session

                                S. 1895

_______________________________________________________________________

                                 A BILL

                      To lower health care costs.

_______________________________________________________________________

                              July 8, 2019

                       Reported with an amendment