Improving Allocation of En Bloc Kidneys Public Comment Proposal Kidney Transplantation Committee Finally, I will be presenting the Kidney Committee’s current public comment proposal, “Improving Allocation of En Bloc Kidneys.”

What problem will the proposal solve? No OPTN policy on allocating en bloc kidneys DonorNet® overestimates KDPI score for en bloc kidneys, potentially screening medically suitable candidates off the match run DonorNet ® has communication limitations As you all know, demand for kidneys far exceeds supply. One strategy to increase the donor pool is to utilize kidneys from small pediatric donors. To mitigate the complications and challenges associated with transplanting kidneys from these donors singly, both kidneys, including major vasculature, can be transplanted en bloc into a single recipient. However, there are currently several challenges to allocating kidneys en bloc. First, OPTN policy lacks provisions on how an OPO should allocate these kidneys, or which kidneys qualify for en bloc allocation. As a result, kidneys are often offered as en blocs late in the game, or not recovered at all. The Double Kidney Allocation policy does not cover en bloc kidneys, because clinically, en bloc kidneys will not meet the criteria in that policy. Although only about two percent of all kidney transplants are en bloc transplants, members frequently contact UNOS regarding how to allocate these kidneys, prompting us to develop a policy. Another issue is DonorNet® overestimates the KDPI score for en bloc kidneys. This has the potential to screen medically suitable candidates off the match run. The current KDPI scoring does not reflect graft failure risk for kidneys transplanted en bloc, since the implemented KDPI score assumes each kidney will be transplanted singly and does not account for the survival advantage associated with en bloc usage. Therefore, potential candidates who might benefit from en bloc kidney transplant may be screened off the match run because the KDPI for en bloc kidneys are inflated. Many candidates on the waiting list have a maximum acceptable KDPI value that may preclude them from these offers. In addition, DonorNet® currently does not allow for efficient communication. An OPO cannot indicate when it has en bloc kidneys to offer, nor does it require transplant centers to indicate that they accept and transplant kidneys en bloc.

What are the proposed solutions? Base allocation of en bloc kidneys on donor weight Allocate en bloc kidneys according to Sequence A Mask KDPI score in en bloc kidney allocation Centers must indicate to the OPTN Contractor that they accept and transplant en bloc kidneys in order to receive en bloc offers Surgeons can still split en bloc kidneys if they determine they can be transplanted singly Thus, we are proposing a new policy to address these challenges. There are five key tenets: First, allocation of en bloc kidneys will be based on donor weight. This donor characteristic is readily available prior to organ recovery and is a significant predictor of organ recovery from small pediatric donors. Second, en bloc kidneys will be allocated based on a deceased donor KDPI of less than or equal to 20%. Recent studies have found that en bloc kidneys have graft survival outcomes comparable to an ideal deceased or living donor. This will ensure all potentially eligible candidates have a chance to receive en bloc kidney offers. Third, the Committee opted to mask the KDPI value in DonorNet. Masking the KDPI will prevent candidates from being screened off the match run for high KDPI kidneys. Fourth, this proposal requires transplant centers to indicate to the OPTN Contractor whether they accept en bloc kidneys. Although this preference is already a part of the minimum acceptance criteria centers are asked to submit annually, many centers do not update their acceptance criteria on an annual basis or leave the en bloc kidney question unanswered. Furthermore, these criteria are only applied when allocation is facilitated by the Organ Center. Finally, it will be permissible for surgeons to split en bloc kidneys if they determine they can be transplanted singly into two recipients. We recognized that prohibiting splitting en bloc kidneys may be perceived as dictating medical practice, in addition to causing the unintended consequence of reducing the number of single kidney transplants. Thus, we attempted to reconcile these concerns by including a provision that allows the transplanting surgeon, based on his or her medical judgment, to split en bloc kidneys upon receipt of those kidneys. However, the receiving transplant program must do one of the following: Transplant one of the kidneys into the originally designated recipient and document the reason for not transplanting the kidneys en bloc. The receiving transplant program will decide which of the two kidneys to transplant into the originally designated recipient, and release the other kidney according to Policy 5.9: Released Organs. OR Release both kidneys according to Policy 5.9: Released Organs.

Supporting Evidence Before I get to the proposed policy solution, I’d like to share some supporting evidence with you. There is more in the paper for your review, but this graph is crucial to understanding how we arrived at our proposed weight thresholds. This figure describes current practice for en bloc kidneys: from 2010-2015, all kidney transplants from donors less than or equal to 5 kg were performed en bloc, and a vast majority of transplants from donors less than or equal to 12 kg were performed en bloc. For donors weighing 13-16kg, about half were performed en bloc, and half as single kidney transplants. En bloc transplants were very rare for donors greater than 25 kg. These data, in addition to recent studies, informed how we arrived at the proposed weight thresholds.

What are the proposed solutions? Weight recommendations Less than 15 kg = MUST offer as en bloc At least 15 kg and less than 25 kg = OPTION to offer en bloc or individually How will they be offered? En bloc: according to Policy 8.5.G to centers who have indicated they accept en bloc kidneys Individually: According to deceased donor’s KDPI Feedback: Should we increase weight threshold for mandatory en bloc kidney allocation and remove option to allocate kidneys from donors 15 to 25 kg? That being said, here is the heart of the proposal. We are asking for feedback from the community regarding the weight thresholds. As previously noted, allocation of en bloc kidneys will be driven by donor weight. If a donor is less than 15 kg, the OPO MUST offer those kidneys en bloc. If the donor is at least 15 kg and less than 25 kg, the OPO can offer those kidneys en bloc or as singles. However, the Committee is concerned we did not include explicit direction about when an OPO can switch from allocating kidneys individually to en bloc. We seek specific feedback pertaining to these weight thresholds. Should the weight threshold for mandatory en bloc kidney allocation be increased, and if so, should the option for OPOs to allocate kidneys from donors 15 to 25 kg as singles or en bloc be removed altogether? The provision allowing surgeons to split them if they determine upon receipt that they can be transplanted singly would remain. If kidneys are allocated en bloc, they will only be offered to candidates registered at centers that have specified to the OPTN Contractor that they are willing to accept en bloc kidneys, according to Policy 8.5.G Allocation of Kidneys from Deceased Donors with KDPI Scores less than or equal to 20%. If kidneys are offered as singles, they will be allocated as they are now, according to the deceased donor’s KDPI.

How will members implement this proposal? Transplant programs Must indicate willingness to accept en bloc kidneys if you want to receive offers This proposal impacts transplant centers and OPOs. Transplant centers: This proposal requires transplant centers to indicate to the OPTN Contractor whether they accept en bloc kidneys if they want to receive offers for en bloc kidneys. This proposal will allow transplant centers to manage acceptance of en bloc kidneys at the candidate or center level using listing defaults and Waitlist utilities. This option should mitigate administrative burden and more effectively ensure that only those candidates and centers willing to consider accepting an en bloc kidney offer appear on the match run. There may be financial implications to transplant centers, such as increased travel costs for high volume en bloc transplant centers to procure en bloc kidneys from regions or geographies that lack a center that transplants these kidneys. Current practice of charging one acquisition fee for en bloc kidneys is not expected to change in light of this proposal. OPOs Policy does not currently list donor weight as a required data element for kidney offers. It will now be required. If a surgeon opts to split en bloc kidneys, the OPO may be asked to allocate a single kidney.

How will the OPTN implement this proposal? June 2017 Board of Directors Requires programming in UNetSM IT Policy notices Communications Requires an education program Education Monitoring methods will not change Members are required to provide documentation as requested Compliance monitoring The Kidney Committee anticipates sending this proposal to the OPTN Board of Directors in June 2017 for consideration. This proposal will require programming in UNet. The IT estimate for this proposal is Very Large due to changes required in both the Waitlist and DonorNet. The OPTN will follow established protocols inform members and educate them on any policy changes through Policy Notices posted on the OPTN website and in Transplant Pro. This proposal will require an instructional program and will be monitored for specific needs throughout the development and implementation to determine the appropriate modality for educating members. Any data entered in UNet may be subject to OPTN review. Members are required to provide documentation as requested. UNOS will continue to review deceased donor match runs that result in a transplanted organ to ensure that allocation was carried out according to OPTN requirements.

Questions? Mark Aeder, MD Committee Chair mark.aeder@uhhospitals.org Project liaison: Kimberly Uccellini, MS, MPH kimberly.uccellini@unos.org I’d be happy to take any questions you have on the en bloc proposal before I move on to the Dual Kidney project update.