I 117th CONGRESS 2d Session H. R. 9644 IN THE HOUSE OF REPRESENTATIVES December 21, 2022 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 , Education and Labor , and Armed Services , 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.

1. Short title This Act may be cited as the National All-Payer Claims Database Act of 2022 . 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 Director of the Agency for Healthcare Research and Quality and in consultation with the Secretary of Labor and the Assistant Secretary for Planning and Labor of the Department of Health and Human Services, 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 public and 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 and ensuring quality assurance and privacy and security of such claims data; (B) supporting academic, private, and purchaser research on health care costs, spending, and utilization for and by privately or publicly 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 (or, in the case of the first such contract awarded under this section, for a period of 10 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 and other standards prescribed by the advisory committee under subsection (e). (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) during the 18-month period ending on the day of the expiration of such contract 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) Develop cross-State and regional reporting using data submitted to such database to support Federal and State analyses of health care access, utilization, and costs. (I) Develop dashboards and other tools in such database to allow entities authorized to use such database to view subsets of nationally aggregated data. (J) Respond to State, Federal, and Congressional requests relating to data maintained in such database. (K) Establish a committee that includes representatives from Federal and State governments and health care consumers to ensure operations transparency and accountability for the actions of the entity. (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 the data submitted under subsection (d) (in accordance with privacy and security policies established by the committee described in subsection (b)(5)(K)), at cost (taking into account any cost associated with the acquisition and processing such data and other administration costs of the entity) or, in the case of a Federal or State agency or State all-payer claims database sharing data with the entity, at no cost, not later than 6 months after such data is so submitted— (A) to patients; (B) to health care providers and hospitals; (C) to group health plans and health insurance issuers offering individual or group health insurance coverage; (D) to States; (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 that shares data with the entity; (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 Secretary of Veterans Affairs for purposes of carrying out the VA health care program; (I) 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 (J) to the Director of the Congressional Budget Office, the Comptroller General of the United States, the Administrator of the Centers for Medicare & Medicaid Services, 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 (J) 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 accordance with policies and procedures established by the committee described in subsection (b)(5)(K), shall make available reports or analyses based on data from such database, including aggregate data sets, free of charge. In the case of any such user who accesses such data for research purposes, such entity shall require such user, as a condition of accessing such data, that such user make any research arising from such data available on such database free of charge. (B) Customized reports Group health plans and health care providers 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 HIPAA 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. The preceding sentence shall not apply with respect to claims data submitted to an all-payer claims database established by a State if such database shares complete data with the database maintained under this section. (2) Scope of information and format of submission The entity maintaining the health care claims database under this section, in consultation with and approval from the committee convened under subsection (e), shall— (A) specify the data elements required to be submitted under paragraph (1) (and update such elements as the entity determines necessary on an annual basis), 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) on an annual basis, specify the form and manner for submissions under this subsection and the historical period to be included in the initial submission; (C) review such submissions for alignment with national data standards, internal consistency, cohesiveness (such as cross-file linkage), completeness, quality assurance, accuracy, and reasonableness, taking into account input from group health plans and health insurance issuers; (D) offer an automated submission option to minimize administrative burdens relating to the submission of data under this subsection; (E) develop a data collection standard for use by State all-payer claims databases receiving Federal funds pursuant to subsection (h); (F) curate and normalize cross-State and cross-payer data to support comparability and analytic use; and (G) ensure that States submitting data to the entity and using such database have access to claims data from Federal health care programs and self-insured group health plans at times and in a manner agreed to by the entity and the States. (3) De-identification of data The entity maintaining the health care claims database under this section, in consultation with the 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), prior to release 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) release 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), unless otherwise determined appropriate by the committee convened under subsection (e); and (D) ensure that data is encrypted, in accordance with the HIPAA privacy regulation. (4) Other data (A) Medicaid and Medicare 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. ), including claims data with respect to items and services furnished under part C or D of such title, 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 receiving funds under subsection (h) may require health insurance issuers and other payers to submit claims data (including data from self-insured group health plans) to a State-mandated all-payer claims database, provided that such data is submitted in accordance with the standard described in paragraph (1) of such subsection. (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) Governance 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 a governance 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 and other activities carried out by the entity with a contract in effect 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. (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, who may not be a representatives of the Federal Government or any State government; (II) one representative from 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; (VI) one representative from the Office of the National Coordinator for Health Information Technology; (VII) one representative of the National Center for Health Statistics; and (VIII) seven representatives from State all-payer claims databases electing to submit data to the national database established by the entity with a contract in effect under this section; 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 or health care purchaser association; (III) two researchers with expertise in health economics or health services research; (IV) two patient advocates; (V) one health data privacy and security expert; (VI) one representative with expertise in the governance of State all-payer claims databases; (VII) one representative from the Employee Benefits Security Administration of the Department of Labor; and (VIII) three additional members, at the discretion of the Comptroller General. (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 (directly or through the use of contractors)— (A) assist and advise the Secretary on the awarding and 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; (ii) the appropriate formats, methods, and thresholds for collecting data under the national database; and (iii) 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; (F) establish objectives for research and public reporting, including setting strategic, reporting, and data release objectives and priorities, and including advising on the development and implementation of a strategic and operating plan for the entities awarded contracts under subsection (b); (G) solicit and consider public comments in undertaking any duty specified in a preceding subparagraph; and (H) establish minimum State health data collection, exchange, use, privacy, security, and release standards for State all-payer claims databases receiving Federal funds under subsection (h). (f) Funding There are appropriated, out of monies in the Treasury not otherwise appropriated, $50,000,000 for each fiscal year (beginning with fiscal year 2023), for the implementation of the initial contract and establishment of the database under this section. (g) Annual report Not later than 2 years after a contract is first awarded to an entity under this section, and May 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 national and regional health service prices, coverage and service costs, access gaps, behavioral and substance use disorder treatment health needs, telehealth adoption, and health care utilization, including a geographic analysis of differences in such trends; (2) limitations in the data set; (3) progress towards the objectives of this section; (4) the performance by the entity of the duties required under such contract; and (5) security methods employed by the entity to protect data submitted to the entity. (h) Grants to States (1) In general The Secretary may award grants to States for the purpose of maintaining, establishing, or utilizing State all-payer claims databases that improve transparency of the health care system (including by updating standards or data submission requirements) or for the purpose of expanding the capacity of an existing State-all payer claims database (including integration with other data resources). A State shall be eligible for a grant under the preceding sentence only if such State agrees to report claims data collected under such State all-payer claims database to the national database established by the entity with a contract in effect under subsection (b) in a time and manner specified by the entity and to ensure that such database complies with the standard described in subsection (d)(2)(E). No State may receive an aggregate of more than $10,000,000 with respect to all grants awarded to such State under this subsection, except that such limit shall not apply to grants awarded jointly to multiple States for the purposes of establishing regional all-payer claims databases. (2) One-time health data innovation grants The Secretary may award each State a one-time health data innovation grant to allow such State to undertake activities relating to health data innovation that the Secretary determines to be of potential national interest. (3) Funding There is authorized to be appropriated $40,000,000 for each of fiscal years 2021 through 2028 for the purpose of awarding grants to States under this subsection. Of amounts appropriated under the preceding sentence, not less than 10 percent of such amounts shall be made available for grants described in paragraph (2). (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 privacy 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: 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 National All-Payer Claims Database Act of 2022. . (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: 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 National All-Payer Claims Database Act of 2022. . (B) Clerical amendment The table of contents in section 1 of such Act is amended by inserting after the item relating to section 715 the following new item: 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: 9816. Health care claims database reporting requirement A group health plan shall comply with the provisions of section 1(d) of the National All-Payer Claims Database Act of 2022. . (B) Clerical amendment The table of sections for such subchapter is amended by adding at the end the following new item: Sec. 9816. Health care claims database reporting requirement. . 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; (3) the costs incurred by such entity in performing duties under such a contract; (4) any barriers preventing States from accessing health claims data from Federal health care programs or self-insured group health plans that is necessary to effectively oversee State markets; (5) the extent to which the Federal Government has access to health claims data; and (6) the extent to which health claims data is efficiently submitted to the national database established by such entity and efficiently distributed by such entity to authorized users of such database. (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.