Comments

Hume-Lee Transplant Center | 03/18/2023

We support this rule. Our allocation is within 500nm and this policy addresses arbitrary decision making. It addresses a disparity and makes liver kidney allocation more equitable,

UC San Diego Center for Transplantation | 03/15/2023

The UC San Diego Center for Transplantation strongly supports the proposal to expand required simultaneous liver-kidney allocation from the current limit of 250 nautical miles to 500 nautical miles. Better aligning the simultaneous liver-kidney policies with those of other mandatory multi-organ shares will promote more equal access (nationally) for these transplant candidates and is an appropriate next step as the community moves away from rigid geographical boundaries and towards continuous distribution.

Infinite Legacy | 03/15/2023

The proposed policy will bring consistency to OPO allocation and is an appropriate next step as the community moves away from rigid geographic boundaries towards continuous distribution. According to OPTN data, the percentage of total kidney transplants that were multi-organ have been stable over the past few years at 10%, so implementation of the proposed policy does not appear as though it will negatively impact kidney alone candidates. The policy outcome would need to be monitored due to the higher percentage of multi-organ transplants involving kidneys that have low KDPIs than adult kidney-alone transplants and have worse long term graft survival. The policy should also consider laterality language in required shares.

Region 6 | 03/15/2023

1 strongly support, 6 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

During the discussion there were several attendees who supported aligning liver-kidney with heart-kidney allocation. Two attendees had concerns that expanding simultaneous liver-kidney allocation would disadvantage both liver and kidney only candidates. Another attendee commented that the expanded allocation would disadvantage candidates in the region given the geography. One attendee commented that if the simultaneous liver-kidney does not use the combined organs, the single liver or kidney should be offered within the accepting centers donor service area. 

Region 11 | 03/15/2023

1 strongly support, 12 support, 6 neutral/abstain, 3 oppose, 0 strongly oppose

Members commented that 500 NM is too large of an area and it could have unintended consequences and that simultaneous liver-kidney should not be based on heart allocation policy. A member commented that they do not have trouble getting simultaneous liver-kidneys in the 250-500NM range but supports this proposal as others may not have the same experience. Another member stated that all candidates who could potentially receive an organ need to be prioritized on one list.  

Association of Organ Procurement Organizations | 03/14/2023

Thank you for the opportunity to submit comments on the Organ Procurement and Transportation Network’s (OPTN’s) policy development process on behalf of the Association of Organ Procurement Organizations (AOPO). AOPO collectively represents 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, which together serve millions of Americans. As an organization, AOPO is dedicated to providing education, information sharing, research, technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplantation rates while consistently improving towards the singular goal of saving as many lives as possible. We offer the following comments for your consideration:

In regard to the OPTN proposal to Expand Required Simultaneous Liver-Kidney Allocation, AOPO supports this proposal. The policy will align the rules for simultaneous allocation of liver-kidney with heart-kidney policy and eliminate the confusion of different rules for simultaneous kidney allocation. Current rules require offering SLK out to 250 NM to candidates with a MELD of 29 and above, or Status 1A or 1B. The proposal will increase the distance to 500 NM and align the policy with simultaneous heart-kidney rules. This change is anticipated to have minimal impact on access to transplant for kidney-pancreas or kidney alone candidates.

Anonymous | 03/14/2023

I do not support this proposal.

Donor Network of Arizona | 03/14/2023

Donor Network of Arizona supports this proposal. We believe that it provides clearer guidance on when kidneys must be shared and reduces the arbitrary decision-making that can occur under the current system.

Region 7 | 03/14/2023

0 strongly support, 10 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose

A member commented that multi-organ allocation is already challenging and having to offer up to 500NM could prolong allocation of other organs and could potentially increase non-utilization. Another member commented that this will further disadvantage kidney candidates and utilization. Another member supports the increase to 500NM as long as it is closely monitored for negative consequences.

Region 1 | 03/14/2023

3 strongly support, 4 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Region 1 generally supported this proposal. There were no comments.

Gift of Life Michigan | 03/14/2023

Regarding the OPTN proposal to Expand Required Simultaneous Liver-Kidney Allocation (SLK), Gift of Life Michigan supports this proposal. It will better align the rules for simultaneous allocation of liver-kidney with heart-kidney policy and eliminate the confusion of different rules for simultaneous kidney allocation. Current rules require offering SLK out to 250 NM to candidates with a MELD of 29 and above, or Status 1A or 1B. The new rules will increase the distance to 500 NM and align it with simultaneous heart-kidney rules. This change is anticipated to have minimal impact on access to transplant for kidney-pancreas or kidney alone candidates.

Transplant Families | 03/14/2023

Transplant Families supports the comments of the OPTN Pediatric Transplantation Committee.

American Society of Transplant Surgeons | 03/14/2023

The revised SLK policy is being proposed in order to provide alignment for lung-kidney and heart-kidney which do share the kidney for eligible patients out to 500 NM. In order to provide similar access to transplant for SLK candidates, the proposal seeks to align the SLK and expand allocation of kidneys for SLK candidates with MELD 29 and higher out to 500 NM. The medical eligibility criteria for combined SLK remain the same. Under the current policy, OPOs may opt to share out to 500 NM for SLK, but it is not required. This has led to a considerable amount of variability around the country which is also not optimal. A potential unintended consequence may be decreased access to the kidney transplant alone patients, specifically vulnerable populations. Additionally, there is concern the highest quality kidneys will also not be available to the kidney alone list. This proposal should be supported to align all multi-organ policies.

View attachment from American Society of Transplant Surgeons

Region 8 | 03/14/2023

0 strongly support, 7 support, 7 neutral/abstain, 4 oppose, 1 strongly oppose

The majority of Region 8 members support this proposal but there was some opposition. An attendee commented that it is highly likely there will only be a small increase in MOTs, but each kidney in the MOT is an optimal kidney that would otherwise been allocated to a kidney-alone candidate. The member said that this is not an unintended consequence, it’s a known one. An attendee suggested to readjust heart down to 250 Nautical Miles (NM) to account for MOT rather than offering the SLK to eligible candidates beyond the 250 NM. Another member commented that the expansion of SLK to 500 NM makes the allocation process more complex which means the allocation process take significantly more time. The member suggested to put limits on the number down the list, to make all multi-organ allocation less confusing and more efficient. In support of utilizing more kidneys with livers, an attendee also pointed out that this should not take away from dual organ heart/kidney candidates, since those candidates are very sick as well. The member did not support decreasing the heart/kidney allocation to 250 NM. An attendee slightly favored the 250 NM limit for all, as opposed to the 500 NM, but believes that consistent alignment seems reasonable. An attendee explained that at first it makes sense to align SLK sharing policy with other MOT policies – but said its institution is concerned there will be a negative effect for kidney-alone candidates, including pediatric kidney-alone candidates. Another attendee said this proposed policy will delay organ offers and increase organ ischemic time. Currently, its institution is already receiving SLK offers after cross-clamp. An OPO member requested as much clear guidance and information as possible for when and where a kidney should be allocated with another organ. 

American Society of Transplantation | 03/14/2023

The American Society of Transplantation (AST) offers the following comments for consideration in response to the public comment proposal, “Expand Required Simultaneous Liver-Kidney Allocation:” •Although there is general support for appropriately aligning all multi-organ allocation policies, including simultaneous liver-kidney allocation, significant concerns were identified with this proposal as outlined below.

•There are concerns that the proposal does not sufficiently address potential impacts on single-organ transplant candidates and has the potential to further increase the number of multi-organ transplants that are performed in the setting of inconsistent practices; SLK utilization has already increased since the last policy was implemented. Any policy that increases mandated multi-organ allocation necessarily impacts single-organ transplant access. Specific items that warrant further consideration in the creation of a revised proposal include the following:

o Identify local single-organ candidates who should be prioritized for transplant above multi-organ candidates at distances from 251-500nm. For example, pediatric kidney-only candidates, 0 ABDR mm, or those with CPRA 99%+ that are within 250nm of the donor hospital might be prioritized for these organs before they are allocated to liver-kidney candidates 251-500nm away.

o Identify a stratum of organ quality within which organs might be allocated to local candidates before multi-organ candidates at distances from 251- 500nm. For example, KDPI top 20% kidneys might be prioritized for local allocation before they are allocated to liver-kidney candidates 251-500nm away. Most of the kidneys going to multiorgan allocation have KDPI < 25.

o A clearer rationale for why the first allocation sequence for multi-organ transplants should be extended for 500nm for multi-organ allocation but remain at 250nm for single-organ allocation. •There are concerns that the MELD >29 threshold will exclude patients listed with MELD exception (i.e., MMaT-3) from broad sharing policies.

•There are concerns that these proposed changes will perpetuate the allocation of low KDPI kidneys to high EPTS candidates to the detriment of pediatric kidney candidates.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/14/2023

This proposal is not pertinent to ASHI or its members.

OPTN Liver & Intestinal Organ Transplant Committee | 03/14/2023

The OPTN Liver and Intestinal Organ Transplantation Committee thanks the OPTN Ad Hoc Multi Organ Transplantation Committee for their efforts on creating a proposal to expand required simultaneous liver-kidney allocation. The idea for this project originated within the OPTN Liver and Intestinal Organ Transplantation Committee and the Committee is supportive of the effort to expand required SLK allocation and align SLK allocation with other multi-organ combinations. This proposal will address a current disparity in the allocation of SLK offers and will increase equity in access to SLK transplant across the country. The Committee supports this proposal and is eager to see it implemented in OPTN policy.

OPTN Transplant Administrators Committee | 03/14/2023

The Transplant Administrators Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this proposal.

There was some concern about the additional travel distance being required with this change but recognition for the need to address inequities in access for certain regions by increasing the distance.

NATCO | 03/14/2023

NATCO appreciates the opportunity that the Ad Hoc Multi-Organ Transplantation Committee has provided to review their “Expand Required Simultaneous Liver-Kidney Allocation” proposal. We provide the following feedback to the Committee’s specific questions:

1. Do you anticipate any unintended consequences of expanding required SLK shares from 250 NM to 500 NM for certain adult liver-kidney candidates? Do not foresee any unintended consequences for liver-kidney candidates with this expansion, as many OPO’s are already doing this in practice.

2. Does the proposed expansion of required SLK shares to 500 NM appropriately balance access to transplant between liver-kidney candidates, other multi-organ candidates who need a kidney, and kidney-alone candidates? The expansion does align with other multi-organ transplant policy, which provides consistency and balance. Theoretically, however, there will be an impact on some kidney-alone candidates, in particular, that would otherwise be offered those kidneys if not paired with the livers.

3. After the OPO completes required offers to qualifying SLK candidates, should the OPO be required to offer the kidney to kidney-alone candidates, or should the OPO be able to offer the kidney in accordance with any other policy? Similarly, should the OPO be required to offer the liver to liver-alone candidates, or should the OPO be able to offer the liver in accordance with any other policy? After offers are complete to qualifying SLK candidates, OPOs should then offer to kidney-alone or liver-alone candidates prior to extending offers in accordance with any other policy(ies).

4. Do the non-substantive changes to policy provide clear direction to OPOs regarding their obligation under the policy, while also providing OPOs enough flexibility to manage dynamic allocation scenarios? Yes, these changes are appropriate.

5. Are there other aspects of simultaneous liver-kidney policy that the Committee should clarify further? No other aspects are in need of clarification at this time. In summary, NATCO supports the proposed changes and agrees that enhanced clarity as well as standardization of SLK allocation is necessary.

OPTN Transplant Coordinators Committee | 03/14/2023

The Transplant Coordinators Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this proposal. 

A member noted that late turndowns in the OR can complicate allocation. For example, if a liver is turned down and the next patient on the match run is a simultaneous liver-kidney candidates, the kidney may no longer be available. She added that this creates challenges for OPOs who should not be required to hold the kidney for a potential SLK candidate further down on the match run. 

A member added that pediatric programs like to bring their pediatric candidates into the transplant center as early as possible when there is a potential offer. It can be frustrating with late declines in the OR for MOT. She suggested that once OR time is set, then the OPO can’t allocate to another MOT candidate if there is a late decline. She further expressed concern about how MOT might negatively impact highly sensitized and 0-ABDR candidates. 

 A member thought that the MOT proposals should have been combined since one could potentially impact the other. She acknowledged that it is complicated to establish rules while also allowing flexibility as individual cases change. However, she expressed frustration because there have been times when her center has called in a patient three times without getting the kidney. Some of these patients live 4-6 hours away. Additionally, case times have been increasing to the point where it could be 2-4 days after the initial offer before the donor goes to the recovery OR. 

A member suggested having the ability to “opt in” similar to expedited liver offers. This would allow transplant centers to identify when a surgeon is unwilling to accept a liver without a kidney. This could include a donor selection preference of “must receive MOT” or “willing to accept liver alone.”

OPTN Organ Procurement Organization Committee | 03/14/2023

The OPO Committee thanks the Ad Hoc Multi-Organ Transplantation Committee for their efforts in developing this proposal and offers the following comments:

Concern about extending cold time on organs with the increased distance and the potential impact on kidney non-use.

Several members supported this change to align the required share distance with heart-kidney allocation.

Support for providing clarity in the policy so that OPOs aren’t making clinical decisions on kidney shares outside the current 250 nautical miles.

Anonymous | 03/13/2023

This proposal will adversely impact pediatric kidney candidates, who repeatedly lose offers to multi-organ candidates.

Roberta Reed | 03/11/2023

I feel very strongly that a person who donated a kidney to save a life of someone else should retain priority on the transplant waitlist in the future should they find their remaining kidney failing them. A man in New Jersey (57 years old), gave my son in Pittsburgh, PA (age 25) a kidney so he could have his life back. I am so thankful to this man for saving my son. If this man should have issues with his kidney in the future he very much deserves to be given priority on the waiting list. It is the bare minimum we can do as a means of thanking him for saving the life of someone else.

Region 9 | 03/09/2023

1 strongly support, 5 support, 3 neutral/abstain, 3 oppose, 1 strongly oppose

Region 9 generally supported this proposal. During the discussion, a member stated they have spoken to several OPOs who would like policy to clearly explain how the order and priority should be given. A member expressed concern that this proposal would exclude even more kidney-alone candidates from access to the best kidneys and create more opportunities to manipulate the system. An attendee stated support for aligning this more closely with heart-kidney policy. Another member believed that comparing access to heart-kidneys versus liver-kidneys is irrelevant to some extent since there are criteria for liver-kidneys, but no criteria yet for heart-kidney. 

OPTN Ethics Committee | 03/08/2023

The OPTN Ethics Committee thanks the Ad-Hoc Multi-Organ Transplantation Committee for the opportunity to provide feedback on this proposal. Overall, this policy increases equity between patients in different OPTN regions and between SLK and SHK candidates. It also standardizes allocation for multi-organ transplants. Therefore, the Ethics Committee supports the proposed policy change and notes the following suggestions: 

• The data analysis looked only at the number of kidneys available for kidney-only allocation. Expanding required SLK allocation may also increase the amount of time spent in allocating organs and therefore increase the CIT of kidney-only transplants, potentially increasing DGF rates for kidney-only recipients. The Ethics Committee recommends that kidney-only CIT be included in policy evaluation efforts.

• Further work needs to be done to evaluate SPK allocation policies in light of these changes.

• The proposal is not expected to increase overall SLK volume, however, it would be prudent to follow up on this as well as on return of native kidney function in the AKI SLK subpopulation. This impacts the kidney-alone pool.

• It is reasonable to offer kidney alone and liver alone after all SLK offers made.

American Nephrology Nurses Association (ANNA) | 03/08/2023

See Attachment

View attachment from American Nephrology Nurses Association (ANNA)

Region 5 | 03/03/2023

7 strongly support, 14 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose

Region 5 supports the proposal. A member commented that there has been confusion on the differences in nautical miles, and that it should be standardized to eliminate the confusion. The member said that having some patients that are 250 nautical miles for liver and kidney is okay. From a pediatric candidate perspective, a member commented that this proposal will adversely impact pediatric kidney candidates, who repeatedly lose offers to multi-organ candidates. A member institution expressed its strong support of the proposal to expand required simultaneous liver-kidney allocation from the current limit of 250 nautical miles to 500 nautical miles. It commented that the change better aligns the simultaneous liver-kidney policies with those of other mandatory multi-organ shares and will promote more equal access (nationally) for these transplant candidates. And that it is an appropriate next step as the community moves away from rigid geographical boundaries and towards continuous distribution. A member suggested that delayed kidney transplantation needs to be considered more frequently in order to reduce the excessive kidney graft failure in MOT population.

Region 10 | 02/28/2023

2 strongly support, 5 support, 6 neutral/abstain, 5 oppose, 1 strongly oppose

Overall, members in the region were split on their sentiment for this proposal. One attendee noted that this is an important step towards making multi-organ allocation criteria similar across all organ types. Conversely, another attendee stated that this proposal will need to be addressed further once more data is available; increasing allocation distance does not necessarily result in more organ transplants. Other attendees expressed concern with sharing SLKs out to 500 nautical miles, noting it results in increased logistical challenges, increased costs, and an increase in organ non-utilization. An attendee suggested that OPTN policy needs to move away from allocation based on nautical miles since there is high geographical variation across the country. Population density would be a better basis for allocation. Another attendee added that allocating SLKs out to 500 nautical miles and still allowing liver programs the ability to accept two livers for the same candidate will lead to more late turndowns and organ non-utilization. Another attendee noted concern that the proposed allocation expansion could result in fewer offers for pediatric, highly sensitized, and medically urgent kidney-only candidates. Perhaps this would be mitigated if the priority shares in kidney multi-organ allocation concept paper is implemented in a manner which addresses this concern. Lastly, an attendee suggested that instead of offering SLKs out to 500 nautical miles to mirror heart-kidney allocation, heart-kidney allocation should be changed to mirror current SLK allocation policy.

OPTN Kidney Transplantation Committee | 02/27/2023

The Kidney Committee thanks the MOT Committee for the presentation and the opportunity to provide a public comment on the proposal. The Committee supports the proposal’s goal to ensure there is consistency in MOT policies. Regarding the question on what OPOs should do after completing required SLK offers, Committee members felt the originally offered kidney should not default to another MOT combination and kidney-alone candidates should be considered. Furthermore, consideration should be given to medical need of kidney-alone candidates as well as pediatric candidates (see Committee’s comment on the Identify Priority Shares in Kidney Multi-Organ Allocation concept paper).

Region 3 | 02/24/2023

1 strongly support, 11 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose

Region 3 generally supported this proposal. During the discussion, one attendee supported the concept but commented that we need to put all the multi-organ allocation requirements in one table to make it as simple as possible.  Another attendee recommended standardizing OPO practices as they relate to multi-organ allocation. 

OPTN Pediatric Transplantation Committee | 02/23/2023

The OPTN Pediatric Transplantation Committee thanks the OPTN Ad-Hoc Multi-Organ Transplantation Committee for the presentation and the chance to provide feedback. The Committee is supportive of aligning this policy, but there is some concern for unanticipated negative consequences on pediatric candidates. The Committee recommends following outcomes pediatric candidates, including pediatric liver and kidney candidates, closely in the post-implementation report. This includes waiting time, waitlist mortality, transplant rates and post-transplant mortality by age and MELD/PELD allocation score. Additionally, the Committee underscored the importance for transparent, clear policies for OPOs to follow.

Region 2 | 02/21/2023

3 strongly support, 9 support, 5 neutral/abstain, 2 oppose, 2 strongly oppose

Although supported by the region, several members raised concerns about the proposal. Most notably, there was concern that sharing SLKs more broadly will negatively affect kidney alone candidates. There needs to be an assessment on the impact of this proposal to potential kidney alone candidates. Additionally, this proposal should not be implemented until after the safety net for heart/kidney candidates goes into effect. Without a safety net option for both organ combinations, then the two policies will never be aligned. There was additional feedback that this proposal will only delay the allocation process which could lead to an increase in out of sequence allocation. The proposal also has the potential to increase organ non-utilization. 

Region 4 | 02/21/2023

2 strongly support, 12 support, 6 neutral/abstain, 2 oppose, 0 strongly oppose

Region 4 generally supported the proposal. Several attendees supported consistency with other multi-organ allocation systems but were concerned that increasing the number of kidneys going to multi-organ transplants was disadvantaging pediatric and kidney alone candidates. One attendee was concerned about the utility of low KDPI kidneys going to high EPTS candidates.