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Eliminate the use of DSAs in thoracic distribution

Proposal Overview

Status: Board Approved

Sponsoring Committee: Thoracic Organ Transplantation Committee

Strategic Goal: Provide equity in access to transplants

View the policy notice (PDF; 6/2019)

View the Board report (PDF - 1.5 M; 6/2019)

Read the proposal (PDF; 1/2019)

Contact: Kimberly Uccellini

View the thoracic proposal dashboard

Data request from the Heart Sub-Committee of the Thoracic Organ Transplantation Committee
Results for four DSA-free models of heart allocation

View analysis report (PDF; 10/2018)

Executive summary

The Organ Procurement and Transplantation Network (OPTN) Final Rule (hereafter, Final Rule) sets requirements for allocation policies developed by the OPTN/UNOS, including sound medical judgement, best use of organs, ability for transplant hospitals to decide whether to accept an organ offer, avoiding wasting organs, promoting patient access to transplant, avoiding futile transplants, and promoting efficiency. The Final Rule also includes a requirement that allocation policies “shall not be based on the candidate’s place of residence or place of listing, except to the extent required” by the other requirements of the Final Rule listed above.

In the past year, the United States Secretary of Health and Human Services (HHS) received critical comments regarding compliance with the National Organ Transplant Act (NOTA) and associated regulations under the Final Rule with respect to the geographic units used in lung and liver distribution. The OPTN/UNOS made rapid changes to resolve using donation service area (DSA) and OPTN/UNOS regions (Regions) in lung and liver distribution, respectively. Furthermore, the OPTN/UNOS Executive Committee directed the organ-specific committees to analyze those distribution systems and replace DSAs and OPTN/UNOS regions with a more rational and defensible unit of distribution.

Policy 6: Allocation of Hearts and Heart-Lungs currently uses DSAs as a geographic unit of distribution. These are poor proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs result in an inconsistent application for all candidates. This presents a potential conflict with the Final Rule.

The OPTN/UNOS Thoracic Organ Transplantation Committee (hereafter, the Committee) proposes replacing DSAs with a 250 nautical mile (NM) distance from the donor hospital. The goal of this change is to make heart allocation policy more consistent with the Final Rule and provide more equity in access to transplantation regardless of a candidate’s place of listing. In addition, this proposal realigns the first units of distribution for heart and lung allocation, addresses the limited utility of the exception for sensitized heart candidates, and finally, resolves several clerical artifacts that remain as a consequence of removing DSA as a unit of distribution from heart allocation policy.

Feedback requested

The Committee encourages all interested individuals to comment on the proposal in its entirety. Members are asked to comment on both the immediate and long-term budgetary impact of resources that may be required if this proposal is approved; this information assists the Board in considering the proposal and its impact on the community. The Committee requests specific feedback on the following item:

Members are asked if they would recommend an alternative distance for thoracic distribution, versus the proposed distance of 250 NM? If so, what distance do you recommend and what evidence justifies this distance?

Comments

Cassandra Smith-Fields | 02/07/2019

The pediatric impact is not fully appreciated in this modeling and will pull pediatric organs into the adult recipients.

Anonymous | 02/08/2019

Region 7 vote-7 strongly support, 7 support, 1 opposed While the region was supportive of this proposal, there was concern that this policy does nothing to improve waitlist mortality which is related to a number of subgroups. There was a recommendation that the committee improve current policy to even out wait list mortality with different groups and regions. There was also a recommendation that the issue of wait list mortality should be addressed by the OPTN/UNOS Board. Members also commented that this change would have limited impact on pediatric transplantation. The region was generally supportive of the 250 NM circle.

Robert Goodman | 02/12/2019

Although I do believe I have a rather broad perspective in general, as a heart transplant recipient, I have a keen interest in the how this policy plays out. In addition to being one of the PACC members who was asked to review this policy change, I listened to the webinars, attended one of the Regional meetings and purposely went to the Thoracic program directors meeting beforehand. I support the 250 NM approach for these reasons: 1. It meets the goal of replacing DSAs and regions as the distribution model; 2. 250 NM seems reasonable and doesn't go too far out, so it won't likely threaten the cold ischemic times required for successful heart and lung transplants; 3. It ensures consistency with the newly revised lung policy of 250 NM; and 4. It should more fairly distribute organs even though it may take some time for adoption of this new broader distribution to take hold.

Region 1 | 02/18/2019

Region 1 vote-7 Strongly support, 5 support, 4 abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/21/2019

Region 5 Vote: 6 strongly support, 23 support, 4 abstain, 3 opposed : One member commented that fixed distance is not the best solution and there should be discussion about population and transplant hospital density, perhaps change circle size for areas west of the Mississippi. He stated that surgeons would have to fly more unless cardiac surgeons trust local surgeons to recover for them. Another member asked how many more surgeons will have to die and suggested that be included in modeling. It was suggested to make statuses 1 and 2 allocation to 250 nm instead of the 500 nm.

Anonymous | 02/21/2019

Region 2 Vote: 0 strongly support, 16 support, 7 neutral/abstain, 4 oppose, 0 strongly oppose A comment was made that by removing policy for sensitized heart candidates that those patients would be negatively affected by this policy proposal. One member proposed that a population based model be used instead of a fixed distance circle. The fixed distance creates a cliff at the boundary that could negatively impact a patient just outside of the circle. They feel that such disparities could open up the possibility for more litigation. It was also asked why the same sized circle is being proposed as lung allocation. Since hearts have shorter cold ischemic time limits, it would seem that the circle size should be smaller.

Anonymous | 02/26/2019

Region 8 vote: 2 strongly support, 3 support, 3 neutral/abstain, 4 oppose, 10 strongly oppose Members shared a few concerns about the proposal as written. Much of the concern centered on the desire to first assess the impact of the recently implemented heart allocation changes before considering an alternative. There was also concern to first understand what, and the degree to which, geographic disparities may exist in the current distribution system. Justification for this concern was based on the experience operating under the new allocation policy; members reported dealing with increased length-of-stays for heart transplant recipients, and more heart fly-outs following implementation of the new heart allocation changes. In addition to not making any change to the current to heart distribution policy, some members suggested decreasing the fixed distance in the proposal to 150 nautical miles (NM). This distance would be proximate to the current system and would allow post implementation evaluations to see if an expansion of the distance was prudent. It also maintains local community benefit. Other members expressed support for a distance of 250 NM. A member commented that the committee should consider a continuous distribution model in the near future and that the patient perspective should be considered in decision making (e.g.: heart failure candidates that receive a ventricular assist device (VAD) and have longer waiting times).

St. Luke's Hospital of Kansas City | 02/27/2019

Since the new allocation has been in affect, most of our local donor hearts have left our area. We have received only one of thirteen total. Including myself and a donor in the future, many residents may be hesitant to donate knowing that those organs will not be used here locally where they live, get their care, and know of others dying or waiting on organs. Staying more local allows increased organ allocation and decreases organ wastage. Also with reading the Final Rule, our recipients are going to be skipped over for an organ due to their place of residence. For our organization and our surgeons and staff, our distance to travel for an organ has increased from a mean of 150 miles to now 445 miles. This is an increased burden on our program as we may not be able to perform close together transplants if the team is already traveling for hours. Our acquisition charges have almost doubled since the allocation change. Also our median Cold Ischemic time has increased, placing our recipients at a higher risk for rejection. Our patients also have to be "sicker" to be a status 2 which increases risks of longer recovery and higher incidences of complications. More depend use of LVADs who then become status 4 and may never get a transplant. Kind of death sentence for them, especially the younger patients.

Anonymous | 02/27/2019

Our region (and in particular our DSA) is disproportionately affected by the recent allocation change and will be further challenged by the proposed change. I choose 250 mile circle

Anonymous | 02/27/2019

10/18/18 Allocation has adversely affected region 8 We vote NO on proposal because this will further reduce the available donors for status 3-6 patients – “Let the dust settle before considering this” IF the UNOS mandate to eliminate DSA is mandatory, then vote for 250 mile instead of 150 mile circles – 150 mile circle will further adversely impact a sparsely populated region like ours Suggest looking at “continuous” circle with ever expanding circles from the donor hospital – whichever program is closest in this model, will be offered the organ Consider using population densities to create “circles” – a small radius on the coasts are equivalent to large “circles” in the Midwest

Anonymous | 02/27/2019

The Minority Affairs Committee (MAC) thanks the Thoracic Committee for its hard work in developing this proposal and presenting to the MAC. The MAC was interested in the modeling that went into developing the proposal; in particular, the MAC wanted assurance that vulnerable populations were duly considered and modeling identified potential impacts for these populations. The Thoracic Committee presenter identified that each of the models looked at impact by gender, population density, geography by states, center volume, and waitlist mortality. No negative impacts were seen according to the metrics tied to vulnerable populations. A question was asked whether there are non-contiguous thoracic programs that potentially getting disadvantaged by lack of a "regional" distribution level. The Thoracic Committee presenter clarified that thoracic policy doesn't have a regional distribution currently, and also that no non-contiguous areas have heart transplant programs that would be receiving organ offers to transplant at the non-contiguous area.

Anonymous | 02/28/2019

Region 10 Vote: 7 strongly support, 12 support, 3 neutral/abstain, 2 oppose, 0 strongly oppose

Anonymous | 03/04/2019

The Pancreas Committee thanks the Thoracic Committee for its work developing this proposal to remove DSA from heart allocation. The Pancreas Committee asked whether the TSAM modeling showed a decrease in transplant counts compared to the baseline, which it does not. In response to a question regarding whether the Thoracic Committee considered including proximity points in its modeling options, the Thoracic Committee presenter indicated that the Thoracic Committee did not include proximity points because the recent changes to lung allocation were significant and further complication of heart allocation with proximity points was considered unnecessary and potentially problematic. In the long term, the Thoracic Committee will transition to continuous distribution for both heart and lung allocation. The Pancreas Committee agreed with the Thoracic Committee presenter that issues of cost and availability are pertinent to the discussion of changing geographic distribution. A member noted that surgeons flying more would mean that these surgeons wouldn’t be available at the hospital during those times, a separate issue than the cost of flying more. The Pancreas Committee noted that the presentation did not focus on data analyses performed, and that would have been helpful to include. One Pancreas Committee member indicated they strongly support the proposal, 6 members indicated they support the proposal, 2 members indicated they were neutral or abstained, and one member indicated opposition to the proposal. No Pancreas Committee members indicated strong opposition to the proposal.

Anonymous | 03/11/2019

10/18/18 Allocation has adversely affected region 8 Looking at “continuous” circle with ever expanding circles from the donor hospital – whichever program is closest in this model, will be offered the organ Consider using population densities to create “circles” – a small radius on the coasts are equivalent to large “circles” in the Midwest

Felicia Wells-Williams | 03/13/2019

Organ discard remains a concern for me, as this is an area I believe we can have an impact in increasing transplants. I am confident that the OPTN will maintain and analyze data relating to this change so that the impact of this proposal on discard rates can be monitored with adjustments made as needed. I think it will be important for the transplant community to be able to articulate the reasons for varying distances (for the concentric circles) that may be selected for different organs. The public will want to know that there is significant thought and purpose in the selection of the varying distances. As we come into agreement as a community, it will be important that we have the trust of transplant patients and their families. Our decisions should be focused on fair and equitable access to transplant for all patients.

Anonymous | 03/13/2019

OPTN/UNOS is also proposing to modify the geographic algorithm applied in heart allocation. The current heart geographic algorithm utilizes defined distances (500 nautical miles) as well as DSAs defined as the geographic area served by one Organ Procurement Organization (OPO). Concerns were raised by the Department of Health and Human Services that OPTN policies may not provide equitable access to donor organs. As a result, changes were made in the lung and liver allocation system to eliminate the use of DSAs. This proposal seeks to replace the DSAs with a 250 nautical mile distance from the donor hospital for heart allocation. There are several potential advantages to this proposal. First, it appears to reduce some of the geographic variability seen in waitlist mortality and variability in time on the waitlist. Second, the proposal would better align OPTN policy with language in the OPTN “Final Rule” which requires equitable access to donor organs no matter the recipient’s geographical location. Third, it would create a heart allocation model that harmonizes with other cadaveric organs. Potential drawbacks are the potential to increase the distance from the donor hospital to the recipient hospital, therefore increasing travel time, heart ischemic time, costs, and the frequency with which caregivers are exposed to the hazards of non-commercial air travel. In principle, STS supports the elimination of DSAs in the heart allocation system. However, the heart allocation model, whose framework remained essentially unchanged for approximately 20 years, was drastically reconfigured in October 2018. The impact of this new heart allocation paradigm remains uncertain. The modeling used in the assessment of the current proposal reflects heart transplantation practices prior to the recent heart allocation change. The impact of the current proposal on the newly implemented allocation system is unknown. Therefore, STS supports a future plan to eliminate DSAs but recommends that implementation is delayed until there is a better understanding of the impact of the recent October 2018 heart allocation model, particularly with regards to waitlist mortality, post-transplant survival, and cost.

Anonymous | 03/13/2019

The Ethics Committee thanks the Thoracic Committee for its effort in developing this proposal to remove DSA from heart distribution. The Committee discussed how the distances modeled by the Thoracic Committee differed in terms of recipient outcomes. While there was some support for a smaller 150 NM circle, the modeling did not show a significant difference between 150 NM and 250 NM in terms of outcomes, which was a key factor in the Thoracic Committee’s decision to replace DSA with 250 NM. Besides questioning the outcomes of the different options considered, the Ethics Committee members did not express significant concern with the proposal. In a poll issued during the call, a majority of the Ethics Committee (8 out of 10 responding members) indicated support for the proposal.

Anonymous | 03/14/2019

The Organ Procurement Organization (OPO) Committee discussed the proposed allocation changes and their impact on OPOs and offer the following responses: o The Committee voiced concerns about the cost impact as well as transportation methods (recovery teams having to fly vs. utilization of local recovery teams). There will be an increase in case times, decrease in available resources, and an increase in the workload on staff. o The Committee recognizes the impact that broader organ distribution will have on donor families. Increased donor case times can have a negative impact on donor families and donor hospitals. o The Committee recommends improving efficiencies within the system that will enable the ability to cut down on case times and ensure organs are allocated in the most timely and efficient manner possible. OPO Committee Vote: 1 Strongly Support, 11 Support, 2 Oppose

Anonymous | 03/14/2019

Region 4 vote-3 Strongly support, 16 support, 1 abstain, 1 oppose, 0 strongly oppose

Anonymous | 03/15/2019

The OPTN/UNOS Patient Affairs Committee (PAC) thanks the Thoracic Organ Transplantation Committee for the opportunity to comment on the proposal to eliminate DSA from heart distribution. The PAC complimented the Thoracic Committee with regards to the way the proposal was written; most felt it was written in a way that members of the general public would understand. The Executive Summary was especially straightforward and easy to follow. The PAC also noted the Thoracic Committee avoided proposing a distance that essentially mimics the status quo. The PAC asked the following questions, which were answered by the sponsoring committee’s presenter to the satisfaction of the Committee: Q: Although there isn’t a formal definition of a “sensitized candidate”, the PAC asked what some characteristics are of a “sensitized” heart candidate, and recommended including a detailing of how these patients are currently handled would be helpful. A: There is ongoing discussions within the OPTN Thoracic Committee on the definition and details regarding “sensitized candidates”. The current challenge is that many transplant centers do not report unacceptable antigens for heart candidates. As such, without at least a years’ worth of data reporting to inform an evidence-based policy, the Thoracic Committee opted to address this issue in a separate project. Q: There was much discussion and debate amongst the proposal review group about access to mode of transport and what happens at the 251st NM. How will OPTN/UNOS monitor impacts when lack of transport impacts the successful implementation of this policy, or, if it isn’t monitored, why is that the case? What happens beyond the edge of the 250NM cliff? A: The speaker affirmed that during the Thoracic Committee’s discussions, there was concern about an increase in travel costs, specifically air transportation. For example, flying to procure an organ costs more than traveling by car. Furthermore, if an organ recovery team were to fly and decide not to procure the heart, then the transplant program will be forced to absorb the transportation costs. In terms of concentric circles, the “cliffs” of this distribution system may impact a candidate’s access to organs. Due to this concern, the Thoracic Committee is interested in pursuing a continuous distribution framework, lung being the first organ to start transitioning. It would take more effort to convert the heart distribution system to a continuous framework. Q: With this proposed policy change, the costs associated with the recovery event itself may increase, but a broader definition of cost (to include hospital stay, operations, procedures, devices, and medicines), may well see lower utilization, and lower total cost, because the allocation area expanded to a 250NM radius around the donor hospital. A: It is possible that the new allocation system may lead to a decrease in hospital-stay time, however if the heart has more ischemic time, then the opposite may occur whereby the patient must stay in the hospital for a longer period of time and may experience graft failure. Also, some transplant programs might shut down if they cannot absorb increased costs, however short-term. Q: Would less populated, western states be disadvantage if this proposal? A: The Thoracic Committee analyzed the difference across a variety of metrics for centers east and west of the Mississippi, but overall there were negligible differences. It was noted that transplant centers may have to export more hearts to other states. The speaker cited a recent article that concluded population density may not have a huge impact on the allocation of organs. Due to these concerns, the Thoracic Committee will continue to assess any future impacts stemming from this allocation change. Q: What is the preliminary feedback so far from the OPTN Regional Meetings regarding this proposal? A: So far there has been general support from the community for 250NM. Region 8 was more split in their favor for this proposal, however they still agreed to adopt the 250NM concentric circle. Q: Has there been any specific feedback from pediatric transplant centers regarding the potential impact on pediatric candidates? A: The presenter shared he had presented to the OPTN Pediatric Committee last week, and overall, the changes implemented to the adult heart allocation system in October 2018 had resulted in increased access for pediatric candidates. Under the new allocation system, pediatric candidates are on par with Status 1 adult heart candidates. The TSAM modeling did not show that 250 NM would negatively impact pediatric candidates, though both 500 NM distances might further advantage them. Also, the sickest pediatric candidates are already offered hearts from 500 NM. Q: Did the Thoracic Committee take into account U.S. military veterans, specifically those veterans whom may be dependent on a limited number of VA hospitals that have heart transplant programs? A: The Thoracic Committee did not specifically look at this metric. Overall in the U.S. there are a limited number of heart transplant programs. The presenter did not think that any of the areas with high numbers of U.S. veterans would be disadvantaged, however agreed that the Thoracic Committee may consider looking at the potential impact post-public comment. Q: What effect will this new heart allocation system have on multi-organ transplants? A: The presenter acknowledged that multi-organ policy was beyond the scope of this project, and that only a minor clarification to multi-organ policy was included in this proposal. Broader distribution may further complicate allocation. The PAC supported the Thoracic Committee’s proposal to replace DSA with 250NM radius around the donor hospitals as the overall unit for distribution. The Thoracic Committee presented a compelling case that this distance is the best option due to their consideration of Final Rule requirements and neutral impact to wait list mortality.

Association of Organ Procurement Organizations (AOPO) | 03/17/2019

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 and cost-effectiveness. We advocate for policy that is sensitive to specific cases in order to maximize utilization and that allows for flexibility to take into account special geographic considerations. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. To accomplish this objective, we believe development of an allocation policy that achieves distribution without boundaries is the best path forward. Such a framework allows for one or more organ-specific medical factors, such as medical urgency or pediatric donors, to be included as one component (medical priority score) of a composite total score. The second component (proximity score) can and should be tailored to control for distance between the donor hospital and the transplant center, considering clinically relevant organ-specific factors, such as cold ischemic time. Importantly, the relative weighting of the medical priority score and of the proximity score can be easily refined over time to fine-tune allocation policies to achieve the stated goals. With the exception of kidney transplant, in the vast majority of cases accepting transplant center teams travel to the host OPO to perform organ recovery. On an ad hoc basis, centers may agree to a local team recovering the organ on their behalf, although the practice is not widespread. Broader organ sharing calls for an exploration of a systematic process to reduce surgeon and recovery team travel by using a local recovery team. Such a system of regional organ recovery teams has been implemented in the United Kingdom and should be studied by the OPTN.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation supports this proposal in concept and offers the following comments: There is a strong sense among the Society’s pediatric thoracic transplant community that this proposal of broader organ sharing starting at 250 NM will likely be beneficial for pediatric thoracic transplant recipients. The lung transplant field has already adopted this allocation scheme and adapted accordingly with no objective undue burden to pediatric transplant care providers or any subjective deleterious effect on the relationships that constitute the foundation of the present DSA model. Given the relative scarcity of appropriately-sized thoracic organs, adult and pediatric thoracic transplant providers have continued interest in expanding the catchment area for available organs. Therefore, while the pediatric thoracic transplant community supports this policy allocation change, it is felt that longer-term consideration for further expanding this range to 500 NM would most benefit pediatric thoracic organ recipients, and best promote safe and effective growth of the field. Among the Society’s adult thoracic transplant community there was general support from the cardiac constituency. There was a suggestion that prior to the adoption of the proposed Thoracic Organ distribution policy, it would be potentially informative to the heart community to more fully take advantage of the results of the lung allocation policy results by: 1. Review of the 9-month analysis of lung data that was assembled by the thoracic committee (Ref). Data reflected only an approximately 50 NM increase in median distance lungs travel from donor hospital to transplant hospital, yet anecdotally, Committee members cited a significant increase in travel and associated costs. 2. Review of a comprehensive description of the lung experience of transplant centers and OPOs relating to impact on organ acceptance, late declines, organ discard, DCDs, sensitized candidates, procurement costs. Reference: OPTN/UNOS Descriptive Data Report “Monitoring of the Lung Allocation Change, 9-month report removal of DSA as a Unit of location. Prepared for the OPTN/UNOS Thoracic Organ Transplantation Committee.

Anonymous | 03/19/2019

The Pediatric Transplantation Committee (Pediatric Committee) commends the Thoracic Committee for their effort in creating this policy proposal and thanks them for their presentation on the document. A Pediatric Committee member asked if the Thoracic Committee considered creating a review board to address access for highly sensitized candidates in the proposed policy. Another Pediatric Committee member asked if there would be a benefit for pediatric programs having a larger area of distribution as compared to adult programs. The Pediatric Committee was in support of the 250 nautical mile circle.

Anonymous | 03/20/2019

To Whom it May Concern: The Heart Failure Society of America (HFSA) appreciates the opportunity to comment on the OPTN/UNOS Thoracic Organ Transplantation Committee proposal to eliminate the use of donor service areas (DSAs) in thoracic organ allocation. HFSA is a multidisciplinary organization working to improve and expand heart failure care through collaboration, education, research, innovation, and advocacy. HFSA believes it is crucial to address the inequities in Policy 6: Allocation of Hearts and Heart-Lungs. This policy uses DSAs as a geographic unit of distribution. HFSA agrees that these are poor proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs result in an inconsistent application for all candidates. HFSA supports the proposal of the OPTN/UNOS Thoracic Organ Transplantation Committee to replace DSAs with a 250 nautical mile distance from the donor hospital. We believe this will foster the goal to provide more equity in access to transplantation regardless of a candidate’s place of listing. Some recent studies in heart and lung transplant confirm that broader geographic donor organ sharing does not worsen post-transplant outcomes and provides greater equity in the distribution of organs. Importantly, expansion of DSAs has been associated with reduced mortality for patients on the waiting list for thoracic organs. Below are links to recent literature for your information: Journal of Heart and Lung Transplantation: https://www.jhltonline.org/article/S1053-2498(18)31654-1/pdf American Journal of Transplantation: https://www.srtr.org/media/1093/tsuang_et_al-broader-geographic-sharing-of-pediatric-donor-lungs.pdf Thank you for your consideration of these views.

American Society of Transplant Surgeons | 03/21/2019

In the OPTN/UNOS Thoracic Organ Transplantation Committee proposal to “Eliminate the Use of DSAs in Thoracic Distribution” which was put forward for public comment, OPTN/UNOS proposes to remove the donation service area (DSA) from thoracic organ distribution and propose an allocation area of 250 nautical miles (NM) from the donor hospital. There is strong support for the concept of more broad sharing as there are arbitrary boundaries and much variability in DSAs thus giving the potential for limitations to access. Removing the DSA geographic boundaries would foster more broad regional sharing. The modeling of OPTN/UNOS has investigated variations in organ utilization and wait list mortality with several models and the 250 NM radius appears to enhance access with no overt harm. The proposed change in geographic boundaries would have an impact on the cost of thoracic organ transplantation: increased monetary costs, increased logistic burden, and increased risk to recovery teams who would be traveling more often and farther. Concurrent to the change is geographic distribution where there have been recent changes to the heart transplantation allocation status system. In preliminary data, there are changes in practice pattern of the transplant centers in the short time since the status change has been enacted. The impact of these practice changes is likely not reflected in the organ utilization model. While we are still early in the allocation status chance, a longer temporal period that would allow reflection on and reassessment of the impact of the new model would be prudent before additional major changes are enacted. The proposed change has been developed over several years and with extensive modeling. The 250 NM radius is reasonable as the modeling does not show improvement to 500NM, in terms of organ utilization and decreasing of wait-list mortality. The ASTS supports a proposed change in thoracic organ allocation from the DSA to a 250 NM radius from the donor hospital which may balance access issues with cost and logistical challenges associated with other models.

International Society for Heart and Lung Trasplantation | 03/21/2019

The International Society for Heart and Lung Transplantation (ISHLT) is a multidisciplinary, professional membership society dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. The nearly 4000 members of the Society include professionals from over 45 countries, representing 15+ different disciplines involved in the management and treatment of end-state heart and lung disease in both children and adults. Approximately 70% of the society’s members practice in the United States. The OPTN Board of Directors recently approved modifications to the Adult Heart Allocation policy, creating a new 6-tier system for medical urgency. In this new scheme, donation service areas (DSAs) were maintained as a geographic unit of distribution. These have been deemed to be poor proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs result in an inconsistent application for all candidates. This presents a potential conflict with the Final Rule. The OPTN/UNOS Thoracic Organ Transplantation Committee therefore is proposing replacing DSAs with a 250 nautical mile (NM) distance from the donor hospital. The goal of this change is to make heart allocation policy more consistent with the Final Rule and provide more equity in access to transplantation regardless of a candidate’s place of listing. In addition, this proposal realigns the first units of distribution for heart and lung allocation, and addresses the limited utility of the exception for sensitized heart candidates. ISHLT supports the elimination of DSAs and the creation of a more equitable 250NM service radius and provides useful framework to further assess effect on waitlist mortality. The proposed distance is a fair compromise with regard to travel time, need for costly air travel for procurement (with its intendant risk to procurement teams) and organ ischemic times. The proposed distance also allows standardization with the lung policy and therefore facilitate acquisition of heart-lung blocs. We do however acknowledge that with increasing mean donor age and increasing urgency and surgical complexity of patients awaiting heart transplantation, prolonged ischemic times may impact post-transplant outcomes. The ISHLT however acknowledges that the likelihood of adoption of ex vivo perfusion platforms and donor recovery centers may have an impact in the not too distant future since donor recovery centers are already operational. These changes should prompt a review of the policy. The elimination policy 6.4.B is reasonable due to its impracticality and lack of use. We do share the Committee’s concern that this leaves no options for the sensitized candidates, particularly as sensitization rates continue to rise for patients awaiting heart transplantation as more patients require bridging with mechanical circulatory support. There also appears to be some inconsistency in the policies for prioritization of sensitized patients between the solid organs. We concur that the Committee should work with the Histocompatibility Committee on developing an optimal policy as a matter of priority. The issue of prioritization of sensitized heart transplant candidates should be addressed immediately with a reasonable solution devised. ISHLT appreciates the opportunity to respond to the proposed policy and to provide feedback that we anticipate will contribute to the development of a meaningful improvement in organ allocation.

Saint Luke's Hospital, Kansas City | 03/21/2019

I am writing to express our heart transplant program’s (Saint Luke’s Hospital of Kansas City) significant concerns regarding both the current allocation scheme for status one and two heart recipient candidates and the proposed geographic allocation amendments for status three through six recipients. First, the initial change for status one and two recipients removing DSA boundaries was well meant, but defining an arbitrary 500-mile radius from the transplant center has resulted in several unintended adverse consequences. We have reviewed data on 17 accepted donors since the new policy went into effect on October 18, 2019 and wish to share it with you. While our overall transplant volumes have declined slightly since the allocation change, virtually the only transplants being carried out are in status one or two recipients. We have had no mortalities. Since October, all but two donors have been distant retrievals. Prior to the change in policy, 60% of donors to our program were from within the DSA. Cold ischemic times have increased by over one hour, as most of the donor retrievals are “fly-outs.” Problems with logistics, planes, pilots and other teams have become a nightmare. Time from heart acceptance to being on site at the donor facility has doubled. Our retrieval teams have been required to be out of the city on donor retrievals for up to eight hours. It is now nearly impossible to find surgeons willing to undertake this responsibility. Acquisition charges have more than doubled primarily related to travel. An other unexpected consequence is the fact that patients considered stable on VADs listed as status four will in most cases never be transplanted due to increased total cold ischemic times imposed by out of town travel on top of the increased dissection time required for most VAD explants. Prior to the allocation changes many programs including ours relied on “in DSA donors” to provide VAD-patients an option of transplant with a relatively shorten cold ischemic times and thus reasonable outcomes. We support eliminating geographic barriers (DSA) that arbitrarily prevent equal access to transplant, however, prior to any further change to extend geographic allocation to status three through six listed recipients, we ask that the current policy of 500-mile radius be thoroughly examined and the unintended consequences be fleshed out before compounding one possible mistake on the other. If 250-mile inclusion is good for the status three through six waiting recipients it should be best for the status one and twos, as well. It is understandable that at times intended consequences of change, may not always fulfill the desired outcome. While computer modeling maybe reasonable in helping to formulate decisions, it does not tell the whole story. In this case the intent of equal allocation by the "letter of the law" has not taken into consideration the resultant consequences of markedly increased travel, travel time, expense, logistics and risk. It also underestimated the impact that the allocation change would have for the stable VAD-patients who were "bridged" with the thought that transplant would be their end game. Under the current scheme there are few status four recipients left after donors are awarded to the status ones and twos and there will be less donors left for the 250 mile-radius distribution, as well. At some time, the data needs to be examined as "equal access for all" needs to be balanced against the adverse consequences noted above. Clearly, there have been programs that have become winners and losers as a result of this decision. Unfortunately, it is really patients and patient outcomes that we should be concerned about. I would ask that the UNOS thoracic committee examine data and specific feedback from as many of the heart transplant programs, as possible, before moving forward with any additional changes. Thank you for allowing me to submit these thoughts and comments.

Anonymous | 03/21/2019

I believe support the 250 NM proposal as I believe it address these issues: 1. It meets the UNOS goal of replacing DSAs and regions as the broadest and most equitable distribution model 2. 250 NM seems was felt to be fair and reasonable with consideration given to cold ischemic times that could affect the outcomes of transplants; 3. It is consistent with the recently revised lung policy of 250 NM 4. Once effectively implemented and given time for OPO's and Tx centers to experience the policy change it will likely and hopefully result in more fairly distributed organs

Anonymous | 03/22/2019

7 strongly support, 16 support, 4 abstain, 6 opposed, 16 strongly opposed Some members feel a 250 mile circle will reduce their offers significantly based on the some of their primary donor hospitals being just outside of that distance and feel that 250 miles discriminates against sparsely populated areas. However, members from Portland expressed concern that if the circle were increased to 500 miles they would lose organs to the Bay area. The region expressed concern over how Alaska would be considered in the new allocation model and recommended adding a variance. One member expressed the presentation did not provide enough information for the region to make an informed decision. Amendment: Increase circle to 500NM - 9 strongly support, 11 support, 5 abstain, 9 oppose, 14 strongly oppose Amendment: Add variance to treat Alaska donors as originating at SeaTac - 30 strongly support, 14 support, 4 abstain, 1 oppose, 1 strongly oppose

Anonymous | 03/22/2019

6 strongly support, 14 support, 7 abstain, 6 opposed, 1 strongly opposed

Anonymous | 03/22/2019

3 strongly support, 0 support, 1 abstain, 3 oppose, 22 strongly oppose Amendment: Cannot support this proposal because of a lack of data and/or information- 20 Yes, 2 No Comments: The region was not in favor of the proposed solution, citing a lack of information regarding outcomes and consequences of such changes. Some members did not feel the modeling results were valid, and that outcome measures (specifically, waitlist mortality) were not granular enough (DSA or region outcomes) or accurately assessed. In addition, members noted that the modeling did not capture the effect of transporting organs. Members generally felt that broader distribution and transplanting higher acuity (high LAS, high heart status) patients will equate to poorer outcomes and that per the most recent lung monitoring report, there would be more discards. There was consensus that broader distribution would move organs out of underserved, poor, rural areas and into major urban areas. They questioned why 150NM was not selected-starting locally is better for efficiency and donor families. Does the 150NM not accomplish eliminating DSA? One member opined that the heart community was just starting to understand the new allocation system, and struggling to understand what the waiting times will be, especially for specific subgroups. Finally, several comments were made regarding travel and logistics. Currently, there are a lack of standard processes regarding transport of organs, and the system has not planned for the impending shortage of planes and pilots. The system needs to develop a comprehensive logistics system, and have a better operational plan before broader distribution is implemented.

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) abstains on commenting on adoption of this proposal ASHI has no comment on alternative distances for the concentric circles in this proposal Although most histocompatibility laboratories are familiar with retrospective crossmatching for thoracic organs, ASHI is concerned that this proposal encourages transplant programs to rely heavily on “virtual crossmatching” for MOTs in which a kidney is involved. ASHI reminds OPTN/UNOS that the CLIA section of CMS has yet to rule on whether virtual crossmatching meets the requirement of having the results of a pre- transplant crossmatch for renal and, tandem transplants which include a kidney, found in CLIA ’88 at 42CFR §493.1278 (f)(2).

S Little | 03/23/2019

Yes, all proposal review group members agreed with the adoption of a 250NM radius around the donor hospitals as the overall metric for distribution. The Thoracic Organ Transplantation Committee appears to have presented a compelling case that this distance is the best options, and the paper goes on to note there were many topics considered (financial cost, transport time, CIT, etc.) as this distance was selected as their preferred choice. With the adoption of a 250NM radius around the donor hospitals as the overall metric for distribution is both believed and expected that potential candidates will be transplanted sooner. Those with the greatest medical urgency should be prioritized, regardless of their geographic location or arbitrary DSA boundary line.

Joseph Hillenburg | 03/23/2019

My support is measured primarily due to my preference for moving quickly to a Continuous Distribution-based model. Shallow cliffs are preferred, at a 250nm distance.

Anonymous | 03/26/2019

Vote: 3 strongly support, 18 support, 2 abstain, 0 oppose, 0 strongly oppose Comments: Some members commented that traveling 500 miles for a HR is not unusual.