Comments

Anonymous | 03/26/2019

* 17 - fixed concentric circles * 7 - hybrid * Circle size: * 150 NM- 5 * 250 NM- 2 * 300 NM- 6 * 500 NM- 15 * Hybrid (inside the circle): Shallow- 3 Steep-5 No points- 13 * Hybrid (outside the circle): Shallow- 2 Steep-6 No points- 13 * Should there be different distribution systems for kidney and pancreas: Yes- 21, No-3 Comments: There was support for having a fixed concentric circle with no points. Some members commented that including proximity points is just a proxy for local distribution and defeats the purpose of broader sharing. There was also a comment that the size of the distribution circle for kidney should be larger than for heart, lung or liver since kidneys can travel further and tolerate longer cold ischemic times. There was interest in seeing data that would show how any of the frameworks would affect the waiting time by region. Although there was broad support for having a separate distribution system for pancreas, there was not consensus on the right size for the circle. Some members were in favor of larger circles and some for smaller. Those who supported larger circles commented that they already import a large percentage of pancreas for transplant and although traveling longer distances for pancreas was more expensive, the cost was off-set by the lower organ acquisition fees charged by some OPOs.

Anonymous | 03/23/2019

Removal of DSA and region from kidney and pancreas allocation- • 12 - fixed concentric circles • 21 - hybrid • Circle size: 11-150NM, 9-250NM, 5-300 NM, 11-500NM • Hybrid: 8 shallow points within circle, 10 steep points within circle, 10 none 5 shallow points outside circle, 13 steep points outside circle, 9 none • Should there be different distribution systems for kidney and pancreas: 19 yes, 15 no Comments: One member stated that it is important to remember that shipping kidneys has the added complication of commercial flight schedules and sometimes that means extra miles to get to a destination. Another member shared concern about the modeling and feels as though people are being asked to believe the favorable numbers and to not believe the unfavorable results.

NYKidney | 03/22/2019

NYKidney, a consortium of New York State kidney transplant professionals and advocates, values the effort the OPTN/UNOS Kidney/Pancreas Workgroup has put into their concept paper ‘Eliminate the Use of DSAs and Regions in Kidney and Pancreas Transplant’. In order to comply with the Final Rule, changes that remove arbitrary geographic boundaries are necessary and as New Yorkers, we support the broadest allocation feasible to benefit the most patients with ESRD. The group is concerned that, despite disclaimers about the limits of KPSAM, all five models predict a decrease in the number of kidney transplants. Any adopted policy should maintain, if not grow the total number of transplants. It is appreciated that the number of pediatric deceased-donor renal transplants is predicted to increase and is a focus of the workgroup. We recommend that the pancreas allocation be developed based on the factors unique to pancreata, and not required to fit into the kidney allocation model. NYKidney looks forward to future proposals from the workgroup to help further the goal of enhancing equity in kidney transplantation without decreasing transplant number.?

Anonymous | 03/22/2019

I feel that donated organs within states should be used patients within that state and not shipped to more populous states. I would not be an organ donor if I knew that they would go outside my state. The proposals suggested will result in a decrease in the number of useable organs for folks that are suffering from serious organ failure diseases.

UNOS Pediatric Committee | 03/22/2019

The UNOS Pediatric Committee recognizes that this is a concept paper rather than a policy proposal. The Pediatric Committee appreciates the HRSA mandated requirement for kidney and pancreas allocation to be altered in a way that makes the allocation policy compliant with The Final Rule. The Committee is supportive of the Kidney and Pancreas Committee’s efforts to broaden organ distribution and appreciates that each of the modeled options thus far is anticipated to be beneficial for children with increased in volume and rate of transplantation. That said, this broad examination of the allocation system for kidneys gives our community an opportunity to attempt to address some of the current concerns related to deceased donor pediatric kidney transplantation. The Pediatric Committee of UNOS would like to offer some comments and suggestions for consideration; 1. The decreased percentage of total DD kidneys that have been allocated to children under KAS is concerning. We look forward to children benefiting from the increased numbers of DD transplants that are anticipated to occur under broader sharing. 2. Multi organ transplant rates continue to increase. Currently 1700 MOTs occur yearly that involve a kidney. These transplants are commonly occurring with low KDPI kidneys that decrease the availability of DD kidneys for children, depending on the Region and DSA. We would suggest that consideration be given to placing pediatric DD kidney candidates above MOT in the allocation sequence for donor kidneys with KDPI < 35. 3. There have been higher delayed graft function rates for children receiving DD kidneys since KAS was initiated. With any new allocation system, DGF rates, which are critical with regard to impact on rejection rates and to kidney longevity, must be monitored carefully. We feel caution is necessary since with broader distribution, DGF rates for children may further increase and ultimately have an unintended consequence of decreased organ longevity which has critical impacts on children. 4. Mortality on the wait list for the youngest kidney candidates has increased slightly under KAS. We believe any new allocation system must not only monitor the effects on children as a whole but on the stratified age groups. 5. Presently the vast majority of pediatric deceased donor kidneys go to adults and many never are offered to children due to the calculated high KDPI that may occur in the youngest deceased donor kidneys. We suggest that the KDPI calculation, as it currently stands, is suboptimal and inaccurate for many pediatric donor kidneys. We present for consideration a few options; a critical re-examination of the legitimacy of the KDPI calculation for pediatric deceased donor kidneys, the preferential offering of kidneys from all donors 10-18 yrs of age to children prior to allocation to the adult waiting list, and/or consideration of placing local and regional pediatric candidates above local and regional adults for sequence C kidneys in order to allow children to capture more of the “high KDPI” kidneys from pediatric donors.

Anonymous | 03/22/2019

The Transplant Coordinators Committee reviewed the proposal during a meeting on February 19, 2019. Members acknowledged the complexity of this proposal and supported the hybrid model in principal. Members also supported: • Kidney and pancreas distribution being separate distribution methodologies. • The use of population density in future modeling. Members verbalized concerns regarding potential impact on highly sensitized transplant candidates and the need to carefully consider the amount of points for human leukocyte antigen (HLA) matching between the donor and potential recipient(s). Members requested post-implementation monitoring include analysis of changing transplant program practices as a result of kidney and pancreas distribution changes. The Committee appreciates the opportunity to provide feedback to the Kidney Transplantation Committee.

Michael Moritz | 03/22/2019

My comments reflect my 33 years of transplant surgery experience in kidney, pancreas and liver transplantation at 3 different adult and 2 pediatric centers. Kidneys and pancreata are different than heart, lung, and liver. In designing allocation systems for kidney and pancreata in compliance with the final rule, it is not necessary to apply rules similar to those utilized for vital organs, and thus there can and should be an entirely different conceptual framework. There are multiple reasons for the necessity of having a different conceptual framework. Optimal List Size The 1999 IOM report explored liver allocation (in a DSA-based pre-MELD world) and created an Organ Allocation Area concept and stated that the optimal size for allocating livers in the US was “a population base of at least 9 million people (unless such an area would exceed the limits of acceptable cold ischemic time)”. While this number was specific to livers and 1999, the concept is sound and has been ignored since and in the newest vital organ allocation schemes. Nothing in the new heart, lung, and liver allocation schemes or the kidney pancreas concept paper addresses this key parameter. A better concept than fixed circles, consistent with prior UNOS/OPTN efforts, consistent with eliminating DSA boundaries, but better than fixed circles, would use variable concentric circles about the donor hospital with the distance increasing until it captures a standard proportion of population (or better a proportion of the national waiting list, the optimal list size). I do not personally have the computing facility to determine the numbers of transplant centers to reach a proportion of the wait list about a donor hospital, but easily available mapping websites provide the population within a circle of user-defined center and diameter. Exploring the mid-atlantic area, the densest population area of the country: Million population within the nautical mile diameter Circle centered about: 25 50 100 250 Boston MA 3.9 7.2 11.3 49.5 Hartford CT 2.0 4.5 29.2 57.8 NYC (Manhattan) NY 14.7 20 31.2 59.8 Trenton NJ 4.4 15.8 31.1 64.1 Scranton PA 0.6 2.0 27.2 75.0 Hershey PA 1.3 5.9 19.6 66.1 Philadelphia PA 5.1 9.2 31.9 65.1 Baltimore MD 3.0 8.1 18.0 63.0 Washington DC 4.7 7.7 14.7 60.8 Richmond VA 1.0 1.7 9.6 46.8 Pittsburgh PA 2.1 3.4 8.5 63.3 Cleveland OH 2.5 3.9 13.0 51.1 Columbus OH 1.5 2.5 8.8 48.7 Cincinnati OH 1.9 3.1 10.0 51.0 The above data point out the absurdity of large circles, those > 100 nautical miles, in areas of dense population. A 100 mile circle captures 31.9 million of the U.S. population for a donor in Philadelphia, almost 10% of the U.S. population, which if extrapolatable to the kidney waiting list would capture thousands of kidney waiting list patients, a profoundly unfair proposition compared to say Denver, CO where the same circle would encompass 22% of the U.S. population)! A variable circle system is a better balance of fairness to the candidate and efficiency on the part of the transplant centers and the system as a whole. Efficiency, which is a significant part of the final rule, can be variously defined but includes cold ischemic time which is so directly proportional to early function of the transplanted organ, and transportation distances with their inherent safety and cost considerations, all thus far lacking from allocation schemes. Unfortunately, it appears that there is no data or available modeling which has explored optimal population basis or waiting list size for allocation. Certain aspects of the KAS have performed as desired and should be retained, for example the priority accorded highly sensitized patients. Similarly, access to kidney transplantation for previous living donors and pediatric candidates also appears to function as desired. I believe, based on the limited data that UNOS has released, that this is not true of the low EPTS group who have not received their share of donor kidneys that had been expected when the KAS was designed and launched. Part of the answer to this underserved group must be addressing the grossly unfair priority accorded heart-kidney, lung-kidney, and liver-kidney candidates, who obviously deprive the low EPTS group, the “young adults” who have the best post transplant survival, of access to good quality donor kidneys. Here the shortcoming is not the kidney allocation scheme, but the kidneys over generously allocated to multi-organ candidates which deprive the kidney waiting patients of potentially life-extending organs. Discard Rate The number 1 problem in kidney allocation is the discard rate for deceased donor kidneys which is stubbornly and persistently high. This is a complex phenomenon, but organ viability and utilization for transplantation do clearly decline with increasing cold ischemic time. Thus, a strong case can be made for minimizing cold ischemic time for all kidneys, particularly those at risk of discard. The kidney allocation system initiated in December 2014 did, in a limited way, do the opposite. The KAF applied regional sharing for high KDPI donor kidneys. This was an experiment whereby investigating the value of broader levels of sharing in an attempt to improve utilization of kidneys at high risk for discard, and and can be considered a failure as discard rates have not fallen. We would propose the opposite principle, namely focusing on minimization of cold ischemic time in an attempt to improve utilization of high KDPI kidneys, which would be accomplished with variable circles focused on the appropriate waiting list within the circle. All 5 of the proposed frameworks are fatally flawed. The first 3, with their fixed circles, would be rejected by any rational observer or by any court given that 1) the fixed diameter has no rational, medical basis and 2) the boundary effect is profoundly unfair and discriminatory (i.e. that the difference between 499 and 501 miles is not 2 miles but life and death). The other 2 may be defensible, but are substantially and unnecessarily complicated compared with the principle proposed here, namely circles tiered to encompassing a fair, reasonable, and efficient proportion of the U.S. population or U.S. waiting list. Michael J. Moritz, M.D.

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) opposes this policy and has doubts on whether any of these proposed allocations schemes would be sufficient under the “Final Rule” (42CFR§121.8) to meet the requirement of 42CFR§121.8(a)(8) without also compromising the requirements of 42CFR§121.8(a)(1-5).. It is very important to consider that while sections 1 – 5 of the section in question deal with allocation being based on sound medical judgment for the best use and lease wastage of organs, section 8 of the final rule can be summarized as “geography shall not be a consideration unless it renders an organ not transplantable and subsequently wasted”. The modeling of all of these DSA-elimination proposals suggests that more organs could be wasted than under current OPTN guidelines. In addition, this proposed guidance will more than likely encourage transplant programs to rely further on “virtual crossmatching”. This could leave ASHI-member histocompatibility laboratories in a bind since the CLIA section of CMS has yet to rule on whether virtual crossmatching meets the requirement to have the results of a pre- transplant crossmatch for renal and, tandem transplants that include a kidney as defined in CLIA ’88 (42CFR §493.1278 (f)(2)).

Anonymous | 03/22/2019

• 8- fixed concentric circles • 10 - hybrid • Circle size: o 150 NM- 15 o 250 NM- 4 o 300 NM- 1 o 500 NM- 2 • Hybrid (inside the circle): Shallow- 3 Steep-9 No points- 2 • Hybrid (outside the circle): Shallow- 2 Steep-9 No points- 3 • Should there be different distribution systems for kidney and pancreas: Yes- 16, No-5 Amendment: Do the proposals meet the regulatory requirements as written under the OPTN Final Rule? Yes- 1, No- 18, Abstain- 7 Comments: Overall, the region is not supportive of the concepts proposed by the committees. There is concern regarding consideration for vulnerable populations, waiting time, meeting the requirements of the OPTN Final Rule, and OPO performance. Specifically, the region provided the following comments on this concept paper: • Limitations of the SRTR modeling regarding outcomes, because increased distance will lead to worse outcomes and increased discards, and the SRTR modeling is limited to only 1 year post transplant outcomes. • In the discussion about vulnerable populations, in addition to pediatrics, they also brought up vulnerable low SES and rural populations • Liver pales to kidney in the number of programs that will shut down. • Multi organ – the changes to liver will incentivize liver to share more higher MELD, that are more likely to need a kidney, which could have a huge impact on kidney transplant. • The committees need to consider how to address back up offers, virtual cross-matches, and geographically isolated areas such as Puerto Rico and Alaska. • How will the committees consider vulnerable populations? Concern was specifically expressed about pediatric candidates and that they are disadvantaged under KAS. Kidneys from pediatric donors are being allocated to adults. How will the committees make sure pediatric kidneys are allocated to pediatric candidates in order to prioritize this population? Members want to see modeling data by region. • A member’s opinion is that rural populations such as Alabama will lose in a concept such as this, and other areas such as NY will gain and increase # of transplants. • Waiting time is more important than distance. What will waiting times look like in different areas? The modeling needs to include waiting time and how it is distributed. • Members questioned if the concept paper meets requirements of the OPTN Final Rule, specifically 121.8, sections 1-5. • OPO performance continues to be an issue that UNOS must address. • It was recommended that the committees develop an intermediate step before transitioning to a completely new allocation policy.

Maine Transplant Program | 03/22/2019

The Maine Transplant Program supports the concept of broader sharing of kidneys as well as the elimination of “border effects” in allocation outcomes. We recognize that every allocation change is an exercise in balancing equity and utilization. We note that all of the current proposed models adversely impact outcomes to at least some extent. We strongly feel that the likelihood of problematic unintended consequences is highest with all three of the 500 mile options. We are extremely concerned that in the Northeast, such a radius puts together a very large number of programs that would make it difficult for surgeons and donor organizations to maintain strong working relationships. We are also concerned that in the congested northeast corridor, cold ischemic times will be impacted more than what is modeled by transportation difficulties. We also worry about access to organs with reasonable cold ischemic times for our rural patients as we will be the program at the farthest point northeast in any such circle. We note the 500 mile options are associated with the largest degradation in national outcomes in the limited modeling done so far. For all these reasons, we feel that the 150/300 NM concentric circle makes the most sense, followed by the 250/500 NM model. These two options should eliminate the most egregious of the equity problems, and we feel would best preserve access to transplantation for our patients while maintaining outcomes.

Anonymous | 03/22/2019

To Whom It May Concern: Sanford Health is a non-profit integrated health system headquartered in the Dakotas. We are one of the largest health systems in the nation with 44 hospitals, 1,400 physicians, and more than 200 Good Samaritan Society senior care locations in 26 states and nine countries. Sanford Health's 48,000 employees make it the largest employer in the Dakotas. Sanford operates kidney transplant centers in Sioux Falls, SD, Fargo, ND, and Bismarck, ND. Our transplant centers provide patients access to high quality care in the Upper Midwest and work with an Organ Procurement Organization to procure organs for use in other hospitals. While we are not considered large donor hospitals, we provide key services to underserved populations in rural areas. We appreciate the opportunity to comment on the OPTN/UNOS Concept paper. After reviewing the proposed distribution concepts, we have several comments as outlined below: 1. Organ Distribution to the Upper Midwest We are extremely concerned about the impact of the proposed organ allocation methods on patients in the Upper Midwest. As evidenced by the distribution maps provided with the Concept paper, there are no large donor hospitals in the Upper Midwest and only two large donor hospitals on the West Coast. As a result, the majority of organs are procured in the eastern half of the United States. We believe this creates an imbalance of organ availability which will be exacerbated by the implementation of the proposed concentric circle concept. By offering organs within a specified mileage radius from the donor hospital, patients in densely populated areas of the East Coast will be prioritized over patients in other areas of the country. We agree with the concept of treating organs as a national resource, but we believe prioritizing based on mileage goes against that ideal. We also realize that we would continue to have access to organs procured within our geographic region and have access to organs that did not have a match near the donor hospital. However, we would like to remind the committee that states such as North and South Dakota have lower population density than other states. As a result, our ability to procure organs for our patients locally is not always possible. We rely on large donor hospitals to find matches for local patients. If the pool of organs available on a national scale shrinks, our patients will be disproportionately impacted. We are also concerned about the potential impact on our patients. Patients in rural areas already travel great distances to find a transplant hospital. In fact, our transplant hospitals treat patients from multiple states including Montana, Idaho, and Wyoming which currently have no transplant hospitals. This results in significant cost to the patient in the form of mileage, airfare, hotels, etc. If organs are distributed based on distance from the donor hospital, patients may experience even more difficulties finding a match at a local or regional transplant hospital. As a result, patients may need to travel across the country to register with multiple transplant hospitals, hoping for a match. We believe this may create a significant disparity between patients who have the financial means to travel to multiple locations and those who do not. 2. Impact on Small Transplant Hospitals We noted the Concept paper focuses on the large donor hospitals and the ability of these hospitals to distribute organs under the proposed methodology. We are concerned the focus on the large hospitals ignores the potential impact on small transplant hospitals. At Sanford, we are proud to provide high­ quality care to patients in our region. If we are unable to procure viable organs, our hospitals and communities are at risk of losing a local option for transplant services. Without sufficient transplant volume, we fear many small transplant programs could close, leaving even larger portions of the country without access to local transplant services. The result would be a small number of large transplant hospitals that require patients to travel significant distances. We do not believe it is appropriate for seriously ill patients to expend additional resources when care could be provided close to home. We also believe prioritizing organ distribution based on mileage creates concerns from a public health standpoint. Most of North and South Dakota are designated as Medically Underserved Areas. In our region, patients have fewer options for healthcare and travel further distances to receive care. If transplant centers in our area have difficulty meeting the needs of our patients, we are concerned the mortality rate for kidney disease in our area could increase disproportionately to the rest of the nation. 3. Projected Impact on Transplant Rates The supplemental analysis provided with the Concept paper indicates the proposed allocation method may lead to an 11% decrease in transplants, a slight increase in waitlist mortality, and a potential increase in graft failure rates. We are extremely concerned about these projections and urge the committee to re-evaluate the proposed methodologies. Any proposed methodology should improve transplant rates across the country and should not lead to a decline in outcomes. 4. Suggestions for Alternatives As noted above, we are concerned about the impact of the proposed methodologies on transplant hospitals in the Upper Midwest. Our geography requires our patients to travel great distances to transplant hospitals, and our population density requires us to extend our search for organs farther than in other areas of the country. Given our geographic limitations, we suggest the committee revise the proposed methodologies to take into account the disparities between high- and low-density population centers. Specifically, instead of creating circles around a donor facility, we recommend a creating a national list of transplant hospitals. Each hospital could indicate how far they are willing to travel to obtain an organ, which may be farther for rural hospitals. In addition, hospitals could indicate other criteria which would help facilitate a match. We believe this approach may ensure rural areas are able to continue to access organs and serve their local population. If the committee decides to implement the concentric circle methodology, we believe the circle radius must be a minimum of 500 miles. As a result, we believe the 250 NM/500NM circles would impact our region the least of the five stated options. To be clear, we believe implementation of the 250 NM/500 NM option will negatively impact the Upper Midwest, but we also believe anything less than 500 miles will have an even greater negative impact. In addition to the proposed concentric circles, we also recommend the committee consider assigning points for rural and small transplant hospitals . Keeping care close to home is important for the mental, physical, and financial well-being of transplant pat ients . We believe encouraging patients to receive care in their communities will result in better outcomes. In addition, we recommend the committee review the practices and procedures ofthe Organ Procurement Organizations. While we are fortunate to have an efficient OPO in the Upper Midwest, we are not confident all OPO's operate under the same standards. Particularly, we encourage the committee to review the OPO's donor management practices to ensure all viable organs are used and distributed efficiently. Reducing the number of discarded organs may improve transplant rates around the country. Ideally, a distribution method should allow equal access to organs across the nation , ensure efficient distribution, decrease waitlist times, and increase the number of overall transplants. We do not believe the proposed methodologies accomplish these goals. As a result, we recommend the committee reconvene to discuss alternative options with a focus on ensuring organs are truly treated as a national resource. We appreciate the OPTN/UNOS committee's consideration of these comments.

Goran Klintmalm | 03/22/2019

PUBLIC COMMENT: Eliminate the use of DSAs and regions from kidney and pancreas distribution This comment is written for U.S. patients awaiting kidney transplant. It is directed to DHHS Secretary Alex M. Azar II, our elected officials responsible for the health of its communities and the state overall, as well as for our transplant community colleagues at large who are also alarmed at the specter of the loss of kidney transplants not only for their friends and neighbors, but for the nation itself. This comment regards: “Eliminate the use of DSAs and regions from kidney and pancreas distribution”. The title accurately reflects the primary overriding goal of the policy, which is to eliminate the use of DSAs and regions from kidney allocation. What it does not do is increase the number of kidney transplants, save lives, improve the donation and transplantation system, reduce cost, increase quality or alleviate disparity. It will accomplish the opposite of these positive health care policy goals. You will see none of those vital concerns or results in the modeling of five scenarios. You will see a disastrous prediction of 1,074 to 1,746 FEWER kidney transplants nationwide and no difference in mortality. These five modeled scenarios, these ‘concepts’, are the recent progression (first lungs, then livers and now kidneys) of the appropriation of organs from communities and states with the highest waiting list mortality where they are needed and the distribution of those organs to large cities with the lowest waiting list mortality under the direction of the federal contractor for the OPTN - UNOS. DHHS Secretary Azar gave a speech two weeks ago to the National Kidney Foundation. His office sent out press releases announcing his speech which included his written comments. His remarks were moving. How does it square with his speech, however, at the very moment he is delivering his speech, the federal contractor chosen by Azar’s agency, DHHS, had posted and was accepting comments on modeled scenarios for kidney allocation, all of which caused massive decreases in the number of deceased kidney transplants performed in all 5 proposals – from an unthinkable 1,074 decrease (8%) in 1 to a shocking 1700+ (13%) decrease in 3 of the 5 proposals. Excerpts from DHHS Secretary Alex M Azar’s speech to the National Kidney Foundation (taken from the DHHS Secretary Press Release that was sent widely throughout the healthcare community and posted on the DHHS website) : “One hundred thousand Americans begin dialysis each year, and one in four of them are likely to die within that same year. Meanwhile, kidney transplants are hard to come by. There are more than 100,000 Americans currently on a waiting list for a transplant.\ I’ll mention three particular areas we’re thinking about, and already working on, to focus our efforts on kidney disease. First, we need more efforts to prevent, detect, and slow the progression of kidney disease. Second, we believe patients with kidney failure deserve more options for treatment, from both today’s technologies and those of the future. Third, we’re going to look at how we can deliver more organs for transplants … Even though a transplant improves health and dramatically lowers the cost of care, from the perspective of a dialysis company, every transplant is one less customer. A system that pays for health, as we envision for all of healthcare, will pay for the healthiest possible outcomes. Ideally, we’d want to offer dialysis providers incentives to get patients off dialysis through transplants. We want to make the outcome that’s good for the patient and good for the system good for their business, too. Today, we also simply don’t have enough kidneys to meet demand, and there is room for improvement here as well.” The transplant community and specifically the signers of this public comment view on Secretary Azar’s address: • “Kidney transplants are hard to come by.” Check/Agree. • We “need to look at how we can deliver more organs for transplants…” Check/Agree • “The most transformational change for a kidney patient’s life, of course, is … a kidney transplant.” Check/Agree • “…a transplant improves health and dramatically lowers the cost of care…” Check/Agree • “Kidney transplants are a more humane way to treat people with loss of kidney function.” Check/Agree • “More transplants are needed and can be achieved with increased donation.” Check/Agree Secretary Azar should know that the federal contractor for the OPTN just put out 5 scenarios for kidney allocation in a concept paper that is titled “Eliminate the use of DSAs and regions from kidney and pancreas distribution” that will cause the following losses in transplants: 1CR_nopts: 1,746 fewer kidney transplants (national -13% decrease from current 13,473) 1CR_steep: 1,734 fewer kidney transplants (national -13% decrease from current 13,473) 1CR_shallow: 1,706 fewer kidney transplants (national -13% decrease from current 13,473) 2CR_150: 1,074 fewer kidney transplants (national - 8% decrease from current 13,473) 2CR_250: 1,492 fewer kidney transplants (national -11% decrease from current 13,473) It is inconceivable that these results, even published in a concept paper and not as a policy proposal, were ever published on the federal contractor’s website or given to thousands in the transplant community for comment. Proposals such as these should not have been advanced and we hope it was not done to test and/or dull community reaction to a future proposal that would also cause a DECREASE in kidney transplantation, albeit perhaps smaller in order to make it more acceptable. Any future proposal that promotes a decrease in transplants must be a non-starter. We should surmise as much based on the remarks by Secretary Azar1. On this basis of decreased access to transplant alone, all the proposals must be rejected as fatally flawed public health policy. There is no reason to believe, unless a reprieve is granted by DHHS, that this unabated rush to abolish state boundaries in order to access organs will stop any time soon. With that in mind, we offer the following comment for future kidney modeling: The modeling of any kidney allocation proposal must include outputs by Region, DSA, and transplant center: 1. The disparity metric – Median Waiting Time, Patients Transplanted, Solitary Kidney (non-multi- organ transplant) and KP. 2. Median waiting time, Patients Transplanted, Solitary Kidney (non-multi- organ transplant) and KP, patients with low PRA ( 80 4. The disparity metric – Effect on disadvantaged populations; Effect on minorities. 5. Cost per kidney acquisition. 6. Cost per kidney transplant. 7. Number of kidney discards 8. Number of ECD kidney transplants. 9. Number of DCD kidney transplants. 10. Percent locally transplanted organs. 11. Changes in logistics, shipping and cost for change. Comments on the above requested modeling outputs: WAITING TIME: MEDIAN WAITING TIME OF TRANSPLANTED PATIENTS Unbelievably, there is no equity metric advanced in the concept paper put forward by UNOS. There are no predictions, no modeling done on of what any of the scenarios do to waiting times. It is simply absent. In fairness, the title of the concept proposal says nothing about equity or disparity so perhaps we should just say that it achieves its purpose by removing boundaries regardless of equity, utility, common sense, cost and so on. It is a glaring absence that effect of the modeled scenarios on waiting times, the equity metric, is not front and center. The primary, overriding equity metric in kidney transplantation is waiting time. The Gold Standard – waiting time. The American public understands waiting in line, waiting your turn. How long has the patient endured dialysis, how long has the patient been waiting for a kidney transplant? Kaplan Meier estimates of waiting time focus on waiting time of patients on the kidney transplant waiting list. This metric, useful for liver transplants where un-transplanted patients die from their disease, is meaningless for dialysis patients who remain on dialysis. Two-thirds of the patients on the list at large centers are sensitized with antibodies to other potential donors that make them difficult to match with a donor. This is a biologic disadvantage unaffected by public policy. A more meaningful metric for kidney transplant access is median waiting time for patients transplanted with a deceased donor (DD) kidney. It measures how long patients without a biologic disadvantage get to the front of the queue at their center and realize their dream by receiving a kidney transplant. These are hard numbers, un-gameable, and can compare access to transplant between centers and regions of the country. Most importantly, it measures what centers actually do, who they actually transplant and how long those patients actually wait, including high responders who are transplanted; thus these are the cohorts we should be measuring. However, patients with low PRA do not get allocation preference and consequently better reflect the local transplant activity. We propose that the following metrics for transplant centers should be provided on an annual basis: 1. Median waiting time, ALL deceased donor kidney transplants, solitary kidney (non-multi- organ transplant) and KP. 2. Median waiting time, deceased donor kidney transplants, solitary kidney (non-multi- organ transplant), patients with CPRA < 20 and KP. 3. Median waiting time, deceased donor kidney transplants, solitary kidney (non-multi- organ transplant), patients with CPRA > 80 and KP. DISCUSSION: COMPARISON OF STATES/DSAs WITH LONG WAITING TIMES AND THE NUMBER OF KIDNEY TRANSPLANTS PROJECTED UNDER THESE 5 MODELED SCENARIOS: Alabama and San Antonio, TX currently and historically have always had among the longest, if not the very longest waiting times in the U.S. i: Alabama - MWT of kidney transplants in 2016 was 39.4 months; San Antonio 36.3. For that same year, New York City had a MWT of 29.7 months, with one large center as low as 22.1 months. Alabama’s waiting times, consistently the longest in the country, variously: 60.4 mo., 2011; 66.6 mo., 2012; 62.4 mo., 2013; 67.1 mo., 2014; 47.1 mo., 2015; and 39.4 mo., 2016. For the same time periods, NYC has had a steady drop in MWT of transplanted kidney patients: 37.6 mo., 2011; 35 mo., 2012; 36 mo., 2013; 32 mo., 2014; 30.1 mo., 2015; and 29.7 mo., 2016. It defies logic and perception of fairness that Alabama and San Antonio will do fewer kidney transplants in every one of the five aforementioned scenarios, as much as 25% fewer, while New York City will do significantly more kidney transplants under every scenario of around 35% and in one scenario, 36.1%. Alabama, a southern state with a 25% African American population and with the longest waiting times in the country will do fewer kidney transplants for their residents under the UNOS proposals, while kidney transplants in New York City may increase as much as 36.1% - the highest projected increase in the nation using any of these modeled scenarios. The state of New York’s population is 17.7% African American. DISPARITY METRIC – EFFECT ON DISADVANTAGED POPULATIONS AND MINORITIES Kidney transplants are unique in that the burden of kidney disease and those treated are visited disproportionately on African Americans. African Americans comprise 13% of the U.S. population but nearly one third of the patients on the kidney transplant waiting list. UNOS has an unenviable record of having ignored equity in kidney transplant allocation. It was noted in 1988 that HLA matching allocation discriminated against African Americans, who constitute 35% of the kidney transplant waiting list; some OPOs responded to this by not using HLA matching for kidney allocation to improve minority access for transplant. This action resulted in at least one case of a DSA having equal waiting times for African Americans and Caucasians, something not repeated throughout the rest of the country , . Despite this, UNOS persisted in its use of HLA matching for kidney allocation for nearly two decades before discarding this misbegotten policy. The silence in the concept paper over the impact the various policy proposals will have on minority access for transplant is thus disconcerting. REMAINING REQUESTED MODELING OUTPUTS: COST PER KIDNEY ACQUISTION; COST PER KIDNEY TRANSPLANT; NUMBER OF KIDNEY DISCARDS; NUMBER OF ECD KIDNEY TRANSPLANTS; NUMBER OF DCD KIDNEY TRANSPLANTS, PERCENT KIDNEYS LOCALLY TRANSPLANTED DHHS Secretary Azar spoke about cost and value in his speech. Another way to understand the huge burden of this disease is just to look at the financial cost. In 2016, Medicare spent $79 billion to cover people with kidney disease, and $34 billion on patients with end-stage renal disease, adding up to $113 billion in total spending. That represents more than one in five dollars we spend in Medicare. Increased cost, travel: The massive cost of ESRD treatment, including transplantation is well known. A system that already struggles to reduce costs and is under significant pressure to do so would increase kidney travel on average by 226%. The cost of all these kidneys flying must be calculated and presented publicly. The percent locally used kidneys, a modeling feature in previous iterations of transplant policy was omitted from these scenarios and needs to be put back into SRTR calculations of allocation changes studied. That metric provides an assessment of the level of efficiency of proposed changes as well as an indication of the potential disruption to the process, system and most importantly, the patients. Increased cost, projected nationwide decrease in kidney transplants: However, in addition the cost assessment of increased travel and logistical changes to the system, the cost assessment must include the devastating cost of 1,700 fewer transplants resulting in 13% more patients each year remaining on dialysis, year over year, adding to the Medicare burden. Transplant centers will have the fixed costs of providing service, spreading these costs across 13% fewer transplants. Increased cost, discards: The effect of a massive increase in kidney travel on discards needs to be modeled. Increased cost, utilization of marginal kidneys, DSA by DSA, based on center behavior/acceptance rates: We request that the number of ECD, DCD transplants as well as percent kidneys locally transplanted are added to the modeling outputs in order to further assess cost increases to Medicare. The utilization of ECD kidneys effects transplant centers practice when losing kidneys to transplant. If centers in New York City can simply wait to have the best kidneys sent to them, the number of DCD and ECD kidneys recovered in NYC may not increase to help get more patients off the list and more than likely will decrease. While this will not hurt New York, since they are accessing kidneys from other states, it will hurt the states sending kidneys out, who will not likely be using the marginal kidneys from New York. The consequences to that are grave: Fewer kidneys transplanted across the nation. For centers in states doing fewer kidney transplants under these scenarios, the temptation to use more marginal kidneys (due to the loss of offers from good kidney donors in their state) is tempered by the specter of worse outcomes reported on the SRTR website. Patients comparing center outcomes will choose centers with better reported outcomes, possibly made better by accepting the better kidney offers and foregoing local utilization of marginal kidneys. The end result will be an overall decrease in kidney transplants and tragically, damage to the overall the complex health systems in states losing their own resources. Residents of those states will suffer. SUMMARY: The glaring, intentional and steadfast refusal to acknowledge that increased organ donation will save more lives, get patients off dialysis and do so at a fraction of the cost compared to the current proposals, is the Achilles heel in the performance of the federal contractor. A small group of people have driven this process at and within UNOS at which the beating heart has always been the abolition of DSA/state boundaries. The proponents’ communities (those on the ‘winning’ end) as well as the creators of the proposal (UNOS) do not need to be worried about the daily, monthly and year-over-year consequences of such draconian change. Bureaucratic and organizational inertia will virtually ensure that the system will never return to a system that focuses on ‘local’, tying together the community/state on both the donation and transplantation side. Any future potential changes will undoubtedly be small and incremental, designed to provide the illusion of being sensitive to supply side; they will be a mere ‘nod’ to provide cover and deflect criticism, never catching up to the initial ‘take’. Accountability for organ production and utilization will be forever disassociated with end-users of these life-saving resources. The sad truth is that if the New York City DSA/OPO performed even at the national average last year, they would have produced 156 more kidney transplants from the NYC OPO/DSA ii. In these proposals, they achieve that the same goal by getting nearly the same number of extra kidneys: 161, 165, 169, 136, 149 for each of the 5 proposals iii. How can it be defended that they get the same number of transplants without any effort on their part, by taking the best kidneys from neighboring communities and states? And, the community should aspire for New York City to be better than ‘average’. If New York City would improve to what its neighbor Philadelphia does, it would have 352 more transplanted kidneys recovered in their community, dwarfing what they will get by taking from nearby communities. A staggering number. NYC can achieve that performance – 14 other DSA/OPOs are already in that top quartile of performance. Yours sincerely, Göran B.G. Klintmalm M.D., Ph.D., F.A.C.S. Chief and Chairman; Annette C. and Harold C. Simmons Transplant Institute W.W. Caruth Chair in Organ Transplant Immunology Vice Chair, Department of Surgery; Division Chief, Transplant Surgery Professor of Surgery, Texas A&M College of Medicine Baylor University Medical Center Dallas, Texas Devin E. Eckhoff, MD Chair of Transplantation Surgery, UAB School of Medicine Director, Division of Transplantation University of Alabama Hospital Birmingham, AL Charles T. Van Buren, M.D. Emeritus Professor of Surgery University of Texas Medical School Houston Houston, TX For Immediate Release. Monday, March 4, 2019. Alex M. Azar II. Remarks to the National Kidney Foundation. Washington D.C.) SRTR Data Request. Variation in months to transplant deceased donor organ recipients. Median Waiting Time, DD non-multi-organ kidney transplants, by center, by DSA. 4/18/2018. Van Buren CT, Levin BS, Shafer TJ, Andrews CE. Racial Equity in Kidney Transplantation: A Better Model. XIX International Congress of The Transplantation Society. August 25-30, 2002: Miami, USA Van Buren CT, Shafer TJ, Andrews CE. Does Kidney Allocation Based on HLA Matching Adversely Affect Minority Access to Transplantation? Joint Meeting: American Society of Transplant Surgeons and American Society of Transplant Physicians. May 15, 2001: Chicago, Illinois Table 2a: Kidney Transplant Counts by DSA. Scott Castro M.P.P. and Abigail Fox M.P.A. UNOS Policy & Community Relations Department. Concept Paper: Eliminate the Use of DSAs and Regions in Kidney and Pancreas Distribution OPTN/UNOS Kidney and Pancreas Committees. Scientific Registry of Transplant Recipients. SRTR, KI2018_01 Data Request on Circle Based Allocation: DSA level data tables. SRTR Data. Deceased Donor Kidneys Transplanted by Recovery DSA - 2018; DSA Total Deaths 2015 taken from Osr_final_tables1701.xls http://www.srtr.org/reports-tools/opo-specific- reports/page 7. Based on OPTN data as of January 15, 2019. Kidneys Transplanted by Recovery DSA per 10,000 deaths

Gift of Life Donor Program | 03/22/2019

Gift of Life believes any policy for broader sharing of kidneys needs to address the practical implications for OPOs and transplant centers. Kidney recovery and transplantation and the success we have enjoyed as a national system has greatly benefited from the relationship of the local transplant center and the local OPO working together in their community to impact patients awaiting kidney transplantation in their community. We strongly believe the kidney committee needs to evaluate theses concerns and have effective policies to address some potentially significant unintended consequences sharing kidneys may have on decreasing donation and increasing kidney discards. We have listed some of these concerns below. Additionally the committee should eliminate any concentric circle model as urgency for kidney transplantation is different than in the extra renal organs and the concentric circle model in the densely populated mid-atlantic area has a much more deleterious effect than in other less densely populated areas of the USA. Effect on innovation: DCD donation has had significant growth in the last 15 years and is really a great example of the effect of local transplant center and local OPO cooperation. Fundamental to its success was the inherent benefit derived for local candidates from the significant local resources needed to get a program off the ground. This type of investment and risk would not have occurred with out the incentive of being able to prioritize local candidates for these organs. With broader sharing rules in place this type of innovation will be hampered and the committee should consider the potential future effects of stifling innovation and what effects it may have on performing donor intervention research. Effect on transplant center cooperation with the local OPO: Unlike other organs kidney recoveries are not performed by the surgeon who is accepting for a particular candidate. Transplant centers rely on the local team to perform this function. OPOs have agreements in place for local surgeons to perform kidney recoveries with the knowledge the kidney will most likely be offered first to a local program (with obvious exceptions for current limited mandatory sharing). We recognize now that many of the kidney recoveries are performed by liver centers and would most likely continue (although there is no rule that liver team must do this) We are concerned however that kidney only donor recoveries (DCD and kidney donors at the margin) it may be difficult to locate a recovery surgeon given lack of potential benefit to local candidates. The recovery of organ responsibility will then fall on the OPO and while a few have begun to hire independent recovery surgeons, we believe in the short term it will have a dampening effect on recovering what are considered marginal donors and could actually decrease organ availability. Effect on efficient allocation: Our OPO due to the number of kidney centers (15) and the largest kidney recovery and distribution in the US over the last decade has had the unique benefit of experiencing some of the unintended consequences of sharing with a large number of centers and has developed local "rules" to allow the process to be more efficient. This has greatly enhanced our ability to not only increase the number of kidneys recovered and transplanted but to also increase the efficiency at which kidney placement takes place. However when we attempt to place kidneys outside our local DSA, we routinely experience that other transplant centers and OPOs have not adopted some of these practices. To have a more efficient national system it will be important for the committee to consider the following: 1) Rules re when a xmatch (virtual or serologic) needs to be completed and in what time frame 2) Rules re tx ctr locating, medically clearing and candidate accepting 3) Rules re accepting center having appropriate back up in place 4) Rules on opos sharing blood pre recovery 5) Rules on tx role in kidney recovery 6) Rules on number of candidates cleared 7) Rules on tx centers accepting more than one kidney at a time (particularly important in dense geographic areas as mid atlantic region ) multiple simultaneous donors of same blood type will be significantly difficult to work through the allocation 8) Rules on waivers, what do they mean? 9) Increased complexity of allocation will decrease overall efficiency and will lead to an increase in kidney discards 10) Rules on biopsy of kidneys (local determination?) 11) Requirement for back up patients and a definition of what that means 12) Role of third party screening 13) accurate candidate listing by transplant center and monitoring of inappropriate organ turndowns Effect on organ preservation 1) Shift of organ pulsatile preservation from OPOs to tx center? 2) What kidney gets pumped who determines? Effect on cost 1) Increase in travel costs (ground and air) 2) Increase in OPO workload coordinating not only your local activity but now import activity 3) Increase in transplant center workload with the number of offers Gift of Life, its 15 affiliated transplant centers and our local community hospitals have demonstrated our commitment to candidates awaiting transplantation by consistently increasing donation over the past 40 years. We have also shared the largest volume of organs outside our DSA to take care of ill patients across the United States. We would ask that the committee and the OPTN seriously consider the unintended consequences of broader kidney sharing and have effective policies and tools in place to mitigate these concerns before any policy is implemented. Gift of Life is committed to be an active participant in improving our nations organ donation and transplantation system

Anonymous | 03/22/2019

I think we should not eliminate DSAs.

Anonymous | 03/22/2019

20 - fixed concentric circles 16 - hybrid Circle size: 14-150NM, 11-250NM, 6-300 NM, 11-500NM Hybrid: 5 shallow points within circle, 10 steep points within circle, 14 none 2 shallow points outside circle, 10 steep points outside circle, 14 none Should there be different distribution systems for kidney and pancreas: 27 yes, 9 no Comments: Some members asked if the committees had discussed what would happen to Alaska donors. One member commended the committees for giving more prioritization to pediatric patients. A suggestion was made that since we cannot model behavior, to conduct future modeling using an ideal state where it is assumed that the organ is accepted by the first transplant hospital to which it was offered. The region discussed whether the urgency or the problem the committees are trying to solve is outweighed by the risk of unintended consequences and spillover costs and encouraged careful consideration by the committees and Board. In addition, a comment was made that the removal of DSA and Region in the proposed models, appears to make no improvements in overall volume of patients receiving kidney and pancreas transplants, hence, why are we proposing these policies? One member requested evidence of the limitations of modeling, stating that if he is being directed to consider that the modeling limitations include lack of predictability for changes in behavior, then a margin of error and historic evidence should be included with the results for the public to consider.

Jaime Bartley | 03/22/2019

These proposals fall short in seeking to achieve the best use of donated organs. All models propose a significant decrease in overall transplants, which is unacceptable. Additionally, consideration needs to be given to promote the efficiency of managing and placing donated organs. Increasing cold ischemic times, costs, and efforts to coordinate transplants is counterproductive to the ultimate mission of all transplant professionals. As a registered organ donor, these models also concern me, as it relates to the best use of my donated organs, should I be eligible to donate at the time of my death. I recognize the inequity in wait times to transplant across the nation, however the focus needs to be placed on the inequity of donation rates among regions and promotion of optimal management of eligible potential donors. Focus and improvements are needed to promote organ donation and organ donor management vs. having organs travel further for transplant, which will inevitably complicate an already complex and fragile process and increase healthcare related expenses.

Houston Methodist Hospital | 03/22/2019

This comment is the opinion of the Houston Methodist Hospital regarding the current deliberation by the United Network for Organ Sharing (“UNOS”) Kidney and Pancreas Transplantation Committee (“Committee”) in reference to the deceased donor organ allocation policy. As you are well aware, this issue is complicated by the variability in geography, population density, and disease distribution across the country. While clearly the Committee must choose an allocation model that is fair and equitable to all potential recipients, we believe that patients from Houston and South Texas have specific vulnerabilities regarding some of the options being considered for allocation. This letter focuses on the hybrid framework with a single 500 NM circle that utilizes a large number of proximity points (steep points) inside and outside of the circle. First, it is important to note that we are in full support of the continuous effort of the Committee to achieve a fair solution for the problem of geographic disparity in transplantation. We also are, at this time, in support of the concept of concentric circles of distribution for kidney organs in a manner similar to that applied to other organs. However, our patients are especially concerned that half of any proposed circle used for organ distribution area will be negated by the presence of the Gulf of Mexico on our southern border and will limit their access to donors. While this is a problem for other regions of the country located on the coast, a notable difference in Texas is that there are no large population centers for quite a distance inland from where the majority of all Texas listed patients are located. The other population centers in the state of Texas are all located at a distance of over 150 miles. Houston and South Texas patients represent 41.5% of patients on the waiting list for kidney transplantation in the State of Texas. Thus, to our patients, a circle of distribution of less than 250 miles means erecting a barrier for organ allocation that does not currently exist and is likely to limit their opportunities based on geography. As of today, our patients in Houston are served by LifeGift OPO which has coverage in 3 different corners of the State including the Houston area, the Lubbock area (northern portion of the State), and the Fort Worth area (middle of the State), all of which are separated from Houston (southern portion of the State) by 532 miles (462 nm) and 269 (233 nm), respectively. Additionally, another high performing OPO, STA, produces 232 kidneys annually for Dallas / Ft. Worth. This enhanced access to kidneys within the current Donation Service Area (“DSA”) that has a 500 mile radius allows our patients a minimally acceptable transplant access area. Our patients would be severely harmed by any consideration of a smaller circle for the distribution after dissolving the DSAs and regions as units of distribution. A 150 mile circle around the Houston area would exclude access to donors from the Fort Worth and Lubbock regions which currently provide our patients with a significant number of kidneys equivalent to 354 in the last 3 years or approximately 118 kidneys per year. Thus, imposing a 150nm or 250 nm mile circle for patients, rather than the current sharing across all the State of Texas and Oklahoma, would significantly shrink our patients’ access to kidneys and would impose a new form of circular DSA that uses geography to limit access of our patients to life saving treatment. Enacting a concentric circle of distribution smaller than 250 miles will create a geographic barrier that is no different than the concerns with the current DSA and OPTN Region schemes and would be contradictory to the OPTN Final Rule of December 4, 2017 “(OPTN Final Rule”) and 42 C.F.R. 121.8. As stated in the OPTN/UNOS Public Comment Proposal “a circle drawn too small could improperly prioritize local organ offers and fail to balance all of the requirements of the OPTN Final Rule”. Houston and the South Texas region are prime examples of the effects of such an outcome. Despite the potential arguments that may be used to rationalize the smaller geographical circles, including balancing the need to drive or fly less, the fact is that despite higher logistical and CIT barrier considerations, the UNOS Board of Directors imposed the 250 mile radius as a boundary for lung and liver distribution and UNOS has successfully implemented this policy in lung distribution with uniform acceptance by transplant centers and patients across the country. Anything short of that standard would be hard to justify or defend. Indeed, smaller circles run contrary to the directive set forth in HRSA’s July 31, 2018 letter to UNOS which states that “‘[a]llocation policies shall be designed to achieve equitable allocation of organs among patients consistent with [42 CFR 121.8(a)]’ through several articulated performance goals, include ‘[d]istributing organs over as broad a geographic area as feasible under [42 CFR 121.8(a)(1)-(5)]’.” In addition, establishing circles within the Hybrid 500 NM geographic range will meet the four Principles of Geographic Distribution adopted by OPTN/UNOS. Specifically, these are that geographic constraints must: 1. Reduce inherent differences in the ratio of donor supply and demand across the country; 2. Reduce travel time expected to have a clinically significant effect on ischemic time and organ quality; 3. Increase organ utilization and prevent organ wastage; and 4. Increase efficiencies of donation and transplant system resources. We acknowledge the difficulties of creating an allocation system across a wide variation of geography and population density in a country as the large as the United States. However, we believe that a reasonable and fair solution is the hybrid framework with a single 500 NM circle that utilizes a large number of proximity points (steep points) inside and outside of the circle. This distribution is rational, meets the criteria required by HRSA and applicable regulations and guidance, does not create a geographical barrier for most centers and patients, and has proven to be workable with lung allocation. We appreciate the opportunity to bring our concerns on behalf of Houston and South Texas patients to the Committee and we look forward to the Committee reaching a solution that achieves the goals of reorganization needed to maintain an equitable and fair system for transplantation.

Anonymous | 03/22/2019

I am having a difficult time understanding why we are focused on choosing between the models offered up for discussion when all models are predicted to decrease the total number of transplants annually. This predicted outcome directly contradicts our goals and responsibilities to our patients as transplant professionals.

American Society of Transplant Surgeons | 03/22/2019

The American Society of Transplant Surgeons (ASTS) is responding to the request from the OPTN to indicate why one or more suggested options would be a better as replacement of the current distribution system for Kidney and Pancreas Transplantation. As the representative organization for transplant surgeons, physician assistants, and administrators at US transplant centers who are on the frontlines of transplant care, we are responding within the context that one of the options must be chosen, but remain concerned about the rapidly and foundation of this decision. The ASTS perspectives are grounded on evidence tied to the Final Rule, particularly the impact on efficiency in organ placement and on achieving the best use of donated organs. Furthermore, the ASTS will indicate its preference with comments on the defining characteristics of the size of circles and the number of proximity points that should be awarded. ASTS recognizes the evolving priorities of the national organ allocation system. This includes an understanding that current policy development efforts to remove donation service areas (DSAs) and OPTN regions from all organ distribution policies, including the upcoming kidney and pancreas allocation policies. This is consistent with The Final Rule requirement that policies “shall not be based on the candidate’s place of residence or place of registration, except to the extent required” by the other requirements of the Final Rule. These “other requirement” include use of sound medical judgement, achieving the best use of donated organs, avoiding wasting organs, promoting patient access to transplantation and promoting the efficient management of organ placement. The ASTS agrees with The Workgroup’s decision to reject the option of a national allocation system that places no limitations on geographic distribution for either kidney or pancreas.This type of system is clearly likely to increase organ discard and is logistically and clinically impractical. ASTS has concerns, however, that some of the proposals in the concept document are over reaching and may have inadvertently conflated the need to eliminate DSAs with the idea that the larger the area of distribution the more it will comply with that ideal. The goal of removing geography in other organ allocation systems has been aligned with efforts to improve other metrics (equality of access, improved organ utilization, reduce waitlist mortality). It is not clear from the concept document, how these important metrics will be advanced by the proposed variations. ASTS has concerns about the following considerations because the larger 500 NM circles (including the hybrid models) of distribution, compared to the smaller circles, result in progressively more burdensome and inefficient management of organ placement including substantially increased travel distance (longer driving distances and more flights – a safety issue) and increased costs that are not offset by a meaningful, if any, increase in organ utilization or transplant rate, number of transplants performed, wait list mortality rates, or waitlist mortality counts. In fact, all these components demonstrate setbacks compared to the current system or the smaller 150 NM option and 250 NM option. As a primary goal of the OPTN is to increase the use of organs, we would oppose any option that is likely to increase organ discard. We oppose all of the following: 1. 500 NM circle, no points: 2. 500 NM circle, shallow points: 3. 500 NM circle, steep points (the document shows the wrong option highlighted): The modeled analysis of the larger distribution area considerations indicates that transplant rates may decrease, that wait list mortality may increase, that the proportion of kidneys requiring air travel will increase dramatically, that procurement management will become more inefficient, costs associated with the overall organ procurement process will increase dramatically, and there are safety concerns with increasing driving times and distances and increases in air travel. ASTS does not agree with the notion in the report that the projected decline in efficiency and organ utilization which are likely to result from an over reaching, logistically complex organ distribution system will be corrected by transplant center behavior changes.There is clear evidence the KAS system which distributed high KDPI kidneys over larger regional areas (rather than the smaller local distribution areas) resulted in poor kidney organ utilization, high discard rates, fewer patients transplanted. The experience that behavior changes did not correct an inefficient distribution system. (Please see: Stewart, D. and Klassen, D. “Early Experience with the New Kidney Allocation System: A Perspective from UNOS,” Clin J Am Soc Nephrol; (December 2017) and Friedwald, J. and Turgeon, N. “Early Experience with the New Kidney Allocation System: A Perspective from a Transplant Center,” Clin J Am Soc Nephrol, (December 2017) ASTS is in favor of a DSA-free kidney distribution system that also rigorously applies sound medical judgement to achieve the best use of organs (i.e., increasing utilization and reducing discards), that avoids wasting organs, considers limiting cold ischemia time, and promotes efficiency (i.e., keeping costly and potentially less safe air travel to a minimum and limits cost increases), and considers travel safety issues. The ASTS position is that the most reasonable starting point for a new DSA-free distribution system for kidneys is to adopt a smaller fixed concentric circle model. The smaller fixed concentric circle framework variation aligns with the principles in the Final Rule and is based on sound medical judgement and promotes the best use of organs (including less cold ischemia time), as evidenced by limited impact on graft outcomes. This will also result in a starting point with less uncertainty compared to a kidney distribution system with larger circles in which undue burdens of inefficient management of organ placement, increased travel (including longer drive times, and more flights, and the attendant safety concerns) and increased costs are imposed without an increase in organ utilization or reduction in organ discards. This system also allows effective use of preservation technology (including pulsatile perfusion) and will allow the use of higher risk organs by centers with a minimal of cold ischemic time. ASTS believes the smaller concentric circle model would provide a stable starting point on which a future continuous distribution system can be built. The ASTS supports further iterations to include additional factors such as medical urgency, likelihood of graft survival along with proximity between the donor location and the transplant hospital. Candidates who best meet the combination of factors would receive the highest priority and those at closer hospitals would receive more relative priority than those at more distant hospitals. In addition, the priority given to the distance between donor hospital and transplant hospital could be adjusted over time as data becomes available on which to base new parameters. ASTS agrees with the Pancreas Committee recommendation that the pancreas allocation framework be determined separately as the tolerated ischemic time is lower for pancreata than kidneys. The lower tolerated ischemic time could impact acceptable travel distance, procurement process and the post-recovery organ utilization. The new Pancreas Allocation systems has been effective in stemming the reduction in the use pancreas allografts. In addition, the allocation system created a nationally consistent model which we strongly support.

Susan Ibanez | 03/22/2019

I DO NOT support any of the proposed models as each one predicts fewer transplants nationwide. The proposed changes are in violation of the Final Rule. Reducing the number of transplants will result in fewer lives saved, which goes against what we transplant professionals are trying to accomplish.

National Kidney Foundation | 03/21/2019

The National Kidney Foundation believes any replacement of the current distribution system should be designed to 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 future modification in organ distribution policy must also enhance access to transplantation for minority populations and those with low socioeconomic status as these groups have not historically had equal access to transplants. In addition, with any proposal implemented, we believe it is critical to monitor rates in organ donation, organ recovery and discarded organs as a result of the change in allocation policy.

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

We echo the concerns of many providing public comment on the removal of DSA and Region from kidney and pancreas allocation. These are: (1) the possibility of fewer kidney transplants being performed when compared to the current allocation rules, (2) the potential for a negative impact on socioeconomically challenged patients with limited access to tertiary care, and (3) the lack of effective modeling that identifies a framework compliant with the Final Rule, while maintaining current, or potential increases in transplant volume. This program’s experience with the October, 2018 heart transplant allocation changes has resulted in a significant increase in cost associated with surgical team travel, prolonged periods of time between organ acceptance and organ recovery, inconsistent processes and communication challenges while working with multiple OPOs and an increase in ischemic times. Our suggestion would be that the Committee identify acceptable allocation models that actually maintain or increase the current volume of kidney transplants, without the potential to limit patient access to transplantation. This would allow public comment on viable options that equally represent all geographic areas, not simply redirecting organs at the expense of patients residing in areas of lower population densities.

Saint Barnabas Medical Center | 03/21/2019

We recognize that the proposed modifications to the historical designation of donor service areas (DSAs) are intended to eliminate disparities in waiting times for kidney transplants among DSAs. While the intent of these changes is laudable, all 5 proposed allocation options appear associated with a troubling decrease in overall transplants and an increase in cost and waitlist mortality. Based on the information and modeling data from the guidance document, none of the suggested frameworks and variations is ideal, in that all of them are projected to produce an overall decrease in kidney transplants. Of these suboptimal choices, the only suggested framework that our team feels could be considered is the hybrid with a 500 nautical mile (NM) circle and a larger # of proximity points. Additional points that should be considered if this concentric model is pursued are as follows: • An expanded geographic model could result in increased cold ischemic time and cost of transplantation. Increased ischemic time could negatively affect patient outcomes and transplant rate. The increased cost, due to increased travel, could impose a burden on programs and payors, and ultimately upon patients. • We do not agree that proximity points should only be awarded to the donor hospital, but we do agree that additional factors could be vital to improved distribution, such as dialysis time and CPRA. • Programs located in coastal regions appear to be further disadvantaged, due to the limited area of the NM circle. • While the proposed frameworks seek to correct a current perceived disadvantage to some geographical areas, the new system will initially create significant disadvantages to a larger number of patients and will take years to ultimately reach a truly equitable distribution. • Additionally, on a regional note, the advent of the new allocation systems will result in a sudden disadvantage for wait-listed patients who are not listed in an area that has the longest current wait-time. While equitable distribution should be the goal, this change needs to be done in a gradual fashion so that, for example, a wait-listed patient who is expecting to receive a DDKT in the next 3-6 months is not suddenly expected to wait-time 2-3 years for a DDKT. A gradual change in the allocation system can be achieved by assigning 2 points to a wait-listed individual if the donor organ is procured in that individual’s OPO. Over several years, the assigned points can be gradually decreased down to zero. This will ensure that current wait-listed patients do not have a dramatic increase in their wait-time through while still gradually ensuring equitable deceased donor organ distribution.

Anonymous | 03/20/2019

1. FEWER Kidneys Transplanted. 2. Longer distances traveled, Increased Cold Ischemic Time, Increased rates of Delayed Graft Function, Worse outcomes for recipient patients, more expense for transplant programs and lower outcomes. 3. More harm than good, and FAR MORE COMPLEXITY. 4. This policy makes no sense to anyone who does not have a strong pre-determined bias that geography must change. 5. Agree that we need to focus on INCREASING transplantation to all in the country by removing the disincentives to transplant. These disincentives are chiefly outcome measures as calculated and determined by MPSC/SRTR/CMS, and the poor reimbursement of cost of transplantation to programs if they dare to transplant any risky organs or patients. If you do not address the actual major disincentives to transplant, you will not solve the problem.

Thomas Waid | 03/20/2019

I believe the model further advantages large urban centers, mostly in California and New York, and disadvantages the heartland of the country who already lack resources and where patients travel longer distances for their transplantation access and care. Heart quality organs will be shunted to the above-mentioned Urban centers leaving high K DPI organs to be transplanted locally. This will likely increase the rate of delayed graft function and decrease graft survival for the disadvantage centers. I believe the proposed changes are in violation of the Final Rule (121.4-121.8) i.e. policies for the equitable allocation of cadaveric organs… shall be designed to avoid wasting organs, avoid futile transplants, promote patient access to transplantation, and promote the efficient management of organ placement.. The proposed changes will decrease access to transplantation in my region by 30% and leave us with many more high K DPI kidneys which will continue to be discarded.

Thomas Waid | 03/20/2019

I believe that any proposal which decreases the number of kidney transplants by 1100-1300 kidneys per year is poorly designed. The majority of DSAs will see an overall decrease in the number of kidney transplantations performed. In my region the average distance and organ travels a 67 miles and that is due to increase by 104% to 408% depending on the distance traveled within this concentric circle model. This is certain to increase cold preservation time and more importantly will significantly increased cost of transportation. Waitlist mortality is projected to rise in every statistical model. Likewise graft failure rates are projected to increase. This is contrary to the stated goals of CMS for patients needing kidney transplantation.

Kevin O'Connor | 03/20/2019

The most recent SRTR program specific reports show that program level kidney offer acceptance practice ratios (compared to national offer acceptance practices) vary widely, from < 0.5 to > 2.0 [https://www.srtr.org/reports-tools/program-specific-reports/] Further, the kidney concept paper states: According to the SRTR analysis report, “the KPSAM was fit on acceptance occurring within a local (DSA), regional, and national framework, wherein there’s a strong preference for local offers. Acceptance behavior will likely change in response to changes in organ availability at a center, and transplant counts and rates may not decline in reality. Previous experience with the SAMs suggests that they under-predict the number of transplants that would occur in reality if a given policy scenario were adopted, although they typically predict the direction of subgroup changes.” It would be informative to run the simulation model with the behavioral assumption that every kidney would be accepted by the first center it was offered to. Then we would know the “true” impact of the policy change on redistribution of kidneys and on transplant volumes, rather than the KPSAM results based on historical acceptance practices that vary widely from center to center, and will almost certainly change in response to a new set of allocation rules.

Jennifer Watkins | 03/20/2019

It would be very difficult to support any of the frameworks discussed in the proposal, as ALL of them reduce the number of transplants being performed. Our priority should be the best use of the gift of life so graciously offered by our donors and donor families. Reducing the number of transplants and, subsequently, saving fewer lives, is contrary to our calling as transplant professionals. I look forward to seeing additional proposals that do not reduce transplant numbers. Thank you.

Anonymous | 03/20/2019

We commend the OPTN for seeking new ideas to improve the allocation and distribution of deceased donor organs. The purpose of this memo is to stimulate productive discussions and accelerate changes needed to facilitate more life-saving transplants. This memo reflects input from the National Kidney Registry (NKR) and our constituents; and is offered in response to the OPTN’s request for feedback from the NKR related to the following concept papers: o Eliminating the use of DSA and regions from kidney and pancreas distribution o Guidance on effective practices in broader distribution The NKR is the largest paired exchange program in the world and has facilitated over 3,200 transplants since its inception in 2007. The NKR facilitates transplants for the most difficult cases including incompatible donor-recipient pairs, high cPRA patients, patients with more time on dialysis, etc. These transplants demonstrate a 34% lower death censored graft failure rate at seven years compared to all U.S. living donor transplants. The NKR graft survival advantage is statistically significant at 3, 5- and 7- years post-transplant. Approximately 80% of NKR facilitated transplants involve the shipment of a kidney on a commercial airline, charter flight or ground courier. The NKR has never lost a kidney or discarded a kidney due to a logistics problem or the accumulation of cold ischemic time (CIT). In 2019, the NKR expects to facilitate over 700 KPD transplants, complete over 35,000 online living kidney donor registrations and provide life and disability insurance for over 1,000 living donors. The issues under review in the above concept papers are core to the operational success of the NKR. Because NKR draws its experience from facilitating only kidney transplants, our recommendations are not necessarily intended for, but may be applicable to, other organ systems. We believe the solutions to the problems outlined in the concept papers require a broader view of the issues, so we have provided recommendations that go beyond the initial parameters of the concept papers. Benefits Changes to the OPTN system have the potential to achieve the following objectives: ? Increase the number of transplants: The number of transplants can be increased by utilizing thousands of deceased donor kidneys that are currently being discarded. ? Improve equity and access to transplants: Equity and access to transplants can be improved by ensuring that the majority of waitlisted patients, regardless of where they live, experience similar wait times for a deceased donor kidney. Also, simplifying the organ allocation process so that it is easier to understand will improve the perception of equity and fairness. ? Improve waitlisted patients’ and transplant recipients’ outcomes: Reducing wait times and facilitating more transplants through the utilization of kidneys that are currently discarded will improve the outcomes for waitlisted patients and transplant recipients. Improved donor-recipient matching, and less CIT will drive better graft and patient survival rates, thus improving outcomes. ? Promote transplant recipient safety: Transplant recipient safety will be promoted by reducing wait times and facilitating more transplants through the utilization of kidneys that are currently being discarded. ? Better serve the most vulnerable populations: The most vulnerable populations will be better served by improving the accuracy of the cPRA calculation and enhancing the precision of the points awarded to hyper-sensitized patients. Approximately 1,000 100% cPRA patients – who are essentially stuck on the wait list – will have a better opportunity for a transplant. ? Improve OPTN efficiency: By utilizing kidneys that are currently being discarded, each additional deceased donor kidney transplant will save Medicare and private health insurance providers approximately $500,000 per transplant (present value). Better donor-recipient matching, and less CIT will also reduce graft failure rates and save on dialysis related costs. ? Reduce Healthcare Costs: If 2,000+ additional kidney transplants per year can be facilitated, Medicare and private health insurance providers will save approximately $1 billion annually. If kidney discards can be reduced, and facilitate more transplants, the savings will more than offset the costs to improve the deceased donor kidney match offer & logistics process. The OPTN should be reimbursed by Medicare and the private health insurance providers for facilitating more transplants. One approach that would better align the financial interests of the parties would be to replace the current OPTN registration fee with a higher transplant success fee. Recommendations We recommend that the OPTN streamline its decision-making process to better support faster decision making and implementation. Vesting more decision-making authority in senior OPTN leadership and reducing the size of the board are a few strategies that may help facilitate a more streamlined decision-making process. We recommend that the OPTN move from the current sequential match offer process to a batch match offer process. This will speed up the kidney offer/acceptance process, reduce cold ischemic time and reduce organ discards. The batch match offer process should execute in three tiers with three hours allotted for each tier. If there are no potential match offers in a tier, the system would immediately skip to the next tier and make the next batch match offer. The first two tiers would complete in a total of six hours allowing the final batch offers to go out with only six hours of match offer related CIT. The final batch of match offers would go out nationally and allow for the placement of organs which are currently being discarded. The following is an outline of the three-tier batch match offer approach. Tier-1: Special Situation Offers o Offer timing 0 – 3 hours o Target: 1%-5% of transplants facilitated in tier-1 offers o Offers would target approximately 0 – 5 potential matches o National in scope: no geographic limits o Target examples: 99.99%+ cPRA patients, great donor-recipient matches, etc. o The patient with the highest points, that accepts, receives the offer o No patient wait time limitations on tier-1 offers Tier-2: Local Offers o Offer timing 3 – 6 hours o Target: 70%-80% of transplants facilitated in tier-2 offers o Offers would target approximately 0 – 20 potential matches o Ground moves only: 400 miles radius from donor recovery hospital ? The 400-mile limit equates to about an 8-hour max drive time ? The 400-mile limit avoids air moves that are riskier and less reliable ? The 400-mile limit could be reduced or increased but should be standardized nationally based on the logical limits (drive time) of ground moves o The patient with the highest points, that accepts, receives the offer o Only offered to patient with, for example, > 4 year wait time o Max points allocated to patients with, for example, > 5 year wait time o The above conditions will stabilize the entire system around a 4-5 year wait time o The wait time range (4-5 years) could gradually be narrowed (e.g. 4.3 – 4.6 years) o A narrower wait time range would allow centers/patients to better prepare for offers and would eliminate the current incentive for patients to multi-list Tier-3: Clearing Offers o Offer timing 6 – 9 hours o Target: 20%-30% of transplants facilitated in tier-3 offers o These are the kidneys that are currently being discarded o Waive CMS outcome related penalties for tier 3 transplants o Reduce the SAC fee to 50% to offset extended hospital stay costs, etc. o The first center/patient to accept the kidney, receives the offer o National in scope: no geographic limits o No wait time limitations Transplant centers would be encouraged to maximize utilization of donor preferences to filter out match offers that will not be accepted, thus reducing the number of match offers requiring responses, improving the overall efficiency of the system. Center match offer declines and non-response rates would be tallied and published to provide transparency for patients. Non-responses and declines should be minimized. Batch Match Offer Examples: Scenario 1: Two patients are offered matches in the first batch offer and both centers/patients accept the offers. Patient 1 has a cPRA of 99.990% and is an ‘A’ blood type (odds of match = 1 in 10,000). Patient 2 has a cPRA of 99.990% and is a ‘O’ blood type (odds of match = 1 in 10,000). Since patient 2 will be drawing from a smaller donor pool and has a higher cPRA, they will accrue more points (see section on Calculated Panel Reactive Antibodies) and receive the match offer. Scenario 2: The centers caring for the two patients in scenario 1 either decline or do not respond. After three hours, the first match offers are closed out and a second batch match offer is sent to 18 patients within 400 miles of the donor center. All of these patients have been on the wait list for some minimum amount of time (e.g. 4 years). After three hours, 4 offers have been accepted, 8 offers have been declined and 6 offers have not received a response. Out of the 4 offers that have been accepted, the patient with the highest points receives the offer. Scenario 3: All of the offers in scenario 1 & 2 have either been declined or have not received a response. After three hours the tier 2 match offers are closed out and a third batch match offer is sent to 45 patients that are biologically compatible, preference compatible and have opted into tier 3 offers. After 45 minutes, a center accepts one of the offers and the remaining 44 offers are closed. Eliminate Provisional Acceptances The batch match offer process requires the elimination of the ‘provisional’ acceptance which is always problematic in time sensitive processes. If an offer is accepted, the kidney must go to the intended recipient. If the kidney does not go to the intended recipient and the center is above a cutoff threshold for this kind of situation (e.g. > 5% kidneys not going to intended recipient), the recipient center would pay an out of compliance fee (e.g. $20,000). This will encourage centers to only accept offers for kidneys that are actually acceptable for patients that are available for surgery. When kidneys are frequently given to backup patients because the intended recipient fails the cross match, is not ready for surgery, etc. it undermines fairness and trust in the system. The rate of kidneys not going to intended recipients should be published to support transparency for patients. The elimination the ‘provisional’ acceptance also requires all information related to the kidney to be online before the offer is made. If this information is not available or is inaccurate when the offer is made, the procuring OPO should pay the out of compliance fee. When certain critical information cannot be made available before the match offer goes out, this should be noted in the match offer and should automatically generate a root cause and correct action plan request. Revise Calculated Panel Reactive Antibodies The OPTN needs to change the current cPRA calculation to a ‘brute force’ calculation so that the cPRA is precise and can better serve hyper sensitized patients. The brute force calculation will better reflect changes in the donor pool composition and accurately differentiate between a 99.990% cPRA patient and a 99.999% cPRA patient, the later which is ten times as hard to match as the former. The current OPTN kidney point allocation rounds a 99.51% cPRA patient up to a 100% cPRA. This point allocation needs to be enhanced to differentiate between patients with very high cPRAs (e.g. 99.9%, 99.99%, 99.999%, etc.) and point assignments must also be adjusted to reflect the expected donor pool volume for a given patient blood type. For example, a 99.99% ‘O’ blood type patient is twice as hard to match as a 99.99% ‘A’ blood type patient. Currently, the OPTN kidney cPRA point allocation ignores the patient blood type and rounds to the nearest percent (e.g. 98%, 99%, 100%). This approach is far too imprecise to equitably serve the thousands of hyper sensitized patients on the wait list. We recommend enhancing the point allocation for highly sensitized patients by basing it upon the patient’s expected wait time. This approach would use the more precise brute force cPRA and the expected blood compatible donor pool (e.g. projected based on the past 2-3 years) to calculate the expected wait time for each patient. This approach has helped the NKR consistently match and transplant hyper sensitized patients with cPRAs up to 99.7% on a living donor pool of only 700 donors per year. Based on the NKR experience and the larger deceased donor pool, we would expect the OPTN to consistently match and transplant patients with cPRAs up to 99.997% if the point allocation for highly sensitized patients was enhanced. The following are expected wait time calculation examples: ? If a patient has a 99.99% cPRA (match odds = 1 in 10,000), is an ‘A’ blood type and the donor pool will provide approximately 12,000 blood compatible donors/year; this patient’s expected wait time would be approximately 1 year (10,000/12,000). Minimal points needed to find a match. ? If a patient has a 99.999% cPRA (match odds = 1 in 100,000), is an ‘A’ blood type and the donor pool will provide approximately 14,000 blood compatible donors/ year; this patient’s expected wait time would be approximately 8 years (100,000/12,000). Maximum points needed to find a match. ? If a patient has a 99.999% cPRA (match odds = 1 in 100,000), is an ‘O’ blood type and the donor pool will provide approximately 6,000 blood compatible donors/ year; this patient’s expected wait time would be approximately 17 years (100,000/6,000). Maximum points needed to find a match. Because many transplant centers cannot perform accurate virtual cross matching, which is critical for matching highly sensitized patients in a time sensitive environment, the OPTN should designate high cPRA centers of excellence. Any patient with a cPRA greater than the high cPRA cutoff (e.g. 98%) should be referred to one of these high cPRA centers of excellence so that the highly sensitized patients have an opportunity to receive a well-matched deceased donor transplant. As a point of reference, there are over 6,000 wait list patients with a cPRA of over 98% and approximately 1,000 patients with a cPRA of 100%. Improve Logistics The logistics required to support an effective batch match offer process should include the following key components: o RCCAP Process: Any match offer or logistics failure should automatically generate a request for a Root Cause and Corrective Plan (RCCAP) from the organization responsible for the failure. For example, if a kidney did not get transplanted into the intended recipient, a RCCAP should be completed by either the transplant center or the OPO. A Pareto analysis should be performed on the RCCAPs monthly to initiate solutions for recurring problems that can be systematically corrected. The Pareto analysis should be published to support transparency. o GPS Tracking: Utilize smart phone GPS technology for all shipped organs. Integrate GPS tracking with ‘fail-safe’ systems to ensure positive confirmation of all inflight organ moves (e.g. wheels-up and kidney on plane, plane landed and kidney on the move, etc.). o Logistics Monitoring: Implement real-time logistics failure reporting systems that are integrated with the GPS smart phone technology and the national courier vendors. Examples of these real-time integrated monitoring systems include the NKR’s swap tracker and move tracker. o OPO Efficiency: There are currently 58 Organ Procurement Organizations operating individual geographic monopolies in the United States. The lack of competition in any market allows for poorly performing organizations to stay in business and underserve their markets. This is true for the OPO market as it is for all markets. To foster competition and systematically close poorly performing OPOs, a process should be created whereby the lowest performing OPOs (e.g. 2-5 per year) are merged into the strongest bordering OPOs. This would also allow OPOs to leverage economies of scale which are significant in the OPO industry. o National Couriers: The OPTN, working in partnership with the OPOs, should contract with 2-4 national organ couriers to move all organs beyond the local OPO donor service areas with an option to provide services within donor service areas. These courier vendors should be positioned to back each other up. The best performing courier vendor(s) should receive the largest portion of the business so that competition is fostered and top performance is systematically rewarded. The courier contracts should include clear service standards and penalties. o Avoid Connector Flights: When shipping organs via commercial air, connector flight moves should be replaced with charter or charter/commercial hybrid moves whenever possible. If there is no other option, connector flight moves should always utilize an onboard courier to mitigate the extreme risk inherent in this mode of transport. o Charter Flights: The national courier vendors should manage the acquisition of charter flights to concentrate purchasing power across all OPOs. Generally, prop charters should be used for shorter distances (e.g. under 1000 miles) and jet charters should be used for longer distances (e.g. over 1000 miles). Charter/commercial hybrid moves are generally the fastest and most cost-effective method of moving a kidney more than the maximum driving distance (e.g. 400 miles). The NKR has not experienced problems with a shortage of charter flights or pilots. o Organ Containers: The OPTN, working in partnership with the OPOs, should develop & deploy a standardized kidney shipping container that supports a standardized kidney pump, built-in signage and a compartment for holding a standardized GPS smart phone. The advantages of pumping a deceased donor kidney is well documented. These standardized kidney containers should be purchased in volume (including a national maintenance contract) and seamlessly shared across all OPOs. o Lost or Damaged Organs: The OPTN should provide a quarterly report on all organs lost in transit of damaged (e.g. kidney frozen in flight, kidney ended up in wrong city, etc.). A RCCAP should be completed for every lost or damaged kidney keeping in mind that each kidney has the potential to save someone’s life and also save Medicare and the private insurance companies approximately $500,000. Enhance Donor-Recipient Matching The current OPTN point allocation for donor-recipient matching is based on A, B, DR antigen miss-matches. This point allocation approach to donor-recipient matching is dated and should be upgraded to reflect the latest science for evaluating the quality of the donor-recipient matches (e.g. Living Donor KPI, specific antigen mismatch risk for de novo antibody, epitope matching, etc.). This is an opportunity for collaborative research to find the best approach for improving long term graft survival through better donor-recipient matching. Conclusion Thank you for requesting feedback from the National Kidney Registry on these important concept papers. Please let us know if you have any questions or if we can be of any additional service to the OPTN on these important matters.

Jeffrey Meador | 03/20/2019

I do not support the proposals as each model predicts fewer transplants performed nationwide in violation of the Final Rule. Any proposal with even the potential to result in fewer transplants overall should not be under consideration. I believe all the models would lead to wasting organs and decreasing patient access to transplantation across many areas of the country to the benefit of a select few. Decreasing geographic disparity and increasing equity is a worthwhile and necessary goal however it cannot happen at the expense of an overall benefit to the majority of people.

Asif Sharfuddin | 03/20/2019

Response to Removal of geographical boundaries of DSA from allocation. Geography and population density: The CR150/300 and 250/500 assumes the donor density is same across the country which is not the case. Anytime there is an allocation based on geography this is a critical factor which needs to be adjusted so as to avoid skewing of organs and not go against the final rule where geography population density does not make it an uneven field. The hybrid system may be the best way of accomplishing this. Multi-listing: How does UNOS intend to handle patients who are now multi-listed across different DSA’s? in any of the new proposed systems. How will that transition happen ? What advantage or disadvantage does a candidate have in multi-listing ? How do they plan to educate the members and the candidates about the options of multi-listing ? Median Wait times- Based on current donation rates for last 5 years, as of Dec 2014 since new KAS , can UNOS project the change in median wait times for different sub groups such as > 65, Blood types atleast , in different regions or prior DSA boundaries and in different centers? This will help members educate the candidates more effectively. Can the KPSAM, project change in number of transplants changing in regions and different centers ? Part of this data is available in general on the maps , but more concrete data will help centers prepare accordingly to educate their candidates. Ethical Travel Costs: If there is still an advantage of a candidate getting listed at different centers to potentially increase their chances (if any), we need to remember not all socio-demographic populations can afford to travel and get multi-listed – that gives an unfair advantage to those who are financially able to do so. Although unfortunately this advantage currently exists, we don’t want to exacerbate this if a particular lower socio-economic region ends up with a longer than currently projected wait time, and they cant afford to multi-list. Prolonged Cold Ischemia Times: May increase DGF rates, and lower graft survival which in turn may increase the wait list. We are always under the scrutiny of CMS/MPSC, and can this affect behavior of acceptance patterns which may further decrease transplant rates. Acceptance behaviors are unpredictable as CIT increases. Data on CIT would be usedule to review by the committee and members. Pump Time / Costs : Changes in program activity may negatively impact resources allocated by that program. Loss of resources puts a substantial drain on the work up times which has downstream impacts etc. KDPI high – may need to be allocated differently, as the acceptance behaviors are highly variable for such offers amongst centers particularly low volume centers. This can have two consequences – take higher risks to keep up numbers and potentially suffer inferior outcomes and come under review / OR / no change in behavior and potentially suffer lower volumes. This can be better addressed by simulation of center volume or regional volume changes as mentioned above. OPO performance efficiency is variable. Since pay back is already eliminated, are their any incentives for an OPO to increase their performance where their own local efforts amongst their community(region) may not result in organs staying in their own region. Again this can be simulated on how many organs would have been offered outside the “local” offers to make a projection. Local community engagement with OPO. OPO’s are heavily involved with the local hospitals and community. Although this may end up being a net even situation, a particular donor hospital or community may not become as engaged if it siphons organ offers to non-local regions. Directed Donation – We believe there is an exception which will be in place.

Anonymous | 03/19/2019

The proposals and their models do not provide good and ethical distribution of organs for transplant patients. These models will impact transplant patients by decreasing the number of organs available in a Region. It is also a violation of The Final Rule CFR 121.8. These proposals are not helping donor allocation it is hurting donor allocation.

Anonymous | 03/19/2019

To Whom it May Concern, On behalf of the American Nephrology Nurses Association (ANNA), thank you for allowing us the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Public Comment Proposals 01/22/19- 03/22/19. Our comments for several of the current policy proposals are as follows: OPTN Standards for Public Comment 01/22/19 – 03/22/19 Eliminate the use of DSAs and regions from kidney and pancreas distribution: ANNA supports a hybrid version with a shorter distance. However, we are do not support a model that would decrease the number of kidney transplants; we also have concerns about the cost and challenges of shipping and potential discards.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation recognizes that this is a concept paper as opposed to a policy proposal and is keenly aware of the broad spectrum of opinions on this topic across the kidney and pancreas communities, particularly given the limitations of the modeling. The Society appreciates the HRSA mandated requirement for kidney and pancreas allocation to be altered in a way that makes the allocation policy compliant with The Final Rule. The Society is supportive of the OPTN/UNOS Kidney and Pancreas Committees and applauds efforts thus far to model allocation algorithms that would broaden organ distribution and work toward a framework of continuous distribution. The Society membership found it challenging to come to a consensus and provide the specific feedback requested by the Kidney and Pancreas Committees in this concept paper. Given the lack of consensus among the Society’s stakeholders in this area, we offer specific comments and suggestions for consideration: 1. Acknowledging the HRSA mandate to make all organ allocation systems compliant with The Final Rule which necessitates elimination of DSA and regions as units of organ allocation, the limitations of the presented SRTR modeling makes modeled options presented appear unsatisfactory. In the current modeling variations presented for consideration, none of the options modeled outperform the transplant rates and transplant numbers that are present in the current allocation system. The rationale for acceptance of any new allocation schema that has the projected potential to decrease transplant volume and rates while increasing distance, cost and ischemia time is not clear. It is understood that the modeling does not predict future behavior and the modeling estimates for transplant rate and volume may be inaccurate and an underestimate. 2. To comment on the question if Pancreas distribution system should differ from kidney, the Committee needs to provide additional data: ‘Outcomes Metrics for Five Proposed Framework Variations, Figure 4’ for pancreas alone as well as for ‘Allocation Distance for Pancreas, Figure 12). 3. Equity concerns: What impact will the proposed allocation system have on transplant candidates’ residence preference and will that result in inequality based on the individual’s financial means? In other words, with the publicly available data on ‘Top Volume Donor Hospitals’ and the proposed allocation system based on distance from the organ donor hospital, will more affluent transplant candidates be motivated to move to the ‘desired’ area to optimize their transplant opportunities? 4. Access concerns: The density of transplant candidates varies from region to region, yet the proposal uses similar distance criteria and distance point value for each of the candidates independent of the number of individuals awaiting organ transplantation in their areas (‘competition’). How does this provide equal access of similar quality (cold ischemia time) organs across the US? 5. The nautical mile allocation solution will clearly disadvantage some centers more than others. Not all centers will have access to the full nautical mile radius (i.e. coastal areas). Some areas like the NE will have more advantages as they will have access to more donor hospitals, while areas like California and Texas will likely be unchanged in overall net access. 6. What impact will this have on multi-center listing of transplant candidates, if any? 7. Minimization of cold ischemia time is an important goal. However, it is not true that Top Volume Donor Hospitals are always located near Top Volume Transplant Hospitals. With respect to transplantation, will the local run based on distance delay allocation nationally that would result in better utilization? Will transplant hospitals located near high volume donor hospitals be placed under undue pressure to accept organs that they normally would not and created increased risk for patients as well as transplant program outcomes? 8. The pediatric constituency of the Society remains concerned that there will be an increase in the mean travel distance for clinical procurement teams and organs, and consequently, increased cold ischemia times for children specifically. This will be particularly challenging in children when crossmatching logistics are coupled with mobilizing a patient who lives far from their transplant center. 9. Cost and sustainability. It is unclear who will pay for the requisite increased logistics and resources that inextricably accompany longer transport times and efforts. 10. The pediatric constituency of the Society remains concerned as to the impact of broader allocation and its effect on MOT, specifically KP transplants and the effect of increasing numbers of low KDPI kidneys being allocated to MOT. The pediatric constituency would like to see more specific data on how the proposed policy implementation would impact specific pediatric recipient cohorts, i.e. the highly sensitized pediatric patient. 11. Although challenging to model, there is no data projecting the incidence and outcomes of DGF which increase the risk of shortened graft survival which in a child is unacceptable. Children have the highest need for graft longevity and they can least afford the morbidity of prolonged dialysis.

Malay Shah | 03/19/2019

All proposals are simply not viable for consideration. All proposals are predicted to result in 8-13% FEWER kidney transplants performed nationwide (net of 1074-1746 FEWER total kidney transplants depending on the model). Numerous areas of the country will be devastated and access to treatment for ESRD will be lost. And for what? To largely benefit only a handful of areas. It is unclear how areas with the largest wait times (Alabama) stand to lose kidneys. The Final Rule (CFR 121.8) states: (a) Policy development. The Board of Directors established under §121.3 shall develop, in accordance with the policy development process described in §121.4, policies for the equitable allocation of cadaveric organs among potential recipients. Such allocation policies: (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; (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. It seems the kidney committee and UNOS leadership are interested in meeting ONLY the aspect of the federal law that pertains to geography, while conveniently ignoring the fact that the geography stipulation of the Final Rule states that paragraphs (a)(1)-(5) cannot be forgotten. It is also interesting to me that other comments have suggested that increased distribution of high quality kidneys could incentivize use of marginal kidneys. Not surprisingly, the beneficiaries of the high quality kidneys are the ones making those statements. So to translate, "send me your best kidneys, you keep your bad kidneys". If that statement is entertained, it is immoral. This policy is in violation of the Code of Federal Regulation 121.8(a)(5). All of these proposals result in significant organ wastage, a decrease in access to kidney transplant and does not promote the efficient management of organ placement. I feel as though the kidney committee was handed a dictum from those above it and were forced to present this flawed proposal to the community. UNOS should be ashamed of even allowing a proposal like this to go to the community rather than hitting the trash can. I have a simple question... who is creating policy these days? Is policy being created by a select few at the expense of the remainder of this country? I wish that one day someone at UNOS would take a stand against wrong. This is WRONG.

Jonathan Berger | 03/19/2019

While I agree in principle with the goal of reducing the effects of arbitrary geographic boundaries on organ allocation, I have major concerns with the proposed changes to kidney allocation which would need to be addressed in order to gain my support. As they are presented in this proposal I cannot support any of the proposed models. First of all, each of the proposed allocation schemes are predicted to DECREASE the overall number of transplants performed by anywhere from 8% to 13%. If the fundamental problem in transplantation is the organ shortage, we should not support a less efficient allocation model which does not maximize organ utilization. This decrease in efficiency will impact the system most at the margins. By that I mean if we decrease efficiency in allocation, marginal organs will be become discards, and marginal candidates will be dropped from waitlists. If organs are a national resource, then adopting a less efficient allocation system cannot be endorsed. Some of the language in the proposal is imprecise, casual and unconvincing. Specifically: 1. The authors state that though the models decrease the absolute numbers of transplants, “Previous experience with the SAMS suggests that they under-predict the number of transplants that would occur in reality if a given policy scenario were adopted…”. They site data after implementation of share 35 in liver transplantation. This is a single policy change in a different organ system in the context of record high levels of organ donation (possibly related to the opioid epidemic). This argument is unconvincing. 2. The vast majority of DSAs will see an overall DECREASE in the number of transplants performed. Small centers in lower population areas may struggle to remain viable, and may ultimately close. In order to achieve transplant, candidates served by these centers may have to travel even farther to be considered for transplant at a remote center. This will limit access to the waitlist for candidates with financial or transportation barriers. 3. Waitlist mortality AND graft failure rates are projected to increase in every model proposed. Given stated goals of CMS to increase referral and listing rates for renal transplant, inevitably we will see longer waiting times, a less efficient allocation model will not serve these goals. Waiting times and wait list mortality will not benefit. 4. We have seen record deceased donation rates in recent years. Many believe this increase is related to an opioid overdose epidemic, which will hopefully some day pass. How will these models perform if our current record high organ donation rates cannot be sustained? In short, how can we strive to increase access to the wait list but at the same time decrease the efficiency of organ allocation? I agree our current system of allocation is not ideal, and DSA and regional boundaries are somewhat arbitrary and should be optimized to decrease disparity. But as we strive toward equitable allocation, we need to commit to systems that IMPROVE access to organs. These proposals do not.

Association of Organ Procurement Organizations (AOPO) | 03/18/2019

The Association of Organ Procurement Organizations (AOPO) strongly supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. In support of this goal, organ procurement organizations remain committed to partnering with transplant programs to adapt to changes in allocation policy and develop innovative new approaches to increasing transplantation, with a focus on efficiency and cost-effectiveness. We advocate for policy that is sensitive to specific cases in order to maximize utilization and that allows for flexibility to take into account special geographic considerations. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. To accomplish this objective, we believe development of an allocation policy that achieves distribution without boundaries is the best path forward. Such a framework allows for one or more organ-specific medical factors, such as loss of dialysis access or pediatric donors, to be included as one component (medical priority score) of a composite total score. The second component (proximity score) can and should be tailored to control for distance between the donor hospital and the transplant center, considering clinically relevant organ-specific factors, such as cold ischemic time. Importantly, the relative weighting of the medical priority score and of the proximity score can be easily refined over time to fine-tune allocation policies to achieve the stated goals.

Michael Daily | 03/18/2019

I read with some interest the recent Concept Paper titled “Eliminate Use of DSA’s and Regions in Kidney and Pancreas Distribution”. The paper appears to be advocating for a conclusion that has already been reached, rather than impartially evaluating the data, and generating the best recommendation. Using The Final Rule as the spring-board, the paper describes modeling which predicts transporting organs over longer distances (based on pushing out the cold ischemic time) will decrease kidney transplants (See Figure 4 in Concept Paper). In fact, modeling predicts an increase (over the current baseline) in waitlist mortality, and graft failure for all five proposed alternatives! Another metric which will certainly increase is cost to transplant organs (both by increasing the cost of shipping, and increasing the rates of delayed graft function and primary non-function, as ischemic time are increased). The only metrics which do not increase are transplant rate and number of transplants. Now, it is true that these differences are small, and in some cases may be insignificant. Still I am unconvinced that the system needs to be changed. I am particularly reluctant to change the system to one which has predicted worse outcomes. Changes to the system add complexity, and should not be done lightly. If we are going to change the system, I think it should be to a better system, not just a different system. I challenge you to read the Concept Paper and reach a different conclusion.

Anonymous | 03/15/2019

The OPTN/UNOS Patient Affairs Committee (PAC) thanks the Kidney and Pancreas Transplantation Committees for their proactive approach to bringing these two organ’s distribution frameworks into alignment with the OPTN Final Rule by presenting multiple options for consideration. The PAC considered two main questions: 1. Is there one of the five frameworks that impacts equity and outcomes in kidney and pancreas distribution better than the other four or was there an additional framework variation that should be considered and why? 2. Should this distribution framework combine or separate kidney and pancreas allocation policy and why? The PAC generally supported an allocation policy that optimizes equity in access and maximizes recipient and organ outcomes. Overall, PAC members had difficulty recommending a specific framework due to the complexity of the supporting documentation but did lean towards the hybrid model. In regards to separating the kidney and pancreas allocation systems, it appears that cold ischemic times may be the main factor to consider for recipient and organ outcomes. As such, more modeling will most likely be required based on the allocation models selected for the policy proposal. The PAC noted the following: • Avoid the term “cadaveric”, and consider using “deceased” when referring to deceased donor and organs. This verbiage change should occur in all transplant discussions as it is more descriptive and more sensitive to the donor family members. • For the same reasons, the PAC also recommends changing terminology from national “resource” to “life source”. • While the concept paper’s “Executive Summary” does a nice job describing how this paper was developed and identifying the recommended “options” under consideration, the potential impact of these options is not written in a language that the general public would understand. This can hinder the general public in making a valid argument for one framework over the other. • If the OPTN wants to seriously include patients (including recipients, donors, and family members) throughout the policy discussion process, then the PAC continues to recommend stronger patient presence and participation in Committee work (or workgroups) and a “Layman’s Abstract” for all policy proposals. The PAC asked the following questions, which were answered by the sponsoring committee’s presenter to the satisfaction of the Committee: Q: Is there any utility of standardizing all organ distribution frameworks into one instead of separate frameworks for each organ system? Is it clinically feasible? A: The KP Workgroup did not consider standardizing all the organ specific allocation systems because organs have different ischemic times and scoring systems. This question is more appropriately answered by the OPTN. Q: Additionally, is the timeline for implementation, particularly with the hybrid models, realistic or is the OPTN going to settle on the “fastest” model for implementation in light of the highly-charged environment pertaining to DSAs and Regions in OPTN allocation policy? What impact would this have on the recipients and outcomes from organs subjected to this model? A: The KP Workgroup is currently working on new modeling with the SRTR that would focus on separate models for kidneys and pancreas. The Workgroup plans on continue modeling a variety of different models, and assessing the outcomes This modeling should be available for the PAC to review in future public comment cycles. Q: If the kidney can tolerate a longer cold ischemic time than the pancreas due to technology options available for recovered kidneys, how will this impact recipient and organ outcomes? A: Currently, the pancreas has a tighter threshold in terms of ischemic time, and cannot travel as far distances as kidneys. Because of this, the KP Workgroup is looking at separating kidney and pancreas allocation. In future models showing this allocation separation, the Workgroup will assess the impact on recipients and on organ outcomes. Q: Is the KP Workgroup working towards a continuous distribution model for both kidneys and pancreas? A: Currently, the concept paper only reflects the SRTR modeling done in fall 2018. At the time, the BOD did not mandate the KP Workgroup model continuous distribution for kidneys or pancreases. However, in the December 2018 BOD meeting, the Workgroup became committed to moving towards a continuous distribution system. It was noted that it is important for the Workgroup to weigh decisions carefully, and are currently working closely with the SRTR on a plan to proceed with continuous distribution modeling. For now though, the Workgroup is focused on removing the term DSA and region from kidney allocation policy. It is the Workgroup’s hope that a new model can be implemented while the OPTN works towards a continuous distribution framework. The reasoning behind this is that there are many limitations of the KSAM modeling which may result in unintended consequences if modeling pushed too quickly. Implementing a continuous distribution system too early may disadvantage certain groups, such as pediatric candidates. Q: Is the KP Workgroup concerned that waiting times for donor families may increase with increased travel distances? A: The KP Workgroup has discussed the increase in waiting time for donor families, because there is a longer time period between brain death declaration and recovery which may result in organ damage. Unfortunately, this factor cannot be modeled in the KSAM, but should be taken into consideration. In the speaker’s opinion, any broader distribution system may negatively impact donor family waiting time. Compared to 20 years ago, the waiting time is much longer due to logistics. Q: (In regards to costs) How long before budgets and contracts are renegotiated? A: The speaker acknowledged that insurance companies and other payers need to be brought into the discussion, especially in regards to an OPO’s average monthly expense report. Overall, about half of PAC members did not feel comfortable choosing one proposed framework over another (hybrid versus circles, 250NM versus 500NM), because the data presented was difficult to comprehend and showed a decrease in organ transplantation rates. The PAC members that did vote supported the hybrid model, with a 250 NM circle size. A majority of PAC supported a separate distribution system for kidney and pancreas. All PAC members abstained from voting on proximity points.

Anonymous | 03/14/2019

Region 4 vote: • 16- fixed concentric circles • 8- hybrid • Circle size: 19-150NM, 4-250NM, 0-300 NM, 2-500NM • Hybrid: Shallow points within circle-2, Steep points within circle-10, No points within the circle-4 Shallow points outside the circle-5, Steep points outside the circle-5, No points outside the circle-6 • Should there be different distribution systems for kidney and pancreas: 18-yes, 6-no Comments: There is concern that the concepts in the proposals model a decrease in the number of transplants and longer wait times. This would mean fewer transplants for those candidates on dialysis. This change would further impact areas with long wait times for kidneys. Several members requested modeling for transport time and discard rates, not currently in the concept paper. Consideration for increased travel, including cost and flight patterns on commercial flights should be factored into proposal. There was concern raised that the committee is prioritizing equity over utility and there needs to be consideration for using kidneys from younger, lower KDPI donors in younger recipients. The committee should evaluate post-transplant patient and graft failure. Members commented that there is a belief that because kidneys can handle more cold ischemic time, that broader sharing is easier in kidney distribution. In fact, shipping kidneys takes more time due to transport on commercial flights and the need for a crossmatch. One member brought up reviewed, unreleased data shown to model a decrease of four times the procured kidneys kept locally in high performing OPOs, with less of a decrease in low performing OPOs. This may mean many more kidneys would be shipped out than are currently kept locally. There was concern that OPO performance should be considered when sharing more broadly. There was also support to ensure more kidneys are transplanted locally.

Anonymous | 03/14/2019

The Organ Procurement Organization (OPO) Committee discussed the proposed allocation changes and their impact on OPOs and offer the following responses: o The Committee voiced concerns about the cost impact as well as transportation methods (recovery teams having to fly vs. utilization of local recovery teams). There will be an increase in case times, decrease in available resources, and an increase in the workload on staff. o The Committee recognizes the impact that broader organ distribution will have on donor families. Increased donor case times can have a negative impact on donor families and donor hospitals. o The Committee recommends improving efficiencies within the system that will enable the ability to cut down on case times and ensure organs are allocated in the most timely and efficient manner possible. o The Committee members agreed that if positive cross match results are received after the kidney has been shipped farther away, there is the potential to increase the number of local import offer cases. The Committee recommends that this be monitored under a new broader distribution policy to evaluate how often kidneys are not transplanted into the original intended candidate. OPO Committee Vote: • Which framework do you prefer? Vote: 9 Hybrid, 5 Fixed Concentric Circles • Within the framework you selected, which circle size(s) do you prefer? Vote: 2 (150nm), 7 (250nm), 1 (300nm), 3 (500nm) • Should there be different systems for kidney and pancreas organs? Vote: 7 Yes, 5 No

Anonymous | 03/13/2019

The Ethics Committee thanks the KP Work Group for its effort in developing this concept paper and presenting the options for modifying kidney and pancreas distribution. The Committee expressed significant concern about the balance between equity (justice) and utility (efficiency) in this project. The Committee considers that equity and utility should be balanced, and this project may overly prioritize equity over utility. It is important to quantify the extent to which utility is reduced compared to the increase in equity, and the populations who are likely to be disproportionately harmed must be identified and alternative ways to protect against such harm must be addressed. Committee members expressed concern about how proximity points would disproportionately adversely affect rural areas, and whether the distribution change would lead to a net loss in organs retained locally for rural areas. The Committee discussed the potential reduction in transplant counts, which could imply an increase in discard rates. An increase in discard rates would negatively impact utility. The Ethics Committee abstained from a polling question assessing their opinion of the concept paper. Committee members were concerned that there was inadequate information for them to evaluate whether the concept paper overall should be supported or opposed. The Committee did answer other polling questions ascertaining feedback on the framework options reviewed in the concept paper and whether kidney and pancreas should have different distribution systems. Voting members indicated greater support for the hybrid framework (of 9 respondents, 8 members indicated support), and for pancreas and kidney having different distribution systems (of 8 respondents, 6 members indicated support). Overall, the Committee is not convinced that utility and equity are balanced in the proposal put forth by the KP Work Group at the current time.

Seth Karp | 03/13/2019

This policy primarily benefits New York, the area with among the worst donation in the country whose OPO has been threatened with decertification on multiple occasions. The price of supporting New York's failure to develop a high performing OPO is about 1500 additional patients across the country who will not get a transplant. Wouldn't it be better to help New York improve donation? Of note, in Alabama (UAB), one of the poorest states in the country, only 7% of patients receive a transplant within 3 years. This rate is lower than every program in NY and 1/3 of some of the programs in NY. And yet Alabama will lose significant access to organs under the new policy. Hard to understand how this improves access to organs. This is clearly in violation of the final rule 121.4. It hard to image who would be in support of such a policy and with what justification. At some point UNOS is going to have to get serious about supporting donation and put resources into fixing the real problem. Unfortunately that time dose not seem to be now.

Anonymous | 03/09/2019

Do not penalize regions with good donor percentages by taking those organs away from the region. Promote donations in the other regions instead.

Charles Van Buren | 03/06/2019

Should have 10% of donor kidneys assigned for redistribution. Decreases, but does not eliminate the disadvantage of being in a poor performing OPO.

Anonymous | 03/01/2019

Eliminating the DSA will increase the cost of organ distribution and transplant as well as increase the cold ischemic time on the organs. This will lead to increased discard rates and more travel for surgeons and organs. The entire country needs to focus more on increasing the number of organ donors and working with their OPOs to increase this as opposed to just changing where patients are transplanted.

Anonymous | 02/28/2019

The members of Region 10 voiced many concerns over the five concepts brought forth in the concept paper. The biggest concern is that the modeling for all five concepts show a decrease in the number of transplants. With the current modeling, it seems very irresponsible to uproot the entire kidney and pancreas allocation systems and hope that the transplant rates do not go down. Any change that is made needs to be data driven. As the modeling stands now, one of the only groups that will benefit are patients that have over ten plus years on dialysis. Dialysis centers will greatly appreciate any such change, but it will greatly disadvantage patients. The goal of any allocation change should be to reduce the amount of time on dialysis. It was also mentioned that with broader distribution there will be an increase in travel costs, which will be a large burden for the OPOs to cover. One member stated that SRTR modeling cannot be trusted since it does not account for varying practice behaviors. Any future modeling should focus on population density instead of a single system that applies to all parts of the country. The northeast has a very high population density and in those areas, they should have an even higher number of proximity points, as much as six points, and to then flatten out the proximity point curve by going down to two points. That would prevent unnecessary sharing between major metropolitan centers. As you move west and population density decreases larger circles with fewer proximity points could be used. As part of the Final Rule, geography can be used as a determining factor to prevent the wastage of organs. The models brought forth in the concept paper all show a decrease in transplants, so all of the options go against the Final Rule. In terms of how behavior may change with any allocation change, one member stated that they will still remain skeptical of any offer that comes from outside their DSA. If a large and aggressive DSA has already declined an offer, there must be some reason not to accept. There was large support to have separate allocation systems for kidney and pancreas. Region 10 Vote: • Which framework do you prefer: 0 fixed, 11 hybrid • Within the framework you selected, which circle size(s) do you prefer: 7 for 150NM, 1 for 250NM, 4 for 300NM, and 7 for 500NM • If you prefer a hybrid framework, please indicate whether you prefer shallow, steep, or no proximity points within the circle: 3 shallow, 6 steep, 0 no points • If you prefer a hybrid framework, please indicate whether you prefer shallow, steep, or no proximity points outside the circle: 4 shallow, 3 steep, 1 no points • Should there be different distribution systems for kidney and pancreas organs: 16 yes, 2 no

Anonymous | 02/28/2019

The OPTN/UNOS Transplant Administrators Committee (TAC) would like to thank the OPTN/UNOS Kidney/Pancreas Workgroup for their ‘Concept Paper’ to ‘Eliminate the Use of DSAs and Regions in Kidney and Pancreas Transplant’. The concept paper has met its intended purpose of providing five potential allocation options, which in turn has initiated a dialogue within the transplant community. After review of the proposal and clarification of inquiries put forth, the TAC agrees with the ‘concern’ expressed by the Kidney/Pancreas Workgroup ‘…about drawing implications from the SRTR data results regarding crucial metrics…’. For example, the TAC understands the limitations of the KPSAM modeling and its ‘fit on acceptance occurring within a local (DSA), regional, and national framework’ but one cannot ignore that the modeling for each of the proposed allocation options predict lower kidney transplant volumes compared to the current structure. Despite a logical explanation of the model limits and an understanding of transplant rates with KAS modeling were 8% lower than actual, there is a possibility that the models could be accurate. Members expressed concern supporting an allocation option not consistent with the Final Rule in that it reduced the number of transplants performed. Other concerns raised by the TAC include an increase in organs recovered but not transplanted, potential negative impact on the poor and underserved of lower socioeconomic areas and increases in operational costs related proposed variations. As disclosed by the Workgroup, the SRTR model used to evaluate the proposed allocation options was not designed to predict any potential impact on these important aspects related to allocation. The OPTN/UNOS Kidney/Pancreas Workgroup considers the five proposed variations more consistent with the Final Rule ‘…providing more equity in access to transplantation regardless of a candidate’s place of residence or registration…’ The TAC noted it was difficult to evaluate changes in rates of transplants due to a lack of visualized data. The TAC appreciates acknowledgment of this gap and looks forward to additional materials from the workgroup to help further evaluate this goal. Our review of the options proposed did see some improvement over baseline but persistence of wide ranges in rates of transplant across OPOs does continue. The TAC understands the Workgroup has put forth these five proposed variations, not as a permanent solution but ‘small progress’ toward the Continuous Distribution Framework. The TAC also understands the ‘time-sensitive’ constraints related to the elimination of DSA and Region from the current allocation scheme. During this interim period, the TAC supports an allocation option that: 1.) Increases the number of transplants; 2.) Increases equity in access to transplant by reducing disparate transplant rates; 3.) Mitigates unintended impacts to vulnerable populations 4.) and minimizes the increase in operational costs related to allocation changes. In concert, these tenets are difficult to solve and current model limitations on the five options are less than definitive.

Anonymous | 02/27/2019

The Minority Affairs Committee (MAC) thanks the Kidney and Pancreas Committees for their hard work developing this concept paper and presenting to the MAC. MAC members emphasized the importance of looking at cost as an impact of changes to geography in any future modeling and any future proposal options. MAC members also questioned whether the KP work group (comprised of Kidney Committee and Pancreas Committee members) considered larger circle sizes than the options presented in the concept paper. Extending the radii of circles considered could show a greater impact on variance in waiting time, which can differ greatly according to where a patient lives. Waiting time was emphasized as a very important metric to consider in any potential change to kidney and pancreas distribution.

Anonymous | 02/25/2019

The region is supportive of moving forward with a continuous distribution model for kidney allocation, but does not support the concepts proposed by the committee. A primary concern is the overall decrease in the number of transplants performed. This is unacceptable to members. Eliminating donation service area (DSA) and region needs to be done in a measured way that doesn’t decrease transplants. Members commented that donor families need to be considered and the promise organ procurement organizations (OPOs) make to them to maximize the gift of organ donation. The data doesn’t support this promise. It was suggested that the committee also consider incorporating population density into future proposed solutions. Additional comments: • There is concern about an increase of kidneys being shipped by air. Kidneys fly unaccompanied and have been lost in transit. • Flying more kidneys may create a challenge for remote areas and areas with small airports. • Cost is a concern. Broader sharing for lung has increased cost. The community cannot sustain these increases in cost. The burden of these costs will be on the transplant hospitals. Small programs operate on a tight margin and broader sharing will be a challenge for them. The community deserves to know the impact on cost to the members. • Increasing sharing is likely to decrease efficiency. • A concern was expressed for the veteran population. Veteran’s Administration (VA) transplant hospitals are concerned that broader sharing will negatively impact the veteran population. • Consideration needs to be given for high Kidney Donor Profile Index (KDPI) kidneys. Kidney pumps help improve function, but cannot be shipped very far. • Other points in the Final Rule need to be addressed, not only geography. A member noted that it hasn’t been decided in a court of law that DSA and region are not compliant with the Final Rule. • Maintaining some local priority for organs is important to encourage organ donation. • Prioritization for local areas is important. Several members mentioned that keeping organs local is important to donor families. • Team safety and organ loss must be considered by the Committee. • Strategies to decrease discards should also be identified.

Anonymous | 02/25/2019

FORUM OF END STAGE RENAL DISEASE NETWORKS February 25, 2019 Re: UNOS/OPTN Proposal to remove DSA and Region from Kidney and Pancreas Allocation The Forum of ESRD Networks appreciates the opportunity to comment on this OPTN/UNOS proposal. The Forum of ESRD Networks believes that all End Stage Renal Disease (ESRD) patients should have equal access to renal transplantation, the preferred treatment for ESRD. Geographic disparity is disallowed under the Final Rule, and we believe that efforts should be taken to ensure that ability for that patient to receive a kidney transplant is not affected by where a patient lives. In addition to geographic disparities, there are other disparities that affect ESRD patients. Racial minorities, such as African Americans, and those of lower socioeconomic status, historically have had less access to the transplant waiting list, compared with other groups. We believe that whatever solution UNOS adopts to reduce geographic disparity should not increase disparity in transplant access for racial or ethnic minorities, or for patients who are socioeconomically disadvantaged. We encourage UNOS to carefully study the effects of any proposed changes to the kidney allocation system to be sure that there are no unintended consequences. All patients, no matter where they live, whatever their race or ethnicity, and whatever their socioeconomic status should have equal access to a potentially lifesaving renal transplant. Thank you for your consideration, David Henner, DO Chair, Forum Medical Advisory Council Donald A. Molony, MD President, Forum of ESRD Networks

Ryutaro Hirose | 02/25/2019

I commend the kidney committee in their efforts to eliminate dsa and region as units of distribution as they were not designed to be used as such and they create much inequity in access evidenced by the variance in median wait time for a kidney transplant by geography I have suggested a disparity metric based on time to first non 0 Ag MM offer for a typical unsensitized patient with an average KDPI kidney - one of the goals of a new allocation system should be to reduce the variance of this metric by geography The committee should model 750, 1000 and 1500 Ike’s as kidneys can be transported sage,y across much longer distances. More competition should result in increase in use if more marginal kidneys, but the system should incentivize for increased use of the organs. Broader distribution of the highest quality kidneys could incentivize this

Anonymous | 02/21/2019

Region 2 Vote: • Which framework do you prefer: 5 fixed, 22 hybrid • Within the framework you selected, which circle size(s) do you prefer: 9 for 150NM, 2 for 250NM, 2 for 300NM, and 14 for 500NM • If you prefer a hybrid framework, please indicate whether you prefer shallow, steep, or no proximity points within the circle: 7 shallow, 14 steep, 5 no points • If you prefer a hybrid framework, please indicate whether you prefer shallow, steep, or no proximity points outside the circle: 5 shallow, 12 steep, 9 no points • Should there be different distribution systems for kidney and pancreas organs: 23 yes, 4 no The members in region had a lengthy and robust discussion of the concept paper. There was great concern that the models used in the concept paper show a decrease in the number of transplants across all five options modeled. This is unacceptable since the goal should be to increase transplants. If a plan is implemented, that ultimately results in fewer transplants then it will go against the Final Rule. Several options were brought forth during the discussion. One member noted that any allocation scheme should take population density into consideration because there are vast differences throughout the country in terms of population density and distance. If an allocation system is to be applied to the entire nation, a one size fits all system does not make sense. It was also mentioned that OPO performance needs to be considered since some areas have lower access to donor organs. One member said that since kidneys can withstand the longest cold ischemic time than any other organ there is no reason why we cannot implement national distribution. There was some agreement by others in the audience to this option, but it was brought up that higher KDPI kidneys are less likely to withstand long cold times. It was then stated that there should be separate allocation systems for lower KPDI kidneys and high KDPI kidneys. The low KDPI kidneys could be shared nationally, while the high KDPI kidneys should be shared more locally due to their need for lower cold times. Those in attendance did voice their opinion that kidney and pancreas should have separate allocation systems. In terms of how people’s behavior will change with any distribution change, members felt that it is very difficult to determine that this early in the process. They stated that SRTR used behavior models from pre-KAS implementation and that behaviors have already changed since then. One member stated that it is possible that if a fixed circle based model is adopted that centers just outside of a given circle will accept kidneys that normally they wouldn’t have taken in the past.

Anonymous | 02/21/2019

Region 5 Vote: • 14 - fixed concentric circles • 24 - hybrid • Circle size: 5-150NM, 14-250NM, 27-300 NM, 24-500NM • Hybrid: 8 shallow points within circle, 10 steep points within circle, 15 none 13 shallow points outside circle, 9 steep points outside circle, 13 none • Should there be different distribution systems for kidney and pancreas: 30 yes, 9 no Suggestions for future modeling: • Inflation adjusted report of data points to account for increase in donors • Risk of decrease in transplants due to transportation risks • Effect of keeping high KDPI kidneys local or giving priority points to patients willing to accept these kidneys • Model using transportation time instead of miles • Include minimum waiting time • Effect of ischemia time on national list • Expanded miles for optimal donors • Effect on wait time on an area • Effect on wait time for “typical patients” vs subsets such as highly sensitized One member stated that the decrease in transplants shown in the modeling could be the result of increased discards due to broader sharing of difficult to place kidneys. He added that although kidneys are assumed to tolerate ischemic time, some kidneys, such as high KDPI, should not be shared. Although we may end up with more sharing and less disparity, less transplants overall does not benefit transplant and continued use of geography is still a component of disparity; we should go straight to continuous distribution and eliminate all circles. Another member stated that kidneys are not a lifesaving organ (disagreement was voiced) and should be shared differently, he expressed that there is no fair way, but we should find an acceptable way and believes the Final Rule should be changed and that there should be a minimum waiting time before transplant with a deceased donor. One member asked why use a continuous curve with the suggestion that there should be a discontinuous curve and it should not be shallow, as it does not make much of a difference. It was pointed out that Policy 8.2.A Exceptions Due to Medical Urgency will need to be addressed to determine how this will be done or if it will be removed. Lastly, it was recommended that the disparity metric has to be well defined and specific to subsets of people and their wait time so that you can make accurate comparisons.

Alejandro Diez | 02/19/2019

The current proposals aim to increase equity in access to transplantation via eliminating the use of DSAs and regions from kidney and pancreas distribution. There are currently 5 variations under consideration, which all have merits as they pertain to increasing the number of simultaneous kidney and pancreas (SPK) transplants. The modeling that has been performed shows that the rates of SPK increase with almost all models as compared to baseline; in contrast with the rates of kidney only transplants (K) and pancreas only transplants (P) both of which decline. One of the great strengths of the Kidney Allocation System (KAS) enacted in 2014 was that it increased equity in the allocation of K transplants, particularly in the highly sensitized, difficult to match blood types, and those who had been on dialysis for the longest periods of time. Although the current modeling describes the changes in access in terms of “transplant per patient year” a more telling metric would be “average time on the wait list”. It is well known that the wait times for SPK are significantly lower than K alone; these proposals may further exacerbate this difference. In selecting one plan among the five presented the 2CR_150 presents the least amount of travel; suggesting perhaps, decrease in the cold ischemia time, ease in allocation, decrease organ acquisition costs, and (hopefully) increase organ utilization as compared to the other 4 proposals. However, all current proposals may attenuate the previously attained gains in equity achieved by KAS and disadvantage patients on the K wait list.

Aaron Cohen | 02/18/2019

I thank the committee for taking on the task of trying to find a way to make everyone the “least upset” via these proposals. After review of the proposals and listening in on the discussion at the Region 5 meeting, I want to point out that all proposal documentation to date, does not address what will happened to policy 8.2 Exceptions, in particular 8.2.A Exceptions Due to Medical Urgency. Based on all 5 proposals, the provisions spelled out in policy 8.2.A will be voided, as the “agreement from other kidney transplant programs in the DSA to allocate the kidney out of sequence” will be null and void as DSA as a unit of allocation will not exist. In OneLegacy’s DSA, the policy has been utilized effectively to give access to patients on their last point of access for dialysis and in danger of the access point collapsing. The 10 local kidney transplant centers have been very cooperative by approving these medically urgent patients allocation exception priority. Often these patients had years to go before they would matriculate to the top of the list. The patient would be allowed to receive the offer in front of the other patient’s in the “local list”. With allocation units moving to concentric circles, it would be near impossible to execute this policy, as “agreement between centers” would need to extend to all centers within the bounds on the concentric circle. Assuming the 500NM circle is chosen, the number of kidney transplant centers within that circle would be numerous and would be changed based on the donor hospital location. Has the committee looked into this matter? The Heart/Lung Committee had the same issue and addressed it in their proposal paper. Policy 6.4.B Exceptions to Allocation for Sensitized Patients, will be eliminated in the new proposal. They note that the allocation exception is rarely used, therefore, will not have significant impact if eliminated. I am not sure how rarely used policy 8.2.A is.

Anonymous | 02/18/2019

Region 1 vote: • 3- fixed concentric circles • 12- hybrid • Circle size: 7-150NM, 3-250NM, 1-300 NM, 4-500NM • Hybrid: Shallow points within circle-7, Steep points within circle-6, No points within the circle-2 Shallow points outside the circle-4, Steep points outside the circle-8, No points outside the circle-4 • Should there be different distribution systems for kidney and pancreas: 8-yes, 7-no Comments: There was a concern raised that broader sharing would decrease incentive to use high KDPI kidneys particularly if you are at a center with long waiting times and a recommendation that the committee come up with a tighter description of how EPTS and KDPI will be matched with waiting time. Some members raised the issue of pumping kidneys since pumping is usually done locally. Several members were concerned that any change using concentric circles would have a much greater effect on highly populated areas on the east coast. There was also concern that the candidates at centers with long waiting times within each circle would have priority for all of the organs. One member commented that there will be a bolus effect with any change, but that over time the waiting times will become more even across all centers. One member reminded the committee to keep living donation in mind when developing policy. There were requests to model: cold ischemic time for each model, high KDPI utilization and transplant rates by region.

Diane Cibrik | 02/18/2019

.All these models will have our area losing 30-40% volume. Overall the models have less transplants nationwide, more discards, more travel and increased cost. I am against eliminating DSA for kidney and pancreas transplantation.

Jason Rolls | 02/14/2019

I understand that legal challenges forced allocation changes on other organs, in service of the Final Rule. I understand that UNOS/OPTN wishes to make this new allocation method consistent across its purview, including kidney and pancreas. I understand the kidney committee and others are doing the best they can, with the extremely difficult task assigned them. I understand that the modeling of the five proposed allocation schemes comes with the repeated caveat that the results are only rough estimates, may be inaccurate, and that it is very difficult to model real-world transplant center behavior. If we assume that the modeling is inadequate to the task of predicting what the proposed KPSAM schemes will result in, then we stand to completely change - on the basis of faith, not backed by evidence - our current allocation model, at great cost of resources, both at the time of the change (repetitive re-orientation of personnel, altering distribution networks, financial costs associated with these), and in perpetuity (ongoing higher costs of transporting organs longer distances). If we take the position that some belief may be legitimately placed in the modeling shared with the membership in recent UNOS/OPTN communications, then, clearly, outcomes of the five proposed allocation schemes do not appear to bring net improvement, and in fact, may bring harm in terms of reducing overall transplant activity. On balance, it appears that they do not support the Final Rule more than current practice, and therefore fail to adequately answer the order given to UNOS/OPTN by the Secretary of HHS. Speaking more specifically, the five proposed new models potentially bring improvement as follows: KP generally does better under the new schemes, but there are ~800 KP transplants per year, vs 14,000 for deceased-donor kidney. Pediatric deceased-donor renal transplants stand to do better under the new schemes, but they are ~500 cases per year. Kidney waitlisted patients with PRA’s >90% do better in the single concentric ring models. They are ~10% of the waitlist. The five new models bring equal or worsened outcomes as follows: They do not favor different geographic area types (cities, towns, rural) - all are disadvantaged. No race or ethnicity is advantaged by the proposed schemes. On the basis of dialysis time, patients are not advantaged by the new schemes until they have been on dialysis for ~10 years. This is unacceptable - a decade of dialysis will vastly reduce patient health and life expectancy. I believe that the patients the transplant community serves would be best advantaged by an allocation scheme that collectively minimizes dialysis time for all waitlisted patients, nationwide, and minimizes geographic variances from that national norm. Thank you, Jason Rolls

Anonymous | 02/08/2019

Region 7 feedback- • 4- fixed concentric circles • 8- hybrid • Circle size: 4-150NM, 3-250NM, 1-300 NM, 4-500NM • Hybrid: Shallow points within circle-4, Steep points within circle-6 Shallow points outside circle-3, Steep points outside circle-7 No points-1 • Should there be different distribution systems for kidney and pancreas: 4-yes, 7-no Any changes that remove region/DSA need to be regarded as a first step. Upcoming innovation in the kidney field like normothermic technology should be considered in policy development. We don’t want to implement a policy that would stifle innovation. There were issues raised about how the need for crossmatching will influence timing constraints and organs traveling. Some members were concerned that the models showed a decrease in transplant counts and rates. Some members commented that the concept paper indicates that the committee favors the hybrid models due to its similarities to a continuous distribution framework. There was concern with this since the decrease in the transplant counts and rates is much more significant in hybrid approach as is increased CIT. There was also concern raised that the committee can’t get discard rates included in any of the modeling. One member had concerns about the limitations of KPSAM modeling and thinks that the model needs to be improved before a policy can be developed. There was some support for kidney and pancreas to develop a policy that would be consistent with the other organ distribution systems. One member recommended that the committee consider how the different models will increase disparities in urban versus rural access to transplant. This could be particularly significant in models with a steep points. There was a question about how Alaska and Hawaii will be included in the allocation systems. One OPO member commented that this distribution system would not change their behavior because the OPO is not limited to local now. They are frequently importing and exporting organs outside of the DSA.

Cassandra Smith-Fields | 02/07/2019

The pediatric transplants performed since the implementation of the last change in kidney allocation policy in 12/14 has not resulted in the growth experienced in the adult population, and in regions, such as region 5, we are in fact living with a substantial decrease in pediatric transplants performed. I strongly urge the committee to thoroughly vet the impact on pediatric transplants prior to recommending change, and that simply maintaining the status quo of 2018 is not acceptable.