Skip to main content

Clarify Multi-Organ Allocation Policy

Skip secondary navigation

eye iconAt a glance

Current policy

Current policy addresses multi-organ combinations for heart, lung, and liver candidates on the waiting list that require a second organ. It does not address which match run is used for the second required organ or specifically define the second organ. This results in inconsistent application of the policy.

Supporting media

Presentation

View presentation slides

Proposed changes

  • Identify criteria for when Organ Procurement Organizations (OPOs) are required to offer the liver or kidney to a heart or lung candidate, if available, from the same donor.
  • Address heart-liver, lung-liver, heart-kidney, and lung-kidney multi-organ combinations.
  • Establish requirements for when OPOs must offer the liver or kidney when allocating according to the heart or lung match run.

Anticipated impact

  • What it's expected to do
    • Provide OPOs clearer direction when offering multi-organ combinations by establishing medical criteria for when OPOs must offer the liver or kidney to heart or lung candidates
      • Heart Adult Status 1, 2, and 3, Pediatric Status 1A and 1B
      • Lung Candidates with a lung allocation score of greater than 35
    • Increase “required offer” distance from the donor hospital to align with thoracic allocation
      • Heart – increase from 250 nautical miles (NM) to 500 NM to better align with current heart allocation
      • Lung – increase from 250 NM to 500 NM to be consistent within the proposed policy
    • Address 84% of combinations not currently addressed in other policies (heart-liver, lung-liver, heart-kidney, and lung-kidney combinations)
  • What it won't do
    • Does not address medical eligibility criteria or a “safety net” as used in current simultaneous liver-kidney policy
    • Does not establish requirements for which organs must be allocated first

Themes

  • Multi-organ policies
  • Heart and lung match runs

Terms to know

  • Organ Procurement Organization: An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation.
  • Match run: A computerized ranking of transplant candidates based upon donor and candidate medical compatibility and criteria defined in OPTN policies.
  • Safety Net: A concept that would increase priority on the deceased donor kidney waitlist for previous liver alone recipients that later develop end stage renal disease.
  • Click here to search the OPTN glossary

eye iconComments

OPTN Lung Transplantation Committee | 01/26/2021

The Lung Transplantation Committee appreciates the opportunity to comment on the Clarify Multi-Organ Allocation Policy proposal. The Lung Committee asks the OPO Committee to ensure that lung-liver candidates who urgently need a liver will receive adequate priority for transplant even if the candidate’s lung allocation score (LAS) falls below the LAS threshold of 35. The Lung Committee acknowledges that the LAS threshold of 35 was selected based on available data for the small population of lung-liver candidates, and appreciates that if a candidate has a high Model for End-Stage Liver Disease (MELD) score, then the liver could “pull” the lung. A member suggested allowing transplant programs to choose whether organs for lung-liver candidates are allocated primarily based on the candidate’s MELD or LAS. The Committee acknowledged that generally speaking, candidates who are listed for lung-liver are predominately listed due to their lung disease but struggle to get offers for a liver. The Committee appreciates that this proposal would help to improve access to livers for those lung-liver candidates. A member noted that using LAS to establish a threshold does not apply to patients ages 0-11, who are not assigned an LAS for allocation. While it is rare to have multi-organ candidates in the 0-11 age group, the OPO Committee may want to consider this age group in their proposal.

Region 4 | 02/04/2021

Region 4 sentiment: 5 strongly support, 15 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member commented that the heart adult status 1 and 2 were the most appropriate and added that a heart-kidney safety net should be developed. One attendee commented that heart adult status 3 should also be included. Another attendee suggested using waitlist mortality as a measure where candidates should be prioritized on multi-organ lists. One attendee supported using a 500 NM threshold for sharing multiple organs. Another attendee supported 500 NM for heart adult status 1 and 2 and 250NM for status 3. One attendee commented that LAS often does not capture the severity of disease, particularly with teens with CF who also need a liver and added that waiting time for these candidates is unacceptable.

OPTN Operations & Safety Committee | 02/10/2021

The Operations and Safety Committee thanks the OPTN Organ Procurement Organizations Committee for their efforts in developing this public comment proposal for the Clarify Multi-Organ Allocation Policy. A member suggested the development of an algorithm related to multi-organ allocation within the system. Although this is out of scope for this project, it should be in consideration for the next phase of the project when programming is discussed. The Committee supports this proposal. The Committee agrees that 500 nautical miles is an appropriate distance for when OPOs must offer a liver or kidney to a multi-organ candidate meeting the proposed criteria. A member suggested that the OPO Committee consider maintaining consistency with Heart Adult Status 1 and 2 as it pertains to heart/lung candidates. It would be more consistent with prioritization of heart candidates above heart/lung candidates.

Children's Hosp Los Angeles | 02/11/2021

Main concern has been raised by others... Adult congenital heart disease patients with Fontan physiology commonly are listed at status 4, often by exception, because inotropic support and VAD do not help their physiology. If also listed for liver, these patients may be disadvantaged by policy which does not pull a liver with the heart, especially as their MELD score may also not be as high as some other liver candidates. We advocate for liver to be allocated to the heart recipient at status 4 as well as at status 1,2 and 3.

Region 3 | 02/18/2021

Region 3 sentiment: Strongly support-6, Support-11, Neutral/Abstain- 3, Oppose - 3, Strongly Oppose - 1. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Several members commented on the need to establish criteria to qualify for a kidney, comparable to the simultaneous liver kidney criteria, for all multi-organ transplants. There were several comments related to the inconsistency of multi-organ allocation and the need for standardization, including the order of matches run, and clear criteria. Several comments were made about the complication of multi-organ allocation including inconsistent local resources, variability of timing of test results, and the tremendous effort of the OPO staff. An attendee commented that multivisceral transplant candidates are being badly denied access to transplant and that liver needs to be allocated with intestine, not the other way around. Several comments were directed at the need to evaluate the anticipated benefits and consequences, including the impact on kidney allocation, and what the impact on the number of extra organs offered and transplanted would be if the distance is increased to 500 NM. Other comments included that this would exclude patients with Durable VADs without complications, that it is important that 100% pra patients are not disadvantaged, and that this does not account for either the very ill or the stable patients.

Region 5 | 02/19/2021

Region 5 sentiment: 9 strongly support, 24 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member stated that knowing this is a data driven proposal, they think it is problematic for an adult status 4 heart patient to not have a kidney offered, because these patients have increasingly little options when they move up in status and get sicker in terms of support. Needing a left ventricular assist device (LVAD) and dialysis is devastating – but can be a reality for Heart status 4. Those patients tend to do poorly in the long run. Whether preemptive to dialysis or on dialysis, they should be given priority at a status 4 level. Previously, people were more amenable to allocating the kidney with the heart, but now that we are crossing over into circle based and continuous distribution allocation models, getting these things hammered out is important. The member felt if you are listed for a heart-kidney you should get the kidney no matter what priority. Otherwise, we are setting ourselves up for long-term trouble, with the patient not having as many options down the road. Another member was in agreement with the comments, stating that we need a special consideration for dual organ for congenital heart patients who are normally status 4. The increase of 500 miles for the liver to pull liver-heart may be concerning for overall ischemic time. Another member agreed that Adult Status 4 should be included for dual organ for congenital heart patients (for example Fontan procedure patients) listed for heart-liver as status 4, or heart re-transplant listed as a status 4 who needs a kidney, both have limited support options and would benefit from being able to get the liver or kidney with the heart allocation. Another member stated that when we deal with OPOs we rarely deal with, those conversations are more difficult to have. The member only had one anecdotal experience but did not know why we would not give a heart status 4 a kidney automatically if they needed it. One member stated that matching to the concentric circles seems logical but worries that by just choosing distance we may be disadvantaging some potential recipients, if the system can better stratify life years it would show more equitability. Another member stated the proposed threshold refers to the urgency of the heart or lung transplant but not necessarily urgency of the liver or kidney transplant. This proposal is a good start – they look forward to the committee's future work to tease out the relative indication of the primary and secondary organs. The member followed up; part of the problem is that right now, a lot of the urgency criteria assumes a heart-kidney and heart-liver – that the urgency of the secondary organ is what is driving mortality on the waiting list. As a nephrologist, they did not think that is settled or true.

Anonymous | 02/25/2021

Appreciate the efforts of this joint committee effort. The proposal is necessary but far from sufficient. Somewhat disappointed that medical criteria did not get sorted out, at least for lung-kidney and liver-kidney candidates. This needs to be done ASAP, and should have been done by now. The success of the SLK policy and the safety net should be used as an example. This is of limited usefulness without these pieces. Please prioritize and get going. A point of clarification - as far as I know, there is no way to prioritize or triage three possible types of candidates that require sharing oft he kidney in the case that there are simultaneously liver-kidney, lung-kidney and heart kidney recipients that come up on the match run lists. The committee should try to sort out predicted 7 day mortality or other metrics to resolve this conflict in policy when it is mandated that all three types of candidates meet criteria for mandatory offer of the kidney when there are only two kidneys available.

ANNA | 02/25/2021

ANNA supports this proposal.

Attachment