1. Care Coordination and Interoperable Health IT Systems
Unit 7: Policy and Interoperable Health IT
Lecture b – Meaningful Use, ONC Certification, and Interoperability (Part 1)
Welcome to Care Coordination and Interoperable Health IT Systems, Policy and Interoperable Health IT, Lecture b.
This material (Comp 22 Unit 7) was developed by Columbia University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number 90WT0004.
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2. Policy and Interoperable Health IT Learning Objectives
Objective 1: List and discuss the impact of key health interoperability related topics in health care legislation (Lecture a)
Objective 2: Identify and discuss how the Meaningful Use program and the ONC certification programs have impacted interoperable health IT (Lectures b and c)
Objective 3: Assess and leverage Meaningful Use, ONC certification, and other health IT policy activities to facilitate interoperability (Lecture d)
This unit will cover the following learning objectives: 1) List and discuss the impact of key health interoperability related topics in health care legislation; 2) Identify and discuss how the Meaningful Use program and the ONC certification programs have impacted interoperable health IT; and 3) Assess and leverage Meaningful Use, ONC certification, and other health IT policy activities to facilitate interoperability. This lecture will focus on the initial regulations from 2011 to 2015 and how they have impacted interoperability.

3. Meaningful Use (MU) and Stage 1
Mostly in the past
ONC 2011 certification of EHRs
Eligible providers and eligible hospitals attest to meet certain objectives using ONC 2011 certified EHRs.
There are many objectives, so for more information on the full list of Stage 1 Objectives, go to component 1
Meaningful Use and ONC certification has been covered in other units and in other components so you may be familiar with Meaningful Use already and if covered in another component. Note that the CMS EHR Incentive Program required the Meaningful Use of Certified EHR technology in a staged approach starting with the easiest requirements (Stage 1) through the most difficult (Stage 3). ONC published regulations specifying certification requirements and standards requirements for certified health information technology to be used with each of the stages of meaningful use. ONC 2011 certified systems were used with Stage 1. Although Stage 1 and ONC 2011 Certification are now mostly in the past, it is still good to understand how they improved interoperability. You might recall that eligible hospitals and eligible providers were required to implement electronic health records. To be able to meet the MU Stage 1 requirement for the EHR incentive program, the EHRs that were implemented had to be certified based on the ONC 2011 certification regulation. The eligible hospitals and eligible providers were required to utilize the EHR to meet certain objectives. For a complete list of the objectives and for more information on Meaningful Use in general, please go to component one. But let’s look at some of the stage 1 objectives and see how they impact interoperability.
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4. Examples of MU Stage 1 objectives and interoperability
Prescribe medications electronically
Provide patients with an electronic copy of their health information upon request
Provide patients with a clinical summary of their office visit
Maintain an active medication list
Test capability to exchange key clinical information among care providers and patient-authorized entities
Test capability to submit electronic data to immunization registries
Send patient reminders
Collect information in the EHR to calculate quality measures
This slide shows a subset of the Stage 1 objectives. One objective was that providers needed to electronically prescribe medications. A prescription was written directly into the EHR and then was automatically sent to a pharmacy by using an interoperability standard called NCPDP script. Providers no longer had to write paper prescriptions and there was an electronic recording of the prescriptions in the EHR. It was convenient for the patients because they no longer had to take a piece of paper to the pharmacy, and as a result more medications were filled promptly. E-prescribing showcased the true benefit of interoperability. Another objective was that providers had to provide patients with an electronic copy of their health information upon request. It could be on a USB drive, but the point is, if a patient requested it, the provider had to provide it in an electronic standard format. This could help if a patient moved and needed to see another primary care provider and would have liked to give them a copy of their medical record. Another objective that overlapped with the objective in which patients were provided an electronic copy of their data was the objective in which providers had to provide patients with a clinical summary of their visit, in any format – even paper was acceptable. Both of these objectives began to change health care workflow and culture in preparation for interoperability between providers and patients. By providing even paper clinical summaries to patients, providers were getting used to giving patients their data and patients were starting to learn that they had a right to their information. And patients were able to take their summaries along with them when they went to other doctors. This helped start a culture change, although there is still room for improvement, towards transparency and patient engagement. Providers also had to maintain an active medication list. So whatever medications the patient was on, they had to record them. This is critical for interoperability since before you can share information, you need to have it collected in an accessible format. Additionally, the providers had an option to perform medication reconciliation, which means to compare medications that the patient was taking before they saw the provider and what they would be receiving from the provider. The medication reconciliation could be done manually, but it would have had to been recorded electronically. Medication reconciliation helped prepare for an interoperable health IT because it got providers used to using the EHR as a care coordination tool, comparing information received externally from information that the provider authored. Another example of an objective and its effect on improving interoperability is more explicit. Providers had to test their EHRs’ capability to exchange key clinical information among care providers and patient-authorized entities. Another clear example of underlying interoperability in Stage 1 was to test their capability to submit electronic data to immunization registries. Although these were just testing functionalities, it helped to start lay the foundation for interoperability. Another example is to send patient reminders either via , paper, or phone. The reminder had to be of clinical relevance to the patient. If this was done electronically, this would enhance interoperability because it is an exchange of data, like appointments and scheduling, between systems. This was a simple, yet effective example of the importance of workflows and that they were starting to come into place. Finally, the EHR had to collect information that could be used for quality measures. This was an improvement because beforehand, this was normally done manually via chart abstractions. There are many Stage 1 Meaningful Use objectives, but here we have highlighted several that had interoperability implications.
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5. ONC 2011 regulation standards
Terminology
Problem list: ICD-9; SNOMED-CT
Procedures: ICD-9 procedures; CPT4
Laboratory results: LOINC
Medications: any source vocabulary in RxNorm
Immunizations: HL7 Standard Code Set CVX - Vaccines Administered
Race and ethnicity: Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity
Privacy and security
Encryption and decryption of electronic health information: any encryption algorithm identified by NIST as an approved security function in Annex A of the Federal Information Processing Standards (FIPS) Publication 140-2
For data exchange: any encrypted and integrity protected link
Verification that electronic health information has not been altered in transit: SHA-1 (Secure Hash Algorithm (SHA-1) or alternative equal in greater in strength
With certification of EHRs, there were standards that were included in the ONC 2011 regulation. Here we just list the standards, but if you would like more information on standards, see unit 5 and component 9. There were standards for terminology, privacy and security, and data exchange. On this slide, we list the regulation standards for terminology and privacy security.
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6. ONC 2011 regulations standards: data exchange
Patient Summary Record Standard: HL7 CCD HITSP C32 or ASTM CCR
Electronic Prescribing: NCPDP SCRIPT Version 8.1 or Version 10.6
Electronic Submission of Lab Results to Public Agencies: HL7 Version Implementation Guide: Electronic Lab Reporting to Public Health, R1
Electronic submission to immunization registries: HL Implementation Guide for Immunization Data Transactions using or HL Implementation Guide for Immunization Messaging Release 1.0
Quality Reporting: CMS Physician Quality Reporting Initiative (PQRI) 2009 Registry XML Specification and PQRI Measure Specifications Manual for Claims and Registry
On this slide, we list the ONC 2011 regulations standards for data exchange. By requiring that EHRs use standards, data began to be structured and standardized so that sharing would be easier. With Meaningful Use Stage 1 and the requirements for ONC 2011 certified EHRs, providers and hospitals began to adopt standards for interoperability.
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7. How did Stage 1 help with interoperability?
Certified EHRs were implemented
Certain data needed for sharing was now regularly collected as structured data
Some public health interfaces were built
Patients were provided with a way to electronically access their data
There was widespread adoption of some standards useful for interoperability
The objectives we discussed may have seemed simple on the surface, but they laid the foundation and exhibited the importance of interoperability. Where providers and hospitals did not have EHRs before, they now could have implemented certified EHR systems. Interoperability requires data to be regularly collected and structured and EHRs provided the means. As the result of sharing data, some public health interfaces were built. Importantly, patients were provided a way to electronically access their data. And there was some widespread adoption of some standards useful for interoperability – most notably, NCPDP Script for e-Prescribing.
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8. Yes (ambulatory setting only)
Stage 2 objectives related to interoperability and patient-centered care
Functionality
Is it a Meaningful Use Stage 2 objective?
Is it an ONC 2014 certification criteria?
Viewing, downloading, and transmitting to a 3rd party
Yes
Secure messaging
Yes (ambulatory setting only)
Sending clinical summary to patient portal
Now let’s move on to Stage 2 and its impact on interoperability with patients. The ONC regulation that supported the certified health IT for Stage 2 was referred to as ONC 2014 certified technology. Eligible hospitals and eligible providers now had to implement ONC 2014 certified technology and attest to a more advanced set of objectives. Lets look at the ones related to patient centered care. First of all, many of the Stage 1 “menu” objectives that related to patient engagement now became required, such as giving patients education materials and sending patients reminders. Stage 2 also added several other related objectives. First, was the ability to view, download, and transmit data to a third party. This means that eligible providers and eligible hospitals needed to give patients access to their data electronically. The data would go to a patient portal, the patient had to be able to access it, and be able to view, download, and / or transmit the data to a third party if they wanted to do so. Second, was the sending of secure messages between providers and to patients. This objective only applied to the ambulatory care setting. Third, instead of giving a paper clinical summary, it was now electronic.
7.2 Table (Lorenzi, V., 2016)
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9. Stage 2 objectives related to interoperability and care coordination
Functionality
Is it a Meaningful Use Stage 2 objective?
Is it an ONC 2014 certification criteria?
Creating and transmitting care summaries for transitions of care / referrals
Yes
Receiving and displaying care summaries for transitions of care / referrals No
Transmitting electronic lab results to ambulatory providers
Yes (menu)
E-prescribing
Yes (eligible providers only)
Performing clinical reconciliation
Yes (medications only)
Yes (medications, problems, and allergies)
From a care coordination interoperability perspective, there were some other key Stage 2 objectives. ONC 2014 certified EHRs provided the ability to reconcile problems and allergies in addition to medications. Eligible hospitals and eligible providers were required to do medication reconciliation (note that this was only a menu option in Stage 1). However, they did not yet have to reconcile allergies and problems even though their EHR supported the functionality. We discussed clinical summaries and how they are important for transitions of care. Providers in hospitals now had to create, transmit, and send clinical summaries to the next provider of care for 10% of their transitions. Although that does not sound like a lot, it was for those who were not doing that before and for EHR vendors, who had to support the ability to receive and display care summaries for a care transition and referral. Another objective was to transmit electronic lab results from a hospital lab to an ambulatory provider. Therefore, lab results were getting structured and electronic. The e-prescribing requirement’s threshold increased from Stage 1 and became an optional objective for inpatient EHRs. So here we see care coordination being better supported through Meaningful Stage 2 objectives and ONC 2014 criteria related to interoperability.
7.3 Table (Lorenzi, V., 2016)
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10. Stage 2 objectives related to interoperability and the learning health system
Functionality
Is it a Meaningful Use Stage 2 objective?
Is it an ONC 2014 certification criteria?
Transmitting syndromic surveillance information to public health authority
Yes (menu only for eligible providers)
Yes
Transmitting reportable lab results to public health authority
Yes (eligible hospitals only)
Transmitting to immunization registries
Reporting of cancer cases
Yes (menu)
Submitting electronically of clinical quality measures No
Using InfoButton query for clinical decision support
There were also some criteria to support the learning health system through public and population health. This required public health authorities to support interoperability, as well as eligible providers and eligible hospitals, to enter into active engagement with their public health authorities working at building the required interoperability functionality. Thanks to Meaningful Use, information that is useful to public and population health was now being shared with public health authorities and with registries. To learn more about public health interoperability standards, please see component 13. Stage 1 had begun the work of capturing quality information electronically and producing electronic quality measures and beginning to report these electronically in some cases. Stage 2 built on the progress of Stage 1 now supporting more clinical quality measures and a richer, higher, encoded, structured standard format to electronically produce and potentially e-submit the measurement data to the government on both the summary and patient level. Additionally, clinical decision support informed by knowledge sources was included, where if a provider wanted to know more about a patient’s diagnosis, problem, and best practices, they could click an Infobutton. The Infobutton would display the results of a query of a knowledge resource and return information for the provider, as well as for patient education. For example, a query based on a patient’s diagnosis could be made to the National Library of Medicine’s knowledge source called MedLinePlus that would return information about the diagnosis, what symptoms to expect, what good self-care would entail, and what treatments were common.
7.4 Table (Lorenzi, V., 2016)
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11. Advanced standards named in ONC 2014 certification criteria
Demographics: Language ISO639-2, CDC Race and Ethnicity Value Sets
Problem List and Encounter Diagnoses: SNOMED-CT July 2012 and ICD-10
Medications and Medication Allergies: RxNorm
Medication Allergy List: RxNorm
Smoking Status: SNOMED-CT
Lab Results: LOINC, UCUM units of measure, SNOMED organisms, HL7 V2 Lab Results Interface Implementation Guide, HL7 V2 Reportable Results Implementation Guide
Transitions of Care and Patient Engagement: All terminology standards, required as well as C-CDA and NHIN Transport standards; No more CCR or CCD (CCD subsumed in CCDA)
CQMs – electronic submission: QRDA Level 2 and 3 and NHIN Transport Standards (no more PQRS layout)
Public Health: HL7 V.5.1 implementation guides for immunization and syndromic surveillance and HL7 V3 Cancer CDA spec
Infobutton: HL7 V3 Context Specific Knowledge Query
Family History: HL7 V3 or SNOMED-CT
Now moving on to standards, the ONC 2014 required health IT standards, which is key for scaling interoperability because information should be exchanged in a structured, standard format. Because of the requirement from ONC 2014 criteria, standards were being adopted in a more widespread way. Let’s talk about some of the standards required and some of them are here on the slide as examples; most of which are terminology standards. Most of these ONC 2014 standards are new for vendors and providers because they were not required in Stage 1. For more information on standards for health care interoperability, please see unit 5.

12. Stage 2 interoperability efforts / challenges for providers and hospitals
Mapping patient information to data standards
Mapping internal terminologies to standard terminologies
Testing implementation for all types of patient encounters and different data types
Analyzing referral and transition patterns
Identifying data exchange and transition of care partners
Encouraging patients to log into patient portal, view their data, and send secure messages to providers
Educating clinicians
Enhancing clinician workflows
Testing content and send / receipt methods with each partner due to CCDA variances
Resolving privacy / consent issues with sending data to transition of care providers and / or to patient portals
Having a short timeline for implementation
Having multi-site hospital networks and physician organizations at multiple stages
Being audited for Stage 1 while working on Stage 2
Stage 2 interoperability was hard because of the implementation work. On this slide is a list of challenges and efforts for providers and hospitals. These include mapping to standards, conducting numerous implementation tests, identifying partners, encouraging patients and providers, and multi-tasking during a short timeline with multiple stakeholders in different stages. There were many challenges, one of which was that many vendors were not able to certify for Stage 2, and so providers could not use them. So implementing certified technology for Stage 2 was difficult to achieve in the timeframe proposed. Therefore, there were flexibility options in 2014 that allowed some providers to meet meaningful use with Stage 1 objectives and ONC 2011 certified technology. In 2015, vendors and providers continued to struggle, especially since the measurements were now going to be done on a year’s worth of data which proved harder to achieve. Providers especially struggled with the interoperability related objectives. Then in October 2015, CMS published a regulation that both defined Stage 3 but also defined a modified version of Stage 2 that took some immediate pressure off the hospitals and doctors by reducing and focusing objective requirements for the immediate timeframe and then signaling threshold increases over time.
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13. Interoperability accomplishments from 2011 and 2014 ONC criteria regulations
Vendors were tested and certified to have standards-based interoperability functionality
Even functions that were not directly related to exchange proved to be foundational
ONC included additional interoperability functionality not yet required
However, despite the challenges, there were some accomplishments for interoperability. Vendors were being tested and certified to have interoperability functionality based on standards. ONC 2014 certification requirements made vendors adopt many more health IT standards that were also more robust than what was available in the past. Even functions that were not directly related to data exchange proved to be foundational. For example, ensuring that important data types were collected and stored on the EHR in a structured format. This was a key prerequisite for data exchange. Workflow and culture began to change to support care coordination and patient centered care and population health. To prepare for the future, ONC criteria regulations included additional interoperability functionalities that were not yet required by Meaningful Use to help phase the advancements towards interoperability.
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14. Unit 7: Policy and Interoperable Health IT, Summary – Lecture b, Meaningful Use, ONC Certification, and Interoperability (Part 1)
Stage 1 of Meaningful Use helped lay the foundation for interoperability by encouraging the implementation of EHRs, which could regularly collect structured data for exchange
It also encouraged adoption of standards that supported interoperability for patient-centered care, public and population health, care coordination and a learning health system
Although there were challenges with Stage 2, interoperability has become increasingly important and incorporated into Meaningful Use
This concludes Lecture b of Policy and Interoperable Health IT. In this lecture, we focused on the original policies from 2011 to 2015 that are related to interoperability. To summarize, Stage 1 of Meaningful Use helped lay the foundation by encouraging the implementation of EHRs, which could regularly collect structured data for exchange. Stage 1 encouraged the adoption of standards, which is key to scale interoperability and ultimately for supporting patient-centered care, public and population health, care coordination, and the ONC vision for a learning health system. Stage 2 built on this foundation adding many new standards requirements and key objectives to support interoperability with patients and to support care coordination and to start lay a foundation of interoperability to support a learning health system. Although there were challenges with Stage 2, it played a key role in improving healthcare interoperability in the United States.

15. Policy and Interoperable Health IT References – Lecture b
Hillestad, R, Bigelow, JH, Fonkych, K, Bower, AG, Fung, C, Wang, J, Taylor, R, Girosi, F, Meili, RC, & Scoville, R. (2006). Health information technology, can HIT lower costs and improve quality? RAND Research Brief.
MedLinePlus.
Charts, Tables, and Images
7.2 Table: Lorenzi, V. (2016). Stage 2 objectives related to interoperability and patient-centered care.
7.3 Table: Lorenzi, V. (2016). Stage 2 objectives related to interoperability and care coordination.
7.4 Table: Lorenzi, V. (2016). Stage 2 objectives related to interoperability and the learning health system.
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16. Unit 7: Policy and Interoperable Health IT, Lecture b – Meaningful Use, ONC Certification, and Interoperability
This material was developed by Columbia University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number 90WT0004.
No audio.