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Immunization Information Systems (IIS)








Meaningful Use and Immunization Information Systems						Print
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			EHR-MU IncentivesLimits of IIS RolePreparing for MURelated ActivitiesResources
		
Meaningful Use of Electronic Health Record Systems
One of the stated goals of the American Reinvestment & Recovery Act (ARRA or “the Stimulus Package”), enacted in February 2009, is to increase the “meaningful” use of Electronic Health Record (EHR) systems among medical providers. The Centers for Medicare and Medicaid Services (CMS) established an incentive program using ARRA funds to encourage eligible providers and hospitals to adopt and use EHR systems.
For specific information on CMS’ incentive program, see Overview EHR Incentive Programs.
For information on how to prepare for meaningful use, see Preparing IIS for Meaningful Use.
For information on related projects, see Interoperability Projects.Public Immunization Information Systems and EHR-MU Incentives
To receive EHR-MU incentives, participating providers and facilities must meet various operational and public health criteria established by CMS with the Office of the National Coordinator for Health Information Technology (ONC). The incentives will be released in three stages over several years. The immunization-specific criteria for meaningful use have been finalized for Stage 1 and are under development for Stages 2 and 3.
Stage 1
To qualify for stage 1 incentives participating providers and facilities must meet one of three public health criteria. One available criterion is to test, and if successful, establish a connection from the EHR to the IIS in the provider’s jurisdiction. (Note that either a successful or a failed test is acceptable for Stage 1 incentives.)
For EHRs to be able to connect to an IIS, providers must adopt, implement, or upgrade their EHR to ONC-certified software capable of communicating using the Health Level 7 (HL7) standard protocol version 2.3.1 or 2.5.1. Once the upgraded EHR software is in place, the IIS must have the capacity to accept connections and the necessary local implementation guidelines that govern IIS data exchange (see below). The local implementation guide establishes the interoperability requirements that are specific to each IIS.
Stage 2
The final rules for Meaningful Use Stage 2 were published in the Federal Register on September 4, 2012. Among the significant provisions in this new rule are the endorsement of a single standard, HL7 2.5.1, for all immunization messages submitted from EHR systems to IIS, and the requirement for “ongoing submission” of production immunization data (as opposed to test data) to an IIS. Eligible Hospitals and Providers will begin attesting to Stage 2 Meaningful Use in January, 2014. The complete text of the Final Rule can be found at the following links:
CMS: Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2
ONC: Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information TechnologyStage 3
Neither the calendar nor the exact content of the rules for Stage 3 have yet been set. It is currently anticipated that Stage 3 will begin in 2016. CMS stated in the Stage 2 Final Rule, that “Stage 3 is likely to enhance [immunization] functionality to permit clinicians to view the entire immunization registry/immunization information system record and support bi-directional information exchange.”
Questions on meaningful use implementation should be referred to CMS Regional Offices [3 pages]  or  Frequently Asked Questions EHR Incentive Programs.
Eligible providers/hospitals desiring more information on MU implementation should see the CMS EHR Incentive Program or contact their State Medicaid office.
Limits of Public Immunization Program’s Role in EHR-MU
The EHR-MU program is under the auspices of the Centers for Medicare and Medicaid Services (CMS).
Meaningful Use does NOT create a mandate for Public Immunization Programs to:
Set or clarify MU standards. The standards have been created by the Office of the National Coordinator (ONC), and only ONC can interpret its intention in the standards.
Certify providers as meeting any MU standard. ONC/CMS determine eligibility for incentive payments, and providers are required to self-certify as having met ONC’s standards. Public Health’s sole role is maintaining the IIS and providing the Local Implementation Guide to delineate data exchange standards.
Certify or promote any EHR product as MU-ready. This certification is done by the Authorized Testing and Certifying Bodies (ATCBs) approved by ONC.
Adapt its immunization registry (IIS) to accommodate non-standard (i.e. other than HL7 2.3.1 or HL7 2.5.1) Electronic Health Record (EHR) submissions. MU specifically requires that the EHR product be certified. However, certification alone does not guarantee successful interoperation. Public Health still has the responsibility to set the standards for data exchange to its IIS in order to maintain the quality of IIS data.
Support the installation or configuration of any EHR. This is the vendor’s role.Top of Page
Preparing IIS for Meaningful Use
Provide an HL7 Local Implementation Guide
EHR vendors and users will need the immunization registry’s HL7 Local Implementation Guide. CDC has developed templates to assist local and state programs in the development of this document. Along with this Guide, a standard methodology for testing and approving providers for data exchange with the IIS should be developed.
Review System Capacity
The issue of server capacity and network bandwidth to handle the increased IIS usage created by the new meaningful users must be considered. Systems that adequately support current IIS workload may be challenged with increased demand. Partial funding support for system capacity upgrades may be available through Medicaid Health Information Technology (HIT) initiatives for implementation and technical support, so the Immunization Program and the State Medicaid offices are encouraged to establish a close collaboration.For information on other potential funding sources, see the CMS Whitepaper on Funding Immunization Registries [11 pages].
Verify Use of ONC-Certified EHR Software
Meaningful Use requires use of an Office of the National Coordinator (ONC)-certified Electronic Health Record (EHR) system. While the IIS may choose to establish data exchange with non-certified providers for programmatic/public health reasons, such exchange does not qualify the provider for MU incentives. For details, see the ONC Certified Health IT Product List (CHPL).
Test Messages
Once a provider has an ONC-certified system, a test message needs to be sent to the immunization registry. That test message may succeed or fail. ONC certification is not a guarantee of interoperability with any specific IIS, as local regulations or standards may still require additional configuration. See the NIST Immunization Test Suite for information and access to NIST tools, developed in collaboration with CDC, that support a broad range of immunization testing, including transport, HL7 messaging, and functional capabilities.Related Activities
Immunization Information Systems Support Branch (IISSB) encourages grantees to work with viable Health Information Exchange (HIE) initiatives to seek areas of potential synergy. There is no doubt that a successful HIE could be a valuable partner in supporting Immunization Program efforts to maintain high levels of protection against vaccine preventable diseases with immunization information and a fully functional IIS. It is important to ensure that as these initiatives grow, the vital functionality provided by your IIS is neither compromised nor diminished.
While the level of pressure varies greatly, some grantees have also reported expectations to contribute some measure of IIS financial support to the HIE effort. In this light IISSB has compiled a list of known federal grants and cooperative agreements issued for the development of HIE infrastructure over the past four years, which indicates that over $1.5 billion has been awarded to the states or territories for HIE development.
It may be appropriate to explore with some of the recipients of HIE development funds whether they might be able to support partnerships with IIS in which they assist in connecting more providers and provider networks to the IIS. Grantees established IIS, experience with data quality and clinical workflow, may well be valuable assets to developing HIE networks.
See HIE Funding Summary [2 pages] for a list of known federal grants and cooperative agreements that have been awarded.
Important Resources
CDC MU
CMS MU
ONC Final Rule
ONC ATCB
ONC-certified EHRsTop of Page
							
					
							Last Reviewed:  October 3, 2022						Source: 	National Center for Immunization and Respiratory Diseases
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