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

2. 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…

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

4. 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

5. 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

6. How will the OPTN implement this proposal?
Committee will make recommendations to Board at June 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

7. 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

8. Questions?

9. Extra Slides

10. 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