Kidney Transplantation Committee Update

1. Kidney Transplantation Committee Update Spring 2012 Regional Meetings

2. Ongoing Projects • Progress to develop a new national kidney allocation system • Recommendations regarding variances • Living donor priority policy • Kidney paired donation (KPD) proposals • Creating policy for KPD to replace KPD Operational Guidelines • Allowing bridge donors in the OPTN KPD Program

3. National Kidney Allocation System

4. Current Working Model • Patients rank ordered by • Waiting /ESRD time • DR matching • Sliding scale CPRA • System features • A2 -> B • Nat’l sharing CPRA>=98% • Patients rank ordered by • Waiting/ESRD time • System features • Regional sharing • A2 -> B • Nat’l sharing CPRA>=98% Top 20 % KDPI to Top 20 % EPTS Allocation under “current rules” Opt in system of highest 15% KDPI kidneys “Think improved ECD” 0--------------------------------20-------------------------------------------------85------------------------100 KDPI Scale

5. Addressing System Limitations

6. Highlights (1) • Allocation based on longevity matching is accepted and sustains legal scrutiny • The majority of kidneys are still allocated very similarly to current rules • Waiting time remains the primary determinant of kidney allocation with a more inclusive definition

7. Highlights (2) • Improved “ECD” system addresses concerns of older recipients • “Opt in” preserves choice • Allows trade off of a kidney with more longevity for more rapid transplantation • Regional allocation might improve recovery and placement • Allocation on time alone makes it predictable and allows list management.

8. Current Status • Awaiting final simulation modeling of • Sharing for candidates with CPRA>=98% • Regional sharing of ECD kidneys • Earliest proposal release: Fall 2012 with earliest Board consideration in June 2013

9. Variance Review Process

10. Variances Reg 1 PADV PATF VATB OKOP TXSB TXGC The Committee received rationales from the above OPOs wishing to keep existing variances in the new allocation system

11. Decisions • The Committee decided to recommend discontinuation of all variances except for • Dialysis waiting time study • A2/A2B • The Committee will recommend these changes to take place at the time a new system is implemented

12. Next Steps • OPOs that currently have a variance not recommended for inclusion • May apply for a 1-step transition • May apply for a new variance • Details for each option were sent to OPOs which submitted appeals

13. Timeline

14. Living donor priority proposal

15. Problem Statement • Current policy does not clearly state whether prior living organ donors should get priority with each and every kidney registration or just one registration

16. Data • 280 prior living donors listed for kidney transplant since 1996 • 33 prior living donors have been listed for more than one kidney transplant

17. Proposal • Policy language now clearly states that the local priority and 4 points for prior living donors applies with each and every kidney registration.

18. KPD Proposals: Spring 2012 Public Comment Kidney Transplantation Committee

19. KPD Proposals • Proposal to Establish Kidney Paired Donation (KPD) Policy • Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD) Program

20. KPD Work Group Composition • Kidney Transplantation, Living Donor, and Histocompatibility Committee representatives • Representatives from Members participating in the OPTN KPD Pilot Program • An OPO representative, and • Technical advisors who wrote the optimization algorithms used in the OPTN KPD Pilot Program.

21. Proposal to Establish Kidney Paired Donation (KPD) Policy

22. Background • The pilot program is governed by a set of rules called Operational Guidelines. • The OPTN contractor has operated the OPTN KPD Pilot Program since October 2010.

23. Background • Participating transplant hospitals signed a contract stating that they agreed to abide by the Operational Guidelines. • If the Membership and Professional Standards Committee (MPSC) found a transplant hospital to be in material non-compliance with the Operational Guidelines, it could remove that transplant hospital from the OPTN KPD Pilot Program.

24. Background • There were no other actions available to the MPSC. • With KPD policy, the full range of adverse actions will be available to the MPSC for violations of KPD policy, up to and including member not in good standing.

25. Living Donation & KPD Policy Structure • Rules that apply only to the OPTN KPD program: • Enrollment • OPTN program specific consent • Required data, including HLA • Rules for choosing matches • Preliminary crossmatch • Rules that apply to all pairs, but only to pairs: • additional items for informed consent specific to KPD • Policy for all living donors: • OPTN policy section 12

26. Details of Proposal • Table 1 of the proposal outlines the requirements in each section of the bylaws and policy and how it was developed. • Many elements were in the Operational Guidelines or part of KPD Manual Solution operations (i.e., the way day to day operations works; they are being included in KPD policy to promote transparency)

27. Policy for All Living Donors • Located in Policy 12- Living Donation

28. Proposed Policies that Apply to All Paired Donation • All KPD donors must be informed of the risks and benefits of participating in KPD • 8 specific items outlined in policy • All KPD non-directed donors (NDDs) must be informed of options for NDDs • 3 specific items outlined in policy • If a center will ship a kidney, the donor must specifically consent to it.

29. Responsibility for KPD Informed Consent • Responsibility for informed consent is with the center entering the candidate or donor in the KPD Program • Typically, this is the donor’s evaluating hospital, which is also the intended recipient’s transplant center • The recovery hospital is still responsible for all informed consent elements in Policy 12.

30. Proposed Policies for Transplant Centers that apply only to the OPTN KPD Program • Donors must be informed of the OPTN KPD Process requirements • The donor and candidate must specifically consent to: • Release of PHI • Participate in the OPTN KPD Program

31. Proposed Policies for Transplant Centers that apply only to the OPTN KPD Program • Requirement for a preliminary crossmatch before the donor recovery. • The need for a final crossmatch is left up to the candidate’s Transplant Hospital based on its crossmatching standards.

32. Proposed Policies for Transplant Centers that apply only to the OPTN KPD Program • In the OPTN KPD Program, the recovery Transplant Hospital must specify the name and telephone number of any person or company who will be packaging, labeling, or transporting the kidney. • Rules for when participants can meet

33. Proposed Policies for how the OPTN Contractor operates the OPTN KPD Program • From KPD Operational Guidelines: • Histocompatibility Requirements • A2 and A2B Matching • Unacceptable Antigens and All Other Antibody Specificities • Prioritization Points • Donor Chains

34. Proposed Policies for how the OPTN Contractor operates the OPTN KPD Program • From current KPD Manual Solution operations: • Requirements for match run eligibility for candidates • Requirement for match run eligibility for donors • Screening Criteria: Blood Type • Screening Criteria: Candidate and Potential Donor Choices • Two and Three-Way Matches

35. Specific Requests for Comments • Is it clear what the policy requirements are for Transplant Hospitals? Is it clear how the OPTN Contractor will audit these requirements? • Is the process for matching participants in the OPTN KPD Program transparent? • Are the informed consent elements that are specific to KPD appropriate and complete?

36. Proposal to Include Bridge Donors in the OPTN Kidney Paired Donation (KPD) Program

38. Bridge Donor Definition • A donor who does not have a match identified during the same match run as his paired candidate

39. Details of Proposal • The bridge donor policy modifies policy language currently out for public comment in the KPD Policy proposal. • A donor chain in the OPTN KPD Program may end with a donation to a waiting list candidate or a bridge donor.

40. Details of the Proposal: Choices • A chain will end with a bridge donor only if all of the following are true: • The donor at the end of the chain agrees to be a bridge donor • The potential bridge donor’s center is willing for the donor to be a bridge donor • The center entering the NDD that started the chain agrees for the chain to end with a bridge donor

41. Details of the Proposal: Consent • In order for a potential donor to be a bridge donor, the potential donor must consent to be a bridge donor at the following times: • Before the potential donor’s Transplant Hospital enters that the potential donor is willing to be a bridge donor in the KPD℠ application in UNet℠ (typically at the time of informed consent to participate in the OPTN KPD Program),

42. Details of the Proposal: Consent (cont.) • In order for a potential donor to be a bridge donor, the potential donor must consent to be a bridge donor at the following times: • When the potential donor is identified as a bridge donor in a chain, and • Every 3 months after match run in which the potential donor has been identified as a bridge donor.

43. Details of the Proposal: Consent • Each time the potential donor consents to be a bridge donor, the potential donor’s Transplant Hospital must inform the potential donor that he may • continue to be a bridge donor, • donate to the waiting list, or • decline to donate.

44. Details of the Proposal: Consent • The potential donor’s Transplant Hospital must inform potential bridge donors: • of the process for determining whether a potential donor will be a bridge donor, and • that they may have to have another medical evaluation in the future.

45. Details of the Proposal • The potential donor’s Transplant Hospital may refuse to allow the potential donor to serve as a bridge donor. • When a chain breaks, the final donor in the chain may become a bridge donor provided that they meet the bridge donor requirements defined in the policy.

46. Specific Requests for Comment • Should there be a limit on how long a bridge donor will be allowed to wait in the OPTN KPD Program after his candidate receives a transplant?