Perverse Incentive System How Regulations and Perceptions are: - Costing Lives - Wasting Dollars - Dishonoring the Gift of Donation

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Perverse Incentive System How Regulations and Perceptions are: - Costing Lives - Wasting Dollars - Dishonoring the Gift of Donation J. Kevin Cmunt, President and CEO, Gift of Hope Organ & Tissue Donor Network

Conflict of Interest Disclosure I have no relevant financial relationships to disclose

The Story of Our DSA ILIP Donors Recovered (12-month Rolling Average 2012 through January, 2016) 45% increase in last 3 years

The Story of Our DSA ILIP Organs Transplanted (12-month Rolling Average 2012 through January, 2016) 40% increase in last three years

The Story of Our DSA Why Donation Has Increased Specialized Functions Encouraged Can-Do Attitude Focused on Hospital Relationships Increased Operations Staff by 40% With 5000 people on the waiting list in Illinois, 300 deaths per year: Local Transplant should have increased 50% What Actually Happened??

ILIP Liver Local vs. Export 100% The Story of Our DSA 232 227 320 90% 80% 25 50 73 116 70% 60% 50% 40% 30% 180 182 154 204 20% 10% 0% 2012 2013 2014 2015 Local Export

The Story of Our DSA ILIP Kidney Local vs. Export 100% 90% 50 52 93 80% 157 70% 60% 50% 40% 344 379 377 30% 321 20% 10% 0% 2012 2013 2014 2015 Local Export

ILIP Kidney Utilization The Story of Our DSA 2012 2013 2014 2015 2014 to 2015 Recovered Total Recovered for Transplant Transplant - Local Transplant - Export Recovered for Transplant but not utilized Imported Net (Import-Export) 491 558 622 690 + 11% 396 431 579 654 + 13% 345 379 379 301-26% 51 52 91 157 + 76% 87 (22%) 99 (23%) 109 (19%) 196 (30%) + 11% 43 54 29 49 + 69% - 8-2 - 63-108 + 71%

Kidney Discards National Data GOH Discard Rate 30% overall 50% higher discard rate than national average Source: UNOS/OPTN Kidney Transplant Committee Fall 2015 Presentation

The Story of Our DSA Kidney O:E Ratios 2012 through 2015 1.02 1.00 1.00 1.00 0.98 0.99 Local Programs Flagged 0.96 0.94 0.94 0.92 0.91 0.90 2011 2012 2013 2014 2015

Conclusion We discarded approximately 65 kidneys that should have been transplanted based on OE and National discard rates Local program transplant should have been 150 to 200 kidneys higher ( 108 net export + 65 excess discards) Could we have eliminated ½ of the deaths on the waiting list in Illinois? Question: Why were these organs not transplanted in our DSA?

ILIP Flagged Local Kidney Programs Source: SRTR Transplant Center Reports http://www.srtr.org/csr/current/centers/transplantcenters.aspx?organcode=ki; Accessed 02/22/2016 Largest Programs average transplant rates apx. 60% of expected in 2015

Regulations and Perceptions What we heard from our Programs: Fear of Flagging results in decreased transplants Natural tendency of programs is to go conservative : Reduce marginal organ usage Cost of transplant with marginal organs goes up Increased DGF, dialysis required etc. Patients want best kidney, won t accept high KDPI

Impact on System Costs Impact on Kidney Standard Acquisition Charges Issue: ILIP discarded approximately 60 kidneys that should have been transplanted Year Kidney only donors are not the issue # Kidney Only Donors # Kidneys Utilized 2014 27 41 of 54 76% 2015 25 38 of 50 76% Utilization Rate Excess Discarded Kidneys are primarily from marginal Liver donors CMS requires costs to assigned to kidney if there is intent to transplant Should we even recover these kidneys, from Marginal L-K donors??

Kidney Acquisition Fees Impact on System Costs Incremental Direct Costs Kidney Only Kidney/Liver Liver Only Kidney Hospital Costs/Prof Fees $13,300 $13,300 $13,300 $0 Trans/Shipping/Packaging 3,000 3,800 2,200 1,600 Laboratory Testing 7,785 8,185 2,335 5,850 Procurement Fees 1,250 1,250-1,250 Pump Supplies 3,400 3,400-3,400 Total Costs $28,735 $29,935 $17,835 $12,100 Cost per Organ $14,368 $9,978 $17,835 $6,050 Above costs do not include allocation of overheads and salaries

Impact on System Costs Kidney Acquisition Fees Kidney Procured 100 Liver Procured 50 Kidney Transplanted 38.0% 38 Liver Transplanted 86.0% 43 Incremental Kidney Revenue $36,800 $1,398,400 Incremental Kidney Cost $6,050 $605,000 Incremental Revenue/Cost $793,400 16% utilization rate for kidneys is the break-even point for liver kidney donors

Kidney Acquisition Fees Impact on System Costs 60 discarded kidneys @ $34,000 = $2,000,000 in lost reimbursement CMS Requires costs be spread over transplanted kidneys Result: ILIP forced to raised 2016 SAC for Kidneys by $2000! I CMS Regulations force underutilization of marginal organs: CMS regulations force increase in cost of kidneys! PS: How much post transplant care does $2MM buy you??

Opportunities for Improvement Change the Regulations! We Can Solve This Problem UNOS CMS and HRSA need to get on the same page: Three projects on-going this year at UNOS to address the issue Need to stay focused and make sure change happens this year CMS and HRSA need to engage fully and agree to adopt new UNOS measures simultaneously Nationally we are wasting 500 to 1000 kidneys per year, Every Year until we fix this problem Note: We have the same problem and opportunity with other organs too!

Opportunities for Improvement Financial Incentives We Can Solve This Problem Issue: using high KDPI kidneys results in increased DGF and higher patient costs of care Proposal: Explore method to provide programs with reimbursement for incremental costs for each transplant done with a high KDPI kidney Question: Would this increase local utilization?

Opportunities for Improvement Change Perception We Can Solve This Problem SRTR data shows that use of high KDPI kidneys does not harm a program s ability to meet regulatory requirements Need to educate programs, more discussion of successful programs (e.g. Oshner for marginal livers, UC Davis marginal kidneys) Need to educate insurance carriers and patients that OE, acceptance rates and transplant rates are more important than simple 1 year survival rates This will take time and we can t wait. There are things we can do now to improve utilization

Opportunities for Improvement Targeted Kidney Allocation We Can Solve This Problem Protocol: Donors with KDPI > 85%, >60years old, or >50 years old with Hx of CVA or HTN In addition to the initial cross-match list generated per protocol, a targeted allocation list is generated Pre-procurement Each center has the option to select one candidate meeting the following criteria for the Targeted Allocation List Suitable to receive an ECD kidney with more advanced vascular disease/histologic injury Transplant ready and available Absent DSA In cases of limited center interest, participating centers may add additional name(s) to generate a list maximum of 7 candidates Kidney allocation follows UNOS priority listing. Failure to allocate the kidney under this protocol is considered a strong indicator of no local interest and further cross-match testing is not allowed due to delay in regional/national allocation.

Opportunities for Improvement Targeted Kidney Allocation We Can Solve This Problem KDPI > 85 2014 2015 # of Donors meeting Criteria 76 90 # of Times utilized 20 21 # of Kidneys transplanted 14 18

Honoring the Gift of Donation Gift of Hope Vision: That every opportunity for donation is successful When a family says yes to donation, we make a promise to do everything we can to maximize that gift Families want and expect that their loved ones organs will be used to highest benefit possible We owe them better than we are doing now All data other than Slides 10 and 11 provided by Gift of Hope