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Update on the Continuous Distribution of Organs Project

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What is current practice and why address it?

The current system allocates lungs by placing candidates into categories that are considered and prioritized in sequence. When reviewed in sequence, sometimes candidates are placed on the side of a hard boundary that would stop them from being prioritized further on the match run. This proposed framework will consider multiple patient factors all at once with an overall score. This overall score includes not only medical urgency and patient outcomes, but also factors such as biologic match and efficiency of organ transport. This paper is an update from the Lung Committee and a request for community feedback through an exercise that will help inform the Committee’s work. Read more about continuous distribution.

Update on the Continuous Distribution of Organs Project

Dr. Erika Lease, Chair of the OPTN Lung Transplantation Committee, reviews the Update on the Continuous Distribution of Organs Project request for feedback item.

Terms you need to know

  • Attribute: Factor used to classify, sort, and prioritize candidates. For example, in this concept paper, lung allocation attributes include medical urgency, travel time, ischemic time, blood type compatibility, and others.
  • Composite Allocation Score: The total number of points assigned to a candidate on the wait list, which would determine their rank on a match run.
  • Rating Scale: Method used to calculate number of points awarded to candidates for each attribute. For example, if everything else is equal, should a candidate with twice as much medical urgency as another receive twice as many points? Applying the rating scale to each candidate’s information and combining it with the weight of the attribute results in an overall composite score for prioritizing candidates.

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What’s been done since the last update?

  • Composite Allocation Score components determined
    • 5 goals make up the score
      • Prioritize candidates who are expected to survive at least one year after receiving a transplant (Post-Transplant Survival)
      • Prioritize sickest candidates first to improve waitlist mortality (Medical Urgency)
      • Increase transplant opportunities for patients who are medically harder to match (Candidate Biology)
      • Increase transplant opportunities for patients under the age of 18 and patients who previously donated an organ/part of an organ (Patient Access)
      • Consider resources required to match, transport, and transplant an organ (Placement Efficiency)
    • Each goal includes specific patient attributes
    • Each attribute will have a rating scale
    • Candidates receive points for each attribute
    • These points combine into a total score for the candidate
  • The Committee needs community feedback on how to prioritize the attributes
    • How much weight given to each attribute has not been determined
    • There is no definitive “right” answer
    • The Committee is inviting the donation and transplant community to participate in an exercise to help inform its decisions on the importance, or “weight”, of each attribute

What this concept could accomplish

  • Provide a more complete approach to matching candidates and donors
  • Remove hard boundaries that prevent candidates from being prioritized further on the match run
  • Establish a system that is flexible enough to work for each organ type on the match

What this concept wouldn’t do

  • This paper is not a proposed policy change

Themes to consider

  • Attributes identified to be included in score
  • Additional attributes that should be included
  • Weight of attributes in final score

Overview

Status: Review

Sponsoring Committee: Lung Transplantation Committee

Strategic Goal: Provide equity in access to transplants

Contact:

Sara Rose Wells

Documentation

Supporting documentation will be added here when available.

Comments

Anonymous | 08/13/2020

Coming from a lung recipient family, this is a step toward a welcome change to removing hard geographic boundaries from lung allocation, and this will be especially beneficial for highly sensitized patients. The current allocation exceptions for highly sensitized patients aren't sufficient, and incorporating CPRA would help ensure access.

Anonymous | 08/13/2020

Would give more weight to patient acuity and equal to the remainder.

Steven Potter | 08/23/2020

Laudable concept. The various weights attributed to the goals that form the composite allocation score will be critically important and debate over this will likely be contentious. Of the composite elements, placement efficiency seems to be the least important and should be given the least weight. The aura concept seems extremely problematic, and the committee's apparent lack of favor at this time for the aura approach to allocation is noteworthy and correct. As the committee has noted, the aura approach is in violation of a long held paradigm of placing organs with candidates, not with programs, and the committee should be lauded for discarding the aura approach.

Region 4 | 08/26/2020

During the discussion, one attendee commented that with increasing use of OCS systems, maybe distance should be less a priority. If an individual center does not have OCS, they can still decline. A couple attendees noted that the request for feedback identifies reasoning for some but not all excluded attributes and thought that there should be reasoning documented for all the exclusions. One attendee recommended the use of Transplant Benefit as a metric on the Comprehensive Allocation Score.

Region 5 | 08/28/2020

Region 5 had the following comments: • Doing away with miles puts responsibility on transplant centers to calculate cold ischemic time. • Transplant outcomes need to be considered. Taking away distance could negatively affect cold ischemic times and transplant outcomes • Will the committee give any consideration for the use of lung profusion devices to negate some of the efficiency and distance concerns? • Modeling will bolster community confidence. • Support that you are looking at cost of flights in both direct flight cost and time. • This system provides for a more equitable allocation of organs • I think COVID should be a separate category and outcomes tracked carefully

OPTN Pancreas Transplantation Committee | 09/03/2020

The Pancreas Committee thanks the OPTN Lung Transplantation Committee for the opportunity to review their Continuous Distribution update. The Committee provided the feedback below: • The Committee inquired about the data being used to weigh attributes and if it has been a straight forward process. There is clinical data for some attributes, which should be direct, but there is no data when measuring the importance between attributes. • The Committee expressed concern that other organ groups have put more emphasis on access to transplant or decreasing waitlist mortalities than post-transplant survival. The Committee inquired whether there was any additional feedback on other attributes that should be considered or of importance to the lung organ group.

LifeGift | 09/07/2020

LifeGift supports the continuous distribution concept and its framework of the 5 goals in order as written in the proposal material. It reduces the impact of accidents of geography and is generalizable to all organs. It will be important to consider the increasing presence of new preservation devices and modalities in the fifth goal. These devices allow for longer preservation times if the organ is transported on device and thus distance attribute points assignments will need to be modified for this welcomed advancement in organ preservation.

Region 7 | 09/10/2020

Region 7 had the following comments about this project: • An attendee agreed that this is an important concept to develop. They are pleased that the lung committee is taking the lead on this and stated this should be expanded to all organs. They agreed that this project makes the most sense to balance travel times with addressing geographic disparities. • One attendee suggested emphasizing placement efficiency for DCD and marginal BD lungs. They added that offering these organs to every patient on the wait list is not a good use of resources and results in lost opportunities. • An attendee commented that pediatric status should be given a higher weight due to conditions such as a child's failure to thrive while waiting. • Three attendees commented on cost, ex vivo perfusion and sensitized candidates with the continuous distribution model. One stated that the committee should consider looking at cost/efficiency consideration and proximity to major airports (less relevant for more highly time sensitive organs like lung). They added that they would not recommend using this as a factor for kidney allocation it would discriminate against smaller market transplant centers.

Histocompatibility Committee | 09/10/2020

The Committee is overall supportive of the work in progress to create an organ allocation system based on continuous distribution. The Committee is concerned that sensitized transplant candidates, especially lung candidates, may need unique considerations per candidate beyond what a weighted score or extra points may offer. As the workgroup considers incorporating CPRA into allocation, please ensure the Histocompatibility Committee has the opportunity for timely and frequent input. Allocation of organs should be approached with value or equity at the forefront, but with preservation of a center’s ability to make final decisions about a recipient’s transplant. The Committee looks forward to being an impactful stakeholder in collaborating in this long term effort.

Region 3 | 09/15/2020

Comments: Ex vivo lung perfusion and onsite organ recovery centers were mentioned as factors that should be considered in the model. A member addressed placement efficiency and stated that placement efficiency isn’t just about the cost of transporting an organ, which others reiterated. It was recommended that the match run should take into account a transplant center’s acceptance history; OPO perspective is important for the prioritization exercise and understanding placement efforts will be critical as all of the organ specific committees work on continuous distribution. Another member stated that looking at travel efficiency and cost is important and should be done consistently when organ allocation is changed. Follow up comments added that it will be important that the attributes are regularly evaluated and are able to be adjusted as technology and procurement practices advance. The recent increase in local recovery in response to COVID was mentioned as a change and that if the practice continues, it could increase efficiency. Lung placement was also mentioned as a consideration since OPOs vary in how much time they will invest in lung donor management and consider having OPOs review successful lung placement and why lungs are not placed. Additional comments submitted online during meeting: • I reiterate comments regarding placement efficacy. Time is LIFE and the longer the allocation process takes, the more viable organs are buried. This needs to be a priority in the points system • Support the OPTN lung committee's work on this continuous distribution of organs project • Significant consideration should be given not just to one year survival, but also longer term survival • This is important in not just Lung, but all solid organ transplant in my opinion. • Regarding PRA or sensitization status are you only considering points for cPRA or have more granularity regarding points by loci like DQ? • Seems guidelines will enhance distribution. • Hard to justify prioritizing proximity, travel costs in lung while the cost / travel / recovery / efficiency concerns were not acknowledged during liver allocation changes. Liver is a much more common transplant with much greater overall costs and impact. Consistency in approach should be an aim among different organ allocation schemes (not all same, but at least consistent) • I have concern with this continuing to negatively impact the ability of OPO's to get lungs placed efficiently and drive up expenses and fees • Priority should be on the patient and not the ease of OPO placement • What is the current death rate on the waitlist by specific lung disease? • Has the committee given any consideration for how allocation would be affected when lung is involved with a multi-organ situation; i.e. heart-lung, where heart 'pulls' lung, and can potentially pull from a high LAS recipient or lung-liver where there isn't a very clear path?

OPTN Operations and Safety Committee | 09/18/2020

Update on the Continuous Distribution of Organs Project The Operations and Safety Committee thanks the OPTN Lung Transplantation Committee for their efforts in developing this public comment proposal for the Update on the Continuous Distribution of Organs Project. The Committee supports the discussion around travel efficiency attributes. It was suggested to consider the complexity of travel as a way to analyze the failure aspect of placement efficiency. Additionally, the Committee suggested reviewing other organs’ travel efficiencies.

Region 8 | 09/22/2020

Comments: A member provided feedback that they are concerned about candidates under the age of 12 and competition with older pediatrics and also that further segmentation of pediatric candidates is not scientific and that the committee should clearly articulate their intent to ensure patients under 12 are not disadvantaged. One member commented that this should have a significant impact on diminishing unnecessary travel. The committee was asked to carefully review the impact of these changes on the financial viability of small programs and programs in less populous areas and, if possible, to consider how patient's insurance access/options disadvantages some populations, particularly the Medicaid populations as part of this framework. A comment was made that surgeon availability and travel time are key factors that could be really important and may be difficult to track. One member made a comment that this could increase cost and complexity. Several comments were made in general support of the project.

American Society of Transplantation | 09/24/2020

The American Society of Transplantation supports the Continuous Distribution of Organs Concept which uses 5 components in a Composite Allocation Score to overcome long-standing problems of accidents of geography created by arbitrary geographic borders. We acknowledge and appreciate the timely actions taken by UNOS to address evolving issues and needs within the transplant and donation community related to the Continuous Distribution Project. However, we do also want to ensure that young pediatric candidates are not disadvantaged (see comments below). We found the document to be extremely helpful in understanding the process and steps involved in determining the goals and attributes which are being considered for the Composite Allocation Score. The discussion on why or why not specific attributes were being used was transparent, not difficult to follow the reasoning and based on prior literature. We support the dissolution of hard boundaries in the current classification system and agree with the proposed attributes that make up the composite allocation score. The Priority exercise was helpful to understand this process. The AST encourages all lung transplant professionals to complete this survey. We believe there is value in other solid organ professionals’ review of this exercise, as although the attributes may be different from lung, the goals remain similar for all organs. At the direction of the HHS secretary in response to a court challenge several years ago, the most recent change to the pediatric donor sequence in the lung allocation policy prioritized access for pediatric lung candidates under 12 to adolescent donor organs (including priority over other adolescents within 1000 nm of the donor) while protecting priority for under 12 candidates to access under 12 donor organs. In the proposed continuous distribution framework, candidates under 12 will lose both sets of priorities. Although the proposal outlines steps intended to mitigate these changes (assigning pediatric lung candidates under 12 medical urgency and post-transplant survival scores based on historical cohorts, giving pediatric candidates as a group additional points and giving smaller patients additional points based on the proportion of donors with suitably sized organs), it remains to be seen whether modeling will verify that these changes will not negatively impact access to transplant and waiting list outcomes for children under 12. Because the numbers will likely be too small to reach statistical significance, gathering sufficient evidence to make a change post implementation may be challenging. To ensure that this project continues to move forward in a timely manner, we recommend that the committee consider including in their modeling requests alternate constructs that protect access for this small but vulnerable patient population. The conversion of attributes into points should result in marginal negative impacts to organ utilization rates, waiting list mortality rates, and post-transplant survival. As described currently, the fifth goal, Placement Efficiency, is of particular importance to the Society’s Recovery and Preservation Community of Practice. It is and will be increasingly important to allow for flexibility of the nautical mileage attribute as a proxy for ischemic time as more preservation devices are being used to extend preservation time and thus distance, if the organ is going to be transported on device. Careful deliberation with community involvement on how to appropriately weight this factor fairly and ensuring future ability to revisit frequently as perfusion technologies evolve, is requested by some of our COP members. Additionally, in situations where initially declined organs are sent to regional perfusion centers for repair or rescue treatment, the distance starting point for the subsequent allocation of the organ after treatment should be from that perfusion center’s location. This is important to accurately calculate where the organ will be traveling from and also to limit disincentives for utilizing regional perfusion centers as a key strategy for increasing the availability of transplantable organs.

Region 1 | 09/24/2020

Comments: Members stated the committee is doing an excellent job presenting the material and the work will serve as a good template for other organ types. One member is in favor of including the anticipated duration of graft survival. One member stated that the Policy Oversight Committee is helping to orchestrate Continuous Distribution and the work of the lung committee will inform the other organ-specific committees.

Region 2 | 09/25/2020

Comments: • One commenter noted that the Lung Committee should be lauded for leading this OPTN initiative for all organ transplants as our transplant system migrates from a local defined matching and allocation system to a more national and continuous distribution strategy to improve fairness, equity, efficiency, and cost-effectiveness in the spirit of NOTA and the Final Rule. • Another commenter agreed that this is really impressive work by the Lung Committee and it is a very thoughtful and cogent approach to difficult and sometimes conflicting allocation factors. • Another commenter stated that as the work continues across all organs, patient predicted outcomes should be part of the allocation system. • Another attendee commented that they support the idea to encourage less geography as a factor guiding allocation. However, the pressures to consider expenses needs to be taken into consideration. As organs are traveling farther distances, the cost of transplants is rapidly rising. • In addition, another attendee agreed that distance and travel include cost concerns, but air travel is a transplant team safety concern, especially in unpredictable and inclement weather. The financial proxy considerations does not consider these safety concerns. • Lastly, one attendee noted that this is excellent work by the Lung Committee and the process should be replicated as all organs move to a Continuous Distribution model. After implementation, it will be very important for the committee to develop extensive education for patients, families, donor families, and the general public to help explain this new distribution model.

AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 09/28/2020

The American Society for Histocompatibility (ASHI) and it's National Clinical Affairs Committee (NCAC) is supportive of ongoing efforts to revise organ allocation based on a continuous distribution model to eliminate inequities introduced by donor service area and region. ASHI/NCAC is pleased to see that there is consideration for incorporating a cPRA sliding scale as one component of a composite allocation score for lung allocation. ASHI/NCAC is willing to provide any needed expertise in addition to that of the OPTN/UNOS Histocompatibility Committee to address this issue.given the uncertainties of what agents might be targeted for testing.

Region 6 | 09/29/2020

Comments: A member commented that including some type of priority for all previous living donors would be a great way to encourage living donation. A couple members felt that using more than just one year post transplant survival as part of the score would be a good idea. Many members commended the committee on its work and expressed interest in completing the prioritization exercise.

Region 10 | 09/29/2020

Comments: • An attendee voiced concern that this further removes any predictability for the candidates and will further lengthen the amount of time it takes for organ placement – currently this is taking days. Waiting time is an important attribute to consider, especially for kidneys. It will be a problem if there are sick people who need a transplant but do not fit into the designated attributes. • Another attendee noted that it makes sense to include pediatrics in the patient access attribute, but it is unclear why priority is given to prior living donors. • Another attendee commented that the committee should consider adding machine perfusion to one of the attributes, as it is becoming more commonplace. • It was also noted that the issue of people at higher risk for graft failure may be disadvantaged by that one-year post-transplant survival metric. The committee should work with the Minority Affairs committee to make sure there is no bias. • In addition, another attendee commented that it appears this distribution model will eventually make it to the other solid organs, the committee should ensure all aspects of ethics be taken into consideration. Ensuring vulnerable populations (lower socioeconomic status, African American ethnicities, pediatrics, previous living donors, etc.) are able to provide significant comments will be important. Therefore, this committee should get input from Minority Affairs committee, Living Donor committee, Pediatric committees, etc. • Another attendee commented that the committee needs to work on defining the process for consensus from the community with varied preferences for weightage of the five attributes. It will be important to know how the differing weights will be adjudicated. • An attendee expressed that the public comment involves input from professionals, transplant staff, patients who are on committees, and some educated participants. There is no input from the true population of patients who are ill, and their level of education is not adequate to understand the attributes. The process is for all patients and the language needs to be simplified for their input. • An attendee expressed support for the concept but concerned about execution. For example, equitable access to care and placement efficiency are vital but simpler concepts likely to prevail. Propose that the "best" model agreed to by majority of the community move forward prior to modeling regional/center impact since that is where the push back comes from. • One attendee noted that waiting time should probably be listed amongst the main attributes, even if not strongly weighted, to set the precedent for other organs. There is concern that this will dramatically increase the complexity and time of allocation, which has already become long with the prior changes. It is also concerning that, unless distance is heavily weighted, this will further exacerbate the socioeconomic disparities that worried us for the acuity circle model. Please recall, our region previously strongly opposed this kind of broadened sharing on those grounds. • Another attendee commented that the idea that lung continuous allocation will serve as "the model" for other organ allocation is extremely disturbing. The idea that a few lung physicians have any understanding of the needs of organ recipients was clearly shown to be erroneous given the discussion during the meeting.

American Society of Transplant Surgeons | 09/29/2020

The American Society of Transplant Surgeons (ASTS) supports the concept of continuous distribution of organs with the following concerns. We appreciate the complexity of the task, the efforts of the OPTN Lung Transplantation Committee and the diligence of the process they are following. We do reserve judgement until the final proposal is reached as further details emerge and will solidify the final intended actions. 1) ASTS believes the OPTN can do better with helping the public understand how this proposal is being developed. The given algorithm is not that easy to understand. In general, the ASTS agrees with the recommended attributes to align the process with other organs and how they are considered. 2) We agree with the committee’s recommended attributes but are concerned about the failure to account for multi-organ transplants within the proposal. Clearly, patients with the need for a multi-organ transplant are currently disadvantaged and will remain so in the proposal as it stands. We have reservations about the current proposal’s approach to the pediatric patient - drawing a line at 18-years old is biologically arbitrary and binary - as such it is at odds with the overall move towards continuous variables. 3) The proposal fails to adequately explain the process that will be used to calculate cost (somewhat euphemistically referred to as travel efficiency) and proximity efficiency. We believe, as it currently stands, that the placement efficiency attribute is the weakest of the five and recommend it be given the least weight in the composite score. It is the most easily influenced by outside parameters (especially with the pandemic transport freeze in effect) and would prioritize largest cities over others. We strongly support and encourage members of the ASTS, and other transplant professionals, to participate in the “exercise to prioritize the attributes.” Broad participation in this will likely result in a more balanced final proposal. ASTS suggests the OPTN make the document/video more widely available understanding that weighting each of these parameters will be very important as will be voting by as many vested parties in the proposed Analytical Hierarchical Project (AHP). We look forward to the continued development of the proposal and strongly support the stated intent for periodic re-evaluation and changes in the future.

Kidney Transplantation Committee | 09/29/2020

The Kidney Transplantation Committee (the Committee) thanks the Lung Transplantation Committee for the opportunity to provide feedback on the Update on the Continuous Distribution of Organs Project. The Committee supports the current approach of the project and looks forward to hearing the feedback regarding how the community prioritizes attributes that is received from the prioritization exercise. The Committee also appreciates that the work undertaken by the Lung Transplantation Committee may serve as a model for the efforts for the kidney allocation system.

Patient Affairs Committee | 09/29/2020

The Patient Affairs Committee (PAC) appreciates the opportunity to provide feedback on this project. Overall, the PAC continues to support this project and the work to include the patient community. While the members appreciate the efforts made to help explain the project to lay audiences, they do suggest continuing to make this project even more understandable (adding a glossary, providing more context to visuals, etc.). The committee suggested sharing the raw data from the AHP exercise, as well as providing a real life application of the results to the community. Some members said that using one year post transplant survival as a metric is not particularly useful and suggested the committee consider a longer time period. Members felt it was important to include more explanation around the attributes that were discussed but not included.

Society of Pediatric Liver Transplantation | 09/30/2020

The Continuous Distribution of Organs Project (Lung) has created a paper outlining the development of a composite allocation score that will be applied broadly to allocation across the organ systems. The Committee is asking for community feedback on how to prioritize the attributes: 1) Post-Transplant Survival 2) Medical Urgency 3) Candidate Biology 4) Patient Access and 5) Placement efficiency. As a voice representing the needs of children in an environment of organ scarcity, The Society of Pediatric Liver Transplantation (SPLIT) urges strong consideration of unequivocally prioritizing pediatric age recipients as they cross 4 of the 5 attributes. In the UNOS white paper, Ethical Principles of Pediatric Organ Allocation, published as a joint effort of the Ethics and Pediatrics Committees, there are well-established ethical reasons for prioritizing children. We urge all of the members of our pediatric community to give feedback on this via the online tool and exercise presented with this proposal

Ethics Committee | 09/30/2020

The OPTN Ethics Committee thanks the Lung Transplantation Committee for presenting its update on Continuous Distribution. The Committee supports this proposal overall and encourages broad outreach when collecting input to capture many viewpoints, including those of the general public. The Committee suggests providing more transparency in how the criteria are weighted and how consensus is reached among the various members of the transplant community. The Ethics Committee looks forward to providing ethical analysis as this project progresses.

Anonymous | 10/01/2020

Fully support the concept. Placement efficiency attributes should be deprioritized as it could disadvantage certain centers unnecessarily. On the other hand, size matching and age matching attributes should be reconsidered. They are the only way any donor factor is considered in this composite allocation score and would be an important step towards making a successful match.

Association of Organ Procurement Organizations | 10/01/2020

AOPO appreciates the opportunity to comment on the update to the concept document for implementation of continuous distribution for lung allocation and continues to support this framework as an effective way to incorporate and balance multiple medical and efficiency-based factors in a manner that is patient-focused. Continuous distribution will also provide future flexibility by allowing the OPTN to be more nimble in its ability to adjust and change the relative rating of attributes over time as conditions for organ distribution evolve. For example, as perfusion and other ex vivo devices provide for viability over longer time periods between recovery and transplantation (as is already happening with lungs), the continuous distribution framework can adjust for the relative weight of time/distance in those case-specific circumstances as part of the overall composite score. AOPO strongly urges the OPTN to consider all of these factors when identifying the attributes and developing the composite allocation score for lung allocation. AOPO appreciates the ability to participate in the exercise to inform the relative weight of different medical and efficiency attributes and views the ultimate goal of this work as ensuring fair distribution of available organs and increasing transplantation to the patients most in need. AOPO also would like to highlight the importance of the OPTN continuing its work through the identified strategic policy priority to develop and implement policies, process and systemwide tools designed to improve the efficiency of the matching process. This work towards a more efficient system is crucial in order to support the full value of any allocation framework by facilitating maximum utilization of transplantable organs.

Pediatric Transplantation Committee | 10/01/2020

The Pediatric Transplantation Committee (the Committee) thanks the Lung Transplantation Committee for their Update on the Continuous Distribution of Organs Project and the opportunity to provide feedback. The Committee encourages consistency in the pediatric designation in allocation and feels strongly that this should be reflected in all future continuous distribution efforts. The Committee looks forward to further updates regarding the Lung Transplantation Committee’s decision on the prioritization of attributes in the continuous distribution framework.

Carolina Donor Services | 10/01/2020

Carolina Donor Services supports the continuous distribution framework to eliminate hard boundaries and balance medical need with system efficiency. We urge the OPTN to continue to evaluate and collect data regarding tools that add placement efficiencies to include preservation devices and the local recovery of organs.

TransMedics | 10/01/2020

TransMedics, Inc. (TMDX) is writing in response to the request for feedback on the OPTN Lung Transplantation Committee’s “Update on the Continuous Distribution of Organs Project.” TMDX is the developer of the Organ Care System (OCS™) which is the only portable extracorporeal warm perfusion and assessment technology for thoracic donor organs for transplantation. The OCS™ Lung is the only FDA approved device for both standard and expanded criteria DBD and DCD donor lungs for transplantation. To-Date, more than 500 lung transplants have been successfully performed utilizing the OCS™ Lung technology. TMDX demonstrated that OCS™ Lung technology plays a substantial role in eliminating the discussion around cold ischemic storage as TMDX recovered lungs in Hawaii and transplanted these lungs successfully in North Carolina and Arizona, with a preservation time of 22 and 11 hours respectively. Given the capabilities of the OCS™ Lung technology, we support the Committee’s intent to eliminate the historic geographic “hard” boundaries and allow for broader distribution of organs. We agree with the Committee’s decision to eliminate ischemic times as a specific factor in determining lung allocation. However, our rationale differs from the Committee’s concerning predicting travel-related ischemic time and “because transplant programs do not accept organs when ischemia time is expected to be problematic.” (p. 8). The Committee is basing this conclusion on the assumption that cold preservation of lungs on ice (and its inherent ischemic time limitations) will continue to be used almost exclusively as the method of preservation. We strongly believe that portable extracorporeal perfusion is well underway to replace cold ischemic storage as the new standard of care for lung preservation and this should be an important consideration in developing the updated allocation schemes. In the discussion of the “Efficient Management of Organ Placement” (p 16), the Committee noted there was a “relationship between efficiency and proximity between the donor and transplant hospital. . .hospitals are less likely to accept organs that are from further away . . . [as] surgeons are out of the hospital for longer periods of time if they have to procure an organ from further away.” These statements are reasonable if one assumes that the current system of procurement remains in place, i.e. transplant surgeons travel from the transplant center to the donor hospital to observe and procure the donor lungs. Within the current confines of cold ischemic storage, once the aorta is cross clamped, the transplanting surgeon has no ability to assess the lung functions, perform diagnostic bronchoscopy or initiate therapeutic or recruitment maneuvers to improve lung function. Essentially the transplant surgeon is flying blind. With OCS™ Lung, the transplant surgeon gains the ability to perform recruitment maneuvers, continuously assess organ function during transport and initiate diagnostic and therapeutic interventions all the way through the time the lungs are ready for reimplantation into the recipient. These new OCS Lung clinical capabilities open the door for potential new models to make thoracic organ retrieval more efficient and maximize donor lung utilization for transplantation. TransMedics has initiated a new national program in collaboration with major OPOs and transplant programs that would transform the way thoracic organ retrieval would work. This new model is later described below. In a related area, (p18-19) the Committee declines to consider local recovery of lungs as an attribute to include in developing allocation priority, noting that “This attribute would be more meaningful if there already existed a broad system of local lung procurement teams” The Committee notes this issue is “worth further research and possible inclusion in a future iteration of continuous distribution.” We strongly urge the Committee to reconsider this conclusion. TransMedics is currently creating a national network of highly qualified thoracic transplant and surgical recovery experts to enable recovery of donor lungs. TransMedics will be using this network of qualified surgical experts to procure lungs allocated and accepted by not only their own transplant program, but also transplant programs around the country. In addition, TransMedics has established collaboration with major OPOs and invested in creating a national network of regional OCS Lung perfusion management expertise at or near these OPO DSAs. Using this new approach and leveraging this national network, should maximize donor lungs utilization for transplantation from both standard and extended criteria DBD and DCD donors without taxing the resources of the transplant program with the lung retrieval and OCS Lung management process. We strongly believe that this could be the next frontier for thoracic organ retrieval and assessment. In summary, we applaud the work of the Committee but are concerned that its conclusions are being based on the current, imperfect system of organ procurement and preservation using ischemic cold storage. The Committee makes reference to considering factors beyond ischemic cold storage in future iterations which we believe may be a missed opportunity given that the OCS Lung System is the only FDA approved platform for all types of donor lung preservation and assessment in the U.S. Along with the TransMedics growing national network of OCS Lung perfusion and management expertise, a model already exists to address the Committee’s concerns. We kindly ask the committee to seriously consider the potential significant positive impact of the OCS Lung technology and the national model being established by TransMedics for thoracic organ retrieval and OCS perfusion management in this revision of lung allocation. Organ allocation protocols change very slowly and the next iteration is likely to be five to seven years away. The OCS™ Lung technology is an FDA approved product that is increasing the pool of available donors, streamlining the allocation process and replacing cold storage. We are grateful for the opportunity to provide input to the Committee’s deliberations. We would very much welcome the opportunity to discuss our national model with the Thoracic Organ Committee and would be delighted to provide any assistance as the policy development process moves forward. Best regards, Waleed Hassanein, MD President & CEO

Cystic Fibrosis Foundation | 10/01/2020

October 1, 2020 Erika Lease, MD Chair, Lung Transplantation Committee Organ Procurement and Transplantation Network United Network for Organ Sharing 700 N 4th Street Richmond, VA 23219 RE: Update on the Continuous Distribution of Organs Project Submitted electronically at optn.transplant.hrsa.gov. Dear Dr. Lease: On behalf of the Cystic Fibrosis Foundation and the below signed individuals of the CF Lung Transplant Consortium, we write in response to the OPTN/UNOS Public Comment Proposal, Update on the Continuous Distribution of Organs Project. UNOS Must Revise the Benefit Component: One-year survival rate alone does not accurately reflect how beneficial a transplant is for any given patient. It is unlikely that people undergo lung transplantation with the aim of only surviving for one year. Instead, we should be using endpoints that are more reflective of transplant success and patient wishes. It is critical that the inputs used in the continuous distribution algorithm are as appropriately reflective as possible in measuring the factors they are designed to assess. We therefore urge UNOS to move away from use of one-year survival to either three- or five-year survival at this time. We recognize that using long-term survival measures in place of one-year survival introduces more uncertainty in the model given that predictability of survival decreases the further out a patient is from the time of transplant. UNOS should therefore consider whether incorporating age as a predictor for transplant outcomes can be used as a proxy for long-term survival. The data demonstrating that post-transplant survival decreases with older age is compelling. Providing a similar benefit score to individuals where long-term survival is likely similar based on age may provide a more reliable measure for the benefit an individual is likely to receive from a transplant. This measure could be used in concert with other measures of survival. Long-term Survival Should Be Given the Most Weight in a Composite Score: Finally, in terms of weighting different categories of attributes based on importance, we believe long-term post-transplant survival is of highest importance in determining allocation of donor organs. As stated above, we believe that long-term post-transplant survival is a stronger measure for transplant benefit compared with one-year survival and urge UNOS to pursue this change in conjunction with the move to continuous distribution. Long-term survival additionally supports the goal of ensuring fair innings for transplant candidates. Following long-term survival, candidate biology and patient access should be considered given the importance of improving access for otherwise difficult-to-match patients. Placement efficiency should have the least bearing on a person’s prioritization for a given donor organ. Continuous Distribution Has the Potential to Improve Patient Access: We are supportive of UNOS’s aim to move to a continuous distribution framework for organ allocation, and we believe the strength of this model lies in its flexibility. With the shift to continuous distribution, UNOS has the opportunity to improve upon accommodations for individuals who are medically harder to match or have other special considerations with bearing on access. The challenge with this model will be successfully identifying appropriate factors and their weights for inclusion in the final allocation system. We feel the categories of attributes identified by UNOS included the most recent update to the continuous distribution project are appropriate. In particular, we are pleased to see that UNOS has included sensitization and candidate height as attributes for candidate biology in order to address certain patient access challenges. We additionally appreciate that UNOS has ruled out the use of ischemic time as an attribute for placement efficiency. While we believe it is reasonable to include a placement efficiency score as a component of the model, ischemic time is not a valuable measure for efficiency of organ placement. UNOS should further consider adding multi-organ transplant as an attribute under the candidate biology category in order to improve access to needed donor organs for this vulnerable patient population. The present allocation system has failed to adequately address the needs of this population, and UNOS should take this opportunity to improve access to multi-organ transplants. We are aware that UNOS is working on a project to look at the needs of multi-organ transplant candidates at this time, and we look forward to seeing this work reflected in future iterations of the continuous distribution project. Background on Cystic Fibrosis and the Foundation: Cystic fibrosis (CF) is a rare genetic disease that affects over 30,000 people in the United States. In people with CF, a defective gene causes a thick buildup of mucus in the lungs, pancreas and other organs. In the lungs, the mucus obstructs the airways and traps bacteria leading to infections, extensive lung damage and eventually, respiratory failure. Over 280 people with CF received transplants in 2018, the majority of which were lung transplants. However, some people with CF also may require liver or kidney transplants due to the disease. In order to address the needs of people with CF living with advanced lung disease, as well as those considering transplant, the CF Foundation launched the Lung Transplant Initiative in 2016. Through this initiative, the Foundation is working to improve and standardize the care received by people with CF for whom transplant is an option and to find solutions to barriers that may adversely impact a person with CF’s chance of receiving a donor organ. Conclusion: We believe the continuous distribution framework has the potential to best address the need to appropriately weigh meaningful factors in organ allocation as proposed, and we are pleased to see UNOS moving forward with this model. We hope to see UNOS be receptive and adaptable in responding to data and making necessary changes in the future in order to get the most benefit out of the shift to continuous distribution. We are happy to serve as a resource and look forward to working alongside OPTN/UNOS in the future on this issue. Sincerely, Albert Faro, MD Vice President, Clinical Affairs Cystic Fibrosis Foundation CF Lung Transplant Consortium Members: Kathleen Ramos, MD, MSc Assistant Professor of Pulmonary, Critical Care, and Sleep Medicine University of Washington, Seattle Ramsey Hachem, MD Professor of Medicine, Lung Transplant Program Medical Director Washington University School of Medicine Joe Pilewski, MD Associate Chief, Division of Pulmonary, Allergy & Critical Care Medicine University of Pittsburgh Medical Center Courtney Frankel, PT, MS Research Program Leader Duke University Medical Center Matthew Morrell, MD Medical Director, Lung Transplant Program University of Pittsburgh Medical Center Laurie Snyder, MD, MHS Associate Professor of Medicine, Pulmonary Allergy & Critical Care Medicine Duke University School of Medicine Stephen Weigt, MD Associate Professor of Medicine, Pulmonary and Critical Care UCLA Medical Center Christian Merlo, MD, MPH Associate Professor of Medicine and Epidemiology, Division of Pulmonary and Critical Care Johns Hopkins University School of Medicine Jagadish Patil, MD Assistant Professor of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine University of Minnesota Matthew Hartwig, MD, MHS Associate Professor of Surgery with tenure Duke University Health System Stuart Sweet, MD, PhD Professor of Pediatrics, Division of Allergy, Immunology and Pulmonary Medicine Medical Director, Pediatric Lung Transplant Program Washington University School of Medicine in St. Louis Steven Hays, MD Medical Director, Lung Transplant Program University of California San Francisco Jason Christie, MD, MS Chief, Pulmonary, Allergy and Critical Care Division Penn Medicine Isabel Neuringer, MD Associate Medical Director, Lung Transplant Program and Adult Cystic Fibrosis Center Massachusetts General Hospital Luke Benvenuto, MD Assistant Professor of Medicine, Center for Advanced Lung Disease and Transplantation Columbia University Medical Center Pali Shah, MD Medical Director, Lung Transplant Johns Hopkins University School of Medicine Fanny Vlahos Cystic Fibrosis Lung Transplant Consortium Patient Representative Erin Lowery, MD, MS Associate Professor of Medicine and Pediatrics, Pulmonary and Critical Care Loyola University Medical Center Daniel Dilling, MD Medical Director, Lung Transplantation Loyola University Medical Center Gundeep Dhillon, MD, MPH Medical Director, Heart-Lung & Lung Transplantation Program Stanford HealthCare

Region 9 | 10/01/2020

Comments: A member encouraged the rest of the region to take the AHP prioritization exercise, since this framework will be expanded to other organs in the future. Another member commented that post-transplant survival is a goal that is hard to measure, and if it is used to determine who receives an organ offer, it would be a dramatic shift from current policy.

Minority Affairs Committee (MAC) | 10/01/2020

The OPTN Minority Affairs Committee (MAC) thanks the OPTN Lung Transplantation Committee for their efforts in developing this request for feedback and the opportunity to comment. The MAC commends the OPTN Lung Transplantation Committee for leading the charge to operationalize the continuous distribution framework. While the MAC finds the project innovative, they encourage that the weighing of different attributes limit subjectivity to avoid unintended consequences on vulnerable populations.

Region 11 | 10/01/2020

Comments: Two attendees commented that the committee needs to consider socioeconomic disparities and access to healthcare. One attendee was encouraged that the OPTN Ethics Committee was involved in the project and supported having an Ethics Committee member serve on the Lung Committee during the development of the CD score. This attendee also asked that all data presented to the committee be readily available to the public. Two attendees encouraged the committee to consider how perfusion devices will effect distance, cost, cold ischemic time and patient survival. Several attendees supported the committee work and valued the opportunity to participate in the prioritization exercise.

Sam Dey | 10/01/2020

Yes, as proposed