Michael Shapiro | 8/6/2018 

Geography has been used in organ allocation since before the establishment of the OPTN, and, despite both NOTA and the Final Rule, has continued to be used to limit broader organ allocation. Thus, the work of the ad hoc committee is to be celebrated, to the degree that it de-emphasizes geographic allocation. The continuous distribution framework does this to the largest degree, although all of the frameworks recognize geographic distance as a potential good, which remains questionable. The only acceptable use for geography is described in Final Rule Para 121.8(a) 2 + 5, in making best use of organs, and avoiding waste. Thus, geography is limited by acceptable transport times, and, to a lesser degree, transportation costs. The continuous model allows for greater consideration of geography initially, and decreasing emphasis on geography over time, as other factors, such as urgency, or medical suitability, etc. become more important. I would use geography as a continuous variable, if at all, as in the 'Burdick Plan' for Region 1 kidney allocation, or base it on flight distance so three transplant centers using the same airport would have the same geography points. I applaud the work of the committee.

John Hodges | 8/7/2018 

Continuous Distribution is the only one of the three that will truly allow compliance with the demands of the Final Rule. It will be calculated for the allowed reasons to curtail completely flat national access to each and every offered gift. It will be weighed against all the considerations developed and yet to be proposed, and each time will meet the requirements of the Rule. I commend the Ad Hoc Committee for offering this alternative to both the current geographically inequitable systems that vary by location as well as organ. No one is unjustifiably advantaged or disadvantaged by national continuous distribution, though edge effect and discontinuous island weighting may be appropriate. Routing and cost considerations, to the extent they are permissible variables, can be calculated in real time, or a look up table of routinely updated expert knowledge could be used, as long as it was transparently available for public review. I asked why this wasn't the default the first day I arrived for service on the Board of Directors more than a decade ago. Make it so. Soon.

Anonymous | 8/9/2018 

This is the only one of the three models that balances medical urgency, compatibility, and geographic distance.  Simply casting wider fixed distance only addresses a broadening of sharing but does not optimize cold time or factor in compatibility between donors and recipients; further, a 500 mile circle in the Midwest, Southwest, or Northwest has a very different impact than one in the densely populated Northeast, Southern California, or the Great Lakes.  Similarly, optimized neighborhoods or districts addresses the population density question but is difficult to explain to the public and practitioners alike while still not addressing compatibility or adequately balancing in cold time (logistics).  The continuous model brings all factors, not just urgency, into the equation to optimize allocation.  In the end I believe this is most logical and defensible as it weighs and factors in multiple variables, not just urgency.

Charles Van Buren | 8/9/2018

I am submitting this comment via email because the three options available via the UNOS comment form require choosing one to submit a comment; all, however, are fatally flawed. There are three problems with all the proposed schemes.  1) There is ample discussion of donors being a national resource. There is no discussion of the region differences in recipient selection and how that impacts the ratio between donors and potential recipients. New York varies widely from the national norm by giving far more exceptions to adding MELD points to their potential liver recipients. Since donors are a national resource, the discussion of who qualifies for a redistribution scheme must be based on a national consensus, not local whims. Any scheme for redistribution must be consistent with national consensus upon who is qualified to benefit. 2) The previous successful collaborative to increase organ donation focused upon emulating best management practices. The three proposed models for redistribution of organs will instead perversely reward those programs exemplifying worst practices of organ utilization. New York and New England liver transplant programs are far below the norm in utilizing DCD livers for their patients, yet they are major beneficiaries of any of these proposals. Why should national policy reward programs that squander local resources that are used with successful results in other areas of the country? None of these schemes address the variances in organ utilization. 3) The proposals are illegal. When it was apparent that there would be variances in expansion of Medicaid by the states, the federal government attempted to withhold federal funds for other nonhealth activities to coerce the states to comply. The Supreme Court found this coercion to be illegal, allowing for states to vary in their decision to expand Medicaid. Most states which expanded Medicaid will benefit from all of these proposals; most states that will lose lifesaving organs have not expanded Medicaid, hence have smaller recipient waiting lists. If it was illegal to withhold federal highway funds to coerce states to expand Medicaid, why is it not even worse for an agency holding a federal contract to punish these same states by removing organs that could save lives on statewide transplant waiting lists? These proposals transform vast areas of the Southeast and the Northwest into organ donor colonies for New York, New England, and California. At least when the original American colonies shipped goods to England, they received finished wares in return. I suspect the new donor colonies for their efforts will only receive instructions to work harder to increase the "national resource".

Eric Gibney | 8/10/2018 

A concentric circles approach has been used in other organ allocation systems (heart, lung) and is similar in logistics with share 35, and the DSA/region approach for high KDPI kidneys.     The size of the circle and fairness is an obvious point of contention. We must consider all organs, and the impact of the circle size on the ability of transplant programs to offer services in their area. For example, a very large circle might shift livers toward centers with a larger number of high MELD candidates, but also devastate kidney programs with shorter waiting times for years. We cannot have large programs / states that suddenly cannot perform deceased donor organ transplants for 2-3 years until the 8-10 year waiting year programs have transplanted down their list, while at the same time arguing that liver programs can receive organs over a 1000 mile distance but have artificial reasons why kidneys could not.     In summary, a moderate concentric circle approach could spur broader sharing and could be introduced without devastating disruption and travel costs. A 150 to 250 mile radius could potentially unite the transplant community as a reasonable solution.      While kidney allocation is based on objective criteria, broader liver sharing should not be based on MELD exception points beyond the region that granted the exception. Ignoring the allocation vs calculated MELD argument will harm individuals who did not receive exceptions based on regional practices. A proposed National Liver Review Board would be a reasonable solution for future candidates, but would not mitigate the disparities in allocation vs calculated MELD for existing candidates. One possible solution is for any previous exception points granted to only be valid in the region where the exception was granted.   

OPTN/UNOS VCA Transplantation Committee | 8/15/2018 

The VCA Committee heard the presentation during a conference call on August 8, 2018. Members discussed each model and commented that simplicity in a model was very relevant for VCA currently. Members agreed the fixed distance model appeared to hold the most potential for VCA transplantation in the very near term. Members discussed the need for basing geographic distances in organ allocation on OPTN data and data from other sources to avoid the perception of developing distances that could be seen as arbitrary in nature. Members noted this model may benefit from periodic amendments to OPTN policy language to reflect advances in the field of VCA.

Members discussed the mathematical optimization model, expressing that the complexity of this model was not well-suited for VCA at this time. This approach may be better suited for organs with greater experience and greater case volumes. Members shared that this model appeared to still have the potential for transplant candidates being “stuck on the edges” of boundaries, even if only separated by a few miles. Also, members felt that this model could engender problems for a transplant hospital in proximity to an under-performing OPO, and this may create unintended inequities in organ distribution.

Members also discussed the continuous sharing model briefly, also expressing that this model was not well-suited for VCA at this time. Members expressed that the body of data to make informed decisions on this model was still accumulating, the field is currently working towards consensus on definitions of success and definitions of outcomes, and the idea of “medical urgency” [among others] in this model was not a good match for VCA transplants.

Despite the complexity of the mathematical optimization and continuous distribution models, members felt that each may be promising for VCA allocation in the future and once the numbers and experience in VCA transplants increase. The Committee commended the Geography Committee for their forward-thinking work, and appreciates the opportunity to provide feedback on this concept document.

Suzanne Conrad | 8/17/2018 

Matching the right organ to the recipient most likely to do best and survive post transplant is an incredibly complex undertaking both biologically and logistically. Whether the recovered organ is transported in a box on a commercial carrier or an entire surgical team moves from place to place by chartered jet, mistakes can be made and things can go wrong.  Either transport scenario is not a light undertaking and we should work to minimize transport times and risks. At the same time, there are organs that can withstand greater travel times than others.Kidneys being the obvious example. For this reason, I support Continuous Distribution as the overarching framework as it best allows for the complexity of what we do while maintaining efficiency and maximizing the transplantation of all of the various organs we are discussing. As a community, we can do more to minimize surgical team travel risks by allowing local transplant teams to remove and send organs to distant transplant centers. What is commonly done with kidneys is rarely done for thoracic organs and sporadically done for livers. I support exploring measures to gain acceptance of the practice of allowing other, remote transplant surgeons to recover and send hearts, lungs and livers as a matter of routine.

Ryan Davies | 8/21/2018 

Continuous distribution has several advantages over other models: (1) it can incorporate factors from several models including ischemic time, supply/demand estimates, etc... (2) it can provide a consistent model over multiple organ types with variability in specific factors to account for differences between organs in terms of response to ischemia, etc... (3) it will provide flexibility moving forward as the allocation rules can easily be changed with minimal changes to programming to account for changes in preservation techniques, travel, etc... Overall I would recommend adoption of this as the standard model across all organ types.

Tara Storch | 8/21/2018 

This seems to be the most flexible option with the best outcomes for the patient. Although it might be confusing to doctors up front, a best practice system would likely be in place quickly to help with this issue.

Angie Korsun | 8/22/2018 

Appears to provide the greatest flexibility in addressing certain geographic concerns while being able to maintain an ability to address some logistical concerns that must be factored into equation when distributing organs over greater distances to limit ischemic time and possible increased discards.  Based on metrics for distribution that are developed, may provide best ability to develop most effective metrics and facilitate more effective organ allocation.

Aimee Hagerty | 8/22/2018 

While the fixed model seems to solve problems of time (CIT, travel, etc.), it may create a disadvantage to centers that are in less densely populated areas. Though not tested, the continuous model seems to provide the most equity while avoiding geographic boundaries. It would be helpful to see this model simulated with all organs to have better predictive knowledge of how organs could be distributed.

Anonymous | 8/22/2018 

I was required to pick one from above.  I believe continuous has the most promise but so many variables to be answered. However, I cannot commit to any of the three at this time, as I would want to see better modeling data.

Anonymous | 8/23/2018 

The mathematically optimized proposal seems to provide the most empirical data to provide the sickest patient with the top priority of available organs.

Betsy Stein | 8/23/2018 

The concentric circle model is favored by my institution.

Andrea Tietjen | 8/23/2018 

While it is difficult to predict the operational logistics of each proposed model, it appears that in theory, the continuous model would best achieve eliminating disparities in distribution, which is the intent of the framework proposal. There are many unknown variables at this time - such as the algorithm and the determination of statistical coefficients necessary for this model - however we should seek a model that equitably, fairly and safely allocates a very precious resource. Model changes may significantly impact many transplant centers, as well as organ procurement organizations, both positively and negatively, but that should not detract from adopting a new model that better serves our patients. Of note, the logistical changes that would be required to affect change appear to be extremely complicated, costly to develop and implement and necessitate tremendous resources. The proposed models somewhat simplify the efforts that will be required to develop and implement the intended modifications.

Neeraj Singh | 8/23/2018 

The argument that DSA boundaries are arbitrary and constrains the wider organ distribution might be true but are the proposed frameworks perfect? We are being told that the three frameworks are consistent with 'OPTN Final Rule' a rule which sets the requirement that access to transplant shall not be based on the candidate's place of residence or place of listing, except as required by the permissible reasons like avoiding organ wastage and promoting patient access. Frameworks 2 has not been used in organ distribution and framework 3 has not been modelled or used in organ distribution. We don't know if any of these models will reduce cost and organ wastage (paradoxically organ wastage may increase with increase travel and cold ischemia time). The wider organ distribution may worsen existing inequalities in access to transplant if organs are shipped from marginalized, economically and medically backward areas (with higher concentration of poor/minority and vulnerable population who have less access to medical care/information) to more affluent areas/bigger cities/transplant centers? Hence, none of the frameworks address the permissible reasons of Final Rule.  The proposed frameworks importantly ignore the fact that regions with underperforming OPOs may become net importer of organs while performing OPOs get penalized.  The framework 3 does not define how the medical urgency will be measured. Are there any acceptable formulas for measuring/grading medical urgency for waitlisted kidney transplant candidates? Despite these flaws, these frameworks are being forced down our throat without allowing us any other alternative to choose. The proposed wider distribution of organs may also be damaging to several smaller transplant centers in remote areas which cater to more marginalized, and minority populations if organs get shipped out to bigger transplant institutions who comparatively list more high-risk and complex patients. The idea of a uniform organ redistribution needs more discussion, deliberation, time, and national consensus building and shouldn't be seen as a potentially harmful to certain geographic regions and to vulnerable/minority populations to benefit privileged others.

Anonymous | 8/24/2018 

While I support that the sickest patients get transplanted, I do not see the benefit in changing to a large radius distribution.  I think this will cost transplant centers large amounts to cost to fly-out and may not actually increase transplant numbers.  Additionally, centers located in South Florida, for example, are surrounded by water on 3 sides, limiting the donor access dramatically, compared to some of the mid-west areas.  

Anonymous | 8/24/2018 

This options appears to be more flexible for a better long term fix.  the other 2 models do not seem to be adjustable for changes in populations and ultimately would continually need to be adjusted. The continuous model may cause challenges for the OPOs for back offers and expedited placement when organs are declined in the OR.

James Pittman | 8/24/2018 

After reviewing all three proposals, it is my opinion that the 'Continuous Distribution' model will be most apt with incorporating the guiding geography principles for organ distribution policies. The Continuous model provides the greatest transparency and its algorithmic structure allows significant agility if needed. For example, if a programed model results an unintended result (e.g. decrease in pediatric rate of transplant), the model coefficients can be throttled up or down to result the intended outcome. Changes in transportation, logistics and preservation will likely alter current capabilities and the Continuous model can be easily adjusted when technical advances occur. The versatility of the model will likely be the most challenging aspect in that the transplant community will have the ability to specifically decide how organs are allocated.

Randee Bloom | 8/25/2018 

I support the Continuous Distribution framework amongst the three. I strongly suggest the inclusion of 'Time' rather than exclusively geographic distance as that measured variable. Multiple factors, faced daily and routinely, effect transportation efficiency. Weather, time-of-day traffic, mode of transportation (automobile, airplane) and many others result in time being the consideration for safe organ transportation. Tools that are readily available and commonly used (MapQuest, Google Maps, etc). provide a real time accuracy for such calculations and thus organ sharing distribution decisions.

Chad Ezzell | 8/28/2018 

After reviewing all three proposals, it is my opinion that the 'Continuous Distribution' model will be most apt with incorporating the guiding geography principles for organ distribution policies and the Final Rule. The Continuous model provides the greatest transparency and equity in the distribution of organs. 

Anonymous | 8/28/2018 

The continuous model appears to best meet the goals of equitable distribution of organs while adhering to the 'Final Rule'.  Although there is limited information on the details of possible configurations of this model, it appears to be the most flexible for organ specific adjustments.

Anonymous | 8/28/2018 

Of the three distribution frameworks, the continuous distribution model is the only that serves to balance geography, medical urgency, organ allocation 'economics' such as ischemic time and supply/demand matching. Also, the continuous framework seems to provide the fairest level of consistency across all organs. And lastly, as this continuous model currently stands, there seems to be greater flexibility for adapting to future changes in organ allocation and preservation science. As science and society change, so too should the policies that govern the distribution of organs. 

Anonymous | 8/28/2018 

Weighted consideration of all factors, including medical urgency and geography (reduce CIT and, potentially, cost)

Nancy Metzler | 8/28/2018 

By utilizing the continuous framework it appears that we will eliminate the sharp dividing lines of a straight circle model and hopefully achieve the goal of ensuring the fairest distribution system that would allow equal access to organs for everyone.  However, it will be important to see the data for each framework before coming to a final conclusion as to the best model to move forward.

Region 4 Vote | 8/30/2018 

8 fixed distance, 6 mathematically optimized boundaries, 15 continuous distribution

The region shared the following comments:
• If the future framework selected is fixed distance from the donor hospital, population density must be considered due to variability across the country. If the concentric circles or zones used are smaller than those in current organ allocation policy, we run the risk of being legally challenged again.
• Concern was expressed about the membership of the Ad Hoc Geography Committee. A member commented that members opposed to modifying liver distribution aren’t members of the committee. Another commenter also noted that the Ad Hoc Geography Committee was initially proposed to be time limited and convened for a few months and now the committee is proposing frameworks that are out for public comment and providing oversight to organ specific committees.
• A member asked how the kidney allocation system might be modified in light of changes in kidney distribution.
• An attendee noted that the OPTN webpage for collecting public comment requires commenters to select a framework for organ distribution, and an option to abstain or oppose is not available.
• The organ donation and transplantation field has evolved over the last 30 years and many things have changed, with the exception of allocating organs by local, regional, and national areas. Given this, it makes sense for the OPTN to address this topic, regardless of a pending lawsuit.
• It was noted that continuous distribution is the most flexible framework of the three, and least subject to legal challenge. The community also needs to keep in mind that this conversation is not about only liver distribution, but other organ systems as well and we need to focus on the framework discussion.
• A member suggested that instead of referring to organs as a national resource, organs are a national life source. It was felt that this more adequately captures that without organs you do not have life. The region voted to support this change: 25 members in favor.

Mary Callahan | 8/31/2018 

It is difficult for me to fully grasp any of the frameworks, but I believe the focus should be based on what is best for the patient while keeping respectful consideration of the donor family at the forefront of all decisions.

Tara Storch | 8/31/2018 

I feel that this gives the best chance for those with most medical need to receive the organ they are needing.

Rene Romero | 9/3/2018 

The public comment asks to opine upon three outlined 'frameworks' for organ distribution and derives from a previously stated 'principle' that donor organs are a 'national resource.' I find this language unfortunate, as it translates organ donation from what we in the transplant community have called the 'gift of life' into a commodity like minerals or grain. I feel it demeans the act of giving, which in most cases, someone died to let someone else live.     The true national resource is the patient in need of a transplant whose life could be saved. That is the national resource that should be preserved regardless of location. That means the transplant community must serve equally regions of the country with the highest burden of disease and poorest access as well as the regions of the country with the best access to transplant centers and the most listed patients. That balancing act cannot be accomplished solely on the fulcrum of organ redistribution. It also requires improvement in organ donation and recovery in regions that have underperformed and improved access to healthcare in regions that do not have an adequate response to the burden of disease in their population. Our transplant community must continually use language that encompasses all these concepts in order to build a sense of equitably shared challenges and solutions. A focus on redistribution of donated organs alone is not an equitably shared solution to the challenges we face as a community.     Conceptually, the continuous distribution model in theory may come close to addressing certain aspects of geography and includes the concept of medical need. It does not address access to care nor equitable organ recovery efforts. Full-fledged support of this 'framework' is, however, not possible without adequate modelling and knowledge of the data elements that would comprise included variables of medical urgency and its impact on various populations. While this 'framework' may be reasonable to explore, it is likely that alternative 'frameworks' may arise from within the transplant community that are worth considering.

Anonymous | 9/3/2018 

Due to the logistics involved and the CIT for ensuring transplantable organs, the fixed concentric circles are the best framework.  As the broadening of sharing organs have increased, so has the average organ donor case times, which has a major impact on the donor families. I am concerned that even wider sharing will result in more time constraints and loss of transplantable organs. Additionally, the wider sharing will increased cost of transportation, resulting in increased transplantation costs.

Anonymous | 9/4/2018 

I'm not sure I really prefer any of the three choices.  I feel that there has to be some criteria outside these three that would adequately address the critical shortage of organs, the geographic inequalities, and the disparity in MELD score in the regions.  I dislike the term 'national resource' and feel it makes the organs akin to a commodity.  This organization has fought hard against that terminology in the past.  I do believe that expanding the circles/neighborhoods can help the geographical disparity, but it won't solve all the problems.    I think it's possible that there is no one size fits all option, and nothing is going to make all the issues with geographical distribution disappear.

Anonymous | 9/4/2018 

It will be easiest to explain to patients. It can be made to look exactly the same as mathematically optimizing it. It will be flexible and comprehensible.

Sarah Sampsel | 9/5/2018 

This proposal needs more input from patients AND caregivers/family members.  This was the resounding feedback at the PACC August 27 meeting, and just requires careful consideration.  I would most support the Continuous Distribution Framework because of the fewer negative outcomes, and more opportunity for benefits for the transplant community.  Whichever framework is chosen, there is a definite and strong need for patient, family and stakeholder education.

Malay Shah | 9/6/2018 

I am submitting my comments via email since the three options on the public comment board do not allow for disagreement with any of the three frameworks. I believe all are flawed and I cannot select any of them as acceptable. My comments are as follows why are three frameworks and potential proposals are being viewed incorrectly and are inherently flawed. Let me provide examples of why these proposals are flawed based on zones.

Zone A (Appalachia, rural population, poor access to healthcare, poor access to hospitals, socioeconomically challenged areas with regard to extreme poverty/unemployment rates, etc).

Zone B (Large metropolitan area such as New York, excellent access to healthcare, excellent access to hospitals with subspecialized care, socioeconomically well resourced individuals).

None of these models:

1. Account for differences in the actual risk of death based on access to healthcare, patient illness severity markers, geographic barriers to healthcare access. Zone A patients are extremely disadvantaged in every category that would ensure a successful patient outcome compared to a patient in Zone B (who could literally fall ill, collapse, and be driven a few minutes away to a hospital that has advanced level care for patients with end organ failure). Zone A patients have no such luxury and are often times hours away from advanced/tertiary care hospitals that can provide advanced level care for complications from end organ failure.

2. Account for differences in OPO performance. Zone A patients (who are reside in areas with smaller population bases) are served by an OPO that identifies and aggressively pursues donors, while Zone B patients (who reside in areas with significantly larger population bases) are served by an OPO that inadequately pursues donors. Why should Zone A patients be made to suffer due to the relative incompetence and poor performance of the Zone B OPO? The population of the Commonwealth of Kentucky is approximately 4.454 million, while the population of New York City alone is 8.538 million, and the entire state of New York is 19.849 million. If organs are to be considered “national resources”, then it is reasonable and appropriate for OPO’s to be held to a similar standard of performance and have established practice guidelines. Transplantation and organ donation are tied at the hip. Transplant and organ donation CAN NOT be thought of as independent entities. One simply doesn’t happen without the other one.

3. Account for differences in listing practices for recipients. A transplant center in Zone A does not evaluate patients with cholangiocarcinoma for transplant. A transplant center in Zone B will consider patients with cholangiocarcinoma under certain circumstances. The reasons why certain centers choose to consider these patients while other do not are various. A transplant center in Zone A does not evaluate patients who are actively drinking for transplant. A transplant center in Zone B will consider patients with acute alcoholic hepatitis for transplant. Again, the reasons why certain centers will choose to transplant (or not transplant) patients with acute alcoholic hepatitis vary. The simple point is that there are not established guidelines and restrictions on which patients should qualify for transplant. If we are to consider a “socialist” model of organ allocation (that organs are a national resource for the benefit of all of society), then the recipients of that limited resource should be chosen carefully, with established guidelines, and not left to the determination of any given transplant program. As an alternative example, if we were to look at a patient in need of a fem-pop bypass graft… if I were to perform a heroic bypass that I was confident was going to fail, but my intention was to do everything possible to save that patient’s limb, I would have all the cryo-vein, PTFE, etc to perform the bypass. Even with failure of limb salvage in that situation, my utilization of bypass grafts does not compromise my ability to help the next patient also in need of a bypass. Transplantation is a completely different situation. We utilize a scarce resource and have to determine the ideal candidates who will benefit from the maximum life years and have the best chance for survival. This is a zero sum “game”. Futile transplants and transplants done for ambiguous/controversial indications negatively impacts our ability to provide life-saving transplant for other individuals. Therefore, any proposed model is a moot point until definitive indications and guidelines for listing patients for transplant can be established.

And finally, my view is that the process in which this public comment is being conducted is simply non-democratic. It is inappropriate to not have additional options such as, 1) none of the above, or 2) other. I compare the choices provided here to the manner in which “choices” are offered in a country ruled by a dictator of a third world country. This is not how we function in the United States, and nor should it be the way public health policy is conducted.

Julie Heimbach | 9/7/2018 

I support the fixed circle model, or the mathematically optimized model.  Both of these models have strengths and weaknesses.  However they are well-defined and would address the geographic disparity and improve access for the sickest patients.  The continuous model is problematic for several reasons.  Most importantly, it is not well-defined and thus, risks further dividing the community as we try tore, re, re re-draw every line every different way.  It relies on recipient factors of medical acuity (well-defined), donor characteristics (no robust predictors of donor quality exist to differentiate the majority of organs, though the extremes are easy to separate), and distance (the population is not evenly distributed so unless there is a very large area, this would favor patients listed at center the more densely populated areas since there will be multiple donor hospitals rear by.  All of the organ specific committees are currently working on some form of a fixed distance circle, with liver being furthest along.  IF the borderless allocation model is passed, the committee will need to start over yet again.  This is very confusing for patients and for transplant professionals, and is extremely disheartening for the volunteers who put countless hours into this.  Plus the cost of programming and re-programming to a new system  must be considered, along with the missed opportunities for the committees to address any other issue since they are required to be continuously revising and re-revising organ distribution policy.

Laura DePiero | 9/7/2018 

Organ distribution is complicated.  Although the person who is the neediest should be at the top of the list, the most important decision for me is that the donated organs do not get wasted because of geographical location.  The priority is to make as many matches as possible and serve as many of those in need, regardless of where they live.

AOPO | 9/10/2018 

The Association of Organ Procurement Organizations (AOPO) strongly supports the UNOS Ad Hoc Geography Committee work developing guiding principles for organ distribution and helping the organ-specific committees transition organ distribution policies to be aligned with the Final Rule and provide frameworks that will better facilitate improvements into the future. To accomplish this objective, we believe that the third framework, distribution without boundaries, is the best path forward. This framework allows for one or more organ-specific medical factors, such as high CPRA for kidney allocation, or medical urgency for liver allocation, or pediatric donor for all organ allocation, to be included as one component (medical priority score) of a composite total score. The second component (proximity score) can 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 for thoracic organs. Importantly, the relative weighting of the medical factors, and relative weighting of proximity, can be easily refined over time to fine-tune the organ-specific allocation policies to achieve the stated goals. We believe that the first two frameworks are variations on the third framework, since by adjusting the proximity score in a non-linear fashion, the same outcome, in terms of distribution zones, can be reached. In other words, if the proximity score is held constant for the first 250 nautical miles from the donor hospital, this is identical to using a circle with a 250 nautical mile radius centered on the donor hospital as the initial distribution zone, which is the current schema for lung allocation. 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 anomalies. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. In conclusion, we support the goal of the UNOS Board, the UNOS Ad Hoc Geography Committee and the organ-specific UNOS committees to align organ allocation policies with the Final Rule, and we believe the third framework, distribution without boundaries, is the best way to achieve this goal.

Helen Nelson | 9/10/2018 

This framework allows for one or more organ-specific medical factors, such as high PRA for kidney allocation, or medical urgency for liver allocation, or pediatric donor to be included as one component (medical priority score) of a composite total score.

Region 3 | 9/11/2018 

Members noted that while there is a need for the community to retain its ability to make its own decisions, they have serious concerns.

Members believe that the geography committee is biased because many members of this committee have been openly in favor of broader distribution. Members feel that there are no voices on the geography committee that are in opposition of broader sharing and region 3 is underrepresented on the committee. The committee should be made of either entirely unbiased members or needs to be better balanced with members in opposition of broader sharing. Without these other viewpoints, it creates mistrust in the system. Others felt that the committee composition also needs to include expertise from outside of the transplant field to provide better information on rural vs urban populations, costs, transportation, etc.

Members felt that the circles model was not ideal.  The challenge of the circle model is that there is less impact in certain areas of the country than others – especially in the west.  The circles need to account for places such as Puerto Rico and areas with unique geography such as the water surrounding the Florida peninsula.

One member proposed an alternative option to the three frameworks that is based on existing state boundaries.  To summarize, this alternative option is largely focused on liver allocation and is based on:

1. MELD-based geographic disparity is an issue of local utilization
2. National fixes to local problems disproportionately hurt rural, poor, and minority patients and worsen actual disparities in survival and access to care

This option proposes replacing the DSA with state boundaries as the first unit of allocation.  Although they may be arbitrary in nature, they are fixed boundaries and are used in other areas of healthcare such as Medicaid reimbursement.  The region was open to this alternative idea and requested to add it the voting options.

Region 3 Vote: 0 fixed distance, 0 mathematically optimized boundaries, 4 continuous distribution, 28 replace DSA with state distribution

Additionally, members did not agree with the idea of imposing the same framework on all organ types.  If any of the frameworks would be acceptable under the Final Rule, then each organ type should be allowed the option of the selecting the framework that best addresses the needs of that population.  As a result, the region requested to vote on the following statement: I think that each organ-specific committee should be able to choose from the acceptable frameworks that best works for them.

Region 3 Vote: 30 agree, 1 disagree

Duane Zadarosni | 9/12/2018 

I don't really agree with any of the frameworks. I have advanced cirrhosis and I'm extremely frustrated with the process of making the decision of who gets a liver, and when or where that happens. When I first became ill with alcoholic cirrhosis, 7 years ago, I had a Meld of 17. Along with that I was told, by the transplant hospital, I was too ill for surgery of that caliber. (I think it's more realistic to say the decision was, 'he's an alcoholic' which translated, under current regulations, means 'no transplant') I was told I needed to get healthier first, which would make the possibility of surviving a relatively long surgery a reality. But I admit, that part of the reasoning made sense. It took about a year or so but I finally reached a level where the transplant hospital would consider me. But first I had to visit with a social worker for further evaluation, which I did. After his evaluation he required me to attend and complete a state accredited rehab program, which I did. I not only completed it, but earned an early discharge from the program with all three of my counselors giving me their highest complements on my recovery in their final report. They went further to say that they were learning things from me and my perspectives that they could never learn in any school, and could see me returning as a guest speaker. I realize I may be the exception to the norm, but my point is don't write off people with alcoholic backgrounds as unworthy. NorthPoint Recovery is already challenging that issue, and it's about time. I've been arguing that very point for years. Even though I jumped through all the hoops required of me, submitted the discharge papers to the hospital, an additional visit with the social worker, I was told I needed some further testing. After more testing I was informed that I was no longer considered 'transplantable'. (again, I believe that's because of an alcoholic background) After speaking with my liver specialist he told me the people who make these decisions consider me 'too healthy' to receive a liver. I was told I needed to be sicker, much sicker, even though I still have stage 4 cirrhosis. He also told me he doesn't agree with the process when it comes to anyone in my present condition. I'm sure there's probably many other Doctor's that feel the same. He also told me, as he did 7 years ago, that most of my liver is dead, there's very little if any regeneration of healthy tissue, and the day will come when I will need to have a transplant. My point is this, I understand the sickest deserve to get preference over someone like me. I did the research and found that candidates with a high Meld score have an approximately 20% chance of surviving 6-12 months and only a 40% chance of a long life after. A person with my current status (Meld 9) has an 80% chance of not only surviving the surgery but living 20+ years. It's not my intention to sound cold and cruel, but even you admit there's not enough supply to go around. It's more than a bit hypocritical to say you don't want to 'waste' a liver, and then say you have to give it to the sickest first who have the slimest odds of survival. As long as the candidate has jumped through all the hoops put before them, candidates should be selected according to how well they would do in surgery, recovery, and life expectancy after a transplant.

Region 8 | 9/12/2018

Region 8 Vote: 0 fixed distance, 0 mathematically optimized boundaries, 19 continuous distribution, 7 abstentions

Members stated that they understand that there is a need for compromise and for the community to retain its ability to make its own decisions.

 

Some members thought that the purpose of the ad hoc geography committee was to provide guidelines, not to develop proposals. Given this belief, some members were surprised that the committee was putting forth three frameworks for a vote and felt that this was outside the scope of this committee. One member noted that ad hoc committees should be developed to review all points of the Final Rule for compliance and not just the section related to geography.

 

Members believe it will be difficult to have one framework for all organ types even when individual parameters for each organ type are applied. There was a comment that a uniform framework is not realistic given the different factors such as medical urgency and location that impact each organ differently. There is significant concern from the region that the liver committee’s pursuit of a circle-based model will be at odds with the geography framework selected and the community will be asked to readdress liver allocation again in short order.

 

One of the kidney programs noted that the number of waitlist registrations should not be used in SRTR modeling as an indication of demand because waitlist practices are varied and do not reflect true demand.

 

The community also still needs to understand the impact of socioeconomic issues on each framework. OPO performance is still an issue that needs to be addressed regardless of the framework chosen.

 

It was noted that it would be difficult to get consensus on the supply and demand measures needed to create mathematically optimized boundaries. Members felt that the continuous distribution had less constraints than the other options and could be more customizable for each organ type. Members strongly believe that they will need modeling data to determine the appropriate solution for each organ type.

 

Members commented that without understanding the specific characteristics/details of these frameworks and their impact on each organ type, it was difficult to make a decision and requested that the region be offered the opportunity to abstain.

Darnell Waun | 9/12/2018 

A single standardized organ distribution system would give the perception that equity between organ systems is being addressed.  This has strong implications for public trust in the system.  The continuous distribution model provides the highest potential level of equity without the geographic 'cliffs' of the other models, allows for other variables, such as time, to be considered besides just 'distance' alone, and patients may have increased confidence  in the non-discriminatory factors that may be seen as influencing their organ offer.

Seth Karp | 9/13/2018 

I do not support any of these proposals but have checked one of the circles in order to place a comment. The issue here is that all of these proposals violate Final Rule 121.4 and 121.8 in moving organs from areas of socioeconomic disadvantage to areas of socioeconomic advantage, increasing logistical complexity, increasing waste, and increasing cost. Any allocation system must recognize and respond to these clear mandates and not political and legal pressure being exerted by attorneys representing wealthy hospital interests. The framework therefore must include explicit recognition and consideration of these socioeconomic realities.  How can it be justified that in all iterations of these frameworks South Carolina, with a high waiting list mortality, low capture of patients on the waiting list, and severe socioeconomic disadvantage, loses significant amounts of organs whereas New York, with low waiting list mortality, high capture of patients on the waiting list, and socioeconomic advantage, gains large numbers of organs. There is no reasonable person who could think this is fair or consistent with the final rule. It is also relevant that the membership of the geography committee was not determined in a transparent or democratic fashion which has biased the recommendations.

Region 5 | 9/14/2018 

Region 5 Vote: 3 fixed distance, 3 mathematically optimized boundaries, 30 continuous distribution

There was a robust discussion with questions about how organ quality, cross matching and pumping are considered in the frameworks.  There was also a question about how to account for centers on the coasts in the circle or neighborhood model.  Travel time and cost was also brought up as a concern for all organs.  There was some consensus that continuous distribution would be the most defendable and would look the fairest to the general public.  Finally, there was some concern that none of the frameworks would help the disparity for candidates in southern California.

Raymond Rubin | 9/16/2018 

I respectfully submit my comments by email rather than directly online because the latter option requires me to vote for choices that are unacceptable. My vote is for none of the above. Even this voting procedure illuminates much of what is wrong with this proposal process: the transplant power brokers are ramming untested schemes down the throats of the rest of the country. This framework for organ distribution document is a thinly veiled deception. A lot of words are devoted to presenting two options without merit making it appear that continuous distribution is the only reasonable conclusion. While continuous distribution deserves further exploration, that is completely dependent on the absent specific details and the non-existent supporting data at this time.

We need to take a few steps back to get perspective. This document focuses on one piece of the Final Rule while completely ignoring another, that OPTN is responsible for developing transplant policies that  “reduce inequities resulting from socioeconomic status” [42 C.F.R. § 121.4(a)(3)].  It is no surprise that this crucial component of the mandate is nowhere to be found as a consideration in these proposals. Many Americans do not have access to sub-specialty care provided by a transplant center. Instead, they die of liver disease in their own communities and never get a chance to see a liver specialist or get on a transplant list. In Georgia (where I practice), there are two adult liver transplant centers in a state with more than 10 million people. There are only three liver transplant programs within 200 miles of Atlanta. In contrast, there are five adult liver transplant centers in New York City alone with another in Westchester and another being proposed on Long Island (where I’m from); there are 15 liver transplant centers within 100 miles of New York City.  A higher percentage of our patients in the Southeast are from rural, underserved, and socioeconomically disadvantaged communities. If they overcome the geographic and financial hurdles to get evaluated for candidacy for liver transplant, they may still be unable to afford traveling long distances to see liver sub-specialists to stay alive while awaiting a transplant. Organ allocation policies that completely ignore this front end inequity to access to care and unabashedly favor geographic areas with vastly greater access to pre and post-transplant care only accentuate the regional disparity in surviving end stage liver disease in the United States. We in the Southeast cannot support proposals that disregard the higher burden of liver disease in our population, ignore increased wait list mortality among poor and rural populations, and discount the possibility that, while we may not like it, keeping organs in local communities may increase overall donation.

Keep in mind that the  Ad Hoc Geography Committee is comprised of those who are friends or toadies of the OPTN Board of Directors. Most work in areas that stand to benefit the most from these proposals. They audaciously insist that the Board of Directors and Geography Committees do not need to represent each region of the country. They bully opponents, threatening their future career success. They have taken advantage of their affluent benefactors and paid lawyers and lobbyists millions of dollars to push their agenda. They accuse poorer areas of the country of profiting too much from” transplant tourism” to compromise on policy. The truth is that less than 1% of our transplant recipients come from outside the Southeast. They are not objective stewards of our precious resources.

The timing of this proposal is remarkable. In June, the Centers for Medicare and Medicaid Services announced it would not renew the New York OPO’s contract because it failed to meet minimum performance standards. New York City has the worst organ donation rate in the entire country. The solution for an underperforming local OPO, however, should not be penalizing patients who live in areas where the OPOs excel. While patients in California need to be sicker to get transplanted than patients in many other parts of the country (and this must be addressed), the New York area is a leader in granting MELD exception points to its own patients to make it look like their patients are sicker than they are. How can we justify to families in the Southeast that organs donated here will be flown to New York because too few New Yorkers donate themselves and that the New York programs are experts at gaming the rules of the allocation system?

Saying no to these 3 proposed options is the right answer. We should all be extremely cautious about basing liver allocation policy on the radical alterations for lung allocation until there is a detailed analysis of the intended and unintended consequences of those lung revisions. How  can we advocate for continuous distribution seriously without much more robust modeling based on specific input? There is no question that the devil is in the details and that these details are AWOL. There is an overwhelming likelihood that this proposal will result, intentionally or intentionally, in reassigning organs donated in underserved, socioeconomically disadvantaged areas like Georgia to well-served, more affluent areas in the Northeast.

Saying no to these proposals does not mean that everything is perfect as it is and that we shouldn’t take action. We need to fix the front end inequities to advanced liver care, the culmination of which is liver transplant. We need to increase organ donation across the entire country, but particularly in areas where the donation rate lags far behind. We need to rein in MELD exception points immediately to level the playing field between regions. We need to simplify the byzantine, gerrymandered geography of the OPOs. These are no-brainers. Why not make these meaningful changes and quickly analyze the impact before abandoning the existing allocation system? We need to reconsider the redistribution policies that were planned to be implemented in 3 months, but somehow were discarded before their impact could be evaluated. We also need to think through the differential impact our policies have on patients who live in states that have elected to expand Medicaid and those that did not. This may align with an alternative proposal that OPOs are aligned with statewide boundaries. From a more global perspective, since organs are in fact a national resource, maybe the time has come to consider national financial coverage for access to advanced liver care and organ transplant. While some of these concerns will not be fixed overnight, this does not mean we leap abruptly into untested waters blindly hoping that things will be better.

OPTN/UNOS Liver and Intestinal Transplantation Committee | 9/18/2018 

The Committee discussed this proposal during a conference call on August 28, 2018.

The committee expressed concerns over the fact that the geography committee proposal for consideration of 3 different frameworks is being proposed at the same time as the liver committee proposal which is one of the 3 frameworks. If the public supports one of the other 2 frameworks, then it will be in direct conflict with a proposal potentially being presented for approval by the liver committee at the same board meeting. It is very confusing for the regional members and the public at large. They stated that having organ specific committees making changes that necessarily adhere to only one of the frameworks at the same time that the geography committee has three frameworks out for public comment is causing confusion. It is unclear how much rework will have to be done once a framework is chosen. While some members thought that a fixed circle framework like that being pursued by the liver committee could be a step toward borderless, others feared that it would require another complete revision quickly after passing a large change. Another Committee member expressed confusion over having multiple committees making separate recommendations to the BOD at the same time and felt it is likely causing confusion in other committees as well.

The committee discussed the fixed-distance circles and suggested that travel time was likely a better measure than distance, but would be more difficult to define the variables.

The committee also discussed the borderless framework and had concerns about the amount the lack of definition of the variables in the borderless allocation model, and specifically how distance and donor factors would be addressed and how agreement could be reached, especially in order to ensure that the decisions were rationally justified. Because liver allocation does not have a kidney donor profile index (KDPI) equivalent, the factors involved in a borderless system for liver would probably be just MELD and distance, which could appear to favor urban centers with a lot of donors around recipients.

The committee asked whether there was any consideration given to disparity or donor availability in terms of geography. For example, would a patient in a location that has fewer donors have equal access to an organ from a location with many donor organs? The first principle of distribution allows constraining geographic distribution for the reduction in differences in donor supply and demand, so therefore would be allowed for consideration. The committee acknowledge that there were still questions about how that would work operationally.

Kevin Myer | 9/17/2018 

LifeGift, the OPO serving Houston, Fort Worth and West Texas supports the recommendations of the Ad Hoc Geography Committee.     Consistent with AOPO's comment, we also believe that the third framework, distribution without boundaries, is most practical and addresses the main principles advocated for in the proposal. This framework allows for one or more organ-specific medical factors, such as medical urgency for liver allocation, to be included as one component (medical priority score) of a composite total score. The second component (proximity score) can be tailored to control for distance between the donor hospital and the transplant center, considering clinically relevant organ-specific factors, such as cold ischemia time. We believe that the first two frameworks are variations of the third framework, since by adjusting the proximity score in a non-linear fashion, the same outcome, in terms of distribution zones, can be reached. In other words, if the proximity score is held constant for the first 250 nautical miles from the donor hospital, this is identical to using a circle with a 250 nautical mile radius originating from the donor hospital. We support the 250 nautical mile radius if used in the interim. We oppose any use of a 150 nautical mile radius as this small distribution unit is more restrictive than the current DSA-based allocation.    Regarding costs and logistics, our organization is preparing to adapt to anticipated changes by adding logistics expertise to our team, and to find ways to more effectively and efficiently move organs and/or organ donors from one location to another. The assumption that the recommendations of the Ad Hoc Geography Committee will increase cost is based on assuming the current approach to coordinating organ recoveries will be the future approach. The proposed changes will require all agents in this system to modify and evolve current practices and consider new alternatives to optimize recovery and distribution, such as regional recovery teams and hospital-based organ recovery centers.     Thank you for the opportunity to comment.

Mitchell Farmer | 9/17/2018 

Fixed and mathematically optimized do not take all factors into account. Distance needs to be factored to make sure the organ stays viable, but the best candidate should get priority. Children's medical urgency also needs to be assessed correctly to make sure that they aren't skipped.  Some sort of inverse relationship based on age should be factored also, for example a 10 year old child would benefit longer than a 60 year old.  Make sure wealth doesn't allow medical urgency to be undermined by verifying medical urgency by independent medical professionals.

Carolyn Light | 9/19/2018 

This seems to be the most comprehensive and straightforward approach to organ allocation that takes all relevant factors into account.

Region 1 | 9/17/2018 

Region 1 Vote: 0 fixed distance, 0 mathematically optimized boundaries, 15 continuous distribution

The region supported the continuous distribution framework and had the following comments:  The continuous distribution framework would stand up to any legal challenge and was patient centric.  This is also the one framework that eliminates boundaries and a mindset of “this is mine”.  The committee and the OPTN needs to educate the community on the differences in the frameworks and the big picture moving forward.  There was concern that without a good understanding of the big picture, people will choose the one that is easiest to understand and explain to patients.  One member cautioned using distance as a proxy for ischemic time in any allocation policy and urged the committees to look at real travel time versus mileage.  It was also pointed out that pre-KAS, Region 1 had a KI variance that was similar to continuous distribution that worked well.  The variance included proximity points and points for totally waiting time in allocation.  There was a question about whether or not the community had to use the same framework for all organs.  It was explained that there were a lot of benefits to having one framework and an explanation that although the framework may be the same across organs, there was flexibility within each framework so that it could be applied differently for each organ.

Anonymous | 9/20/2018 

Geography should NOT come into play. Biological match and urgency should be the only factors.

Samantha Endicott | 9/21/2018 

My comment is on my own behalf and not as a representative of a UNOS committee or my OPO.  I support the continuous model of allocation as it appears to be the most fair to candidates waiting, regardless of geography.   I wanted to comment as the fear of unintended consequences has been raised in many conversations, and is one I share.  One of the statistically significant findings from the 6-month review of lung allocation impact was that the duration of donation cases has increased.  As we move toward broader sharing, I think it will be important for the transplant community to make a commitment to efficiencies around the response to organ allocation offers.  Many centers are using services to field offers, with those services delaying responses until their patient becomes primary.  This leads to delays for grieving donor families, as well as increased consumption of OPO and partner hospital ICU resources.  In extreme circumstances, this may even lead to loss of donation opportunities.  We've seen the increase in case duration after the allocation changes for lungs - it's possible there will be additive effects as other organs go through similar changes.  I support the efforts toward broader sharing, but hope the community will simultaneously make a commitment to stakeholders on the donation side to be good stewards and efficiently respond to these opportunities from outside their respective regions.

Randall Caldwell | 9/24/2018 

The Fixed Distance form Donor Hospital has served the thoracic transplant programs well in that it best decreases ischemic time for the donor organ.  If an organ is not placed within the Zone A boundaries, it then becomes available more broadly to Zones B through F.

Denise Neal | 9/24/2018 

I feel that the Concentric Circle Framework will keep donated organs closer to the community where the donation occurred and reduce cold ischemic times for donated organs. This model will also help contain the increasing travel costs that teams and centers will be saddled with if they have to travel/fly hundreds of miles to recover an organ.

Anonymous | 9/24/2018 

this seems to be the most information used with multiple factors to help determine allocation- many factors need to go into this complicated process to help to implement the best solution that we can to meet the needs of the waitlist as well as realistic process

Anonymous | 9/24/2018 

There are many variables to transplant and donation. I think this option has the best potential to incorporate them into an allocation plan.    Missing from all frameworks is comments about efficiencies. Some organs can tolerate more cold time and can withstand being flown to and from when needed. Others cannot. This may lead to more back up patients being transplanted. It is important that the system prevents any unintentional or intentional change in allocation via back-up patients. Monitoring the use of back up recipients will be very important.

Megan Stack | 9/24/2018 

I do not support any of the 3 models.   Every organ has specific criteria that is clearly researched and published for patient and organ survival. Ultimately, voting on a theoretical 'fix' that has yet to be modeled has potentially grave outcomes for patients, donor families and the transplant community. Even a retrospective analysis would provide some enlightenment. Moreover, this set of lawsuits while it attempts to create a equitable approach to organ access fails to address the gross disparities between OPOs and the rate of consent and donors made available, the profound differences between transplant centers regarding criteria and safety to the patient.   Haste makes waste...

Anonymous | 9/24/2018 

Continuous distribution takes illness severity into account as a priority governing organ allocation, and so best serves our patients.

Anonymous | 9/24/2018 

Geography has to be considered in the context of avoiding waste so it has to be given some weight; but, if eliminating arbitrary boundaries is sovereign (which is seems to be according to the prevailing interpretation of the Final Rule), the continuous framework is the only one of the three that meets this criterion. Moreover, it is arguably the best way to balance equity and utility -- speaking of which, elements to protect the priority of pediatric recipients need to be considered in any chosen framework.

Robert Cannon | 9/24/2018 

I selected the fixed framework only because I am required to choose one of the three in order to leave a comment on the board. The fact that we are being forced to choose from three unsatisfactory options without the alternative of 'none of the above' is one of the problems I have with this proposal. To commit to one single framework for distribution of all transplanted organs seems foolish, as each organ has its own unique set of factors that play into what constitutes an 'ideal' distribution scheme (if such a scheme exists, which it likely doesn't). In a field as complex as organ transplantation and distribution, one size does not fit all, and to try to force such a fit is folly.     Aside from the lack of acceptable choices above, I believe that the entire premise under which the geography committee has been working is fundamentally flawed. To remove geography completely is not a mandate of the final rule. Section 121.8.a.5 specifically states that organ distribution 'Shall be designed to avoid wasting organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement'. The requirement to promote patient access to transplant is specifically listed as a reason for geography to play a role in organ distribution.     Under nearly all the proposed schemes for broader liver distribution, areas with diminished access to healthcare and low socioeconomic status such as the South are expected to see significant decreases in the availability of donor organs, to the benefit of areas with greater access to care and higher socioeconomic status. To paraphrase Ross Perot, there would be a giant sucking sound moving organs out of socioeconomically disadvantaged regions of the country and into New York and California. Those proponents of broad sharing claim that they are seeking to remove geography from organ distribution consideration in order to promote fairness. This is completely disingenuous, what they really want is their own local area and center to benefit. In the case of New York, this may be to make up for the completely lackluster performance of their own OPO. If these groups get their way, large swaths of the country will see access to transplantation dry up, and instead be turned into organ farms for their bicoastal taskmasters.     In fairness, I do agree with my would be future overlords on one point, and that is the arbitrary nature of the DSA as a local allocation unit. The boundaries of many DSAs are so irregular and out of touch with any rational geographic or demographic reality that they resemble gerrymandered congressional districts. If we are to preserve local allocation of organs in a defensible manner, then DSAs must be replaced with more logical boundaries. State based allocation as proposed by region 3 on this comment board would represent one such reasonable solution. The state as a legitimate and important political unit is enshrined in the constitution as one of the pillars of our federal system. As such, a state based allocation system could not be criticized as having arbitrary boundaries.     Finally, I disagree with the geography committee on the principle that donated organs are a national resource. To describe organs as a national resource is tantamount to stating that they should be shared as broadly as possible. Broad sharing sounds nice in theory, but as I have stated above, what this means in practice is populous areas with high socioeconomic status will be 'enriched' at the expense of the poor and disadvantaged. Nationalization of vital resources has been a favorite tactic of third world dictators for much of the past two centuries, and I urge UNOS not to follow in those footsteps.

Richard Cummings | 9/24/2018 

While I think this is the most challenging of the three, I feel it can be the most equitable.

Robert Sawyer | 9/25/2018 

Least opportunity to game the system.

Rachel White | 9/25/2018 

I think the continuous distribution model provides the most opportunity to customize organ allocation while taking into account the most variables such as location of the donor, acuity of the recipient, age of the recipient, ischemic times, etc.

Anonymous | 9/25/2018 

To me, it seems the most efficient

OPTN/UNOS Pediatric Transplantation Committee | 9/26/2018 

The Pediatric Transplantation Committee reviewed the proposal during a conference call on September 19, 2018. The goal of pediatric transplantation is to transplant a child with an organ that will have long-term function and last into adulthood. The consideration of an organ offer from deceased donor is to get a pediatric transplant candidate “the right organ”, rather than “an organ”. A fair and equitable organ allocation system must distribute pediatric organs as broadly as possible, reduce disparity across the country, be transparent, and readily explainable to the public.

Fixed Distance Model
Members shared that a fixed distance framework would need to consider elements unique to pediatric transplantation that are not seen in adult transplantation. Distances indicated for adult organ distribution are likely not well-suited for pediatric organ distribution. The clinical reality is pediatric transplant teams’ frequently travel farther than their adult colleagues to recover organs. As a result, greater distances should be modeled and considered for pediatric organ distribution. Also, this model may not capture the opportunities equally for transplant candidates in proximity to coastal areas or national borders.

Mathematical Optimization Model
The Committee felt the mathematical optimization model could result in similar inequities seen in the Fixed Distance Model with transplant candidates separated by, or just outside a determined geographic boundary. Further, this latter model may not be easily understood by candidates/families or the community.

Continuous Distribution Model
The Committee felt this distribution model would distribute pediatric organs as broadly as possible, reduce disparity across the country, and be understood by the public. Further, such a model may be able to respond to changes in clinical practice, and the emergence of new technology (e.g.: patient support devices, or organ perfusion). Members felt that a continuous distribution model would help a pediatric candidate be offered “the right organ”. The continuous distribution model can best incorporate “pediatric age” as a variable that determines the composite score and thereby incorporate pediatric priority directly into the allocation framework.

However, other policy elements need to be considered within the distribution framework. The Committee is ready to be engaged in, and supports, future discussions with other OPTN committees to ensure policies:
1. Prioritize pediatric donor organs to pediatric candidates
2. Reflect the consensus of the transplant community regarding the right degree of prioritization of pediatric transplant candidates within an allocation sequence (as compared to zero antigen mis-match candidates, prior living donors, and true highly sensitized candidates)
3. Strongly consider equity in access to offers for pediatric candidates in need of a solitary organ transplant as compared to those candidates in need of multi-organ transplants

The Committee is concerned that changes to organ distribution that result in wider sharing may have an unintended consequence of increased length of donor cases, as seen in some out-of-region sharing of adult donor organs. Lengthening case times will be an issue with both donor families and partner donor hospitals. Post-implementation monitoring of any future policy changes should include surveillance for impact from longer procurement case times on instances of withdrawal of donor authorization by a decision maker, changes in organs recovered per donor, and changes in recipient or graft survival.

The Committee appreciates the opportunity to provide feedback to the Geography Committee.

Region 2 | 9/26/2018 

Region 2 Vote: 4 fixed distance, 5 mathematically optimized boundaries, 25 continuous distribution

Members expressed multiple concerns in regards to geography.  Circles in various parts of the country are going to be different based on population.  Supply versus demand is very different on the coasts where there is a high population density as compared to areas in the middle of the country.  It may be more practical to develop different frameworks for various parts of the country.  There was also a concern that logistics and cost are very important aspects of any possible change, but it does not seem that they are being considered.  For example, has the committee considered that with wider distribution more OPOs and transplant centers will be flying for organs, and will there be enough airplanes to accommodate that increase in aircraft usage?  It was stated that the Operations and Safety Committee is developing a questionnaire for OPOs to address that situation.

There was also concern over the increase prevalence of perfusing organs at a facility that is different than the donor hospital.  If allocation is based off of the donor hospital, it would not take into account the difference in geography if organs are taken to an outside perfusion facility.  It was also noted that some OPOs have started using donor recovery facilities and that opens up the potential for gaming the system.  The OPO could build a facility that geographically advantages their “local” transplant centers.

For the Continuous Distribution framework a member noted that they would like to see donor quality added to the algorithm to determine a patient’s allocation priority score.

OPTN/UNOS Patient Affairs Committee | 9/26/2018 

The Patient Affairs Committee thanks the Ad Hoc Geography Committee for the opportunity to comment on various geographic distribution frameworks to inform future allocation policy more consistent with the OPTN Final Rule.

The PAC applauds OPTN/UNOS pursuit of standardizing organ distribution and operationalizing a single framework that better meets the needs for equity for transplant candidates. Use of the current arbitrary and outdated DSA and Regional criteria in organ distribution has created the perception of inequity and damaged public trust in the system. While a singular framework for organ distribution will not guarantee equitable distribution in the truest sense of the word, (e.g. health systems that pre-position patients to another same-health system center in a more robust donor area to increase likelihood of their being transplanted), it is likely there will generally be increased equity and access improvements across organ systems. Improving the public perception of equity in access to transplantation for all patients has the potential to improve trust in the system of allocation which is essential in maintaining the support of the donating community.

The Continuous Distribution model is our recommended framework for further development for the following reasons:

1. Provides highest potential level of equity without the geographic ”cliffs” of the other frameworks
2. Allows for other variables, such as time, to be considered besides just “distance” alone.
3. Patients may have increased confidence in the non-discriminatory factors that may be seen as influencing their organ offer.

The variables for each framework are well defined but may not be totally inclusive. We suggest the addition of the variable of TIME. While distance can be a proxy for donor organ transportation time it is not constant. Travel time can be influenced by time of year (weather impacts), and method of travel (land, air, etc.). Additionally the impact of candidate travel time is not specified.

Was data showing the number of patients who resort to multi-listing analyzed? The PAC felt this would have been useful information to help assessing the frameworks. It seems that a system that eliminates that advantage, only available to some, may be a good consideration for assessing these distribution models.
The PAC expressed concern about the lack of basic modeling with the organ distribution scenario for the continuous distribution model. This does not mean it should not be considered, but does need to have more modeling, specifically with the organ distribution process, to make sure this option is truly better than another framework for the needs of the transplant community.

While the sponsoring committee reviewed twelve “other distribution frameworks”, (per the webinar on this proposal), it is unclear how diverse those frameworks were. Has the sponsoring committee considered best practices on distribution systems from other industries like Amazon or FEDEX as well as some of the national grocery chains that are developing technology and logistics for driving efficiencies in the delivery models they use?
In various discussions on this proposal in public comment and our review, the responses have run the spectrum from “We need this” to “This is fatally flawed”. As we move toward the selection of a single framework, the proposal is not clear regarding the specific criteria being used by the OPTN/UNOS Board of Directors in the selection process of a single framework.

Finally, the figures used to demonstrate the various models are not intuitive and very hard to extract patient impact implications.  These would not be understood by the general transplant patient population.

The PAC asked the following questions:
Q: There was a request to explain the composite scoring in the Continuous Distribution model.
A: Simply put, allocation would rank candidates by score. The score would have three components: biologic match, proximity to the donor, and medical urgency. Each organ would customize the parameters/variables that make up their organ’s medical urgency score.

Q: Would it be feasible, after a model is adopted and implemented, to show patients, visually, real-time, based on their score, where they are on the list, even if it’s an approximation?
A: The presenter deferred the question to UNOS staff. UNOS staff advised there might be a way in the future to visually depict to candidates where they are on a match, but more research would be required in how to develop that in a way that is understandable to patients.

Q: How will exceptions and the review board systems impacted by the changes in geographic distribution?
A: Exception policies that contain references to DSA will be modified. Lung, and liver, imminently, have national review boards. Local geography should matter less with changes to liver exception policies. If broader distribution equalizes access, then gaps in scoring should be smaller and it should matter less if your exception score is attuned to the local geography.

Q: A donor family member asked whether organs could be referred to as a national lifesource, versus resource. “National resource” is comparable to natural gas, versus water, like organs, is a “lifesource”-without it, an individual would die.
A: The presenter acknowledged this seemed like a reasonable request.

Gene Ridolfi | 9/26/2018 

Per communication from UNOS, the argument is that the DSA boundaries are arbitrary and limits wider organ distribution.  We all may agree that the current model is not a perfect model but are the proposed frameworks any more perfect?

We are being told that the 3 proposed frameworks are consistent with the OPTN Final Rule, a rule which sets the requirement that access to transplant shall not be based on the candidate’s place of residence or place of listing, except as required by the permissible reasons like avoiding organ waste and promoting patient access.

Framework 2, which proposes optimized regions or neighborhoods, has not been used in organ distribution and framework 3, which proposes continuous allocation, has not been modeled or used in organ distribution. We don't know if any of these models will reduce cost and organ wastage. Paradoxically organ wastage may increase due to increased travel and cold ischemia time. This potential result goes against the UNOS goal of increasing the number of transplants. The wider organ distribution may worsen existing inequalities in access to transplant if organs are shipped from marginalized or economically disadvantaged areas and areas of limited medical resources to more affluent areas, bigger cities, or larger transplant centers. Populations with limited medical resources include communities with a higher concentration of poor, minority, or vulnerable populations who have less access to medical care and medical information. Hence, none of the frameworks address the permissible reasons of the Final Rule.
More importantly, the proposed frameworks ignore the fact that regions with underperforming OPOs may become net importer of organs while high-performing OPOs are penalized.

We believe the proposals ignore the significance of existing relationships between transplant centers and OPO’s. These relationships that have effectively advanced identification of donors within the DSA, improved donor management, and advanced organ yield. These best practice models should be emulated, instead of attempting to fix poorly functioning OPOs by re-direction of organs from high performers.

There has been little attention in this debate of geography concerning the opportunity for multi-listing. If the problem is that the arbitrary boundaries of a DSA imposes a disadvantage for a patient listed in center A when a donor is closer to center B in another DSA, doesn’t listing the patient at both centers A and B circumvent this? The cost to multi-list patients and provide the necessary resources will be substantially less than the cost of long distance organ transportation, flying surgical teams around the country at all hours of the night.
When will costs become part of the equation to evaluate organ allocation decision making? The OPTN 6- month data analysis on the new lung allocation model shows little impact on this population. There has been little change on who is being transplanted yet significant increase in the cost of organ allocation. The increased cost will clearly be a burden on smaller centers unable to offset the increased cost and ultimately eliminating another access point for patients in more rural locations.

What have we learned from broader sharing of lungs? Although there was a small increase in LAS for recipients at the time of transplant, the change and magnitude varied across the region.  There was an increase in median distance between donor hospital and transplant center and a significant decrease in local lung transplants.  Most concerning was the decrease in the deceased donor utilization nationally and an increase in discard rate nationally.

Our single center experience is a complete shift from local lung utilization to import lung utilization. This has increased ischemic time and travel time. The overall cost of organs procured has seen a mean average increase of $40,000.
Based on the lack of data modeling to measure the impact of any of the three frameworks and the reasons listed above, we would favor no proposal come to vote until it has been fully modeled to take into account increased availability, costs, and travel time. We strongly recommend any new allocation model require national standards on handling exceptions. The allocation model and standard of practices must be proposed together.

Jeffrey S. Crippin, MD
Marilyn E. Bornefeld Chair in Gastrointestinal Research and Treatment
Associate Chairman of Clinical Programs, Department of Medicine
Professor of Medicine
Division of Gastroenterology

William C. Chapman, MD
Professor and Chief, Section of Transplantation
Chief, Division of General Surgery
Washington University in St. Louis

Gene Ridolfi, RN, MHA
Transplant Center, Administrative Director

Gregory Ewald, MD
Heat Transplant Medical Director

Akinobu Itoh, MD
Heart Transplant Surgical Director

Tarek Alhamad, MD
Kidney and Pancreas Transplant Medical Director

Jason Wellen, MD
Kidney and Pancreas Transplant Surgical Director

Kevin Korenblat, MD
Liver Transplant Medical Director

Majella Doyle, MD
Liver Transplant Surgical Director

Ramsey Hachem, MD
Lung Transplant Medical Director

Daniel Kreisel, MD
Lung Transplant Surgical Director

Becky Rengering | 9/26/2018 

Fair and equitable organ distribution should be the goal of any organ allocation policies.  A consistent practice that prioritizes candidates by medical urgency followed by reducing complications related to CIT will create better organ access and outcomes for those in need.  The current Region/DSA allocation system is set up for disparate opportunities.  Some regions are more heavily populated than others allowing for more donor opportunities within the region's distribution area.  The option for patients to be double listed at centers in multiple regions tends to improve this access, however, creates a burden on the family who then need to travel farther distance for their post-transplant management.    I understand what the committee is attempting to accomplish and if I had to choose one it would be the continuous distribution model as this model is the only one that meets the principles of geographic distribution as approved by the Board of Directors (reducing population disparity, reducing unnecessary travel time, and increases organ utilization).  This model is more flexible than the others and allows for organ-specific individualization based on standards for CIT and donor criteria.  This model could positively impact organ allocation coordination with donor hospitals closer to recipients.    The continuous distribution model also treats recipients of similar geographic location the same by delineating medical urgency with points awarded for proximity. I do still have concerns about the utility of prioritizing those closest to the donor hospital.  For example, how would a status 1 patient play into this system if they lived in a remote location? Is the patient's recipient hospital their 'location' or is it their home address?  Large centers pull candidates from all over the country.  I assume location is defined by the candidates transplanting hospital.  We currently make any candidate living > 5-6 hours drive time to fly to our center at the time of organ offer.  If we are consistently pulling organ opportunities from less of a distance, would we need to require our patients be more local to the recipient hospital while waitlisted?  Would that increase expense to the family and insurance company to ensure quick arrival for an opportunity?    I also worry about centers manipulating the medical urgency scoring system by continuing to request exception points not realizing there are sicker patients with natural scores who can't get exception points across the nation.  I would think national control over exception points based on a distribution model would need to be implemented to provide a big-picture perspective on fair distribution.   I can't speculate which model is best, but if I had to choose, I lean more towards the continuous distribution model because it achieves the goals of the Board of Directors while putting the patient first.

Tim Schmitt | 9/26/2018 

I am a registered donor, transplant surgeon and UNOS board member. First the development of this ad hoc committee was for guiding principles not to develop a framework.  I would vote for none, as the committee is outside its intended scope.  Second circles and math formulas are arbitrary.  I agree with the new proposal that is out there about state wide and bordering state allocation.   It makes sense.   Health care and insurance companies are often limited to this boundary.  Patients support systems are local.   The AMA ethics committee in 1996 made the statement about donors as a national resource.  Unfortunately this socialistic view failed to take into account the fact that in the United states donation is an 'opt in'  Organs are a gift that is influence by the local environment, education and effort put in by that community.  As a potential donor if  I choose to bury my organs that is my right.  State boundaries exist, are logical, defensible and will create an incentive to improve donation.

OPTN/UNOS Organ Procurement Organization Committee | 9/27/2018 

The OPO Committee met by teleconference on 08/28/2018 to discuss the Frameworks for Organ Distribution proposal. Most of the Committee members supported the continuous distribution model for the following reasons:
     Uses multiple factors to help determine allocation priority. This is the best solution that will meet the needs of the candidates on the waitlist.
     Allows multiple organ-specific medical factors to be included as part of the score.
     Provides the greatest transparency and equity in the distribution of organs.

One Committee member commented that the fixed distance from the donor hospital was the best framework due to logistics and cold ischemia time. Broader distribution increases donor case time, results in more time constraints, and increased costs.

Another Committee member noted that none of the frameworks mention the efficiencies in the system. Not all organs can tolerate increased cold ischemia time and broader distribution may lead to an increased use of backup offers. This may lead to more backup candidates being transplanted so it will be important to monitor the use of backup offers.

Anonymous | 9/28/2018 

Equality and fairness in the distribution process are essential!

Kym Watt | 9/28/2018 

There is not enough data to support really any of them, particularly the continuous model, which has absolutely no data. The whole point of all of these discussions is to remove geographic disparity, but this model INCLUDES GEOGRAPHY- distance from transplant center- as an allocation metric. The idea that the clinical need portion - which we are told individual organ groups can 'sort out and determine' is a very very loosely guided framework. I cannot understand why there is even a vote on this, without more data on what this framework would actually mean. It cannot possibly be a good thing for less population dense areas. it will not solve the geographic disparity. Every organ group currently working on allocation policy change will be stymied by this.  The fact this is out for a vote without any data or detail feels very much like the vague political move 'trust me - we will make this better'.

Evelyn Hsu | 9/28/2018 

Studies in Pediatric Liver Transplantation (SPLIT) represents the majority of pediatric liver transplant centers in the United States and has repeatedly advocated for the rights and lives of children on the liver transplant waitlist. The efforts of UNOS to address these concerns directly and to actively engage all stakeholders must be lauded. The ad-hoc geography committee has used the December 2017 Board-approved '5 principles of Geographic Distribution' to identify and distribute 3 geographic frameworks for review for public comment. SPLIT is particularly concerned with the fate of pediatric donor livers in this country. Previously published work has shown that in a five-year period where 316 children died on the liver wait-list, more than 1600 adults were transplanted with livers that came from pediatric donors. Due to the prioritization of local adults over critically ill children on the waitlist nationally, a number of adults, the majority of whom are not critically ill, are transplanted with livers from pediatric donors without ever being offered to a child. A fair and equitable organ allocation system must 1) distribute pediatric organs (defined as all donors < 18 years of age) as broadly as possible and reduce disparity across the country and 2) be transparent and readily explainable to the public. As providers for this vulnerable population, SPLIT believes that broader sharing of organs benefits children. We remain concerned that all three of the frameworks are designed to apply to adult waitlist populations. No matter which framework is ultimately applied, special consideration must be given to pediatric wait-list patients in order to assure equity and access to transplantation for our children. For example, if fixed distance circles are employed, larger distances should be modeled and considered for pediatric candidates. In the continuous distribution model, pediatric candidates should be given added consideration as a factor to calculate the composite relative distribution score more appropriately for this population. Recent studies suggest that the PELD score underestimates mortality in children relative to adults, and any changes in our allocation system need to allow processes that consider children in order to reduce waitlist mortality and morbidity. Submitted by Evelyn Hsu on behalf of the SPLIT Council (members: Susan Feist, (UCLA) Simon Horslen (Seattle Children's Hospital) George Mazariegos (Children's Hospital Pittsburgh) Vicky Ng (SickKids Toronto), Nitika Gupta (Children's Hospital of Atlanta) Dana Mannino (Dupont) Julie Economides (Texas Children's) Saeed Mohammad (Lurie Children's) Sue Rhee (UCSF) Riccardo Superina (Lurie Children's) Beau Kelly (DCI Donor Services)

Jonathan Hundley | 9/28/2018 

I am submitting my public comment via email since the online process doesn’t allow for selecting “none of the above” as is customary for public comments.

First, I would like to take this opportunity to publicly protest the composition of the Ad Hoc Geography Committee. I have already done so privately via an email to then-president Yolanda Becker and subsequently in a public setting at our Region 3 meeting with Brian Shepherd representing UNOS. In short, UNOS should be ashamed of itself for the composition of this committee. The committee is formed of two categories of members: members who have been silent on the liver allocation debate and members who have been publicly in favor of models that will shunt livers from poor rural areas to wealthy urban areas of this country. Not a single member of this committee was part of the uprising against the liver allocation eight district model that was voted down by 80-plus percent of our transplant community.

Second, I would like to briefly outline my support for a state-based distribution framework as presented by Dr. Ray Lynch at the Region 3 meeting. This framework received 87.5% of Region 3’s votes. Different iterations of a state-based distribution framework are possible. Using liver allocation as the example, organs could be allocated within a distance circle prior to the state of recovery for high MELD patients. Alternately, organs could be allocated to contiguous states for high MELD patients prior to the state of recovery.

A state-based distribution framework has many advantages:

1. States form the only truly non-arbitrary methodology for apportioning organs, and therefore are the best boundaries to allow OPTN/UNOS policy to comply with the law. The argument that state boundaries are arbitrary is simply not defensible based on common sense.

a. Individual states are well recognized as units of socioeconomic status and overall quality of health care.

b. State-level differences in Medicaid have profound effects on access to transplant for socioeconomically disadvantaged patients.

c. States are primarily responsible for setting up donor registries and promoting donor awareness. Brain death is determined by state law, and the Uniform Anatomical Gift Act is enacted at the state level.

d. States are recognized as a community unit and represent common interests and relationships across the political, social, and financial spectrum.

2. This framework would establish communities of donation around common interests and resources with strong accountability for performance. This would force those DSAs with low performing centers or low performing OPOs to work together.

3. A state-based distribution framework replaces DSAs simply and effectively without massive disruption to our current systems.

Andrew Rivard | 9/29/2018 

On November 19th, 2017, a 21 yr old Miriam Holman, who had been waiting for a donor lung in a NYC hospital filed a temporary restraining order against the United States Department of Heath and Human Services (HHS) to allocate donor lungs based on medical priority instead of a priority based on a candidate's place of residence. At the time of the lawsuit, lungs were allocated first to candidate's within a geographic Donation Service Area (DSA) operated by the Organ Procurement Organization, then to other candidate's in transplant centers further away. Since the geographic territories of the DSA are arbitrary it was possible that a candidate registered in Jersey City, NJ with a medical priority less than Miriam's. The US District Court did not issue an injunction, but ordered the Health and Human Services to undertake and immediate review of the lung allocation policy in light of the Final Rule requirements. The plantiff appealed and the judge required the HHS to respond in 3 days - so over Thanksgiving holiday the Organ Procurement and Transportation Network (OPTN) board met and concluded that a policy that does not depend on DSAs as the primary unit of allocation is consistent with the OPTN Final Rule. Thus in less than a week, organ allocation for donor lungs was changed in what was not possible 'despite numerous opportunities of the course of many years, the OPTN board has failed to provide a justification as to how DSAs and Regions meet the requirement of the OPTN final rule.' The Final Rule was issued by the HHS Secretary Donna Shalala in 1998 to distribute organs more equitably by replacing the locall allocation system with a system based on dedicated priority over as broad a geographic area as possible. Under the OPTN Final Rule, the OPTN board is required to develop and study policies for the equitable allocation of donor organs for potential recipients that comply with the following principles: (1) Shall be based on sound medical judgment; (2) Shall seek to achieve the best use of donated organs; (3) Shall preserve the ability of a transplant program to decline an offer of an organ or not to use the organ for the potential recipient (4) Shall be specific for each organ type or combination of organ types to be transplanted into a transplant candidate; (5) Shall be designed to avoid wasting organs, to avoid futile transplants, to promote  patient access to transplantation, and to promote the efficient management of organ placement; (6) Shall be reviewed periodically and revised as appropriate; (7) Shall include appropriate procedures to promote and review compliance including, to the extent appropriate, prospective and retrospective reviews of each transplant program's application of the policies to patients listed or proposed to be listed at the program; and (8) Shall not be based on the candidate's place of residence or place of listing, except to  the extent required by paragraphs (a)(1)-(5) of this section. At this time, an ad hoc geography committee of the OPTN is deliberating three different conceptional structures for distribution of donor organs to comply with the HHS mandate. The first framework creates fixed geographical shells (i.e. 250 miles, 500 miles, 1000 miles) which the distance between the donor hospital and the potential recipient is arbitrarily  determined - such as currently done for lung transplantation as follows an OPTN emergency policy change initiated from the lawsuit as described above. The second framework uses mathematical optimization to establish distribution boundaries using a yet-to-be-determined statistical formula with geographic boundaries customized to account for unique issues of demographics, geography, or clinical factors. The third framework again uses a statistical formula but doe not create boundaries. This formula would allocate organs purely upon medial urgency and likelihood of graft survival along with proximity to the donor organ location. Each of the three proposed frameworks has advantages and disadvantages, however, as stipulated by the HHS, the choice of the framework must comply with the Final Rule and should be based primarily on medical urgency and not geography unless geographical distribution can avoid organ wastage, limit futile transplants, and promote patient access, and efficient management of organ placement. The purpose of this research is to describe current geographical disparities to access and quality of donor hearts and describe why the (THIRD?) framework balances equity and utility in the context of the physiology of donor organ preservation - which essentially limits the distance in which an organ can be maintained in a viable state for transplantation. The existential problem faced with transplant surgeons is the random nature of donor organs.  All eligible donor organs come from declaration of brain death, a majority of which are from a preceding traumatic event. Because events are random and of varying severity, the subset of donors presented for potential procurement are likely heterogeneous in both their geographic location and quality as defined by medical criteria (the OPO refusal code). The transplant surgeon must take in account the expected cold ischemic time of the donor heart; as longer transport times are directly related to poorer transplant outcomes.(CITATION)  Using data from the OPTN, we should begin our study with the hypothesis that donor organs quality and utilization is uniform across the United States and argue that the heterogeneousf and random origin of donor organs must be used to define new donor allocation scheme. This new scheme would be based upon the first offer going to the closest recipient with the highest medical priority followed in sequence with the second offer to the next closest recipient with the highest medical priority (Status 1), followed in turn to the closest recipient with the next highest medical priority (Status 2). This process could then be repeated for all six medical urgency statuses; thus allowing medical priority of the transplant candidate to take precedence over geographical distribution.

Douglas Keith | 9/30/2018 

Distribution of kidney donors I believe is more difficult for a number of reasons and I believe that the mathematically optimized and continuous will be very difficult to apply to kidney donors. The current organ distribution system for decease donor kidney transplantation is the product of historical alignments among transplant hospitals decades ago when the national transplant system was forming and demand for organs was less dire. As the demand for kidneys had grown over time, the disparities in waiting times have worsened. The Organ Procurement and Transplantation Network (OPTN) Final Rule states that organs should be allocated according to need and all barriers in access based on socioeconomic status and geography should be minimized in order to provide equitable care for all patients with end stage organ failure. At least from the OPTN point of view, donor kidneys are a national resource and efforts to decrease the regional disparities should be a priority. There are obviously a number of issues when considering changing existing organ distribution boundaries. Changing existing donor kidney distribution is a highly charged issue and pits shorter waiting time DSAs and their associated transplant centers against longer waiting time DSAs and their transplant centers. An abrupt change in the rules governing distribution could see some centers experiencing large drops in volume while others an abrupt increase. The infrastructure needs of a program would necessarily change as a result. This has significant financial implications for the hospitals and providers of kidney transplant services and is a major concern if changes are made to the existing system without consideration of the impact to volumes at individual programs. Clearly for some organs there are time constraints regarding cold ischemia and viability that limits the ability ship organs long distances.  By virtue of their longer tolerance to cold storage and pumping of kidneys, kidneys can be shipped successfully across the continental United States, and for the zero mismatch program and now for the highly sensitized recipients has been successfully done. So at least for standard criteria kidneys, theoretically it is possible to ship kidneys throughout the continental United States without compromising recipient outcomes significantly due to longer cold ischemia times. The effect of greater national sharing of donor kidneys would mean a significant redistribution of organs, and number of issues would have to be considered before embarking on such a program. First, widespread sharing of organs from regions with high donation rates to areas with low donation rates would decrease the incentives of lower performing DSAs and associated transplant programs to improve local procurement rates. Similarly, the higher performing DSAs and their associated transplant programs may have less incentive to retrieve kidneys if they are just going to be shipped out of region and not be available for local use. Although the OPTN appears to consider donor organs as a national resource, the public may feel differently. They may view donors are a local or regional resource, and it is possible that donation rates could be affected if it was felt the donor organs were not going to benefit people in their region. Another issue that needs to be considered is the large regional differences in listing rates. Access to kidney transplant is a multi-step process including identification of renal disease, progression to a listable stage, referral and evaluation for transplantation, listing for transplantation and ultimately the transplant itself. Waiting for transplant is just one aspect of access and the easiest to measure but depends on many factors including listing rates in DSA, living donor transplant rates and availability of deceased donor organs.  We know that some areas appear to be more aggressive in their listing practices, listing higher risk patients with potentially poorer outcomes, and those DSAs by virtue of the higher listing rates have longer waiting times in their DSA as a result. DSAs with low listing rates have shorter waiting times. Centers with conservative listing practices that shorten waiting times for their candidate pool would be negatively impacted by changes in the distribution system. Since the optimal listing rate is unknown and there are no universal listing criteria, and particularly in DSAs with multiple centers competing for organs, listing may be more aggressive in attempts to secure more transplants in their DSA, areas with poor access to transplant would get even poorer as organs are exported to other DSAs with longer wait times. Except in the case of lack of vascular access for dialysis, medical urgency is not a factor that can easily be implemented in kidney transplant since everyone by default qualifies for dialysis and there is a very large difference in age and projected survival among candidates. One could incorporate distance as a continuous variable in the ranking system independent of DSA but appropriately weighting the system with other factors in the point system may be a difficult balance to achieve the desired goal of improving disparities in waiting time. Another important issue is the transition process to a system with greater organ sharing between DSAs creates a period of disequilibrium. If waiting time remains the most important factor in allocation, initially during the transition from the DSA based system to wider sharing, the majority of the donor kidneys would go to the DSAs and their candidates who have the longest waiting times. If there is a large disparity among the sharing DSAs, this would result in most of the kidneys going to the DSA with the longest waiting time until that backlog of long waiting time candidates is diminished and the median waiting times start to equalize among the DSAs. How long this process would take would require simulation but it is likely that it would take several years given the current disparities in waiting time. For the very short waiting time DSAs that would mean they would do very few deceased donor transplants until their population of candidates accumulate two to three years of extra waiting time to bring their waiting times nearer the median for the region or country. The greater the disparities the more difficult this transition becomes. Delaying a decision on changes to organ distribution will make the disequilibrium problem worse since the disparities appear to be continuing to worsen over time. In our DSA this happened with the change to a regional list for ECD kidneys. Because several of the DSAs in our region have considerably longer waiting times than our DSA, the change to regional sharing resulted in fewer ECD kidneys being transplanted in our DSA. Candidates in our DSA were not waiting time competitive for ECD kidneys. For our DSA it really defeated the purpose of listing patients for ECD kidneys because all the reasonable ECD kidneys would go to the DSAs with long waiting time and our patients that might be reasonable candidates for an ECD kidney would get no waiting time advantage over a local SCD kidney because of the impact of the regional list with its large waiting time disparities by DSA. One intermediate solution would be to share only a portion kidneys procured in a DSA. Since most standard donors produce two transplantable kidneys, it would be possible to have the first kidney distributed within the DSA while the second kidney would be placed in the larger regional or national pool for distribution. This would lessen the blow with regard to transplant volumes within the shorter waiting time DSAs and provide an incentive to programs in those DSAs to procure kidneys aggressively. It would, however, lengthen the time taken to bring the system back into equilibrium with regard to lessening disparities in waiting time. The other consideration is the disparate impact of living donation. Some areas have maintained reasonable waiting times by virtue of having high living donor transplant rates. (Minnesota or Utah) In these areas, candidates dependent on deceased donors would penalized due to the high living donor transplant rate in their area. Another consideration is the impact of changes on transplant programs of different sizes. Larger more established programs in shorter waiting time DSAs will likely be able to adapt to and survive the new changes easier than smaller programs. My program is only two years old but I can tell you that having programs dispersed in the United States improves access to transplant. The nearest transplant program to ours is 3 hours drive and all the other surrounding programs are over 4 and half hour drives. When our program was established we listed many people who could not afford to travel for their kidney transplant, many of whom had been on dialysis over 5 years as a result. I worry that any abrupt drop in our volume of transplants may dissuade the administration of the hospital from continuing the kidney transplant program if that is the effect of the new allocation system. The closing of the program would have the net effect of decreasing access to transplant in our area. While I applaud the attempts to address the disparities in waiting time, it is important to remember that waiting time is only one measure of access to kidney transplantation.   Equalizing time on the list does not address issues such as lack of referral for transplant, differences in listing rates and criteria for listing across the country or differences in the rate living donor transplant and its local effect on transplant rates. Whatever changes are made, careful consideration must be made how these changes will impact programs across the country.  Sincerely,  Douglas S. Keith, M.D., F.A.S.T.  Sacred Heart Kidney Transplant Program  Pensacola, Florida

Harrison Pollinger | 9/30/2018 

I am submitting my public comment via email since the online process doesn’t allow for selecting “none of the above” which I feel is the only choice at this time.

Speaking as someone who has been performing liver transplants for the past 14 years, all I can say is that UNOS has let me, and more importantly the sick patients of the southeast down with the lastest liver allocation models and proposals. All are critically flawed, reward areas with the lowest wait list mortality, inflated MELD scores and the poorest performing OPO’s.

The geography committee is a sham. Not a single member of this committee was part of the uprising against the liver allocation eight district model that was voted down by 80-plus percent of our transplant community. It’s members are all inherently biased on this subject or have no skin in the game with respect to the patients they serve.

I would like to briefly outline my support for a state-based distribution framework as presented by Dr. Ray Lynch at the Region 3 meeting as many of my colleagues have so eloquently done before me.

This framework received 87.5% of Region 3’s votes. Different iterations of a state-based distribution framework are possible. Using liver allocation as the example, organs could be allocated within a distance circle prior to the state of recovery for high MELD patients. Alternately, organs could be allocated to contiguous states for high MELD patients prior to the state of recovery.

A state-based distribution framework has many advantages:

1.) States form the only truly non-arbitrary methodology for apportioning organs, and therefore are the best boundaries to allow OPTN/UNOS policy to comply with the law. The argument that state boundaries are arbitrary is simply not defensible based on common sense.

a.) Individual states are well recognized as units of socioeconomic status and overall quality of health care.

b.) State-level differences in Medicaid have profound effects on access to transplant for socioeconomically disadvantaged patients.

c.) States are primarily responsible for setting up donor registries and promoting donor awareness.  Brain death is determined by state law, and the Uniform Anatomical Gift Act is enacted at the state level. 

d.) States are recognized as a community unit and represent common interests and relationships across the political, social, and financial spectrum.

2.) This framework would establish communities of donation around common interests and resources with strong accountability for performance.  This would force those DSAs with low performing centers or low performing OPOs to work together.

3.) A state-based distribution framework replaces DSAs simply and effectively without massive disruption to our current systems.

most sincerely,
Harrison Pollinger DO, FACS | Program Director
Piedmont Transplant Institute
Clinical Associate Professor of Medicine, Mercer University School of Medicine

AST | 10/01/2018 

The American Society of Transplantation is supportive of the OPTN/UNOS and the Ad Hoc Geography Committee’s goal to bring UNOS allocation policies in line with The Final Rule by eliminating systems of prioritization and distribution that are “based on the candidate’s place of residence or place of listing, except to the extent required” while including in the allocation policies “sound medical judgement, best use of organs, the ability for centers to decide whether to accept an organ offer, to avoid wasting organs, and to promote efficiency”. We appreciate the opportunity to provide feedback at this stage.

Unfortunately, the American Society of Transplantation cannot, with the information provided, support any one framework over another. The lack of sufficient data and even preliminary modeling prevents informed opinion regarding impact and projection of downstream effects particularly for vulnerable populations. That said, the Society’s diverse membership has carefully reviewed the proposal and does wish to take this opportunity to provide feedback regarding the frameworks suggested for consideration.

1.) Fixed Distance from the Donor Hospital - This framework creates fixed geographic areas or concentric circles based on the distance between the donor hospital and the transplant candidate’s listing center. While local matches may receive priority, this approach may also allow wider distribution for other characteristics such as medical urgency. This proposal will lead to more organs being distributed along a wider geographic area compared to the current system.

• Pros –
o Potentially shorter travel time for organ and procurement teams compared to other frameworks provided that the radius of the circle remains short
o Potentially lower cold ischemic times, which would allow the optimal and successful transplant of higher risk, more marginal organs.
o May allow for adjustments to widen distribution for medical urgency;
o May incentivize OPO to increase performance and productivity;
o May encourage local donation
o Lower transportation cost for OPOs and Centers compared to proposals that favor a larger distribution area.
• Cons –
o Presence of a defined line or “cliff” which would make two candidates who live on either side of the line be prioritized differently, even if they have the same medical urgency.
o Some areas in the country may have very few or no donor hospitals nearby
o Broader distribution circles may negatively impact efficiency of the system when organs/procurement teams will need to fly instead of drive.
o Broader distribution circles may lead to increased organ discard rates when more marginal organs are accepted and then rejected over longer distances.
o Broader distribution will also lead to significantly increased cost to the system.
o Concentric circles may be less suitable for coastal areas or areas on the border with other countries

2.) Mathematically Optimized Boundaries - Mathematical optimization can be used to establish distribution boundaries. The boundaries are based on a statistical formula derived from metrics and constraints and designed to achieve the best results for one or more specific goals, such as having a consistent ratio of donors to potential recipients within each distribution area. Size of distribution area can be scaled up and down.

• Pros –
o Uses objective criteria that will provide the results.
o Can use population density bubbles depicting differences between fixed radius circle and a fixed population circle around a transplant center.
• Cons –
o Presence of a defined line or “cliff” which would make two candidates who live on either side of the line be prioritized differently, even if they have the same medical urgency
o Complex to understand; statistical formula used to determine boundaries is historical and may not be sensitive to changes in organ utilization that should also impact allocation;
o Data variables used in statistical formulas may not be known to the public; modeling data have not been shared with the public

3.) Continuous distribution - Organs can be distributed to candidates using a statistical formula that combines important clinical factors, such as medical urgency and likelihood of graft survival, along with proximity to the donor location. Using this approach, all candidates would receive a relative distribution score, but there would be no absolute geographic boundary. Candidates who best meet the combination of factors receive the highest priority.

• Pros –
o Considers medical urgency and proximity as the most relevant factors for the best use of organs
o May offer the most optimal framework to improve efficiency by providing a singular distribution framework while maintaining flexibility to optimize outcomes, improve efficiency and improve patient access.
• Cons –
o Entails more travel and cost; may deter local donations; may create more disparity for smaller programs who have less capacity to travel

For liver allocation, it is not clear how MELD exceptions will be handled amongst the physiologic MELD scores in the continuous distribution framework.

For kidney allocation under any model chosen, we suggest that zero mismatch be maintained as high priority. Significant changes will need to be adopted for kidney allocation which presently represents approximately 80% of all organs allocated annually (https://optn.transplant.hrsa.gov).

For heart allocation, the development of a heart allocation score (HAS) will be a critical next step particularly given that the use of mechanical circulatory devices (MCS) have changed the landscape of patients with end-stage heart disease. Currently, the patient with the highest medical urgency can be stabilized with a mechanical circulatory support device and hence become a better transplant candidate. In lieu of a heart allocation score, concentric circles (#1) may be the best alternative for now until a HAS that considers the impact of MCS can be established. Once a validated HAS is developed, the continuous distribution model (#3) would likely serve as the most efficient allocation system that includes allocation of hearts. The budgetary impact of resources for heart transplantation will be substantial to establish a heart allocation score that truly represents medical urgency.

For lung allocation, the continuous distribution framework appears to be the most desirable and may work effectively as it de-emphasizes geographic allocation while considering medical urgency and proximity as relevant factors for the best use of donor organs. The current lung allocation score (LAS) represents medical urgency and has been vetted to determine true severity of illness. The proximity score would also serve to minimize long ischemic time by factoring in proximity of the donor to the recipient. The exact weighting of a medical urgency score and a proximity score would need to be assessed with simulations performed to ensure best use of donor lungs that results in acceptable post-transplant outcomes.

With regard to vulnerable populations, children and others, regardless of which framework is chosen, modeling within each organ for the effect on equity and access to organs for children and other vulnerable populations will need to be carefully analyzed for unintended consequences. The Society supports maintaining pediatric priority within the allocation policy and would like to emphasize the need to proactively assess the impact of new allocation policies on children.

The development and implementation of a new distribution framework will necessitate tremendous resources both nationally, within the OPTN/UNOS, as well as institutionally. We believe it is essential to emphasize the cost impact to programs with any changes made. If programs are going to have increase air travel (seems illogical with equally ill patients) this may result in greater cost (2 OPO fees, plane, fuel, surgeon's absence from program more) and greater risk (potential for ischemic times longer, jeopardized post-transplant outcomes). Such challenges could force programs to close or restrict who they transplant which will decrease access to transplant for patients and essentially subvert the Final Rule.

When broader distribution is considered for all organs, any policy needs to take into account the impact on utilization of marginal, life-saving donor organs. Broader sharing of higher risk organs with longer cold ischemic times may lead to higher organ discard rate. For example, with the broader sharing of kidneys with KDPI > 85% from local to regional sharing in the newly implemented kidney allocation system, organ discard rates increased. Marginal organs are less likely to be accepted and transplanted when cold ischemic times are prolonged due to longer travel distances. These factors need to be considered when deciding which deceased donor organs should be offered over a broader distribution area.

An important caveat to the development of any new organ distribution policy is the need for assurance that the new allocation algorithm will not hinder access to transplantation services for patients from less populous areas, especially where candidates lack the financial means to relocate. For instance, it is possible that some smaller centers may not be able to afford the initial investments in the most advanced technologies; however, these possibilities depend heavily on how allocation capabilities and costs change as technology changes, as well as on how the lines are drawn upon the elimination of the DSAs as a factor in allocation.

Advances in preservation technologies will likely play an important role in maximizing the potential of any chosen distribution framework.

Finally, justification for a common model across all organ allocation policies has not been made sufficiently clear.  It could be argued that common allocation policies might be unnecessary, and indeed counterproductive. The Society supports the current UNOS organ specific committee work which is modeling the effects of the proposed frameworks on individual organ allocation and encourage the OPTN to remain open to potentially disparate allocation frameworks if it is felt by the organ specific committees that a single framework across all organs is not optimal.

American Nephrology Nurses Association (ANNA) | 10/01/2018 

ANNA supports Continuous Framework.

NATCO | 10/01/2018 

NATCO believes that Framework 3, the Continuous Distribution Model, addresses three important factors that must be considered in organ allocation: equitability, consistency, and transparency.  The Continuous Distribution Framework attempts to balance medical urgency, compatibility, and geographic distance, and incorporates variability in specific factors to account for differences between organs. This model does not limit allocation based on a fixed boundary, which has been a restrictive factor in previous organ distribution models. It is a model that could be utilized for all solid organs because it allows for organ specific variation in determining the suitability score. We recognize that it may not be completely suitable as a framework for VCA. It allows for organs to be best matched with their candidate based on multiple organ-specific clinical factors that are proven to result in better outcomes. Optimizing the best match between organ and recipient increases the likelihood of long-term graft survival. We believe it is imperative to uniquely consider the pediatric population to assure that this framework will provide a fair and equitable system for this patient population. With no fixed boundaries there will need to be an assessment of impact on CIT, transportation, staffing and costs. Determining how to best allocate a limited resource is very challenging, and we fully support and commend the Ad Hoc Geography Committee's commitment to improve this process with the goal of optimizing equitable access to organs and increasing the number of organs transplanted.

Anonymous | 10/01/2018 

Though this may be challenging to explain to patients seems to be the most consistent with the Final Rule

OPTN/UNOS Minority Affairs Committee | 10/01/2018 

The Minority Affairs Committee reviewed the Geographic Frameworks proposal during their September 17th in-person meeting in Chicago. One member noted that although organs are considered a national resource, messaging and education often focuses on local donation, so there could be an opportunity for better alignment with education and messaging efforts. There was some concern expressed about the impact on small volume and rural programs with broader sharing. It is likely that changes to geographic allocation may create new vulnerable populations as well as impact currently vulnerable populations. Therefore, organ-specific committees should be aware of these potential unintended consequences while they work to develop new allocation policies.

Region 9 | 10/01/2018

The Region 9 vote was as follows:

9 fixed distance, 3 mathematically optimized boundaries, 10 continuous distribution

Members commented that it is important that committees make sure that any framework that is chosen is appropriate for each organ.  There was concern about how any framework that incorporates medical urgency would apply to kidney allocation since there is no medical urgency for kidney candidates.   There was a recommendation to make sure the committees understand what the community wants the system to accomplish prior to moving forward with any changes.  One member commented that UNOS should approach changes to distribution in an integrated manner rather than making a sweeping change.  There was also a comment that while these frameworks may help with inequities on the waiting list, there still needs to be a solution for differences in the biology of candidates on the waitlist (e.g. ABO).   There was concern that it is difficult to predict the outcome of the frameworks due to changes in behavior that follow changes in allocation policies.

American Society of Transplant Surgeons | 10/2/2018 

The American Society of Transplant Surgeons (ASTS) applauds the efforts of the OPTN/UNOS Ad Hoc Geography Committee in creating new guiding principles and models by which organ allocation may ultimately be determined. ASTS supports four fundamental aspects of these various proposals: 1) there can be no fixed geographic boundaries 2) the framework should take into account numerous components and be able to apply them in an organ specific manner, 3) the criteria that define the actual model must be simple and objective to best achieve transparency and garner public trust, and 4) that cost and logistical considerations be applied.

Mark Russo | 10/2/2018 

I am concerned the proposals will have a negative impact on vulnerable rural populations that do not have the same access to medical centers as metropolitan populations. Smaller volume liver transplant centers may close leaving rural populations who do not have the means to travel to larger cities with transplant centers The consequence will be an increase in mortality of poorer, socioeconomically disadvantaged rural patients with chronic liver disease. The increase in mortality may not be captured and appreciated because these patients will not reach medical care. Second, we should first address MELD inflation by standardizing MELD exception.  Perhaps the perceived disparity in MELD score is just that perceived and not a reality. Why not implement the national review board for MELD exception first and see how that impacts wait list mortality. Lastly, OPO performance must be addressed. While I agree with broader sharing, changes in policy should not be driven by politics, legal pressure or disadvantage rural populations.

The American Society for Histocompatibility and Immunogenetics (ASHI) | 10/2/2018 

The American Society for Histocompatibility and Immunogenetics (ASHI) strongly supports the discussions in changing the allocation frameworks. However, ASHI understands that this is going to be a fundamental change in the way that OPTN/UNOS handles allocation across geographic regions and will likely be controversial for all of the various organ-specific allocation systems. It may be that a hybrid system blending fixed distances, mathematically-optimized boundaries and continuous distribution will come to fruition for each of the organ allocation systems when individual differences of each specific patient population are taken into account.
ASHI also strongly suggests that UNOS carefully assess the impact of changes in allocation on the histocompatibility testing process. For example, with much broader sharing, the role of virtual crossmatching may increase.

Zakiyah Kadry | 10/2/2018 

I disagree with all 3 proposals by the committee and I find it disappointing that in order to submit a public comment we are being required to choose one of the 3 proposals without being given a fourth opt out choice. Wider distribution proposals are being pushed forward based on the argument that the Final Rule requires that organ allocation shall not be based on the candidate's place of listing or place of residence. However the final rule also states that there should be best use of donated organs, that patient access to transplantation be promoted and that the allocation system should allow efficient management of organ placement.

OPTN appears to be ignoring these additional legal requirements for the following reasons:
a. Current allocation policies are based on prioritization of the sickest first. Those that are on the top of the list form the primary recipient with back up of the next higher MELD cases. These new wider distribution allocation policies allow the primary choice for the sickest recipient but the distances involved with the wider geographic areas will not allow the next sickest back up patients access to the organ should the primary recipient have a problem given the limitations of cold ischemia time. As a result, these sick patients will not have access to the organs they are back up for and the liver will instead become an open offer to allow its speedy utilization out of the allocation sequence. This defeats the purpose of back up listing of patients and could allow gaming of the system.

b. Densely populated urban areas such as New York have multiple transplant centers with large waiting lists, and given their low organ donation rates, they have had a strong reliance on MELD exceptions. These patients have ease of access to excellent health care, and with the new allocation proposals organs will preferentially go to these densely populated urban areas effectively reducing the access to liver organs for lower socio-economic sick patients from rural areas of the country. Wait list death rates in New York are significantly lower compared to other areas of the country and yet organs will be preferentially sent to New York given its dense patient population numbers.

c. Efficient management of organ allocation as required by the final rule is not being met as there appears to be a gross underestimation of the rising costs of transplantation based on the travel imposed by the wider geographic distribution. Finally, this concept of wider sharing has been pushed by areas of the country where donation rates are not sufficient to meet demands. OPO performance is unfortunately highly variable in different geographic areas. This geographic variance in organ donation needs to be addressed first: optimal OPO performance and improvement in donation rates needs to be looked at, and should NOT be separated as a different issue to allocation by either the geographic committee and/or the liver committee. New York's OPO is being threatened with closure for poor performance and yet millions of dollars have been invested on a law suit to allow access to organs outside New York rather than invest in improving organ donation rates and OPO performance in New York. UNOS needs to examine this problem of variations in OPO performance and organ donation rates in conjunction with liver distribution, and not separately. Geographic disparity in liver organ donation rates needs to be addressed first, followed by well thought out organ allocation policies. The two are integral to each other. Additionally there have been expressed concerns that areas where organ donation rates have been typically high will face a negative public perception with a reduction in organ donors as local patients see a reduced access to transplantation due to organs being sent out to wider distribution areas and in particular to areas of the country where organ donation rates are low.

Region 11 | 10/2/2018 

Region 11 Vote: 3 fixed distance, 0 mathematically optimized boundaries, 3 continuous distribution, 19 leave the choice of the framework to each organ-specific committee

Region 11 members were mixed in their support of the proposed geography frameworks. Members believe that the geography committee lacks a balance in viewpoints/perspectives from parts of the country that are in opposition to broader distribution. They do not believe that their concerns will be considered and this is creating mistrust in the system.

There was some acknowledgement from members that the current DSA model needs to be changed, however, members felt that the framework and allocation policies should be compliant with all aspects of the Final Rule, such as reducing inequities resulting from socioeconomic status. Members noted that they are concerned about the rural and underserved populations in region 11, for example, those patients in the Appalachian mountains. Members feel that they have a moral and ethical obligation to help these patients, but do not feel like their voice is being heard. Concern was also shared that donor families in poverty in the rural areas would be prevented from having a connection to recipients if more organs were shipped out of the area.

It was noted that access to healthcare impacts the size of the waiting lists which they believe will mean more organs going to the northeast where there is a greater access to healthcare.  Members expressed disappointment and concern that there was no reference to this included in the OPTN’s adoption of principles of geographic organ distribution.

Members are concerned that the concentric circles model does not adjust for coastal cities.  There was some support expressed for the continuous distribution model.  However, it was noted that costs and outcomes need to be addressed in any final allocation policies.  Although a few attendees pointed out that the frameworks can be tailored by each organ-specific committee, most members felt that choosing a framework without the details or data to support this choice was putting the cart before the horse.  Therefore, the region requested that they add a fourth option to leave the choice of the framework to each organ-specific committee. 

Anonymous | 10/3/2018 

concerns are that redistribution will  negatively impact rural socioeconomically disadvantaged populations  be costly without changing mortality

Elizabeth Rubinstein | 10/3/2018 

After attending both in person presentations, webinar discussions, online discussion forums, and as a regional representative serving the OPTN PAC, the most logical framework for organ distribution from a patient perspective is the continuous distribution framework. It provides the best of both the fixed and mathematical concepts, abides by the Final Rule section 121.8 #8 of which there has been concern and legal challenge. In theory, the continuous distribution model would allow for nimble and timely improvements and take into consideration numerous factors in organ distribution. But there is no true 100% solution and there will be disagreement from different camps of various affiliate interests. This is not easy and it does not happen overnight nor under outside pressures forcing the OPTN hand. This is a step by step process that needs to be carefully thought out, tested, and carefully implemented. The number one interest we should all be concerned with is that of the public in providing safe, equitable transplantation options and establishing trust in the process to honor all aspects of the organ transplant process fairly. We must remember that we have been entrusted with honoring and respecting the gift of life provided by our revered organ donors and the families who represent them as proxies to enable the full potential of every gift. I am in full agreement with the OPTN/UNOS Patient Affairs Committee 9/26/2018 posting to the public comment section of this proposal. Our discussions were robust, respectful, educational, probing, and innovative but with patient/family/donor interests as our highest priority. As to the topic of OPTN charging organ specific committees to work on providing distribution model solutions while concurrently having the geography committee provide three conclusive distribution model options, this seems to be very counterproductive in achieving a cohesive solution that all may be able to work towards. This broadcasts a very confused message to the general public of which we are trying to secure trust in the OPTN/UNOS system of policy development and implementation. When we have on public view committees charged with an assignment that sends each into different directions without having the benefit of a possible community solution, the public perceives an element of chaos which undermines any element of goodwill and trust in the system. Again, this observation is from a patient perspective and if one patient or donor family observes this, there are many more who have not expressed their voice in this process who harbor observations in the same vein of thought.

Lon Eskind | 10/3/2018 

I voted for 'continuous' to be able to leave a comment, but my vote is NONE OF THE ABOVE. I recognize that UNOS is attempting to set a Mission Statement with regard to organ distribution, however, as an organ donor and Transplant Surgeon, its my opinion that these 3 options miss the mark. The reasons are clearly delineated in the dissent already addressed by other comments before mine.  Any proposal that would cause even one less transplant to occur in the US is disgraceful and I'm embarrassed for us. If your loved one died because of that one graft not placed, you would be livid. I will not support any proposal that INCREASES flying of organs and transplant teams- a perfect example of how UNOS' Geography committee missed the mark.  It's ironic that the members of the Geography committee don't represent each geographical region in our country equally.  Transplantation isn't a one size fits all field of medicine. We are scientists, but there is very little science going on here.   I support a studying a State Based Organ Allocation System, again for all the reasons previously mentioned in comments before mine. UNOS needs to slow down- this is a great opportunity for the Transplant Community to finally get things right.

Cystic Fibrosis Foundation (CFF) | 10/3/2018 

On behalf of the Cystic Fibrosis Foundation (CFF), we write in response to the OPTN/UNOS Public Comment Proposal, Frameworks for Organ Distribution.

Cystic fibrosis (CF) is a rare genetic disease that affects over 30,000 people in the United States. Over 250 people with CF received transplants in 2017, the majority of which were lung transplants. However, some people with CF also may require liver or kidney transplants due to the disease.

As we have previously stated, we ask that UNOS and all transplant providers remain focused on what matters most: the people on the waitlist. They deserve an allocation scheme that aspires to reduce waitlist mortality to zero, transplants the most medically urgent, minimizes the risk of post-transplant complications, and does so in a resource efficient manner.

Determining an appropriate geographic framework that minimizes the impact of arbitrary barriers while maintaining donor organ viability and reasonable resource use is critical to ensuring an equitable allocation policy. We offer a number of issues below for UNOS to consider as it continues to assess geographic frameworks appropriate for all organ types.

Overall, we believe if these concerns are addressed thoughtfully, UNOS' proposed continuous distribution framework will best address appropriate use of geographic consideration in organ allocation while honoring the intent of the OPTN Final Rule.

Benefits of Selecting the Continuous Distribution Framework:  The continuous distribution framework appears to be the best candidate for eliminating the use of arbitrary boundaries in determining appropriate recipients for available organs. This framework has the best potential to balance the use of proximity with medical urgency in order to minimize the role of geography in determining transplant recipients. It is critical that this model be built to account for the fact that transport time plays a role in the viability of the donor organ and the safety of the transplant procedure.    A strong reason for our preference for the continuous distribution framework is that among the proposed models, it is the most flexible option. In looking for a geographic framework that can be used across organ types, it is important to identify a framework nimble enough to accommodate special considerations for different organ types such as different medical urgency scoring systems, factors like cold ischemic time, and the need for modifications to the framework as technology or patient populations change over time. The continuous distribution framework can be adjusted by changing the factors included in the allocation assessment as well as the weighting of those factors.

Assessing Factors Used in the Continuous Distribution Framework:  The design details of the adopted geographic framework are incredibly important, especially in the continuous distribution framework where the inappropriate weighting of factors may adversely impact donor organ allocations and recipient outcomes. Robust modeling is required to fully evaluate how allocation outcomes may change and whether those changes reflect overall improvements to the system.

Measuring proximity between donor and recipient:  UNOS should carefully consider how it will measure proximity between donor organ and recipient. We ask that UNOS consider the benefits and feasibility of using travel time versus travel distance as a factor in the continuous distribution framework. Travel time may more accurately account for natural barriers, transportation infrastructure, population density, etc. in determining the resources and time needed to transport a donor organ to a recipient. We request that UNOS assess the feasibility and benefits of different measures of proximity as they continue to assess geographic distribution frameworks.

Considerations Regarding Clinically Similar Medical Urgency Scores and Proximity:  We applaud the Committee's consideration of the issues raised by geographic 'cliffs' in the zone model for individuals with the same medical urgency score as it is presented on page six of the proposal. This is an important equity issue that optimally will be addressed by the Committee's chosen geographic framework. However, we believe the Committee also needs to consider a related problem: addressing cases where individuals with clinically similar medical urgency scores have vastly different proximities to the donor organ.

In response to the OPTN/UNOS Public Comment Proposal, Modifications to the Distribution of Deceased Donor Lungs, we proposed the creation of a tiered allocation scoring system for transplant recipients in an effort to reduce undervaluing of geographic location. We believe it is important to ensure that organs are allocated at greater distances only when the difference in medical urgency score meets a defined minimum threshold between a local recipient and a regional recipient to utilize available organs and other resources in an efficient and equitable manner.

For example, under the current lung allocation system a patient with a lung allocation score (LAS) of 51 located 249 miles away from the donor organ would be prioritized over a patient with an LAS of 50 who is located in the same hospital as the donor. Small differences in LAS do not necessarily reflect a substantive difference in medical urgency between patients. An equitable allocation system should strive to reduce discard rates and resource use in cases such as the example mentioned above.

Conclusion: We believe the continuous distribution framework has the potential to best address the need to appropriately weigh geographic considerations in organ allocation. This framework is consistent with the OPTN's Final Rule, which requires the implementation of policies that prioritize medically urgent cases over as broad a geographic area as feasible. It can achieve this goal by weighing geographic location in balance with medical urgency without using arbitrary borders to determine a patient's location. However, we believe further assessment of the continuous distribution framework is needed.

We are happy to serve as a resource and look forward to working alongside OPTN/UNOS in the future on this issue.

OPTN/UNOS Pancreas Transplantation Committee | 10/3/2018 

The Pancreas Committee reviewed the Geographic Frameworks on a September 19th call. The Committee found the background on the history of the DSA and region helpful to contextualize the geographic changes. The Committee discussed the need for a framework that can be adjustable to avoid disadvantaging certain candidates and making sure disease severity is not over inflated. A Committee member asked a question about how local back up for non-mandatory shares could change if DSA is removed. Another Committee member expressed concern about the potential impact of changing geographic allocation for small volume programs compared to larger volume programs. There was also a comment that it may be difficult to implement continuous distribution for the pancreas allocation system because of challenges in defining medical urgency and donor matching. For the fixed distances model, there could be some concentric circles with no pancreas transplant programs and some with several large volume pancreas programs. Looking at where patients are waiting on the list may be helpful in considering changes to allocation. 

Anonymous | 10/3/2018 

My concern with proposed changes to the framework for organ distribution is how this will affect patients in our region.  We are a rural/suburban region incorporating 17 plus counties.  Patients in our rural area face numerous disparities in health care, education, upward mobility, job training, etc.    As you know, patients with Hep C face numerous barriers to access care even when diagnosed with Hepatitis C.   Even those who access care face barriers for treatment of Hep C.   The same barriers apply to patients with cirrhosis.  Those patients with cirrhosis who do manage to make it to a transplant program will then face another barrier if organs are redistributed to other areas.   It is vital to the health of our patients that organs remain local.  Changes to the framework for organ distribution, whether a fixed model or mathematically optimized or a continuous mode will have a negative impact on our rural patient population.  By trying to adjust the model to help others in urban areas (where there are larger patient populations, several transplant programs), you will by default have a negative impact on those in rural areas.  The focus needs to be improving the procurement rates at other OPO's in the urban areas.

Ryan Geisler | 10/3/2018 

I am posting a comment on behalf of UW Health - University of Wisconsin.   

The UW Health transplant center does not approve of any of the three models as written. We understand the necessity of optimizing organ distribution and applaud the committee for their time and efforts to put together these models, however we feel that without further data, modeling, and clearer projected outcomes for each of the models we cannot hold a vote at this time.

There are many concerns with these models that are not addressed due to a lack of data and modeling. These include: disparities among rural, underserved, and socioeconomically challenged regions and their ability to receive organs; how the pediatric population will be impacted by these models; the rewarding of weak or low-performing OPOs without addressing their deficiencies; the effect on marginal organs and their discard rates; and the cost involved with the potential of organs traveling further than before.   

We feel that the proposal of these models and the voting for them should also be clearer to the community. The models above are to serve as a 'framework' for organ distribution. Does that mean that, if one of the models is approved, this will be the new distribution model that each organ committee must formulate for an organ distribution policy, or is it intended to serve as a suggestion? Centers should be more informed of the exact implications should a framework be approved.

Jorge Reyes | 10/03/2018 

I have checked off the Continuous proposal option only so that I can be 'allowed' to submit a comment.  Sadly, this process is very reflective of our Region 6 meeting where the option to 'abstain' from any proposal was removed the night prior to our meeting; we insisted it be added back on.  Also, we were expressly forbidden by UNOS staff to discuss the 'State first' model for organ distribution to replace the DSA model; we discussed it anyway.  These actions are being taken under the umbrella of the Geography Committee which does not reflect a balanced representation of theTransplant community in the U.S., yet it is on the verge of changing the paradigm of organ distribution in the U.S..  My opinion of their work is as follows:  -These 3 proposals have not been modeled, but clearly will shift a massive # of organs to 3 'geographic' areas (New York, New England, and California).  -These organs will leave socioeconomic disadvantaged areas, increasing mortality in these areas.  -These proposals continue to focus only on allocation MELD, minimizing the impact on waitlist mortality, the impact on pediatric transplantation, the logistical burden of travel cost.  -Clearly having the focus on allocation MELD  hides the fact that the centers at most to benefit from this hold on to the MELD by Exception algorithm (overused in the areas most to benefit), given that it is clear that the laboratory MELD is the only # that will truly reflect the benefit of life or death with transplant for our patients.  -The emphasis to hide this fact is what has prompted the push to a National Liver Review Board (a noble effort nonetheless), but yet untested in terms of clinical accuracy and fairness.  I urge UNOS to be inconclusive of the community which has sent so many strong messages with important contributions to consider in this challenge of organ distribution, the latest being the State First model.  The challenges to health care must consider the important factors of community, population, epidemiology, laws, policies, insurance, to name of few; these are the factors that help frame health care, this is Geography.

Luis Mayen | 10/3/2018 

I acknowledge the efforts of the the Ad Hoc Committee on Geography for their thoughtful work to develop three alternatives to arbitrary distribution units; all in compliance with the Final Rule. Of the these, continuous distribution stands out for its  wide support by patients, for its transparency, its ability to be easily understood, as well as the inherent agility it would provide to appropriately weigh the multitude of confounding variables that currently and do not currently exist. As described by the committee, 'this model contains all of the benefits described in the fixed distance framework' yet incorporates a flexibility necessary to provide a uniform framework for all organ distribution schema.

Region 7 | 10/03/2018 

Region 7 Vote: 3 fixed distance, 0 mathematically optimized boundaries, 4 continuous distribution, 19 abstentions

Members are very concerned about the lack of modeling data for the three frameworks. Members believe that people support the continuous distribution model without modeling data because it appears idyllic, but people may not actually understand it. It was recommended that modeling include impact on rural versus urban populations, vulnerable populations, such as highly sensitized candidates and pediatrics, and discard rates.

Additionally, the region believes that it is inefficient for the organ specific committees to work on allocation proposals while the Geography Committee is working on identifying a single framework as the outcomes may not align. While a few members believed that selecting a framework was directional/advisory in nature, most members felt that endorsing a particular framework without modeling data would be premature.

It was also noted that the proposed frameworks may work better in theory than in practice and clinical expertise is needed to weigh in. However, clinical experts are losing their decision making ability in the current regulatory environment.

Costs are a significant concern and understanding the impact of each framework is critical.

It was noted that policies also need to address reducing inequities in socioeconomics and access to care.

One member noted that a state distribution model should be considered as it accounts for access to care, and socioeconomics and would meet the obligations of the Final Rule to promote access, efficiency, and equity.

Region 7 members overwhelmingly believed that they should decline all three frameworks due to the lack of modeling data and insisted on adding the option to abstain. They did not feel like they could make a decision without more information. Members stated that they want to send a strong message to the Board of Directors that more information and analysis is needed prior to approval of any of the proposals submitted by the Ad Hoc Geography Committee.

Region 6 | 10/3/2018 

Region 6 Vote: 0 fixed distance, 0 mathematically optimized boundaries, 22 continuous distribution, 31 abstain

Members of Region 6 had a large amount of feedback for the committee in terms of the three proposed frameworks. There was a concern that if one framework is selected, would it be a one size fits all for all organ systems. It was stated that each organ system will have the opportunity to establish an allocation system in the future that falls within the parameters of the framework selected by the Board.

One member expressed a need for the committee to consider special populations, especially pediatrics. Of the three proposed frameworks, Continuous Distribution appears to be the framework that will be most able to accommodate such special populations. There was also a question as to how current national sharing practices, like zero antigen mismatch and high CPRA sharing, will fit into the frameworks. The committee needs to take those into consideration when developing a framework.

OPO performance was also brought up as something important for the committee to consider. In areas with poor OPO performance demand outweighs supply and the areas with high OPO performance will lose organs. The frameworks should incorporate OPO performance to not disadvantage areas with high performing OPOs.

A fourth geography framework was suggested for the committee to consider, state-based distribution. The region’s greatest concern is that mortality rates will rise in a fixed distance framework. The areas of the country that stand to gain in a fixed distance framework already have low mortality rates, and that will disadvantage Region 6. In a state-based distribution system, population, state law, access to healthcare, healthcare coverage and peripheral states would be taken into consideration in developing an allocation system. Mostly, the region would like the committee to consider something other than the three proposed frameworks. Members are being forced to make a choice on frameworks that do not have modeling or data, so they opted to vote with an abstention option along with the three proposed frameworks.

Washington University Medical Campus in St. Louis, Missouri  | 10/3/2018 

We are writing on behalf of the institutions that comprise the Washington University Medical Campus in St. Louis, Missouri – Barnes-Jewish Hospital, St. Louis Children’s Hospital and the Washington University School of Medicine – to express our concerns with the proposal “Frameworks for Organ Distribution” as issued by the Ad Hoc Geography Committee on August 3, 2018. The United Network for Organ Sharing (UNOS) has an important obligation to ensure fair and equitable allocation of organs, and we appreciate the work done so far by the members of the Ad Hoc Geography Committee.

Given that the purpose of the public comment is to build consensus around a particular framework, it is troubling that according to the proposal, of the three frameworks recommended, two have never been used in organ distribution and one has never been modeled. This makes it very difficult to intelligently choose among the frameworks and anticipate unintended consequences that could arise. Without explicitly modeling example allocation scenarios for each framework, it is difficult to be able to provide the requested information about both the immediate and long-term budgetary impact of resources that may be required by the distribution frameworks.

This proposal does not provide the information necessary for stakeholders to adequately evaluate the frameworks recommended – especially for the purpose of building a consensus around a framework that will be used by the OPTN and its organ specific committees to create new distribution policies. Since the Geography Committee was “ad hoc,” and selected by the UNOS President, there has been concern that the committee is not representative of the views of the broad transplant community. This situation has (and will) affect broader acceptance of committee recommendations.

The Ad Hoc Geography Committee should be allowed to continue its work and model example allocation scenarios to enable a better evaluation of proposals brought forward to stakeholders. These example scenarios should also better address how these frameworks could impact meeting other parts of the final rule, including socioeconomic inequities.

A more comprehensive examination of the proposed frameworks, and potentially others brought to the attention of UNOS during this comment process, should help the transplant community to better find the framework that that will be in the best interest of patients, no matter which part of the country they seek care.

We urge UNOS to allow the Ad Hoc Geography Committee to do the more in depth modeling of example scenarios before constraining the community and organ-specific committees to a policy development path that may create adverse unintended barriers or consequences. UNOS should allow the committee to continue its work, taking a broader view to seek solutions that will have a positive impact on procurement, allocation, and outcomes.

We stand ready to support this important work.

Sincerely,
John P. Lynch, M.D.
Vice President, Chief Medical Officer and Chief Operating Officer
Barnes-Jewish Hospital

Paul J. Scheel Jr., MD, MBA
Associate Vice Chancellor for Medical Affairs
CEO, Washington University Physicians

Donor Network West | 10/3/2018 

Donor Network West supports fair and equitable access to donated organs and applauds the UNOS geography committee for addressing this issue by proposing frameworks to align organ distribution with the Final Rule. The Continuous framework (proposal 3) is the best way forward in that it removes fixed geographical boundaries and allows for consideration of multiple factors including urgency, geography, and matching. As an OPO with a large experience in pediatric donation and a close relationship with several large pediatric transplant centers, we also advocate that the committee take into account the expected post-transplant survival, unique needs of pediatric candidates, and special considerations regarding pediatric donors and recipients into the model. It is our understanding that proposals 1 and 2 rely on a fixed circle from the hospital where the donor died. In our area, many organ donor recoveries do not occur at the hospital where the donor died rather at recovery centers as far as 260nm away. As a large and busy OPO, we are concerned with logistics of organ distribution including transit time, safety, and traffic. We acknowledge that broader distribution of organs will come with challenges in back up offers and ensuring utilization for possible late declines, and foresee strategic changes in the OPO community to ensure that we remain excellent stewards of the gift.

One Legacy | 10/3/2018 

On behalf of OneLegacy, our comment supports the Continuous Distribution Framework proposal. We feel the flexibility inherent to the proposal will meet the legal needs related to the challenges to allocation, by eliminating allocation borders. The proposal allows for medically sound judgement to be utilized to build the weighting algorithms related to the 3 sections of the allocation score, Distance from Donor Hospital, Medical Urgency and Close Biological match.   

We submit that the committees contributing to the Distance from Donor Hospital discussions to not use a one-size fits all approach. Fixed distances from Donor Hospitals across the nation do not equate to equal access to organs in all parts of the country.

Swedish Liver Transplant | 10/3/2018 

Swedish Liver Transplant supports the Region 6 response, which favors a mathematically optimized or continuous approach. Within any framework, this center prefers prioritizing medical need of recipient over geographic distance from donor.

Joseph Roth | 10/3/2018 

I support the AOPO position on this proposal. 

Andrew Scanga | 10/3/2018 

I do not support any of these proposals but have checked one of the circles in order to place a comment. The issue here is that all of these proposals violate Final Rule 121.4 and 121.8 in moving organs from areas of socioeconomic disadvantage to areas of socioeconomic advantage, increasing logistical complexity, increasing waste, and increasing cost. Any allocation system must recognize and respond to these clear mandates and not political and legal pressure being exerted by attorneys representing wealthy hospital interests. The framework therefore must include explicit recognition and consideration of these socioeconomic realities. How can it be justified that in all iterations of these frameworks South Carolina, with a high waiting list mortality, low capture of patients on the waiting list, and severe socioeconomic disadvantage, loses significant amounts of organs whereas New York, with low waiting list mortality, high capture of patients on the waiting list, and socioeconomic advantage, gains large numbers of organs. There is no reasonable person who could think this is fair or consistent with the final rule. It is also relevant that the membership of the geography committee was not determined in a transparent or democratic fashion which has biased the recommendations.

Society for Transplant Social Workers (STSW) | 10/3/2018 

The Society for Transplant Social Workers (STSW) appreciates the Ad Hoc Geography Committee's hard work on framework proposals for organ distribution. STSW supports the selection of a standard distribution model across organ groups. We further support the continuous distribution model because it strikes the best balance between medical urgency and proximity, without the use of arbitrary boundaries. Fairness should trump simplicity. The continuous distribution model will certainly be harder to implement and explain than the fixed-distance model, but its benefits to the sickest patients should be clear.

OPTN/UNOS Transplant Coordinator Committee | 10/3/2018 

The OPTN/UNOS Transplant Coordinator Committee thanks the Ad Hoc Geography Committee for the opportunity to comment on various geographic distribution frameworks to inform future allocation policy more consistent with the OPTN Final Rule.

 There was consensus around support for the continuous distribution model. The TCC felt is seemed to be the most in alignment with the demands and requirements of the Final Rule, and that it has the most potential to work for all organ groups. The medical priority and proximity scores will need to be developed from the clinical characteristics for each organ type.  These characteristics can be more easily adjusted or weighted differently as the model is reviewed and not alter the entire distribution process. However, there needs to be consideration for donor families and efficiency; there cannot be major time delays that may impact a donor family’s decision to donate. 

The TCC expressed concern about disadvantaging candidates who lack resources (whether monetary, insurance, or location) and smaller programs being forced to close due to increasing costs of organ allocation and other factors that may not impact larger programs in the same fashion. In addition, they advised that following outcomes is going to be critical in evaluating any framework, as one of the overarching goals is to transplant the most medically urgent patients first. One member advised that modifying organ distribution systems, without consideration for fiscal impact, will have negative implications for transplant program bottom lines, especially if insurance providers don’t also make adjustments.

The following questions were asked and answered to the satisfaction of the Committee:
Q: Isn’t the fixed distance framework still dependent on geography? How does that pass muster legally?
A: This model was deemed to be more consistent with the Final Rule than DSA or region, but may not be the most consistent. It is the model that was determined to be easily implementable within the stringent timeframe mandated by HRSA.

Q: For the continuous distribution model, is the medical urgency score weighted, compared to the other two variables?
A: It is too be determined how the variables would be weighted.

Q: Is waiting time being considered with any of these models?
A: It has not been determined whether waiting time will be incorporated in any of the models, or play a role beyond what it currently plays. That decision may be organ specific.

Q: How does this proposal dovetail with the work the organ-specific committees are currently undertaking? If the community feels that continuous distribution is the best model, how does that impact the other proposals?
A: Based on the aggressive timeline for the organ-specific committees to modify their distribution systems, the fixed distance model was deemed to be most feasible. The framework that receives the most support may be considered a more ideal “future state”.

Q: With organ acquisition costs increasing, along with travel and logistics expenses, occurring in the middle of a budget cycle, transplant programs are having to make cuts. How is fiscal impact to transplant programs being considered?
A: Cost and efficiency align with one of the organ distribution principles (that in turn align with the Final Rule) approved by the Board of Directors in June 2018. That being said, it has been extremely challenging to source transplant center financial data to support limiting geographic distribution for financial reasons. The OPTN Operations and Safety Committee in conducting an industry questionnaire to get at some of the data the OPTN does not collect, but it is obviously limited to the current distribution systems. A Committee member advised ASTS and ASTS may also be looking into this.

Q: Will the distances of the circles vary depending on where the donor is, i.e. Alaska, Hawaii, and Puerto Rico?
A: No, but the non-contiguous states are a special circumstance. The Geography Committee discussed these outliers and determined not to make a change at this time.

Q: What about OPO’s who use organ recovery centers? Will the circle originate at that location?
A: No, circles originate at the donor hospital.

Raymond Lynch | 10/3/2018 

This comment is submitted via email, as I do not support any of the three frameworks.

The events of the last ten months have served to illustrate the real driver of this debate: unacknowledged conflicts of interest within the community that render key persons unable to impartially perform their duties. These frameworks are the ‘answer’ to a manufactured crisis. No one should have any illusions that the sterile descriptions of mathematically pure algorithms and shapes are anything other than a pretext for a veritable land-grab over organs.

I will not belabor the points from both sides in this debate. Suffice to say that in every example of a framework model yet produced, there are substantial increases in travel cost and risk, with the same or fewer transplants performed. In the liver modeling, organs consistently leave areas with the highest population and waitlist mortality, and move to areas with fewer medically and social underserved persons. In defense of these irrational policies, we have heard once-respected community members utter nonsense such as “the supply of organs has nothing to do with donation,” and that exacerbating inequities against vulnerable groups is “not included among the considerations” in crafting policy.

Wider distribution along the lines proposed by the Geography Committee is a sham. It will serve to enrich a few, including the Greater New York Hospital Association that is funding the lawsuit against UNOS and HHS, but it will impoverish and endanger many small centers through more travel for less volume. More broadly, it will cement the idea that demand in organ failure is a function of access – social, financial, and political – rather than true need.

I urge the board and the community to reject the proposed frameworks because of their conflicted origins, arbitrary basis, and unrestricted scope. Instead, we should embrace the most consistent and non-arbitrary unit in American geography: state borders. If you don’t believe me, try asking the US Senator from the 250 nautical mile circle around Chicago, or the US Representative from the Neighborhood of Portland, or the Governor of the Continuous Scale extending from Boston. These positions obviously don’t exist, but the residents of all these areas do have administrative systems to serve their needs -- all built on the concept of the state. Social and economic disparities, and the policies to address them, align well with states and their governments. From a transplant perspective, the laws and organizations pertaining to donation have strong state links, and local accountability for organ availability incentivises collaboration between OPOs, community hospitals, and transplant centers. Beyond this, a system built on state networks can be as broad or narrow as needed depending on organ-specific considerations, while retaining fidelity to in-state needs and disparities. From the viewpoint of medical utility, system efficiency, and social justice, it has distinct advantages over the nebulous alternatives offered by the Geography Committee.

We have much to be proud of in transplant, but the same successes in scientific discovery and clinical care also hold us to a high standard. Donors, recipients, and the community at large all have a right to expect us to act in good faith. If we decide to forfeit our obligations to sound medical judgment, best use of organs, and reduction of socioeconomic inequities – all of which are spelled out in the Final Rule and in basic medical ethics – we should be prepared to accept harsh judgment. Pretending to be forced into a bad, self-serving policy makes us unworthy of the trust of patients and the legacy of donors. We should and can do better.

Shehzad Rehman | 10/3/2018 

I am commenting via email as I do not have the information necessary to support one of the three presented frameworks.

While I appreciate the need for compliance with the Final Rule, any proposed changes to the current allocation system can not and should not be rushed. Out of the currently proposed models, only fixed distribution has been modeled for liver transplantation. Continuous distribution, which seems to be the model most widely supported in Regional Committee meetings and the model that the ad hoc committee is most enthused about, has not been modeled at all. As a result, we are asked to vote on proposed ways of allocating organs without any idea on what the actual distribution system will be outside broad strokes. Neither the specific needs of each organ community, nor the financial impact of potentially transporting more organs across broader distances have been incorporated into the modeling.

The ad hoc committee is to be commended for their work but before committing to such a broad-based overhaul of the current allocation paradigm, further study and modeling need to be done and presented to the community. 

I would also like to endorse the comments made on behalf of the American Society of Transplantation above, as they expand on my thoughts in much more detail.

Derek Dubay | 10/3/2018 

I do not support any of these proposals and thus am submitting my public comment via email since the on line process does not allow for a “none of the above” option.

Let me first acknowledge my great disappointment in the biased process by which this committee was created by UNOS. I have privately and publically appealed to members of UNOS leadership for representation by liver transplant physicians who have reservations about allocation changes, to counterbalance the heavily weighted outspoken proponents of broader organ allocation. To be clear, I am not opposed to any persons currently on this geographic committee, but I am vehemently opposed to the fact that the committee composition is not representative of both sides of this debate. I believe this unbalanced representation has lead the geography committee to ignore portions of the Final Rule that are important to organ failure patients of low socioeconomic status and from rural geographies.

The first guiding principle of the geographic committee is to “reduce inherent differences in the ratio of donor supply and demand across the country”.  At what point do communities, transplant centers and OPOs bear responsibility for improving local organ donation (i.e. supply)? The party line is that organ donation rates do not drive geographic disparities in transplantation. All modeling data demonstrates this claim to be patently false and all 3 geographic proposals will continue to reward poorly performing OPOs with donor organs from highly performing OPOs. Interestingly, the OPOs and transplant centers that stand to benefit the most from changes in allocation are well represented on the geography committee.

The proposals only consider patients on the transplant waitlist (i.e. demand). Studies have clearly demonstrated, however, that there is up to an 8-fold difference between states in the probability of organ failure patients gaining access to the transplant waitlist. Highly urban states that adopted Medicaid expansion have the highest probably of access to a transplant waiting list whereas less populated, rural, and poor states have the lowest probably of access to the transplant waiting list. How are these proposals impacting demand if small volume transplant programs that serve a large rural geography close? I am curious how the general public would define (deceased donor organ) “demand”? If these 3 proposals simply equalize organ-specific allocation scores, are we as a community going to support allocation models that will result in more transplants in affluent states with better access to the transplant waitlist? I find it egregious that UNOS leadership openly states that they “cannot fix healthcare access” or “address differences in poverty” while at the same time railroad though allocation policies that will take organs from these same states they ‘cannot fix’ to remedy differences in organ allocation scores in effort to create a “fair system” that benefits affluent states. I do not think these approaches will be interpreted as fair in the court of public opinion.

There has been a grassroots effort outside of UNOS to produce a 4th alternative allocation model titled “state-based”. While not perfect, I believe it is a model that addresses the ALL mandates of the Final Rule, and a model that a much larger proportion of the transplant community would support. There are many advantages over the 3 models proposed by the geography committee. These advantages have been clearly detailed elsewhere in the public comments.

Derek DuBay, MD
Division Director, Transplant Surgery
Transplant Service Line Director
Medical University of South Carolina

National Kidney Foundation (NKF) | 10/3/2018 

The National Kidney Foundation recognizes the importance and significant difficulty that the Ad Hoc Geography Committee has to recommend a single framework that can be used across organs. Each of these frameworks have pros and cons to them. The National Kidney Foundation supports a solution that will improve equality, efficiency and transparency in organ allocation. Most recently African Americans have seen an increase in transplantation that has been attributed to the current kidney allocation policy that was updated in 2014. Any modification in organ distribution policy must enhance access to transplantation for minority populations and those with low socioeconomic status as these groups have not historically had equal access to transplants.

OPTN/UNOS Ethics Committee | 10/3/2018 

The OPTN/UNOS Ethics Committee thanks the OPTN/UNOS Ad Hoc Geography Committee for presenting on the challenging work surrounding geography and appreciates the opportunity to provide feedback.

Following a presentation by the Ad Hoc Geography Committee in August 2018, the Ethics Committee discussed equity; socioeconomic factors within broader distribution; and transitioning patients currently on the waitlist. Ethics Committee members noted that equity and access to transplant were not goals of the frameworks, but future organ-specific allocation policies should have equity as a primary goal. Committee members also encouraged both the Ad Hoc Geography Committee and organ-specific committees to consider the impact of geographic allocation changes on patients currently on the waitlist. This includes committing research to socioeconomic factors affecting patients within broader distribution.

The Ethics Committee appreciates the Ad Hoc Geography Committee’s recognition of equity as integral to successful broader distribution regardless of which allocation system is ultimately adopted. The Ethics Committee is prepared to assist the Ad Hoc Geography Committee and organ-specific committees in ensuring equity during these changes.

OPTN/UNOS Living Donor Committee | 10/3/2018 

The OPTN/UNOS Living Donor Committee (LDC) acknowledges the OPTN/UNOS Ad Hoc Geography Committee’s challenging work and associated time constraints and appreciates the opportunity to provide feedback at this stage.

The LDC’s primary interest with respect to the frameworks and any organ-specific allocation changes is to preserve the priority status in the kidney allocation system - and consequent short wait periods - currently afforded to all living donors (of any organ type). Specifically, in the very rare circumstance where living donors become kidney transplant candidates, such persons currently receive allocation points and priority for kidneys recovered within their DSA. (See Policy Sections 8.3 and 8.5.E). As such, the priority status given to living donors has resulted in appropriately short wait times for kidney transplantation.

The policy and/or legal rationale for pursuing geographic adjustments to allocation systems are important to the transplant community; but, any changes to geographic allocation should not disrupt, even inadvertently, the priority status currently given to living donors who become kidney transplant candidates.  Additionally, current living donors expect the priority status based on rules in place at the time of their donation and the transplant community should continue to honor that expectation. 

The LDC appreciates the Geography Committee’s recognition of the need to maintain living donors’ priority status in the kidney allocation system in whatever allocation system UNOS ultimately adopts. The LDC stands ready to assist the Geography Committee in ensuring this outcome.

Region 10 | 10/3/2018 

Region 10 had a lengthy and productive discussion around the proposed geography frameworks.  There is a concern for geographically unique areas, like the state of Michigan, that are surrounded by water on three sides.  They want to make sure that the committee is taking these unique areas into consideration.  It was also stated that the proposed frameworks do not take into consideration socioeconomic status.  Patients in poverty stricken areas have less access to healthcare and by broadening organ distribution those patients will be unfairly disadvantaged since they do not have the means to travel another transplant program.  By further disadvantaging that community, it has the potential to open the OPTN up to more lawsuits.  One member also commented that with broader distribution donor families would not be able to have a connection with their loved one’s organ recipient.  The region is concerned that the committee did not take into consideration special populations as the ones listed along with pediatric patients.

There was also a concern over the credentialing of OPO recovery surgeons.  As it stands now, most transplant centers have relationships with the OPOs in their area and know the recovery surgeons.  If organs are to be shared more broadly, that transplant center/recovery surgeon relationship will no longer exist.  There needs to be a defined set of credentialing for the recovery surgeons so that accepting transplant centers can trust the recovery process.  Additionally, since transplant teams will be traveling more, either by automobile or airplane, their safety needs to be considered.  The more traveling that is done, the greater possibility for accidents that could injure or kill members of the traveling transplant teams.

The region also voiced major concern over OPO performance.  They feel that the committee did not take that into consideration in any of the proposed frameworks.  Areas with high OPO performance will be disadvantaged since more of the organs recovered will be shared outside of their area, which is a disservice to the patients listed in those areas.

One member voiced a concern that the region is being forced to select a framework when there is no modeling or data available for any of the proposed frameworks.  It was suggested that the region be able to vote on the proposal with a ‘none of the above’ option.

The region supported voting on the proposal with a forth option of ‘none of the above’ frameworks:

Region 10 Vote: 3 fixed distance, 1 mathematically optimized boundaries, 11 continuous distribution, 13 none of the above

After the initial vote, the councillor asked that an additional vote be taken on the proposal as written with only the three proposed frameworks:

Region 10 Vote: 4 fixed distance, 2 mathematically optimized boundaries, 16 continuous distribution

OPTN/UNOS Thoracic Committee | 10/3/2018 

The OPTN/UNOS Thoracic Committee thanks the Ad Hoc Geography Committee for the opportunity to comment on various geographic distribution frameworks to inform future allocation policy more consistent with the OPTN Final Rule. There was some confusion regarding committing to a fixed distance model now, as part of eliminating DSA from thoracic organ distribution, versus one of the frameworks proposed. UNOS staff clarified that fixed distance was selected as it is already used in thoracic organ distribution, and thus modifying it would be relatively easy. The community was asked to provide feedback on a model that would be a more ideal way to distribute organs in a future state.

Thoracic organs are currently distributed via a fixed distance framework, so there was little discussion regarding this model. Members acknowledged a disadvantage of this framework was the hard stop at a determined geographic boundary. The Committee surmised that mathematically optimized distribution may be a more efficient way to distribute organs, in addition to being more fair and equitable. Members also agreed that this framework was more predictable, as programs would more or less still be working with the same OPOs they have a relationship with now.

There was some consensus around support for continuous distribution, but members grappled with the lack of evidence that this model would be any better than the current systems. They agreed it seemed more flexible and customizable. In addition, it appeared it would accommodate special populations well, such as pediatrics, sensitized candidates and other special disease groups. However, members commented that without any data or supporting evidence this would in fact be better, it was challenging to commit to this (or mathematically optimized) framework. It would have been helpful to provide more detail regarding the advantages and disadvantages of each framework, using an example for each organ. Members agreed it was difficult to evaluate the theoretical.

Finally, Committee members pondered whether the continuous distribution model would be feasible for heart. Heart, unlike lung, assigns medical urgency by status, not a continuous score. Would heart need-or would it be beneficial to-develop a heart allocation score first?

Phillip Williams | 10/3/2018 

This framework give each person on a transplant waiting list to have an equal opponunity to receive a transplant, subject to established medical criteria; base on the best interest of all patients waiting for transplants.

Sommer Gentry | 10/3/2018 

The OPTN is advancing these proposed geographic frameworks to meet its obligation to adopt organ allocation policies that comply with the final rule. The new frameworks are a response to several recent legal challenges to the use of DSA and region boundaries in allocation policies, and the July 31st memo from HRSA to OPTN was explicit in stating that OPTN has not and cannot justify the use of DSA and region boundaries in allocation.    DSA and region boundaries are unallowable.  Does it then follow that any allocation system that avoids these boundaries is allowable?  No!  The July 31st memo further states that 'The OPTN is required to establish ''a national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included in the list ...' and shall 'assist [OPOs] in the nationwide distribution of organs equitably among transplant patients.' 42 U.S.C. §§ 274(b)(2)(A)(ii); 274(b)(2)(D).  The OPTN contract requires that '[a]llocation policies shall be designed to achieve equitable allocation of organs among patients consistent with [42 CFR 12l .8(a)].'' What the final rule requires is more than eliminating DSA and region references.  What the final rule requires is equitable distribution of organs among transplant patients.     Under the fixed distance and continuous distribution frameworks, the devil is in the details and all of the details have been left unspecified. Fixed-distance circles that are too small, or continuous distribution rules that overweight travel distance and underweight medical priority, would sustain the current imbalances that deny organs to the patients who have highest medical priority.     The reason that the community is discussing geographic frameworks is because transplant candidates are not being treated equitably and organs are not reaching the candidates with highest medical priority. The problem is inequity, so the solution should be to intentionally design allocation systems that reduce inequity. The only framework that intentionally designs allocation systems to reduce inequity is mathematical optimization. It is also possible to design systems that would reduce inequity substantially under the other frameworks of fixed distance and continuous optimization, but this would be a byproduct of changing allocation whereas mathematical optimization centers the problem that must be solved.      Regardless of which of these three frameworks is used, the focus should be on measuring whether the proposed changes have substantially reduced geographic disparities in, say, transplant rates or medical urgency scores of transplant recipients. New policy designed under any of these frameworks could and likely will be challenged again if policy changes fail to reduce geographic disparity in access to transplants.

The Society of Thoracic Surgeons (STS) | 10/3/2018 

Background

The OPTN/UNOS Ad Hoc Geography Committee has requested feedback from the community regarding three proposed distribution frameworks, with the goal of identifying a single framework to be used for distribution of all transplant organs. The stakeholder community has been encouraged to provide rationales for preferring one specific framework of the three proposed, and to comment on both the immediate and long-term budgetary impact of resources that may be required by the distribution frameworks.

General Comments 

STS applauds efforts by the OPTN/UNOS Board of Directors to develop policies of organ allocation that adhere to principles and requirements of the Organ Procurement and Transplantation Network Final Rule (referred to as the OPTN Final Rule). More specifically, STS supports the statement by the OPTN/UNOS Board of Directors in its Principles of Geographic Distribution that “[d]eceased donor organs are a national resource to be distributed as broadly as feasible. Any geographic constraints pertaining to the principles of organ distribution must be rationally determined and consistently applied.”

The OPTN/UNOS Ad Hoc Geography Committee has proposed three potential geographic frameworks. The three frameworks outlined by the Committee include:

1. Fixed Distance from the Donor Hospital
2. Mathematically Optimized Boundaries
3. Continuous Distribution

While each framework has important advantages and disadvantages, STS would require considerably more detailed information regarding each proposed framework in order to rationally assess the associated budgetary impacts

The first geographic scheme, using a fixed distance from the donor hospital, is the easiest of the three models to implement and can be readily modified to accommodate the differing tolerances of cold ischemic time for each organ. This model has recently been adopted for donor lung allocation and will soon be implemented for donor heart allocation. Additional time is needed to assess the effects of a fixed distance model on thoracic organ allocation. The Society recognizes that, while easy to implement, a fixed distance model may unnecessarily limit the ability of high urgency waitlisted patients, who reside just beyond the defined fixed distance from the donor hospital, to gain access to donor organs.

The mathematically optimized boundaries model has the advantage of incorporating selected objectives (e.g. minimize the effect of geography) and constraints (e.g. amount of travel) into the model to define optimized districts, optimized neighborhoods, and population density bubbles. However, many versions of the model maintain fixed borders that result in waitlisted patients having different levels of access to organs, similar to the fixed distance model.

The continuous distribution model is attractive because it eliminates specific geographical boundaries and accounts for the feasibility of donor organ procurement as a function of the distance between a waitlisted patient’s residence and the donor hospital, but details of the modeling for each specific organ would need to be developed.

STS supports a geographic allocation policy that results in the fair and equitable distribution of scarce donor organs to our patients. In the course of developing that policy, the OPTN/UNOS Board of Directors should take the following guiding principles into consideration:

Consider how ill a potential recipient is, as well as that individual’s potential for a successful outcome, with the goal of maximizing cumulative years of life for both the patient who receives the transplant and those patients who remain on the waiting list. We reference the existing Model for End-Stage Liver Disease and the Lung Allocation System as examples of ensuring equitable and fair methodologies that consider the medical variables that may indicate a predicted prognosis for transplantation.

Ensure the policy is not overly burdensome or onerous to transplant centers and professionals. A policy that unduly increases the cost and burden of transplantation activities to transplant centers could have adverse consequences on patients’ access to transplant services. This is of particular concern for socioeconomically disadvantaged areas in the U.S.

Ensure the policy does not unduly increase thoracic organ ischemic times and recognize that each transplant center has a preference as to the ischemic time it will tolerate. Thoracic organ ischemic time is an important determinant of recipient survival and long-term viability of the thoracic organ. ,2

Ensure the policy does not unduly increase the need for air transport activities. Air transport activities significantly increase the expense of organ transplantation and need for additional personnel, and pose additional risk to medical personnel who participate in air transport activities.

Permit variance to address issues unique to each organ. This is of particular importance in the case of thoracic organs, where the relatively shorter durations of safe ischemic times must be considered in maintaining safe geographical limits. Newly available alternative technologies or strategies to provide organ preservation could possibly extend the period of safe ischemic time, permitting extension of geographical limits in a new geographical framework. However, these technologies, to date, remain either investigative or lack significant robust data demonstrating transplant outcomes. Additionally, these technologies significantly increase both donor acquisition cost and the need for additional transplant personnel, and have not been routinely adopted into clinical practice.

Any geographic allocation policy developed by the OPTN/UNOS Board of Directors should include steps to assess the impact of a specific geographic allocation scheme in light of the above factors.

Finally, it should be noted that beginning in mid-October of 2018, a new heart allocation policy will be put into effect. STS believes it is important to fully understand the impact of this change in heart allocation policy, as well as the recent change in donor lung allocation, prior to implementing further changes in thoracic organ allocation based upon geographic factors. It is important that data on the impact of these new polices for donor heart allocation and donor lung allocation be reviewed and appropriate data-driven changes be considered in the development of any new geographic allocation policy.

STS deems it imperative that OPT/UNOS continually engage transplant professionals and professional societies, along with all other stakeholders, in the development of a geographic allocation policy. To that end, STS looks forward to working with OPTN/UNOS in the ongoing development of a geographic allocation policy that addresses the needs and views of all stakeholders.

We appreciate the opportunity to comment on these proposals and would welcome the opportunity to serve as a resource to OPTN/UNOS as it continues its work on these important issues. Please contact Courtney Yohe, STS Director of Government Relations, at cyohe@sts.org or 202-787-1230 should you need additional information or clarification.

Sincerely,
Keith S. Naunheim, MD
President