1. North Carolina Health Information Exchange Governance Workgroup Date: February 1, 2011 Time: 10:00 am – 12:00 pm Location: Conference Call ONLY Dial in: 1-866-922-3257; Participant Code: 654 032 36#

2. 2 Agenda TopicLeadsTime Welcome Roll call Co-Chairs10:00-10:10 Update on Statewide HIE Progress Discuss Relaunch of Workgoup Co-Chairs10:10-10:30 Approach to Statewide HIE – Qualified OrganizationsManatt10:30-11:15 Approach to Statewide HIE – Participation AgreementsManatt11:15-11:30 Enforcement and OversightManatt11:30-11:45 Public CommentN/A11:45-12:00

3. 3 Recap and Relaunch

4. 4 Progress to Date North Carolina HIE Strategic and Operational Plans Approved In October 2010, ONC formally approved NC’s HIE Strategic and Operational Plans North Carolina can now access funding for implementation NC HIE to serve as North Carolina’s “State Designated Entity” On December 22, Governor Perdue issued Executive Order #73 which identified the NC HIE as North Carolina’s State-Designated Entity, replacing the Health and Wellness Trust Fund Commission. New HIE Activities In December 2010, planning begins on a pilot project to deliver lab results to EHRs using specifications developed under federal government’s “Direct Project” In January 2011, ONC awards NC HIE a $1.7 million Challenge Grant to deploy medication management services

5. 5 Relaunching the Governance Workgroup What remains the same... Workgroup still the forum for updating stakeholders, identifying priorities, getting feedback, building consensus, and making recommendations to the board on governance matters. Core workgroup membership Workgroup supported by Manatt What has changed.... New Staff: NC HIE staffing has expanded with the addition of interim Chief Information Officer New Tasks: (1) develop recommendations for Qualified Organizations for NC HIE participation, (2) develop written participation agreements, (3) assist in development of goals, objectives and performance measures for the exchange of health information. New Roles and Responsibilities: Continued HIE implementation progress depends upon delivery of key decisions and deliverables on schedule.

6. 6 Governance of Statewide HIE in North Carolina

7. 7 The Approved Operational Plan...Foundation for Statewide HIE Vision Vision Statement: The NC HIE, a public/private collaboration, will provide a secure, sustainable technology infrastructure to support the real time exchange of health information to improve medical decision-making and the coordination of care to improve health outcomes and control health care costs for all residents of North Carolina. Governance Model and Guiding Principles Public-Private Partnership model to govern HIE Statewide HIE governance entity may serve operator role (i.e., contract with vendors for and manage services to be utilized by all HIEs across the state) Recommendations Related to Bylaws Board Composition and Nomination Process State Role in NC HIE and Board Selection Process Transparency and Conflict of Interest Participation Approach Commitment to “no provider left behind” Qualified Organization model for participation in statewide HIE Key principles to inform the development of qualified organization criteria and creation of participation agreements

8. 88 Statewide HIE Infrastructure...Vision and 2011 Goals The Foundation of Trust Fundamentally (either through incentives or what we know to be good practice of care) providers and hospitals will be exchanging more protected health information electronically with an expanding array of external entities. Participants will exchange data only if they can trust their trading partners. By the end of 2011, NC HIE's core infrastructure will provide the technical tools and policy mechanisms to have the foundation of trust in place. Trust will be based on a clear understanding of: (1) who is on the exchange; (2) participants’ conformance to agreed upon policies and standards, and (3) the mechanisms for oversight and enforcement.

9. 9 Statewide HIE Governance...Primary Tasks 1. Who Will Participate in Statewide HIEStatus 1. Participation Model Board determined participation to be voluntary Board determined that participation would be through “Qualified Organizations” 2. Definition of Qualified Organization Board approved definition of a Qualified Organization Board approved principles for Qualified Organizations 3. Candidates for Qualified Organizations Board identified candidate types of organizations 4. Criteria for Qualified Organizations  To be developed 2. Rules and Policies for ParticipationStatus 1. Participation Mechanism Board determined that Qualified Organizations must sign a participation agreement with NC HIE 2. Terms and Conditions  To be developed and informed by Legal/Policy and Clinical/Technical Operations Workgroups 3. Enforcement and OversightStatus 1. Enforcement Approach Board determined that there will be a process and policies established for ongoing oversight 2. Enforcement and Oversight Roles and Responsibilities  To be developed 3. Enforcement and Oversight Mechanisms  To be developed

10. 10 Statewide HIE Governance...Timelines & Interdependencies JanFebMarAprMayJunJul Develop Qualified Org Criteria Qualified Organizations Participation Agreements Develop Participation Agreement Tasks Legal/Policy Workstream Finalize draft legislation 2011 Enforcement and Oversight Define Oversight Roles and Enforcement Mechanisms Develop RFPReview, Negotiate, Award Core Services Deploy Services Develop Privacy and Security Policy and Procedures

11. 11 Approach to Statewide HIE – Qualified Organizations

12. 12 Qualified Organizations Goals for Today’s Discussion Review agreed-upon principles Identify threshold questions for Qualified Organization concept Begin to develop recommendations regarding criteria for qualified organizations

13. 13 Principles to Guide Development of Qualified Organizations 1.Workgroup recommends a Qualified Organization approach to participation in the NC statewide HIE. 2.The NC HIE should establish an application process for organizations that wish to participate as a Qualified Organizations. The Statewide HIE will need to verify Qualified Organizations (through a structured review or accreditation process). 3.Qualified Organizations will have a participation agreement/contract with the Statewide HIE, binding participants to compliance with the Statewide HIE’s policy guidance and rules and there will also be policies and processes in place to identify “bad actors” and terminate their participation. Accountability and enforcement of policies must be central in implementing this model. 4.Accepted Qualified Organizations would be able to connect to the Statewide HIE to access core and value-added services.

14. 14 5.Participation in the Statewide HIE will be voluntary. If an organization elects to withdraw its participation, they will be subject to reasonable withdrawal rules and processes. 6.Statewide policy would include application process, privacy and security rules, technical rules, financial rules, vendor contract requirements, ongoing governance structure and participation and enforcement mechanisms. 7.The Statewide HIE should have a commitment to a principle of “ No Provider Left Behind ” and provide reasonable alternate pathways for eligible providers that are not part of a Qualified Organization to be able to participate. 8.The Workgroup recommends that the Clinical/Technical Operations and Finance Workgroups explore including an internet-based connection portal that clinicians could access in cases where participating through another Qualified Organization is not a possibility and suggested that the NC HIE should consider partnering with the Regional Extension Center for identification and outreach of those providers. Principles to Guide Development of Qualified Organizations

15. 15 Key Questions for Qualified Organizations & Participants 1.What is a Qualified Organization? 2.What are the value and benefits of the Qualified Organization approach? 3.What are the criteria for being a Qualified Organization? 4a. How do Qualified Organizations participate in statewide HIE? 4b. How do providers or organizations unaffiliated with a Qualified Organization participate in statewide HIE? 5. What are a Qualified Organization and/or Participant’s responsibilities as a participant in statewide HIE? 6. How much does it cost to participate in statewide HIE? 7. What happens if a Qualified Organization or participant withdraws from participation in statewide HIE?

16. 16 1. What is a Qualified Organization? A Qualified Organization is a health care organization or aggregator of organizations that is capable of fulfilling the technical, legal, policy, and procedural obligations defined by the Statewide HIE, and willing to enter a binding contract with the Statewide HIE that specifies these requirements and the legal consequences entailed therein. Qualified Organizations may be, but are not limited to: –Provider Networks Hospitals Health systems Integrated delivery networks (IDNs) Provider groups Consortia of providers FQHCs/RHCs Public Health Regional HIOs – Private Networks Clearinghouses Pharmacy Vendor Lab enterprise – Medicaid Network – Payors

17. 17 2. What are the value & benefits of the Qualified Organization approach? From the NC HIE Operational Plan: The qualified organization approach allows for flexibility and for organizations to emerge as provider aggregators as the HIE market evolves, presenting important benefits for North Carolina, including: –Efficiency and cost savings from aggregation of providers and data –Support for innovation in the marketplace and the emergence of new partnerships and collaboration –Leverages existing private and public infrastructure and investments among health care organizations –Responsiveness to North Carolina’s complex health care landscape What are the benefits of being part of statewide HIE for Qualified Organizations? Facilitate satisfaction of meaningful use requirements among QOs and participants Increase access to important data at POC by enabling HIE w/ orgs outside of a QOs existing network infrastructure, more rapidly and at lower cost Offer broader referral/care coordination services to members Access to NC state government info, including Medicaid data, that will only be made available via participation in statewide HIE Lower development cost of shared services offered through participation in NC HIE (e.g., MPI, consent management.) Access to Medicaid meaningful use incentive payments Electronic access to public health data Access to best practices and learnings gathered by NC HIE Participation in the multi-state/interstate HIE and the NHIN

18. 18 CriteriaSub-elements and additional questions Governance Organization Type (require specific categories or leave open?) Participation (require specific participants or participant categories?) Documentation (proof of incorporation?) Policies (open and transparency?) Technology Exchange capabilities (required, preferred, optional?) Adherence to standards (which standards and for which use cases/services?) Connectivity (required acceptance and response to authorized requests from state HIE?) Legal Ability to enter into contracts Insurance (what forms of liability insurance?) Policy Agree to abide by and meet all applicable state and federal privacy and security laws Agree to abide by agreed upon statewide policies Financial Viability Audit (how often and by whom) Remediation (conditions for correcting “going concerns” or adverse opinions) Other Considerations Participation in statewide process (required, preferred, optional?) Economic development (require percentage of staff reside in North Carolina?) 3. What are the criteria for being a Qualified Organization?

19. 19 Key Questions for Qualified Organizations & Participants STRAWMAN 4a. How do Qualified Organizations join the Statewide HIO? Qualified Organizations must sign a participation agreement/contract with the Statewide HIO, binding them to compliance with the Statewide HIO’s policy guidance and rules Qualified Organizations must integrate with and connect to the Statewide HIO 4b. How do providers/orgs unaffiliated with a Qualified Organization connect to the NC HIE? The Statewide HIE may wish to consider options to insure every provider has access to at least one qualified organization, for example: –Requiring that a qualified organization accept any provider that applies – with possible subsidies to the participant or the qualified organization in cases where the costs exceed the provider’s ability to pay –Requiring that qualified organizations “bring on” a portion of providers who would otherwise lack access to statewide HIE (e.g. 10% of total provider participants) –Coordination with the Regional Center to identify small and solo practitioners for alignment with a qualified organization

20. 20 Key Questions for Qualified Organizations & Participants STRAWMAN 5. What are a Qualified Organization or Participant’s responsibilities as a participant in statewide HIE? –Agree to send and receive health information to and from participants in accordance with the Statewide HIE’s rules –Comply with all of the Statewide HIE’s policy guidance and rules –Enforce the Statewide HIE’s rules with all of its own members and participants, including technology vendors that it employs –Participation in governance process managed by Statewide HIE (e.g. participation in Workgroups or Advisory Bodies) –Participation in generation and evolution of technical, legal, and other policy guidance as deemed necessary by governance process

21. 21 Key Questions for Qualified Organizations & Participants STRAWMAN 6. What is the cost to participate in statewide HIE? –Pricing is still under development. The following costs are being considered at this time: Upfront connectivity costs Membership costs in proportion to the number of participants or the number of transactions Staging of costs based on which value-added services, in addition to core services, the Qualified Organization or Participant wishes to utilize –There may be subsides for Qualified Organizations that connect participants outside their typical membership profile (e.g. RHC, small provider practices, etc.) –Overall per participant costs will decrease with broader participation 7. What happens if a Qualified Organization/Participant withdraws from the Statewide HIE? –Participation in statewide HIE is voluntary –Withdrawal from participation is subject to reasonable withdrawal rules and processes

22. 22 Approach to Statewide HIE – Participation Agreements

23. 23 Participation Agreement Goals for Today’s Discussion Discuss key questions Review approach for developing participation agreements

24. 24 Key Questions for Developing Participation Agreements 1.What are the foundational policy considerations? 2.What warranties will be in place? 3.What duration? 4.Will there be different participation agreements for the development phase and operational phase?

25. 25 Approach for Developing Participation Agreements Feb-Mar... Collect and analyze state and HIOs participation agreements Mar-Apr... Develop first draft of standard participation agreement Apr-Jun...... Finalize standard participation agreement

26. 26 Enforcement and Oversight

27. 27 Enforcement and Oversight Goals for Today’s Discussion Review key considerations for enforcement and oversight Discuss other states’ approaches to enforcement and oversight.

28. 28 Key Questions for Enforcement and Oversight 1.What is the source of authority? 2.Who oversees enforcement? 3.What entities are governed and what is their scope? 4.What is the accreditation process? 5.What are the mechanisms of enforcement?

29. 29 Oversight and Enforcement... Models in Other States MinnesotaMarylandNew York Source of Authority New Statute Contracts New Statutory Authority Oversight State Commissioner of Health administers penalties & enforcement authority. In developmentState Department of Health via contracts and new regulatory authority Key Entities Certified HIOs Health Data Intermediary (HDI) Management Services Organizations (MSO) Collaborative Care Community Regional HIOs Geographic considerations No geographic boundaries Geographic boundaries defined by state Accreditation Process Statute directs MN to consider EHNAC as accreditor EHNAC designated as accrediting body for MSOs Currently via grant application process; accreditation being considered Status As of July 2010, all HIOs & HDIs must apply for Certificate of Authority First two HIOs applied for certificates in Dec 2010 Law enacted May 2009 In June 2010, Statewide HIO, CRISP, began entering into contracts with MSO In development

30. 30 Oversight and Enforcement... Oversight Straw Model for New York DOH NYeC Provides Input Statewide Collaboration Process Runs Creates Statewide Policy Guidance HIE Service Vendor Abide Statewide Policy Guidance Provider Collaborative Care Community Qualified HIT Entity Contract for care coordination support Contract for access to HIE services Contracts for statewide HIE services Contracts for access to HIE services, with reciprocating agreement to abide by Statewide Policy Guidance

31. 31 Oversight and Enforcement... Oversight Straw Model for New York HIE Service Vendor Provider Collaborative Care Community Qualified HIT Entity Contracts for access to HIE services, with reciprocating agreement to abide by Statewide Policy Guidance Contract for care coordination support Contract for access to HIE services Contracts for statewide HIE services DOH NYeC Regulates Oversight Oversees qualification process Oversight via contracts

32. 32 Public Comment

33. 33 ATTACHMENTS

34. 34 Current Landscape - Minnesota’s Approach to Qualified Entities Statewide Governance Structure The Minnesota e-Health Advisory Committee and workgroups that make policy recommendations to the Commissioner of Health State health information exchange oversight processes as established by the Commissioner of Health The State Government Health Information Technology Coordinator and Minnesota Department of Health Office of Health Information Technology that oversees the collaborative governance model, including staffing the Minnesota e-Health Advisory Committee, workgroups, and health information exchange oversight processes Roles and Relationships The legal framework for health information exchange and oversight also provides key definitions of entities participating in health information exchange activities, and outlines requirements for those providing health information exchange services. These service providers include: –Health data intermediary: an entity that provides the infrastructure to connect computer systems or other electronic devices used by health care providers, laboratories, pharmacies, health plans, third-party administrators, or pharmacy benefit managers to facilitate the secure transmission of health information, including pharmaceutical electronic data intermediaries as defined in 62J.495. This does not include health care providers engaged in direct health information exchange. –Health information organization: an organization that oversees, governs, and facilitates the exchange of health-related information among organizations according to nationally recognized standards.

35. 35 Current Landscape - Minnesota’s Approach to Qualified Entities Qualifying Criteria Minnesota Certified Health Information Organizations... –Must provide all transaction capabilities necessary to fully support meaningful use as defined by CMS and DHS –Must demonstrate compliance with requirements of certification criteria –Must interoperate with all other state-certified HIOs and state- registered HDIs. –Be compliant with criteria established under the Health Information Exchange Accreditation Commission (EHNAC) or equivalent criteria established by the Commissioner of Health –Demonstrate interoperability with all other state-certified health information organizations using nationally recognized standards –Meet the requirements established for connecting to the NHIN with the federally mandated timeline or within a timeframe established by the Commissioner of Health –Comply with specific national standards called out in law. State Certified Health Data Intermediary (HDI)... –Must be registered with the State. –Must be in compliance with state criteria for certification. –Must connect to at least one state-certified HIO

36. 36 Current Landscape - Maryland’s Approach to Qualified Entities Statewide Governance Structure Governance structure consists of the MHCC Policy Board, Board of Directors, and an Advisory Board with three committees (Exchange Technology, Clinical Excellence and Exchange Services, and Finance). Each committee has a specific set of objectives with which they are charged. Policy recommendations emerging from the Advisory Board are forwarded to the Policy Board for deliberation. The Policy Board is convened by the MHCC, acting as an oversight body to ensure that public interests remain at the forefront in all decision- making. Policies developed by the Policy Board are forwarded to the Board of Directors for implementation. The Board of Directors provides oversight to the implementation of policies and operational activities and is accountable for all aspects of the statewide HIE. The Advisory Board, Policy Board, and Board of Directors meet regularly. The statewide HIE, CRISP, operates under the oversight of an Advisory Board, which is accountable to the Board of Directors. The Advisory Board includes a diverse group of approximately 30 stakeholders to ensure that a breadth of interested organizations can make certain that the interests and perspectives of their respective constituencies are heard with respect to the HIE services. Management Service Organizations (MSOs) offer centralized administrative and hosted technology services and are considered a viable alternative to traditional EHR client-server models where the technology is maintained at the provider site. MSOs enable physicians to access patient records wherever access to the Internet exists. MSOs are capable of supporting multiple EHR products at reduced costs through economies of scale and bulk purchasing. Technical support usually extends beyond the standard business hours and in some instances is available on a 24/7 basis. Data is safeguarded through a network operating center that, by design, ensures high quality and uninterrupted service. Remotely hosted EHRs enable providers to focus on practicing medicine rather than dedicating staff to support the application and technology. 36

37. 37 Current Landscape - Maryland’s Approach to Qualified Entities 37 Qualifying Criteria Management Service Organizations must... –Offer a hosted EHR solution that is certified by a nationally recognized certifying organization. –Complete an application and self-assessment manuscript using the Criteria recognized by the MHCC. –Provide services (i.e., education, technology, support, etc.) using a workforce where at least 50 percent of the resources originate in Maryland. –Establish and maintain an active connection to the state designated health information exchange. –Agree to a bi-annual site visit. –Re-apply every two years and meet the requirements outlined in the MSO State Designation Criteria. –Support state efforts and the efforts of the state designated health information exchange in advancing health information technology consistent with the goals of the Office of the National Coordinator for Health Information Technology.