Comments

OPTN Organ Procurement Organization Committee | 09/21/2023

The OPTN Organ Procurement Organization Committee thanks the Kidney and Pancreas Transplantation Committees for their work and for the opportunity to comment on this request for feedback. The OPO Committee’s comments focus on Dual Kidney allocation. 

A member commented that the system isn’t set up successfully right now to have efficient dual kidney placement. This could be attributed to how the match run looks, how it is unclear who is and is not accepting dual kidneys, or who is managing dual kidney organ offers altogether. They emphasized that there are more issues to this process than what was presented in this proposal.

One member expressed concern that running a new match run would require the OPO to make new offers to the same candidates and programs, including those where the program has entered a provisional yes. Another member explained that the “carry over refusal” functionality and updates to the “donor refusal” functionality will hopefully reduce this. The member also noted that the OPO would likely have received declines from those programs and candidates on the single kidney match run before beginning to allocate on the dual kidney match run.

A member shared that their OPO aggressively offers kidneys as dual once the donor meets certain criteria, including cold ischemic time considerations. The member noted that their OPO is transparent when making single kidney offers if the donor is more likely to meet that criterion. The member continued that dual allocation for hard-to-place kidneys needs to occur quickly, so that the organs can be rapidly transported to the programs that will transplant them so cold time can be minimized. 

A member agreed and noted that their OPO uses a cold ischemic time trigger to begin dual allocation The member expressed support for OPO discretion in dual kidney allocation, particularly because each OPO’s practice currently vary based on local programs and considerations specific to the OPO. Another member shared that the timing of biopsy results is a potential trigger for dual kidney allocation at their OPO.

American Society of Nephrology | 09/19/2023

Dear Dr. Rudow, Dr. Kim, and Dr. Olaitan:

On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) request for feedback on “Efficiency and Utilization in Kidney and Pancreas Continuous Distribution.”

Maximizing patients’ access to kidney transplant—and ensuring that access is equitably available to all patients—is of utmost priority for ASN. The society stands ready to work with OPTN, and the OPTN Kidney and Pancreas Committees, to achieve this goal. The OPTN Kidney and Pancreas Committees have put several years of work into envisioning a future system of continuous distribution, and as the operational considerations and next steps outlined in the request for feedback make clear, more crucial work remains before this vision can be finalized and implemented.

Accordingly, ASN supports the Wednesday, September 13, 2023, announcement that the originally anticipated timeline for progression to continuous distribution for kidney and pancreas is being revised to allow the committees to further consider and apply approaches to increase organ usage and increase efficiency in their eventual proposals. ASN appreciates OPTN’s commitment to creating numerous opportunities for the entire community to provide input to the task force’s important work, including through the forthcoming September town hall, and stands ready to support this effort however possible.

Identifying strategies to mitigate the growing number of organs that go unused, tackling the root causes of out-of-sequence offers and “list-diving,” expanding adoption of best practices to increase efficiency, and embracing emerging science in terms of organ donation, recovery, and preservation, are all examples of efforts that will strengthen the transplant ecosystem overall and contribute to a more successful eventual new approach to kidney and pancreas allocation. Increasing transparency, particularly to patients, is likely to play a key role in achieving many of these objectives. In addition to policy considerations, ASN also highlights that numerous advancements in infrastructure and technology must first be achieved to realize the promise of continuous distribution.

This task force, together with the OPTN Modernization Initiative, represent important opportunities to implement structural and policy changes, and invest in innovative technologies, that will pave the way for optimal eventual adoption of a system of continuous distribution. Throughout these efforts, ASN urges OPTN, the task force, the Health Resources and Services Administration, and other stakeholders to continue to prioritize maximizing patient access to transplantation and ensuring that access as equitable regardless of race/ethnicity, socioeconomic status, geography, and sex/gender.

While ASN strongly supports the integration of the results of the task force into the continuous distribution system, the society also recommends that OPTN consider opportunities to adopt policy changes such as those described above on an ad hoc basis in advance of implementation of the continuous distribution system.

ASN offers input on select aspects of the request for feedback on “Efficiency and Utilization in Kidney and Pancreas Continuous Distribution.” Again, the society commends the committees for their extensive consideration of these wide-ranging operational details.

Continuous monitoring:
As this multifaceted, detailed paper makes clear, there are a host of nuanced technical aspects that must be considered in the transition to a system of continuous distribution. ASN commends the committees’ and OPTNs’ efforts to identify the best possible approaches to addressing these complexities, including seeking community input, in advance of policy finalization. As we move, in the coming years, into implementation, close monitoring of the new system utilizing both process measures and outcome measures will be essential to allow us to assess whether the system is meeting its intended goals and if there are unintended adverse consequences. The results of these monitoring efforts should be shared with the research community in as close to real-time as possible to facilitate understanding of the effects of the new system and to support opportunities for improvement to increase patient access and equity as new knowledge is obtained.

Released Organs:
Overall, ASN encourages prioritizing minimizing the risk of potential organ nonuse, improving utilization and thereby increasing access to transplantation, in any policy governing how released organs are handled.

The committees seek input regarding whether to “carry over” certain refusals from an original single match run to subsequent released kidney match runs (which may occur in instances such as when a program has accepted an organ and subsequently choose not to transplant the organ, releasing it back to the organ procurement organization). Given that a released kidney would be in jeopardy of discard, ASN believes that utilizing a shortened list of potential centers who are willing to accept the organ makes sense. OPOs should run a released organ match run carrying over refusal reasons from the original match run.

ASN recommends that all refusal codes be carried over, not just the list of suggested refusal codes included in Appendix A. Carrying over some refusal codes and not others is likely to result in gaming: some centers may disproportionately select the decline codes that do not carry over. In particular, ASN recommends that the projected cold ischemic time (CIT) be carried over, as the time will likely have already accrued. However, this approach would need to be monitored and studied to understand the effect on utilization over time.

As noted later, ASN does not support “carrying over” qualifying refusals from the single kidney match run to the dual kidney match run. The society believes centers would likely have very different reactions to being able to use both kidneys versus one kidney, and would be most inclined to consider them for patients who have been prespecified as dual kidney candidates.

ASN generally agrees with the committee’s recommendation to support an increased weight for placement efficiency on the released kidney match run. However, safeguards should be put in place to ensure increased efficiency weights do not allow a center to game the system by accepting a kidney and subsequently decline it, releasing it back to the pool in a manner that ensures that is returns to the same center. It is impossible to address the extent to which placement efficiency should be prioritized be on the released kidney match run without modeling.

Crucially, rates of organ releases by centers should be tracked and publicly reported.

National Kidney Offers and Kidney Minimum Acceptance Criteria Screening Tool:
The differences between Kidney Minimum Acceptance Criteria (KiMAC) and organ offer filters are subtle and confusing even to experts who have given significant attention to these issues. ASN recommends that the nomenclature be modified so that there is one set of program level filters and one set of patient level filters to limit confusion.

The committee recommends that KiMAC would apply to candidates on the last 92% of the match run, based on the program’s indicated donor criteria. ASN respectfully posits that it should instead apply to 8% of the candidates. Currently, centers are less likely to accept marginal kidneys for patients at the top of the list and more likely to accept them for those patients who have accrued fewer allocation points. As a result, centers tend to be the most selective for patients with the highest priority. It makes more sense to apply filters (or KiMAC) to the top of the list rather than the bottom of the list. Also, centers should be able to determine where to set their threshold (i.e. to which sequence numbers they wish to apply these filters).

ASN believes that it should be up to the discretion of each center which patients KiMAC applies to, as opposed to having a blanket nationwide mandate (such as based on CPRA, or for whom the program’s minimum acceptance criteria does not apply). Further research into clearly defining “hard to place” kidneys to improve the utilization of such organs using KiMAC should continue.

Dual Kidney Allocation:
ASN supports allocating kidneys as dual via a separate, dual kidney specific match run, however, the society notes that offering dual kidneys with KDPIs as low as 35% would not make sense. The goal of dual kidney allocation is to provide a patient survival advantage over single high KDPI kidney transplantation, and to encourage utilization of more medically complex kidneys—kidneys that are definitionally not going to have a KDPI in the vicinity of 35%.

ASN does not support “carrying over” qualifying refusals from the single kidney match run to the dual kidney match run. Dual kidneys should have their own match run. The society believes centers would likely have very different reactions to being able to use both kidneys versus one kidney and would be most inclined to consider them for patients who have been prespecified as dual kidney candidates.

Clearly defined criteria should be established for when kidneys should be considered for dual placement. The committees and/or OPTN should identify characteristics that lead to a kidney being considered primarily for dual placement and develop policy so that all OPOs use those same donor factors in their decision-making, as opposed having each OPO make its own determination as to whether kidneys are run as a single or a dual match run. As part of the considerations regarding dual kidney allocation in the new system, ASN also encourages OPTN to surface the successful features KSAM for duals in the past.

The committees inquire whether programs should be required to obtain patient consent prior to opting candidates into receiving dual kidney offers. ASN strongly encourages the use of prospective shared decision-making tools in informing the decisions made on patients behalf regarding organ offers, as well as greater routine retrospective information sharing with patients regarding organ offers that were declined on their behalf. However, there is nothing inherently “bad” about a dual kidney, and studies have shown their function and relative benefit to being off dialysis. Education and consent prior to the surgery are essential, but a nationwide policy mandating prior consent at the time of listing does not seem necessary at this time.

Kidney-Pancreas Offers:
The committees inquire what candidate characteristics should be considered in determining the mandatory Kidney-Pancreas shares threshold. ASN supports maintaining the 250 nautical mile distance for facilitated pancreas bypasses as well as the proposed qualifying criteria, including a metric to weigh the severity of hypoglycemic unawareness. For example, a threshold of events per year could be considered (recognizing, however, that one event is enough to change an individual’s mental function and capacity.)

In sum, ASN appreciates OPTN’s and the committee’s dedication to ensuring every aspect of the anticipated transition to continuous distribution, including factors that will be considered by the forthcoming task force, are given appropriately detailed consideration. The society appreciates the opportunity to provide input and looks forward to continuing to do so through every possible avenue moving forward. Please contact ASN Strategic Policy Advisor Rachel Meyer at rmeyer@asn-online.org with any questions or to discuss this letter in more detail.

Sincerely,

Michelle A. Josephson, MD, FASN
President

View attachment from American Society of Nephrology

Region 8 | 09/19/2023

A member said that it will be important when reallocation match runs are utilized to be sure centers that are receiving a repeat offer from the same donor are clearly informed of that fact as a part of the notification. And added that the reason for the reallocation should be clearly provided in the donor information on DonorNet. A member institution said they agree that the "utility" aspect of donation/transplantation needs to be given more weight. Overall, OPOs need to be able to proceed to dual allocation earlier, or to be granted more leeway with released kidneys. There needs to be a higher weight to proximity especially for released kidneys. And they do not support medical urgency for pancreas allocation. An attendee said the OPTN should provide guidance to OPOs when re-running the list (particularly as operational details of re-running the list and managing previous responses is in one of the current public comment proposals). They suggested that if a list is re-run and an organ re-allocated then the OPO should put the reason the list was re-run and the key changes to the donor history (if any) at the top of the donor information you see when you pull up the donor in DonorNet. Ideally that information (or at least the fact that this is a re-allocation) would also be part of the DonorNet offer notification.

·      A member pointed out that prior to developing continuous distribution for kidney and pancreas, the committee should look at the lessons learned from the lung implementation and make adjustments to improve efficiency.

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Dual Kidney Eligibility Requirements

§ Several members emphasized the need to look at efficiency in organ placement. Attendees suggested the single kidney should be offered before the dual kidney. And when offering the dual kidneys timing and logistics should be factors to consider. As far as what percentage of single kidney match run should be allocated, the percentage should be based on technology and an algorithmic input of donor criteria, post cross-clamp logistics, and using artificial intelligence to determine the likelihood of placing the kidneys as single versus dual. An attendee explained that exhausting a single kidney match run first is inefficient and that we have the technology to look at the non-utilized organs that have not been placed. A member suggested to look at a combination of donor criteria and how the single match run is progressing and has progressed. A group of members said they don’t support in percentages because they vary by blood type and by area. And do not support the combination because that’s what is currently in effect with single and dual and is inefficient.

§ Regarding the policy definition of when an OPO should begin allocating kidneys as dual, 25% of virtual attendees believed it should be based on donor criteria alone, 16.7% of virtual attendees believed the kidney should be offered as single first, and 58.3% of virtual attendees believed it should be a combination of donor criteria and offering the kidney as single kidney first.

o  Pancreas Medical Urgency clinical guidance

§ Several virtual attendees supported the inclusion of an exception-based medical urgency attribute for pancreas and suggested hypoglycemic unawareness as the qualifying criteria.

o  Mandatory Kidney Pancreas Shares Threshold

§ Regarding re-running match runs, an attendee suggested that if there is going to be another match run then the information of why another match was run, and notification that another match was run, is important to communicate. A member commented that from an equity standpoint, all allocations of kidneys with an extra renal organ should occur in order of the candidate on the kidney list. 

Association of Organ Procurements Organizations | 09/19/2023

As we have stated in our previous comment on this proposed policy in 2022 and earlier this year, AOPO continues to support the ongoing efforts of the OPTN to implement the continuous distribution of kidneys and pancreata based on the current data.

 In general, AOPO is hopeful that the continuous distribution methodology for kidneys will help reduce the substantial variation in utilization of kidneys based on the Kidney Donor Profile Index (KDPI) calculation as well as other factors. AOPO is hopeful that the continuous distribution methodology will be constructed in a manner that significant increases in kidney transplantation rates by increasing utilization of kidneys from medically complex donors.

AOPO agrees with the goal of ensuring any changes to allocation do not create unintended disparities for either kidney or pancreata recipients, especially for any vulnerable or already disadvantaged populations. AOPO recommends the OPTN collect more granular data to assess HLA matching for both kidneys and pancreata as part of this allocation process.

 AOPO supports prioritizing highly sensitized candidates, prior living donors, and pediatric candidates in the new system. AOPO believes in a piece-wise linear approach and emphasizes the importance of assigning more points to attributes that will drive increased efficiency of allocation for organs with lower quality or complexity (such as DCD). It is imperative that the OPTN develop and implement the use of transplant program organ acceptance filters and predictive analytics to match medically complex organs with candidates at transplant centers that will accept them in order to reduce non-utilization rates. We implore you to implement the usage of these tools before execution of this policy. In general, organs from medically complex donors should be allocated to candidates at transplant programs closer to the location of the organ recovery in order to minimize the impact of travel time on organ utilization and outcomes.

 In addition to proximity and transportation, a points-based system should be considered for the virtual crossmatching of recipients to drive efficiency and minimize the time for organ allocation, placement, and transplant time. Additionally, a continuous distribution framework should allow OPOs the freedom to use dual allocation of marginal quality kidneys to increase utilization and decrease non-transplantable organs.

In closing, as part of their research to develop this policy we implore this policy development committee to learn from other developed countries where 62% of kidneys declined in the United States would have been successfully accepted and transplanted.1

1. Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 October1; 179(10):1365-1374.

OPTN Transplant Administrators Committee | 09/19/2023

The OPTN Transplant Administrators Committee thanks the OPTN Kidney Transplantation Committee for their dedication and work on this project. The Committee recognizes the difficulty in developing a continuous distribution policy that works for all programs and applauds the Kidney Committees efforts as they develop this further. The Committee looks to engage in future conversations regarding attributes for allocation.

Region 9 | 09/19/2023

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Pancreas Medical Urgency

§ One group stated that there isn’t a lot of information for this criteria to define whether it should be included, and they suggested engaging endocrinologists to better define pancreas medical urgency.

§ Another table shared that OPOs currently struggle with placing kidney/pancreas and isolated pancreas, so they’re not confident that if they’re already exhausting the list right now, what a medically urgent pancreas patient would gain. They also added they’re not really sure what pancreas medical urgency means.

§ A member commented that there are very few pancreas candidates as it is, so the number who would qualify as medically urgent would be very small; therefore the impact of having a medically urgent classification would be minimal on the entire population, so they support pancreas medical urgency.

o  Mandatory KP Shares Threshold

§ One table remarked that from an OPO perspective, defining criteria for mandatory kidney/pancreas shares is a good thing, but mandatory multi-organ shares policy overall needs to be clarified. There needs to be a definition of criteria of what patients take priority and specifics on where kidney/pancreas allocations fall with other multi-organ policies.

§ An attendee commented that the community is constantly trying to adjust the kidney/pancreas allocation, but there is an opportunity to use data to evaluate the benefits of simultaneous kidney/pancreas transplants. 

o  Dual Kidney

§ A group wondered if there was an opportunity to have two separate match runs, based on percentage or on cold ischemic time. A percentage of the match run is too broad due to the size of the match run, so maybe cold ischemic time would be a better option.

§ Another table said they think it should a combination of donor factors and a percentage of the match run. They also suggested looking at cold ischemia time and the size of the kidney; should also provide the tx center for recipient considerations. 

§ An attendee commented that 50% of high KDPI kidneys are not used and suggested allocating all those kidneys as dual and let the center decide whether to keep them as dual or use them as single. The attendee thought this would lead to better outcomes and more transplants.

NATCO | 09/19/2023

We thank the OPTN Kidney and Pancreas Transplantation Committees and the Utilization Considerations Workgroup for looking at components and operational considerations that increase the efficiency and utilization of kidney and pancreas organs while looking at individuals holistically. NATCO is in support of proposals with the following feedback:

Released Organs:
• All components of the kidney and pancreas continuous distribution policy must also support the reduction in non-use of donated organs. We fully support an increased weight for placement efficiency on the released kidney match run, which should be significantly higher given the likely CIT at the time of new match run generation. We support both carrying over refusals and the recommended refusals to be carried over to the released kidney match to promote efficiency. We believe policy should also include that all centers who accept an organ must identify and prepare a suitable back up candidate. This safety measure avoids preventable discard of otherwise transplantable organs. Finally, we strongly believe a 3rd option for the Donor OPO to grant center back-up should also be included for kidneys. Based on the existing factors, including but not limited to why the organ was declined after acceptance and the current CIT, the Donor OPO can choose which option will maximize the opportunity for a transplant outcome.

Kidney Minimum Acceptance Criteria Screening
• We support applying the KiMAC at 8% of the match run, with the exclusions as proposed.

Dual Kidney Allocation:
• Dual kidney utilization continues to be underutilized for hard-to-place donors. However, the new continuous allocation system should continue to promote the best utilization of these rare gifts. While we understand the concept of allocating kidneys as dual via a separate, dual specific match run, we believe this will add unnecessary complexity given the number of offers being considered at any time by centers. There should be a way to simultaneously allocate down both pathways on the same match, requiring centers to decline or express interest for individual candidate(s) or for all candidates as either single, dual, or both when reviewing the offer. It shouldn’t require a separate match run or separate offer. OPOs should be able to see potential interest in single and dual kidneys on the match run and make the decision to move to dual kidney allocation to maximize kidney utilization based on indicated interest and dual kidney eligibility criteria.
• If dual kidney eligibility threshold is based on criteria, it should incorporate a combination of CIT > 4 hours, any history of diabetes, hypertension of any duration, glomerular sclerosis > 10% regardless of KDPI, DCD status, and/or CVVH/CRRT/dialysis during terminal admission.
• If a separate dual kidney specific match run is adopted, we support the proposed efficiency considerations and carrying over qualifying refusal codes. Dual kidney match runs should incorporate an increased weight on placement efficiency given the impact of CIT on successful allocation.
• If dual kidney eligibility requirement is based on offering the kidney as single first, we would support using the same proposed 8 % of the single match as the KiMAC
• Transplant programs should be required to obtain patient consent prior to opting candidates into receiving dual kidney offers and should have to qualify to be eligible to receive dual kidney offers and maintain their eligibility by performing a certain number of dual kidney transplants in a specified timeframe.
• While the offer filters tool will include dual kidney as a filter option, efforts should be made to accelerate their mandatory use, make them even more dynamic, and require continuous re-evaluation and updating, to make both single and dual kidney allocation more efficient.

En Bloc Kidney Allocation
• We support the committee’s recommendations to utilize the en bloc coefficient within the KDRI calculation.

Facilitated Pancreas/Mandatory Kidney-Pancreas Offers/Pancreas Medical Urgency
• We support the recommendations of maintaining the 250NM distance for both the qualifying criteria and when facilitated pancreas bypasses are applied and increasing the number of pancreata transplanted from 2-4.
• When determining the mandatory KP shares threshold, we support maintaining a KP priority like current policy to promote successful placement and use of pancreata, given the overall decrease in pancreas utilization. However, we should continue to evaluate the overall impact of multi-organ shares and their specific impact on priority kidney alone candidates including pediatrics.
• We agree that pancreas urgency should be determined due to hypoglycemic unawareness, however, establishing criteria for this is difficult. For example, individuals who control their diabetes well may have fewer hypoglycemic episodes. On the flip side, an individual who has poorly controlled diabetes may experience a multitude of hypoglycemic episodes. How do we determine who is suitable for a pancreas transplant using hypoglycemic unawareness fairly if it heavily depends on the patient’s management? We need to understand how this data will be captured and reviewed for accuracy. Should we look at providing two to three instances of hypoglycemic unawareness as part of the definition? Careful consideration with caution should be placed so that we are not denying individuals who deserve to be listed.
• Things that need to be considered in terms of pancreas medical urgency are establishing a point system, length of DM, and ensuring there are standardized expectations.
• We need to ensure that nothing in the policy will further restrict those patients who need multi-visceral and liver transplants.

Region 3 | 09/19/2023

Several attendees recommended that the committee take distance into consideration when modeling the composite allocation score. 

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Pancreas Medical Urgency clinical guidance

§ One group recommended incorporating medical urgency. The two main factors discussed were age, particularly reaching a specified age point established by the center, and the rapid progression of peripheral vascular disease. The concern arises from the potential for an elevated non-utilization rate due to broader distribution and a 250nm system with kidney/pancreas.  They added that there needs to be specific criteria to ensure fairness for all centers utilizing medical urgency.

§ One group talked about exhaustion for dialysis as medical urgency for pancreas and kidney pancreas candidates.

o  Mandatory Kidney Pancreas Shares Threshold

§ Two groups commented that if we move towards a composite score, the proximity points need to be the weighted the heaviest. They added that commercial flights and cold ischemic time are important factors. The ability to accept an offer without relying on commercial flights is important. They added that the emphasis should be on quick, nearby placements for pancreas.

§ One group commented that it will be important for the Pancreas Committee to collaborate closely with the OPO Committee. They also recommended using efficiency matching so that candidates get more points the closer they are to the donor hospital. 

§ One attendee attending virtually commented that kidney/pancreas allocation should not go to continuous distribution based on the current non-utilization rate but should be used locally. They added that any composite allocation score should be heavily weighted for candidates within 150NM of the donor.

o  Dual Kidney Eligibility Requirements

§ One group commented that the requirements should be a combination of donor factors. They went on to comment that selecting criteria based on a number of factors such as donor age, hypertension, biopsy results, and pump characteristics.  Another suggestion was using a timeframe for pivoting to dual allocation. The group did not support allocating down a certain percentage of the single kidney match before moving to dual.

§ Another group agreed that a percentage threshold is not the way to go. They recommended rather than a percentage of the match run, the committee should consider donor characteristics that would impact the likelihood of the kidney being placed as a single. 

§ Virtual attendees commented that they agreed with the comments in the room about donor criteria and added that cold ischemic time (CIT) should be a factor used by OPOs to move to dual kidney allocation.  

Gift of Life Donor Program | 09/19/2023

Gift of Life Donor Program (PADV) appreciates the work of the Kidney and Pancreas Transplantation Committees work in this area. While we are generally supportive of a continuous distribution model, we believe more work is needed in ensure kidneys and or pancreases are allocated efficiently with shared accountability between OPOs and transplant centers from allocation through acceptance. As shared in past comments the increase in kidney nonuse has not yet been fully understood since the implementation of KAS 250 in March 2021. Furthermore, the implementation of continuous distribution of lungs has not been studied to identify areas of improvement for future policy in this area. Experience in both KAS 250 and continuous lung distribution should inform future policy development and consider rates of organ nonuse, impact on cold ischemic time and impact on OPO & transplant center resources. Without modeling it is hard to assess the impact of continuous distribution will have on the current transportation infrastructure used to move deceased donor kidneys. As of 8/31/2023 we have placed 2,531 kidneys under KAS 250, 90% were placed within the 250 nautical mile sharing radius and shipped via ground courier. While the overall distance traveled and cold time at time of transplant have increased, ground transportation failures are rare. It is not clear if, under continuous distribution, more kidneys will travel via commercial air flights thus increasing the opportunity for organ nonuse due to logistical failures.

We believe efficient kidney and pancreas allocation begins prior to donor recovery. Policy must include requirements for transplant centers to fully evaluate primary and back up kidney offers pre-recovery, determine recipient appropriateness, complete a final cross match (all kidney centers should have the capability to perform virtual cross matching to reduce need for sharing donor blood prior to recovery), ensure patient readiness & availability, and commit to accepting a kidney with acceptable intraoperative findings. Every kidney donor should have at least 5 potential candidates identified prior to organ recovery. When centers refuse to consider an offer until all intraoperative information is available, cold ischemic time increases and OPOs have trouble in completing sequential allocation. Well defined rules and definitions on the requirement of transplant centers to respond to pre-recovery offers, center back up, waivers and transplant center responsibilities during the allocation and acceptance process must be included in any policy related to broader organ sharing. As well as a system to hold both transplant centers and OPOs accountable to following these guidelines, e.g., a board to whom issues can be reported, statistics on issues with centers visible on the match run, mandatory use of filters for centers that repeatedly act in bad faith.

KDPI is the existing grading scale for donors and should be used to develop placement efficiency weighting. However, it could be improved by including other donor factors like DCD status, acute kidney injury, relevant medical history like hypertension and diabetes history, and timing of allocation. For example, if a case was expedited and allocation is beginning post recovery, greater emphasis should be placed on proximity as compared to a case in which allocation occurs pre-recovery. OPOs still spend too much time interacting with transplant centers who ultimately decline hard-to-place kidneys during sequential allocation. Upon receipt of electronic offer, most kidney centers enter a “Provisional Yes” on the match run without evaluating the offer. Even when called by the OPO, in most cases centers refuse to fully evaluate the offer until primary, resulting in multiple calls, and then they ultimately refuse. Each of these interactions increases cold ischemic time and the likelihood of kidney nonuse.

Regarding specific considerations related to released organs we believe that under continuous distribution, policy should allow OPOs to grant transplant center back up in the event the intended patient is unable to receive the kidney after its arrival. UNOS should monitor transplant center utilization in back up patients to ensure that an accepted kidney is not used for a backup patient more than 5% of the time. From the implementation of KAS 250 through 8/30/2023 2,525 kidneys have been placed for transplant from our DSA, 120 (3.7%) were ultimately used in a back up patient at the accepting center. We have not observed any concerning trends by centers when center back up is granted. In most cases, by the time a center notifies us that a kidney is not appropriate for the intended patient significant cold time makes sequential allocation of a released kidney challenging and would jeopardize utilization Additionally, tissue typing material may not be available to ship with the released kidney, and in some cases, the accepting center may have already started preparing the kidney for implant, this could create challenges in successfully repackaging the kidney and the availability of packaging supplies at the transplant center. In most cases it would be impractical for the OPO to retrieve the kidney and repackage prior to reallocation. Any policy change related to the released kidney policy should consider these concerns, all that could impact use of the kidney.

Gift of Life Donor Program supports broader use of KiMAC and making it available to OPOs for kidney allocation. We believe that the tool should be available for use prior to making electronic kidney offers and that OPOs should be able to re-apply the tool at any time as additional donor information is available. The KiMAC should not be applied to priority candidates such as high CPRA or 0 mismatch patients and apply only to candidates greater than 250 nautical miles from the donor hospital. Centers should be required to update their KiMAC twice per year based on realistic acceptance practices. During kidney allocation it remains evident many kidney transplant centers do not utilize the screening criteria available; most keep criteria wide open believing a good offer will be missed. It is our understanding from UNOS that thus far, only 146 or 63% of the 230 kidney centers are using offer filters to some degree. This results in match runs that are saturated with patients for whom the transplant center is not truly interested in considering. The use of offer filters in UNET should be mandatory for centers to reduce unwanted offers and allow OPOs and centers to quickly identify appropriate recipients.

For dual kidney allocation we do not believe a separate match run is needed. Transplant centers should have the opportunity to indicate on the single kidney match run whether they would consider a dual kidney and for which sequence number, this could speed up kidney allocation, or refuse the donor for both single and dual kidney acceptance. All refusal codes entered by a center on the single kidney match run should carry over to a dual kidney match run or if both single and dual kidney patients are on one match run, centers should be able to consider single and dual kidney offers concurrently.

Jonathan Fridell | 09/19/2023

I have concerns regarding the facilitated pancreas allocation protocol as described and the mandatory share. First of all, in the continuous distribution model, why is 250 nm still relevant?

In terms of the facilitated placement, I think the combination of increasing the amount of time prior to procurement and the number of "long distance" required imports in order to participate is ill advised. It seems to me that many OPOs haven't even started pancreas allocation until this point due to the complexity of multiple organ sharing. This would allow OPOs to wait until the the five-hour mark and only run a limited expedited list. Based on current transplant program volumes, I would guess that there are less than five, maybe even less than 2 or 3 centers that would meet the threshold of 4 long distance imports over two years. This would allow the OPOs to run a list with very few candidates using delaying tactics. If this has not been done, I would urge the pancreas committee to review the utilization of the facilitated pathway and establish how many programs would actually qualify. When this pathway was originally designed, the goal was to not offer expedited placement to a program that never imports pancreas allografts. 4 is way too restrictive.

For the mandatory kidney with pancreas, if boundaries are eliminated, was the argument made that perhaps all offers should require a kidney share with the pancreas? If the conclusion is to use a threshold, I hope there would be enough of an influence of distance that at least local (or what we used to refer to as local) and regional (or what we used to call regional or 250 AC) are included so we don't step backwards from prior policy.

Thank you for your hard work!

American Society of Transplant Surgeons | 09/19/2023

See attachment.

View attachment from American Society of Transplant Surgeons

Region 10 | 09/19/2023

Overall, participants expressed appreciation for the committee's efforts to enhance organ allocation efficiency. However, there was a shared belief that addressing all aspects requires active input from front-line coordinators in both OPOs and transplant programs. Such input was seen as crucial for identifying barriers that hinder optimal efficiency in the organ offer process. There was mixed feedback about how to define Pancreas Medical Urgency with one attendee saying that there does not need to be a category for pancreas medical urgency. However, another attendee suggested using a scale rather than a binary distinction. Another attendee added that there needs to be clear criteria similar to those seen in the strict cholangitis exception criteria for liver transplantation. For dual kidney allocation, attendees emphasized the importance of applying very strict criteria to avoid denying single kidney offers to unique candidates for whom those kidneys might be the sole option. Another attendee suggested considering the time aspect due to increasing cold ischemic time and decreasing acceptance rates. Additionally, it was recommended that donor eligibility should factor in age and the type of donation, DCD versus brain death. Another attendee noted that OPOs should be allowed to switch to dual kidney allocation after 20 transplant programs decline a single kidney offer from a donor.

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Pancreas Medical Urgency

§ One group stated that generally they support the concept of pancreas medical urgency, with the caveat that the Pancreas Transplantation and/or the Kidney Transplantation committees should work to establish objective criteria to define urgency and leave little room for ambiguity particularly in thinking about allocation. In defining that urgency, whichever criteria is established, it would be helpful to further define the directive and order of multi-visceral allocation. Currently, a lot of discretion is left to OPOs, and further clarification would be very helpful to increase allocation efficiency.

§ Another group felt that too many pancreata are getting turned down by programs already and there is too much room for gaming the system. They do not see a reason for having pancreas medical urgency.

§ Another group disagreed and felt that there is a need for pancreas medical urgency. Patients who have multiple readmissions for hypoglycemia or those with multiple motor vehicle crashes would be considered medically urgent. Most of these patients have medically difficult to manage diabetes, making small changes in insulin can lead to wide swings to blood sugars.

§ Another group discussed establishing a medical review board, as there is lots of experience in the heart and lung community. Certainly, there are challenges and difficulties, but it can help the system be more practical and efficient. It’s going to take a lot of understanding from the community, and there will be a lot of requests which can burden a review board. The lung community suggests having examples and guidance documents on how to write an exception available to the community.

§ Online attendees support the inclusion of an exception-based medical urgency attribute for pancreas. One attendee commented that the criteria should include if a candidate has tried a failed medical treatment for pancreas and has experienced fainting as well as a creatinine over 3mg/dL.

o  Dual Kidney

§ The first group discussed how should post cross clamp data be considered, which is the trickiest part. After some debate, for the purposes of allocation, post cross clamp data should not be considered. Set donor criteria to include Age, DCD, history and lab values, warm ischemic time in the case of DCD, and have criteria similar to split liver criteria. Kidneys that meet that dual kidney allocation would allocate first to dual kidney list and centers would have the opportunity to accept. If only one kidney is transplantable, the kidney is going to trickle down the list anyway to a program looking for a kidney like that. Defining donor criteria is the trickiest part of this.

§ Another group agreed with the first comment about criteria in general and dual kidney match run first. If allocation starts with single, programs should have the option to decline the single kidney offer, but be able to indicate that they are interested in a dual kidney offer. This would help with allocation efficiency as an OPO starts with dual kidney allocation.

§ The next group suggested that instead of offering to a certain percentage of the single kidney allocation match run, the threshold should be by region and number of centers or patients that declined the single kidney offer. They suggested that the threshold should be declines from twenty programs

§ Another group noted the high volume of offers and complexity of allocating donated organs and agreed that it will be difficult to establish dual kidney allocation. However, if accomplished it would greatly improve allocation efficiency.

§ The last group suggested adding dual kidney usage to current data reports. It would be helpful to see who is accepting dual kidneys and establish patterns.

§ A majority of online attendees voted for a combination of donor criteria and offering the kidney as single first. The majority also favored a match run offer threshold of 50-75% before the OPO can offer the kidneys as dual.

o  Mandatory Kidney/Pancreas Share Threshold

§ No comments

UC San Diego Health | 09/19/2023

The UC San Diego Health Center for Transplantation appreciates the Kidney and Pancreas Committee’s foresight in seeking the community’s feedback on how to successfully transition several operational components of allocation to continuous distribution with a focus on improving efficiency and encouraging increased utilization of medically complex donors and organs. The Center recognizes that the work on this project will be extended given the OPTN Board’s recent approval to create a task force to study and improve the efficiency of organ usage and placement. We look forward to additional updates the Committee may provide as this important work continues.

Region 7 | 09/18/2023

· An attendee suggested that the committees wait on releasing a final proposal for public comment until a detailed analysis of efficiency and logistical impacts on the system can be performed. This analysis needs to be considered on a system level, not an individual committee level. For dual kidney allocation, another attendee expressed minimal interest in making offers through a percentage of single kidney candidates, but strongly favored allowing OPOs to maintain discretion in establishing donor criteria. They added that pancreas transplant providers are the best resource to determine the plan for medically urgent pancreas candidates. For mandatory kidney/pancreas (KP) shares they agree with required KP allocation through a point, but without details of the attributes, or composite allocation score, it is difficult to recommend a stopping point before kidneys would be available for the kidney match. Another attendee noted that offer filters should be mandatory, requiring transplant centers to have a minimum of 3 filters for inside the 250NM circle and 3 filters for outside their 250NM circle. Additionally, OPOs should be allowed to perform national allocation. However, for dual kidney allocation should not be at the discretion of the OPOs as they are unaware if a transplant center would choose to accept a single or dual for their candidate with that donor's kidneys. There should be minimum donor criteria (such as percentage of glomerulosclerosis) that triggers an integrated dual list where the kidneys are immediately offered as dual, but the transplant center has the discretion to accept as a single or dual.

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Mandatory Kidney/Pancreas Share Threshold

§ One group noted that for candidate characteristics the committees need to define which characteristics are important for required KP shares. For example, high waitlist mortality due to hypoglycemia awareness.

§ The next group questioned if expanding mandatory KP shares is necessary. It would be helpful to review data on the distance between the donor hospital and the recipient.

§ Another group added that highly sensitized kidney patients warrant priority over KP shares. These patients rarely receive offers and the current allocation algorithm disadvantages high sensitized kidney patients.

o  Pancreas Medical Urgency

§ One group felt that pancreas medical urgency is not a priority since most pancreas candidates have less than a year of waiting time.

§ The next group noted that they would like to see what are the true clinical values that define a pancreas medical urgent candidate.

§ Online attendees favored the inclusion of an exception-based medical urgency attribute for pancreas with one attendee noting that previous transplant outcome should be included in qualifying criteria.

o  Dual Kidney

§ One group noted that there needs to be certain defined criteria that warrants dual kidney allocation, if certain criteria are met OPOs should go straight to dual kidney allocation. Their recommendation was to identify a certain kidney biopsy threshold as part of the potential criteria. 

§ The next group added that it should be the discretion of OPOs for when to allocate dual kidneys. Additionally, allow transplant programs the discretion to accept an offer as either single or dual kidney instead of having a specific dual kidney match run.

§ Another group noted that in order to reduce non-utilization it would be beneficial to define the criteria that transplant programs use when accepting a dual kidney versus a single kidney offer. Additionally, it may help with allocation efficiency to create a list of dual kidney candidates prior to the OR so that OPOs can switch to dual kidney allocation quickly.

§ The next group suggested establishing best practices for dual kidney allocation based on the transplant programs that are currently accepting dual kidneys.

§ Another group suggested that the committee need to determine the societal value of allocating dual kidneys and weigh these considerations before making policy.

§ The majority of online participants felt that the policy definition of when an OPO may begin allocating kidneys as dual should be based on a combination of donor criteria and offering the kidney as single first. The majority also felt that if a donor’s kidneys are being declined then OPOs should offer to less than 50% of the match run before the OPO can move to dual kidney allocation.

Region 1 | 09/15/2023

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

Dual Kidney Eligibility Requirements

One group shared that they believe it should be a combination of single kidney offers and donor criteria because every case is different. They suggested that donor factors and cold ischemic time should be considered. They did not think it should be after a certain percentage of the match run. With higher KDPI kidneys, such as kidneys from older donors, using a percentage of the match run may still take too long for the kidney to be utilized. They think a single placement attempt threshold should be based on CIT instead of a percentage of the match run. 

Another group suggested adding the ability for a center to decline for single kidney, but accept for dual kidneys, so that OPOs could see which programs were interested in what immediately. They also agreed that the policy should focus on cold ischemic time and other donor variables that put these complex organs at risk for non-use.

A member stated that about 50% of donors are over the age of 50 in New England, so these should go right to the patients that will accept them, and that the OPOs trying to place these kidney’s shouldn’t get flagged.

A group expressed support for using a percentage of the match run for dual kidney allocation. They added that kidneys that are taken as dual tend to be more medically complex and would probably need a biopsy. If the biopsy was not good, it would be best to offer those kidneys to programs that would actually accept them. OPOs need to be able to exercise discretion when allocating.

Virtual participants: 60% support a combination of donor criteria and offering the kidneys as single first, 20% support offering the kidneys as single first, and 20% support donor criteria alone. In terms of what percentage of the match run should be offered and decline the primary offer before an OPO can move to dual allocation, 66.7% support less than 50% and 33.3% support 50-75%

Pancreas Medical Urgency

One group said that because they do not believe you can quantify medical urgency for pancreas, they do not believe it should be included. 

Another member pointed out that for a medically urgent kidney candidate who also needs a pancreas, it might be worth having medical urgency for pancreas available for candidates in that situation so they can get offers for both organs. 

A group stated there is no medically urgent reason for allocating pancreas, and while medical urgency exists for kidney, it’s not clear whether that should qualify a candidate as medically urgent for pancreas too. 

A member suggested that perhaps pancreas medical urgency could be something determined by a review board. 

Another group agreed with the fact that pancreas medical urgency is difficult to define and could create an opportunity for gaming the system. 

Mandatory Kidney Pancreas Shares

A group said that mandatory kidney pancreas shares might result in a lot more delays in kidney allocation in cases where the pancreas is not recovered. 

Gift of Life Michigan | 09/15/2023

Thank you for the opportunity to comment on the proposed modifications from the UNOS/OPTN Kidney and Pancreas Transplantation Committees’ Continuous Distribution policy. We applaud all efforts to increase the utilization of all organ types.

We agree that the proposed changes should increase efficiency in the system and maximize the opportunity for timely placement and transplantation of kidneys and pacreata.

In response to the committee’s proposed change to “Released Kidney” placement in the continuous distribution model, we support the committee. The modifications incorporate logical adjustments to account for both proximity and refusal codes that should eliminate wasted time and effort for organs possibly already at maximum acceptable levels of ischemic time, thus improving the chances of the organs being offered to centers and patients equipped for those scenarios, while bypassing those with historical hesitancy about them.
We also support proposed changes to the “Kidney Minimum Acceptance Screening Tool (KiMAC)”. Again, the logic applied to the committee’s suggestions reflects realities in organ allocation that waste time and potentially remove transplantable organs from use.

We SUPPORT the committee’s recommendations to update criteria and policies for dual kidney placement. The proposed modifications to match-runs indeed suggests more efficiency; however, we urge caution unless the offer filters described in the proposal are mandated. Optional use of offer filters creates confusion and wastes time and effort unless all centers utilize the filters appropriately for their centers and patients. The proposed carryover refusals, also proposed for the KiMAC above, would strengthen the process. While we support the overall proposal for dual kidney allocation, it has been our experience that informed discretion in deciding which kidneys are suitable for dual kidney allocation is extremely important. The Kidney Donor Profile Index (KDPI) is a valuable tool; however, no tool can fully account for the unique characteristics of each donor or donated organ.

We believe the proposed modifications to facilitated pancreas placement appropriately adjust for center and/or patient criteria and behaviors in a more efficient manner. For example, pancreas acceptance tends to be low within the 250-nautical mile radius of this OPO, and using the OPTN system’s intelligence to denote those behaviors within and beyond the radius means a better chance of placing the organ in a timely manner wherever the most likely candidate is located. As in the above proposals, patients within the radius are not negatively affected by the change, thus maintaining the intent of broader use but with more possibility of placing the organ eventually. The incorporation of center acceptance utilizes logic to smooth allocation without disadvantaging patients based upon acceptance history.

We offer additional commentary that the utilization of pancreatic islet cells should be an integral part of pancreas utilization. Pancreas-only transplantation is relatively low, as is the number of candidates on the waiting list; however, restrictions and limitations in reimbursement and other factors are unnecessarily limiting the therapeutic transplantation of islet cells for many patients.

We support, in concept, the proposed modifications to Mandatory Kidney-Pancreas allocation. While we do not believe we possess the subject matter expertise to advise the committees on factors to determine a Composite Allocation Score (CAS) for those patients, we believe the CAS applied to this model would maximize the possibility of timely placement of those organs.

Region 6 | 09/15/2023

One attendee recommended the committee monitor cost and non-utilization rate.  

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions: 

oPancreas Medical Urgency clinical guidance 

One group commented that the lists are small and often exhausted without getting the pancreas placed. They supported whatever policy helps to get more pancreas transplanted should be prioritized.   

One virtual attendee supported adding hypoglycemic unawareness as a medical urgency criterion for pancreas distribution.  

oMandatory Kidney Pancreas Shares Threshold 

No comments  

oDual Kidney Eligibility Requirements  

Two groups commented that allocation should be prior to cross-clamp. They supported prioritizing dual allocation higher on the list and potentially including age and KDPI.  

One group commented that selecting specific characteristics of donors in a particular setting is challenging. They added that cold ischemia time should serve as a threshold for OPOs to start offering organs. Dual offers with long cold times are generally undesirable. They also supported using a percentage of the waiting list prior to cross-clamp and then using cold ischemic time as a threshold.  

One group commented that it is difficult to make a recommendation when we don’t know what the lists will look like. They added that it could be a different threshold for different areas of the country.  

One group commented that they recommended using high KDPI and age as a factor in determining how soon to move to dual allocation.  

One group commented that placing dual kidneys is challenging and it will be important to make it clear on the list which centers will accept dual kidneys. This was echoed by a virtual attendee who commented that any change to the process should allow transplant centers to indicate interest in single or dual at the time of the initial offer so that OPOs can allocation duals without having to re-run the match.  

One virtual attendee supported a mix of donor criteria and match run cutoffs to determine when to flip to dual kidney alone allocation. They added that the cutoff should be if the kidney isn't placed in the 100-250 NM range it should be given priority as dual kidney.  

OPTN Ethics Committee | 09/15/2023

The OPTN Ethics Committee thanks the OPTN Kidney and Pancreas Organ Transplantation Committees for their work on this update and for the opportunity to provide input. The Committee offers the following comments.

Comments on the Request for Feedback:

The Committee appreciates the work to increase utilization of kidneys that are hard to place. Dual kidney allocation should be data-driven and support utility. Carryover refusals for released organs and dual kidneys is a good place to start to eliminate duplication of offers/efforts.

Regarding the development of a pancreas medical urgency, this attribute is supported by utility and is in line with the exception process for other organs; however, it may be difficult to identify justifiable criteria.

Identifying appropriate kidney-pancreas shares is supported by the principle of utility; however, there is concern with respect to creating edge cases. This may potentially increase disparity for kidney patients who are not eligible for pancreas transplant. (And if this true, it undermines equity).

Regarding the prior living donor attribute, the Committee agrees that giving extra consideration to prior living donors is an important goal, but there was mixed feedback about the strength of the ethical justification for providing priority for living donors for all organs. It should also be noted that providing priority for all organs is established and a guarantee that prior living donors have been given. A change in policy may result in an imbalance of benefit between prior and future living donors.

Comments on the OASim modeling results:

The simulation results showing that AB transplant rates are more consistent with the other blood types is aligned with fairness in the system.

The Committee noted some equity-related concerns in the modeling results. We suggest that the Liver & Intestinal Organ Committee should proceed with caution given the results of the models that examined kidney transplant rates by race and the potential implications for social justice (especially for Native Americans and under some scenarios, Latino vs non-Latino). It is imperative that any organ allocation policy changes do not widen disparities or undo gains toward transplant equity from prior changes. Additionally, the high travel distance for pediatric candidates and decreased transplant rate for liver safety net kidneys are concerning. Regarding the graphs showing transplant rate by CPRA 60%+, and especially for CPRA under 99.5%, the tradeoff between efficiency and access errs too far on the side of efficiency for these groups.

The Committee asks for clarification on the following:

-         What is the expected impact of multi-organ transplant in considering the OASim results and how does this fit in with the recent MOT white paper?

-         OASim does not take into account the new kidney-after-heart, lung, or heart-lung safety net policy, so how should we anticipate the expected impact of these in CD?

-         What is the purpose and role of donor modifiers?

Finally, the Committee notes that the OASim report presents some complex results that may be difficult for readers with varying degrees of statistical literacy to digest. It may be helpful to include very brief interpretations of the results beside each figure.

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) is generally supportive of what is outlined in the request for feedback, “Efficiency and Utilization in Kidney and Pancreas Continuous Distribution,” and offers the following comments for consideration:

• Placement efficiency is of high importance for released organs to make sure that they are transplanted. OPOs should be allowed to place these organs in similar fashion as hard to place kidneys/pancreata to minimize cold time. The AST suggests that the OPTN require OPOs to run a released organ match run based around the previously accepting transplant program and supports carrying over previous refusals as outlined.

• The Committee has done a lot of background work to calculate percentage and sequence run data for appropriate use of kidney minimum acceptance criteria (KiMAC) in continuous distribution. The AST believes there should be further research into clearly defining “hard to place” kidneys to improve the allocation, placement, and utilization of such organs using KiMAC. The goal of increasing efficiency would be best met by immediately applying KiMAC to the entire match run, with a longer-term goal that transplant centers use the offer filters appropriately, the role of KiMAC will decrease, and the match run can be simplified with a combination of KiMAC and offer filters. Until then, we support KiMAC being run at 8% with the mentioned exclusions.

• The AST supports a dual kidney match run that carries over the qualifying refusals to minimize allocation time. As dual kidney allocations essentially include hard to place kidneys and time is of essence, the AST supports the placement efficiency attribute for this allocation. The AST also recognizes the existing complexities OPOs are required to manage and the lack of clarity around how to prioritize the variety of match runs that exist. If the OPTN determines a second, dual kidney match is not advisable, the AST recommends the creation of clearly defined donor eligibility criteria for dual kidney allocation and a modification to the current match run similar to the appearance of the mandatory kidney share indicator. This would provide OPOs the option to allocate kidneys meeting the aforementioned donor eligibility criteria as either single or dual as they work down the match run.

• If a separate match run on the same donor is generated (either for dual kidney or for released organs) it will be important for both the offer notification and the information in DonorNet to make this clear (including the reason for a separate match run and offer notification) so that centers recognize when they are re-reviewing a donor and can efficiently generate a response.

• The AST recommends that programs obtain patient consent prior to opting candidates into receiving dual kidney offers. Dual kidney transplants carry separate risks perioperatively that ought to be discussed prior to being listed on a dual kidney match run. In addition, without prior consent, the efficiency of placement of dual kidneys may be compromised if the intended recipient declines the offer simply for being a dual kidney offer because they had not previously been consented to opt in for the separate dual kidney match run.

• For dual kidney offers, the AST recommends the donor meet at least two of the following criteria:
o Cold time > 6 hours
o Terminal creatinine >1.5, cerebrovascular accident, and age >60
o Hypertension> 10 years
o Diabetes mellitus
o Kidney donor profile index (KDPI) >60% - glomerulosclerosis (GS) >10%;
KDPI 35-59% - GS >20%
o Vascular disease and >10% fibrin thrombi
o Anuria

• The AST recommends the OPTN creates a unique field for donors to capture dialysis/ continuous renal replacement therapy.

• The AST recommends waiting for 6% or Sequence >500 as a pre-procurement threshold for offering dual organs (given the organs match certain criteria mentioned above).

• The AST supports the recommendations for en bloc kidney allocation. Using the en bloc coefficient within the KDRI calculation to assign en bloc kidneys a KDPI score in continuous distribution is reasonable.

• The AST supports maintaining the 250NM distance for applying facilitated pancreas bypasses and the proposed qualifying criteria. The qualifying criteria should be applied for six months and reassessed on an annual basis. Regarding the proposed qualifying criteria from two to four pancreas transplants from donors > 250 NM in the previous two years- what percentage of pancreas transplants that are performed using grafts >250 NM from the donor are facilitated pancreas offers? With the current two transplants in two years threshold, 46 of 118 (39%) of programs are eligible for facilitated pancreas allocation. Raising the requirement to four transplants in years will reduce this percentage. If a center is no longer eligible for facilitated pancreas offers with this new proposal, and facilitated pancreas allocation is a major factor for how that center obtain pancreas grafts >250NM away, how would the program manage to regain the opportunity for facilitated pancreas offers in the future?

• The AST supports exception-based medical urgency for pancreas based on documented hypoglycemia unawareness.

• The AST wants to underscore the need to capture nuances in the point-based framework which may impact pediatric kidney and pancreas transplant recipients such as size discrepancy, or post-transplant survival, so that attributes which will impact organ access for pediatric patients get adequate weightage or priority.

View attachment from American Society of Transplantation

American Society for Histocompatibility and Immunogenetics | 09/14/2023

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback around the criteria or attributes that will be used for continuous distribution. ASHI supports applying the most weight for medical urgency, candidate biology, and factors associated with post-transplant graft longevity, including HLA matching and CPRA.

View attachment from American Society for Histocompatibility and Immunogenetics

Anonymous | 09/13/2023

It is difficult to know what is going to happen with this without real data. You may think you can predict who will be offered organs but you can't predict what individual centers will do. I am concerned that groups that are supposed to receive priority may not because of factors that are not accounted for with these models including cold ischemia time.

Region 5 | 09/13/2023

An attendee pointed out that donor criteria can change throughout the donation process, and as a result match runs should not be static. The attendee suggested that match runs should be able to evolve as donor information becomes available. Another attendee commented that while KDPI may be a good indicator of a kidney's quality, as time after cross-clamp increases, the kidney’s quality decreases, which should have a corresponding impact on the kidney’s allocation. The member suggested that OPO’s should not begin allocating kidneys after cross-clamp and offers should not be made in the middle of the night.

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Dual Kidney Eligibility Requirements

§ Several attendees suggested that the requirements should be based on cold ischemic time, or a certain number of hours within going to the operation room (6 hours), on the sole organ allocation list, then at a pre-designated time on the sole organ allocation list, switch over to dual kidney allocation list.

§ Attendees pointed out the importance of having another dual match run, one for centers that have a history performing dual transplants and one for those centers who do not. Centers who don't perform duals should be bypassed until they opt in and perform one (efficiency). The percentage of match run centers should be used, not the candidates. Another attendee suggested to only offer to centers that have a history of transplanting at least one dual kidney transplant beyond a certain distance, which will leave opportunity for centers to accept a dual only within a certain distance of a center.  

§ There should be three corresponding refusal codes: one to decline single organ offer, one for dual organ offers, and one for refusal code that says no to single offers but will accept dual organ offers. Another attendee center requested two refusal codes: one to accept as both single or dual, and another to refuse for single but accept as dual. The center also suggested that biopsy results could trigger reallocation as dual off later in the allocation process.

§ It was also suggested to use donor criteria (determined by SRTR) for very difficult to place kidneys that have at high risk of discards, and not have 56 different definitions. The member recommended to not use the percentage of candidates that have refused an offer but rather the percentage of centers that have declined the organ (the top of the match run list can be dominated by a local centers with very large waitlists).

§ A member expressed concern about allowing acceptance criteria metrics to be applied to a dual allocation list and organ utilization used in this manner is too variable for center measurement.

§ The majority of online attendees supported the use of a combination of donor criteria and offering the kidney first for the policy definition of when an OPO may begin allocation kidneys as dual.

§ For what percentage of the match run should be offered and decline the primary offer before the OPO can move to dual allocation, approximately 1/4^th of online attendees supported “50-75%” category, and approximately 1/3^rd of online attendees supported the “less than 50%” category, and approximately 1/3^rd of online attendees supported the "75-90+%” category.

o  Pancreas Medical Urgency clinical guidance

§ Many attendees suggested that pancreas medical urgency should be utilized for type 1 diabetic candidates, there should be standardized exceptions for unaware hyperglycemic candidates for pancreas only, and standard exception form for transplant professionals to utilize.  

§ Several attendees suggested that unaware hyperglycemic candidates should be the only candidates who receive a pancreas medical urgency exception.

§ An attendee suggested the exception should also include a category for diabetics who have been diabetic since childhood. The attendee pointed out the challenge would be around hyperglycemic awareness.

§ An attendee suggested the following clinical criteria for candidates who qualify for pancreas medical urgency: inpatient medical status, lack of vascular access, or inability to support with parenteral nutrition, hypoglycemic unawareness, and other kidney.

§ Several attendees commented that medical urgency scenarios should include lack of vascular access.

§ One member did not support the pancreas medical urgency exception pathway.

§ A center stated they disagreed with the facilitated pancreas policy as proposed. They explained that typically the pancreas match run contains a small number of centers and recipients; and that it is rare to not have a high quality pancreas placed using the traditional match run prior to the donor being in the operating room. The routine bypass of patients at non-facilitated centers by nature disadvantages these patients from equal access to donor organs. This is particularly true for the sensitized patient population, who are already limited in their access to donor pancreata due to the high sensitization. Finally, bypassing "non-facilitated" centers disadvantages all candidates on the waitlist at those centers from access to pancreas transplant, while also discouraging and impairing growth of upstart pancreas programs. If enacted, these members believed the proposed policy will provide an unjust advantage to waitlisted candidates at higher-volume centers, irrespective of their waitlist time or sensitization. They believed the proposed policy is inconsistent with the established criteria for prioritization of kidney-pancreas match run.

o  Mandatory Kidney Pancreas Shares Threshold

§ A patient listed for KP or candidate for KP but no longer has vascular access options should be amongst candidate characteristics considered in determining the mandatory KP shares threshold.

§ A KP should not pull ahead of pediatric candidates.

§ Hypoglycemic awareness should be the medical criterion for higher priority and mandatory KP share. There should be a standard exception form developed to establish the number, frequency, and severity of the episodes and standardized criteria to meet in order to meet the threshold. 

OPTN Pediatric Transplantation Committee Meeting | 09/13/2023

The OPTN Pediatric Transplantation Committee thanks the OPTN Kidney Transplantation Committee for the presentation and work on continuous distribution, and appreciates the opportunity to provide feedback. Overall, the Committee is highly supportive of the goal to increase pediatric transplant rate and access, however, it has significant concerns about the modeling results regarding travel distance.

The Committee is concerned that pediatric access or transplant rate may not actually increase as projected if transplant programs will end up declining many of the offers due to increased distance. The modeled transplant rates may not accurately reflect real-world scenarios because acceptance behavior cannot be accurately modeled, and in considering the two-year results from switching to acuity circles, increases in cold ischemic time and decreases in organ acceptance are predictable results from increased distances. Reduced organ placement efficiency and overwhelming centers with offer volume are very concerning, yet predictable, probable outcomes from the modeling results.

The Committee agrees the center-level acceptance filters do not currently provide adequate specificity to filter pediatric candidates, and that back-channel or indirect workarounds to increased distance for offers to pediatric candidates (e.g. decreasing pediatric priority to reduce their CAS and distant offers) are concerning and should be avoided. The Kidney Committee should consider addition of candidate-specific offer filters to allow centers to better handle offers, so that patients in areas with low population density with commonly longer travel distances can still access offers but centers are able to filter out offers from distances that are not feasible for them. Patient level filtering or sorting would be useful so that centers could distinguish among highly sensitized candidates and among candidates with long waitlist times. Another, more direct option, would be to adjust the travel efficiency attribute based on recipient and donor characteristics that are associated with likelihood/feasibility of accepting distant offers. The Committee notes that the system must be created and validated for use specifically for pediatric candidates (not just an adult system with pediatric switches). There are age-specific considerations within the 0-18 year old group (a 17-year old candidate listed for a second transplant is very different from a baby).

Additionally, historic data on cold ischemic time and distance (even if not included in the modeling) would be helpful in forecasting expected impact of increased distances.

Increased pediatric access is very important, and the Committee recommends that the Kidney Committee move forward with solutions around managing increased offer volume without hampering pediatric access. The solutions around offer volume should be available at the same time as the proposal. The Committee looks forward to being a part of ongoing discussions about how to ensure continuous distribution works for pediatric centers and their candidates.

Region 11 | 09/12/2023

o Dual Kidney

• Several members commented that dual kidneys need to be offered sooner to improve utilization and that the process for expedited placement should be formalized and allow the OPOs more discretion. A member recommended using existing data to predict the probability of a single kidney being turned down and using that as the threshold for when they are offered as dual kidneys. Another member commented that dual kidney allocation is underutilized. In an online poll, over half respondents agreed that a combination of donor criteria and offering the kidney as a single first should be considered. The majority of respondents agreed that less than 50% of the match run should be exhausted before moving to dual allocation. 

o Mandatory KP shares

• A member commented that consideration should be made for kidney-alone pediatric candidates who are increasingly disadvantaged by mandatory kidney sharing with multiple organ adult candidates. Mandatory KP sharing further than currently experienced should occur only after pediatric candidates are offered a kidney. Another member commented that mandatory pancreas share should include other organ combinations as well as with kidney and allocating the pancreas with a liver and intestine or a modified multi-visceral should be highly prioritized due to the many other limitations in access to organs for this unique population of recipients.

o Pancreas medical urgency

• Recommendations from members for pancreas medical urgency included hypoglycemic unawareness, uncontrolled diabetes with multiple DKA events, and that it should only apply to Type 1 diabetics with a low BMI and low insulin requirement with a history of hypoglycemic unawareness. 

Midwest Transplant Network | 09/12/2023

Pancreas programs accept organs often with no intent or commitment for flight information or surgeon buy in..and late declines, no true evaluation of logistics and lack of commitment from these programs is the problem with utilization. More emphasis needs to be placed on looking at declines for perfect organs and the role the transplant center has in not making these perfect donors priorities for pancreas transplant. This is a very large issue and this is a spot where organ utilization is strongly lacking

OPTN Operations and Safety Committee | 09/11/2023

The OPTN Operations and Safety Committee thanks the OPTN Kidney and Pancreas Transplantation Committees for their work and for the opportunity to comment on this proposal.

Committee members provided the following feedback:

Dual Kidney

•There was a comment about how it takes too long to allocate hard-to-place kidneys, which leads to declines from transplant programs that would have accepted the offers if made earlier. Dual kidneys should be considered “hard-to-place” and OPOs should have the flexibility to offer them earlier. This could provide incentive for transplant centers to have separate criteria and identify candidates that are appropriate for dual kidney transplants. There was a suggested hybrid approach where option 2 could be offered out early and another subset of kidneys that for some reason, such as unusual anatomy, are in class 1 and can’t be offered as single kidneys and therefore get offered as part of a dual.

•There was a comment in support of establishing donor criteria over a percentage of the match run because, with complex donors or marginal organs, time is the most important consideration so OPOs should not be required to work down the match run.

•There was a suggestion to use a data-based approach to evaluate which patients are successfully transplanted as duals and developing criteria based on those patients. 

Mandatory Kidney-Pancreas Offers

•There was a comment about how there is a strong push from the pancreas and pediatric community to change multi-organ allocation so that only one kidney goes with any double-organ combination and that should be factored into the analysis. Additionally, it should be acknowledged that there are challenges with recovering pancreata and a high percentage of them cannot be transplanted. This leads to higher quality kidneys being placed with a local candidate and not the original pediatric or other multi-organ candidate. 

•There was a comment about the complex nature of multi-organ allocation and how kidney-pancreas candidates have a higher mortality rate and it is challenging to balance equity and utility with multi-organ transplants.

American Nephrology Nurses Association (ANNA) | 09/11/2023

ANNA supports all aspects of this request for feedback to improve efficiency and utilization of organs.

Region 2 | 09/01/2023

Multiple attendees suggested making offer filters more dynamic and mandatory based on transplant program historical transplant data and not allow the option to disengage the filters. The filters should be reevaluated on a three-year rolling cycle. Another attendee noted that for dual kidney allocation a combination of cold ischemic time, biopsy, anatomy, and match run considerations should be considered. Another attendee added that for dual kidney allocation if kidneys meet certain criteria, such as >30% sclerotic glomeruli, then the OPO should be allowed to go directly to dual kidney allocation.

 During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Dual Kidney Eligibility Requirements

§ An attendee noted that biopsy results should come into play before deciding to allocate as dual. Poor biopsy results should allow for immediate dual kidney allocation.

§ Another attendee stated that the current system fails at trying to place hard-to-place kidneys. There needs to be a whole new one to maximize efficiency, and there should be the flexibility to allocate any kidneys as duals but with the option to place kidneys singly if someone is willing.

§ Another attendee noted their support for allocating single kidneys first and then moving to dual if that is not successful. The focus should be on improving single kidney allocation methods.

§ Another attendee stated that mandatory offer filters are the only way to increase single kidney allocation efficiency. It takes too long to wait for centers to evaluate all of their organ offers.

§ Lastly, another attendee highlighted the need for firm criteria that define candidates as “hard to place” with the data to support it. Currently, offer filters are not suitable since they aren’t mandatory.

§ Online attendees voted for a combination of donor criteria and offering as single first. The majority also favored a match run offer threshold of less than 50% before the OPO can offer the kidneys as dual.

o  Pancreas Medical Urgency

§ One attendee noted that it is important to make sure that nothing in the policy further restricts access to patients needing multi-visceral and liver transplants. Additionally, there is concern that intestines cannot be procured because of pancreas allocation. This is especially a concern for pediatric candidates.

§ Another attendee stated that pancreas medical urgency should be based more on kidney criteria.

§ Another attendee expressed support for including two to three instances of hypoglycemic unawareness as part of the definition.

§ Online attendees supported exception-based medical urgency attribute. One attendee noted that hypoglycemia unawareness is a factor, but concern is how data will be captured and periodically reviewed for accuracy. 

o  Mandatory Kidney/Pancreas Share Threshold

§ No comments

Region 4 | 08/30/2023

One attendee commented that moving kidney and pancreas to continuous distribution needed to slow down so the committee can learn from lung continuous distribution in terms of what is working, what is not, and if there are any unintended consequences. They added that it seems as though each organ committee is working in a silo and not being informed by the practical experience of the community. They went on to comment that non-utilization of kidneys has increased in terms of percentage and real numbers since circles were implemented and we need to understand why before moving to continuous distribution of kidney and pancreas. Another attendee commented that they support investigating continuous distribution adding that the committee needs to prioritize pediatric candidates for kidney donor profile index (KDPI) under 35 donors. One attendee supported the efforts to improve kidney usage rates and decrease non utilization. They added that it will be important to decrease penalties for primary non-function to allow centers to take more kidneys without negative consequences. They also commented that there should be more communication between OPOs and centers to allow expedited offers for expanded criteria donor kidneys resulting in shorter cold ischemic times. 

During the meeting the attendees participated in group discussion sessions and provided feedback on one of three questions:

o  Dual Kidney Eligibility Requirements

§  One group of attendees commented about differences in the combination of using both donor criteria and offering the kidney as single first. They added that requiring allocation of a single kidney until a specific percentage of the match run has been offered to and declined is not the best idea and recommended using classifications and criteria within classifications to offer dual kidney as a better option when determining when to allocate kidneys as duel. They went on to comment that allocation of dual kidneys should be prioritized on the match to give more programs a chance to accept them.  

§ Another group commented that the definition of when OPOs may begin to offer kidneys as duals should be based on donor criteria much like expedited allocation for: DCD, expanded criteria donors (ECD), high KDPI, cold ischemic time (CIT), age, serologies, biopsy. They were not supportive of using a percentage of the single kidney match run. 

§ One group supported offering the kidneys first as single until a specific percentage of the match run had been offered to and declined but thought it should be up to the OPO to weigh in on when to pivot to offering the kidneys as duel.

§ One group supported offering the kidney as single first and if the OPO determines that the kidneys aren’t being taken quickly then offer as open offer allowing centers to choose to take as single or dual.

§ A majority of the online attendees supported using a combination of donor criteria and offering single kidneys first.

o  Pancreas Medical Urgency clinical guidance

§ One group of attendees recommended medical urgency guidance for patients suffering from hyperglycemia unawareness particularly if they are diabetic and had hospitalizations for self-injury from hyper and hypo glycemia. 

§ One group suggested using the criteria for islet transplant as a basis for criteria for medical urgency for pancreas.

§ There was mixed support for inclusion of an exception-based medical urgency attribute for pancreas with equal support for and against. 

o  Mandatory Kidney Pancreas Shares Threshold

§ One group suggested using median waiting time for kidney candidates on list before giving priority to combined kidney/pancreas.

§ One group commented that their biggest concern is prolonged allocation time when trying to place combined kidney/pancreas. 

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Kidney and Pancreas Transplantation Committees for their work and for the opportunity to comment on this proposal.

A member recommended that the OPTN Kidney and Pancreas Transplantation Committees consider applying the kidney minimum acceptance criteria (KiMAC) automatically to all match runs and not exempting the first 8% of the match run. advised starting at 0% in comparison to 8%. A member voiced concern with having two separate lists regarding dual kidneys and advised that they use one list. This can be done similar to how split livers are allocated, where transplant centers can select if they would be willing to accept dual kidney offers. A member suggested creating donor criteria for when potential dual kidneys could be offered, as opposed to creating programming into the match run or the creation of another match run. This would eliminate the back and forth between donor hospitals and accepting transplant centers, as they would know immediately if the potential accepting center would take the kidneys if offered as a dual. A member stated that the goal of this should be to make the process of procurement overall more efficient and running multiple match runs will make that more difficult. Another member recommended that dual kidneys be allocated first and be placed at the top of the match run.