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Pancreas Program Functional Inactivity

Proposal Overview

Status: Board Approved

Sponsoring Committee: Pancreas Transplantation

Strategic Goal 3: Improve waitlisted patient, living donor, and transplant recipient outcomes

Comments

Anonymous | 8/9/2018

Far too many pancreas programs are listing patients but never or next to never doing a transplant.  This is unfair to the patients on their list, it is potentially a safety issue, and it is certainly not an efficient way to operate the system.  Access to transplant is not simply getting on the list...access to transplant is actually being listed at a center where you will have a reasonable chance to be transplanted.  Being listed at a program that is functionally inactive is not access, it is a false sense of access.

Region 4 Vote | 8/30/2018

12 strongly support, 7 support, 1 abstentions/neutrals, 0 oppose, 0 strongly oppose
Region 4 approved the proposal. One comment suggested that pancreas programs performing only two transplants per year shouldn’t be active and that there is a concern with quality of care given this low volume of transplants.

Feedback Question – Should other organ programs be required to send additional information to patients if flagged for functional inactivity?
A couple members addressed the committee’s question about requiring other organ programs to notify patients of functional inactivity and they do support notification requirements for all organs.

Anonymous | 9/7/2018

Still unclear if the patient truly benefits from implementation of this proposal.  Several times in this proposal it points to high volume programs appearing to have better outcomes, sometimes with a lower quality pancreas.  If data point to this being true, then doesn't the current policy of a narrower time window potentially identify low volume programs which should terminate, and therefore push patients to a program with a higher volume of pancreas transplants?  As a patient, I assume that if a center advertises pancreas transplants then it can and will perform the life saving work.  I will probably not ask how many transplants the program performs in a year or read the fine print on a form letter stating I may want to consider other programs within 125 miles as an alternative.  UNOS has a policy in place where almost one-third of the 61 programs which came under review in 2011-2016 resulted in a program shutdown.  Is the current threshold for functional review in fact working and helping the patient by transplanting them at a higher volume center, with the possibility of improved outcomes?  Tell me why it is a negative, from a patient perspective, that 19 programs shut down from 2011-2016?  Tells me UNOS identified programs which did not meet a minimum threshold and therefore, probably not a program I, as a patient, should consider performing the transplantation.  I do not believe this is an urgent issue and in fact believe it may negatively impact the patient by having them transplanted at a low-volume center which may have been deactivated under the current policy.

Region 3 | 9/11/2018

Region 3 Vote: 8 strongly support, 13 support, 0 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported this proposal as written.  There was a question about whether the committee had considered taking into account the offers received for low volume centers.

Region 8 Vote | 9/12/2018

Region 8 Vote: 3 strongly support, 5 support, 9 abstentions/neutrals, 4 oppose, 2 strongly oppose

Members in region 8 were divided on the proposal. Members questioned whether the discrepancy between small, medium, and large programs was statistically significant. It was felt that this proposal was punitive to smaller volume programs and the committee should also take into account whether the center was a single surgeon center vs. a multi-surgeon center. Additionally, UNOS should try to better understand what leads to inactivity to better support these programs.

Feedback Question – Should other organ programs be required to send additional information to patients if flagged for functional inactivity?

One member felt it was unusual for a proposal to ask if the requirement to provide patients at functionally inactive pancreas programs written information a list of other programs and information about waiting time should apply to all programs. All meeting attendees were given the opportunity to respond to an electronic poll to respond to this question. Of the 29 responses received – responses were 34% yes, 52% no, and 14% abstain/neutral.

Darnell Waun | 9/12/2018

The total number of a particular type of organ transplanted at a transplant center is associated with outcomes.  I am wondering if new Type I diabetes management through technology is decreasing the number of people interested in pancreas transplant and this is impacting the low numbers.

Region 5 | 9/14/2018

Region 5 Vote: 8 strongly support, 13 support, 0 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written.  There was concern raised by a program that does pediatric pancreas transplant because they do so few transplants.  If inactivated, they would need to reactivate when they were ready to do a transplant.  The committee needs to come up with a way to address this issue.

Carolyn Light | 9/19/2018

It is difficult for pediatric pancreas programs to meet the current volume requirements given that pancreas transplantation in children is very rare. We should waive the volume requirement for peds programs altogether.

Region 1 | 9/17/2018

Region 1 Vote: 2 strongly support, 6 support, 2 abstentions/neutrals, 3 oppose, 1 strongly oppose

There was concern in the region about using inactive waiting time when calculating average waiting time.  Those who commented recommended only using active waiting time for both flagging and reporting to patients.  In addition, there was support for comparing a centers average waiting time to the average in their state or region when reporting to patients, rather than the national average.

Feedback Question: Should other organ programs be required to send additional information to patients if flagged for functional inactivity?  Members only addressed KI programs and commented that if programs are asked to send additional information to patients when they are flagged, only active waiting time should be used when calculating the average.

Deanna Santana | 9/24/2018

Making sure patients have the tools to make informed decisions about their transplant journey is important.  Not every patient is able to access all of the information and I believe a center should provide them with this information to increase their likelihood of receiving a transplant.

OPTN/UNOS Membership and Professional Standards Committee (MPSC) | 9/24/2018

The MPSC thanks the Pancreas Transplantation Committee for presenting its proposal and for including MPSC members on the working group that helped develop the proposal. The MPSC did not express any concerns about the proposal, but MPSC members did provide feedback on several points.

1. An MPSC member observed that the proposal seemed to imply that a low volume program with short waiting times would have a higher probability of good outcomes. He was unable to find any supporting data via a literature search, and asked if the Pancreas Committee had internal data to support this idea.

The Pancreas Committee chair was not aware of data showing that centers with short waiting times had better outcomes, and stated that it was not the committee’s intent to imply that. While the Pancreas Committee incorporated outcomes in the initial criteria, they steered away from that idea in the final proposal because outcomes are measured separately.

2. An MPSC member asked how frequently the waitlist times would be recalculated to allow a program that was deemed to be functionally inactive to attain a status of functionally active. A low-volume transplant program will have an unstable average waiting time where a single transplant could shift the program’s average significantly one way or the other, but there may be nothing particularly different about the program otherwise.

Currently, the reports on functionally inactive programs are provided 3 times per year. The frequency of the waiting time calculation is still being discussed, as are the details of the reports that will need to be produced if this proposal is approved.

Region 2 | 9/26/2018

Region 2 Vote: 8 strongly support, 13 support, 2 abstentions/neutrals, 1 oppose, 3 strongly oppose

The region supported this proposal as written.  Members had questions about if this applied to pancreas alone transplants or if other combinations (SPK, PAK) would also be considered when assessing functional inactivity.  There was also a request for modeling of transplant outcomes based off of the proposed functional inactivity definition.

Feedback Question – Should other organ programs be required to send additional information to patients if flagged for functional inactivity?
Through a show of hands the region was in favor of other organ programs being required to send additional information to patients if flagged for functional inactivity.

OPTN/UNOS Patient Affairs Committee | 9/26/2018

The OPTN/UNOS Patient Affairs Committee (PAC) appreciates the Pancreas’ Committee’s efforts to improve waitlisted patient and transplant recipient outcomes by creating new thresholds for identifying functionally inactive pancreas programs that operate below the level that is adequate for their waitlisted candidates. The PAC acknowledged the proposal may also promote efficiency in the management of the OPTN, and felt that this seemed to be the emphasis of the proposal, eclipsing the primary goal of improving outcomes. Although access to transplant was not cited as a goal this proposal sought to address, the PAC felt that access to pancreas transplants were clearly going to be impacted. The PAC was skeptical the proposed solution would positively impact increasing the number of transplants, as a majority of candidates listed at functionally inactive centers do not end up listing elsewhere.

The PAC felt that for the average candidate on the waiting list, being informed that your pancreas program in functionally inactive may be confusing, psychologically distressing, and burdensome. The proposal equates patient safety and better outcomes with higher-volume programs with shorter waiting lists; these goals are only assured if these patients end up relisting at higher-volume programs.

They were supportive of the patient notification requirement, but acknowledged that may end up being burdensome to the program and not entirely useful to a patient who cannot afford to travel or otherwise relist at a different center. The proposal did not indicate the working group consulted with patients or a patient advocacy group during the development of the proposal. Patients listed at functionally inactive centers would be educated per procedure, but the PAC recommends taking that a step further and require subsequent outreach after X number of months to determine if their patients were able to relist elsewhere, or needed guidance or help doing so. Finally, the PAC offered to assist in developing the patient notification letter.

The PAC asked the following questions:
Q: How the Committee arrived at proposing patients be notified of pancreas programs within a 125 mile radius (in addition to in-state programs) when seeking out alternative programs?
A: The Pancreas Committee decided to require the patient letter include a more proximate roster of active pancreas programs for practical purposes. Most patients know they can multi-list (the PAC disagreed with this statement, despite there being a policy requirement in place) anywhere but including a list of all active pancreas programs across the country might be counter-productive. The 125 mile radius was informed by the feasibility of estimated travel time (about two hours). The PAC recommended the letter state “125 miles AND in-state or in-US territory” versus “125 miles OR in-state or in-US territory”. In addition, there was a suggestion to include a link to the SRTR beta site, or at least when that site goes into production.

Q: Why the proposal does not require functionally inactive programs to submit a quality or performance improvement plan?
A: The Pancreas Committee deferred and acknowledged that would be up to the OPTN/UNOS Membership and Professional Standards Committee (MPSC) to determine. The MPSC has a different process for evaluating transplant program performance in the Bylaws (Appendix D.11.A) which depends on a program’s graft and patient survival rates. Functional activity is evaluated separately from program performance.

Q: Why aren’t patients currently notified of program waiting time? Why does the solution propose notifying patients after the fact?
A: Many programs do share waiting time information with their patients during evaluation, but that isn’t the standard or mandated by UNOS.

Anonymous | 9/30/2018

Overall, I support the change from 6 months to 12 months to meet volume requirements, but I disagree that low volume is always associated with poor outcomes, as one center that has had 100% outcomes despite lower volumes.

American Nephrology Nurses Association (ANNA) | 10/01/2018

ANNA supports.

American Society of Transplantation (AST) | 10/01/2018

The American Society of Transplantation is generally supportive of this proposal, but offers the following comments:  • The CMS definition of program inactivity remains 0 transplants in 6 months (482.74 Tag X015 CMS CoP's) This will create 2 separate regulatory pathways to manage for notifications of functional inactivity.  • In concept, the MPSC reviewing fewer programs is favorable. However, the data presented in the proposal, spoke to the connection between low volume centers and poor outcomes, despite the use of higher quality organs. Adding the waitlist metric to the algorithm for program review does not seem well supported by the patient outcome data. The additional metric may decrease the number of programs flagged for review, but may not actually improve outcomes at these low outcome centers. There may be data reviewed by the Pancreas Committee linking wait times to outcomes that is not explained in the proposal. The primary aim of the proposal as stated was patient safety, but loosening the review criteria may not entirely support that aim.  • The proposal as written will require low volume, long-wait time centers to use a newly developed data report from UNOS to provide patients with center and national average wait times. While the AST is generally supportive of new secure UNOS data reports, there is already a median time to transplant metric available in the publicly available SRTR Program Specific Reports (Table B9).

Anonymous | 10/01/2018

Leave if this requirement should be extended to other organ groups to the respective organ committees

Region 9 | 10/01/2018

Region 9 vote is as follows:

6 strongly support, 9 support, 0 abstentions/neutrals, 1 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 10/2/2018

Overall, the American Society of Transplant Surgeons (ASTS) supports the pancreas transplantation committee proposal to amend program requirements designed to reduce unnecessary reviews and focus on programs presenting low volume and longer waiting times. The need for continued access to pancreas transplantation for the occasional child needs to be preserved; therefore, pancreas programs at purely children's hospitals should be excluded from general pancreas activity requirements due their intrinsically lower volumes.

American Society for Histocompatibility and Immunogenetics (ASHI) | 10/2/2018

The American Society for Histocompatibility and Immunogenetics (ASHI) strongly supports this proposal. However, ASHI cautions OPTN/UNOS, that as the number of pancreas transplants are declining nationwide, some centers may have extended periods of time where no pancreas is transplanted at an institution. Instead of requiring pancreas programs reaching a certain threshold for 'safety', a lack of pancreas transplants at a particular center needs to be adjudicated on a case-by-case basis.

Clifford Miles | 10/2/2018

I am in support of revising how the MPSC selects pancreas programs for functional inactivity, as this is important to improve the efficiency of the OPTN, from both a staff and member hospital standpoint. However, I am not supportive of the current proposal. As shown in Fig. 3, small volume pancreas programs have significantly worse graft outcomes compared to medium/large programs. This is supported by the literature cited (though the exact criteria for 'small' may have differed). Not included in the data presented are outcomes for small volume programs stratified by average waiting time. As written, essentially half as many programs will be reviewed, but we do not have data showing that that half has different graft outcomes. Thus, it seems that in the spirit of 'access', we would be potentially allowing small volume programs that quickly list and transplant patients to continue to operate without review, in the absence of evidence that they have better graft outcomes. Is rapid access to a poorer outcome 'better'? Further, for programs with small waiting lists and infrequent transplants, the 'average' waiting time is not a statistically stable number. i.e., one sensitized patient that sits on the list for a while could drive up a program's average, and be the only reason they end up under functional inactivity review.   

One recommendation: repeat the graft outcome analysis, stratifying by above/below average waiting time, to see if there is any validity.  In my opinion, offer acceptance is a more palatable metric, and I don't believe it is too complicated to be considered. Because there are considerably more offers than transplants, the modeling would gain power. Plus, it may be a more direct measurement of program behavior (enthusiasm for pancreas transplantation). So second recommendation: look at graft outcome for small volume programs stratified by offer acceptance. If either of these analyses confirms that long WT/low offer acceptance is associated with worse outcomes, then I would be more supportive.

Another issue that is unclear to me: for a program that performs multivisceral transplants, are pancreata used for MV included in the count that determines functional activity/inactivity? If so, I find that problematic, as that is a different surgery and may be cared for by a different team.

Thank you for allowing me to voice my concerns. In disclosure, I am a medical director, and current member of the MPSC

Elizabeth Rubinstein | 10/02/2018

As part of a sub-committee reporting to the parent UNOS PAC Committee in evaluating the Pancreas Program Functional Inactivity policy proposal, the OPTN/UNOS Patient Affairs Committee 9/26/2018 public comment posting reflects our evaluation of the proposal. A more detailed evaluation was provided directly to the Pancreas committee and we appreciated the acknowledgement of the validity of our comments from a patient perspective and careful considerations of the committee suggestions and addressing our supplemental questions. This swayed support from a non-support position on my behalf to a potential support approval with these considerations in play after our review submittal. Upon attending the Region 10 meeting and observing strong support for the proposal, I was struck that the support came from an institutional perspective and did not take into consideration the patient perspective considering that over 50% of the patients displaced by a program declared as functionally inactive did not relist. This may be due to several unrelated factors but this is telling in many ways of a lack of communication and follow up throughout the entire listing process at a center. The proposal does protect patient safety if in reality patients did relist at a functionally active center where waitlist time was reduced and competent medical outcomes were validated within a higher volume center. With this in mind as primary, I supported the proposal at the regional meeting. 

Region 11 | 10/02/2018

Region 11 Vote: 4 strongly support, 11 support, 4 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written. However, there were some suggestions from individual members.  One member noted that small programs that are performing 1-2 transplants per year is better than none at all and suggested that the committee also account for the number of highly sensitized candidates on the transplant center’s waiting list.  There was a request from a member to create guidelines for the Membership and Professional Standards Committee (MPSC) to help them assess pancreas programs and how to determine when to remove the functionally inactive label. 

Luis Mayen | 10/03/2018

I support the pancreas committee's efforts to balance patient outcomes with access to transplantation.      For additional consideration - given the rare need for pediatric pancreas transplantation and the need to preserve this access, excluding pediatric pancreas programs from activity requirements should be considered. 

Region 6 | 10/03/2018

Region 6 Vote: 23 strongly support, 15 support, 0 abstentions/neutrals, 1 oppose, 1 strongly oppose

Region 7 | 10/03/2018

Region 7 Vote: 8 strongly support, 12 support, 2 abstentions/neutrals, 1 oppose, 0 strongly oppose

A member stated that this proposal does not address the issue of lower than expected outcomes despite higher quality organs in low volume centers. One member also suggested excluding certain types of low-volume centers such as children’s programs from functionally inactive status. Another member stated that it is important that access not be limited because of volume and wanted it noted that not all areas of the country will have another pancreas program located in the same state or within 125 miles. 

OPTN/UNOS Transplant Coordinator Committee | 10/03/2018

The OPTN/UNOS Transplant Coordinator Committee appreciates the Pancreas’ Committee’s efforts to improve waitlisted patient and transplant recipient outcomes by creating new thresholds for identifying functionally inactive pancreas programs that operate below the level that is adequate for their waitlisted candidates. The group concurred that the policy revision addresses not only reducing unnecessary work for the MPSC but maintains and patient safety and will hopefully improve patient access.
Members agreed that it was more reasonable to look at inactivity on a yearly basis especially given the relative short waiting time for pancreas. Changing the definition for functional inactivity from "< 1 in 6 months" to "< 2 in 12 months with above average wait times" will reduce the MPSC's need to review pancreas programs based on low volume alone.

The requirements under the new proposal for programs to notify patients is a patient-centric solution that will require programs to give patients the information they may need to make informed decisions about getting on the wait list at a more active program with lower wait times. The additional step to require transplant center to provide not only alternative centers but the waiting time comparison of inactive program to national average will hopefully help address patients that are not transferring after program inactivity, improving their access to transplant. 

One Committee member did advise that the national waiting time average may not be the best metric, as there will be a lot of variation. Median waiting time by region might make more sense, as they are pulling from the same donor pool. Another metric suggested to the Pancreas Committee was organ offer acceptance rate. Programs should not be penalized if they are not getting organ offers. Another Committee member opined that for pancreas allocation, OPOs have some discretion when it comes to how they allocate pancreata-whether multi-visceral offers pan out, non-local offers, etc. Policy should be more stringent around pancreas allocation. 

The group supported communicating additional information to candidates listed at a functionally inactive program, but advocated that each of the organ-specific committees should decide whether that is appropriate. If so, they should also decide what information to communicate. One member supported providing SRTR data (beta site) to patients, to capture not only programs doing more transplants, but programs who transplant similar phenotypes of patients. 

The following questions were asked and answered to the satisfaction of the TCC:
Q: When classifying pancreas programs by volume, did the Pancreas Committee look into whether the center also had a small volume kidney program, or perhaps a large volume kidneys program, and maybe the center wasn’t prioritizing their pancreas program?
A: The Pancreas Committee did not look into whether a pancreas program was part of a center with a large or small kidney program.

Q: Does CMS have similar patient notification requirements that could be mimicked for these purposes?
A: The presenter was not aware of CMS requirements around transplant thresholds, for pancreas in particular.

Region 10 | 10/3/2018

Region 10 Vote: 4 strongly support, 12 support, 4 abstentions/neutrals, 1 oppose, 1 strongly oppose

The region supported the proposal as written. One member asked if the committee had taken into account that smaller centers tend to have higher turndown rates because of the low number of offers they receive. Will those centers be disadvantaged by the proposed functional inactivity definition? 

Phillip Williams | 10/03/2018

New policies and standards; and  transplant surgeons and other transplant professionals to work together cooperatively in the best interest of all patients waiting for transplants. This can only occur if those transplant programs is not flagged for functional inactivity.