Comments

OPTN Region 9 | 03/27/2020

Strongly support (4), Support (8), Neutral/Abstain (0), Oppose (1), Strongly Oppose (0) Overall, the region supports the proposal. There was a question about multi-organ candidates’ priority versus medically urgent candidates – if someone is stable and needs multiple organs, they should not be prioritized over a medically urgent candidate. Another member asked if there would be a timeframe a patient would receive this designation or a limit on the number of offers they could turn down. The concern is that a medically urgent patient should probably be accepting an offer as soon as possible, otherwise they are probably that medically urgent to begin with. The presenter explained that the Kidney Committee was concerned that if they made things too stringent, it would leave them with only patients who have very few options left – wanted to try and get to these patients before they got to such limited options. The presenter also added that other regions have suggested monitoring offer turndowns. There was a suggestion to place a 2 week timeframe on this status, and after two weeks if there were offers that were turned down in that time, require an explanation for why. A member also suggested that these reviews should be done in close to real time, since there should be relatively few of these cases. A member expressed concern that the requirements around this proposal are too stringent and that this classification does not fall high enough on the sequence to ensure patients who are truly in need will get an offer fast enough.

OPTN Pediatric Transplantation Committee | 03/25/2020

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the “Addressing Medically Urgent Candidates in New Kidney Allocation Policy” proposal. The Pediatric Committee believes that medical urgency for the pediatric population should be different, especially for patients under 30 kg. The language asks for exhaustion of upper extremity and lower extremity sites or if there is no contraindication. These pediatric patients are not ideal candidates for lower extremity vascular access (grafts or fistula). In addition, placement of a femoral dialysis catheter in these patients once the upper extremity (IJ and subclavian) veins are thrombosed will commonly result in the thrombosis of the IVC, thus making transplant extremely difficult or not possible. Even though placement of a femoral catheter is not strictly contraindicated in these children, it creates significant problems. The Committee would propose that any child under 30kg who has nearly exhausted all upper extremity access sites and PD sites should be considered as medically urgent. The OPTN Pediatric Transplantation Committee believes that the new medical urgency classification should receive priority outside of the 250 NM circle, giving medically urgent candidates outside of the circle priority before non- medical urgent candidates inside the circle. In regard to the new medical urgency classification included in each KDPI category, the Committee believes that Based on the sentence: “candidates that had completely exhausted dialysis access would only have between 7-14 days to receive a transplant in order to survive, whereas candidates with “imminent risk” of losing dialysis could possibly extend that window for several weeks”, it would seem that these patients (or at least the pediatric patients) should be at the very top of each sequence. The Committee supports the utilization of documentation such as Imaging studies demonstrating occluded access sites in addition to documentation of efforts to establish access and its challenges to ensure the medically urgent classification is being used as intended.”

Region 7 | 03/24/2020

2 Strongly Support, 7 Support, 1 Neutral/Abstain, 3 Oppose, 0 Strongly Oppose Overall members of the region supported the proposal. One member noted that with a retrospective review, it opens up the possibility for gaming. A program might be more willing to list a patient who is borderline with the requirements as medically urgent since the case will not be reviewed until afterwards. There should be a prospective review board. There was another suggestion that pediatric patients should have their own medically urgent status, with their own criteria, that would prioritize them ahead of other pediatric patients. Often times, when a pediatric patient is receiving dialysis in the lower extremities they are no longer viable candidates for transplant. There was a question if the contraindications for dialysis consisted of only clinical criteria or if social criteria could be considered? For example, there are times when a patient is not an ideal candidate for dialysis due to being unable to have at home dialysis or limited access to transportation. Lastly, there was a suggestion that other criteria such as a patient’s EPTS score should factor into the requirements for qualifying for medical urgency.

Region 10 | 03/24/2020

5 Strongly Support, 14 Support, 2 Neutral/Abstain, 2 Oppose, 1 Strongly Oppose Members of the region supported the proposal, but opinions varied as to where medically urgent candidates should fall on a match run. Some felt that if these candidates are completely out of access they should be before highly sensitized candidates. However some members felt that medically urgent candidates should come after pediatric candidates and prior living donors. One member suggested keeping medically urgent candidates behind pediatric candidates and prior living donors for Sequence A and B donors; for Sequence C and D donors, medically urgent candidates should be ahead of highly sensitized candidates. Members of the region expressed interest in having two categories for medically urgent candidates: those completely out of dialysis access who should get top priority, and those who are on their final access who should receive some priority. There was a suggestion to add an EPTS score component to the medically urgent category; those candidates with poorer EPTS scores may have worse outcomes. Overall, the region expressed the need for absolute clarity on what qualifies a candidate to be considered medically urgent.

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is cautiously supportive of efforts to standardize the rare instances of “medical urgency” but offers the following comments for consideration: • There is not support among the AST constituencies for “medically urgent” candidates to receive priority outside of the 250 NM circle. • There is concern regarding the retrospective nature of the review of the ‘Medically Urgent” status. • The criteria for “medically urgent” status as listed in the proposal are focused on adult criteria given that many of the criteria (e.g.; leg graft access) are not feasible or even possible in small children. We suggest consideration be given to development of pediatric criteria or at least modification of the proposal to indicate that the proposed criteria only applicable to adults. • The proposal as written, does not allow for a child with failure of dialysis access (therefore meeting the definition of “medically urgent”) to gain any priority over a child who is listed but stable on dialysis.

NATCO | 03/23/2020

NATCO supports the efforts to address the obsolescence of current policies addressing medically urgent candidates being granted exceptions to allocation policy once the newly-adopted Kidney Allocation policy ceases to use DSA’s as a unit of allocation with strong consideration given to utilizing a prospective review process in place of a retrospective review. NATCO agrees that priority for medically urgent candidates should be awarded to medically urgent candidates inside the 250 NM initial allocation circle from the transplant program where the donor kidney is offered; and, that the medical urgency classification within the kidney allocation tables seems appropriate. NATCO strongly recommends that the process of retrospective review be replaced with a system of prospective review to include examination of documentation by appropriately qualified physicians appointed to an expert review board, or by a sub-committee of the Kidney Transplantation Committee. Regarding the definition of medical urgency, NATCO recommends a Status 1A classification, similar to that used in liver allocation, could be assigned to candidates who are completely out of dialysis access.

OPTN Patient Affairs Committee | 03/23/2020

The Patient Affairs Committee appreciates the opportunity to comment on this proposal. The Committee agrees that a uniform definition of “medical urgency” for kidney candidates is needed. Several members felt that “medical urgency” was the wrong term – all patients waiting for transplant are “medically urgent” – and suggested “highly urgent” or something similar as an alternative. There was also general agreement that if a candidate is facing only days of survival without a transplant, they should get first priority in the allocation sequence. The committee expressed concerns that if the definition of “medically urgent” is too broad, it could make the patient community feel like some are “jumping the line”, but they felt that the professional transplant community has the ability to ensure that doesn’t happen. There was a lot of discussion on the retrospective review of cases – many felt that this was inadequate to prevent the potential for candidates being inappropriately assigned this status. There was discussion of keeping some form of the current system of approvals intact – perhaps by having one other randomly selected hospital in the 250NM circle do a prospective review of the case. This would be in addition to the retrospective review. Lastly, the committee stressed that being engaged in the policy development process much earlier on projects like these that have a patient component would result in their questions and feedback being addressed prior to public comment. Vote: (0) Strongly Support, (6) Support, (0) Neutral/Abstain, (6) Oppose, (1) Strongly Oppose

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) supports this policy proposal. It defines the criteria for medical urgency in kidney transplantation in a more comprehensive and coherent fashion to address the needs of these unique patients. ASTS believes the priority for the new classification for medical urgency should be confined to the 250 Nautical Mile (NM) circle. We also contend that priority should be given only to medically urgent candidates inside the circle to: 1) avoid delayed graft function in patients with poor dialysis access and 2) minimize cold ischemic time. As this is relatively unusual, the majority of these patients would be transplanted promptly using only the 250NM circle. ASTS supports a policy where living donors receive priority over others when determining medical urgency within each KDPI category. Documentation to ensure patients are properly assessed for this classification should include: 1) recent notes from interventional radiology or surgery with imaging confirming thrombosis or severe, untreatable stenosis of the vascular structures and 2) evidence the patient has received a translumbar or transhepatic catheter.

OPTN Region 3 | 03/22/2020

Feedback: • The definition is unclear on how the patient would have to be dialyzed; they should all be retrospectively reviewed but the current proposed language says 'may' • “Unable to get access” is subjective • Possibility of adding priority points instead of classification as a simpler solution • Concern that creating this classification will lead to abuse of it and an unintended increase in the number of patients being transplanted as medically urgent • A retrospective review could allow people to abuse this • The definition as written is open to interpretation and cannot be enforced; there should be a review committee to approve exceptions like other organ exceptions. Vote: 0 strongly support, 11 support, 3 abstain/neutral, 5 oppose, 2 strongly oppose

Membership & Professional Standards Committee | 03/20/2020

The MPSC thanks the Kidney Transplantation Committee for presenting its proposal “Addressing Medically Urgent Candidates in New Kidney Allocation Policy.” Members of the MPSC offered the following questions and comments: • When a candidate has exhausted every access point, then none are left to use during transplant. The policy could require three out of four major access points to be exhausted so one access point remains for transplant. • Since these candidates are considered medically urgent and the Committee anticipates few of them, why are the candidates not prioritized right behind 100% CPRA candidates? • Pediatric candidates are prioritized over medically urgent candidates on the match run. If there are multiple pediatric candidates and one is medically urgent, is that candidate prioritized over the other pediatric candidates? Does a medically urgent pediatric patient get more priority than other pediatric patients? • How will the process for the surgeon and nephrologist to sign off on medically urgent candidates work? Why not have the primary surgeon and physician for the transplant program sign off? • Medically urgent candidates are likely to have higher EPTS scores and may be higher-risk candidates, and Sequence A is preferentially directed toward candidates with lower EPTS scores and higher post-transplant survival. Removing the medically urgent status from Sequence A and moving that status higher in Sequences B, C, and D may help gain additional community support for the proposal. • Dialysis access choices vary between patients. Prospective reviews may be warranted to make sure patients are appropriately prioritized. The results of the sentiment poll were 6 Strongly Support, 23 Support, 2 Neutral/Abstain, 3 Oppose, and 2 Strongly Oppose.

Region 11 | 03/19/2020

Strongly support (8), Support (11), Neutral/Abstain (1) Oppose (1), Strongly Oppose (0) Region 11 generally supports this proposal. During the discussion the following feedback was provided: • Priority in Sequence A is too high • There needs to be priority for pediatrics in sequence C • Some members support a prospective review

American Nephrology Nurses Association (ANNA) | 03/18/2020

ANNA supports this policy proposal. It is important to align with current policy.

Pancreas Committee | 03/18/2020

The OPTN Pancreas Transplantation Committee thanks the OPTN Kidney Transplantation Committee for their efforts in developing this public comment proposal for addressing medically urgent candidates in new kidney allocation policy. The Committee expressed concern about transplant centers incorrectly using the medically urgent criteria to gain higher prioritization for their patients. With medical urgency previously being determined at a DSA level, there can be variation in what is determined to be medically urgent. There should be a way to consider risk of complication when calculating the scores for allocation without penalizing the transplant centers. A member inquired about data showing how many potential medically urgent listings there were that didn’t get transplanted. Additionally, the Committee voiced the importance of evaluating data related to outcomes information on the candidates that were transplanted. It is the hope that this proposed policy change would help improve data collection on medically urgent kidney candidates and recipients. The Committee indicated the following sentiments for the proposal (out of 8 voting members): 1 Strongly Support, 5 Support, 1 Neutral/Abstain, 1 Oppose, 0% Strongly Oppose

Minority Affairs Committee | 03/17/2020

“The Minority Affairs Committee (MAC) appreciates the opportunity to provide feedback on “Addressing Medically Urgent Candidates in New Kidney Allocation Policy”. The MAC strongly supports this proposal. The MAC prefers a prospective review oversight process when considering candidates for medically urgent status.”

Jason Rolls | 03/12/2020

I suspect the number of patients who are both good candidates for renal transplantation and on the verge of losing their very last dialysis access opportunity is very small. Often the loss of venous access that typifies a patient in this group also disqualifies them from receiving a renal transplant, for anatomic reasons. In other cases, medical reasons for the continued loss of dialysis accesses may also contraindicate a renal transplant. That having been said, for the narrow margin of patients who are both good candidates for renal transplantation and are on the verge of losing their last available dialysis access, I believe that they should be placed at the very top of the recipient list, with a national scope, rather than within the regional allocation circle. Clearly there are other groups that need our highest consideration and protection - children, previous living donors, and high PRA. However, people in the group in question are rapidly approaching death unless renal function is restored, and are such a small group that I do not believe that kidneys taken by them will be noticeable in terms of donor volume available to other groups.

Region 1 | 03/10/2020

Strongly support (4), Support (6), Neutral/Abstain (0) Oppose (2), Strongly Oppose (0) Region 1 generally supports this proposal and had a good discussion with multiple comments. Comments (include discussion during breakouts and general session): • Prioritization, we are internally inconsistent. • We need to define medical urgency need to agree on definition. • Medical urgency coming after living donors in prioritization does not make sense • Martha yes it was something of a middle ground • Most of the group agreed with 250 NM

Anonymous | 02/28/2020

2 Strongly Support, 17 Support, 2 Neutral/Abstain, 9 Oppose, 1 Strongly Oppose Members of the region felt a prospective review of potential qualifying candidates instead of the proposed retrospective review. One member commented that instead of having a subcommittee of the Kidney committee perform the reviews, there should instead be a regional review board. Another member suggested that the committee consider setting tighter qualifications on candidates who regularly turn down kidney offers. Members in the region agreed that the qualification to apply for medical urgency should be for those candidates who are completely out of dialysis access instead of the proposed candidates who are on their last dialysis access. There was a suggestion that the committee consider the optics of this policy for patients and potentially change the medically urgent name. The ability to ‘jump the list’ may disenfranchise some patients. The region decided to put forth an amendment that calls for a prospective review of all candidates that apply for medically urgent status and that the candidates should be completely out of dialysis access. Amendment: Prospective Review and No Dialysis Access 7 Strongly Support, 20 Support, 1 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose

Ken Andreoni | 02/28/2020

I agree that there needs to be some medical urgency policy, but I am concerned with this as written. The phrase: candidate must also either have exhausted dialysis, be currently dialyzed, or have a contraindication to dialysis via one of the following methods is very unclear and difficult to interpret and to enforce. Candidates classified as medically urgent may be retrospectively reviewed by the Kidney Transplantation Committee. I would change ‘may’ to ‘will be’ retrospectively reviewed. Every candidate listed for medical urgency and receives a transplant should be mandatorily reviewed I would NOT give medically urgent prioritizing for KDPI

Adam Frank | 02/27/2020

For many years now, the majority of patients awaiting a deceased donor kidney transplant will not get transplant and are more likely to be delisted for loss of transplant candidacy or die. This speaks to the severe shortage of kidneys. This proposal allows a subset of candidates to jump the line. This must be carefully monitored and I would favor this not being offered except for the very young (the pediatric patients and the EPTS>20 group) which already have carve outs in the current system.

Region 5 | 02/21/2020

Strongly support (3), Support (24), Neutral/Abstain (0), Oppose (4), Strongly Oppose (0) Comments (include discussion during breakouts and general session): Region 5 supported this proposal and discussed documentation requirements and how these cases would and/or should be reviewed and monitored. • Required documentation should be specific and address all of the requirements, not just a progress note • Retrospective review, what happens if the retrospective review happens, the urgency is not valid, but the patient is already transplanted? • A gaming concern was raised • Commenter stated that they document two consultations on vascular access and this would be good supporting documentation • Comment was made regarding the consequences of improper use • Commenter stated whether there should be someone outside the institution to validate loss of access • Commenter stated the need for a templated application, and that centers need to work through it methodically. Further commented that liver Status 1A is retrospective and is not worried about consequences of misuse. Final comment was pertaining to whether the transhepatic and translumbar IVC catheters may be excessive if other vascular access has been exhausted/contraindicated. • What happens if the patient gets listed and transplanted and they find it was not sufficient? Would it be a subcommittee? Could you have a designated person do a prospective review? • There are a lot of requests for medical urgency, we always have our patients get two vascular consults

Hans Gritsch | 02/19/2020

I support the creation of a medically urgent category for kidney transplant candidates who have very limited dialysis access. We have done this locally for many years and have not seen abuse of the system. I am in favor of documentation that all readily available dialysis options have been exhausted, but would not require that the patient have either transhepatic or transcaval catheters. This should be documented by two independent vascular surgeons. The documents should be reviewed in a timely fashion by select members of the UNOS Kidney committee. The use of this options by transplant centers should be tracked and audited if necessary. The geographic distance from the donor to the recipient hospital should be consistent with the newly adopted allocation policy.

OPTN Region 8 | 02/18/2020

Kidney Transplantation Committee: Addressing Medically Urgent Candidates in New Kidney Allocation Policy • Review should be prospective to avoid a sudden increase in medically urgent transplants and to protect the integrity of the classification, consider a NLRB model • The definition needs to be more specific • It will be important to monitor the data to ensure the best utility of these kidneys • You can tell someone is headed toward a lack of access ahead of time which allows for prospective review Vote on proposal as written: 3 Strongly Support, 7 Support, 3 Neutral/Abstain, 7 Oppose, 0 Strongly Oppose Vote on support for a prospective review process: 20 Yes, 0 No

OPTN Region 6 | 02/18/2020

Strongly support (0), Support (12), Neutral/Abstain (1), Oppose (2), Strongly Oppose (0) The region generally supported the proposal. For donors with KDPI greater than 85%, all national medically urgent patients should receive priority, not just the medically urgent patients inside the 250 NM circle. Documentation for qualifying patients is important, and the region supports sign off from the patient’s transplant surgeon and nephrologist. A member asked about the outcomes of medically urgent patients, and expressed that we need to track outcomes in this patient population so that we know that we are overall making good use of a scarce resource.

Anonymous | 02/10/2020

Unless you agree to allow potential donors to determine which georgraphical area(s) can receive their organs, I will pull my name off of the national donor list. I do not want my liver, kidneys, pancreas, etc going to a patient in another geographical area of the country. The risk of organ death is too high when they have to be sent that far. I am strong advocate of organ transplantation, but my area's transplant centers work very hard to develop a strong donor base. They should not have to be soliciting organs for other areas of the country. You risk losing many donors because of this policy.

OPTN Region 4 | 02/08/2020

Strongly support (7), Support (18), Neutral/Abstain (0), Oppose (1), Strongly Oppose (0) Comments: Region 4 supported this proposal. Although there was no clear agreement on where medically urgent candidates should fall in the classifications, there was some support for expanding priority for these candidates to include organs from any ABO compatible donor and giving them top priority on the match. Members encouraged the committee to collect data on the types of candidates requesting medical urgency to determine outcomes (highly sensitized, >1 transplants, etc.). There was also some concern that the “other” category could be abused and it will be very important to review these cases in a timely manner.

Hans Albin Gritsch | 01/30/2020

The waiting time for a renal transplant can exceed 10 years at our hospital. We currently have 10 kidney transplant programs in the DSA. A policy for medically urgent needs has allowed some complex patients to have the opportunity to have a life saving transplant. I support the proposed policy and would suggest that two independent vascular surgeons review the dialysis options and write a supporting letter. There may be exceptions to this rule if it would be an undue burden to the patient. I also support exceptions to the 250 nm rule if this would prevent access to transplantation within a reasonable time for a particular patient.

Michael Moritz | 01/23/2020

Medical urgency for kidney candidates is virtually never an emergency. Hence granting medical urgency status should be done prospectively, after the transplant center provides appropriate documentation, not retrospectively as proposed. Similarly, allowing centers 7 days to provide documentation is inappropriate for an issue that has typically been progressing over a prolonged period of time. In our DSA with 5 centers performing pediatric kidney transplants, we have never had an instance of inability to receive dialysis documented over the past 15 years. We have provided medical urgency for only a single instance, a heart-kidney recipient who could not receive the allocated kidney when a small tumor was identified pre-kidney and post-heart transplant. I strongly feel that retrospective review allows the potential for misuse of the status while providing no gain, given the rarity of true medical urgency for kidney transplantation.