Status: Public Comment
Sponsoring Committee: Thoracic Organ Transplantation Committee
Strategic Goal 2: Provide equity in access to transplants
Read the proposal (PDF; 1/2019)
Contact: Kimberly Uccellini
Data request from the Heart Sub-Committee of the Thoracic Organ Transplantation Committee
Results for four DSA-free models of heart allocation
View analysis report (PDF; 10/2018)
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The Organ Procurement and Transplantation Network (OPTN) Final Rule (hereafter, Final Rule) sets requirements for allocation policies developed by the OPTN/UNOS, including sound medical judgement, best use of organs, ability for transplant hospitals to decide whether to accept an organ offer, avoiding wasting organs, promoting patient access to transplant, avoiding futile transplants, and promoting efficiency. The Final Rule also includes a requirement that allocation policies “shall not be based on the candidate’s place of residence or place of listing, except to the extent required” by the other requirements of the Final Rule listed above.
In the past year, the United States Secretary of Health and Human Services (HHS) received critical comments regarding compliance with the National Organ Transplant Act (NOTA) and associated regulations under the Final Rule with respect to the geographic units used in lung and liver distribution. The OPTN/UNOS made rapid changes to resolve 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 those distribution systems and replace DSAs and OPTN/UNOS regions with a more rational and defensible unit of distribution.
Policy 6: Allocation of Hearts and Heart-Lungs currently uses DSAs as a geographic unit of distribution. These are poor proxies for geographic distance between donors and transplant candidates because the disparate sizes, shapes, and populations of DSAs result in an inconsistent application for all candidates. This presents a potential conflict with the Final Rule.
The OPTN/UNOS Thoracic Organ Transplantation Committee (hereafter, the Committee) proposes replacing DSAs with a 250 nautical mile (NM) distance from the donor hospital. The goal of this change is to make heart allocation policy more consistent with the Final Rule and provide more equity in access to transplantation regardless of a candidate’s place of listing. In addition, this proposal realigns the first units of distribution for heart and lung allocation, addresses the limited utility of the exception for sensitized heart candidates, and finally, resolves several clerical artifacts that remain as a consequence of removing DSA as a unit of distribution from heart allocation policy.
The Committee encourages all interested individuals to comment on the proposal in its entirety. Members are asked to comment on both the immediate and long-term budgetary impact of resources that may be required if this proposal is approved; this information assists the Board in considering the proposal and its impact on the community. The Committee requests specific feedback on the following item:
Members are asked if they would 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?