Transplant Program Performance Measures Review Outcome Measures Work Group Update

1. Transplant Program Performance Measures ReviewOutcome Measures Work Group Update Membership and Professional Standards Committee

2. Work Group’s Charge Evaluate ways to decrease perceived disincentives to transplant that the current system for reviewing post-transplant outcomes creates Goal: Increase the number of transplants

3. Work Group Focus • Focus: changing how programs are identified for MPSC outcomes review • Initial focus on kidney – significant data available • Consider similar process for other organs afterwards • No changes to allocation

4. Collaboration • AAAU Group • Tim Schmitt – ASTS • Mark Ghobrial – ASTS • Kim Gifford – ASTS • Tom Pearson – AST • John Friedewald – AST • Shandie Covington– AST • Kevin O’Connor – AOPO • Jay Campbell – AOPO • Elling Eidbo – AOPO • Carl Berg – UNOS • Betsy Walsh – UNOS • Stuart Sweet – UNOS MPSC Work Group David Cronin, Chair David Axelrod Tim Taber Rob Kochik Dennis Martin Nader Moazami Jeff Orlowski Chris McLaughlin, Ex Officio Shannon Dunne, Ex Officio Raelene Skerda, Ex Officio

5. Noticeable Trends D Stewart; ATC 2013; updated 02APR2015

6. Disposition by KDPI Snyder, SRTR, July 2015

7. Patient Survival by Recipient EPTS Score EPTS = Estimated Post-Transplant Survival Kaplan-Meier Patient Survival Curves by EPTS Score Deceased Donor, Adult, Solitary Kidney Transplants from 2003-2010 Based on OPTN data as of Feb 7, 2014

8. Concept

9. Concept • MPSC will review kidney programs for lower than expected graft or patient survival if 1 year kidney graft or patient survival meets the established criteria for both  • All kidney transplants AND • Kidney transplants excluding high risk transplants • High risk transplants = recipient with an EPTS score >80 using a kidney from a donor with a KDPI ≥ 85 • Monitoring of national 1 year graft and patient survival in high risk transplants by MPSC

10. Summary of Concept • What it would do: • Programs would not be flagged for review by the MPSC based on outcomes in high risk kidney transplants (high KDPI and high EPTS scores) • Would NOT do: • Change allocation policy • Change criteria used by CMS for evaluation • May not change public reporting of outcomes – this is directed by HRSA through its contract with SRTR

11. Path Forward • Spring 2016 – request for pre-public comment feedback • Early Summer 2016 – Board feedback • Aug-Oct 2016 – public comment • December 2016 (expected) - Board reviews proposal

12. Request for input • Is there support for specifically excluding higher risk transplants from MPSC review? • Define high risk based on donor characteristics, recipient characteristics or both? • Would this system encourage you to use currently discarded but transplantable kidneys? • Are there other issues the work group should consider?

13. Additional Slides

14. OPTN Bylaws, Appendix D.11.A. For programs performing 10 or more transplants in a 2.5 year period, the MPSC will review a transplant program if it has a higher hazard ratio of mortality or graft failure than would be expected for that transplant program. The criteria used to identify programs with a hazard ratio that is higher than expected will include either of the following: 1. The probability is >75% that the hazard ratio is > 1.2. 2. The probability is > 10% that the hazard ratio is > 2.5.

15. Data reviewed to determine criteria • SRTR risk adjustment in kidney model – 2/26/2015 • UNOS Research data on characteristics of unused kidneys – 4/2/2015 and on kidneys discarded by DSA, region, and median waiting time to transplant – 5/28/2015 • UNOS Research data on relationship between discard rate, KDPI and % glomerulosclerosis for deceased donors based on DSA, region and waiting times – 5/28/2015 • SRTR data on effect of decreased discard rates on program evaluations – 8/4/2015

16. Data reviewed to determine criteria • SRTR suggested reweighting the model • put less emphasis on higher risk transplants rather than excluding them from model – 9/18/2015 • SRTR analysis of the programs that would be identified under the proposed process

17. Additional Data Slides

18. Patient Survival by Patient Status & Center Performance • TX at High Performer • TX at Avg Performer • TX at Low Performer • No Transplant Schold et al, CJASN, 2014 Oct 7;9(10):1773-80

19. Scatterplot of hazard ratios for kidney adult graft survival Snyder, SRTR, July 2015

20. Scatterplot of hazard ratios for kidney adult patient survival Snyder, SRTR, July 2015

21. Graft Survival & Discard Rates by KDPI 2-year graft survival Discard rate (Pre-KDPI in DonorNet) Gradual decline in graft survival, yet steep increases in kidney discard rates. Stewart, et al, ATC 2013 Abstract #301

22. Figure 3. Discard rate of deceased donor kidneys recovered for transplant from 2007 through 2014 by KDPI and whether or not the kidney was pumped. (% pumped inset) • 31% of all kidneys were pumped • Pumping varies by OPO Carrico, UNOS, May 2015

23. Figure 5. Discard rate of deceased donor kidneys recovered for transplant from 2007 through 2014 by KDPI and percent Glomerulosclerosis. Carrico, UNOS, May 2015

24. Model calibration for KDRI, June 2015 PSR deceased-donor adult 1-year graft survival model. Each of the 20 points aggregates approximately 5% of the transplants into bins based on KDRI. Snyder, SRTR, July 2015