Immunization Infrastructure Modernization Act of 2021

IIB 117TH CONGRESS 1ST SESSION H. R. 550 IN THE SENATE OF THE UNITED STATES DECEMBER 1, 2021 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Public Health Service Act with respect to immunization system data modernization and expansion, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 2 HR 550 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Immunization Infra- 2 structure Modernization Act of 2021’’. 3 SEC. 2. IMMUNIZATION INFORMATION SYSTEM DATA MOD- 4 ERNIZATION AND EXPANSION. 5 Subtitle C of title XXVIII of the Public Health Serv- 6 ice Act (42 U.S.C. 300hh–31 et seq.) is amended by add- 7 ing at the end the following: 8 ‘‘SEC. 2824. IMMUNIZATION INFORMATION SYSTEM DATA 9 MODERNIZATION AND EXPANSION. 10 ‘‘(a) EXPANDING CDC AND PUBLIC HEALTH DE- 11 PARTMENT CAPABILITIES.— 12 ‘‘(1) IN GENERAL.—The Secretary shall— 13 ‘‘(A) conduct activities (including with re- 14 spect to interoperability, population reporting, 15 and bidirectional reporting) to expand, enhance, 16 and improve immunization information systems 17 that are administered by health departments or 18 other agencies of State, local, Tribal, and terri- 19 torial governments and used by health care pro- 20 viders; and 21 ‘‘(B) award grants or cooperative agree- 22 ments to the health departments, or such other 23 governmental entities as administer immuniza- 24 tion information systems, of State, local, Tribal, 25 and territorial governments, for the expansion, 26 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 3 HR 550 RFS enhancement, and improvement of immuniza- 1 tion information systems to assist public health 2 departments in— 3 ‘‘(i) assessing current data infrastruc- 4 ture capabilities and gaps among health 5 care providers to improve and increase 6 consistency in patient matching, data col- 7 lection, reporting, bidirectional exchange, 8 and analysis of immunization-related infor- 9 mation; 10 ‘‘(ii) providing for technical assistance 11 and the efficient enrollment and training of 12 health care providers, including at phar- 13 macies and other settings where immuniza- 14 tions are being provided, such as long-term 15 care facilities, specialty health care pro- 16 viders, community health centers, Feder- 17 ally qualified health centers, rural health 18 centers, organizations serving adults 65 19 and older, and organizations serving home- 20 less and incarcerated populations; 21 ‘‘(iii) improving secure data collection, 22 transmission, bidirectional exchange, main- 23 tenance, and analysis of immunization in- 24 formation; 25 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 4 HR 550 RFS ‘‘(iv) improving the secure 1 bidirectional exchange of immunization 2 record data among Federal, State, local, 3 Tribal, and territorial governmental enti- 4 ties and non-governmental entities, includ- 5 ing by— 6 ‘‘(I) improving such exchange 7 among public health officials in mul- 8 tiple jurisdictions within a State, as 9 appropriate; and 10 ‘‘(II) by simplifying and sup- 11 porting electronic reporting by any 12 health care provider; 13 ‘‘(v) supporting the standardization of 14 immunization information systems to accel- 15 erate interoperability with health informa- 16 tion technology, including with health in- 17 formation technology certified under sec- 18 tion 3001(c)(5) or with health information 19 networks; 20 ‘‘(vi) supporting adoption of the im- 21 munization information system functional 22 standards of the Centers for Disease Con- 23 trol and Prevention and the maintenance 24 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 5 HR 550 RFS of security standards to protect individ- 1 ually identifiable health information; 2 ‘‘(vii) supporting and training immu- 3 nization information system, data science, 4 and informatics personnel; 5 ‘‘(viii) supporting real-time immuniza- 6 tion record data exchange and reporting, 7 to support rapid identification of immuni- 8 zation coverage gaps; 9 ‘‘(ix) improving completeness of data 10 by facilitating the capability of immuniza- 11 tion information systems to exchange data, 12 directly or indirectly, with immunization 13 information systems in other jurisdictions; 14 ‘‘(x) enhancing the capabilities of im- 15 munization information systems to evalu- 16 ate, forecast, and operationalize clinical de- 17 cision support tools in alignment with the 18 recommendations of the Advisory Com- 19 mittee on Immunization Practices as ap- 20 proved by the Director of the Centers for 21 Disease Control and Prevention; 22 ‘‘(xi) supporting the development and 23 implementation of policies that facilitate 24 complete population-level capture, consoli- 25 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 6 HR 550 RFS dation, and access to accurate immuniza- 1 tion information; 2 ‘‘(xii) supporting the procurement and 3 implementation of updated software, hard- 4 ware, and cloud storage to adequately 5 manage information volume and capabili- 6 ties; 7 ‘‘(xiii) supporting expansion of capa- 8 bilities within immunization information 9 systems for outbreak response; 10 ‘‘(xiv) supporting activities within the 11 applicable jurisdiction related to the man- 12 agement, distribution, and storage of vac- 13 cine doses and ancillary supplies; 14 ‘‘(xv) developing information related 15 to the use and importance of immunization 16 record data and disseminating such infor- 17 mation to health care providers and other 18 persons authorized under State law to ac- 19 cess such information, including payors 20 and health care facilities; or 21 ‘‘(xvi) supporting activities to improve 22 the scheduling and administration of vac- 23 cinations. 24 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 7 HR 550 RFS ‘‘(2) DATA STANDARDS.—In carrying out para- 1 graph (1), the Secretary shall— 2 ‘‘(A) designate data and technology stand- 3 ards that must be followed by governmental en- 4 tities with respect to use of immunization infor- 5 mation systems as a condition of receiving an 6 award under this section, with priority given to 7 standards developed by— 8 ‘‘(i) consensus-based organizations 9 with input from the public; and 10 ‘‘(ii) voluntary consensus-based stand- 11 ards bodies; and 12 ‘‘(B) support a means of independent 13 verification of the standards used in carrying 14 out paragraph (1). 15 ‘‘(3) PUBLIC-PRIVATE PARTNERSHIPS.—In car- 16 rying out paragraph (1), the Secretary may develop 17 and utilize contracts and cooperative agreements for 18 technical assistance, training, and related implemen- 19 tation support. 20 ‘‘(b) REQUIREMENTS.— 21 ‘‘(1) HEALTH INFORMATION TECHNOLOGY 22 STANDARDS.—The Secretary may not award a grant 23 or cooperative agreement under subsection (a)(1)(B) 24 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 8 HR 550 RFS unless the applicant uses and agrees to use stand- 1 ards adopted by the Secretary under section 3004. 2 ‘‘(2) WAIVER.—The Secretary may waive the 3 requirement under paragraph (1) with respect to an 4 applicant if the Secretary determines that the activi- 5 ties under subsection (a)(1)(B) cannot otherwise be 6 carried out within the applicable jurisdiction. 7 ‘‘(3) APPLICATION.—A State, local, Tribal, or 8 territorial health department applying for a grant or 9 cooperative agreement under subsection (a)(1)(B) 10 shall submit an application to the Secretary at such 11 time and in such manner as the Secretary may re- 12 quire. Such application shall include information de- 13 scribing— 14 ‘‘(A) the activities that will be supported 15 by the grant or cooperative agreement; and 16 ‘‘(B) how the modernization of the immu- 17 nization information systems involved will sup- 18 port or impact the public health infrastructure 19 of the health department, including a descrip- 20 tion of remaining gaps, if any, and the actions 21 needed to address such gaps. 22 ‘‘(c) STRATEGY AND IMPLEMENTATION PLAN.—Not 23 later than 90 days after the date of enactment of this sec- 24 tion, the Secretary shall submit to the Committee on En- 25 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 9 HR 550 RFS ergy and Commerce of the House of Representatives and 1 the Committee on Health, Education, Labor, and Pen- 2 sions of the Senate a coordinated strategy and an accom- 3 panying implementation plan that identifies and dem- 4 onstrates the measures the Secretary will utilize to— 5 ‘‘(1) update and improve immunization infor- 6 mation systems supported by the Centers for Dis- 7 ease Control and Prevention; and 8 ‘‘(2) carry out the activities described in this 9 section to support the expansion, enhancement, and 10 improvement of State, local, Tribal, and territorial 11 immunization information systems. 12 ‘‘(d) CONSULTATION; TECHNICAL ASSISTANCE.— 13 ‘‘(1) CONSULTATION.—In developing the strat- 14 egy and implementation plan under subsection (c), 15 the Secretary shall consult with— 16 ‘‘(A) health departments, or such other 17 governmental entities as administer immuniza- 18 tion information systems, of State, local, Tribal, 19 and territorial governments; 20 ‘‘(B) professional medical associations, 21 public health associations, and associations rep- 22 resenting pharmacists and pharmacies; 23 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 10 HR 550 RFS ‘‘(C) community health centers, long-term 1 care facilities, and other appropriate entities 2 that provide immunizations; 3 ‘‘(D) health information technology ex- 4 perts; and 5 ‘‘(E) other public or private entities, as ap- 6 propriate. 7 ‘‘(2) TECHNICAL ASSISTANCE.—In connection 8 with consultation under paragraph (1), the Secretary 9 may— 10 ‘‘(A) provide technical assistance, certifi- 11 cation, and training related to the exchange of 12 information by immunization information sys- 13 tems used by health care and public health enti- 14 ties at the local, State, Federal, Tribal, and ter- 15 ritorial levels; and 16 ‘‘(B) develop and utilize public-private 17 partnerships for implementation support appli- 18 cable to this section. 19 ‘‘(e) REPORT TO CONGRESS.—Not later than 1 year 20 after the date of enactment of this section, the Secretary 21 shall submit a report to the Committee on Health, Edu- 22 cation, Labor, and Pensions of the Senate and the Com- 23 mittee on Energy and Commerce of the House of Rep- 24 resentatives that includes— 25 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 11 HR 550 RFS ‘‘(1) a description of any barriers to— 1 ‘‘(A) public health authorities imple- 2 menting interoperable immunization informa- 3 tion systems; 4 ‘‘(B) the exchange of information pursuant 5 to immunization records; or 6 ‘‘(C) reporting by any health care profes- 7 sional authorized under State law, using such 8 immunization information systems, as appro- 9 priate, and pursuant to State law; or 10 ‘‘(2) a description of barriers that hinder the 11 effective establishment of a network to support im- 12 munization reporting and monitoring, including a 13 list of recommendations to address such barriers; 14 and 15 ‘‘(3) an assessment of immunization coverage 16 and access to immunizations services and any dis- 17 parities and gaps in such coverage and access for 18 medically underserved, rural, and frontier areas. 19 ‘‘(f) DEFINITION.—In this section, the term ‘immuni- 20 zation information system’ means a confidential, popu- 21 lation-based, computerized database that records immuni- 22 zation doses administered by any health care provider to 23 persons within the geographic area covered by that data- 24 base. 25 VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS 12 HR 550 RFS ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 1 carry out this section, there is authorized to be appro- 2 priated $400,000,000, to remain available until ex- 3 pended.’’. 4 Passed the House of Representatives November 30, 2021. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 06:03 Dec 03, 2021 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H550.RFS H550 pbinns on DSKJLVW7X2PROD with BILLS