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Eliminate the use of DSAs and regions from kidney and pancreas distribution

Proposal Overview

Status: Public Comment

Sponsoring Committee: Kidney Transplantation Committee & Pancreas Transplantation Committee

Strategic Goal 2: Provide equity in access to transplants

Read the concept paper (PDF; 1/2019)

Contacts: Scott Castro and Abigail Fox

View dashboard of proposed kidney distribution circles

Data request from the OPTN Kidney Transplantation Committee
Provide simulation data on effect of removing DSA and region from kidney/pancreas/kidney-pancreas organ allocation policy


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Executive summary

The Final Rule (hereafter “Final Rule”) sets requirements for allocation polices developed by the Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS), including the use of sound medical judgement, achieving the best use of organs, preserving the ability for centers to decide whether to accept an organ offer, avoiding wasting organs, avoiding futile transplants, promoting patient access to transplantation and promoting efficiency. The Final Rule also includes a 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.

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

Policy 8: Allocation of Kidney and Policy 11: Allocation of Pancreas, Kidney-Pancreas, and Islets currently use DSA and region as geographic units of distribution. These are poor proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs and regions result in an inconsistent application for all candidates. As noted in Department of Health and Human Services Administrator Sigounas’s letter to the OPTN/UNOS President, “DSAs and Regions have not and cannot be justified” under the regulatory requirements of the Final Rule.

Members of the OPTN/UNOS Kidney Transplantation Committee, joined by members from the OPTN/UNOS Pancreas Transplantation Committee and the OPTN/UNOS Pediatric Transplantation Committee, created the Kidney/Pancreas Workgroup (hereafter “the Workgroup”) in order to remove DSA and region from kidney and pancreas allocation policies. The Workgroup reviewed OPTN/UNOS data on current distribution practices, engaged Workgroup members on their collective clinical experience, and utilized the OPTN/UNOS Board of Directors’ “Geographic Organ Distribution Principles and Models” to develop five potential allocation options that would eliminate DSA and region from kidney and pancreas allocation policies.

The five variations that the Workgroup chose to model are:

  1. A fixed concentric circle framework with a 150 nautical mile (NM) small circle and a 300 NM large circle
  2. A fixed concentric circle framework with a 250 NM small circle and a 500 NM large circle
  3. A fixed concentric circle framework with a single 500 NM circle
  4. A hybrid framework with a single 500 NM circle that utilizes a small number of proximity points inside and outside of the circle, and
  5. A hybrid framework with a single 500 NM circle that utilizes a large number of proximity points inside and outside of the circle.

These variations will be more comprehensively outlined in this paper’s “What Concepts Are Being Considered?” section. The Workgroup is not limiting itself to consideration of solely these five variations, but rather used these variations as choices to model in the Kidney/Pancreas Simulated Allocation Model (KPSAM) in order to most strategically determine what could be the ideal variation. The Workgroup understands that, given community feedback and additional evidence gathered, it is possible that the framework and variation ultimately selected by the Workgroup may be a combination of these variations, or perhaps a new variation, such as a single-circle hybrid with a smaller concentric circle.

The Workgroup is currently considering these five variations for modifying kidney and pancreas allocation policy to be more consistent with the Final Rule and to provide more equity in access to transplantation regardless of a candidate’s place of residence or registration, except to the extent required by §121.8 (a)(1)-(5) of the Final Rule. The Workgroup requests community feedback in order to better inform the evidence-gathering and decision-making processes.

Feedback requested

Members of the community should indicate why one or more variations would be a better replacement of the current distribution system compared to the other options being considered. Specifically, the Workgroup appreciates feedback grounded in evidence tied to the Final Rule, such as the impact on efficiency in organ placement or on achieving the best use of donated organs. Furthermore, the community should indicate preferences between the two framework types (fixed concentric circle vs. hybrid) and comment on the defining characteristics of each, such as the size of circles and the number of proximity points that should be awarded. The Workgroup also seeks feedback from the community on whether the pancreas distribution system should be separate from the kidney distribution system.

Comments

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.

Region 7 | 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.

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

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.

Region 1 | 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.