Negotiating One of the Largest HIE Agreements in History March 2, 2016 Patrick S. Cross, Faegre Baker Daniels Jeffrey W. Short, Hall Render Killian Health & Lyman
Conflict of Interest Neither speaker has any real or apparent conflict of interest to report
Agenda Introductions History of Indiana Network for Patient Care and Indiana Health Information Exchange Legal and Market Evolution Legal and Market Context Contract Terms and Legal Issues Key Incentives/Drivers in Healthcare Market Discussion of 2010 Negotiations Discussion of Key Health Information Exchange Business and Legal Issues
Learning Objectives Define key legal issues in a HIE participation agreement Explain sensible, middle-of-the road positions for agreement upon key legal issues in HIE participation agreements Analyze lessons learned from the Indiana Health Information Exchange s multi-party contract negotiations
An Introduction of How Benefits Were Realized for the Value of Health IT This presentation will demonstrate the treatment/clinical value step by reviewing the positive impact that health information exchange can have on treatment and clinical interactions
Introductions Patrick S. Cross Partner at Faegre Baker Daniels Represents Indiana Health Information Exchange Jeffrey W. Short Shareholder at Hall, Render, Killian, Heath & Lyman, P.C. Represents numerous Indiana healthcare providers that participate in IHIE
Legal and Market Evolution 1972 Wishard adopts Regenstrief Medical Records System (RMRS) Legal and Market Context First EHR System Contract/Legal Issues
Legal and Market Evolution 1989 IU Hospital adopts Regenstrief Medical Records System Legal and Market Context COBRA 89 Contract/Legal Issues Clinical and Technology Issues Outweigh Legal Issues
Legal and Market Evolution 1994 Regenstrief receives National Library of Medicine Grant for data sharing between Community East Hospital and Methodist Hospital Legal and Market Context Clinton Health Security Act; Medicaid Managed Care Contract/Legal Issues Data sharing between unaffiliated entities (i.e., no university ties)
Legal and Market Evolution 1998 Wishard Hosp., Methodist Hosp., IU Medical Group, Clarian Hosp., St. Vincent Hosp., Community Hosp., St. Francis Hosp. and Regenstrief sign Founding Agreement for ER Data Sharing Legal and Market Context HIPAA passed in 1996; Congress working toward 1999 privacy legislation deadline Contract/Legal Issues Data Ownership and Use Uses for Research (the primary purpose was research)
Legal and Market Evolution 2001 ER and Research Uses are operational Legal and Market Context HIPAA Security Regulations and Guidance Issued Contract/Legal Issues Management Committee begins to address HIPAA compliance
Legal and Market Evolution 2004 IHIE Incorporated (Feb) Agreement revised to address HIPAA 15 Participating Hospitals Legal and Market Context ONC Established (July) Contract/Legal Issues Access and use obligations Termination rights Dealing with research Adding Participants
Legal and Market Evolution 2006 Discussion to share data with Payors (ACO-like, Medical Home-like opportunities) Legal and Market Context EHR Donation Regulations (2007 - IRS permits if data is shared) Contract/Legal Issues Expanding Use Cases
Legal and Market Evolution 2007 Suburban Health Signs to permit members to join IHIE Quality Health First Launched Legal and Market Context Movement towards pay-forvalue Contract/Legal Issues Complexity of Governance
Legal and Market Evolution 2008 First Payor Joins Quality Health First Legal and Market Context Contract/Legal Issues Participation Agreement allows data sharing with payors IHIE signs DUA to receive Medicare claims data
Legal and Market Evolution 2009 Revise Participation Agreement to allow new members to join Quality Health First enrolls in Medicare 646 Demonstration Project Legal and Market Context ARRA/HITECH Contract/Legal Issues
Legal and Market Evolution 2010 New Fee Model and Revised Governance Structure (everyone does not have a seat at the table) IHIE Receives a Beacon Agreement for $16 million Legal and Market Context Affordable Care Act First MU Year Contract/Legal Issues Representative Governance Model IHIE Takes on Full Operational Responsibility and Research is handled as a disclosure Research Opt-Out Liability Issues
Legal and Market Evolution 2011 New Agreement signed with over 100 Participants (May 31 ) Legal and Market Context Contract/Legal Issues
Legal and Market Evolution Legal and Market Context Contract/Legal Issues 2012 - Present Shared Savings Program kicks-off and Quality Health First comes to an end as MSSP grows Close to 90% of Indiana Hospitals participating ACO Final Regulations Meaningful Use Number of approved use cases rapidly increases as incentives change
Key HIE Issues Governance Liability Research and Secondary Uses Privacy and Security Value Proposition / Fees / Sustainability
Governance How do we address early adopters and their capital investment? What are the appropriate representative groups to elect the representative board? How can we efficiently elect representatives to the board? What are the potential conflicts of interest and how can we anticipate and attempt to avoid them? What will be the budget and fee-setting process and required approvals? What are the data use cases and what will be the process to evolve data use cases?
Liability What liability and indemnification obligations will the HIE have to participants? What liability and indemnification obligations will each member have to all other members? How will liability and indemnification by third-party vendors be addressed?
Research and Secondary Uses What level of control does each participant have over their contributed data? Who will review and approve proposed research and secondary uses of data? Will each member have the right to opt-in or opt-out of their contributed data being used for research and secondary uses?
Privacy and Security What are the terms of the HIE s business associate agreement? What is required for the proposed data use cases and how will this be managed? How will violations of the privacy and security protocols be addressed? What happens if there is a data breach?
Value Proposition / Fees / Sustainability How does the governance model address the various groups and their respective value proposition for participating in the HIE? How are budgets and fees set and approved and do members have a circuit breaker for fee increases? Does the structure need to address a run for the door and, if so, how is it addressed?
A Summary of How Benefits Were Realized for the Value of Health IT This presentation also demonstrates the electronic secure data value step by discussing the important privacy and security considerations that arise in negotiating a health information exchange participation agreement
Questions Patrick S. Cross patrick.cross@faegrebd.com 317.569.4844 Jeffrey W. Short jshort@hallrender.com 317.977.1413