Redefining Healthcare Delivery in the 21st Century

1. VALUE BASED CARE: The Role of INTERMACS INTERMACS 8TH Annual Meeting James B, Young, M.D. Study Chair – INTERMACS May 5th, 2014

2. Bob Dylan • 2006 • “…you’d better start swimming or you’ll sink like a stone…for the times they are a-changin!” (1964) Bye Bye Borders (RIP; 1971-2011)

3. The Interagency Registry For Mechanically Assisted Circulatory Support (INTERMACS), a National Heart Lung and Blood Institute–sponsored collaborative database, analyzes United States (U.S.) Food and Drug Administration (FDA)–approved durable mechanical circulatory support (MCS) device implants in the United States MCSD centers. Incorporated into INTERMACS are a set of demographics, procedural, & outcomes measures (including adverse event definitions) which have been agreed upon by Industry, Clinicians and the FDA. Resource utilization can be both measured and modeled.

4. WE MUST TRANSFORM HOW CARE IS DELIVERED… “A medical condition should be defined from the patient’s perspective. It should encompass the set of illnesses or injuries that are best addressed with a dedicated and integrated care delivery process.” - Michael Porter and Elizabeth Teisberg Redefining Health Care 2006

5. “Our system of uncoordinated, sequential visits to multiple providers, physicians, departments and specialties works against value. Instead we need to move to integrated practice units that encompass all the skills and services required over the full cycle of care for each medical condition…..” - Michael Porter NEJM 2009;361(2):109-112 A strategy for health care reform – Toward a value based system WE MUST TRANSFORM HOW CARE IS DELIVERED…

6. APPROACH TO HEALTHCARE21ST Century

7. THE NEW CHALLEGE OF ADVANCED HEART FAILURE CARE • Patient outcomes • Appropriateness, quality & satisfaction • Value • Value = Outcomes/Cost • Bureaucratic regulation • Definitions • Allocation • Justification • Reimbursement

8. Multifaceted Outcome of Care Costs/Burden Direct and Indirect Cost Caregiver Burden Lost Opportunities Adverse Events Survival Outcome Relevant to Patient Quality of Life Physical Function Symptoms Mental, Emotional Social From Robert Kormos M.D.

9. Multifaceted Outcome of Care Current applications within INTERMACS Costs/Burden Direct and Indirect Cost Caregiver Burden Lost Opportunities Adverse Events Survival In hospital mortality Long term mortality Outcome Relevant to Patient Quality of Life Physical Function Symptoms Mental, Emotional Social

10. Inpatient Mortality Functional Level Achieved Pain Level Achieved Extent of return to physical activity Ability to return to normal activities Time to return to physical activity Pain Length of Stay Infection Bleeding Neurological Function Arrhythmias Other adverse events Maintained functional level Ability to live independently Need for readmission Need for other surgery Chronic adverse events Device reliability Infection Stroke Chronic right heart failure From Robert Kormos M.D.

11. Progressive Financial Impact Jan 2014 Jan 2013 Jan 2015 Apr.-Dec 2012 Measurement Period Financial Impact Timeline Oct. 2012 Oct. 2016 Oct. 2013 Oct. 2014 Oct. 2015

12. A proposal • Expand INTERMACS “business world” activities • Provide more value to various constituencies (expand annual reports and increase contract work) • Value = Cost & Outcomes for MCSD/Cost • Objective data • Modeled data • “Consulting” analysis of MCSD programs • Strengthening/Rejuvenating partnerships with FDA, CMS & Industry • Establish relationships with private/public payers • Create “new” model for providing even more value

13. WHY? • We have the expertise • Clinical trial expertise • Clinical registry expertise • We have the data with >10,000 patients • We have the relationships • NIH, CMS, FDA, Industry, Joint Commission, Private payers, MCSD centers, Transplant programs, UNOS/SRTS • We have the need, desire & passion WE ARE YOU AND YOU ARE INTERMACS!