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Apply Transplant Notification Requirements for VCA Program Inactivation

eye iconAt a glance

Current bylaws

Current OPTN policy excludes Vascularized Composite Allograft (VCA) programs from Appendix K: Transplant Program Inactivity, Withdrawal, and Termination, which requires all other organ transplant programs to notify their waitlisted patients if the program is under short or long-term inactive status or can no longer transplant a subset of their patients.

Additionally, Appendix J: Membership and Personnel Requirements for VCA Transplant Programs, categorizes genitourinary organs as one VCA type, for a total of eight VCA program types.

Supporting media

Presentation

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Proposed changes

  • Remove the VCA exclusion from OPTN Bylaws, Appendix K: Transplant Program Inactivity, Withdrawal, and Termination
    • When a program intends to voluntarily inactivate on a short- term basis, notification to the OPTN is not required but the program must provide candidates with a written summary of its Program Coverage Plan
    • VCA programs that long-term inactivate are required to notify the OPTN and follow the outlined requirements should the program seek reactivation or extension of that long-term inactive status
  • Update OPTN Bylaws, Appendix J: Membership and Personnel Requirements for VCA Transplant Programs
    • Split the “genitourinary organ” VCA type into three separate categories of VCA: uterus, external male genitalia, and other genitourinary organs
    • Increase the number of VCA program types from eight to ten

Anticipated impact

  • What it's expected to do
    • Require VCA programs to notify patients if VCA program will be on short-term or long-term inactive status
    • Increase VCA program types from eight to ten types
    • Contribute to continued effort to align VCA programs with all organ types in OPTN Policy, Bylaws, and Procedures
  • What it won’t do
    • This bylaw change does not establish functional inactivity requirements for VCA

Terms to know

  • Short-term Inactivation: A transplant program that is inactive for no more than 14 consecutive days.
  • Long-term Inactivation: A transplant program that is inactive for 15 or more consecutive days.

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eye iconComments

Region 6 | 09/28/2022

Sentiment: 2 strongly support, 11 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

Region 10 | 09/28/2022

Sentiment: 3 strongly support, 6 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. A member noted their support for the proposal and stated that all programs within the OPTN, including VCA programs, should abide by similar policies.

NATCO | 09/28/2022

NATCO appreciates the opportunity to comment, and we agree with the changes being made to this policy. Since vascularized composite allografts (VCAs) were designated organs under the purview of the OPTN in July 2014 it would seem appropriate that VCA programs should notify their patients if they were to be on a short or long-term inactive period. In addition, we do not foresee any potential fiscal impact that this would cause VCA programs but would require institution in new process. Regarding the change in verbiage in Appendix J to include the ten types of VCA transplant programs, NATCO has no opposition to this.

Region 8 | 09/27/2022

Sentiment: 1 strongly support, 9 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

Region 7 | 09/27/2022

Sentiment: 2 strongly support, 7 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. There was noted support for the removal of the VCA exclusion as proposed, and it seems sensible that patients should be informed of periods of inactivity at a center. There was additional support for notification to OPTN for long-term inactivity, and support for the inactivity timelines. Lastly, the member agrees with the split of genitourinary organs in the data from one to three.

American Society of Transplantation | 09/27/2022

The American Society of Transplantation generally supports the changes outlined in the public comment proposal, “Apply Transplant Notification Requirements for VCA Program Inactivation.”

Attachment

Region 11 | 09/26/2022

Sentiment: 5 strongly support, 6 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 09/26/2022

The American Society of Transplant Surgeons (ASTS) is pleased to provide the following feedback to the OPTN VCA Transplantation Committee: ASTS opposes the proposal to remove the exclusion of VCA programs from OPTN Bylaw Appendix K: Transplant Program Inactivity, Withdrawal, and Termination. Relevant considerations include that the original exclusion was based on low transplant volumes for VCA programs. The latest OPTN/SRTR VCA report continues to demonstrate stability in the annual low volumes of VCA other than uterus of between 2 and 7 cases per year (OPTN/SRTR 2020 Annual Data Report: VCA. Am J Transplant. 2022 Mar;22 Suppl 2:623-647). Similarly, the number of waiting candidates remains low at less than 20 patients each year. The increased complexity of the approval process of VCA programs combined with new inactivity requirements could foreseeably decrease the number of active VCA programs and continue to decrease the availability and patient access to specific VCA programs.

Attachment

Region 1 | 09/21/2022

Sentiment: 2 strongly support, 3 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 | 09/20/2022

Sentiment: 1 strongly support, 5 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose

Region 2 | 09/13/2022

Sentiment: 5 strongly support, 11 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. A member noted that VCA transplants are not lifesaving procedures and this proposal is over regulation. Additionally, the OPTN should try to step back from this space and allow VCA programs to assume the dominant role in regulating themselves. VCA programs should be encouraged to be transparent with their candidates about their inactive periods, but placing regulations on them via OPTN Policy could be problematic in this area. OPTN Policies for VCA practices that might impact the use of other organs from a deceased donor would be beneficial for VCA programs, but this is not the case with this proposal. The VCA procedures are not analogous to most solid organ transplants, so having VCA programs match solid organ transplant programs may be just form fitting.

Region 9 | 09/12/2022

Sentiment: 2 strongly support, 3 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 | 09/08/2022

Sentiment: 5 strongly support, 13 support, 11 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 | 08/26/2022

Sentiment: 1 strongly support, 13 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose