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Eliminate the use of regions in VCA distribution

Proposal Overview

Status: Public Comment

Sponsoring Committee: Vascularized Composite Allograft Transplantation Committee

Strategic Goal 2: Provide equity in access to transplants

Read the proposal (PDF; 1/2019)

Contact: Christopher Wholley

Executive summary

The OPTN/UNOS Final Rule (hereafter Final Rule) sets requirements for allocation polices developed by the OPTN/UNOS, including sound medical judgement, best use of organs, ability for transplant programs to decide whether to accept an organ offer, avoiding wasting organs, and promoting efficient management of organ placement. 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.

On July 31, 2018, the Secretary of Health and Human Services (HHS) found that the use of donation service areas (DSAs) or regions in organ allocation policies cannot be justified under the Final Rule. OPTN/UNOS policies for vascularized composite allograft (VCA) allocation use “region” as the first geographic boundary for distribution. In response to the Secretary’s letter, the OPTN/UNOS Executive Committee directed the VCA Transplantation Committee (Committee) to develop a proposal that replaces “region” with another geographic boundary in VCA allocation policy. This proposal would replace use of regions in VCA allocation policies with a 750 nautical mile (NM) concentric circle around a donor hospital. This will address the Secretary’s findings by allowing efficient placement of deceased donor VCAs, help achieve optimal recipient and graft outcomes, and to reduce the risk of organs being recovered but not transplanted.

This proposal is consistent with Goal Two of the OPTN/UNOS Strategic Plan to increase equity in access to transplant. This project aims to implement rational units for geographic distribution that are more consistent with the requirements of the Final Rule.

Feedback requested

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 impact on budgets and other 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 items:

  1. Members are asked if they would recommend an alternative distance for VCA distribution, versus the proposed distance of 750 NM? If so, what distance do you recommend and what evidence justifies this distance?

Comments

LifeGift | 01/30/2019

LifeGift offers authorized VCAs on every appropriately authorized donor in an effort to support those in need of these grafts.We support the committee recommendation of 750nm in an effort to broaden the "reach" of the OPO when so few candidates are listed. We believe this is consistent with efforts to broaden sharing. We also encourage and highlight the need for more VCA transplant programs in the central and southwest regions of the United States, as our geographic location places us beyond the usual acceptable transportation time limits of the programs with candidates listed, while in our experience, so many families of donors wish to provide these gifts to those waiting, many of whom are wounded warriors.

Region 7 | 02/08/2019

Region 7 vote-6 strongly support, 12 support

Region 1 | 02/18/2019

Region 1 vote-1 Strongly support, 6 support, 5 abstain, 2 oppose, 0 strongly oppose Members commented that unless VCA is programmed in UNet, broader sharing could result in many futile phone calls when trying to place the organs. Some members supported collecting data on organs that are ultimately not transplanted and agreed that it would be helpful to know this when considering broader sharing. Currently, OPOs do not always submit spreadsheets if the organs are not placed so there is no way to capture this data. Several members were concerned about the size of the circle as it related to: cold ischemic time which varies depending on the organ, cost which increases with distance, and method of travel and distribution which is based waiting time. Some of the concern about waiting time was due to a situation where one center in the 750 mile circle has longer waiting times than any of the others, particularly new centers, and will always have more priority on the list. Several members supported a smaller 500 NM circle size to decease cold time and cost and increase efficiency. The region was supportive of encouraging more OPOs to pursue VCA donation.

Region 5 | 02/21/2019

Region 5 Vote: 5 strongly support, 20 support, 7 abstain, 1 oppose

Region 2 | 02/21/2019

Region 2 Vote: 2 strongly support, 19 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose Region 2 is bound by the Atlantic Ocean, the centers that are near the coast have large portions of their distribution circles over water. One member felt that could potentially limit the number of offers that VCA candidates have access to. It was noted that the high population density along the east and west coast should help offset those portions of the circle that cover ocean. One member posed the idea to incorporate medical urgency into the allocation system instead of relying solely on waiting time within the 750 nautical mile circle.

Region 8 | 02/26/2019

Region 8 vote: 1 strongly support, 5 support, 10 neutral/abstain, 1 oppose, 1 strongly oppose

Lifebanc | 02/27/2019

In working with our local transplant program in the past with face and uterus transplants, their preference and their local IRB indicated that the donors should remain local and our OPO have actually transferred those local donors directly to the transplant center for recovery in the past to streamline the process. As more VCA transplants are listed and transplanted, the distance traveled could be expanded. However, to set an initial range for 750 nautical miles is unrealistic at this time. A range between 250-500 nautical miles seems much more realistic and does represent broader sharing in comparison to current practice.

Region 10 | 02/28/2019

Region 10 Vote: Proposal as written: 1 strongly support, 5 support, 5 neutral/abstain, 3 oppose, 5 strongly oppose; 500NM Circle Amendment: 2 strongly support, 11 support, 7 neutral/abstain, 3 oppose, 0 strongly oppose. A member expressed the need to add points for sensitization to VCA allocation. These patients tend to be sensitized and working that into the allocation equation would be more equitable than only using wait time. Several members voiced concerns over choosing a 750NM circle. The data presented showed increased graft function once outside of 500NM. VCA is a new field and the number of programs is going to rise. As the field progresses it would make sense to have a 500NM circle as a first step. The region proposed an amendment to the proposal to change the circle size from 750NM to 500NM.

OPTN/UNOS Ethics Committee | 03/13/2019

The Ethics Committee thanks the VCA Committee for its effort in developing this proposal to remove region from VCA distribution. The Committee discussed whether other criteria have been taken into consideration, such as hard-to-match skin tones or pediatric sized limbs. The VCA Committee had considered these criteria, but found that the low volume of VCA transplants made analysis of these considerations difficult. Committee members questioned whether it was premature to change policy without sufficient data. The VCA presenter iterated the need to abide by the Final Rule and assured the Committee that the VCA Committee is using all the evidence currently available. A majority of the Ethics Committee abstained from a vote on the VCA proposal because of concerns about lack of sufficient data, necessary to inform evidence-based policy (of 9 respondents, 5 members were neutral/abstained, 3 supported, 1 opposed).

OPTN/UNOS Organ Procurement Organization (OPO) Committee | 03/14/2019

The Organ Procurement Organization (OPO) Committee discussed the proposed allocation changes and their impact on OPOs and offer the following responses: o The Committee voiced concerns about the cost impact as well as transportation methods (recovery teams having to fly vs. utilization of local recovery teams). There will be an increase in case times, decrease in available resources, and an increase in the workload on staff. o The Committee recognizes the impact that broader organ distribution will have on donor families. Increased donor case times can have a negative impact on donor families and donor hospitals. o The Committee recommends improving efficiencies within the system that will enable the ability to cut down on case times and ensure organs are allocated in the most timely and efficient manner possible. OPO Vote: • What is your opinion of this proposal? Vote: 11 Support, 1 Neutral/Abstain • Do you recommend an alternative distance for VCA distribution other than 750nm outlined in this proposal? Vote: 5 Yes, 7 No

Region 4 | 03/15/2019

Region 4 vote- 2 Strongly support, 7 support, 9 abstain, 2 oppose, 1 strongly oppose Comments: There was a question about the rationale for transport 750 miles, since data shows that VCA’s are always shared within 500 miles. There is concern that this will increase placement and ischemic time due to the increased number of OPOs that need to be contacted. Those who opposed the proposal are in favor of decreasing the circle to 500 NM.

Association of Organ Procurement Organizations (AOPO) | 03/17/2019

The Association of Organ Procurement Organizations (AOPO) strongly supports the goal of the UNOS Board and the organ-specific UNOS committees to align organ allocation policies with the Final Rule. In support of this goal, organ procurement organizations remain committed to partnering with transplant programs to adapt to changes in allocation policy and develop innovative new approaches to increasing transplantation, with a focus on efficiency and cost-effectiveness. We advocate for a policy that is sensitive to specific cases to maximize utilization and allow for flexibility to take into account special geographic considerations. Further we maintain that any policy change must, at a minimum, not decrease utilization of organs. The OPO community has feedback specific to the VCA Committee's question concerning alternative distance. The community recognizes that the data concerning VCA experience is small and in its infancy relative to organ transplantation. However, the data demonstrates that most VCA transplants have been donated from donors less than 200 nautical miles from the center performing the transplant. Since travel consideration is graft and protocol specific, and with current experience, we are concerned that 750 NM is too great of a distance for the first circle of distribution and will create many unnecessary and time-consuming offers. This is particularly a concern under the current manual VCA allocation process. We recommend reducing the distance to 500 NM and encouraging the committee to continue to collect data and monitor outcomes to evaluate the proper distance that balances VCA center outcomes with allocation efficiency.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation supports the proposal as written. The selection of a fixed distance of 750 nautical miles (NM) to replace the current VCA distribution process which relies on waiting time after allocation within the Region is reasonable given that under the present system 75% of VCA transplants are performed within 200 NM of recovery and 87.5% are recovered within 500 NM of recovery. Additionally, current data does not correlate with outcome and cold ischemia time. Going forward, the AST encourages monitoring the effects of this allocation change specifically regarding recovery costs and effect on cold ischemia time and outcomes.

American Society of Transplant Surgeons (ASTS) | 03/22/2019

The American Society of Transplant Surgeons (ASTS) opposes the OPTN/UNOS policy proposal to eliminate the use of regions for vascularized composite allograft as written. We recommend adopting the 250 nautical mile (NM) concentric circle around a donor hospital since there are only a few active programs and they would benefit from a smaller radius. In addition, this model would minimize cold ischemia during the early developmental stages of the procedure.

Region 11 | 03/22/2019

2 strongly support, 4 support, 13 abstain, 5 oppose, 3 strongly oppose Comments: VCA experience in the region is limited; only 2 programs do VCA transplants. One member asked what the cold ischemic times were for VCA, compared to other organs. Members noted that waiting times seem disparate – is it more about relationship with center and OPO? If so, shouldn’t the first unit of distribution be more proximate to the DSA or donor hospital? The region agreed that 750 NM doesn’t seem evidence-based, if 2/3 of the grafts failed after being distributed 250 NM.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) abstains on commenting on adoption of this proposal. ASHI has no comment on alternative distances for the concentric circles in this proposal

Carolina Donor Services | 03/22/2019

Carolina Donor Services supports the elimination of Region as the basis for VCA allocation and supports the concept of allocation according to a nautical mile (NM) concentric circle around a donor hospital. CDS recommends reducing the nautical miles from the 750 proposal to 500 for the first circle of distribution. Available data and acceptance patterns do not suggest that VCA recipients will be disadvantaged by the distance of 500NM and OPOs will be able to identify a recipient timelier, avoiding unnecessary and inefficient time-consuming offers.

Region 3 | 03/23/2019

Region 3: 5 strongly support, 10 support, 1 abstain. No comments.

Region 6 | 03/23/2019

Region 6: 13 strongly support, 21 support, 4 abstain, 0 oppose, 4 strongly oppose. One member expressed concern over the lack of data available to determine proper cold ischemic time for VCA organs.

Region 9 | 03/26/2019

Vote: 0 strongly support, 7 support, 4 abstain, 1 oppose, 0 strongly oppose Comments: Members noted that CIT limitations are not the same for all VCA’s, so establishing a circle is meaningless. Since sharing is more about the relationship between a center and an OPO, VCA’s should be shared nationally giving the option for OPOs to either opt in or opt out.