Comments

Region 10 | 03/19/2025

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. Attendees noted significant concerns regarding kidney distribution, particularly for higher KDPI kidneys. While the current allocation system works well for reasonable KDPI organs, an alternative allocation system may be more effective for kidneys with a KDPI above 60, prioritizing efficiency and speed over strict equity. There was strong support for a formal presentation on this topic to allow for discussion and clarification. The criteria for hard-to-place kidneys needs further refinement, as the current six-hour CIT threshold may be too short, and greater transparency is needed regarding how OPOs select transplant centers. While the overall concept is supported, concerns remain about increased logistical complexity, costs, and the potential for prioritizing sicker patients at the expense of more non-use. Additionally, the significance of small differences in composite allocation scores should be evaluated to determine if categorization is necessary. One attendee mentioned that this system closely resembles LYFT, an allocation model that was previously rejected by the community several years ago. Despite these concerns, continuous distribution of kidneys is seen as a promising and more equitable approach, and the proposed criteria for identifying hard-to-place kidneys appear reasonable. However, all transplant programs should have the opportunity to participate in expedited placement and define which candidates they would consider for these kidneys.

OPTN Pancreas Transplantation Committee | 03/19/2025

The OPTN Pancreas Transplantation Committee appreciates the OPTN Kidney Transplantation Committee’s ongoing work and the opportunity to provide feedback on the recent update. The Committee offers the following recommendations for consideration:

-The Committee recommends that pediatric en bloc kidneys be considered as a predictive factor in the hard-to-place criteria. These kidneys tend to have longer cold ischemic times, and acceptance rates vary widely between surgeons and programs. Including pediatric en bloc kidneys would account for these variations.

-The Committee suggests exploring the use of artificial intelligence (AI) to predict optimal donor-recipient matches based on historical data. This could potentially improve efficiency and accuracy in the allocation process. However, the Committee acknowledges the complexity of implementing such a system and recommends that further research be conducted to assess its feasibility.

-The Committee seeks clarification on whether meeting a single criterion, such as a KDPI greater than or equal to 50%, is sufficient to identify hard-to-place kidneys, or if multiple criteria should be considered. Additionally, as many of the factors contributing to KDPI are already accounted for in the proposed criteria, the Committee recommends reconsidering the use of a KDPI threshold of 50%. Some kidneys with a KDPI under 50% are also difficult to place, and the Committee suggests incorporating multiple factors into the decision-making process rather than relying solely on KDPI.

-The Committee recommends standardizing the process by which OPOs allocate hard-to-place kidneys. Currently, allocation practices are often based on relationships between OPOs and programs, rather than proximity. Establishing a standardized allocation process would ensure fairness and transparency, providing equal opportunity for all programs to utilize these organs.

-The Committee suggests considering including pump parameters as part of the criteria for kidney allocation, as they may provide valuable information on organ viability.

-The Committee recommends further clarification on the definition of cold ischemia time, specifically regarding the six-hour threshold, as there is variability between OPOs, particularly regarding the waiting period for pump numbers and biopsy results. This variability could lead to inconsistent practices and delays in allocation. The Committee suggests considering additional factors, such as weight on sequence, to address these inconsistencies and ensure a more uniform approach.

-The Committee recommends that vascular disease be given more consideration as a criteria, as kidneys with significant vascular disease are often declined due to poor outcomes. This may be a more relevant factor than glomerulosclerosis, and the Committee urges the Kidney Committee to consider this in future criteria.

The Committee strongly supports a standardized definition and pathway for hard-to-place kidneys to be established. Establishing clear guidelines for identifying and allocating kidneys that are difficult to place will improve transparency and ensure a more consistent and equitable allocation process. The Committee appreciates the opportunity to contribute to this important discussion and looks forward to further collaboration.

University of California San Diego Medical Center | 03/19/2025

The data so far indicates that this type of modeling could be helpful and result in less organ non-use. We support this proposal.

National Kidney Foundation | 03/19/2025

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Region 9 | 03/18/2025

This was not presented at the regional meeting, but members were able to submit comments. A member recommended that the committee address rescue allocation and logistical barriers before implementing continuous distribution. An attendee expressed support for this work and encouraged the committee to make sure transparency and education for patients are central to any proposal. Another attendee also shared strong support for the work, underscoring how a more holistic, points-based allocation system will improve equity and efficiency, which should maximize the number of successful transplants and improve overall outcomes.  

Region 11 | 03/18/2025

A member expressed strong support for the proposal, noting it could positively impact kidney non-use issues. The member emphasized the need for specific definitions and allocation policies for hard to place kidneys as part of the continuous distribution policy. They stressed the importance of formalizing and protocolizing allocation practices for hard to place kidneys, especially given the dramatic rise in allocation out of sequence with KAS 250 and other changes. The member suggested that improving transparency around how transplant centers are identified for aggressive center lists would help maintain public trust. They noted that while current allocation policies and IT infrastructure may not improve immediately, making the process more procedural and consistent across OPOs and centers could reassure the public that out of sequence allocation is patient-focused and helps reduce organ waste. The member suggested the proposed change enhances flexibility and equity in kidney allocation, ensuring organs are distributed based on patient needs and medical urgency rather than rigid categories, ultimately improving transplant numbers.

Region 8 | 03/18/2025

The region appreciated the update and was supportive of the committee’s progress. A member recommended the committee to focus on expedited placement policy prior to moving forward with continuous distribution. They explained the system as a whole is increasing the burden on transplant programs to sustain operations in light of increases to costs in travel/transportation, perfusion and preservation devices, and decreases to reimbursement across the system. Additionally, there are major capacity constraints in the health system challenging our ability to increase access for patients requiring end stage disease management and possible organ transplantation. They encouraged the committee to consider lessons learned from lung CAS to determine what changes are needed prior to implementation in other organs. A member thought the data driven definition of hard to place kidneys is reasonable and supported it. They also supported prior behavior to determine eligibility in expedited placement, with an option for a program to request an opt-in (i.e. a new surgeon or resources may justify participation without historical behavior).

University of Arkansas | 03/18/2025

After reviewing the Winter 2025 update to the continuous distribution of kidneys proposal, we appreciate the additional information provided and offer the following feedback. We support defining “hard to place” kidneys but continue to have concern regarding SRTR statistics and believe this concern will only continue to grow after the IOTA model is implemented. Transplant centers who accept “hard to place” organs should receive accurate risk adjustment for SRTR releases. Transplant centers are expected to carry the burden of the additional costs “hard to place” organs incur such as readmissions, increased length of stay, long term care needs, and frequent clinic/lab visits. We feel that “hard to place” organs from donors with a complex medical history cannot always be transplanted into complex patients due to the increased risk of graft failure. Transplant centers should be given the ability to reasonably choose the best candidate for “hard to place” organs based on knowledge about the recipient that the UNET system does not always consider when allocating organs. Recipients of “hard to place” organs require more individualized care and place a greater burden on transplant coordinators and direct patient care staff. In addition, we firmly believe that this should not take away a surgeon/OPOs ability to quickly place organs. It is important that OPOs are allowed to “skip the list” and place organs with known aggressive centers quickly and efficiently versus requiring time consuming and tedious documentation that can lead to negative patient outcomes and increased organ waste.

NATCO | 03/17/2025

NATCO appreciates the opportunity to comment on this Continuous Distribution of Kidneys Update. We continue to support the ongoing efforts to transition to this points-based framework. However, as this new structure is developed, we cannot ignore the complexity of current allocation and the many inefficiencies that have resulted from broader sharing that we encounter every day. We applaud all efforts to make certain any new policy incorporates reduction in non-use and fosters increased sequential placement of kidneys. While there will never be a perfect system, we wish to ensure that both policy and technology synchronize to promote equity and maximize utilization. Policy should strive to be transparent and include accountability standards from OPOs and TXCs alike in both the pre and post recovery phases and should be included in overall policy, not just specific to expedited placement. It should also strive to be dynamic to ensure successful and efficient placement of the most optimal to the most challenging donors, promoting positive outcomes for our recipients. Regarding the specific request for feedback, NATCO applauds the comprehensive analysis completed surrounding efficiency and supports incorporating all these modifications in some form to the continuous kidney distribution model. We also support the preliminary definition of “hard to place”, but we believe anatomical challenges should be considered for inclusion in this definition as well. These could include vasculature compromise, discoloration and petechiae, trauma (hematomas, decapsulation, or lacerations), and lesions with undefined diagnosis on frozen section, which all directly impact proper candidate selection and strongly influence non-use. Expedited placement can only be successful with truly committed transplant programs that have the infrastructure to quickly evaluate these offers and prepare the appropriate candidate for transplant. Only these transplant programs should initially qualify for expedited placement and historical acceptance practices would be the best measure for this. However, there would need to be pathways for smaller and other programs to demonstrate their commitment and ability to accept “hard to place” kidneys for inclusion in these rescue pathways. We look forward to the continued efforts of the OPTN Kidney Transplantation Committee and Expeditious Taskforce as our community progresses towards continuous distribution and makes the necessary modifications to create a transparent, equitable, and efficient Kidney Allocation System.

OPTN Heart Transplantation Committee | 03/17/2025

The OPTN Heart Transplantation Committee (Committee) thanks the OPTN Kidney Transplantation Committee for the presentation regarding Update on the Continuous Distribution of Kidneys, Winter 2025 during the Committee’s February 18, 2025 meeting. The Committee members expressed support for the factors identified for creating a preliminary definition of “hard-to-place” kidneys. The Committee agreed that historical organ offer acceptance patterns could be a valuable metric for qualifying transplant programs to participate in expedited placement. Committee members also suggested a need for transparency and fairness when using such information to ensure all programs have an equal opportunity to participate. The Heart Committee also appreciated the information shared about the Kidney Committee’s efforts developing a continuous distribution allocation framework prior to the OPTN Board of Directors’ September 2024 directive to address non-use, allocation out-of-sequence, and expedited placement. The information provided will assist the Committee in its on-going efforts to develop a continuous distribution of hearts allocation framework.

Emma Roberts | 03/17/2025

PLEASE move this project forward to implementation. The OPTN has worked on this proposal for years while patients continue to wait. I understand the need to analyze the solutions before implementation but I beg you to keep the focus on this priority. Too much time and effort from the OPTN and HRSA are spent on "modernization," which distracts from the very real need to improve allocation to patients like me who are waiting for a transplant. What has "modernization" done to improve the lives of patients? On the other hand, everything I have read indicates that continuous distribution has the very real promise to improve issues of real concern to patients: fairness, decreasing wait times, and prioritizing the sickest patients.

If the OPTN is concerned about allocation out of sequence, then tailor the continuous distribution system to address this. That's a better solution than trying to adjust the current system only to overhaul it with continuous distribution. That's certainly a better use of taxpayer and patient funds - and more "modern" as well!

PLEASE, PLEASE, PLEASE keep your eye on the ball. Move forward with continuous distribution and stop the distraction of governance modernization for the sake of patients.

OPTN Transplant Coordinators Committee | 03/17/2025

The OPTN Transplant Coordinators Committee thanks the OPTN Kidney Transplantation Committee for their hard work and dedication to this project. The Committee submits the following feedback for consideration:

•The Committee supports the development of a “hard to place” list or a group of centers that are more aggressive in accepting these organs to reduce non-use.

• Members seek clarification on whether an “opt-in” option will be available, as staffing changes can influence a center’s organ acceptance practices.
• The Committee emphasizes the importance of maintaining flexibility in any such list or group, as a static system could exacerbate organ non-use and existing concerns regarding allocation.

•The Committee requests clarification on the definition—or plans to define—what qualifies a transplant program as “aggressive” or meeting expectations for expedited placement. Given that acceptance practices vary by center, this variability can create challenges for Organ Procurement Organizations (OPOs) in organ placement.

Overall, the Committee supports this initiative and encourages further consideration of the above comments in developing definitions for “hard to place” kidneys and an eventual expedited placement process.

Region 1 | 03/17/2025

This was not discussed during the meeting, but attendees were able to submit comments. An attendee stated the importance of the committee addressing non-use and the factors that lead to out-of-sequence allocation should be a key component of the work to establish kidney continuous distribution. A comment was made in support of the committee’s work, saying that it is important that the OPTN modernization efforts should not slow down the progress of this important project. A member shared concern that broader sharing of organs has resulted in an increase in non-use, with allocation taking too much time, especially medically complex kidneys.  The member requests that any additional complexity be accompanied by efforts to increase efficiency and consequences for those that use a provisional yes when they have not actually evaluated the offer. One comment expressed skepticism that continuous distribution would measurably improve the system due to the additional complications that would come with it. 

Association of Organ Procurement Organizations | 03/17/2025

Regarding the OPTN Continuous Distribution of Kidneys Update, we appreciate the comprehensive update and specifically the focus on decreasing non-use of kidneys. As stated before, broader distribution appears to have improved the equity portion of the equation, however this has been at the expense of utility and the loss of transplantable kidneys. It is good to see that the committee has recognized this critical issue and remains committed to rectifying that situation. We appreciate the work done on defining “hard to place” kidneys, effective use of filters, recognition of the importance and necessity of expedited placement, and monitoring outcomes.

In considering non-use in the US organ transplant system. As we know, European countries have a high utilization rate of kidneys from older donors with good results. We support the use of elements of the Euro-Transplant (ET) system’s Recipient Oriented Allocation pathway (REAL). If properly implemented simultaneous offering, candidate submission, system-imposed evaluation time limits, and standard allocation candidate prioritization, will support greater organ utilization.

As OPOs, whose critical focus is the expeditious placement of organs to waiting recipients and maximize the number of organs actually transplanted, these elements provided tangible and measurable practices to meet the system’s collective goals of mitigating organ non-use.

Likewise, we encourage significant consideration of the diverse challenges OPOs face. Donation Service Areas (DSA) vary from 3,000 square miles to over 800,000 square miles, some OPOs have multiple kidney transplant programs within their DSA others do not. Transportation logistics, proximity to transplant programs and their willingness to transplant medically complex organs varies greatly and needs to be taken into consideration when developing constraints on OPO expedited placement schema.

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 the transition to continuous distribution of kidneys. However, clear rules must be established to define when a kidney is considered hard to place or at risk of being hard to place. Overall, moving to continuous distribution for kidneys is seen as an appropriate step. 

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 Kidneys, Winter 2025.” The AST is supportive of a points-based framework and the proposed attributes but currently there is not enough data to assess all the potential impacts of this approach. A focus on transparency, equity, consistency, and accountability is critical but should not completely detract from the autonomy of each transplant center in managing their waitlist, standard offers, and out of sequence allocation.

Specific policies that uphold equity and transparency during out of sequence allocations should be considered to maintain the integrity of the process. For example, priority for certain groups such as pediatric potential transplant recipients, high PRA potential transplant recipients, and those in need of a combined kidney pancreas transplant should not be bypassed in favor out of sequence allocation. The inverse qualifying time approach to improve out of sequence allocation offer efficiency as outlined in the update seemingly has potential. The likelihood of acceptance attribute and historical center behavior are also important measures to consider in combination with offer filters to improve the chances that every organ offered is eventually placed; however, the AST cautions that any program-specific attributes have the potential to exasperate program-level discrimination and should be sensitive to program-level changes that commonly occur, such as leadership and faculty changes, and many other factors the model is not sensitive to.

The AST agrees that the kidney donor profile index (KDPI) needs to be refocused as it has created misunderstanding when evaluating donor kidneys for transplant and this metric is not always used as intended. The AST also agrees with efforts to better understand and define “hard to place” kidneys, and recommends a nomenclature change to avoid further stigmatizing these offers. Analyzing out of sequence allocations data and the reasons why it was necessary to deviate from the match run would likely provide additional insights for framework enhancements. Additional considerations to define "hard to place" kidneys from donors with a KDPI of 50% or greater include anatomic variants, tumors of uncertain risk, potentially transmissible infections, surgical injury, pump characteristics, defining hypertension severity using blood pressure measurements, and assessing the underlying rationale for continuous renal replacement therapy (CRRT) to differentiate between CRRT due to reversible causes and CRRT for end-stage kidney failure.

The AST suggests the OPTN also consider additional resources to help transplant programs and organ procurement organizations (OPOs) with “hard to place” kidneys. For transplant programs, guidance on identifying suitable recipients for "hard to place" kidneys and educational resources to review with patients during discussions about the possibility of being offered a “hard to place” kidney would be helpful. For OPOs, standardizing methods for assessing and documenting the quality of “hard to place” kidneys and guidance to encourage close collaboration with transplant programs – including considerations for organ transportation and “waivers” standards – to facilitate the placement of these organs would be beneficial.

Finally, all modifications to the kidney allocation system should be assessed for their impact on equity across various demographics and geographic areas to prevent exacerbating existing disparities in access to transplantation. Establishing monitoring frameworks will help to assess the impact of any implemented changes on patient outcomes, waiting times, and overall effectiveness in transplant rates. The experiences of various stakeholders, including transplant centers, patients, and donor families, should also be considered in the development and implementation of these modifications.

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 project update. ASHI continues to be supportive of prioritizing the attributes of candidate biology for transplant access, especially of the highly sensitized patient population.

ASHI has previously proposed additional strategies to support long-term graft survival, to include the implementation of high-resolution HLA class II matching, as defined by molecular mismatch load between donor and recipient HLA-DR and -DQ alleles. This matching algorithm requires universal high-resolution (allele level) typing data of deceased donor and recipient. There has been significant advancement in making high-resolution HLA typing faster, more accurate and cost-effective and is currently being performed by some laboratories for deceased donors. The inclusion of high-resolution HLA typing in the database is a first step in improving matching and avoiding delays in organ allocation due to the presence of HLA allele-specific antibodies, which should be considered in near future proposals.

Regarding the optimized -cPRA calculation, ASHI and NCAC support efforts towards appropriate weighting as a means of facilitating transplantation of highly sensitized candidates. This remains a particularly important topic given that multiparous women and minorities make up a large portion of that population. However, we request additional modeling to evaluate the impact on the other groups that may or may not be disadvantaged with the implementation of this new weighting scale.

ASHI would like to provide additional feedback on the topic of the Expedited Placement policy and the evaluation of “hard-to-place” kidneys. ASHI and NCAC support efforts toward creating a standard, transparent, and effective process that is evidence-based. The use of higher KDPI or hard-to-place organs for candidates with less wait time, less dialysis time seems appropriate given the data supporting worse outcomes with those who have been on long-term dialysis. Additionally, highly sensitized candidates with shorter wait time may also have the option of receiving a better matched “hard to place” or high KDPI organ using this approach, providing that post-transplant maintenance is not impacted by increased chance of delayed graft function. Both the predictive and identified characteristics for utilizing this approach should include studies around these parameters.

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 Kidney Committee’s update on Continuous Distribution of Kidneys. The Committee offers the following feedback for consideration:

•The Transplant Administrator’s Committee suggests further consideration of new and developing programs.

•The Committee suggests further transparency in the organ offer process.

•The Committee questioned if previous center practices should be included in the organ offer process.

Overall, the Committee is supportive of the developments on Kidney Continuous Distribution and wants transparency to be considered in the development process.

Region 4 | 03/11/2025

Attendees commented that they support the continuation of this initiative but believe greater transparency is needed for those waiting, particularly regarding changes to waiting times and organs that are not accepted. Also, the OPTN should balance both equity and utility as ethical considerations. While the new 250nm radius may enhance equity, it could come at the cost of utility. Open offers and similar tools can improve utility and should not be removed when used appropriately. Smaller centers must have a voice in the allocation process to ensure kidneys are not disproportionately directed to the largest centers. I am willing to contribute to efforts that optimize kidney utilization while maintaining equity within the constraints of the current 250nm system.

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

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Rajeev Sharma | 03/10/2025

I support the individual components that the committee has agreed upon for defining "hard to place" kidneys. However, I propose that similar to the process for consenting patients for kidneys with a KDPI > 85%, transplant programs should be required to maintain a list of patients willing to accept "hard to place" kidneys. These patients should provide a consent for such kidneys, with a separate match run conducted for them, just as is done for KDPI > 85% kidneys. This would increase transparency in the process.

Additionally, I advocate for a framework that does not impose specific program qualification criteria for transplant programs within 250 miles. This would provide smaller programs with the opportunity to grow and better serve their communities. This would enable recipients in rural areas to gain enhanced access to transplantation without the burden of traveling long distances to larger programs. It would also reduce the financial strain on patients and families who must stay locally post-transplant, as well as the travel expenses associated with follow-up care.

Currently, UNOS’s biggest growth opportunity lies in supporting smaller programs receive organs, rather than continuing to prioritize larger programs through the expedited placement pathway. Larger programs already have higher transplant rates, while smaller programs face significant barriers to growth.

Finally, historical organ acceptance practices may not always be reliable, especially in smaller programs with frequent surgeon turnover. A new surgical team in a smaller program may struggle to receive sufficient organ offers, hindering the program's growth. Addressing this could help foster the growth of these programs, benefiting the patients they serve, while improving kidney utilization overall and reducing discards.

OPTN Living Donor Committee | 03/06/2025

The Living Donor Committee commends the OPTN Kidney Transplantation Committee for their continued efforts in developing this project. The Committee strongly supports providing prior living donor priority to all living donors, which is stated as “high priority”. 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, in which the percentage of prior living donors on the kidney waitlist at any point is 0.05%. 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. The Committee strongly supports maintaining high priority for prior living donors and believes this attribute should be given the appropriate weight to maintain their current level of priority in the new continuous distribution system. The Committee emphasizes that prioritizing prior living donors is both medically and ethically justified. Living donors make a selfless decision to put their health at risk to improve the life of another human being. The Committee emphasizes that living donors should not be valued differently based on which organ they donated or the time period since donation, nor does the committee recommend an opt-out for living donor priority.

Keith Plummer | 03/05/2025

It has been brought to my attention that more kidneys are being listed as “Open Offers” due to fear of waste. This was not the purpose of this rule change we must stick to the wait list as long as possible. Open Offers should only be a last resort before losing the kidney.

Region 7 | 03/04/2025

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. Attendees expressed support for the definition change and on moving forward with continuous distribution.

Region 3 | 03/03/2025

Attendees commented that historical organ offer acceptance patterns should be used to qualify transplant programs for participation in expedited placement, provided that each center has the opportunity to update its acceptance practices. Utilizing the Scientific Registry of Transplant Recipients (SRTR) OPO Offer Acceptance Report data and existing process measure data can help establish program candidacy. These patterns demonstrate a program's history of organ utilization while allowing for adjustments in acceptance practices. The committee's careful consideration of strategies for placing hard-to-match kidneys acknowledges the need for changes in allocation to improve organ utilization.

Region 5 | 02/28/2025

The region appreciated the update and supports the committee’s work on this project. A commenter suggested the committee review the successes and failures in the lung process before initiation of continuous distribution of kidneys. A member suggested the committee create a definition of hard-to-place kidneys; create an algorithm to predict which kidneys will be hard-to-place; and create a protocol for the placement of these kidneys. Another expressed concern about centers managing increased costs since the policy could inadvertently increase kidney transplant cost since there will be greater geographic distribution.

Keith Plummer | 02/20/2025

I like most of the proposal but I did not see any mention of travel time allowing the best opportunity for success. I also did not see anything on transplant center and patient communication on possible donations