Paired exchange and Chain Donor Transplants: Decrease the Waitlist & Manage Center Finances

1. Paired exchange and Chain Donor Transplants:Decrease the Waitlist & Manage Center Finances Jeffrey Veale, M.D., Kidney Transplant Surgeon, Director of the Donor Exchange Program, Assistant Professor - UCLA Medical Center Debbie Mast, Financial/Database Manager, Stanford Hospital and Clinics Sean Van Slyck, Director of Procurement, CTDN

2. Questions to run on: • Is my Transplant Center exploring all possibilities in decreasing the wait list, including paired and chain donation? • What opportunities/barriers to success do I see in the paired/chain donor process? • How can your OPO assist with paired exchanges/chain transplantation?

3. The Problem Kidney Exchanges…A New Paradigm • 80,000 people awaiting kidney transplants • 16,000 transplants performed yearly • List continues to expand secondary to obesity, diabetes and old age

5. Possible Solutions • Prolong allograft longevity • Calcineurin inhibitor free protocols • Immune monitoring • Expand the donor pool • Xenotransplantation • Paying donors • Accepting marginal kidneys (ECD, DCD…) • Utilizing incompatible donors

6. Utilizing Incompatible Donors • At least one third of patients with a willing living donor are excluded due to blood type and cross match incompatibility • JAMA 2005 • 35% of any two individuals will be ABO incompatible • 30% of recipients sensitized to allo-HLA due to previous transplants, pregnancies or transfusions

7. Options • Desensitization programs • Paired donor exchanges “SWAP” • Chains • Combination (of the above)

8. Desensitization Programs • Advantages • Expands the donor pool • Friend/loved one donates to intended recipient • Disadvantages • Very expensive – Additional $28,979 (JAMA 2005) • Decreased graft survival rates (AJT 2004, 2009) • 1 yr 84% (vs 96%) • 5 yr 69% (vs 81%) • Decreased patient survival rates (AJT 2004) • 5 yr 87% (vs 94%)

9. Paired Donor Exchanges “SWAP” • First U.S. exchange performed under little publicity in 2000 at Rhode Island Hospital • Slow to catch-on due to NOTA 1984 “unlawful to acquire organ in exchange for valuable consideration” • Johns Hopkins and University of Cincinnati early pioneers • Office of legal counsel “exchanges do not violate NOTA” March 28, 2007 • Opened the door for UNOS and individual centers to develop donor exchange programs

11. Paired Donor Exchanges “SWAP” • Advantages • Expands the donor pool • Greater sense of satisfaction by helping 2 recipients • Disadvantages • Donors anesthetized simultaneously • Donors typically travel • Challenging logistics • Multiple operating rooms, surgeons, nurses… • Compared to chain transplantations • Decreased quality of matches • Decreased quantity of matches D D R R

12. NEJM 2009

13. Chains • Concept first proposed by Dr. Michael Rees, a Urologist at the University of Toledo • First U.S. chain launched in July 2007 and thus far has facilitated 10 transplantations involving six transplant centers in five different states • First California chain launched in July 2008 and thus far has facilitated 8 transplantations involving 4 transplant centers in two different states • First transcontinental transplant chain • First “out-of-sequence” transplant chain

14. First California Chain

15. Altruistic Donor New York, NY July 30, 2008 D1 Cousin of R1 Los Angeles, CA R1 Los Angeles, CA July 24, 2008 D2 Husband of R2 Los Angeles, CA R2 Los Angeles, CA July 24, 2008 D3 Son of R3 Los Angeles, CA R3 Los Angeles, CA October 2, 2008 D4 Wife of R4 Los Angeles, CA R4 Los Angeles, CA October 2, 2008 D5 Husband of R5 Los Angeles, CA R5 Los Angeles, CA November 19, 2008 D6 Wife of R6 Palo Alto, CA R6 Palo Alto, CA November 19, 2008 D7 Wife of R7 New York, NY R7 New York, NY November 19, 2008 D8 Brother of R8 San Francisco, CA R8 San Francisco, CA To be scheduled The chain may continue

16. Chains D D D D • Advantages • Potential for the largest expansion of the donor pool since the landmark brain death act in 1981 (UDDA) • Great sense of satisfaction for donors • Helping multiple recipients • Additional patients on the waiting list move up and into the newly vacated spots • Easier Logistics • Donors don’t need to be anesthetized simultaneously • Donors don’t need to travel • If donor fails to donate, chain ends but no irreparable harm to recipient R R R

17. NEJM 2009

18. Chains: Increased quality and quantity of matches

19. 28.0 Deceased Donor Kidneys Living Donor Kidneys 17.8 14.2 10.5 7.8 7.1 Standard Criteria Donors 0-5 Antigen Match Standard Criteria Donors 6 Antigen Match Extended Criteria Donors 0-5 Antigen Match Extended Criteria Donors 6 Antigen Match Living Donors 0-5 Antigen Match Living Donors 6 Antigen Match Clinical Transplants 2005

20. Chain • Disadvantages • Donate to a stranger instead of your loved one • Some argue an advantage, as greater emotional reward knowing multiple recipients benefit from donation • Billing • Problem essentially solved (Debbie Mast and Nanci Flores) • Requires transplant centers to adopt a new attitude • Cooperation between centers rather than competition • Shipping living donor kidneys

21. Software-Matching Options • Johns Hopkins • New England Program for Kidney Exchange (NEPKE) • Paired Donation Network (PDN) • Alliance For Paired Donation (APD) • Silverstone Solutions-Matchmaker • National Kidney Registry (NKR)

22. National Kidney Registry • No cost • 30 centers across the United States • California Members include: • CPMC, Stanford, UCLA, UCSF (Sharp Memorial?) • Aetna=2,500 patients on deceased donor waiting list • Superior matching software • Facilitated the most chain transplantations (51 thus far)

23. Chains: How to become involved? • Step 1

24. Step 2 • Enter pair into the National Kidney Registry • www.kidneyregistry.org • Phone 1-800-936-1627 • No cost • No identifiers required • Donor/recipient, age, blood type, HLA antigens and antibodies

25. Step 3 • Matches will be arranged • Communication between centers is key • Coordinators - arrange records to be exchanged and confirm details • Surgeons - trust one another • OPOs - transport living donor kidneys

26. A New Paradigm • At least one third of patients with a willing living donor are excluded due to blood type and cross match incompatibility • This is the first opportunity to substantially increase the donor pool by utilizing high quality organs, rather than merely accepting more organs of uncertain caliber (ECD, DCD…)

27. “When will the transplant societies, government agencies or society as a whole realize that we are mired in old paradigms. Attitudinal changes must take place to truly increase donation of high quality organs to make an impact on those dying on the waiting list” • Bromberg and Halloran (AJT 2009; 9: 11-13)

29. Living Donor Transplantation – Medicare Guidelines Medicare guidelines overshadow all the financial aspects of kidney transplantation Pre-entitlement vs. entitlement to Medicare Pre-entitlement: a person with end-stage renal disease who does not yet have Medicare Entitlement: a person who has Medicare eligibility Based on the guidelines, all pre-transplant services for pre-entitled or entitled recipients are charged to the “kidney acquisition” cost center. Donor services are then charged to the “recipient” transplant center (services prior to the admission for organ procurement). Following admission, hospital services are billed to cost center and physician services are billed to recipient insurance.

30. Living Donor Transplantation – Medicare Guidelines Guidelines were written with the presumption that both the recipient and donor are housed in the same facility. *Internal pairs – fits this scenario *External pairs/chains – do not fit! WHAT DO WE DO NEXT? We reviewed the Interpretive guidelines in detail and charted out the billing based on current regulations and providers of care for these paired and chain donors…

31. Current Billing Recommendations for external Pairs/Chains

32. How do we do it? • Work closely with YOUR clinical team-you need to know what they know, when they know it! • Work closely with administrative, financial, and contracting teams from involved centers to ensure letters of agreements in place, insurance information is shared, and authorizations in place. • Determine capabilities of your facility’s billing system to ensure anonymity of donor/recipient relationships. • Most of all, have a sense of humor as you work out the logistics and be proud of YOUR work in reducing the wait list!

33. How your OPO can help you • Logistical support for organ transportation • Arrange all courier needs • Door-to-door service • Perfusion, packaging and labeling support • Recovering center responsible for perfusate • Supply all packaging and labels • A coordinator to ensure adherence to UNOS packaging rules • An ABO verification page • A worksheet documenting all recovery timing and anatomy.

34. What your OPO will need • Once the exchange is confirmed contact the OPO • Be sure you have your UNOS ID and ABO verification complete • Provide the OPO with the relevant info • Date/time of procedure • Accepting program and contact info • Donor Info (UNOS ID, ABO, DOB, etc) • Provide the OPO with a copy of the donor chart to package with organ

35. Suggestions for a successful process • Conference calls with all involved parties (surgeons, coordinators, OPO) • At least one conf call a week prior • Contact between the sending OPO and the OPO of the receiving transplant center • Provide a final, written summary of logistics to all parties 24-48hrs prior to case • Back-up considerations

36. Suggestions for a successful process

37. Financial Considerations • OPO costs passed along to the transplanting center • Minimal packaging costs • Minimal staff costs • Primarily courier costs • OPO costs absorbed by the OPO • OPO charges a full SAC fee

38. Financial Considerations !!