Kidney Paired Donation: Update and Challenges

1. Kidney Paired Donation:Update and Challenges DorrySegev, MD, PhDAssociate Professor of Surgery, Biostatistics, and EpidemiologyDirector of Clinical ResearchTransplant SurgeryJohns Hopkins University

2. Straightforward 2-way (or N-way): KPD that happens simultaneously where all pairs exchange donors among themselves D1 R1 D1 R1 D2 R2 D2 R2 D3 R3

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

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

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

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 dataSegev/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 donorsMontgomery/Segev Lancet 2006: closed chains (dominos)Rees NEJM 2009: open chainsGentry/Segev AJT 2009: open versus closed chainsMelcher AJT 2012: clinical series • Compatible pairsGentry/Segev AJT 2007: framework for inclusion in KPDRatner Tx 2010: clinical series • Combining KPD and desensitizationMontgomery JAMA 2005: first reportSegev 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 • Evaluation of incompatible donors • Evaluation of NDDs • Histocompatibility testing • Center-level administration • KPD program administration • Kidney shipping costs • Donor surgeon professional fees • 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 • Costs of kidneys acquired from other providers; • Transportation of the organs; • Surgeon fees for recovering kidneys; • Tissue typing services furnished by independent laboratories • 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)

22. (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?