Public comment solicitation is a lengthy process--and this proposal has solicited many lengthy comments (for which you'll have to scroll down at the link...)
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
Data request from the OPTN Kidney Transplantation CommitteeProvide simulation data on effect of removing DSA and region from kidney/pancreas/kidney-pancreas organ allocation policy
- View kidney pancreas analysis (PDF; 12/2018)
- Access kidney pancreas results (XLSX; 12/2018)
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:
- A fixed concentric circle framework with a 150 nautical mile (NM) small circle and a 300 NM large circle
- A fixed concentric circle framework with a 250 NM small circle and a 500 NM large circle
- A fixed concentric circle framework with a single 500 NM circle
- A hybrid framework with a single 500 NM circle that utilizes a small number of proximity points inside and outside of the circle, and
- 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.
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