Comments

AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 10/02/2019

ASHI appreciates the efforts put forth by the OPTN Pancreas Transplantation Committee on the development of a revised allocation policy that addresses concerns with the current policy as it relates to the OPTN final rule. ASHI is supportive of the overall policy proposal as it recognizes donated organs as a national resource and addresses the concerns with the use of DSA and Region in allocation while promoting equity and efficiency in allocation. However, ASHI is concerned with the lack of consideration, at least as presented in the public comment proposal, of the potential impact on the logistics of histocompatibility testing. With broader sharing comes uncertainties about the logistics of sharing tissues for crossmatching. In lieu of physical crossmatching, virtual crossmatching will be very important to support broader sharing. As the committee may be aware, the CLIA amendments still do not recognize virtual crossmatching as an alternative to the physical crossmatch. This situation has been addressed with CMS at least 4 years ago without resolution. ASHI urges the committee to work closely with the UNOS Histocompatibility Committee to address the potential impact of broader sharing on histocompatibility testing logistics as well as promoting recognition by CMS of the virtual crossmatch as a viable alternative to the physical crossmatch.

Gift of Hope | 10/02/2019

Our comments on kidney allocation apply to pancreas as well. We also encourage UNOS to look at policy changes to reduce the number of pancreas discards due to OR turndowns. Some type of object minimum acceptance criteria would extremely helpful in guiding decision making.

Vinayak Rohan | 10/02/2019

Strongly Oppose

OneLegacy | 10/02/2019

• What considerations should be taken into account to select a circle size that distributes pancreata broadly and efficiently? o OneLegacy supports the removal of DSA as a unit of allocation. We greatly prefer the use of “Continuous Distribution” over “Circles”, but understand that Circles are the quickest way to eliminate DSA as a unit of allocation. Ideally we support a composite score as outlined in the Continuous Distribution Model proposed by the Ad Hoc Geography Committee. • Proximity points are intended to contribute to efficiency in the broader distribution of pancreata. Should they be used inside the 500 NM circle? Should they be used outside the 500 NM circle? o OneLegacy advocates for ZERO proximity points to be utilized inside and outside of the proposed proximity circles. • What operational concerns should the Committee consider as this policy is being prepared for OPTN board action and implementation? o We feel they have been adequately address in the policy proposal. • For import back up, should the initial distance from the transplant program be 150 NM or another distance, when considering the efficient reallocation of pancreas and kidney-pancreas? Should proximity points be included outside the initial import match run circle to limit travel costs and preservation time, or should there be a secondary circle of 500 NM to address those concerns? o OneLegacy would support a secondary circle of 250 and a tertiary 500NM without proximity points. • Should programs qualify for facilitated placement if the program performs 2 or 5 transplants in 2 years from pancreata imported beyond 500 NM from the transplant program? o We agree with reducing the qualification from 5 to 2.

Anonymous | 10/02/2019

Strongly support (0), Support (5), Neutral/Abstain (1), Oppose (1), Strongly Oppose (0) The region has similar concerns with kidney-pancreas and pancreas allocation changes as they do with the Kidney Committee’s proposal (see region 9 comments on kidney proposal).

OPTN Operations and Safety Committee | 10/02/2019

The Operations and Safety Committee (OSC) thanks the OPTN Pancreas Committee for their efforts in developing this public comment proposal to eliminate the use of DSAs and region in pancreas allocation policy. The Committee suggest specific monitoring to ensure that programs importing kidney-pancreas organs, do not then decline the pancreas as a way to draw the kidney. The Committee suggested that in circumstances where the pancreas is turned down and needs to be reallocated, there should be support within the policy allowing the OPO and transplant program the latitude to back up the organ within their program rather than a requirement to reallocate. As it is not fairly common for a pancreas to be turned down and reaccepted elsewhere, this may be a component that would enable more utilization and less waste of pancreas. The Committee indicated the following sentiments for the proposal: Strongly Support- 0%, Support- 60%, Neutral/Abstain – 20%, Oppose – 20%, Strongly Oppose- 0%

Anonymous | 10/02/2019

Strongly Oppose

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) opposes this policy proposal as written. We recommend the OPTN take an iterative approach to all new organ allocation policies by taking small steps with regular reassessments (e.g., one year) to identify successes and unintended consequences, particularly concerning logistical issues. The American Society of Transplant Surgeons appreciates the opportunity to comment on the OPTN Pancreas Committee Proposal to modify the current Pancreas allocation system to eliminate DSA and Region in allocation. The new proposal would replace the existing allocation system with a proposed 500nm allocation circle (which would define primary allocation) and national allocation beyond this geographic area. The proposal attempts to balance competing priorities including efficiency, access to care, and medical necessity by including graded proximity points which are designed to allocate pancreata (and kidneys where appropriate) to patients who are closer to the donor hospital if allocation priority is relatively similar. While there are significant positive aspects of the proposal, including the inclusion of proximity points, the choice 500nm as the initial unit of allocation may significantly harm access to transplant, organ utilization, and, consequently, patient outcomes as outlined below. While the proposal includes provisions to balance equity and efficiency, the choice of 500nm as the initial allocation region may adversely impact access to pancreas transplant by further concentrating pancreas transplant in larger urban centers. Access to transplant is not simply a function of organ availability. Patients must first have the resources to travel to a center, complete the evaluation, undergo transplant, and return for follow-up in the post-transplant period. As is clear from the policy proposal’s revisions, the volume of transplants performed will significantly increase at a small number of large centers, leaving remaining centers at risk of functional inactivity. If the highest quality donated organs are accepted and transplanted predominantly in larger centers, this may lead to loss of access for vulnerable populations who lack private insurance coverage with travel benefits. Second, organ utilization has already been decreasing nationally. While the proposal suggests that this is due to risk aversion in some centers, in fact, there are multiple factors that contribute to organ discard that may be compounded by the current proposal. As noted, pancreata are more likely to be lost to graft thrombosis than other organs. Among the major risk factors for graft loss is excessive cold ischemic times. Given that most programs are reluctant to add $20,000 for a charter to the cost of an already unprofitable procedure, travel distances which preclude driving will likely lead to organ decline. Furthermore, the majority of programs attempt to keep cold ischemic time less than 10 hours to improve outcomes. Based on figure 13, limiting CIT to 12 hours is best accomplished within a 250nm circle rather than a 500nm circle. Finally, given the lack of pancreas transplant volume nationally, many centers are reluctant to allow inexperienced surgeons to recover organs remotely. As travel exceeds 250 miles, teams will have to fly their teams for the organ or will decline, especially in the case of an organ of marginal quality. Conversely, if the organ can be easily recovered and transplanted locally, centers may be more likely to consider a marginal donor organ as this can be accomplished with existing staff. The proposal’s suggestion that centers will have to increase surgical staff to accommodate this change reflects a lack of understanding that Simultaneous Pancreas-Kidney (SPK) and especially isolated pancreas transplants are generally money losing procedures and centers will not invest more resources to support these programs. Third, the proposal is predicted to lead to further reduction in Pancreas after Kidney (PAK) transplants. Broader use of SPK transplant will reduce kidney transplant alone. Furthermore, lack of access to high quality grafts for PAK will discourage the use of living donor kidney transplant with PAK to follow. This may exacerbate the decrease in access to high quality kidneys, particularly for minority populations who less often receive SPKs. The proposal should ensure access to high quality pancreata for isolated pancreas transplants, as prior studies have confirmed a higher rate of graft loss in this population when marginal donor organs are used. The currently model results clearly demonstrated that the committee’s choice will negatively impact access to isolate organs. For these reasons, the ASTS strongly suggests that the committee reconsider the 250/2/4 option evaluated by the committee. The 250 mile radius would still be consistent with the final rule. As noted, it would allow most organs to be driven rather than flown, reducing cold ischemic time and cost. It would also allow centers to more easily evaluate marginal organs, potentially reducing organ discard. Centers in the 250-500 mile radius would still have improved access with the 4 proximity point system. Thus, if the local center chooses not to use the organs, there is a good chance that the organ may still be used. This will increase competition as desired by the committee. The 250/2/4 allocation system is a balanced approach to expanded sharing and elimination of DSA/Region, while still allowing centers to efficiently transplant organs. After a period of implementation, the proposal could be revisited to assess the benefits of even broader sharing. The ASTS fully supports the decision to reduce the threshold for inclusion in expedited placement to 2 imported pancreata over 2 years. Limiting the program to only 16 centers nationally under the old proposal is not equitable for patients nor practical. In addition, if the threshold for expedited acceptance was 250 NM rather than 500 NM it is likely that more centers would be able to participate. The proposal also needs to be clear that the pancreas offers for SPK candidates both within and outside of either circle are offered with a kidney if needed. Currently, many regions will not share kidneys outside of “local” allocation regions. This limits enthusiasm for imported organs. While implied in the proposal, the language must specify the sharing of the kidney is not at the discretion of the offering OPO regardless of distance. In summary, the ASTS commends the committee for a thoughtful review of the issue. The Society feels that the 500nm circle relies on untested models and may have a detrimental impact on both access and utilization. Implementation of the 250nm allocation system would allow the committee to validate the key policy assumptions, ensure efficacy, and limit potential harm should the logistical barriers to organ transport result in greater organ discard and/or program closure.

Anonymous | 10/02/2019

The Minority Affairs Committee thanks the Pancreas Committee for its work on this proposal. A Committee member suggested that some programs may not accept a pancreas procured by another program. The presenter noted that the use of proximity points will help decrease travel and limit the necessity of having other surgeons procure the pancreas. The Committee discussed whether patients would still benefit from multi-listing, since broader distribution should improve equity in access to transplant. However, it was also noted that programs may vary in listing practices and offer acceptance, so multi-listing may still benefit the patient. The Committee discussed how vulnerable populations may not be able to travel and multi-list, which could impact their access to transplant. The Committee asks the Pancreas Committee to consider this potential inequity in access to transplant when evaluating the proposed impact of removing DSA and region. The Committee expressed concern about non-contiguous areas such as Hawaii, Puerto Rico, and Alaska, where 500 NM circles around donor hospitals would cover water or areas without any programs. A Committee member explained that pancreata are imported and transplanted from Alaska, despite the distance, and suggested that the same variance that exists for liver should be applied to both kidney and pancreas (treating organs from Alaska as from Seattle-Tacoma International Airport). Committee members suggested that the Pancreas Committee could look into whether and how often pancreata are imported from Hawaii, to identify if a disparity exists for Hawaii exporting more pancreata than it imports for its patient population. Overall, the Committee supported a modified proposal that included a variance for Alaska.

Anonymous | 10/02/2019

The OPTN Organ Procurement Organization Committee had the following comments: • Concern about the import OPO being responsible for allocating organs from another OPO as it does not seem like an effective measure nationally. • Support for the smaller distance for local backups because it would be more logistically feasible to get organs placed in a timely manner. • 150 nautical mile (nm) backup for the transplant center should be considered for the host OPOs as well. For example, if the organs are returned to the host OPO and allocated according to a 150 nm circle. • Question about the how the process for allocating a local kidney/pancreas would work. Currently, there is a bypass code available when the kidney/pancreas is declined locally and the host OPO keeps the kidneys locally and offers the pancreas nationally.

Anonymous | 10/02/2019

The OPTN Transplant Coordinators Committee heard a presentation on the Pancreas Committee’s proposal during a meeting on September 9, 2019. The Committee considered the concepts in the Pancreas Committee’s proposal to replace the use of donation service areas (DSAs) and regions in pancreas distribution policy with a 500 nautical mile (NM) concentric circle. Members were in agreement that pancreata are less resilient to ischemic time than kidneys. They disagreed with the mileage distance of 500 NM in the proposal. Alternatives of 100 or 250 NM were suggested. The Committee was asked to consider two elements of the Pancreas Committee’s proposal, 1) changes to facilitated pancreas placement, and 2) managing pancreas import back-up offers. Members discussed the facilitated pancreas placement concept and agreed that the number of pancreata allocated through the facilitated placement mechanism is low. There was general agreement with the framework outlined for facilitated placement. Further clarification was requested whether this policy would apply to solitary pancreata allocated by the host OPO, for imported pancreata, or for pancreata included in a multivisceral graft. There was also general agreement with the changed proposed for pancreas import back-up. The Committee supported post-implementation monitoring of pancreas transplant programs to assess for low case volume and meeting requirements of participation in the facilitated pancreas allocation program. The Committee appreciated the opportunity to provide feedback on this proposal.

Anonymous | 10/02/2019

Strongly support (0), Support (12), Neutral/Abstain (11), Oppose (3), Strongly Oppose (8) Some members believe this policy will have no impact on region 6. The question was raised; since there may be no impact, would it actually help those vulnerable populations. One member stated there need to be rules in regards to the timing of crossmatching. Due to the length of time it takes, it opens up a possibility of gaming if a center takes a long time to crossmatch an organ. Then there will be too much CIT to ship an organ back if they end up with a positive crossmatch. Pancreas may need a smaller circle due to the impact on cold ischemic time on the organ. Cost concerns were raised and even though it was not modeled (and baseline data is sparse) there could be increased costs for both OPOs and transplant centers.

Oregon Health and Science University | 10/01/2019

We do not support the current proposal to remove DSA and region from pancreas allocation. Although we support the goals of UNOS to reduce geographic disparity in access to transplantation we believe the current circle size is too large. The 500 nm circle size disproportionately advantages SPK candidates over kidney alone candidates when the waiting time is already very short for SPK candidates. The 500nm circles also create substantial logistic and cost concerns that may lead to lower utilization through late organ turndowns and prohibitive transportation costs. Disrupting the relationships between local centers and local recovery teams may have very significant effects on pancreas utilization and pancreas outcomes. Approximately 60% of SPKS are currently procured by the transplanting center and the graft survival is about 10% better for grafts procured by the transplanting center versus procured by another team (American Journal of Transplantation, August 2019). The current proposal for proximity points may not make that much sense in pancreas transplantation. Because pancreas patients only get points for waiting time, which very few patients have much of, proximity points will really be the only factor for pancreas allocation. Additional points for matching and sensitization will be needed to bring balance to pancreas allocation policy. Our center is supportive of the current proposal for local back up and facilitated placement but we recognize that the facilitated placement proposal was highly dependent on the use of 500-mile circles. If smaller circles are approved, then this policy may need to be modified to allow an appropriate number of centers to participate.

American Society of Transplantation | 10/01/2019

The American Society of Transplantation appreciates the opportunity to comment on the proposed models for pancreas allocation that remove Donor Service Areas and Regional boundaries from allocation policy. The Society leadership and constituencies acknowledge that to be compliant with the Final Rule, it is necessary to modify allocation policy with the intention to decrease variance in access and transplant rates related to geography. We understand that the OPTN Pancreas Transplantation Committee has put forth this proposal to the community with the intention to improve equity in access after carefully and scientifically analyzing the problem and potential solutions. The American Society of Transplantation is an expansive and inclusive organization. The Society's leadership is committed to accurately represent the interests and expert opinions of its varying constituencies. As such, efforts to construct a unified statement regarding significant changes in allocation policy from The Society may not allow for satisfactory representation of all of our invested members and in reality, may do a disservice to the complexities of the proposals which we are being asked to consider. This proposal attempts to address the multidimensional problem of access to transplant by putting forth a narrowly focused solution. Given the diversity of our Society, which reflects the diversity of the nation, The American Society of Transplantation is unable to render a definitive vote in support or opposition to this proposal. The American Society of Transplantation offers the following comments regarding this proposal to the Pancreas Committee of the OPTN: • The Society, in general, agrees with the 500NM circle for pancreas allocation although some constituents expressed that a primary determinate of circle size should be reasonable driving distance beyond which the costs of air transport may be cost-prohibitive. This was felt to be less significant of an issue for pancreas allocation compared to kidney allocation since the importance of getting pancreata to those centers who are actually willing to transplant pancreata is of critical importance to improve utilization. • Import back up initial distance of 150 NM was favored by the kidney and pancreas constituency. • Use of proximity points only inside the circle was favored by the kidney and pancreas constituency but others who expressed an opinion felt that they should be used inside and outside the circle. There was concern that the proximity points should not be weighted as high as other allocation variables. There was also concern that a large trauma center/large donor center that also had a transplant program would be unfairly advantaged by proximity points compared to another transplant center in the same city that did not have a large volume of donor procurements. It was for this reason that some of our members expressed a preference for a proximity points “plateau” which we understand was eliminated as an option for consideration by the OPTN Pancreas Committee. • All felt that close monitoring of logistics and cost going forward will be key for determining the effectiveness and efficiency of any new allocation proposal. • Facilitated pancreas placement should be considered for programs that qualify with 5 transplants in the past 2 years. • Efforts from local procuring surgeons will be needed to carefully consider all pancreas donors to minimize pancreas discards. • Complete data capture for SPKs that are allocated as dual organs will be necessary in the situation where the pancreas is NOT transplantable and the kidney alone is allocated. Transparency and accurate monitoring by the OPO is key, particularly if out of sequence allocation occurs. • While it is recognized that the current DSAs and regions are arbitrary and do not allow for equity in access nationally, the proposed models do not address the root cause of the variations. Instead, these proposed models have the potential to shift available organs from areas that have high performing OPOs to compensate for areas with lower-performing OPOs. Regardless of using currently defined regional boundaries or a fixed number of nautical miles from donor hospitals, variations in size, shapes, and populations will still exist and impact equity unless the disparities associated with lower-performing OPOs and wide variations in organ acceptance patterns of transplant programs are addressed. • While this allocation proposal is an attempt to decrease disparity related to geography, it does not address disparity in access that is related to geographic concentration of poverty, lack of insurance, lack of health education, etc. • What will be the effect of this allocation policy on pediatric kidney alone recipients? The monitoring plan proposed includes monitoring transplant rates by age but does not specifically address the concerns of the pediatric transplant community relating to the projected increase in the volume of kidney-pancreas transplants. There is clear acknowledgment among the pediatric transplant community that modifying the allocation policy to be in compliance with the Final Rule is necessary with the intention to decrease variance in transplant rates related to geography. Nevertheless, this proposed allocation policy, done in isolation, without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence will potentially further adversely impact, with an uneven distribution, pediatric patients that are within proximity of high-volume kidney-pancreas transplant centers. The pediatric constituency of The Society reiterates its concern for the current prioritization of kidney-pancreas patients above children, the highly sensitized and prior living donors. The pediatric constituency asks that the Pancreas Committee address these concerns and include a comprehensive plan for assessment and monitoring of current and future kidney-pancreas transplant volume effects on pediatric kidney transplant volume and rates at a more granular level than national. • Many of the comments submitted by the Society relating to the proposal to “Eliminate the Use of DSA and Regions from Kidney Allocation” are appropriate to be voiced in this context also, particularly those relating to multiorgan transplant priority within the allocation system. The proposed allocation policy, done in isolation, without consideration of the effect of prioritization of kidney-pancreas recipients within allocation sequence will potentially adversely impact not only pediatric candidates but also the highly sensitized, prior living donors and adult kidney-alone candidates that are within proximity of high-volume kidney-pancreas transplant centers. Given the requirement to make major changes in allocation to be compliant with the Final Rule, this would seem to be an opportune time to address broader community concerns with how multiorgan transplants are prioritized and allocated.

Anonymous | 10/01/2019

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the Pancreas Transplantation Committee’s proposal to eliminate the use of DSA and Region from pancreas allocation. A Committee member was concerned with the projected increase in kidney-pancreas transplants as a result of both the kidney and pancreas proposals. The Committee member noted that the increase in transplant count that was modelled for pediatric candidates was caused by broader distribution, not the increase in pediatric priority in Sequence A or Sequence B. The Committee member also stated that transplant programs may not be as willing to accept marginal organs from farther distances due to increased likelihood of delayed graft function, so the projected increase in transplant count may not play out as modelled. The primary concern of the Pediatric Committee, which is also noted on the kidney proposal, is that there are currently areas of the country where pediatric candidates are disadvantaged due to increased priority for kidney-pancreas candidates. The Committee is concerned that this proposal, as well as the kidney proposal, will increase this disadvantage for pediatric candidates. The Committee encourages the Pancreas Committee to consider if the current priority for kidney-pancreas candidates is appropriate, but recognizes that this consideration may be out of the scope of this project. In response to the Pancreas Committees proposed solution for local backup, a Committee member stated that it makes more sense to have the host OPO continue to hold responsibility for allocating the organ. The Pediatric Committee supports the Pancreas Committee’s proposal to remove DSA and Region from pancreas allocation and looks forward to working with the Pancreas Committee to address the concerns included above.

Anonymous | 10/01/2019

Strongly support (0), Support (0), Neutral/Abstain (3), Oppose (3), Strongly Oppose (15) The members of Region 10 do not support the proposal as written. Members expressed concerns that this proposal will disadvantage smaller pancreas programs. By encouraging broader distribution of pancreata, smaller programs will be less likely to accept a pancreas offer from a donor that is far away. This proposal will favor the larger more aggressive programs that are already importing pancreata from further distances. Since pancreata can withstand less cold ischemia time compared to kidney, it will be difficult to ship these organs farther distances. As more pancreata travel outside of their local DSA there was concern about performing crossmatches for those organs. There is a limited amount of samples that can be sent out, not just for pancreas, but for all organs being allocated from a donor. In regards to import backup, it was noted that once a pancreas travels a certain distance center backup should be granted. Due to the limited about of cold ischemia time a pancreas can withstand, once a pancreas is shipped, there will be very limited time to ship the pancreas to another center if import backup has to be initiated. Members of the region supported the idea of holding off on changing pancreas allocation until allocation changes to kidney settle down. As a lower volume organ it will be beneficial to learn from the experiences of kidney programs before making allocation changes to pancreas.

NATCO | 10/01/2019

We are generally supportive of the pancreas proposal, with the exception of the back-up component. As noted in our response to eliminate the use of DSA and Region in kidney allocation, any policy on local back-up should start with pre-recovery identification of back-up candidates by the potential accepting transplant center. There must be flexibility to ensure successful placement of these organs. Most of our members concerns were with the hybrid framework kidney proposal. However, if a different model for the kidney is evaluated and implemented, it should also be completed for the kidney-pancreas. Kidney, kidney/pancreas, and pancreas allocation are typically performed together and should be aligned. The Board and members of NATCO appreciate the committee’s work on this proposal and the opportunity to provide comments.

Anonymous | 09/30/2019

For kidney distribution the proximal circle should be 250 since this radius both effects substantial reductions in geographic disparities in KTX access while also preserving logistical benefits of local distribution, to reduce cost and discard. The logistic considerations of the wider proximal circle option of 500, regardless of points, has not been sufficiently examined with regard to tissue availability for crossmatching and organ travel. Given these unknowns, we should take smaller incremental steps.

Shane Oakley | 09/30/2019

I oppose this due to the increase in cost of shipping a pancreas, logistical issues which would increase CIT to the organ this would in turn have more kidneys thrown away. Deciding we are going to be "fair" does not mean we have to decide that we are not going to logically think about the consequences of our actions. If we make it "more fair" then we will throw away more gifts given to recipients, which should be our primary consideration.

Anonymous | 09/30/2019

The stated reason for the policy change is to come into compliance with The Final Rule. I am in agreement with that goal. The Final Rule is not a straightforward as you might think, and I encourage anyone interested to review it. The primary tenant is that we should use sound medical judgement achieve the best use of organs. Any changes to organ allocation should be done to promote efficiency, avoid futility, and achieve the most broad geographic sharing (within the confines of medical feasibility). Unfortunately, it seems some people are getting hung-up on the broad geographic sharing bit, while minimizing the best use of organs, efficiency, and sound medical judgement parts. Pancreas transplant, more than many other allografts, are very dependent on recovery techniques. The pancreas is also more sensitive to ischemia than a kidney, for example. I think for these two reasons, it is unrealistic to force the kidney allocation strategy on pancreas as a “one size fits all” solution. Regarding this broad geographic sharing tenant; whether a river, or state-line should keep organs contained is a more difficult question than it might appear. Certainly, I would not propose failing to ship an organ across a bridge, if it could be better used on the other side, but what if the difference was a month of waiting time? Or a minute? Before you send that organ across the bridge, please consider the reason that organ was available on the other side in the first place. If it is because of local initiatives on one side of the bridge, which have not been replicated on the other side of the bridge, then why must the better prepared side be compelled to share it? There has been a great deal said about the inequity of waiting times in cities like New York, but relatively little said about how poorly the conversion rate at NYRT compares with the conversion rate at adjacent OPO’s. If it is true that local initiatives improve organ donation, then shouldn’t the local recipients be rewarded? If not, what is the incentive for the local initiative in the first place? A corollary is why argue about who gets a bigger piece of the pie, when the pie could be made bigger? With regards to the 500 mile circles, one need look no farther than a map with 500 mile circles drawn around Manhattan, Chicago, Houston, Los Angeles, and San Francisco to see why 500 mile circles were chosen. A 500 mile radius around almost every hospital in the country will include one of these cities and over a dozen of the busiest transplant centers in the country. I also think the “distributed over as broad a range as feasible” should be examined. As I mentioned earlier, 500 miles was an arbitrary distance which happens to allow the biggest programs in the country access to almost all of the organs. If this range was determined with best use of organs in mind, clinically relevant information, like “additional cold ischemic time” would have been used instead of distances. Since the pancreas is less tolerant of ischemia, these numbers should be kept small. A question everyone needs to ask themselves is: how much additional money or delayed graft function are we willing to spend to share more broadly? The studies have not been done, but placing organs on a plane, will certainly increase both the time and money required to transplant a kidney that could be used locally with better outcomes, less ischemic time, and less financial resources, and no chance of missing a connecting flight, or getting lost in an airport. This strains the tenant of sound medical judgement. An additional consideration in pancreas transplant is the “Crisis in Confidence” currently gripping the pancreas transplant community. As these operations become less common, programs become more risk averse. It is ironic, but I think if you follow this pathway, broader sharing leads to less local pancreas transplant as the larger centers import the best pancreata, while the local centers get fewer transplants, and are increasingly averse to the procedure. This will, over time, shift the expertise a fewer centers and increase geographic disparity. So, of the tenants of the final rule, the proposed policy does not appear to show sound medical judgement. It also does not appear to promote efficiency, or the best use of organs. It does all this to encourage broader sharing, without mentioning why broader sharing is important, how much broader sharing will cost, why broader sharing should be the goal. Instead, I propose a continuous distribution of organs, with significant proximity points. At some small radius (based on travel time), an expedited placement protocol could take over. Contrary to the current proposal, this will promote efficiency, while removing geographic barriers. This will incentivize initiatives on organ donation. I have been told that “this is too hard”, but it is clear to me that this is the only solution that will promote all four tenets of the final rule. Anything else is a compromise.

Association of Organ Procuremement Organizations | 09/30/2019

The Association of Organ Procurement Organizations (AOPO) strongly supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. In support of this goal, organ procurement organizations remain committed to partnering with transplant programs to adapt to changes in allocation policy and develop innovative new approaches to increasing transplantation, with a focus on efficiency, minimizing discards and cost-effectiveness. We advocate for policy that is sensitive to specific cases in order to maximize utilization and that allows for flexibility to consider special geographic considerations. We support allocation policies that maximize the utilization of all pancreata. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. We also support changes that result in real improvements to the number of pancreata transplanted. In general, AOPO supports any changes that will increase the usage of pancreata. The pancreas remains the most difficult organ to place and for many OPO’s is rarely exported. This is not due to a lack of placement effort by the OPO’s but rather by a lack of centers who are interested/willing to import pancreata alone or in some instances with a kidney. • What considerations should be taken into account to select a circle size that distributes pancreata broadly and efficiently? Ideally, the modeling data will show maximum use of pancreata while accounting for cold ischemia time, cost and process efficiencies. The number of pancreas available for transplantation should not be impacted by broader sharing. Any modeling that shows an increased number of discards is not an acceptable policy. Air travel challenges also must be considered. For many areas of the country, travel is limited during the night, with weather and operational delays posing a further risk. Placing kidney/pancreas that require significant travel will increase cost, increase the likelihood of discard and decrease efficiencies. For this reason, AOPO supports as a first step to remove DSA and replacing it with a 250 NM circle, the same recommended for kidney. • Proximity points are intended to contribute to efficiency in the broader distribution of pancreata. Should they be used inside the 500 NM circle? Should they be used outside the 500 NM circle? Proximity points should be used, with a greater emphasis placed on those closest to the donor hospital and a reduction in the number of points as the distance grows. AOPO supports the use of proximity points within a 250 NM circle. • What operational concerns should the Committee consider as this policy is being prepared for OPTN board action and implementation? Pancreas is the least likely organ to be imported. The data shows a very small number of programs (16) have imported 5 or more pancreata in a 2-year period. For this reason, while AOPO supports the tenet of removing DSA, we recommend that a smaller 250 NM circle be used. Travel expenses and delays have not been modeled. Within a 250 NM circle most organs can be driven versus the dependence on air travel which can be sporadic in many areas of the country and unreliable during the night and during weather situations. • For import back up, should the initial distance from the transplant program be 150 NM or another distance, when considering the efficient reallocation of pancreas and kidney-pancreas? Should proximity points be included outside the initial import match run circle to limit travel costs and preservation time, or should there be a secondary circle of 500 NM to address those concerns? AOPO supports 150 NM with proximity points for import back up. • Should programs qualify for facilitated placement if the program performs 2 or 5 transplants in 2 years from pancreata imported beyond 500 NM from the transplant program? AOPO supports the use of 2 pancreata over 5 in the past two years within a 250 NM circle.

Medical University of South Carolina | 09/30/2019

This policy will increase cold ischemia time and likely pancreas discards, in an organ that we know if very susceptible to ischemia. This will also pose a challenge with logistics and cost of transporting pancreas outside of the region. Once the pancreas outmigrates, returning it to the local region (should there be any issues with intended primary recipient) will prove to be challenging. Chances are the pancreas will have to be offered to the local backup at that time. In the end, the policy attempts to benefit sensitized recipients but this might be at the expense of local recipients who might have been on dialysis for a long time. Working in a single transplant center-single OPO model, we enjoy the advantage of shorter waiting time for our patients. This is extremely beneficial for our local recipients as our state has one of the highest rates of CKD, a great majority of which is due to diabetes, particularly in the African American population. This is a disparity that our transplant center has been trying to address. However, with this proposed policy change, this might mean longer waiting time for our waitlisted patients due to increased outmigration of pancreas offers.

Joseph Hillenburg | 09/29/2019

I will likely be making similar comments to the Kidney proposal, so pardon if you think you're reading double. I support the proposal as an interim path toward Continuous Distribution, though please note that I prefer 250nm circles. While I understand the concerns of many of the commenters with respect to other changes that could be made instead, the fact of the matter is that, while there are many changes that can be done (increasing OPO performance, discussing opt-in vs. opt-out, etc.), those other changes should be considered separately. That is, this proposal is not mutually exclusive to other such changes, and this change is important to both fulfill the requirements of NOTA/Final Rule, and to ensuring that we are taking every individual step we can to improve the system. Unfortunately, this is the world we are in, but delaying this change will put the system at legal risk, which is a jeopardy many of us are now all too familiar with. It should also be recognized that this is just a stepping stone to what we know is our actual goal, and that is Continuous Distribution. I do want to call out (as has been noted by others) the concerns in terms of the pediatric population potentially losing priority to Kidney/Pancreas candidates, and would ask that the Kidney and Pancreas committees, in collaboration with the Ethics committee, ensure that these concerns are given attention. Education and communication with respect to this change is important. It is key that providers are aware of how to best deal with said changes, and that patients are aware of the benefits to them. This will hopefully lessen the "dip" (followed by recovery and improvement) to transplant rates that we have seen in the past when major allocation changes are made. The strong support by the patient community should be noted in considering this proposal.

Anonymous | 09/27/2019

I believe a change is needed to the distribution process; however, I’m not happy with the points system. The modeling by consultants did not show enough variability in the modeled subjects. I also feel points for wait times should be a greater factor in the distribution process. If all things are equal with a patient except the distance from a transplant facility, the recipient with the longest wait time should receive the organ. I also believe transplant centers have a lot of room to “quote” game the system related to organ refusal. This area should be reviewed as well. Centers are held accountable for their transplant rates, but are they held equally accountable for their rejection rate? Are the deaths for patients on a transplant centers waitlist figured into their program success rate. All of these factors impact the lives of the recipients on the waitlist and their families. If this is approved like the liver program, what are the affects to those already on the waitlist? How will the changes impact individuals, has modeling been done to show the change for all patients and what it would mean? I would prefer actual data, instead of a hypothesis. I agree changes should be made, but the actual impact must be shared, as well as looking at the entire process from start to finish, instead of impacting one piece of the whole process.

Anonymous | 09/27/2019

Region 8 voted as follows: Vote: Strongly support (0), Support (2), Neutral/abstain (6), Oppose (6), Strongly oppose (0)

James Sharrock | 09/26/2019

It is appropriate to eliminate DSAs and Regions from the process of pancreas allocation, but the proposed policy as written will impose unnecessary logistical challenges. I support a modification of the proposal to reduce the proposed 500 NM circle to a 250 NM circle. The projected outcome differential between the larger and smaller circle is insignificant when compared to the logistical problems associated with greater distances.

Anonymous | 09/26/2019

Strongly support (3), Support (11), Neutral/Abstain (2), Oppose (2), Strongly Oppose (3) Region 11 supported the proposal. During the discussion some members commented that pancreas is driven by center aggressiveness and that wider circles will satisfy the aggressive centers. There was some concern that there is no priority for pediatric KP candidates. Some members commented that pancreas should be kept locally.

LifeShare Transplant Donor Services of Oklahoma | 09/26/2019

LifeShare (OKOP) embraces the concept of removing DSAs and Regions from pancreas allocation. However, LifeShare strongly opposes the policy proposal as written. There is no effective difference in outcome between the proposed 500 nm circle and the smaller 250 nm circle. With no outcome benefit to justify increased logistical challenges, we oppose the proposed 500 nm circle and strongly suggest/support a similar model utilizing the 250 nm circle instead.

Anonymous | 09/24/2019

Region 1 voted and had the following comments: Strongly support (3), Support (6), Neutral/Abstain (2), Oppose (2), Strongly Oppose (1) Region 1 supported this proposal. Some members supported giving more proximity points for centers closer to the donor hospital. This was primarily due to a shorter ischemic time for PA versus KI. There was some concern with how specimens would be shared when KP’s were reallocated. There was a recommendation that while the transplant center with the initial intended recipient should be back-up, the host OPO should be responsible for the re-allocation, not the import OPO. The committee should review outcomes for outcomes for organs shared outside of 500 NM.

Anonymous | 09/20/2019

Region 2 voted as follows and had the following comments: Strongly support (2), Support (9), Neutral/Abstain (3), Oppose (7), Strongly Oppose (8) The region was not supportive of the proposal as written. There was concern that the proposed facilitated pancreas solution will make it difficult for centers to qualify. As transplant centers adjust to the new allocation system, it may be better to have an opt-in system. Another concern raised was that the proposed import backup solution is not appropriate for kidney-pancreas. Lastly, there was a call for further prioritization of pediatric patients regarding kidney-pancreas and pancreas transplants (i.e. multi-organ recipients). The region proposed an amendment to the proposal utilizing a smaller circle size for allocation since the modeling showed similar outcomes between a 250 NM circle and 500 NM circle. There was some support for a proximity point plateau within the smaller circle, but the region decided on two proximity points within the 250 NM circle and four proximity points outside the circle. Region 2 amendment: Use a 250 NM fixed circle with 2 proximity points within the circle and 4 proximity points outside the circle: Strongly support (2), Support (14), Neutral/Abstain (5), Oppose (4), Strongly Oppose (2)

American Nephrology Nurses Association | 09/20/2019

American Nephrology Nurses Association supports but possibly limit to 250 NM radius due to concerns with increased cold ischemia times.

Anonymous | 09/13/2019

Also need to eliminate state registry and go to National registry.

Anonymous | 09/11/2019

Pancreas Transplantation Committee, Eliminate the use of DSA and Region in Pancreas Allocation Strongly support (1), Support (13), Neutral/Abstain (4), Oppose (9), Strongly Oppose (8) Amendment (Pancreas) - 500 NM circle with no proximity points inside or outside the circle: Strongly Support (0), Support (17), Neutral/Abstain (3), Oppose (6), Strongly Oppose (6) • One member stated that the community may not want to increase the number of pancreas transplants and that the number continues to decrease. • It was suggested that we need stricter definitions and define which transplant hospitals are actually performing pancreas transplants and ensure they have access to pancreata. • The policy as written is attempting to plant the kidney solution on pancreas allocation. • It was suggested there be no proximity points and that transplant hospital activity and past history of acceptance be the main allocation determinant. It was also recognized that this would be difficult to capture in policy development. • Procurement should be more centralized. We need to make sure that the host OPOs can choose to selectively delegate import backup for individual organs if organs are procured simultaneously (kidney/pancreas).

Anonymous | 09/11/2019

Sending transplants out of state would increase the wait time exponentially to those in our own state.

Glen Hammer | 09/08/2019

The proposal demonstrates a lack of focus on the core problem - too few kidneys being available. To disadvantage potential recipients - in favor of others puts at risk the entire system. I am not sure at whose initiation this policy change was developed, but it penalizes those of us who have waited for organ donations with a reasonable expectation - because of the failing of others to encourage and promote the donations in their areas. Equity requires fairness. Why is the focus not on an aggressive policy (with money behind it) to encourage organ donation? The process also seems flawed. The questions that are entertained on the Web site - all ask our opinions about how might modify the proposal - rather than whether it should be abandoned all together. It smack of the "foregone conclusion" approach to policy making - we're doing this - regardless of the feedback.

Anonymous | 09/08/2019

My husband just got kidney pancreas transplant today, after over a year of waiting. If this were to go into effect while he was on the list that wait time would have at least doubled! I am no scientist, doctor, or surgeon but isn’t there a reason why organs do not travel far? Something about organs dieing before they reach the patient... getting viable organs is difficult enough why make it worse? As an Oregonian I urge that this not happen, keep things how they are.

Anonymous | 09/07/2019

• Although not separately discussed, many of the concerns discussed for the kidney proposal were general to the distribution model of 500NM and apply to the kidney proposal as well • There should be medical urgency considerations for pancreas, such as hypoglycemia, as there is for kidney Strongly support (0), Support (2), Neutral/Abstain (6), Oppose (6), Strongly Oppose (14)

Anonymous | 09/03/2019

Region 7 comments are as follows: Comments: Breakout session attendees shared several feedback items on this proposal. This included: • Inquiry on what type of prioritization would exist under this proposal for multi-organ candidates? The Region 7 representative responded the policy on this is not changing. • Committee was encouraged to publish information on pancreas discards or intraoperative turndowns. Would help understand if this is due to organ acceptance practices or changes in a donor’s clinical presentation. • Encouraged colleagues to review their data on acceptance practices; this can guide decision making whether to opt-in or opt-out of accelerated placement mechanisms. • Attendee cautioned the changes to circles may result in organ utilization changes and this is the opposite of what is needed. • OPO staff in attendance felt it was more appropriate for the import back up to be centered on the location of the organ at the time, rather than the location of the original accepting transplant program. • Pancreas transplant program staff in attendance felt the requirements for participation in facilitated pancreas allocation were appropriate. Region 7 voted as follows: 3 strongly support, 6 support, 2 abstention, 3 oppose, 0 strongly oppose

Anonymous | 09/03/2019

The OPTN Patient Affairs Committee had the following comments: • The PAC commends the addition of the Proposal at a Glance portion of the proposal. In addition to the current content, PAC recommends adding a history section, to include the proposal timeline, so the reader has some context for the proposal and a glossary of transplant-specific terms • We agree that the maximum reasonable travel distance should be selected, which in the modelling outlined in the proposal is 500 NM, in order to reduce inequities in access to transplants based on geographic location, socioeconomic status or minority status, while still maintaining integrity and quality of the organ or islet, reducing discards or loss of organ, and reduce waitlist mortality. From modelling studies reported in the proposal, 500 NM is the most reasonable choice, however, we do feel it will be especially important to continue monitoring these metrics carefully at intervals noted in the evaluations section. • We agree that proximity points should be applied both inside and outside the 500 NM circle in order to accomplish the goal of broader distribution for improved equity while still protecting efficiency with minimized travel distance. Modelling supports this effect of proximity points, but some of us still questioned how efficiently these proximity points would achieve this, further emphasizing the importance of frequent reevaluation of outcomes after the proposal is implemented. • Issues regarding behavior of programs in a new system should be addressed directly to transplant programs and OPO’s—this includes concerns about programs being reluctant to accept organs from a farther distance or from a program they have not worked with before. Forging these new relationships may need proactive support from the OPTN. Education of the public, candidates or families is not specifically addressed in the proposal nor is there any consideration of who would be in charge of this education. Pediatric transplantation was not addressed in the proposal, so some clarification about whether this policy would apply to pediatrics is needed. Further, some clarification of how organs are classified as pancreas alone, kidney/pancreas or kidney alone should be clarified. • We agree that the 150 NM circle makes sense in order to maintain broad distribution and efficiency, as well as aligning with kidney import backup for consistency and standardized clarity. • The secondary circle would likely introduce further travel and preservation stresses for an organ with the clock ticking down, so we do not support it. • Since pancreas programs are few in number and we would like to encourage further program development, it makes sense to include more programs in the qualification for facilitated offers with the proposed 2 imports in 2 years suggestion. • It will directly impact candidates by expanding access to transplants geographically with wider distribution, and if modelling predictions bear out, increase access to underserved populations. However, there was concern from some members that kidney-alone patients may be disadvantaged and there would be no specific monitoring for kidney-alone patients. • It is not clear how this policy will be presented to the public in a clear, concise manner, and by whom. The metrics outlined for reevaluation did not include tracking of transportation costs and monitoring of preservation times in relation to changes in transport distance. In order to facilitate understanding by the general public of the proposal and its significance, an introductory section outlining the history that led to this proposal would provide important context. In addition, a glossary for transplant-specific terminology would be helpful for patient readers. We would like to acknowledge that the new “Proposal at a Glance” section is a positive addition to the document, providing a clear, concise, user-friendly entry into the topic. The writing is uncomplicated and to the point with a tone that will be inviting to the general public to encourage joining the discussion. • We recommend approval of this proposal with some additional attention to clarifying some of the details noted in the questions above. This is an important step in the development of a continuous allocation system. Further, this policy more closely approaches satisfaction of the Final Rule requirement that organ allocation shall not be based on a candidate’s place of residence or listing. The policy has been designed with modelling to avoid unnecessary organ loss and promote efficient placement by limiting travel distance with proximity points. It also intends to improve access for historically underserved populations including certain minorities and lower socioeconomic status groups. Finally, it is in compliance with NOTA with a neutral effect on waitlist mortality and broadening of distribution of pancreata while increasing potential pancreas utilization and reducing potential impact of long preservation times on post-transplant mortality. • Some members are concerned about a lack of specific training and policy standards regarding islet transplant programs. Furthermore, without a clear path forward for islet candidates, there was concern that patients needing an islet transplant would be in direct competition with patient needing a pancreas transplant. • The PAC voted on this proposal and the results are as follows: Strongly support (31%), Support (54%), Neutral/Abstain (8%), Oppose (8%), Strongly Oppose (0%).

Anonymous | 09/03/2019

The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this public comment item. The Living Donor Committee is in support of the proposal.

Anonymous | 09/03/2019

The OPTN Ethics Committee thanks the OPTN Pancreas Transplantation Committee for its effort in developing this public comment proposal that describes removing DSAs and Regions from pancreas allocation policy. The Committee expresses its concern that the facilitated pancreas proposed solution could potentially limit small programs from receiving facilitated offers and therefore limit some underserved patient’s access to organs. The Committee believes that the proposal should assess the effects of the proposed policy on pediatric patients, and supports additional evaluation of potential priority for pediatric patients in pancreas allocation. The Committee members indicated 58% support and 42% neutral/abstain sentiments for the proposal.

OPTN Region 4 | 08/30/2019

Strongly support (1), Support (2), Neutral/Abstain (1), Oppose (6), Strongly Oppose (12) Region 4 members did not support the proposal. Although there were fewer concerns with using a 500 NM circle for distribution of pancreas than there were for kidneys, given that most pancreas are shared with kidneys, it would not be efficient to have a different distribution system for pancreas and kidney. There was some concern raised about how new programs or programs who had previously been functionally inactive would be able to participate in the facilitated pancreas program. Region 4 amendment: Use a 250 NM fixed circle with 2 proximity points within the circle and 4 proximity points outside the circle: Strongly support (8), Support (13), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)

OPTN Membership and Professional Standards Committee | 08/30/2019

The MPSC thanks the Pancreas Committee for presenting its proposal. MPSC members asked the committee member presenting the proposal a few questions and provided feedback regarding import backup and facilitated placement under the new proposal. 1. Local backup has always been a challenge, and it’s important that organs are ultimately transplanted. Moving forward with the new allocation system, it will be important to continue to make sure that the intended recipient is receiving the transplant, both for transparency and to ensure the health of the system. It will be important to continue to review allocations in which a transplant program accepts an organ for one candidate and transplants a different candidate, so the organ-specific committees can have an appreciation for how frequently this type of event occurs. The presenter agreed and pointed out that Policy 5.9 says that transplant programs must let the host OPO know when an organ cannot be transplanted into the intended recipient. 2. Will facilitated placement occur within the 500 NM circle? Or do offers to candidates within the circle have to be exhausted in order to use facilitated placement? Facilitated placement can be used if it is within three hours of procurement and offers to candidates within 500 NM have been exhausted.

Wake Forest Baptist Health | 08/13/2019

I don't disagree with the hybrid framework model to replace DSA as a method of pancreas distribution but the 500 NM radius is much too large. When I use the interactive map and use our center (NCBG) as the donor hospital, the distribution/proximity circle in essence encompasses nearly all of the continental US east of the Mississippi River! This represents much too large of a geographic area in order to facilitate efficient placement and transplantation of recovered pancreata, particularly given the constraints of cold ischemia in pancreas transplantation. The logistics involved in such an undertaking are staggering, cumbersome, and counterproductive to optimal utilization of donor pancreata. I would favor lowering the proximity circle to either 150 or 250 NMs. With respect to import pancreata and facilitated pancreas allocation, I would suggest removing the qualifying criteria because you are increasing the definition of "local". Local back-up should be center back-up, again because of cold ischemia considerations. Trying to re-allocate a KP at another center is a near-futile proposition. Pediatric priority should be added to pancreas allocation.

LifeGift | 08/08/2019

Broader distribution is supported by LifeGift. Any improvements in the current pancreas allocation and distribution system are welcome changes to help address the extreme underutilization of donated pancreata. Thank you for the chance to comment.