[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9644 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 9644
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 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.
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 ``National All-Payer Claims Database
Act of 2022''.
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 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:
``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 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:
``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 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:
``SEC. 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.''.
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;
(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.
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