Kidney Paired Donation:Update and Challenges

Dorry Segev, MD, PhDAssociate Professor of Surgery, Biostatistics, and Epidemiology

Director of Clinical ResearchTransplant Surgery

Johns Hopkins University

• 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

• Domino (closed chain): 2-way (or N-way) KPD started by NDD and ending in the waiting list (all happen simultaneously)

NDD

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R2

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D2

Waitlist

NDD

R1

R2

D1

D2 Wait...

R3

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D3

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Waitlist

• Non-simultaneous domino (closed chain)

NDD

R1

R2

D1

D2 Wait...

R3

R4

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D4

Wait...

• Non-simultaneous chain (open chain)

KPD in the US: >2200

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110

100

200

300

400

500

600(OPTN Data)

NDD in the US: ~1000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110

20

40

60

80

100

120

140

160

180(OPTN Data)

KPD+NDD: 12% of LD Transplants

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110

2

4

6

8

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12

14(OPTN Data)

KPD+NDD: 12% of LD Transplants

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110

2

4

6

8

10

12

14

For 12% of the live donor transplants performed in the US, somebody other than the donor decides who the recipient will be

KPD+NDD: 12% of LD Transplants

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 20110

2

4

6

8

10

12

14

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?

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

Progress

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

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

Progress

• KPD is not just for incompatible pairs– Non-directed donors

Montgomery/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

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

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?

Costs of KPD

1. Evaluation of incompatible donors2. Evaluation of NDDs3. Histocompatibility testing4. Center-level administration5. KPD program administration6. Kidney shipping costs7. Donor surgeon professional fees8. Donor complications/follow-up

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

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)

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)

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 laboratories5. 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)

(Rees et al, AJT, 2012)

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)

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)

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

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.

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

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)

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

Needs

• Research Funding– Education/Dissemination/Participation– Logistics/Finances/Optimization– Safety/Outcomes

Needs

• Research Funding• SAC– Medicare to lead / pilot?

Needs

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