Certification / Adoption Workgroup

1. Certification / Adoption Workgroup Larry Wolf, chair Marc Probst, co-chair February 14, 2014

2. Agenda • Review of Agenda • HITPC Charge: Step Two • Continued discussion of proposed Behavioral Health IT certification criteria • Next Steps • Public Comment

3. Updated Call Schedule

4. Behavioral Health EHR Certification Draft Recommendations Proposed LTPAC EHR

5. Medication-related ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification • The majority of ineligible behavioral health providers do not have prescribing authority, however psychiatrists, psychiatric nurse practitioners and psychologists in some states are prescribers • Behavioral health organizations providing integrated primary care will also need med-related functionality in their EHRs. • A ‘prescriber’ module could be useful to address this diversity ONC 2014 ed. CC: § 170.314(b)(3) – Electronic Prescribing § 170.314(a)(10) – Drug-formulary Checks § 170.314(a)(2) – Drug-drug, drug-allergy interaction checks § 170.314(a)(16) – eMAR (inpt) • Support the ability for a user to electronically create and transmit prescriptions/rx-related information. • Support ability to automatically and electronically check whether a drug formulary exists for a given patient or med. • Support ability to enable drug-drug and drug-allergy interaction checks. • Support electronic medication administration record.

6. CPOE ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification • The majority of ineligible behavioral health providers do not have prescribing authority, however psychiatrists, psychiatric nurse practitioners and psychologists in some states are prescribers • Ineligible BH providers typically do not rely on labs test or radiology. However, eligible BH providers (psychiatrists and psychiatric nurse practitioners do and there are ineligible BH providers who capture lab tests for urinalysis and other purposes. ONC 2014 ed. CC: § 170.314(a)(1) – Computerized provider order entry • Support the ability to electronically record, change, and access the following order types: Medications; Laboratory; and Radiology/imaging.

7. Patient Engagement BH Hearing Testimony Proposed Areas for BH Certification ONC Certification Criteria to Support “Patients should have the opportunity to review and correct their records.” “Certification and interoperability could greatly help patients to understand their addictions. Rigorous quantification of data across the longitudinal dimension would be very helpful in showing patients how the development of the disease affects their behavior.” • Support the ability to be able to electronically retrieve patient-specific education from content/ knowledge resources • Support the ability to provide secure online access to health information for patients and authorized representatives to electronically view, download their health information in accordance with the CCDA standard and transmit such information using ONC specified transport specs. • Support the ability to enable a user to create a clinical summary in accordance with the CCDA standard in order to provide it to a patient. • Support the ability to use secure electronic messaging to communicate with patients on relevant health information. ONC 2014 ed. CC: § 170.314(e)(2) - Clinical summary (amb menu) § 170.314(a)(15) – Patient-specific education resources § 170.314(e)(1) - View, download, & transmit to 3rd party § 170.314(e)(3) - Secure messaging

8. Labs/Imaging ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification “Our experience is that medical doctors are mostly interested in receiving information from behavioral health providers on medications, diagnoses, and repeat labs.” • Ineligible BH providers typically do not rely on labs test or radiology. However, eligible BH providers (psychiatrists and psychiatric nurse practitioners do and there are ineligible BH providers who capture lab tests for urinalysis and other purposes. • A labs and imaging module would be useful to address this diversity among BH providers ONC 2014 ed. CC: § 170.314(b)(5) - Incorporate lab tests & values/results § 170.314(b)(6) - Transmission of electronic lab tests & values/ results to ambulatory providers § 170.314(a)(12) - Image results • Support the ability for an ambulatory setting to be capable of electronically receiving, incorporating, and displaying clinical lab tests and values/results. • Support the ability for an inpatient setting to be able to generate lab test reports for e-transmission to ambulatory provider’s EHR systems. • Support the ability to electronically indicate to a user the availability of a patient’s images and narrative interpretations (relating to the radiographic or other diagnostic test(s)) and enable electronic access to such images and narrative interpretations.

9. Usability and Safety ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification BH providers expressed “the need for usable systems that support workflow.” “We do not believe that there should be a voluntary certification process for system usability. We do recognize that usability of EHRs and other electronic health information systems is important, however, usability is somewhat subjective.” ONC 2014 ed. CC: § 170.314(g)(3) – Safety-enhanced design § 170.314(g)(4) – Quality management system • Support user-centered design processes which must be applied to each capability an EHR technology includes that is specified in the following medication-related ONC certification criteria: CPOE, DD/DA interaction checks, med list, med allergy list, CDA, eMAR, eRx, and clinical info reconciliation. • Supports the requirement that developers must indicate the Quality Management System (QMS) used in the development, testing, implementation and maintenance of each capability of an EHR technology for which certification is sought.

10. BH Setting Specific CriteriaPatient Assessments Standards to Support BH Hearing Testimony Proposed Areas for BH Certification “Regarding BH clients, different code sets and assessments are required.” “There are current challenges with comparative data elements.. The “average” number of data elements collected during the intake to treatment planning process is 1,750 to 2,100. In one state alone, 1800 different diagnostic assessment forms styles or versions are in use.” “States have differing requirements for collecting and reporting standardized assessments for BH.” HL7 Implementation Guide for CDA® Release 2: Patient Assessments, Release 1 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=21 HL7 Version 3 Domain Analysis Model: Summary Behavioral Health Record, Release 1 – US Realm https://www.hl7.org/implement/standards/product_brief.cfm?product_id=307 • Support the ability to create, maintain, and  transmit (in accordance with federal and state requirements) assessment instruments and data sets for Behavioral Health. (e.g. ASAM Patient Placement Criteria (PPC), Child and adolescent functional assessment scale (CAFAS)) FUTURE WORK- Expand upon the existing standards to develop relevant certification criteria for this purpose.

11. Data Portability ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification Not highlighted during the BH hearing ONC 2014 ed. CC: § 170.314(b)(7)-Data portability • Support ability to electronically create a set of export summaries on all patients, formatted in accordance with the CCDA.

12. Example of Modular Certification Program A INTEROPERABILITY B PRIVACY AND SECURITY C PATIENT ASSESSMENTS D PATIENT COMMUNICATION • Psychologists- A, B, C, D, E, G, I, J, K • Psychiatrists- A, B, C, D, E, F, G, H, I, J, K • Housing and Urban Development- A, B E CLINICAL QUALITY MEASUREMENT F LABS AND IMAGING G CLINICAL DECISION SUPPORT H PRESCRIBING I CONSENT MANAGEMENT J CLINICAL HEALTH INFORMATION K USABILITY AND SAFETY L DATA PORTABILITY

13. Consideration of other potential criteria • Collecting vital signs • Vital signs, BMI, & growth charts § 170.314(a)(4) • Implementing advanced directives • Advance directives § 170.314(a)(17) • Psych-related advance directives

14. Appendix Behavioral Health EHR Certification Hearing Summary of Testimony Received LTPAC Hearing

15. BH Hearing Summary • Strong support for interoperability • Concerns about compliance with confidentiality requirements • Need to balance need for information with privacy • Varying views on stigma • Some concerns about the cost of certification • Support for a modular program with flexibility to meet the needs of diverse provider types • Some dichotomy between vendor/provider comments: vendors cautioning restraint, providers supporting more robust system to help … • Need for alignment with MU but focus only on critically relevant to BH.

16. BH Hearing Summary Cont. Testimony on Setting-Specific Criteria: • Addressing needs while minimizing burden • Utility for setting standards that can ultimately foster reduced reporting burden/alignment across state and federal programs • Should enable increased clarity and consistency regarding standards

17. BH Hearing Summary cont. • Value of Behavioral Health Certification: • “Has the potential to improve care and care delivery within the practice setting for a variety of stakeholders—including providers, patients, and more.” • Would allow BH providers to collaborate more effectively with primary care by selecting a system that is truly interoperable. • “Currently, no guidance on available EHR products have features that would make them well-suited for BH.” • While these products are available in the marketplace—and are being purchased by BH providers—the systems' appropriateness for BH settings are unclear to policymakers and the public. • Guidance by the ONC through a certification process could serve to demonstrate these products' suitability for our members. • Provides a mechanism for SAMHSA to verify that EHRs purchased using federal funds meet a core set of standards and are interoperable with those being adopted by the broader healthcare system.

18. BH Hearing Summary • Focus on addressing need of BH while minimizing burden and cost • Alignment of standards to foster reduced reporting burden/alignment across state and federal programs • Key themes • Strong support for interoperability • Systems needed to support compliance with confidentiality requirements (balance privacy with integration) • BH setting specific needs (e.g., consent management, assessments, DSM code set issues, group therapy ) • Support for a modular program with flexibility to meet the needs of diverse provider types

19. Appendix Behavioral Health EHR Certification Criteria Reviewed on February 7thC/A WG Call LTPAC Hearing

20. Interoperability BH Hearing Testimony ONC Certification Criteria to Support Proposed Areas for BH Certification “Interoperability is critical – many providers in multiple settings involved in a patient’s care” “Implement a cert program for BH EHRs that identifies that they meet interoperability standards /criteria required for MU providers” “The high prevalence of comorbid conditions among BH patients dictates the need for sharing information and interoperability” “Interoperability is crucial - availability of information with these transitions in care may prevent adverse events and facilitate better determination on level of care, which contributes to faster stabilization and decreased readmission rates.” ONC 2014 ed. CC: § 170.314(b)(1) & (2) - Transitions of care § 170.314(b)(4) - Clinicalinformation reconciliation • Support the ability to receive, display, incorporate, create and transmit summary care records with a common data set in accordance with the Consolidated Clinical Document Architecture (CCDA) standard and using ONC specified transport specifications. • Support the ability of a user to electronically reconcile the data that represent a patient’s active medication, problem, and medication allergy list. • Support the inclusion of emerging TOC  and care planning standards being reconciled as part of Aug. HL7 CCDA ballot  [MUWG-identified MU 3 criteria]. Potential Use Cases: Sharing information between providers (primary use case), with social services to enable service coordination (e.g., criminal justice, HUD) , Standardization of mechanisms; Transitions of Care; Clinical information Reconciliation criteria

21. Privacy and Security ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification • Federal laws protect the confidentiality of substance abuse treatment data • Approximately half of states have similar laws protecting the confidentiality of MH information • Need for EHR systems to support compliance with these laws: • Consent management • Standards for communicating consent obligations • Controlling redisclosure of information • Consent requirements, including the need to name specific providers or provider organizations in the consent are presenting a barrier to HIE • Support for granular data segmentation when standards are ready ONC 2014 ed. CC: § 170.314(d)(1) - Authentication, Access Control, and Authorization § 170.314(d)(2) - Auditable Events and Tamper-Resistance § 170.314(d)(3) - Audit Report(s) § 170.314(d)(4) - Amendments § 170.314(d)(5) - Automatic Log-Off § 170.314(d)(6) - Emergency Access § 170.314(d)(7) - End-User Device Encryption § 170.314(d)(8) - Integrity § 170.314(d)(9) – Optional: Accounting of Disclosures • Support existing ONC-certified Privacy and Security requirements: § 170.314(d)(1)-(9). • Support inclusion of standards for communicating privacy policies (HL7 Privacy and Security classification system) and controlling redisclosure of protected data. FUTURE WORK: • ONC should consider supporting equivalent functionality in MU 3 for standards for communicating privacy policies and controlling redisclosure of protected data. • Incorporate granular data segmentation when ready.

22. BH Setting Specific CriteriaConsent Management Standards to Support BH Hearing Testimony Proposed Areas for BH Certification • Federal laws protect the confidentiality of substance abuse treatment data • Approximately half of states have similar laws protecting the confidentiality of MH information • Need for EHR systems to support compliance with these laws and to enable automated consent management • Electronic signatures • Standards for collecting and communicating consent policies • Standards for communicating privacy obligations HL7 Healthcare Privacy and Security Classification System, Release 1 http://www.hl7.org/Special/committees/secure/index.cfm HL7 Data Segmentation for Privacy (DS4P) Implementation Guide http://www.hl7.org/special/committees/projman/searchableprojectindex.cfm?action=edit&ProjectNumber=1006 HL7 Implementation Guide for CDA®, Release 2: Consent Directives, Release 1 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=280 Support the following functionality: • Use of the HL7 privacy and security classification system to tag records to communicate privacy related obligations with the receiver. FUTURE WORK: Develop consensus on standards for consent management functionality needed by BH providers to comply with diverse federal and state confidentiality laws

23. Clinical Health Information ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification “Our experience is that medical doctors are mostly interested in receiving information from behavioral health providers on medications, diagnoses, and repeat labs.” Another panelist indicated his “agreement on the need for medication information.” ONC 2014 ed. CC: § 170.314(a)(3) - Demographics § 170.314(a)(5) - Problem list § 170.314(a)(6) - Medication list § 170.314(a)(7) - Med allergy list § 170.314(a)(13) - Family health history § 170.314(a)(11) - Smoking status *§ 170.314(a)(9) - Electronic notes *§ 170.314(a)(9) - Patient lists • Support the ability to record, change, and access the following data using ONC specified standards: • Demographics • Problem list • Medication list • Medication allergy list • Family health history • Smoking status • Support the ability for a user to electronically record, change, access, and search electronic notes. • Support ability to electronically and dynamically select, sort, access, and create patient lists. • FUTURE WORK: ONC should consider including DSM-5 standards.

24. Clinical Decision Support ONC Certification Criteria to Support BH Hearing Testimony Proposed Areas for BH Certification “The last certification level we recommend is around Clinical Decision Support (CDS).” “The most needed function is linking the CDS software to managed care, primary care, and EDs.” “There is a strong need for standardization, since CDS support mechanisms can help spur the use of EHRs as well as eliminate more labor-intensive capacity management processes, such as the use of spreadsheets to track referrals and waiting lists.” ONC 2014 ed. CC: § 170.314(a)(8) - Clinical Decision Support Support the ability to have: • Evidence-based decision support • Linked referential clinical decision support • Clinical decision support configuration • Automatically and electronically interact • Source attributes

25. Clinical Quality Measures ONC Certification Criteria & Standards to Support BH Hearing Testimony Proposed Areas for BH Certification “A Certification Program that supports the ability of an EHR to track and report on Clinical Quality Measures (related to behavioral health) would provide BH providers a position in their medical neighborhood that assures they can work with other organizations and focus on the same goals and population management activities.” • There are currently 14 BH related CQMs in MU2 but they primarily focus on primary care based behavioral health services ONC 2014 ed. CC: §170.314(c)(1)-(3) – Clinical quality measures Note: Criteria C1 (capture and export) and C2 (import and calculate) are core functions. C3 (report) is relating to CMS reporting. FUTURE WORK: C/A Workgroup requested that HITPC Quality Measures WG discuss clinical quality measures further and provide recommendations to C/A WG on potential LTPAC/BH CQM opportunities for EHR certification.