Comments

Region 10 | 03/19/2025

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee expressed strong support for a formal presentation on this topic to allow for discussion and clarification.  

American Society of Transplant Surgeons | 03/19/2025

Attachment.

View attachment from American Society of Transplant Surgeons

Region 9 | 03/18/2025

This was not presented at the regional meeting, but members were able to submit comments. An attendee shared strong support for the work, underscoring how a more holistic, points-based allocation system will improve equity and efficiency by prioritizing medical urgency, improving access for hard to match candidates, and addressing geographic disparities, which will ultimately lead to better outcomes and more effective organ use. 

Region 11 | 03/18/2025

Members expressed support for the ongoing effort to create continuous distribution of pancreata. One member expressed support noting they believed this will help reduce non-use of pancreata.

University of Arkansas | 03/18/2025

After reviewing the Winter 2025 update to the continuous distribution of pancreata proposal, we appreciate the additional information provided and offer the following feedback. We believe that it is important to standardize the distribution process for simultaneous Kidney/Pancreas transplants. Creating a standardized process will allow all centers/OPOs to communicate effectively during organ allocation. We feel that multiple patient attributes should be evaluated simultaneously, and a composite allocation score should be created to remove the barriers with categorized scoring.

NATCO | 03/17/2025

NATCO appreciates the opportunity to comment on this paper. We appreciate the committee’s work. In general, NATCO is supportive of Continuous Distribution but believe that changes in the allocation system must be carefully modeled and monitored to ensure that organ discards don’t increase. We are concerned that the number of pancreas transplants has decreased over the last few years. This needs to be studied closely. Possible reasons include KAS implementation, increase in DCD donors and lack of perfusion technologies to mitigate those risks, or simply intolerance of long cold ischemic times due to distance. Distance may also limit the ability of the recipient team to procure the pancreas but they are hesitant to rely on other procurement teams. We would suggest, as other commenters have, that local allocation be prioritized. The medical urgency criteria suggested appears reasonable, although we agree with other commenters that CGM is not accessible to all patients and they may not be able to meet this criteria. We would also support a medical urgency review board.

OPTN Transplant Coordinators Committee | 03/17/2025

The OPTN Transplant Coordinators Committee appreciates the opportunity to comment on the OPTN Pancreas Committee’s update on Continuous Distribution of Pancreata. Overall, the Committee is supportive of the Pancreas Continuous Distribution and appreciates the work that has been put into its development.

Region 1 | 03/17/2025

This was not discussed during the meeting, but attendees were able to submit comments. An attendee strongly supports moving forward with continuous distribution and agrees with the new criterion for medical urgency but raised concerns regarding a significant lack of efficiency in pancreas and kidney/pancreas allocation, with a suggestion that pancreas continuous distribution focus on improving efficiency and establishing more realistic donor criteria. Another comment emphasized prioritizing local allocation first, as time is critical for pancreas transplantation. On member shared that pancreas transplantation is seen as a primarily local-regional treatment, and there is significant variation across regions in the utilization of this therapy for diabetes management. In some regions, like Region 1, pancreas transplantation is rarely used, and expanding the allocation process broadly could unnecessarily complicate the system without offering significant benefits.

Association of Organ Procurement Organizations | 03/17/2025

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process on behalf of the Association of Organ Procurement Organizations (AOPO) during the Winter 2025 period. As we have stated in our previous comments on proposed policies related to the continuous distribution of organs, based on current data, AOPO is supportive of the ongoing efforts of the OPTN to implement the continuous distribution of pancreata. We consider the most critical goal in an allocation framework is to decrease non-use and non-utilization of pancreata. AOPO is concerned with the SRTR assessment that the existing models and methods may not be sufficient for reliably simulating pancreas utilization. AOPO implores the committee to continue work to ensure that organ nonuse will not increase under any proposed policy.

The Committee’s call for public feedback centers on the proposed pathways to identify medically urgent candidates. AOPO defers to the expertise of the patient care community to provide input on the questions raised. In closing, we ask that the committee continue to evaluate the use of medical urgency to increase the utilization of pancreata and to continue working on an allocation framework with an emphasis on efficiency and timely placement of organs.

Region 2 | 03/14/2025

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. There is support for implementing continuous distribution of pancreata to better match donated organs with patients, improving efficiency, equity, and transparency. Overall, transitioning to this system is appropriate. 

American Society of Transplantation | 03/13/2025

The American Society of Transplantation (AST) is generally supportive of what is outlined in the committee update, “Continuous Distribution of Pancreata, Winter 2025.” The AST agrees with the proposed qualifying pathways, noting that the Hypoglycemia Awareness Questionnaire impaired awareness subscale score and continuous glucose monitor time below range data are objective measures of hypoglycemia that pancreas transplant programs can consistently and effectively use to identify medically urgent pancreas transplant candidates.

The AST also supports the inclusion of evidence of a severe hypoglycemic event (SHE) in the previous six months and, separately, evidence of diabetic ketoacidosis (DKA) in the previous six months as medically urgent criteria for pancreas candidates. To support consistent assessment of these criteria for all pancreas candidates across pancreas transplant programs, and particularly considering the patient reporting aspects for documenting DKA and SHEs, the AST recommends the development of supplemental educational materials focused on assessing these medically urgent criteria, communicating with patients about the criteria and their assessment, and directions for submitting these applications for the Pancreas Review Board’s consideration.

In addition to these specific criteria, the AST recommends that the OPTN also includes a pathway that allows pancreas transplant programs to submit other medical urgency priority applications for the Pancreas Review Board’s consideration. This pathway would be limited to pancreas candidates who do not meet these defined criteria but would otherwise be objectively viewed as similarly urgent with comparable benefit as those candidates who meet the defined criteria for pancreas medical urgency priority.

Finally, the AST believes it is critical that the medically urgent criteria for pancreas allocation incorporate some validation that these events are occurring despite appropriate management and are not a response to the patient’s diabetes not being managed well.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/13/2025

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on this update. ASHI continues to be supportive of providing a more equitable approach for matching candidates and donors, including the prioritization of the attributes of candidate biology for transplant access.

Anonymous | 03/13/2025

We thank the Pancreas Committee for their considered approach to a complex problem of ensuring equitable access to pancreas transplantation through continuous distribution among disparate groups of pancreas transplant candidates who are listed on the same waiting list. We applaud the committee for considering providing a medical urgency pathway for those PTA patients who experience a significant mortality risk due to SHE and IAH. We concur that this is appropriate. In addition to using the Hypo A-Q subscale as a measure of IAH, we would like to suggest the committee consider the merits of a Clarke score criteria which is already commonly used, as well as a documented SHE criteria, which would allow patients to meet any one of these criteria and therefore would capture the greatest number of eligible patients.

Having medical urgency criteria is a positive to ensure access to transplantation for PTA patients, but generally leaves out the PAK patient, which generally, like the SPK patient, does not experience many SHE nor do they have a high incidence of IAH. Hence, PAK patients may be disadvantaged and would see a decline in the number of transplants performed and increased waiting times. We urge the committee to be attentive to this possibility and institute a contingency to prevent it.

Because the number of pancreas transplants performed nationally over the last several years has declined dramatically (multifactorial, but some factors include KAS, other multiorgan candidates competing, etc.), we strongly recommend that a primary goal of the proposal should be to create a system that does not further reduce the number of pancreas transplants and even allow increasing numbers of these life-saving transplants (Rana et al JAMA Surgery 150:252-9, 2015). Since the majority of pancreas transplants are SPK transplants and all pancreas transplant centers perform this type of pancreas transplant, it would be important to not witness a further decline in SPK volume after implementing Continuous Distribution. Furthermore, we strongly encourage the committee to put greater emphasis on allocation within closer proximity or within tighter geographic regions. This could easily be done at the time of initial implementation of CD, by increasing the weighting of the Distance proximity score within the total composite score, and/or increasing the steepness of the line which describes the decreasing priority with increasing distance, or both. We would recommend the committee comprehensively evaluate modeling of different set points of these parameters on the impact on pancreas transplant numbers, before implementation of CD and to share these data with the community. There are many practical and logistical benefits to having greater allocation of pancreata to transplant centers that are in closer proximity.

It is critical that whatever policy is implemented that the system be monitored frequently. We feel it is also very important that changes can be implemented rapidly to avoid long-term damage to the system. To date, this has not been the case with UNOS/OPTN, and therefore we encourage the creation of a new system for frequent monitoring and rapid implementation of changes that are beyond the current framework.

The proposal talks about instituting a Pancreas Review Board, but few details are provided. Is it possible for the committee to develop and elaborate on what this would look like?

Finally, we encourage the committee to strongly advocate for significant improvements in modeling capabilities and for recording the data collected and available via STAR files such that post-implementation analysis and future research can be efficiently conducted.

Thank you for the opportunity to comment and make suggestions.

UW Health Transplant Pancreas Program | 03/13/2025

UW Health Transplant appreciates the opportunity to comment on this report and would like to thank the Pancreas committee for their continued work. With decreasing volume of pancreas transplants nationally over the last several years, we believe a primary goal of the proposal should be to create a system that does not disadvantage pancreas transplantation or further reduce the number of pancreas transplants performed nationally. In addition, enhancing access to transplantation by instituting policy adjustments that have a positive impact on improving logistics and decreasing organ acquisition costs in terms of travel considerations, cold ischemia time and efficiency of organ procurement should be considered.

Regarding these areas of focus, we believe there should be greater emphasis and weighting on the distance criteria for greater proximity priority. This is because the interactions of travel distance, cold ischemia time, efficiency of successful procurement of an acceptable organ for transplantation does impact access. Weighting this component greater allows the transplanting team to send their recovery team on more procurements (expertise), thereby increasing surgical organ procurement efficiencies, improve logistics, and reduce costs of long-distance transportation all leading to an increase in the number of transplants and improving access.

We believe that more development is needed with respect to designing a practical and fair system to denote medical urgency. We agree with the committee that impaired awareness of hypoglycemia (IAH) as measured by the Hypo A-Q would be an important measure of urgency. While this method appears useful, the data suggest only being marginally better than the Clarke score which is already in wider usage among transplant centers for PTA and Islet candidates. Therefore, we would like to suggest possible consideration for accepting both measures for eligibility for achieving medical urgency. We also believe that reporting severe hypoglycemic events (SHE) should be a priority in defining medical urgency. It is important that hypoglycemic unaware patients get equal or near equal priority because of having one waiting list for SPK and PTA, to not disadvantage these patients

While we support using Continuous Glucose Monitoring (CGM) in defining medical urgency, we have some concerns regarding access to this technology that may impact a patient’s ability to possibly meet medical urgency by this criterium. We have found having access to a CGM is not always feasible in underserved populations. In addition, the CGM data is not easily obtainable for several reasons, such as access to and expertise with the necessary software. Furthermore, there is extreme variability across the US in who is managing diabetes and how a patient is managed. In many cases in rural America, the patient’s diabetes is managed by their Primary Care Physician and patients, nor their physicians have access or expertise with these tools. Thus, many patients may not have the opportunity to meet a CGM based metric of medical urgency.

UW Health performs SPK, PAK and PTA, as do many large volume centers in the US. Most of the criteria for pancreas urgency apply primarily to PTA patients and the kidney urgency criteria most likely apply to a small fraction of SPK candidates. However, PAK patients or patients with failed pancreas grafts in prior SPK recipients, are very unlikely to reach medical urgency criteria by either criterion. In our opinion, this is because T1D patients who develop kidney disease sufficient to develop ESRD and undergo kidney transplantation rarely have significant IAH, and the proportion of T2D patients undergoing PAK or PASPK rarely if ever have IAH. Thus, there is a potential negative bias against such patients which may further decrease the overall number of PAK transplants. Under the proposed environment, it is possible that PAK and prior SPK patients with failed pancreas transplants may end up waiting significantly longer than other groups. We ask the committee to consider this potential negative bias in the ultimate proposal and implement measures to mitigate it.

We would also ask that after the new policies are eventually instituted, that the outcomes data be monitored very closely and frequently, particularly the volumes of each of the different types of pancreas transplants separately. If there is a decrease in pancreas transplants or we see increased inefficiencies, the proposal should be reviewed and modified as necessary. It is critical to be nimble and institute a policy of regular data review while establishing a system to be able to implement changes rapidly.

Finally, we would ask that with the next iteration of this report, there are more details provided about the Pancreas Review Board. What will the composition of the board be and how will members be recruited? What will the board term limit be? How often will the urgency status need to be updated? Once they fulfill the criteria for medical urgency, would this be subject to change to remove it? Would subsequent submissions be voluntary?

In summary, UW Health supports the work of this committee. As further refinements are discussed by the committee, we would ask the committee to earnestly consider the aforementioned issues and questions.

Anonymous | 03/12/2025

I agree with this change

Amir H | 03/11/2025

I have family I agree with this change

OPTN Transplant Administrators Committee | 03/11/2025

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Pancreas Committee’s update on Continuous Distribution of Pancreata. The Committee offers the following feedback for consideration:

•The Committee suggests further guidance on operationalization of the questionnaire.

Overall, the Committee is supportive of the developments on Pancreas Continuous Distribution.

Region 4 | 03/11/2025

Comments: None

American Nephrology Nurses Association (ANNA) | 03/10/2025

Attachment

View attachment from American Nephrology Nurses Association (ANNA)

OPTN Living Donor Committee | 03/06/2025

The OPTN Living Donor Committee thanks the OPTN Pancreas Transplantation Committee for their work on continuous distribution. The Committee strongly supports the prioritization of prior living donors in the pancreas allocation system. The Committee recently reviewed an OPTN data report compiling the status of prior living donors who have been waitlisted for any organs from 1994-2024. Prior living donors needing an organ is exceedingly rare, with the percentage of prior living donors on the waitlist for pancreas transplant less than 0.03%. Although prior living donor prioritization status would apply to a small number of individuals, it is highly impactful within the living donor and transplant communities by acknowledging the altruism of living donors, demonstrating the value of reciprocity, and recognizing the need to support living donors. The Committee advocates for the recognition of living donor priority as supporting patient access. Ensuring prioritization for prior living donors also maintains confidence in the development of continuous distribution in the organ donation and transplantation system. The Committee emphasizes that living donors should not be valued differently based on which organ they donated or the time period since donation. The Committee also would not support a solution that would allow prior living donors to opt out of their priority. It is important that the system advocates and protects living donors.  

Region 7 | 03/04/2025

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. Most attendees expressed support for moving forward with continuous distribution, and support for the new criterion for medical urgency. One attendee expressed concern that Kidney Allocation System (KAS) 250 may have resulted in fewer pancreas transplants; and with revisions to multi-organ transplant policy and continuous distribution they expressed concern that these policy changes could be detrimental to pancreas only candidates. 

Region 3 | 03/03/2025

No comments

Region 5 | 02/28/2025

No comments

Keith Plummer | 02/20/2025

I did not see miles and patient input in this proposal.

OPTN Kidney Transplantation Committee | 02/20/2025

The OPTN Kidney Transplantation Committee (Committee) appreciates the opportunity to comment on this update. The Committee recommends exploring access to continuous glucose monitoring (CGM) for different patient populations and demographics to assess if the alternate pathways proposed will provide adequate consideration for medical urgency exceptions for patient populations who do not have access to CGM.