1. Interoperability Workgroup Governance Subgroup September 19, 2014 Christoph Lehmann, Co-Chair Carol Robinson, Co-Chair

2. Agenda Revised ONC ask Discussion 2

3. Revised Ask With only two calls remaining before the Subgroup reports to the Interoperability and HIE Workgroup we have scaled back the ask to the Subgroup to two key questions. We request you use the next two calls to deliberate and come to consensus on responses to these two essential questions. – Will continuing with the current governance approach ONC has taken ensure the community can fully achieve the three year goal of providers and patients being able to send, find, receive and use a basic set of essential health information across the health care continuum? – Which governance-focused actions should the government take in order to best protect the public interest, including improving health care, improving the health of the public, and reducing costs in immediate future? 3

4. Three Year Interoperability Goal Ensure providers and individuals can send, receive, find and use a basic set of essential health information.* *ONC has suggested the basic set of essential health information should be the common MU data set 4

5. ONC Current Governance Approach ONC’s current approach to governance has been very light touch and has included – Convening – Guidance – Grant making – Communication 5

6. Question 1 Context Pockets of interoperability exist today where stakeholders have come together and agreed upon interoperability standards and a governance approach to oversee exchange. The three year goal is aimed at scaling interoperability and governance across the nation (ie, across organizations and networks) so that patients and providers can send, find, receive and use a basis set of essential health information across the health care continuum. Question 1 Will continuing with the current governance approach ONC has taken enable the community to reach the three year goal of providers and patients being able to send, find, receive and use a basic set of essential health information across the health care continuum? 6

7. Varying Roles Of Government in HIE Governance Where is ONC Now? Where Should ONC Be in the Future? Market participant Market maker and convener Orchestrator/ regulator Designer, implementer, and funder Gov’t exerts influence through its market participation Connection to DoD/VA/IHS with Direct and open FHIR API and XCA Ongoing collaboration among public and private entities ONC focus on coordination of federal activities with guidance from FACAs “Bottom-up” Less gov’t intervention “Top-down” More gov’t intervention Gov’t actively convenes, jump-starts, and facilitates market-based mechanisms Organize and possibly contract for SDOs or other market collaborative initiatives to launch standards, policies, and coordination mechanisms ONC selectively seed market activities to fill specific gaps ONC, with FACA guidance, determine market gaps and selectively fill Gov’t regulates HIE activity through active orchestration or regulation Use incentives and/or regulations to motivate specific types of health information activity, such as certification of EHRs for Direct and open FHIR APIs and MU requirement to use for exchange ONC provides “central orchestration” functions to align various activities toward specific goals ONC formalize orchestration function on universal capabilities with FACA guidance Gov’t dictates terms of health information exchange Require use of government- sanctioned health information exchange services or infrastructure, such as require participation in Healtheway ONC creates central authority or deeming body to decide priorities and monitor/enforce compliance ??? Role Description Illustrative example of governance function Spectrum of federal government roles in HIE governance Illustrative example of organization form 7

8. Discussion 8

9. Question 2 Which governance-focused actions should the government take in order to best protect the public interest, including improving health care, improving the health of the public, and reducing costs in immediate future? 9

10. Potential Levers Regulatory requirements through Federal Rule or Acts of Congress Federal benefits purchaser requirements (FEHB) Federal agency requirements / incentives / penalties – As a provider (DoD, VA, HIS, etc.) – As a purchaser (CMS through state Medicaid programs: MU, 1115A waivers, 90/10 HIE funding, MMIS, etc.) – As a purchaser (CMS through Medicare: MU, conditions of participation) – As a grantor (ONC, CDC, SAMHSA, CMMI, HRSA, AHRQ, NIH, etc.) – As a regulator (FTC, CMS, CLIA, FDA, CDC, SAMHSA) – As a researcher (NIH, AHRQ, HRSA, CDC, SAMHSA, ONC, etc.) – As a health insurer Federally-developed non-regulatory tools (FAQs, best practice educational toolkits, sample implementation guides, testing suites,, etc.) Market convener (FACAs, S&I Framework etc) Communications, outreach, education Provider codes of conduct Vendor codes of conduct Industry standards and compliance consortia (eg, HL7) Market influence through concentration (eg, Epic, Cerner, CMS, etc) Market collaborations (eg, CommonWell, DirectTrust, NATE, etc) Voluntary accreditation / certification programs (DirectTrust, Healtheway, IWG) Federal levers Market levers State law (MN) State agency requirements / incentives / penalties (NY, CA, Public Health Depts., Medicaid provider contracts, etc.) Voluntary accreditation / certification programs (Texas Health Services Authority, state participation in NATE) State-developed non-regulatory tools (FAQs, best practice educational toolkits, testing suites, independent audits, etc.) State levers 10

11. Discussion 11

12. Draft Workplan Governance Subgroup MeetingsTask Wednesday, July 23 rd 2:00-4:00 pm ET Review charge Governance history Action steps Friday, August 15 th 10:00am-12:00 pm ET Listening session 1 Friday, August 22 nd 10:00am-12:00 pm ET Listening session 2 Tuesday, August 26th 10:30-12:00 ET Summarize listening sessions Finalize problem list, update strawman and discuss governance goal statement Prep for HITPC presentation Wednesday, September 3 rd - HITPC Meeting Progress toward creation of a recommendation governance framework presented to HITPC Friday, September 12 th 10:30-12:30 pm ET Review HITPC discussion and update documents/plans based on feedback Deep dive on deeming program Friday, September 19 th 10:30-12:30 pm ET Review ONC questions Discussion Friday, September 26 th 10:30-12:30 pm ET Continue discussion of responses to ONC questions Finalize responses Interoperability and Health Information Exchange WG TBD Review recommendations with workgroup Wednesday, October 15 th – Joint HITPC/HITSC Meeting Final recommendations 12