Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute David L. Johnson BioCrossroads President and CEO CTSI Annual Meeting April 19,

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute CLINICAL INFORMATION DRIVES INNOVATION The Indiana CTSI spans and strengthens health information technology (HIT) as a national research center and an Indiana signature strength At the national level, the CTSI Program is premised on the importance of electronic communication of clinical information to advance outcomes and drive research “Bioinformatics is the cornerstone of communication within the [CTSIs] and with all collaborating organizations… To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards adopted by the HHS for use in U.S. health care and public health operations.” (U.S. Department of Health and Human Services, RFA for Institutional Clinical and Translational Science Award, March 22, 2007, p. 8) HIT research is inherently translational anyway Constantly seeks to produce, transmit, aggregate and analyze more and higher quality clinical data for better and higher quality health care delivery and health outcomes

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute CLINICAL INFORMATION DRIVES INNOVATION The IUSM-led consortium won Indiana’s CTSI based, in significant measure, on Indiana’s unique strengths in developing HIT assets and applications The Regenstrief Institute (and the Indiana Health Information Exchange) The Regenstrief Center for Healthcare Engineering The IU School of Informatics Specific proposed HIT-driven collaborations with Eli Lilly and Company (disease modeling/personalized medicine) and WellPoint (drug safety and health outcomes) The CTSI is now perfectly positioned to provide and sponsor the continuing, collaborative research components essential to advance the “meaningful use” of HIT throughout the Indiana healthcare system and across the United States Tailored research on HIT standards, interoperability and quality measures Focal point for receiving federal grant funds and coordinating significant programs in comparative effectiveness and clinical effectiveness research (CER)

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute BioCrossroads: WE’RE REALLY IN THIS FOR THE DATA From the beginning, BioCrossroads has promoted strong collaborations that bring the promise of better data to healthcare delivery – and discovery BioCrossroads is Indiana’s initiative to build on our healthcare and life sciences strengths. HIT is one of our very best Indiana assets. BioCrossroads drove the structuring and formation of the Indiana Health Information Exchange in 2004, drawing upon the research strengths of the Regenstrief Institute to aggregate and analyze and transmit privacy protected patient information through the development of one of the nation’s largest and most successful regional health information networks. BioCrossroads coordinated the structuring and formation of the Fairbanks Institute for Healthy Communities in 2006, developing a multi-therapeutic platform for longitudinal studies pairing rich clinical information with clinical samples to achieve better health outcomes for communities like Indianapolis.

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute BioCrossroads: WE’RE REALLY IN THIS FOR THE DATA BioCrosroads worked closely with the IU School of Medicine, the Regenstrief Institute, Indiana University and Purdue University in pursuing the CTSI award in 2008 and in promoting the specific CTSI health outcomes collaborations with our members, Lilly and WellPoint. BioCrossroads continues to work closely today with the State of Indiana, our statewide regional health information organizations (including IHIE), IU, Purdue, the Regenstrief Institute and the Regenstrief Center for Healthcare Engineering and Ivy Tech in assisting with the structuring, formation and submission of grant proposals for ARRA funding that have so far brought over $33 million to Indiana and our HIT sector. Better data will benefit all of our stakeholders (e.g., Lilly, Cook, Roche, Clarian, Covance, Medco, WellPoint) as well as our start ups.

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Indiana is truly a national leader in HIT State’s Robust and Advanced Network Preceded Federal Reform Efforts 5 Health Information Exchange Organizations (HIOs) in Indiana –IHIE (Central), MedWeb/MIE (Northeast), MHIN (North Central), HealthLINC (Southwest), HealthBridge (Southeast) –Different but complementary structures, markets and models –Together, these HIOs cover and connect 45 hospitals, 40 outreach laboratories,12,000 physicians and 12 million patient records and generate over 6.3 million monthly results. These HIOs are innovative enterprises on the frontier of HIT service and software development The network is powered by Indiana’s premier research institutions –The Regenstrief Institute is the largest and most comprehensive medical informatics laboratory in the world

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute The Indiana landscape is conducive to achieving necessary, early success as we move to a national system flowing health information securely from coast to coast Indianapolis-based hospital systems are already freely exchanging data among one another (currently expanding across other communities throughout the state) –Indiana’s medical malpractice environment allows hospitals and physicians to securely share data more readily than most states The Indiana network has also achieved effective interstate exchange of data. –HIOs in Indiana are now exchanging messages with Kentucky, Michigan and Ohio Indiana’s privately funded collaborative model has enabled market driven advancement toward adoption and interoperability Regenstrief’s INPC repository holds promise for the types of data that can be aggregated and analyzed to generate better health outcomes –The demographics of central Indiana’s population can provide valuable insight into therapies for cardiovascular disease and metabolic disorders, as demonstrated by the work of Regenstrief and the Indiana Health Study of the Fairbanks Institute for Healthy Communities

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Indiana has already built workable, regional HIE capabilities with home-grown resources Indiana HIE was opportunistically created, privately funded, AND IS OPERATIONAL Prior to any federal funding, Indiana’s 5 HIOs have collectively invested over $52 million in innovation and implementation of HIE infrastructure and services.

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Loan Program FSSA HIE Operations Coordination, Contracting, Policy, & Certification Governance IHIT Board Patient Care Hospitals and Physicians HHS/ONC Implementation Funding 1.Build-out of required HIE capabilities and services as needed 2.Regional HIE interconnectivity forming the Indiana Health Information Network 3.Expansion to underserved areas Advisory Committees $ $ $ $ Regional Center Program Tech. Assist. Medicaid PayersState $ $ Indiana Health Information Technology, Inc. (IHIT) (CEO/ State HIT Coordinator) Policy & Standards Committee Audit, Cert., & Licensing Committee Adm& Contracting Philanthropy Labs Radiology Pharmacy Claims As needed for meaningful use (TBD) ADT Clinical Hospital Public Health Reporting Provider Desktop Office Applications EHR ePrescribing Clinical Summary (CCD) The result is a rapidly growing – and highly promising -- Indiana HIE network

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Even before the national healthcare debate began, the Federal Government had already secured HIT-enabled “healthcare reform” through ARRA stimulus funding ARRA is funding $35 billion in new programs advancing the development, adoption and use of health information technology to deliver better healthcare for hospitals, doctors and patients across the United States. The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the ARRA, promotes the adoption and meaningful use of health information technology to: –Develop electronic patient records, report test results, prescribe medicines, record doctor visits, and –Exchange clinical information among each provider of care for every patient. Currently fewer than 20% of physicians and fewer than 10% of hospitals employ even basic electronic health records for their practices and patients, but this will change… –Incentives, and ultimately penalties, have been put in place to drive adoption and meaningful use of electronic health records (EHRs) Eligible professionals will receive up to $44,000 over 5 years from Medicare or up to $63,750 over 6 years from Medicaid Hospitals are eligible for incentive payments from both Medicare and Medicaid Failure to achieve meaningful use brings reimbursement penalties, starting 2015

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute HIT enabled healthcare reform will improve healthcare quality, safety and efficiency driving toward Meaningful Use* (MU) of HIT HITECH Policies Meaningful Use Criteria 2015 MU Criteria Promote improvement in quality, safety and efficiency, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data and improving population health 2013 MU Criteria Encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible 2011 MU Criteria Electronically capture health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes HIT Enabled Health Reform 11

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Achieving “meaningful use” will require significant public and private resources Current HITECH funding is the federal down payment for HIT & HIE infrastructure Funding for Health Information Exchange Funding for Health Information Technology Broadband and Telehealth Community Health Centers Incentives for Adoption $564 million for Statewide HIE Development States receive between $4 and $40 million Indiana received $10.3 million on 3/15/10 $220 million for Beacon Community Program 15 HIEs to receive between $10 and $20 million IHIE and Memorial Hospital (MHIN) each applied from Indiana 300 applications were submitted nationwide IHIE awaiting announcement $1.2 billion for loans, grants & technical assistance for: Regional Extension Centers ($640M) Purdue awarded $12M Workforce Training ($80M) Ivy Tech awarded $5M (HIT training) IPIC awarded $4.8M (Healthcare training) University Based Workforce Training Programs Indiana University awarded $1.4M Research Regenstrief awaiting announcement HER State Loan Fund (pending) New Medicare & Medicaid payment incentives for HIT adoption $23 billion in expected payments from Medicare to hospitals & practitioners thru 2016 $21 billion in expected payments from Medicaid through 2021 ~$44 billion expected outlays $1.5 billion in grants through HRSA for construction, renovation and equipment, including acquisition of HIT systems $4.3 billion for broadband & $2.5 billion For distance learning / telehealth grants 12

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Indiana’s HIT strengths give us a head start in achieving meaningful use U.S. HIT Implementation Readiness: Landscape as of December 2008 Source:

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Indiana’s opening advantages in competing for federal funds Indiana has: meaningful data exchange across health provider networks with minimal investment (e.g. IHIE and HealthBridge) a medical malpractice environment (tort reform) that is physician-favorable and allows hospitals to share data a cooperative environment among exchanges working collaboratively to meet meaningful use invested millions of private and philanthropic dollars toward a workable, revenue sustained system already utilized by providers and physicians VS. Other National Models California has: multiple parties competing to lead the state’s program to implement federal grant funding not achieved meaningful data exchange across networks invested billions of dollars in systems that are not self-sustaining Massachusetts (and Boston) have: robust electronic health records in siloed systems that to date have been neither interoperable nor accessible among hospital systems competition for patients and substantial privacy concerns that have inhibited data sharing between hospital systems

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Indiana’s HITECH Funding for HIT and HIE Efforts to date = $33.5 million State Health Information Exchange Cooperative Agreement Program Indiana Health Information Technology Inc. has been established by the Governor to serve as a governance and contracting structure for extending health information technology exchange capabilities to every corner of the state Indiana Health Information Technology Inc. awarded $10.3 million on March 15. Beacon Community Program Indiana Health Information Exchange (IHIE) awaiting award Regional extension center for health information technology $12 million awarded to Purdue Job training and educational/university grants $5 million awarded to Ivy Tech $4.8 million awarded to Indianapolis Private Industry Council $1.4 million awarded to Indiana University Funding for Health Information Technology Funding for Health Information Exchange

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Expansion projects have been identified and coordinated among Indiana’s stakeholders to further interoperability and meaningful use Foundational Projects 1. Statewide Provider Directory 2. Nomenclature Normalization 3. Clinical Message Routing 4. Electronic Results Delivery 5. Computerized Order Entry 6. Patient Health Record Integration 7. Data Source Connectivity Infrastructure Proj. & Use Cases 1.Central Repository 2.Quality Reporting 3. Public Health Reporting 4.Clinical Summary Capability 5. Providing a Medicine List 6.Patient Identity Matching 7.ePrescribing Application Provision 8.Results Discovery/Query 9.ePrescribing Transaction Hub 16

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute THE OPPORTUNITY Models achieving early success will be positioned to attract significant additional resources ARRA and the healthcare reform act have demonstrated the federal government’s resolve for rapid implementation of systematic change –The prior market driven models of opportunistic (and occasional) HIT and HIE development have been surmounted by the ARRA mandate to create a national health information framework that must be deeply adopted, widely interoperable, and eventually self-sustained Initial funding has been directed broadly to develop “a level playing field” for HIT and HIE capabilities over 50 state “laboratories” But state and regional models that are replicable and scalable will be rewarded with increased opportunity and funding Ultimately, widespread adoption, interoperability and meaningful use will likely be achieved by the selective scaling and deployment of the best and most successful models in multiple markets

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute THE VISION FOR OUR MODEL Indiana’s Proposed HIE Network Service Structure Patient Directory MHIN HealthBridge HealthLINC Med Web Health Care Providers Radiology Others Hospitals Pharmacy Data Services Users Government- Public Health Pharma Health Plans- Case Management Payers Government- Quality Reporting Health Information Exchange Organizations Future? Others Physicians IHIE Secure Health Information “Pipeline” *For: CDS- Clinical Decision Support PM- Population Management Medicaid- Case Management Medicare Clinical Laboratories Community Health Centers Patients Message/ Data Routing Patient Directory Provider Directory Central Repository* Electronic HIE Services Clinical Summary Exchange for Care Coordination & Patient Engagement Discrete Data Provision for CDS & PM Clinical Lab Ordering/Results Delivery ePrescribing and Refill Requests Rx Fill Status/Medication Fill History Eligibility and Claims Transactions Quality Reporting Public Health Reporting 18 CTSI – Research Universities CROs

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute THE CHALLENGES Our opportunities to succeed and remain a leader in HIT are tremendous, but challenges remain Historic challenge: Although we have a group of the nation’s largest and longest-running HIOs, optimal connections among the HIOs have been limited and exchanges were not progressing toward interoperability until recently Over the past year, Indiana’s collaborative efforts have identified solutions to solve this problem, but adoption and implementation challenges remain on the horizon…

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Adoption and Implementation Challenges Physician resistance to adoption –Real and perceived costs of implementation may not outweigh the incentives for adoption Questions abound on the credibility of threatened reductions in Medicare reimbursement rates Privacy concerns may inhibit access to repository data that will unlock the true potential of better information for reducing costs and increasing quality of healthcare Are personal EHRs the future of healthcare or a distraction? –Data ownership at the patient level or system level could enable -- or inhibit -- true meaningful use of data

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute Despite challenges, recent business developments show the early promise of HIT application in new settings Drug-safety monitoring Pfizer’s recently announced Aster (adverse drug event spontaneous triggered event reporting) project aimed at making reporting easier and obtaining better data more likely Product registries The Kaiser Permanente National Total Joint Replacement Registry (TJRR) is a national level database designed as a post-market surveillance system for elective total hip and knee replacement. It has resulted in a successful identification, monitoring, and notification of a hip implant recall as well as identification of patient risk factors for postoperative complications and hospital readmissions, leading to significant changes in surgical indications and preoperative care Public Health Alerts The Indiana Public Health Emergency Surveillance System now pushes electronic public health alerts to providers in its network during health crises such as H1N1

Indiana CTSI ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana C linical and T ranslational S ciences I nstitute BETTER HEALTH INFORMATION = BETTER LIFE SCIENCES Success for Indiana HIT and HIE can put all of Indiana’s life science stakeholders at a competitive advantage A centralized repository to study health outcomes and collect post-market data holds tremendous potential to: –Increase the efficiency of clinical development –Increase the safety of products reaching patients –Track clinical outcomes –Conduct post-market evaluation of new therapies –Provide quality reporting to payers and providers –Enhance translational research capabilities –Reward innovation