[House Report 117-178]
[From the U.S. Government Publishing Office]
117th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 117-178
======================================================================
IMMUNIZATION INFRASTRUCTURE MODERNIZATION ACT OF 2021
_______
November 30, 2021.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 550]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 550) to amend the Public Health Service Act with
respect to immunization system data modernization and
expansion, and for other purposes, having considered the same,
reports favorably thereon with an amendment and recommends that
the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary............................................. 4
II. Background and Need for the Legislation......................... 4
III. Committee Hearings.............................................. 6
IV. Committee Consideration......................................... 6
V. Committee Votes................................................. 7
VI. Oversight Findings.............................................. 7
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure 7
VIII. Congressional Budget Office Estimate............................ 7
IX. Federal Mandates Statement...................................... 8
X. Statement of General Performance Goals and Objectives........... 8
XI. Duplication of Federal Programs................................. 8
XII. Committee Cost Estimate......................................... 9
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits..... 9
XIV. Advisory Committee Statement.................................... 9
XV. Applicability to Legislative Branch............................. 9
XVI. Section-by-Section Analysis of the Legislation.................. 9
XVII. Changes in Existing Law Made by the Bill, as Reported.......... 11
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Immunization Infrastructure
Modernization Act of 2021''.
SEC. 2. IMMUNIZATION INFORMATION SYSTEM DATA MODERNIZATION AND
EXPANSION.
Subtitle C of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-31 et seq.) is amended by adding at the end the following:
``SEC. 2824. IMMUNIZATION INFORMATION SYSTEM DATA MODERNIZATION AND
EXPANSION.
``(a) Expanding CDC and Public Health Department Capabilities.--
``(1) In general.--The Secretary shall--
``(A) conduct activities (including with respect to
interoperability, population reporting, and
bidirectional reporting) to expand, enhance, and
improve immunization information systems that are
administered by health departments or other agencies of
State, local, Tribal, and territorial governments and
used by health care providers; and
``(B) award grants or cooperative agreements to the
health departments, or such other governmental entities
as administer immunization information systems, of
State, local, Tribal, and territorial governments, for
the expansion, enhancement, and improvement of
immunization information systems to assist public
health departments in--
``(i) assessing current data infrastructure
capabilities and gaps among health care
providers to improve and increase consistency
in patient matching, data collection,
reporting, bidirectional exchange, and analysis
of immunization-related information;
``(ii) providing for technical assistance and
the efficient enrollment and training of health
care providers, including at pharmacies and
other settings where immunizations are being
provided, such as long-term care facilities,
specialty health care providers, community
health centers, Federally qualified health
centers, rural health centers, organizations
serving adults 65 and older, and organizations
serving homeless and incarcerated populations;
``(iii) improving secure data collection,
transmission, bidirectional exchange,
maintenance, and analysis of immunization
information;
``(iv) improving the secure bidirectional
exchange of immunization record data among
Federal, State, local, Tribal, and territorial
governmental entities and non-governmental
entities, including by--
``(I) improving such exchange among
public health officials in multiple
jurisdictions within a State, as
appropriate; and
``(II) by simplifying and supporting
electronic reporting by any health care
provider;
``(v) supporting the standardization of
immunization information systems to accelerate
interoperability with health information
technology, including with health information
technology certified under section 3001(c)(5)
or with health information networks;
``(vi) supporting adoption of the
immunization information system functional
standards of the Centers for Disease Control
and Prevention and the maintenance of security
standards to protect individually identifiable
health information;
``(vii) supporting and training immunization
information system, data science, and
informatics personnel;
``(viii) supporting real-time immunization
record data exchange and reporting, to support
rapid identification of immunization coverage
gaps;
``(ix) improving completeness of data by
facilitating the capability of immunization
information systems to exchange data, directly
or indirectly, with immunization information
systems in other jurisdictions;
``(x) enhancing the capabilities of
immunization information systems to evaluate,
forecast, and operationalize clinical decision
support tools in alignment with the
recommendations of the Advisory Committee on
Immunization Practices as approved by the
Director of the Centers for Disease Control and
Prevention;
``(xi) supporting the development and
implementation of policies that facilitate
complete population-level capture,
consolidation, and access to accurate
immunization information;
``(xii) supporting the procurement and
implementation of updated software, hardware,
and cloud storage to adequately manage
information volume and capabilities;
``(xiii) supporting expansion of capabilities
within immunization information systems for
outbreak response;
``(xiv) supporting activities within the
applicable jurisdiction related to the
management, distribution, and storage of
vaccine doses and ancillary supplies;
``(xv) developing information related to the
use and importance of immunization record data
and disseminating such information to health
care providers and other persons authorized
under State law to access such information,
including payors and health care facilities; or
``(xvi) supporting activities to improve the
scheduling and administration of vaccinations.
``(2) Data standards.--In carrying out paragraph (1), the
Secretary shall--
``(A) designate data and technology standards that
must be followed by governmental entities with respect
to use of immunization information systems as a
condition of receiving an award under this section,
with priority given to standards developed by--
``(i) consensus-based organizations with
input from the public; and
``(ii) voluntary consensus-based standards
bodies; and
``(B) support a means of independent verification of
the standards used in carrying out paragraph (1).
``(3) Public-private partnerships.--In carrying out paragraph
(1), the Secretary may develop and utilize contracts and
cooperative agreements for technical assistance, training, and
related implementation support.
``(b) Requirements.--
``(1) Health information technology standards.--The Secretary
may not award a grant or cooperative agreement under subsection
(a)(1)(B) unless the applicant uses and agrees to use standards
adopted by the Secretary under section 3004.
``(2) Waiver.--The Secretary may waive the requirement under
paragraph (1) with respect to an applicant if the Secretary
determines that the activities under subsection (a)(1)(B)
cannot otherwise be carried out within the applicable
jurisdiction.
``(3) Application.--A State, local, Tribal, or territorial
health department applying for a grant or cooperative agreement
under subsection (a)(1)(B) shall submit an application to the
Secretary at such time and in such manner as the Secretary may
require. Such application shall include information
describing--
``(A) the activities that will be supported by the
grant or cooperative agreement; and
``(B) how the modernization of the immunization
information systems involved will support or impact the
public health infrastructure of the health department,
including a description of remaining gaps, if any, and
the actions needed to address such gaps.
``(c) Strategy and Implementation Plan.--Not later than 90 days after
the date of enactment of this section, the Secretary shall submit to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the
Senate a coordinated strategy and an accompanying implementation plan
that identifies and demonstrates the measures the Secretary will
utilize to--
``(1) update and improve immunization information systems
supported by the Centers for Disease Control and Prevention;
and
``(2) carry out the activities described in this section to
support the expansion, enhancement, and improvement of State,
local, Tribal, and territorial immunization information
systems.
``(d) Consultation; Technical Assistance.--
``(1) Consultation.--In developing the strategy and
implementation plan under subsection (c), the Secretary shall
consult with--
``(A) health departments, or such other governmental
entities as administer immunization information
systems, of State, local, Tribal, and territorial
governments;
``(B) professional medical, associations, public
health associations, and associations representing
pharmacists and pharmacies;
``(C) community health centers, long-term care
facilities, and other appropriate entities that provide
immunizations;
``(D) health information technology experts; and
``(E) other public or private entities, as
appropriate.
``(2) Technical assistance.--In connection with consultation
under paragraph (1), the Secretary may--
``(A) provide technical assistance, certification,
and training related to the exchange of information by
immunization information systems used by health care
and public health entities at the local, State,
Federal, Tribal, and territorial levels; and
``(B) develop and utilize public-private partnerships
for implementation support applicable to this section.
``(e) Report to Congress.--Not later than 1 year after the date of
enactment of this section, the Secretary shall submit a report to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives
that includes--
``(1) a description of any barriers to--
``(A) public health authorities implementing
interoperable immunization information systems;
``(B) the exchange of information pursuant to
immunization records; or
``(C) reporting by any health care professional
authorized under State law, using such immunization
information systems, as appropriate, and pursuant to
State law; or
``(2) a description of barriers that hinder the effective
establishment of a network to support immunization reporting
and monitoring, including a list of recommendations to address
such barriers; and
``(3) an assessment of immunization coverage and access to
immunizations services and any disparities and gaps in such
coverage and access for medically underserved, rural, and
frontier areas.
``(f) Definition.--In this section, the term `immunization
information system' means a confidential, population-based,
computerized database that records immunization doses administered by
any health care provider to persons within the geographic area covered
by that database.
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $400,000,000, to remain
available until expended.''.
I. Purpose and Summary
H.R. 550, the ``Immunization Infrastructure Modernization
Act of 2021,'' authorizes the Secretary of Health and Human
Services (the Secretary) to conduct activities, including
designating data and technology standards, developing public-
private partnerships, and awarding grants or cooperative
agreements to health departments, in order to expand, enhance,
and improve immunization information systems (IIS).
II. Background and Need for Legislation
IIS are confidential, population-based, computerized
databases that record all immunization doses administered by
providers to persons within a certain geopolitical area.\1\ IIS
are important tools in providing immunization care for patients
by allowing providers to view a consolidated immunization
history of a patient to determine appropriate vaccinations from
childhood to adulthood, and often include features to
automatically remind patients about vaccine schedules.\2\ On
the population level, public health officials can review
aggregate data in IIS to determine overall vaccination levels
to better guide public health decisions.\3\
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\1\Centers for Disease Control and Prevention, About Immunization
Information Systems (https://www.cdc.gov/vaccines/programs/iis/
about.html) (2021).
\2\Lynn Gibbs Sharp, et al., Current Challenges and Future
Possibilities for Immunization Information Systems, Academic Pediatrics
(May 3, 2021).
\3\Supra note 1.
---------------------------------------------------------------------------
IIS were first developed in the early 1990s by local
jurisdictions and private entities, with varying data and
technology platforms.\4\ It was not until 2001 that the Centers
for Disease Control and Prevention (CDC) published the first
complete set of standards for IIS.\5\ These standards provided
minimum recommended technical functions for all IIS, including
allowing input of all personal data elements recommended by the
National Vaccine Advisory Committee (NVAC), establishing a
registry record for all newborn children in a jurisdiction
within six weeks of birth, policies related to confidentiality
and data security, and other important core functions.\6\ These
standards have evolved since 2001, and now include functions
related to resolving duplicate and incomplete patient records,
digital security, encryption, uptime, and disaster recovery
standards, and interoperability standards between data
systems.\7\ Despite improvements to functional standards over
the years, varying policies and interpretation, inconsistent
and antiquated technology in state and local jurisdictions,
incomplete provider participation, and less than full
implementation of bidirectional data exchange have been cited
by experts as challenges to improving data quality.\8\
---------------------------------------------------------------------------
\4\Public Health Informatics Institute, IIS Technology Over Time:
Impact and Changing Roles (available online at https://phii.org/sites/
default/files/iis_history_spotlight-_technology.pdf).
\5\Centers for Disease Control and Prevention, IIS Minimum
Functional Standards, 2001-2013 Historical Information (https://
www.cdc.gov/vaccines/programs/iis/func-stds-2001.html) (2012).
\6\Id.
\7\Centers for Disease Control and Prevention, Immunization
Information Systems (IIS) Functional Standards, v.4.1 (https://
www.cdc.gov/vaccines/programs/iis/functional-standards/func-stds-v4-
1.html) (2020).
\8\Supra note 2.
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H.R. 550 will improve immunization information data quality
by providing grants to state and local public health
departments to enhance these systems and requiring the
Secretary to adopt data standards among grantees.
Grants included in H.R. 550 will be used to assist public
health departments in improving data quality by: assessing data
infrastructure capabilities and gaps among health care
providers to increase consistency in patient matching, data
collection, reporting, bidirectional exchange of information,
and information analysis; providing technical assistance to
health providers and efficiently enrolling them; improving data
collection, transmission, exchange, maintenance, and analysis;
supporting standardization of IIS to accelerate
interoperability, including with electronic health record
systems; supporting training of IIS, data science, and
informatics personnel; supporting procurement and
implementation of software, hardware, and cloud storage;
supporting activities to improve the scheduling of
vaccinations; and other relevant activities. In carrying out
the grant activities, the Secretary is authorized to develop
and utilize contracts and cooperative agreements for technical
assistance, training, and related implementation support.
To improve data standards among state and local
jurisdictions, H.R. 550 would require the Secretary to
designate data and technology standards that must be followed
by governmental entities as a condition of receiving grants,
with priority given to data standards developed by consensus-
based organizations with input from the public and voluntary
consensus-based standards bodies. The Secretary would also be
required to support a means of independent verification of
standards used in carrying out grant activities.
The bill also requires the Secretary to submit to the
Committee, within 90 days of enactment, a coordinated strategy
and implementation plan for updating and improving IIS
supported by CDC and carrying out the activities described in
the bill. In developing the strategy and implementation plan,
the Secretary is required to consult with health departments
and other government entities that administer IIS, professional
medical associations, public health associations, and
associations representing pharmacists and pharmacies, community
health centers, long-term care facilities, and other
appropriate entities that provide immunizations, health
information technology (IT) experts, and other public and
private entities, as appropriate. The bill further directs the
Secretary to provide to the Committee within a year of
enactment a report describing any barriers to implementing
interoperable IIS, exchange of information pursuant to
immunization records, or reporting by health care providers.
The report also must describe any barriers that hinder the
effective establishment of a network to support immunization
reporting or monitoring with a list of recommendations to
address such barriers, and an assessment of immunization
coverage and access to any disparities and gaps in coverage and
access for medically underserved, rural, and frontier areas.
H.R. 550 authorizes appropriations of $400,000,000 to carry
out the activities described in the bill, to remain available
until expended.
III. Committee Hearings
For the purposes of section 3(c) of rule XIII of the Rules
of the House of Representatives, the following hearing was used
to develop or consider H.R. 550:
The Subcommittee on Health held a legislative hearing on
June 15, 2021 entitled ``Booster Shot: Enhancing Public Health
through Vaccine Legislation.'' The Subcommittee received
testimony from the following witnesses:
Phyllis Arthur, Vice President, Infectious
Diseases and Emerging Science Policy, Biotechnology
Innovation Organization;
Rebecca Coyle, Executive Director, American
Immunization Registry Association;
Yvonne Maldonado, M.D., Chair, Committee on
Infectious Diseases, American Academy of Pediatrics;
and
Lijen (L.J.) Tan, Ph.D., Chief Strategy
Officer, Immunization Action Coalition.
IV. Committee Consideration
Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN)
introduced H.R. 550, the ``Immunization Infrastructure
Modernization Act of 2021,'' on January 28, 2021, and it was
referred to the Committee on Energy and Commerce. Subsequently,
on February 2, 2021, H.R. 550 was referred to the Subcommittee
on Health. A legislative hearing was held on the bill on June
15, 2021.
On July 15, 2021, the Subcommittee on Health met in open
markup session, pursuant to notice, to consider H.R. 550 and 18
other bills. During consideration of the bill, a manager's
amendment offered by Representative Bucshon was agreed to by a
voice vote. Upon conclusion of consideration of the bill, the
Subcommittee on Health agreed to report the bill favorably to
the full Committee, amended, by a voice vote.
On July 21, 2021, the full Committee met in open markup
session, pursuant to notice, to consider H.R. 550 and 23 other
bills. No amendments were offered to H.R. 550. Upon conclusion
of consideration of the bill, the full Committee agreed to a
motion on final passage offered by Representative Pallone (D-
NJ), Chairman of the Committee, to order H.R. 550 reported
favorably to the House, as amended, by a voice vote.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
550.
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
VIII. Congressional Budget Office Estimate
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 21, 2021.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 550, the
Immunization Infrastructure Modernization Act of 2021.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Sarah
Sajewski.
Sincerely,
Phillip L. Swagel,
Director.
Enclosure.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
H.R. 550 would authorize $400 million for the Secretary of
Health and Human Services to improve and expand immunization
information systems (IIS). The bill instructs the Secretary to
award grants to state, local, tribal, and territorial public
health departments for IIS improvements, to designate data and
technology standards for IIS, and to submit a Congressional
report.
For this estimate, CBO assumes H.R. 550 will be enacted
near the beginning of fiscal year 2022. Based on historical
spending on similar activities, CBO estimates that implementing
H.R. 550 would increase federal spending by $396 million over
the 2022-2026 period, subject to the availability of
appropriated funds.
The CBO staff contact for this estimate is Sarah Sajewski.
The estimate was reviewed by Leo Lex, Deputy Director of Budget
Analysis.
IX. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
X. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to improve
data sharing and modernization of IIS through developing a plan
and strategy to improve such systems, designating data and
technology standards, and awarding grants to help departments
to carry out activities necessary to improve IIS.
XI. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 550 is known to be duplicative of another Federal program,
including any program that was included in a report to Congress
pursuant to section 21 of Public Law 111-139 or the most recent
Catalog of Federal Domestic Assistance.
XII. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 550 contains no earmarks, limited tax
benefits, or limited tariff benefits.
XIV. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XVI. Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the Act may be cited as the
``Immunization Infrastructure Modernization Act of 2021.''
Sec. 2. Immunization Information System data modernization
and expansion
Section 2 amends the Public Health Service Act by creating
a new Section 2824 to modernize and expand IIS infrastructure.
Subsection (a) of Section 2824 requires the Secretary to
conduct activities to expand, enhance, and improve IIS
administered by health departments or other agencies of State,
local, Tribal, and territorial governments and used by health
care providers. Subsection (a) also requires the Secretary to
award grants or cooperative agreements to health departments or
other government entities to assist public health departments
in: (1) assessing current data infrastructure capabilities and
gaps among health care providers to improve and increase
consistency in patient matching, data collection, reporting,
bidirectional exchange, and analysis of immunization-related
information; (2) providing technical assistance and training to
health care providers; (3) improving secure data collection,
transmission, bidirectional exchange, maintenance, and analysis
of immunization information; (4) improving the secure
bidirectional exchange of immunization record data among
Federal, State, local, Tribal, and territorial governmental
entities and non-governmental entities; (5) supporting the
standardization of IIS to accelerate interoperability with
health information technology (IT); (6) supporting adoption of
CDC's functional IIS standards, and the maintenance of security
standards to protect individually identifiable health
information; (7) supporting and training IIS, data science, and
informatics personnel; (8) supporting real-time immunization
record data exchange and reporting to support rapid
identification of immunization coverage gaps; (9) improving
completeness of data by facilitating IIS to exchange data with
IIS in other jurisdictions; (10) enhancing the capabilities of
IIS to evaluate, forecast, and operationalize clinical decision
support tools; (11) supporting the development and
implementation of policies that facilitate complete population-
level capture, consolidation, and access to accurate
immunization information; (12) supporting the procurement and
implementation of software, hardware, and cloud storage; (13)
strengthening outbreak response capabilities; (14) improving
the management, distribution, and storage of vaccine doses and
ancillary supplies; (15) developing and disseminating
information related to the use and importance of immunization
record data and disseminating it to health care providers and
other relevant entities; and (16) supporting activities to
improve the scheduling and administration of vaccinations.
Section (a)(2) requires the Secretary to designate data and
technology standards that must be followed by governmental
entities with respect to the use of IIS as a condition of
receiving an award, and prioritizes standards developed by
consensus-based organizations with input from the public and
voluntary consensus-based bodies. The Secretary is also
required to support the independent verification of the adopted
standards.
Subsection (a)(3) authorizes the Secretary to develop and
utilize contracts and cooperative agreements for technical
assistance, training, and related implementation support.
Subsection (b) prohibits the Secretary from issuing an
award unless the applicant uses and agrees to use standards
adopted by the Secretary under Section 3004 of the Public
Health Service Act. Such prohibition can only be waived if the
Secretary determines that grant activities cannot otherwise be
carried out within the applicable jurisdiction. Subsection (b)
also includes requirements related to the application for
awards, such as a description of the activities to be carried
out under the award, and how the activities will support or
impact the public health department, and what gaps would
remain.
Subsection (c) requires the Secretary to submit, within 90
days of enactment, a coordinated strategy and implementation
plan to the House Committee on Energy and Commerce and the
Senate Committee on Health, Education, Labor, and Pensions.
Subsection (d) requires the Secretary, in developing the
strategy and implementation plan described in subsection (c),
to consult with health departments or other government entities
that administer IIS; professional medical, public health, and
pharmacist or pharmacy associations; community health centers,
long-term care facilities, and other appropriate entities that
provide immunizations; health IT experts; and other public or
private entities, as appropriate. Subsection (d) also
authorizes the Secretary to provide technical assistance,
certification, and training related to IIS information exchange
and develop public-private partnerships for implementation
support.
Subsection (e) requires the Secretary to submit, within one
year of enactment, a report to the House Committee on Energy
and Commerce and the Senate Committee on Health, Education,
Labor, and Pensions that includes a description of barriers to
the implementation of interoperable IIS, exchange of
information, or health professionals reporting to an IIS;
barriers that hinder the effective establishment of a network
to support immunization reporting and monitoring and a list of
recommendations to address such barriers; and an assessment of
immunization coverage and access to immunizations services and
any disparities and gaps in such coverage and access for
medically underserved, rural, and frontier areas.
Subsection (f) defines the term ``immunization information
system.''
Subsection (g) authorizes appropriations of $400,000,000 to
carry out the section, to remain available until expended.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italics and existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH
EMERGENCIES
* * * * * * *
Subtitle C--Strengthening Public Health Surveillance Systems
* * * * * * *
SEC. 2824. IMMUNIZATION INFORMATION SYSTEM DATA MODERNIZATION AND
EXPANSION.
(a) Expanding CDC and Public Health Department
Capabilities.--
(1) In general.--The Secretary shall--
(A) conduct activities (including with
respect to interoperability, population
reporting, and bidirectional reporting) to
expand, enhance, and improve immunization
information systems that are administered by
health departments or other agencies of State,
local, Tribal, and territorial governments and
used by health care providers; and
(B) award grants or cooperative agreements to
the health departments, or such other
governmental entities as administer
immunization information systems, of State,
local, Tribal, and territorial governments, for
the expansion, enhancement, and improvement of
immunization information systems to assist
public health departments in--
(i) assessing current data
infrastructure capabilities and gaps
among health care providers to improve
and increase consistency in patient
matching, data collection, reporting,
bidirectional exchange, and analysis of
immunization-related information;
(ii) providing for technical
assistance and the efficient enrollment
and training of health care providers,
including at pharmacies and other
settings where immunizations are being
provided, such as long-term care
facilities, specialty health care
providers, community health centers,
Federally qualified health centers,
rural health centers, organizations
serving adults 65 and older, and
organizations serving homeless and
incarcerated populations;
(iii) improving secure data
collection, transmission, bidirectional
exchange, maintenance, and analysis of
immunization information;
(iv) improving the secure
bidirectional exchange of immunization
record data among Federal, State,
local, Tribal, and territorial
governmental entities and non-
governmental entities, including by--
(I) improving such exchange
among public health officials
in multiple jurisdictions
within a State, as appropriate;
and
(II) by simplifying and
supporting electronic reporting
by any health care provider;
(v) supporting the standardization of
immunization information systems to
accelerate interoperability with health
information technology, including with
health information technology certified
under section 3001(c)(5) or with health
information networks;
(vi) supporting adoption of the
immunization information system
functional standards of the Centers for
Disease Control and Prevention and the
maintenance of security standards to
protect individually identifiable
health information;
(vii) supporting and training
immunization information system, data
science, and informatics personnel;
(viii) supporting real-time
immunization record data exchange and
reporting, to support rapid
identification of immunization coverage
gaps;
(ix) improving completeness of data
by facilitating the capability of
immunization information systems to
exchange data, directly or indirectly,
with immunization information systems
in other jurisdictions;
(x) enhancing the capabilities of
immunization information systems to
evaluate, forecast, and operationalize
clinical decision support tools in
alignment with the recommendations of
the Advisory Committee on Immunization
Practices as approved by the Director
of the Centers for Disease Control and
Prevention;
(xi) supporting the development and
implementation of policies that
facilitate complete population-level
capture, consolidation, and access to
accurate immunization information;
(xii) supporting the procurement and
implementation of updated software,
hardware, and cloud storage to
adequately manage information volume
and capabilities;
(xiii) supporting expansion of
capabilities within immunization
information systems for outbreak
response;
(xiv) supporting activities within
the applicable jurisdiction related to
the management, distribution, and
storage of vaccine doses and ancillary
supplies;
(xv) developing information related
to the use and importance of
immunization record data and
disseminating such information to
health care providers and other persons
authorized under State law to access
such information, including payors and
health care facilities; or
(xvi) supporting activities to
improve the scheduling and
administration of vaccinations.
(2) Data standards.--In carrying out paragraph (1),
the Secretary shall--
(A) designate data and technology standards
that must be followed by governmental entities
with respect to use of immunization information
systems as a condition of receiving an award
under this section, with priority given to
standards developed by--
(i) consensus-based organizations
with input from the public; and
(ii) voluntary consensus-based
standards bodies; and
(B) support a means of independent
verification of the standards used in carrying
out paragraph (1).
(3) Public-private partnerships.--In carrying out
paragraph (1), the Secretary may develop and utilize
contracts and cooperative agreements for technical
assistance, training, and related implementation
support.
(b) Requirements.--
(1) Health information technology standards.--The
Secretary may not award a grant or cooperative
agreement under subsection (a)(1)(B) unless the
applicant uses and agrees to use standards adopted by
the Secretary under section 3004.
(2) Waiver.--The Secretary may waive the requirement
under paragraph (1) with respect to an applicant if the
Secretary determines that the activities under
subsection (a)(1)(B) cannot otherwise be carried out
within the applicable jurisdiction.
(3) Application.--A State, local, Tribal, or
territorial health department applying for a grant or
cooperative agreement under subsection (a)(1)(B) shall
submit an application to the Secretary at such time and
in such manner as the Secretary may require. Such
application shall include information describing--
(A) the activities that will be supported by
the grant or cooperative agreement; and
(B) how the modernization of the immunization
information systems involved will support or
impact the public health infrastructure of the
health department, including a description of
remaining gaps, if any, and the actions needed
to address such gaps.
(c) Strategy and Implementation Plan.--Not later than 90 days
after the date of enactment of this section, the Secretary
shall submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a coordinated
strategy and an accompanying implementation plan that
identifies and demonstrates the measures the Secretary will
utilize to--
(1) update and improve immunization information
systems supported by the Centers for Disease Control
and Prevention; and
(2) carry out the activities described in this
section to support the expansion, enhancement, and
improvement of State, local, Tribal, and territorial
immunization information systems.
(d) Consultation; Technical Assistance.--
(1) Consultation.--In developing the strategy and
implementation plan under subsection (c), the Secretary
shall consult with--
(A) health departments, or such other
governmental entities as administer
immunization information systems, of State,
local, Tribal, and territorial governments;
(B) professional medical, associations,
public health associations, and associations
representing pharmacists and pharmacies;
(C) community health centers, long-term care
facilities, and other appropriate entities that
provide immunizations;
(D) health information technology experts;
and
(E) other public or private entities, as
appropriate.
(2) Technical assistance.--In connection with
consultation under paragraph (1), the Secretary may--
(A) provide technical assistance,
certification, and training related to the
exchange of information by immunization
information systems used by health care and
public health entities at the local, State,
Federal, Tribal, and territorial levels; and
(B) develop and utilize public-private
partnerships for implementation support
applicable to this section.
(e) Report to Congress.--Not later than 1 year after the date
of enactment of this section, the Secretary shall submit a
report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives that includes--
(1) a description of any barriers to--
(A) public health authorities implementing
interoperable immunization information systems;
(B) the exchange of information pursuant to
immunization records; or
(C) reporting by any health care professional
authorized under State law, using such
immunization information systems, as
appropriate, and pursuant to State law; or
(2) a description of barriers that hinder the
effective establishment of a network to support
immunization reporting and monitoring, including a list
of recommendations to address such barriers; and
(3) an assessment of immunization coverage and access
to immunizations services and any disparities and gaps
in such coverage and access for medically underserved,
rural, and frontier areas.
(f) Definition.--In this section, the term ``immunization
information system'' means a confidential, population-based,
computerized database that records immunization doses
administered by any health care provider to persons within the
geographic area covered by that database.
(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $400,000,000,
to remain available until expended.
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