1. Kidney Paired Donation: Update and Challenges Dorry Segev, MD, PhD Associate Professor of Surgery, Biostatistics, and Epidemiology Director of Clinical Research Transplant Surgery Johns Hopkins University

2. Straightforward 2-way (or N-way): KPD that happens simultaneously where all pairs exchange donors among themselves R1 R2 D1 D2 R1 R2 D1 D2 R3D3

3. Domino (closed chain): 2-way (or N-way) KPD started by NDD and ending in the waiting list (all happen simultaneously) NDD R1 R2 D1 D2 Waitlist

4. NDD R1 R2 D1 D2 Wait... R3 R4 D3 D4 Waitlist Non-simultaneous domino (closed chain)

5. NDD R1 R2 D1 D2 Wait... R3 R4 D3 D4 Wait... Non-simultaneous chain (open chain)

6. KPD in the US: >2200 (OPTN Data)

7. NDD in the US: ~1000 (OPTN Data)

8. KPD+NDD: 12% of LD Transplants (OPTN Data)

9. KPD+NDD: 12% of LD Transplants For 12% of the live donor transplants performed in the US, somebody other than the donor decides who the recipient will be

10. KPD+NDD: 12% of LD Transplants For 12% of the live donor transplants performed in the US, somebody other than the donor decides who the recipient will be Dilemma: Is this allocation?

11. Decision Paradigms Single-center – Physician running KPD program decides Multi-center – Medical oversight board – Standardized computer (optimization) software – Person running multi-center program UNOS/OPTN – Committee & UNOS board

12. Progress Charlie W. Norwood Living Organ Donation Act (HR710/S487 signed 12/07): KPD is legal

13. Progress Donor and recipient operations do not need to occur at the same time – Or at the same hospital – Live donor kidneys can be shipped: Simpkins/Segev AJT 2007: CIT & long-term outcomes, SRTR data Segev/Montgomery AJT 2012: CIT & short-term outcomes, cohort data – Most multi-center exchanges now ship the kidney

14. Progress KPD is not just for incompatible pairs – Non-directed donors Montgomery/Segev Lancet 2006: closed chains (dominos) Rees NEJM 2009: open chains Gentry/Segev AJT 2009: open versus closed chains Melcher AJT 2012: clinical series – Compatible pairs Gentry/Segev AJT 2007: framework for inclusion in KPD Ratner Tx 2010: clinical series – Combining KPD and desensitization Montgomery JAMA 2005: first report Segev AJT 2005: KPD waiting times, by phenotype

15. Questions Chains – Are longer chains really better, or do they just attract more media? – When do you stop the chain? – To whom does the last kidney go? Matching ("Allocation?") Priorities Optimization – Dynamic versus batch

16. Questions Shipping Kidneys – Safety and logistics with multiple segments – Risk of loss / misplacement? Financial – Usually donor bills recipient insurance – More complex when at different centers – Who covers donor complications? – Who pays for multiple donor/NDD evaluations?

17. Costs of KPD 1.Evaluation of incompatible donors 2.Evaluation of NDDs 3.Histocompatibility testing 4.Center-level administration 5.KPD program administration 6.Kidney shipping costs 7.Donor surgeon professional fees 8.Donor complications/follow-up

18. KPD Financing Strategy Goals Transfer costs from the donor hospital to the recipient hospital Eliminate the volume disparity between centers Reimburse for donor services by out-of-network providers Present consistent/predictable costs for payers Remain compliant with CMS regulations

19. National SAC Better than individual negotiations between KPD transplant centers (Rees et al, AJT, 2012) Avoids volume-related discrepancies All centers pay the same amount for a KPD transplant, representing an average of all the possible charges from a center-specific approach. SAC assessed only to those centers and payers who benefited through completed KPD transplants. Preferred by private payers (Irwin et al, AJT, 2012)

20. Deceased Donor Analogy Why would a payer pay for evaluating and recovering organs from a deceased donor with no guarantee that the organs would be given to one of its beneficiary? (Rees et al, AJT, 2012)

21. Deceased Donor Analogy CMS SAC strategy: OPO charges centers a fee based on cost to recover kidneys; centers incorporate into tx 1.Costs of kidneys acquired from other providers; 2.Transportation of the organs; 3.Surgeon fees for recovering kidneys; 4.Tissue typing services furnished by independent laboratories 5.Preservation and perfusion costs SAC = previous year total / # kidneys transplanted OPO collects SAC for each kidney, CMS reimburses other costs not recovered through SAC… etc… (Rees et al, AJT, 2012)

23. Deceased Donor Analogy Advantage of SAC: – OPO fully covered by CMS (all costs collected without knowing in advance who is the recipient) – Hospitals fully covered (at the time of transplant, recipient is known, so payer assumes SAC fee) Why Would CMS Pay the SAC? – CMS saves $100k-$500k for every kidney transplant performed (versus obligatory coverage for dialysis) (Rees et al, AJT, 2012)

24. KPD SAC Strategy A fee for KPD is defined (not trivial to define) and agreed on by CMS (and other payers) Each center is paid the KPD SAC for every KPD transplant they perform, above and beyond payment for conventional live donor transplant National SAC? Center-Level SAC? (Rees et al, AJT, 2012)

25. Consensus Conference 3/12 Donor Evaluation: Rodrigue/Serur Histocompatibility: Reed/Leffell Geographic Barriers: Segev/Hanto Financial: Rees/Zavala Allocation Policies: Gentry/Leichtman Implementation: Delmonico/Melcher

26. Consensus Recommendations All potential living donors should be informed about KPD early in the educational process, prior to compatibility testing A centralized information resource for NDDs should be developed by the transplant community. Because of their potential to trigger multiple transplants, all NDDs should be informed about KPD.

27. Consensus Recommendations The greatest benefit for candidates can be achieved in a single well-functioning registry that encompasses the successful aspects of currently operating registries National SAC would best serve KPD in the United States financial model

28. Payer Recommendations …the designation of a national organization to administer and provide oversight to KPD would best meet the needs of expanding access to KT in a fair and equitable manner. We are impressed by a number of ingenious and resourceful regional and local approaches that have been used... However, considering the scope of the national KT needs, we believe that a national system that maintains the foresight and flexibility to foster innovative approaches to KPD will allow management of one seamless national effort. …to be successful, a national KPD program would be managed under the auspices of HRSA. (Irwin et al, AJT, 2012)

29. Single National Registry Advantages: – HRSA/community oversight is possible – The most straightforward way to calculate a SAC – Allows optimization of match opportunities for entire national pool – Allows scientific evaluation of different strategies Disadvantages: – Disappointing to those with a competitive nature: ? Less flexible ? Less innovative

30. Needs Research Funding – Education/Dissemination/Participation – Logistics/Finances/Optimization – Safety/Outcomes

31. Needs Research Funding SAC – Medicare to lead / pilot?

32. Needs Research Funding SAC Oversight – Medicare SAC contingent on oversight? – National KPD contractor? – KPD metrics in SRTR Program Specific Reports?