Thoracic Organ Transplantation Committee Spring 2019 Eliminate the Use of Donation Service Areas (DSAs) in Thoracic Distribution Thoracic Organ Transplantation Committee Spring 2019

What problem will the proposal solve? Ensure compliance with the Final Rule by removing DSA from heart allocation policy Ensure compliance with the Final Rule by removing DSA from heart allocation policy As geographic units of allocation, Donation Service Areas are not in compliance with aspects of the Final Rule Using DSA, hearts are allocated to less medically urgent transplant candidates within the DSA before being offered to more medically acute candidates who live farther from the donor hospital (AFTER broader distribution to status 1 and 2 candiddates) No evidence that DSAs are the appropriate geographic unit of allocation for achieving optimal system efficiency and patient access to transplant opportunities DSAs have been determined to be an arbitrary geographic area to allocation policy DSAs reflected the localization of how the organ transplantation program was first structured DSAs are a poor proxy for distributing organs over as broad a geographic distance as possible because the DSAs cover different areas and different populations For these reasons, DSAs are in conflict with the Final Rule Final Rule requires: best use of organs, equity in patient services, and efficiency in management of the organ transplant program Final Rule also stresses the importance of distributing organs over as broad a geographic range as feasible…and in order of decreasing medical urgency Final Rules also stipulates that organ allocation policies “shall not be based on the candidate’s place of residence or place of listing.” How the Committee intends to resolve the problems can be found starting on slide 3…

What are the proposed solutions? Replace DSA with a 250 NM distance from donor hospital Remove policy language that permits prioritization of a sensitized heart candidate Remove the term “zone” from OPTN policy and replace it with actual distances Replace DSA with a 250 NM distance from donor hospital Implementing a 250 NM geographic unit makes heart distribution policy more consistent with the Final Rule in several ways: Expands candidates’ access to transplantation More consistent with the Final Rules’ requirements to distribute organs as broadly as possible Best balances equitable access (as defined by waitlist mortality) and achieving the best use of donor organs with efficiency in organ placement. (only add if you feel necessary) Neutral impact to waitlist mortality Broader distribution is retained for status 1 and 2 candidates (500 NM) Remove policy language that permits prioritization of a sensitized heart candidate Removing DSA as a unit of distribution in heart allocation makes current policy for sensitized heart candidates impractical Policy 6.4.B established conditions under which an OPO may allocate heart to sensitized candidates out of sequence within a DSA Removing the use of DSA as a geographic unit means the use of “DSA” in Policy 6.4.B will no longer have meaning Remove the term “zone” from OPTN policy and replace it with actual distances, as well as revise language elsewhere in policy that is impacted by these changes

Supporting Evidence per the Final Rule Based in sound medical judgement Data driven: modeling, literature, expert and stakeholder input Seeks to achieve the best use of donated organs and promote patient access to transplantation Measured by waitlist mortality and transplant counts Promote the efficient management of organ placement Measured by travel time and costs Based in sound medical judgment Committee considered multiple factors associated with geographic units Modeled different distances. In addition to 250 NM, the Committee also reviewed modeling results for 150 NM and two versions of 500 NM Research suggests worsened post-transplant outcomes among hearts with greater than 4 hours of ischemic time Committee was concerned that longer transport time associated with broader distribution might result in increased cold ischemic times Seek to achieve the best use of donated organs and promote patient access to transplantation Among the benefits of 250 NM distance: Modeling suggested the distance would have a neutral impact on waitlist mortality and post-transplant outcomes overall Less likelihood of ischemic times exceeding four hours Expanded transplantation opportunities because 250 NM approximates or is larger than many DSAs Promote the efficient management of organ placement While 250 NM will likely increase the use of air travel, not going to 500 NM reduces potential travel time and cost increases Realigning the distance for the first units of distribution for heart and lung allocation should reduce confusion

How will members implement this proposal? Transplant Hospitals Surgical teams may be required to travel farther distances to recover organs OPOs OPOs may allocate organs to candidates who are farther away from the donor hospital Policy changes may require surgical teams to travel farther distances to recover organs OPOs may allocate organs to candidates who are farther away from the donor hospital

How will the OPTN implement this proposal? Committee will make recommendations to Board at June 2019 meeting UNet Programming Changes: Update adult and pediatric heart match allocations to replace DSA with 250 nautical mile distance Update lung allocation policy to remove references to “zone” in classification titles Committee will consider all public comments and necessary revisions, if any, prior to bringing the proposal to the Board’s June 2019 meeting IT OPTN/UNOS IT programming changes are required and reflects the bulk of hours on this proposal. Changes will be made to the adult and pediatric heart match allocations to replace DSA with a 250 NM circle. In addition to that, classification titles in lung allocation will also be changed to remove references to “Zone”. The distance in nautical miles will be referenced in lieu of “zone” for both heart and lung allocation. There will be no changes to the lung allocation itself. There is no programming required for the proposed sensitization policy or other minor policy language changes.   Communication and education The OPTN/UNOS will follow normal processes to inform members and educate them on any policy changes through policy notices. This proposal may require instructional support. Compliance monitoring No changes to how members will be monitored for compliance

Is the Committee seeking feedback Would members recommend an alternative distance for thoracic distribution, versus the proposed distance of 250 NM? If so, what distance do you recommend and what evidence justifies this distance? Committee requests feedback concerning alternative distances to the 250 nautical miles

Questions?

Extra Slides

Supporting Evidence The Committee determined that replacing DSA with a 500 nautical mile allocation unit would not result in more consistency with the Final Rule The Committee cited potential decreased system efficiency, decreased utilization, and poorer post-transplant outcomes resulting from the following: Longer median travel times Increased reliance on air travel Higher likelihood of ischemic times exceeding four hours