Comments

UC San Diego Health Center for Transplantation | 03/23/2022

CASD is not opposed to a redesign of the regions with the intent of optimizing the governance and structural effectiveness of the OPTN and generally agrees that the existing regions could be resized to promote balanced boundaries and equitable representation. Absent any irrefutable evidence of derived benefit, we agree that one consistent contiguous regional design, which follows state lines as boundaries, seems a reasonable and more fiscally responsible approach than selecting specialized regional designs to manage the various functions of governance, structure, and data reporting. Specialized regions seem unnecessarily complex and would likely result in increased administrative costs. Further, retaining geographical segmentation will help ensure that stakeholders who are proximate geographically who generally share interests and have common experiences with their patient populations have a unified voice. In determining, which metrics are most appropriate for reconfiguring the existing regions, an emphasis on number of transplant hospitals and number of waitlisted candidates by (primary) transplant center seems most reasonable to ensure equity. It may be of benefit to analyze the number of transplant hospitals offering each organ transplant type within these newly proposed regions vs simply the total number of transplant hospitals. We would advise against any redesign that significantly lowers the number of regions without a simultaneous redesign of the committee and Board structure as well. We share the concerns of other commenter’s that decreasing the number of regions would presumably result in less regional representation, members on the Board and Committees (assuming one representative per region). This would likely negatively influence overall community development by reducing exposure to a broad array of valuable experience from our colleagues across the country; particularly in light of the new structure of regional meetings, which no longer seem to facilitate robust conversation around policy proposals but urge members to “share their sentiments” regarding policy proposals. Likewise, we would advise against any redesign that silos a single state to its own region to avoid limiting community building on a broader scale. While allocation is no longer a pertinent feature of the regions, if considering a system that aligns with the new distribution models, then the 4 equal regions proposed make sense for patients and transplant programs; 6 equal regions does seem to provide slightly more equity. Whether 4 or 6, again such a significant decrease in regions would require a simultaneous redesign of the committee and Board structure that the community largely agrees upon prior to passage and implementation. To address some of the themes noted in the concept paper pertaining to a perceived limitation on the ability to participate in the governance process can and should be addressed in other ways. For example implementing term limits for members who continuously rotate on and off of committees or the Board (accounting for some exceptions– for example, it’s well known that there are only a handful of intestinal transplant surgeons across the country – these individuals should not be limited in their appointments so long as there are no other reasonable candidates for consideration), creating “early career” positions for each committee similar to the structure of the AST Communities of Practice, or creating another pipeline program for members to explore participation without directly appointing them to Committees with little to no prior exposure may increase these opportunities.

Patient Affairs Committee | 03/23/2022

The Patient Affairs Committee appreciates the analysis done by the Executive Committee and the opportunity to provide comments on their request for feedback Redesign Map of OPTN Regions. The Committee has a number of considerations, as follows: 1) This is a large undertaking by the OPTN, and consequently, the improvements that stem from regional redesign should be weighed against the same effort applied to proposals that directly impact transplant candidates and recipients. 2) Rather than redesigning the map of OPTN regions, consideration should be given to changing the number of regional board seats allocated to each region, if the driving factor is representation. 3) With the upcoming allocation changes due to continuous distribution, this action may be premature if new allocation patterns arise following the implementation of continuous distribution. 4) Finally, given the success of virtual meetings, the Committee does not feel that larger regions will limit patient access to regional meetings. The Committee also provides three comments on the proposed metrics for regional evaluation. A number of members felt that regions should not exist as a single state (e.g California as an isolated region). Additionally, a Committee member felt that some regional redesigns could create regions with only “tier three” or “tier two” programs; therefore, any change in mapping should ensure adequate access to program quality across each region. Finally, the Committee agreed working relationships within Organ Procurement Organizations and transplant programs should be examined as a potential basis for regional mapping. The Committee does not support redesigning OPTN regions over the existing regional structure, at this time.

Anonymous | 03/23/2022

The OPO Committee thanks the Executive Committee for their ongoing efforts on the Regional Redesign project. Several members expressed support for establishing continuity between donor service areas and OPTN regions. A member agreed, recommending that the regions consolidate OPO DSAs, such that no DSA is split between two regions. One member noted that fewer regions could be more cost effective to administer. A member recommended the Executive Committee consider which centers and OPO work with each other most often, to encourage effective relationship building. Another member similarly noted that isolating certain states, such as Texas or California, could be detrimental to transplant center and OPO relationship building, and reduce learning opportunities between OPTN members. Several members agreed that fewer regions could challenge productivity of OPTN regional meetings, particularly if regional meeting sizes reach more than 500 members. Members expressed support for increased consideration of access and equity in the regional redesign project, particularly among disadvantaged patient populations. Members noted that this project will affect patient representation in OPTN Committees and Board of Directors. A member remarked that the regions should be representative of the demographics and interests of the patients within the regions; Kentucky, for example, is more aligned with the South or Southeast as far as patient and donor demographics than with Texas or Pennsylvania. A member noted that the proposed maps place too much emphasis on relationships between OPOs and transplant programs over the interests and demographics of the patient populations. Several members expressed concern that fewer regions could dilute the representation that each organization has on OPTN Committees and the Board of Directors. Members noted that this could particularly lead to over-representation of coastal OPTN members, and dilute the voice of OPOs and transplant programs representing more rural patient populations that cover a larger geographic area.

Anonymous | 03/23/2022

If there is a redesign, careful attention needs to be paid to where patients are coming from in relationship to their transplant centers. For example, patients in Idaho and Wyoming are often transplanted in Utah. Currently, these states are in 3 different regions.

Anonymous | 03/23/2022

The Transplant Administrators Committee thanks the OPTN Executive Committee for their review thus far regarding regional structuring and their work in developing this request for feedback. The Committee feels that any redesigning should be backed by conclusive data, as, otherwise, working relationships within existing regions may be compromised. Additionally, the Committee pointed out that, as regions grow in size (as reflected in some of the presentation examples), there could be less “close-knit” collaboration between programs. This request for feedback also comes at a time during which the Centers for Medicare and Medicaid (CMS) regulations may result in significant changes to organ procurement organization donation service areas, and any redesigning of the OPTN regions could add unintended complications.

Anonymous | 03/23/2022

Many attendees were opposed to the redesign, and provide the following comments and suggestions: If Region 6 becomes too large, it will be difficult for members to meet or share important regional information. The OPTN should consider dividing some of the larger states to increase equity, for example, divide California and Texas into two regions. Region 6 has had many innovation projects over the years. This type of regional collaboration and innovation may not be possible under the proposed redesign. If there are concerns about representation on committees, that should be determined separately from the regions. The current geographic grouping for regional meetings makes sense for Region 6 as they have similar experiences around patient population, donor procurement, etc. An attendee stated that Region 6 may not be as populated as other regions, but experiences different challenges with policies based on size and population. In addition, the redesign may result in Region 6 losing the collaboration it currently has. Two commenters were strongly opposed to the proposed changes because of the different time zones encompassed in some of the map redesigns. An attendee from Hawaii noted that despite continuous organ distribution, the state will not be realistically sharing organs with centers in the Midwest or East Coast regularly because of geography. Hawaii has different challenges that distant mainland centers can’t understand, so making a region that involves a large distance between centers does not make sense. The size of some of the proposed Region 6 redesigns would put an undue travel burden on the region’s members.

Richard Gilroy | 03/23/2022

The number of regions should remain the same and the new 11 region model allows for representation of the population demographics, in particular the characteristics of people, hospital systems, classes and academic centers within the population. Appointments should occur by a regional vote of people who nominate for particular position or are nominated by others for these positons. The electoral process needs to be independent of the existing board, UNOS and OPTN influence. At a time when trust in the process of the UNOS is low, this simple change will create trust in the UNOS organization by introducing a democratic process.

American Society of Transplantation | 03/22/2022

The American Society of Transplantation offers the following comments in response to the concept paper on redesigning the map of OPTN regions: • The AST appreciates the need to periodically review OPTN regional structure; however, we are concerned that OPTN has not sufficiently outlined the anticipated benefits and guiding principles for fair representation. Without this clarity, it is difficult to support any of the proposed maps over the current OPTN regional structure. The OPTN needs to carefully weigh the overall returns on investment of redrawing new regions. Any future proposal should provide assurances that such a shift is justified by a quantifiable benefit to patients or OPTN members. Rationale for change should include demonstrated increase to collaboration, decrease in OPTN and OPTN member cost, and improve equitable representation on the OPTN Board and Committees. • Concerns were raised about the use of metrics to equalize regions for purposes of representation such as number of transplants, candidates waiting, donors, and OPTN members without including some measure of overall population (as a proxy for patients in end stage organ failure who do not have adequate access to the waitlist). This could be perceived as under-representing areas where the ratio of these metrics to the population of patients potentially in need of transplant are lower. Feedback on the six maps provided: • As the OPTN considers potential maps, please note AST would not support the regional map models with the most significant consolidation such as 4 or 6 Regions as they would be geographically unwieldy. Because of this, it seems unlikely that regional representatives would be able to fully appreciate and “represent” the needs of their constituencies. It also could be destabilizing to make dramatic changes to the regional representation given all the significant allocation changes underway. • It would be best to keep one consistent regional design for governance, structure, and data reporting. The creation of select specialized regional designs will add complexity without value.

View attachment from American Society of Transplantation

Association of Organ Procurement Organizations | 03/22/2022

Please see attached document.

View attachment from Association of Organ Procurement Organizations

Anonymous | 03/22/2022

The Transplant Coordinators Committee thanks the OPTN Executive Committee for their analysis of regional mapping and their work on the request for feedback Redesign Map of OPTN Regions. The Committee feels that any remapping of OPTN regions should be weighed against the cost of breaking historical collaborations within regions, and at present, there is not enough data to support a redesign. At the heart of the issue is regional collaboration, and facilitating this collaboration should be a key goal of a remapping project. The Committee does endorse a further investigation into program collaboration, both within regions and across regional boundaries. Additionally, consideration should be given to balancing representation from high population density areas and rural areas, as well as the types of specialty centers (e.g thoracic, pediatric). A number of members also contributed that, as regional size grows in some of the maps, both individual voices could become dilute and travel could be a concern. However, the Committee feels that the success of virtual regional meetings indicates that representation and attendance from regional members will continue even through any redesign.

Anonymous | 03/22/2022

A few members noted that if change is to occur then the new regions should make sure to keep transplant hospitals within the same region as their affiliated OPO. There are some OPOs that cover hospitals in multiple states. Another member noted that it would be important to keep major metropolitan areas within one region, for example the Washington DC metro area extends into Virginia and Maryland. It is disruptive and confusing to patients when the health care system is split into multiple areas. Others expressed support in maintaining 11 regions with equitability measures balances. It was also noted that any change should not lose sight of the 11 board members who are elected by the regions. That representation is important to the community and should not be reduced. Another member noted that the changes in organ allocation have minimized the relevance of regions, and they would support the idea of having similar sized areas working more closely together. The strategies that can from that organization can drive improvement.

Anonymous | 03/21/2022

UNOS is waisting their time on things which are not important at the end. As it does not change the number of available kidneys. UNOS should spend their time on trying to persuade government to make a kidney donation being a default option (with the deceased family having an option to opt out) — which is a Spanish model — which works! Also non- monetary incentives (paying for funeral, free medical future medical costs, etc) to the immediate family of deceased donors for allowing organ donations. UNOS seem to wrongly conflating incentives for LIVE kidney donations vs cadaver kidney donations. Roughly 50% of potential deceased donor kidneys go to the grave with them — what a waist!! Why deceased kidney family cannot get non-monetary incentives while hospitals and the rest of medical profession including UNOS stuff getting paid over 1 million dollars for each diseased donor.organs. UNOS to me is a big bureaucratic machine which only wants to create a perception that they are trying to being helpful to the public — but refuse to address the real issues. Thank you UNOS for doing a “great job”.

Anonymous | 03/21/2022

I favor 11 regions, option B. If less than 11, I'd suggest 8, but taking into account appropriately broad representation needs to occur.

Anonymous | 03/21/2022

A member suggested the Committee consider an option that considers equity in underrepresented minority populations. The member added that currently Region 11 serves a similar community with similar demographics and that should also be a consideration. One attendee commented that the regions should be optimized for their current purposes – large enough to promote diversity of opinion, but small enough to encourage open, thorough dialogue. Another attendee expressed concern that small centers and OPOs might get lost in this redesign. A member stated support for the six region map, as it provided the most balance between population, donors, members, recipients, and transplants, with the eight region map as their second choice. An attendee commented that the redesign is needed, but that they did not support fewer than 11 regions, so that the regions can remain a manageable size that allows for more intimate meetings. One member said that due to all of the other changes occurring in transplant, they recommend not changing the regions at this time. Another member shared support for either eight or eleven regions, to try and balance the need for continuity with the need for acknowledging the new relationships allocations changes create. The member added they were not concerned about regions covering large geographic areas since programs already frequently travel long distances between donor hospitals or OPOs.

Pacific Northwest Transplant Bank | 03/21/2022

I believe the current OPTN Regions should remain intact for now. The changes in broader sharing/allocation that have happened so far are significant and we are not in a final state to fully assess the impact. Changing the OPTN Regional map right now will not allow a clean assessment of the impact of that change.

NATCO | 03/21/2022

NATCO appreciates the opportunity to evaluate the current regional model and believes that a redesign can have potential positive or negative impacts to both organ procurement organizations and transplant centers depending on the design. Reducing the number of regions and consequently increasing the areas of coverage may impact potential collaboration within the regions due to distance. The current model of 11 regions provides a substantial longstanding history of valuable collaboration. Which regional redesign map would best serve the OPTN or should the current map be maintained? Why? To promote continued collaboration, we recommend a model that retains the current 11 regions adjusted for some of the key metrics as outlined in this concept paper. Which metric(s) should the OPTN consider for reconfiguring regional boundaries? Number of transplant centers, OPOs, patients on waiting list, attendance at regional meetings Should the OPTN use one consistent regional design for governance, structure, and data reporting functions or select specialized regional designs for each? Why? We suggest one consistent regional design for governance, structure and data reporting.

Anonymous | 03/21/2022

Several commenters voiced support in possibly changing the regional structure and would be in favor of slightly decreasing the number of regions. However, one member stated that the Executive Committee needs to establish the goals for redesigning the OPTN regional map and how it will benefit transplant candidates. It was noted that 4-6 regions would be too few, and with such large regions it would be easy for some voices to be lost. Commenters favored 8-11 regions. With fewer regions, one member suggested increasing the number of regional representatives to allow for different perspectives and to ensure geographic diversity within a region. Another member commented that virtual meeting platforms could help increase engagement, if the number of regions was decreased. It was also noted that geographic area should be taken into consideration since transplant centers and OPOs are currently collaborating within a certain nautical mile circumference for allocation. Another member would be opposed to having an OPO’s donation service area within multiple different regions. Another member expressed opposition to the current regional structure, noting that it is inefficient and ill designed with some areas that already have to operate across regional lines. Additionally, the current committee regional representative appointment process varies amongst regions, and there is an opportunity with restructuring to bring consistency in all regions. Lastly, a member voiced support in redesigning the regional map if it improves patient outcomes and access to organs. An estimate of how the implementation would work with respect to time and resources would be helpful to determine if the effort would be worth the potential benefits. There is no doubt that there could be benefits if you balance the region metrics better.

OPTN Pediatric Transplantation Committee | 03/20/2022

The Pediatric Committee thanks the OPTN Executive Committee for the opportunity to review their Redesign Map of OPTN Regions concept paper. The Committee provides the following feedback: The Committee expressed concerns regarding representation on the Board and committees if the number of regions were to decrease because that could dilute the pediatric voice in the community. The Committee would like to see the distribution of pediatric transplant centers stratified by the following to ensure there is no underrepresentation or unintentional dilution of representation across regions: • Number of centers by organ • Number of transplants by organ The Committee noticed that most of the regional structure options created a huge region that spanned from Minnesota to Washington and members pointed out difficulties, such as time zone differences and attendance at regional meetings, which could result from the larger regions.

Tammy Sebers | 03/18/2022

The current OPTN regional design is meeting our regional needs and I don't feel that a change is warranted. The current regional structure allows for enhanced OPO and transplant center collaboration; the ability to discuss and address challenges that are unique to the region; promotes special interest group collaboration and pilot programs; the ability to provide feedback on policy changes from our unique perspective. Any of the proposed regional redesigns greatly diminishes or eliminates these functions. This is especially true of Region 6 which already covers the largest land area and has unique challenges because of this. Adding more states will increase meeting logistical challenges and impact participation. The larger the region the more dilute our voice will be. I am concerned that transplant center, OPO, and true regional interests will not be recognized or supported and that we will lose our ability to provide meaningful feedback. I am not in support of any of the proposed OPTN regional redesign options.

Anonymous | 03/18/2022

One member commented that instead of changing regions, the OPTN could allow more councilors per capita in terms of volume of programs in that region. Another member stated that smaller regions are better, and if the hope is to increase interaction, the OPTN could alternate how the groups are clustered from time to time. For example, if regions become more homogeneous, some days New Hampshire could cluster with New York and sometimes it could cluster with Pennsylvania. Another attendee shared their institution’s support of redesigning regions to create more equal representation on committees and the Board of Directors, either with a 10 or 11 region model. The member stated that now is not the time for large scale regional consolidation. The member continued that the redesign should focus on balancing the number of candidates, transplants, and transplant programs in the region. The member added that there is value in redesigning the region to include frequent partnerships in clinical activity between OPTN members to assist in performance improvement as well as representational functions.

Society of Pediatric Liver Transplantation (SPLIT) | 03/17/2022

The Society of Pediatric Liver Transplantation (SPLIT) is pleased to comment on this concept paper. SPLIT supports the concept of resizing to provide “balanced boundaries and equitable representation” as it relates to OPTN governance and operational effectiveness. Although community feedback is sought on which regional design would best serve the OPTN, it is impossible to provide feedback without additional data. In particular, we note there is no data presented in the concept paper on pediatric transplant populations or on equitable distribution of minority populations or other disadvantaged populations. We urge the OPTN to take this opportunity in redesigning the regional maps to include metrics that specifically describe how new Regions would impact pediatric candidates and transplant centers as a top priority. For example, we recommend describing for new Regions the number, by organ, of (1) pediatric transplant candidates (2) active pediatric transplant centers and (3) pediatric transplants over a 1-3 year period – and comparing these to representation by existing Regions. This transparency would help ensure that a fundamental goal of NOTA- “to recognize the differences in health and organ transplantation issues between children and adults throughout the system and adopt criteria, policies and procedures that address the unique heath care needs of children.” Patient and Racial diversity in the redrawn regions should be then reflected in the subsequent Board and committee representation. It will be critical also to transparently define what the purpose and responsibilities of Regions and regional divisions are going forward, since they will no longer figure into organ allocation. Defining what the representation of specialized groups like pediatrics will be in these re-defined regions will also be important for considering the impact on ours and other vulnerable populations. In relation to the final feedback requested, SPLIT agrees that, once having met and assured equitable metrics of redesigning the regions, that one consistent regional design be used for the governance, structure and data reporting functions in order to be most efficient.

Douglas Norman | 03/17/2022

I think redesigning the regions is unnecessary. Moreover, the proposed changes would significantly negatively affect region 6. The regions were established to provide a forum for discussion among geographically linked transplant center and their patients. There is no mandate to make the regions be of equal population. We know that in a country of 325 million people there will be many different viewpoints. Some of these are based on geography (east coast v. west coast v. mid-west v. southeast v. southwest, etc). It is unlikely that centers, and their patients, in Seattle have the exact same concerns as centers in Iowa, North Dakota, South Dakota. Regional meetings that spanned that geography would be unwieldly and probably under representative. Region 6 has a different way of voting, that would likely change if it expanded greatly geographically. Each organ program is represented by a physician and surgeon who have a vote on policies. Other regions allow only one vote per transplant center. Region 6's way of voting has fostered greater participation from transplant centers, whose representative feel more connected to policy decisions. Please don't change the regions--they are fine, as is. If you insist on change, instead divide the larger population regions into 2 smaller ones, thus increasing the number of regions. Regional representatives make up 25% of the board of directors. It would be fine to increase that % by adding a few more regions.

Anonymous | 03/17/2022

One member applauded thinking about the functional aspect of changing the region, but added that from an allocation perspective, one thought is to change the regions to align with the proposed changes for continuous distribution. Some members commented that they are not sure about the benefit of changing the regions. One member commented that we should preserve regional representation in any model that is chosen. They went on to comment that if large regions are chosen, they would recommend having multiple representatives from each region to ensure that centers have an opportunity to participate in the governance of the transplant community. Another member commented that more even distribution across regions makes sense to give everyone an equal voice in the governance of the OPTN. They went on to comment that there is benefit to having fewer large regions to benefit regional collaboration.

American Society of Transplant Surgeons | 03/17/2022

American Society of Transplant Surgeons overall supports.

View attachment from American Society of Transplant Surgeons

Anonymous | 03/16/2022

The MPSC thanks the Executive Committee for presenting its proposal and shares the following feedback from its discussion: Larger and fewer regions risk diluting individual voices within a region. It may be harder for members to represent their unique challenges (e.g., a member serving patients in a sparsely populated region), and it could dilute patient and donor family voices. The current structure has served the OPTN very well. Several MPSC members questioned whether changing the regions would further any of the OPTN strategic goals. Another MPSC member expressed concern about losing the ability to meet and discuss local practices in regional meetings if the regions increased in size. The metrics used omit the key issue of diversity of representation. They seem to focus more on equality than equity and do not address socioeconomic factors.

Anonymous | 03/15/2022

I think it is important to ask the question of "why" the regions exist. I hear a lot about relationships among OPO's and Transplant Centers. Does this directly impact how many patients are transplanted? If it does, I think it is important for this to be a factor. If not, I think there are many opportunities within the OPO and Transplant community to learn from others - regardless of the regional framework. How does the designation of the regional boundaries support the Strategic Plan? How does each proposed design increase the number of transplants and give the best representation to patients, donor families, living donors, OPO's and Transplant Centers? Everyone wants a voice - including the patients and donor families in a structure dominated by professionals. While this is understandable to an extent, I would not be supportive of a structure that in any way decreases patient and donor family/living donor representation.

David Gerber | 03/14/2022

With respect to the discussion around a redesign of the regional map, the question should begin with what are we trying to accomplish? There is little argument to be made that the original regions were designed based on state lines and in a way that fostered relationships amongst centers, OPOs, patients and professionals who were in geographic proximity to one another. They occurred at a time that predates the internet, travel was more challenging, and the overall field of transplantation was still in its infancy. While the organic creation of the regions wasn’t built on scientific data the by-product of the regions has been the creation of community hubs for shared ideas that have advanced the field of transplantation. So while many advances have occurred over the last four decades, when we look at the regional map the question needs to be asked in a slightly different way. What is the role of regions as organ allocation has moved to acuity circle methodology? I would argue that some of the positive byproducts of the original design occurred because there are variable/local issues that transplant centers, OPOs and patients face based on the social, demographic and geographic factors that differ across the country. Shrinking the number of regions may make sense from a modeling perspective but it misses the mark on what the new land mass regions would mean to an area that is acutely expanded. Decreasing the number of regions further dilutes the voice of centers in less populous areas using the current voting model. Lastly, agreeing that no model is perfect I would argue that creating a regional map of 10-11 regions accomplishes a critical mass effect with multiple communities of varying backgrounds empowered to articulate the needs that they and their patients face on a daily basis.

American Nephrology Nurses Association (ANNA) | 03/11/2022

ANNA needs more information regarding risks and benefits before commenting or choosing an option on this project.

View attachment from American Nephrology Nurses Association (ANNA)

Chris Connelly | 03/10/2022

The central argument of the proposed redesigned maps is that equity should be defined based on the creation of regions that are numerically/proportionally equal based on population, regardless of other factors. This video and and the presentation to our region 6 meeting explicitly suggest that landmass is not relevant, and this assumption is a central tenant of the proposed options. I would suggest that there is more to equity than just numbers, and the foundational postulate that landmass is not relevant is in fact false, and is not an acceptable assumption to make when redesigning UNOS regions. We face geographic challenges in our region that are not relevant in more populous/population dense regions with more transplant centers and greater access to transplant care. Furthermore, the presumption that continuous distribution solves this inequity is spurious. Patients who live in remote parts of the country, far away from a transplant center, experience inequities in transplant care which likely will not be solved through continuous distribution. Preserving our region preserves our voice to continue to raise these concerns and advocate on behalf of the patients we serve.

Cristy Smith | 03/08/2022

Any adjustment to the regional maps that dilutes the representation of centers from less dense or distant centers would disadvantage any influence that each of those centers may have at the board level or for policy. Though the idea that population equity would make for “balance” representation that completely misses the fact that the challenges and needs of centers in less dense population areas have unique needs and concerns for our patients that are often not considered in national policy. I would suggest that maintaining a larger number of regions with less dependence on population as a mechanism for division would be preferable.

Virginia Mason Franciscan Health | 03/08/2022

We feel strongly that enlarging Region 6 to increase "members" would not lead to equity and would have a number of unintended consequences; less involvement at regional meetings, decreased input from centers, lower personal involvement within UNOS committees. The changes in kidney/liver distribution abrogates a need for re-drawing the OPTN regions. The current system is not broken, why try to reinvent this? Thanks.

Anonymous | 03/02/2022

• Comments: o One commenter preferred the model with eight regions, noting it may save money in organizing meetings and provide members with more feedback from peers during discussions; this model seems to align centers with centers with whom they have formed relationships in the current regional map. o Other feedback was that models 6 and 4 appear to align more with the current allocation structure, which will allow for better communication and help drive process improvement. o Several attendees expressed concern regarding the motivation to redesign the regions.

John Durning | 03/02/2022

Thanks for the opportunity to comment on potential changes the OPTN regions. I think going to a more balanced region breakout has merit. The critical point is what aspect to balance. The current proposals seem to "discount" land mass. The one aspect where land mass plays is the logistics as a function of land mass. The larger the area the more difficult it may be for the donor and recipients to get together. The distance between the west end of the upper west/mid west regions and the eastern most part can be ~2,000 miles. I don't have a preferred recommendation, just observing some challenges with the proposed options. Also, with the increased popularity of "paired exchange" programs i am not sure how these region breakouts play. I entered the paired exchange program 5 years ago (i live in MD) and i received a kidney from living donor from California and my donor gave to a recipient in Ohio. The pair exchange program is a game changer for finding compatible kidneys and the program needs to operate at the national level and not at the regional level. As long as these regions don't become an impediment to the exchange program - they focus on administrative functions - then whatever is the most administrative efficient regional mapping should be considered.

Anonymous | 03/01/2022

The OPTN Liver and Intestinal Organ Transplantation Committee thanks the OPTN Executive Committee for the opportunity to provide feedback on Redesign Map of OPTN Regions. Should the transplant community support an OPTN map with fewer regions, the Liver Committee asks the Executive Committee to consider having more than one representative in each region to prevent the reduction of regional representation on OPTN Committees and the OPTN Board of Directors. When considering changes to the OPTN regional structure, the Liver Committee encourages the Executive Committee to take transplant and OPO performance, waitlist access for vulnerable populations, and allocation patterns into account. The Liver committee also urges the Executive Committee to preserve current transplant center and OPO working relationships.

Anonymous | 02/24/2022

A restructuring of the regions makes sense for a number of reasons. 1) There is no rationale for the current structure. Legend has it they were originally drawn on a napkin! 2) Since regions have less to do with allocation and more to do with collaborating at regional meetings and appointments to the Board and committees, we should optimize them for their current purposes. 3) As long as there is a major airport and a virtual component to regional meetings, I don't have strong feelings about the number. The bylaws will need to be rewritten for any change. We could have fewer regions but multiple regional reps to keep a similar amount of Board members selected by regions.

Anonymous | 02/23/2022

Several members commented that regional meetings promote networking so member travel convenience should be taken into consideration if there is a change to the regional map. Several members support a change to the regional map and commented that this change is an opportunity for robust quality improvement and overall organizational quality improvement. A member explained that the regions serve as a forum for robust and healthy dialogue for proposed policy. A region should be small enough to encourage open, easy, thorough and comfortable discussion for everyone, and large enough to promote a healthy diversity of opinion. A member pointed out that historically regions have served as smaller units to execute exploratory “variances” from policy and test potential improvements. It was suggested to change the regional map to four regions total, but initially begin with the change depicted on map 11A. Several members did not support changing the number of regions and believes the eleven equal regions, in option A, provides the most consistency, and noted that the percentage of land area is not relative. If there are eleven regions the regions should be balanced between the percentage of centers, transplants, and OPOs. A member explained that its institution supports eleven regions because that number of regions increases the number of voices at the Board level. It was pointed out that serval of the presented examples break up an OPO designated CMS area and that should be taken into consideration if there is a change to the regional boundaries. A member did not support changing the regional maps and did not believe that any of the proposed changes, or any change, will improve the current regional map structure. The member felt that current representatives do not represent the region, but only act in the OPTN’s interest. The member also suggested to reduce the Board size. A member explained that in light of continuous distribution, the regions seem less necessary than they were in the early days of the OPTN. And now, with the OPO Tier model and metrics, the OPO map will likely change significantly. Assuming Tier 1 OPOs begin taking over the Tier 3 DSAs, it is conceivable that one OPO could operate several DSAs all across the country. The member suggested to eliminate the regional map, and consider the country one region. Several members believe that equity of representation is the most important factor to consider if there is a change to the regional map. It was asked if there is a risk if a region is different than a DSA boundary. A member suggested to consider looking at acceptance patterns for organs and keeping in mind that the DSAs only exists for the purposes of managing referrals and community engagement. The member also suggested to consider symmetry around logistical hurdles – and to keep in mind that OPOs that are located in cities may have limited commercial airline availability. The member suggested creating regions around OPOs that have similar challenges.

Anonymous | 02/23/2022

The OPTN Vascularized Composite Allograft (VCA) Committee appreciates the opportunity to provide feedback on the OPTN Executive Committee’s Redesign Map of OPTN Regions project. The VCA Committee’s discussion included support for fewer regions, but cautioned against making regions too large since it would be difficult to have thoughtful discussion with too many attendees. The VCA Committee also felt consideration should be given to the convenience of travel versus the actual physical distance (e.g. based on access to airports and airline routes) but noted that larger or different regions would provide a benefit of interacting with new peers. It was also suggested that travel burden for members of the public and patient affairs individuals should be thoughtfully considered since if travel becomes too difficult they are even less likely to attend. With that in mind, the Committee recommends that virtual attendance should remain an option and suggests that the OPTN should consider sponsoring travel for patients. Finally, members supported equal representation on the Board of Directors, particularly for voting on high-impact proposals like changes to organ allocation.

Anonymous | 02/18/2022

Many attendees had feedback for the committee and provided the following comments: Do not believe a change in regions represents enough quantifiable benefit to patients or providers to justify the sacrifice of decades of working relationships within regions or of region specific process management, physical meeting sites, etc. Benefits of changing are not well-defined, particularly with the dissociation of regions from organ allocation policy. There is no compelling data to justify any benefit to redesign of OPTN regions. It is unclear how any of the alternatives would increase equity on the board. Any regional map is going to have disparities in terms of population and not sure if any of the proposed maps will reduce that disparity. Support moving to a regional model of using 4-6 geographic units to allow for greater system efficiency and reduction in meeting costs etc. The use of virtual meetings allows for multiple ways to gather feedback and ideas so arbitrary lines on a map seem less important. The larger units are more consistent with broader allocation as continuous distribution expands. Each OPOs DSA these days is the USA, so collaboration with a larger group of centers and areas makes sense, even if it means change. Much needed re-alignment of the OPTN/UNOS. Moving to CD will help equity for patients. The variety in practice is something that we need to take into account. Any redesign should account for regional variabilities in practice patterns of transplant centers and OPOs.

Christopher Anderson | 02/17/2022

I do not consider the current regions inequitable and I find that my current region is a collaborative group of centers that share best practices and participate significantly in regional meetings and UNOS matters. Also, since regions are not tied to allocation any longer, I don't fully understand the purpose of redesigning them as they still foster member feedback and collaboration. It seems that the decision for a re-design has been made. If that is the case, I think that an 11 region model is still the best in order to keep the regions as balanced as possible and to have regional meetings in which all members can be heard.

Anonymous | 02/16/2022

The member believes that the current eleven regions produce unequal representation and suggested there should be between four to eleven regions, and pointed out that the regions should also be a manageable size. Several members suggested to see where patients travel from in order to keep the patient population and center in the same region. For example, there are a large number of patients from Idaho that travel to Utah for transplant, but Idaho and Utah are currently in different regions. Members expressed the desire to see a more even population distribution across the regions, by potentially balancing populations and number of transplant centers. Several members support California being its own region. Several members support eight to eleven regions. Another member pointed out that Region 5, as is, is too big and he supports any map that decreases the size of the region to at least California alone. In addition, he supports increasing the diameter of acuity circles from 250 to 300 nautical miles. Transplant centers in California on the coast are at a significant disadvantage as compared to more inland centers as our range is restricted due to water along the western side of the acuity circle. A member suggested that it would be helpful to see the distribution of pediatric transplant centers for each organ in the proposed regions. A member suggested that the centers that work more closely together should be located in the same region. The member also said that her institution thinks that it makes sense for centers that have similar geographic challenges (transport times, etc.) to be in the same region. A member suggested to look at the number of donor and recipients in order to achieve more equitable regions. A member thought that map 11A was the most equitable map. Another member supported the redesign project but asked that the community be mindful about the new structure and function of the regions, and to not limit regional representation based on fewer regions since his would negatively impact overall community development by reducing exposure to broader experience and view points. A member supports creating fewer regions in order to promote greater collaboration.

Anonymous | 02/16/2022

Multiple states within a region are beneficial. Even though this redesign proposal will not change organ allocation, hopefully voices will be heard more equally.

Anonymous | 02/16/2022

A member stated that whatever is option is chosen needs to be balanced not just in terms of the metrics already considered, but also in terms of the number of OPOs and transplant programs in each region. They would advocate for similarly sized regions so there can be distinct representation. Another member also voiced support of the metrics being considered with percent of membership and number of recipients being the most important metrics. It was also noted that the current regional map allows the regional representative to accurately gauge the membership opinions due to size and personal contacts. If change must occur the proposed eight region map does best job of continuing those relationships for the region. Another member voice support for smaller regions to facilitate regional meeting attendance. Having more regions will likely result in more feedback and thoughts on proposals with more voices being heard. Some members noted opposition to the possible regional redesign noting the lack of a sufficient reason to change the regions. Now that regions are no longer used as units for allocation, there does not seem to be a strong rationale to break apart such a collaborative group.

Anonymous | 02/15/2022

The OPTN suggested that the redesigns should have enough representation from the rural communities so that larger areas don’t dilute them. One issue that might occur is that a region could get too big and this could end up resulting in having difficulty managing the given feedback. Having the knowledge and being able to use technology for communication models opens up many more doors for possible ways of communicating. Allowing the 4 regions would divide our country into four sections. While this seems to have both pros and cons, I see one of the cons being that now since there are only 4 sections, each one is going to be very populated. Larger sizes could result in a more difficult time communicating and hearing out all ideas though with a bigger population comes more ideas though it would be more chaotic than a smaller sized population and it would make for a better discussion.

Anonymous | 02/14/2022

The Operations and Safety Committee thanks the OPTN Executive Committee for their efforts on the OPTN Regional Review Project. The Committee suggests that any redesign should ensure that rural communities have enough representation. For example, North and South Dakota’s largest populations are American Indian/Alaskan Native and if this region expands, it could result in a decrease in the inclusion of their voice and representation. The Committee suggests that any redesign should consider regional meetings/feedback as well as collaboration. If the regions get too big, it may become difficult to manage feedback and collaborative efforts. The Committee suggests that data reporting should be more fluid than regions. For example, the OPO clusters that were developed have been helpful in performance improvement. The Committee also cited that currently established regional relationships are important.

LifeGift | 02/10/2022

While LifeGift has enjoyed the collaboration and input in the current and historical model, we believe reducing regions to a 4-6 region administrative unit model is more consistent with how we operate in the new environment. Regarding loss of opportunity for collaboration and input, we have all learned that using virtual and electronic communication models allows for many opportunities to communicate and collaborate successfully, regardless of arbitrary lines on a map. Regarding OPO communication across fewer regions, this actually is much more consistent with current practice where the OPO DSA is the USA and all of us in this community interact more than ever with "newer" or non-DSA transplant centers and other OPOs. We also believe this will reduce administrative cost for UNOS and members in travel and meeting expense.

Luke Preczewski | 02/08/2022

In general, a regional realignment to rebalance the regions is sensible, so long as the number of regions is maintained. Reducing to 4 or 6 will dilute representation unacceptably. I would caution on timing, however, that this proposal is occurring at a time of significant mistrust in multiple regions related to the policymaking process related to eliminating DSA and region in allocation of organs. I would suggest shelving this until the community has moved past that and then consider a realigned 11-region map. Commenting as a transplant professional and not on behalf of any employer or organization.

Anonymous | 02/07/2022

I think that since we are doing away with UNOS regions and going with distance from the donation/ procurement hospital that moving away from the current region system makes sense. I would seem to favor the 4 region model since basically divides the U.S. into four larger regions but the only concern I would have is will this lead to better regional meetings or less functional meetings since there will be so many people involved in each region. The current benefit to the smaller regions is that I feel there is better discussion since the size of the group is smaller but not sure how that will change if we go to a larger representation in each region. Overall, I still think the large 4 region plan seems to be the best option.

Rachel Engen | 02/07/2022

As region is removed from allocation policy, the purpose of the regions is primarily the governance of OPTN. With that in mind, a map that more evenly distributes the regions across donors/recipients/population makes sense to give everyone an equal voice. However, I am concerned that a 4-region model would result in a regions too large to allow full participation of members at regional meetings and on committees. I do feel bad for the northwest; in all the new equal region models, that region extends across 3 time zones, Minnesota to Washington. Transit time to attend regional meetings, or even logistics of scheduling virtual regional meetings, will be a problem in that area.

Peter Fee | 02/07/2022

With the advent of newer procedures not available at the time of the last redesign such as DCD, the constraint in time to implant of the donor organ is now increased. This makes the larger regions more viable; I would recommend the four-region approach o something similar along that line.

Hans Gritsch | 02/03/2022

There is a benefit to having multiple states within a region. I am in favor of having fewer large regions, since the regional structure is slowly not being used for organ allocation. I think the optimal number is in the range of 4 - 6. We want to continue to have regional collaboration, but work toward an equitable national organ allocation system.

Anonymous | 01/31/2022

I like the 11 equal regions, slide B, idea.

Anonymous | 01/28/2022

What is the purpose of UNOS Regions? They have no relation to either organ procurement nor organ allocation. They were created in an era before widespread use of the internet, and served as a means for discussion of issues among nearby transplant professionals. But with modern online communication, is there any need to continue having regions?

Anonymous | 01/27/2022

New Mexico should be in the same region as Colorado and Arizona. Many New Mexican candidates transplant in those states.

Anonymous | 01/27/2022

Agree that the redesign would be beneficial I’m reducing waitlisted patient death.

Anonymous | 01/27/2022

Option A for 11 regions or going to 4 regions seems to make sense, based on the information provided. Please consider: What would the cost difference be for either of these options? Is there cost savings going to 4 regions? What is the long-term benefit comparison? How will patients benefit from a change?