[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8967 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 8967

   To require the Secretary of Health and Human Services to award a 
 contract to an eligible nonprofit entity to establish and maintain a 
health care claims database for purposes of lowering Americans' health 
                  care costs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 15, 2020

  Mr. Beyer introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, Oversight and Reform, Armed Services, and Education and 
 Labor, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
   To require the Secretary of Health and Human Services to award a 
 contract to an eligible nonprofit entity to establish and maintain a 
health care claims database for purposes of lowering Americans' health 
                  care costs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Federal All-Payer Claims Database 
Act of 2020''.

SEC. 2. ESTABLISHMENT AND MAINTENANCE OF HEALTH CARE CLAIMS DATABASE TO 
              LOWER HEALTH CARE COSTS.

    (a) In General.--Not later than the date that is 180 days after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ``Secretary''), acting 
through the Administrator of the Centers for Medicare & Medicaid 
Services and in consultation with the Secretary of Labor, shall award a 
contract in accordance with subsection (b) to an eligible nonprofit 
entity described in such subsection for purposes of carrying out the 
requirements of such entity under this section.
    (b) Contract With Eligible Nonprofit Entity.--
            (1) Competitive procedures.--The Secretary shall award the 
        contract described in subsection (a) to an eligible nonprofit 
        entity described in paragraph (2) using full and open 
        competition procedures pursuant to chapter 33 of title 41, 
        United States Code.
            (2) Eligible nonprofit entity.--An eligible nonprofit 
        entity described in this paragraph is a nonprofit entity that--
                    (A) is governed by a board that includes--
                            (i) representatives of the academic 
                        research community; and
                            (ii) individuals with expertise in 
                        employer-sponsored insurance, research using 
                        health care claims data, and actuarial 
                        analysis; and
                    (B) conducts its business in an open and 
                transparent manner that provides the opportunity for 
                public comment on its activities.
            (3) Considerations.--In awarding a contract to an eligible 
        nonprofit entity under this section, the Secretary shall 
        consider the experience of each eligible nonprofit entity in--
                    (A) collecting and aggregating health care claims 
                data, ensuring quality assurance and security of such 
                claims data, and securing such claims data;
                    (B) supporting academic research on health care 
                costs, spending, and utilization for and by privately 
                insured patients;
                    (C) working with large health insurance issuers, 
                group health plans, and third-party administrators of 
                group health plans to assemble a health care claims 
                database;
                    (D) effectively collaborating with and engaging 
                stakeholders to develop reports;
                    (E) meeting budgets and timelines, including with 
                respect to developing reports; and
                    (F) facilitating the creation of, or supporting, 
                State all-payer claims databases.
            (4) Period of contract.--
                    (A) In general.--A contract awarded under this 
                section shall be for a period of 5 years and may be 
                renewed, subject to the full and open competition 
                procedures described in paragraph (1).
                    (B) Transition of contract.--In the case that a 
                contract is not renewed for a subsequent 5-year period 
                under subparagraph (A) after the use of the full and 
                open competition procedures described in paragraph (1), 
                the Secretary shall require the entity whose contract 
                is expiring to transfer all data maintained by the 
                health care claims database described in paragraph 
                (5)(A) to the entity to whom the Secretary has awarded 
                a contract for the subsequent 5-year period. The entity 
                whose contract is expiring may not disclose such data 
                to any other entity or keep such data after the 
                expiration of such contract.
            (5) Requirements of contract.--Each contract awarded under 
        this section shall require the entity awarded such contract to 
        carry out each of the following:
                    (A) Establish and maintain a health care claims 
                database in accordance with the requirements of the 
                HIPAA privacy regulation.
                    (B) Ensure that such health care claims database 
                makes available data submitted under subsection (d) in 
                accordance with the requirements of subsection (c).
                    (C) In the case that the contract is not renewed 
                after the end of the 5-year period of the contract, 
                carry out the transfer of data required pursuant to 
                paragraph (4)(B) in accordance with a schedule and 
                process determined by the Secretary.
                    (D) Comply with the HIPAA privacy regulation in the 
                same manner and to the same extent as such regulation 
                applies to a covered entity (as defined pursuant to 
                such regulation).
                    (E) Strictly limit staff access to such health care 
                claims database to staff with appropriate training, 
                clearance, and background checks, and require such 
                staff to undergo regular privacy and security training.
                    (F) Maintain effective security standards for 
                transferring data from such health care claims database 
                and making such data available to all individuals and 
                entities who are authorized users pursuant to 
                subsection (c)(2).
                    (G) Adhere to best security practices with respect 
                to the management and use of such data for health 
                services research, in accordance with applicable 
                Federal privacy law.
                    (H) Report on the security methods of the entity 
                to--
                            (i) the Secretary;
                            (ii) the Committee on Health, Education, 
                        Labor, and Pensions, the Committee on Finance, 
                        and the Committee on Commerce, Science, and 
                        Transportation of the Senate; and
                            (iii) the Committee on Education and Labor, 
                        the Committee on Energy and Commerce, the 
                        Committee on the Judiciary, and the Committee 
                        on Ways and Means of the House of 
                        Representatives.
    (c) Availability of Data From Health Care Claims Database.--
            (1) In general.--Subject to paragraph (2), the entity 
        maintaining the health care claims database described in 
        subsection (b)(5)(A) shall make available, at cost, the data 
        submitted under subsection (d)--
                    (A) to patients to inform such patients about the 
                cost, quality, and value of their health care;
                    (B) to health care providers and hospitals--
                            (i) to assist such providers and hospitals 
                        in making informed choices while providing 
                        health care; and
                            (ii) to enable such providers and hospitals 
                        to improve health care services provided to 
                        patients and health care outcomes for such 
                        patients by benchmarking their performance 
                        against that of other health care providers and 
                        hospitals;
                    (C) to group health plans and health insurance 
                issuers offering individual or group health insurance 
                coverage to assist such group health plans and health 
                insurance issuers in evaluating and reducing health 
                care costs for enrollees of such group health plans and 
                individual or group health insurance coverage, 
                respectively;
                    (D) to States to facilitate State-led initiatives 
                to lower health care costs and improve the quality of 
                health care;
                    (E) to any State all-payer claims database and 
                regional health care claims database operated pursuant 
                to the authorization of each State covered by such 
                regional health care claims database;
                    (F) to any individual or entity conducting 
                research;
                    (G) to the Secretary of Defense for purposes of 
                carrying out the TRICARE program under chapter 55 of 
                title 10, United States Code;
                    (H) to the Director of the Office of Personnel 
                Management for purposes of carrying out the Federal 
                Employees Health Benefits Program established under 
                chapter 89 of title 5, United States Code; and
                    (I) to 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.
            (2) Authorization for access to data.--
                    (A) In general.--The entity maintaining the health 
                care claims database described in subsection (b)(5)(A) 
                may only make available the data described in paragraph 
                (1) to an individual or entity described in any of 
                subparagraphs (A) through (F) of such paragraph if such 
                individual or entity submits an application to such 
                entity requesting authorization for access to such 
                database in accordance with this paragraph.
                    (B) Application.--An application under this 
                paragraph shall be submitted at such time, in such 
                manner, and containing such information as the 
                Secretary may require and shall include--
                            (i) in the case of an individual or entity 
                        requesting access to the health care claims 
                        database described in subsection (b)(5)(A) for 
                        research purposes--
                                    (I) a description of the uses and 
                                methodologies for evaluating health 
                                system performance using the data from 
                                such database; and
                                    (II) documentation of approval of 
                                such research purposes by an 
                                institutional review board, if 
                                applicable for a particular plan of 
                                research; and
                            (ii) in the case of a group health plan, 
                        health insurance issuer, third-party 
                        administrator of a group health plan, or health 
                        care provider requesting access to such health 
                        care claims database for the purpose of quality 
                        improvement or cost-containment, a description 
                        of the intended uses for the data from such 
                        database.
                    (C) Data use and confidentiality agreement.--Upon 
                approval of an application under subparagraph (B), the 
                authorized user shall enter into a data use and 
                confidentiality agreement with the entity that approved 
                such application, which shall include a prohibition on 
                attempts to reidentify and disclose protected health 
                information and proprietary financial information. In 
                the case of an approval of an application for quality 
                improvement or cost-containment purposes under 
                subparagraph (B)(ii), access to data from the health 
                care claims database described in subsection (b)(5)(A) 
                shall be provided in a form and manner such that the 
                authorized user may not obtain individually 
                identifiable price information with respect to direct 
                competitors.
            (3) Availability of reports and analyses based on data.--
                    (A) In general.--Subject to subparagraph (B), the 
                entity maintaining the health care claims database 
                described in subsection (b)(5)(A), in consultation with 
                the advisory committee convened under subsection (e), 
                shall make available to all individuals and entities 
                who are authorized users pursuant to paragraph (2) any 
                report or analysis based on data from such database, 
                including aggregate data sets, free of charge.
                    (B) Customized reports.--Group health plans may 
                request customized reports from the entity maintaining 
                the health care claims database described in subsection 
                (b)(5)(A), at cost, but subject to the requirements of 
                the HIPPA privacy regulation.
    (d) Submission of Data to Health Care Claims Database.--
            (1) In general.--Subject to paragraphs (2) and (3), a group 
        health plan (through its sponsor, third-party administrator, 
        pharmacy benefit manager, or other entity designated by the 
        group health plan) or a health insurance issuer offering group 
        or individual health insurance coverage shall electronically 
        submit to the health care claims database maintained under this 
        section all claims data (including claims with respect to 
        treatment of substance use disorders and prescription drug 
        claims) with respect to the plan or group or individual health 
        insurance coverage, respectively.
            (2) Scope of information and format of submission.--The 
        entity maintaining the health care claims database under this 
        section, in consultation with the advisory committee convened 
        under subsection (e), shall--
                    (A) specify the data elements required to be 
                submitted under paragraph (1), which shall include all 
                data related to transactions described in subparagraphs 
                (A) and (E) of section 1173(a)(2) of the Social 
                Security Act (42 U.S.C. 1320d-2(a)(2)), including all 
                data elements normally present in such transactions 
                when adjudicated, and enrollment information;
                    (B) specify the form and manner for submissions 
                under this subsection and the historical period to be 
                included in the initial submission; and
                    (C) offer an automated submission option to 
                minimize administrative burdens relating to the 
                submission of data under this subsection.
            (3) De-identification of data.--The entity maintaining the 
        health care claims database under this section, in consultation 
        with the advisory committee convened under subsection (e), 
        shall--
                    (A) 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;
                    (B) ensure that any third-party subcontractors who 
                perform the de-identification process described in 
                subparagraph (A) retain the minimum necessary 
                information to perform such process and adhere to 
                effective security and encryption practices in data 
                storage and transmission;
                    (C) 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
                    (D) ensure that data is encrypted, in accordance 
                with the HIPAA privacy regulation.
            (4) Other data.--
                    (A) Medicaid data.--The Administrator of the 
                Centers for Medicare & Medicaid Services shall submit 
                all health care claims data with respect to the 
                Medicare program under title XVIII of the Social 
                Security Act (42 U.S.C. 1395 et seq.) and the Medicaid 
                program under title XIX of such Act (42 U.S.C. 1396 et 
                seq.) in accordance with scope, format, and de-
                identification requirements applicable pursuant to 
                paragraphs (2) and (3).
                    (B) TRICARE.--The Secretary of Defense shall submit 
                all health care claims data with respect to the TRICARE 
                program under chapter 55 of title 10, United States 
                Code, in accordance with scope, format, and de-
                identification requirements applicable pursuant to 
                paragraphs (2) and (3).
                    (C) FEHB.--The Director of the Office of Personnel 
                Management shall submit all health care claims data 
                with respect to the Federal Employee Health Benefits 
                program in accordance with scope, format, and de-
                identification requirements applicable pursuant to 
                paragraphs (2) and (3).
                    (D) State data.--The entity maintaining the health 
                care claims database under this section may collect 
                data from State all-payer claims databases that seek 
                access to such health care claims database. A State may 
                require health insurance issuers and other payers to 
                submit claims data to a State-mandated all-payer claims 
                database, provided that such data is submitted in a 
                form and manner established by the Secretary. A State 
                may also require health insurance issuers and other 
                payers to submit claims data to the health care claims 
                database maintained under this section, provided that 
                such data is submitted in a form and manner established 
                by the Secretary and consistent with scope, format, and 
                de-identification requirements applicable pursuant to 
                paragraphs (2) and (3).
            (5) Prohibition.--Any individual or entity required to 
        submit data under this subsection may not place any 
        restrictions on the use of such data by authorized users under 
        subsection (c)(2).
    (e) Advisory Committee.--
            (1) In general.--Not later than the date that is 180 days 
        after the date of the enactment of this Act, the Secretary 
        shall convene an advisory committee (referred to in this 
        subsection as the ``Committee'') to advise the Secretary, any 
        entity awarded a contract under subsection (b), and Congress on 
        the establishment, operations, and use of the health care 
        claims database established and maintained under this section.
            (2) Membership.--
                    (A) Appointment.--In accordance with clause (ii), 
                the Secretary, in consultation with the Comptroller 
                General of the United States, shall 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 health care claims 
                database established and maintained under this section, 
                including patients, health care providers, group health 
                plans, health insurance issuers, and third-party 
                administrators of group health plans.
                    (B) Composition.--For purposes of clause (i)--
                            (i) the Secretary shall appoint to the 
                        Committee--
                                    (I) one member to serve as the 
                                chair of the Committee;
                                    (II) the Assistant Secretary for 
                                Planning and Evaluation of the 
                                Department of Health and Human 
                                Services;
                                    (III) one representative from the 
                                Centers for Medicare & Medicaid 
                                Services;
                                    (IV) one representative from the 
                                Agency for Health Research and Quality;
                                    (V) one representative from the 
                                Office for Civil Rights of the 
                                Department of Health and Human Services 
                                with expertise in data privacy and 
                                security; and
                                    (VI) one representative of the 
                                National Center for Health Statistics; 
                                and
                            (ii) the Comptroller General of the United 
                        States shall appoint to the Committee--
                                    (I) one representative from an 
                                employer that sponsors a group health 
                                plan;
                                    (II) one representative from an 
                                employee organization that sponsors a 
                                group health plan;
                                    (III) one academic researcher with 
                                expertise in health economics or health 
                                services research;
                                    (IV) one patient advocate;
                                    (V) one representative of 
                                Designated Standards Maintenance 
                                Organizations named by the Secretary of 
                                Health and Human Services to maintain 
                                standards adopted under regulations 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996 (42 U.S.C. 
                                1320d-2 note);
                                    (VI) one representative with 
                                expertise in the governance of State 
                                all-payer claims databases; and
                                    (VII) two additional members.
                    (C) Terms and vacancies.--Members of the Committee 
                shall serve three-year terms on a staggered basis. A 
                vacancy on the Committee shall be filled by appointment 
                in a manner consistent with the requirements of this 
                subsection not later than 90 days after the vacancy 
                arises.
            (3) Duties.--The Committee shall--
                    (A) assist and advise the Secretary on the 
                management of contracts awarded under subsection (b);
                    (B) assist and advise entities awarded such 
                contracts in establishing--
                            (i) the appropriate uses of data by all 
                        individuals and entities who are authorized 
                        users pursuant to subsection (c)(2), including 
                        developing standards for the approval of 
                        applications submitted pursuant to such 
                        subsection; and
                            (ii) the appropriate formats and methods 
                        for making available to the public reports and 
                        analyses based on the health care claims 
                        database maintained under this section;
                    (C) conduct an annual review of whether data from 
                such health care claims database was used according to 
                the appropriate uses described in subparagraph (B)(ii);
                    (D) report, as appropriate, to the Secretary and 
                Congress on the operations of such health care claims 
                database and opportunities to better achieve the 
                objectives of this section;
                    (E) establish additional restrictions on 
                researchers who receive compensation from entities 
                specified by the Committee in order to protect 
                proprietary financial information; and
                    (F) establish objectives for research and public 
                reporting.
    (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 2021, 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 2022 through 
        2026, for purposes of carrying out this section (other than the 
        grant program under subsection (h)).
    (g) Annual Report.--Not later than March 1, 2022, and March 1 of 
each year thereafter, the entity with a contract in effect under 
subsection (b) shall submit to Congress and the Secretary, and make 
publicly available on an internet website, a report containing a 
description of--
            (1) trends in the price, utilization, and total spending on 
        health care services, including a geographic analysis of 
        differences in such trends;
            (2) limitations in the data set;
            (3) progress towards the objectives of this section; and
            (4) the performance by the entity of the duties required 
        under such contract.
    (h) Grants to States.--
            (1) In general.--The Secretary may award grants to States 
        for the purpose of establishing and maintaining State all-payer 
        claims databases that improve transparency of health care 
        claims data.
            (2) Funding.--There is authorized to be appropriated 
        $100,000,000 for the period of fiscal years 2021 through 2028 
        for the purpose of awarding grants to States under this 
        subsection.
    (i) Exemption From Public Disclosure.--
            (1) In general.--Data submitted to the health care claims 
        database under subsection (d) shall not be considered public 
        records and shall be exempt from any Federal law relating to 
        public disclosure requirements.
            (2) Restrictions on uses for certain proceedings.--Such 
        data may not be subject to discovery or admission as public 
        information or evidence in judicial or administrative 
        proceedings without the consent of the affected parties.
    (j) Definitions.--In this section:
            (1) HIPAA privay regulation.--The term ``HIPAA privacy 
        regulation'' has the meaning given such term in section 
        1180(b)(3) of the Social Security Act (42 U.S.C. 1320d-
        9(b)(3)).
            (2) PHSA definitions.--The terms ``group health plan'', 
        ``group health insurance coverage'', ``health insurance 
        issuer'', and ``individual health insurance coverage'' have the 
        meanings given such terms in section 2791 of the Public Health 
        Service Act (42 U.S.C. 300gg-91).
            (3) 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).
            (4) Proprietary financial information.--The term 
        ``proprietary financial information''--
                    (A) 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 health insurance coverage; and
                    (B) does not include any billing or payment 
                information from claims between such a provider or 
                facility and such a health plan, managed care 
                organization or other managed care entity, or health 
                insurance issuer.
    (k) Conforming Amendments.--
            (1) PHSA.--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 new section:

``SEC. 2730. HEALTH CARE CLAIMS DATABASE REPORTING REQUIREMENT.

    ``A group health plan and a health insurance issuer offering group 
or individual health insurance coverage shall comply with the 
provisions of section 1(d) of the Federal All-Payer Claims Database Act 
of 2020.''.
            (2) ERISA.--
                    (A) In general.--Subpart B of part 7 of subtitle B 
                of title I of the Employee Retirement Income Security 
                Act of 1974 (29 U.S.C. 1185 et seq.) is amended by 
                adding at the end the following new section:

``SEC. 716. HEALTH CARE CLAIMS DATABASE REPORTING REQUIREMENT.

    ``A group health plan and a health insurance issuer offering group 
health insurance coverage shall comply with the provisions of section 
1(d) of the Federal All-Payer Claims Database Act of 2020.''.
                    (B) Clerical amendment.--The table of contents in 
                section 1 of such Act is amended by inserting after the 
                item relating to section 714 the following new items:

``Sec. 715. Additional market reforms.
``Sec. 716. Health care claims database reporting requirement.''.
            (3) IRC.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986 is amended by adding at 
                the end the following new section:

``SEC. 9816. HEALTH CARE CLAIMS DATABASE REPORTING REQUIREMENT.

    ``A group health plan shall comply with the provisions of section 
1(d) of the Federal All-Payer Claims Database Act of 2020.''.
                    (B) Clerical amendment.--The table of sections for 
                such subchapter is amended by adding at the end the 
                following new items:

``Sec. 9815. Additional market reforms.
``Sec. 9816. Health care claims database reporting requirement.''.

SEC. 3. STUDY AND REPORTS BY COMPTROLLER GENERAL.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study on--
            (1) the performance of each entity awarded a contract under 
        subsection (b) of section 1;
            (2) the privacy and security of any data submitted to such 
        entity under subsection (d) of such section; and
            (3) the costs incurred by such entity in performing duties 
        under such a contract.
    (b) Reports.--Not later than two years after the effective date of 
the first contract awarded under section 1(b), and again not later than 
four 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 subsection (a), together with 
recommendations for such legislation and administrative action as the 
Comptroller General determines appropriate.
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