Comments

University of Arkansas | 09/26/2024

After reviewing the proposed changes, we fully support increasing the flagging threshold for MPSC review. The current flagging system discourages transplant centers from accepting higher risk organs in fear of “bad outcomes” that would result in MPSC review. This forces transplant centers to review organ offers based on previous transplant outcomes versus what is in the best interest of the patients on the waitlist. In order for transplant centers to grow and increase deceased donor transplants, a less restrictive flagging threshold is necessary. This proposal will allow centers to focus on the needs of their patients versus the potential penalties that come with transplanting higher risk organs and complex recipients. While we fully support this proposal, it is important to note that our surgeons are in full agreement that organ offers will still be thoroughly reviewed and we are first and foremost focused on the outcomes of our patients.

Anonymous | 09/25/2024

Strongly support this proposal that begins the process of removing disincentives for transplant centers to transplant patients. This begins to address the "fear of scrutiny" by the MPSC which is overly punitive and overly involved in transplant centers. This will also, hopefully, help the transplant community to address the serious problem of organ discards. There are clearly more organs that could be transplanted - were it not for the punitive actions of the MPSC

Lorrinda Gray-Davis | 09/25/2024

I feel this change is moving the goal post to meet the goals and it is late in policy. My question is why is this just happening?

I believe some patients might feel that the “goal line” is being moved to benefit the OPTN rather than ensuring patient safety and optimal long-term results, potentially compromising their trust in the transplant system.

I know ultimately this means potentially shorter wait times and a better chance of receiving a transplant. By adjusting the threshold for performance metrics like 90-day and 1-year graft survival, programs may feel less pressured by strict performance reviews and more willing to take calculated risks with complex organs that could still provide life-saving opportunities. Ultimately, this could decrease pre-transplant mortality, giving patients a better chance at receiving the transplants they need.

National Kidney Foundation | 09/25/2024

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Hospital of the University of Pennsylvania | 09/25/2024

We strongly support the proposal which equates to a thoughtful alignment of goals and thresholds to the intent of increasing access to organ transplantation and balancing risk/benefit. The post-transplant graft survival metric criteria adjustment will benefit patients and lead to an increase in organ utilization and encourage transplantation of complex patients.

We strongly encourage formal alignment between the post-transplant performance metrics and the published SRTR reports. The SRTR bar rating serves as a recognized benchmark for assessing the quality and effectiveness of transplant programs. This alignment also facilitates better communication with stakeholders, ultimately supporting program approvals and inclusion in insurance networks. Many payors have their varied thresholds embedded within Center of Excellence quality metrics which often require higher performance across pre- and post-transplant metrics than is expected from the OPTN.

Further, we concur with and support the statements by the ASTS. Thank you.

University of California San Diego Medical Center | 09/24/2024

We strongly support the changing of the threshold for MPSC review of adult 90-day and 1-year conditional on 90-day graft survival from 50% probability that the transplant program’s hazard ratio is greater than 1.75 (75% higher than expected) to 50% probability that the transplant program’s hazard ratio is greater than 2.25.

Shayne Kendra | 09/24/2024

I fully support the proposed increase in the post-transplant survival hazard ratio from 1.75 to 2.25 and appreciate the efforts of OPTN to remove barriers that may currently limit the number of transplants.

As an advanced heart failure coordinator, I work closely with patients who are waiting for life-saving transplants, and I have witnessed firsthand how crucial it is to maximize opportunities for these individuals. By increasing the hazard ratio, we are allowing providers the flexibility to take calculated risks, which can ultimately result in more transplants and save more lives. This change will encourage innovation and adaptability in clinical decision-making, allowing us to focus not only on short-term survival but also on providing more patients with a chance for long-term recovery and improved quality of life.

I strongly believe that this adjustment will have a meaningful impact on increasing the overall number of transplants and benefiting the community of patients who are currently on waitlists, facing uncertainty. Additionally, increasing the survival ratio will help us as healthcare providers to offer a more balanced approach to patient selection, where higher-risk candidates are not excluded simply due to rigid survival estimates.

HCA Florida Largo | 09/24/2024

This proposal is long overdue. For decades transplant hospitals have demonstrated risk avoidance behavior including turning down or discarding donor organs and denying transplantation to higher risk patients because of a fear of being “flagged”. This behavior has resulted in numerous potential recipients dying without an opportunity to receive a transplant. This proposal will allow transplant professionals to provide greater opportunity for patients at higher risk and for higher risk organs which will allow more transplants and save more lives.
James D. Eason, M.D.
Chief of Transplantation
HCA Florida Largo Hospital
Largo, FL

Anonymous | 09/24/2024

Strongly Support

Anonymous | 09/24/2024

Updating the ratio would allow surgeons to impact and treat more patients, and take on appropriate risk to help more patients achieve a healthier life. Thank you.

Anonymous | 09/24/2024

Strongly Support

Hackensack University Medical Center | 09/24/2024

We strongly agree with the OPTN proposal to raise the flagging threshold for 90-day graft survival and 1-year conditional on 90-day graft survival for adult transplant recipients from a 50% probability that the transplant program’s hazard ratio is greater than 1.75 (75% higher than expected) to a 50% probability that the transplant program’s hazard ratio is greater than 2.25 (125% higher than expected). This will remove barriers to broadening organ acceptance practices by transplant centers and likely increase the utilization of non-used kidneys in the US for life-saving transplantation.

Anonymous | 09/23/2024

The current threshold is difficult to reach unless outcomes are significantly poor. In my experience, some programs are unwilling to address what they see as "normal variation" in outcomes. Moving the flag criteria expands what some will view as normal, and therefore patients will suffer the consequences of poor program performance that goes unaddressed.
If the volume should increase, we should do that safely as a community. Allowing more graft failures and deaths is not going to help our patients.
If the whole community is increasing volume and taking on more risk, the average will move along with that change, and the current threshold will call out programs who are taking on more risk than they can handle.

Methodist | 09/23/2024

I believe this will allow hospitals to do what we do best, rather than worry about being pulled for review.
Transplant is very critical and complex, there isn’t a surgeon that isn’t always putting his best foot forward when he steps into the OR, this will also allow the hospitals to focus on the patient and taking care of what is necessary in the 90 day and 1 year mark.
I believe that moving this metric back will give hospitals more of a feeling of being supported by Unos rather than feeling like the center is being watched and scrutinized along the way.
This will allow the center to feel as though it really is ok to transplant and do what it should to build what they are trying to build.

Anonymous | 09/23/2024

The proposal to adjust the threshold for MPSC review of adult 90-day and 1-year graft survival metrics is reasonable, as it aims to reduce program concerns about performance monitoring. By raising the threshold, transplant centers may feel more confident in accepting complex donor organs, potentially increasing transplants and reducing pre-transplant mortality. However, maintaining stringent monitoring is essential to ensure patient safety. The lack of change for pediatric programs or other metrics should be clearly communicated to avoid confusion. Overall, this seems like a balanced approach to improve organ utilization without compromising oversight.

Manish Talwar | 09/23/2024

Patients with frailty, poor social support, non compliance, low EF, lack of transportation and organs which are marginal require a lot more resources to be taken care of. Just adjusting the outcome metrics will lead to system burnout if we transplant much more than we are already transplanting. I still support the proposal.

Anonymous | 09/23/2024

Will support individualized decisions for organ usage and allow appropriate risk taking rather than overly risk adverse decisions.

Anonymous | 09/22/2024

Prior to receiving clarifications and answers to questions I am currently opposed. Questions: 1. Can OPTN expand on how the proposed change will decrease candidate pre-transplant mortality, and clarify over what time period? Is it simply by decreasing the candidates time on dialysis and the waiting list? If so, should OPTN be testing alternative interventions to speed up the transplants? e.g. increasing supply such as a refundable tax credit for altruistic donors 2) Has the proposed change been modeled for a future projected estimate of the impact on patients, and/or applied retrospectively to the historical data. 3) How will this added risk be communicated to patients?

The Nebraska Medical Center | 09/20/2024

The transplant program at Nebraska Medicine strongly supports this proposal to update the criteria for post-transplant graft survival metrics. The expansion for the 90 day and 1-year conditional thresholds from 50% probability that the transplant program’s hazard ratio is greater than 1.75 (75% higher than expected) to 50% probability that the transplant program’s hazard ratio is greater than 2.25 (125% higher than expected) will lead to higher transplant rates, lower discards, and less risk aversion for transplant programs like ours. This proposal also fits in with the OPTN expeditious task force initiative by reducing barriers to transplant by encouraging transplant programs to evaluate and transplant complex cases that otherwise might have been avoided due to the high risk. Thank you to the committee for all your hard work in this area!

Baylor St. Luke's Medical Center | 09/20/2024

Baylor St. Luke's strongly supports this change. This will enable teams to consider more complex organs and patients for transplant, and represents a big step forward for our patients!

Texas Health Harris Methodist Hospital | 09/20/2024

this is an excellent proposal. by increasing the hazard ratio, this will certainly increase the number of transplants, increase transplant utilization, and decrease the number of discards.

Hartford Transplant | 09/20/2024

This represents a move in the right direction to help support transplant centers in their mission to help patients, their families and their communities.

Anonymous | 09/20/2024

I agree with this change to the 90 graft survival. I think it will support more utilization of kidneys. I also recommend the MPSC look at removing the acceptance rate monitor as this can help speed up allocation decrease discard rate.

UNC Health | 09/20/2024

As a Senior Quality Leader that has supported the UNC Center for Transplant Care for over 13 years, I am in full support of this change to a higher threshold for flagging. With the push for higher volumes comes higher risk taking. This cannot be avoided. It is especially important for lower volume programs to have "more freedom" to take risks in becoming medium to high volume programs. The other feedback I would provide, though, is that SRTR will need to modify its reporting to reflect this industry shift. There needs to be some sort of mechanism of reporting such that programs that are increasing volumes and taking risks are not unfairly "discredited" with a poor "report card" to the public on the SRTR website every 6 months which will work to defeat a center's growth efforts.

Anonymous | 09/19/2024

Any proposed changes must align with the SRTR. The rationale for requesting that performance metrics align with the SRTR bar rating is rooted in the need for standardization and relevance in program evaluation. The SRTR bar rating serves as a recognized benchmark for assessing the quality and effectiveness of transplant programs. By aligning our performance metrics with this established rating system, we can ensure that our evaluation criteria are consistent with the expectations of payers during program reviews and approvals. This alignment not only enhances the credibility of our performance assessments but also facilitates better communication with stakeholders, ultimately supporting our programs and access to care.

Anonymous | 09/19/2024

Any proposed changes must align with the SRTR. The rationale for requesting that performance metrics align with the SRTR bar rating is rooted in the need for standardization and relevance in program evaluation. The SRTR (Scientific Registry of Transplant Recipients) bar rating serves as a recognized benchmark for assessing the quality and effectiveness of transplant programs. By aligning our performance metrics with this established rating system, we can ensure that our evaluation criteria are consistent with the expectations of payers during program reviews and approvals. This alignment not only enhances the credibility of our performance assessments but also facilitates better communication with stakeholders, ultimately supporting our case for program sustainability and funding.

Anonymous | 09/19/2024

It is my understanding that the change would be beneficial.

Theodore Frank | 09/19/2024

Will increase organ utilization

Keith Plummer | 09/19/2024

These moves should lead to more “high risk” kidneys being used, which will help reduce wasted organs. The end game is to reduce waste of all organs.

Anonymous | 09/18/2024

As a heart transplant physician, I strongly support the proposed change as a way to improve pre-transplant mortality, increase organ utilization, and accept higher risk organs and higher risk transplant candidates.

Tufts Medical Center | 09/18/2024

As a transplant center, we fully support the proposed changes to the MPSC performance monitoring criteria, which increases the threshold for review of adult 90-day and 1-year conditional graft survival. This modification is essential in reducing the number of programs unnecessarily subjected to review, thereby enabling us to expand the use of more complex donor organs without the constant concern of triggering performance monitoring. By relieving this pressure, transplant centers can more confidently pursue higher-risk organs, which will enhance organ utilization and, in turn, improve our transplant rates. This proposal aligns closely with the OPTN’s mission to increase the number of transplants and reduce pre-transplant mortality, ultimately saving more lives. This change represents a pivotal step forward in strengthening our capacity to perform more transplants and better serve the growing needs of the transplant community.

Anonymous | 09/18/2024

I believe it's a positive alteration and helps OPO's do more transplants with less risk.

American Society of Transplant Surgeons | 09/18/2024

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Anonymous | 09/18/2024

I strongly support updating the metrics for post-transplant survival. This would allow for all centers to take on higher risk donors, as well as more complex medical recipients, thus increasing the overall access for patients.

Harish Mahanty | 09/18/2024

I would support the proposals for kidney transplantation. However, it may make more sense to limit the 2.25 threshold to high kdpi kidneys that are accepted as these organs are more likely to be discarded.

Anonymous | 09/17/2024

Strongly Support

Nancy Marlin | 09/17/2024

I support this change. Consistent with the work of the Expeditious Task Force, centers need to be supported when undertaking more complex transplants.

Anonymous | 09/17/2024

Strongly Support

Anonymous | 09/17/2024

I strongly support this.

Anonymous | 09/17/2024

I strongly support this proposed change. This will allow transplant centers to accept more "marginal" kidneys and support the Expeditious Task Force initiatives without the fear of being flagged for MPSC review.

Duke Transplant Center | 09/17/2024

Duke supports this proposal as it is in the best interest of our waitlisted patients.

Anonymous | 09/17/2024

I support this change and think that it will help to increase access but continues to provide appropriate safety margins. In particular, it will give smaller programs more flexibility to take on more medically complex patients. This should be something that we think about strongly for pediatric programs as well, almost all of which are very small and 1 bad outcome will make programs hesitant to transplant complex patients for several years because of the risk to their metrics.

Anonymous | 09/17/2024

I would support changing the metrics to allow transplant programs to take on more risk in order to transplant more people. I feel that the pressure and restrictions that are placed on a transplant program push them to be more limited in taking organs or doing higher risk transplant. Bottom line is that our goal should be to transplant more patients , save more lives and reduce suffering. Importantly, I believe changing these metrics will allow centers to maintain good outcomes while being able to transplant more people.

R. Todd Frederick | 09/17/2024

I fear this change would encourage more high risk transplants and lead to more lost lives as opposed to reducing wait list time and increasing organ acceptance offers. I think we all need to be held accountable for maintaining excellent post-LT outcomes. I hope that with broader use of organ perfusion techniques we will be able to continue to expand donor organ usage and help more LT recipients while maintaining excellent outcomes.

Anonymous | 09/17/2024

I strongly support this proposal. As a Transplant Administrator, I know firsthand the concern of MPSC flagging and review. This will encourage programs to accept and transplant more and reduce pre-transplant mortality.

Liise Kayler | 09/17/2024

I support the 2.25 flagging threshold in adult transplants. This change is highly likely to increase kidney utilization.

Ryan Helmick | 09/17/2024

The current flagging threshold for transplant is unfortunately restrictive and opposed to the overarching goal of increasing access to transplant. Particularly for programs of a smaller volume, the 1.75 flagging threshold introduces a very conservative behavior pattern, where transplant teams and surgeons are very restrictive in their acceptance of useable organs because a "bad outcome" may put the program in an unfavorable position regarding MPSC review.

Furthermore, many aspects of post-transplant outcome are beyond the scope of control of a transplant program or surgeon. I have taken care of a patient who was lost early after transplant because of a violent encounter in the community, and a separate patient was a pedestrian hit by a car. These situations are entirely outside of the control of the transplant center, but the resulting behavioral changes for the center are to be more restrictive regarding patient selection, or more conservative regarding a useable but non-perfect graft.

If the main goal is patient access to transplantation, the OPTN needs to encourage transplant centers to give patients opportunities and access to transplant. The current system with a 1.75 flagging metric does not foster this philosophy, rather it encourages centers and surgeons to stay within a lane of acceptable "good outcomes." Centers are also not likely to provide substandard care, as all centers want to give the best possible care to their patients, as well as stay within good standing for insurance providers. However, relaxing the threshold for MPSC review will encourage centers to provide wider access to patients who would benefit from the lifesaving gift of organ transplantation while making good use of potential useable organs. If there is any confusion as to why the discard rate for kidneys with a KDPI >= 60% is about 48%, the reason is that transplant surgeons and centers do not want to be penalized for taking chances that are most likely going to get a patient off dialysis, but also have a high potential to result in graft loss and risk flagging.

In summary, the OPTN should increase the flagging threshold to 2.25 expeditiously if the goals are to increase access to transplantation and increase organ utilization.

Anonymous | 09/17/2024

I strongly support to update the criteria.

Shar Senor Carlyle | 09/17/2024

I received a living donor transplant on March 2 2005 at Sutter Health California Pacific, Medical Center. Over the past 20 years, I have listened to horror stories, another transplant centres, including one I nearly went to Kaiser Permanente in San Rafael, which was shut down for malfeasance. I think there needs to be the strictest criteria for performance of the transplant centers. Please do not lower the performance bar. Instead, raise it.

David Silber | 09/17/2024

While I am strongly interested in promoting increases in transplant and also interested that transplant outcomes are maintained. I thus support this proposal. I do think there will be some interest in taking on riskier patients or riskier donors as a result of this proposal but if it ends up being riskier patients it will not necessarily increase the transplant volume. If no greater organs are taken there will need to be other proposals to promote taking on riskier donors thereby excepting a greater number of organs for greater degree of recipients.

Anonymous | 09/17/2024

I think this would be very beneficial to our transplant center because a marginal candidate may not be listed due to potential poor outcomes. This may also increase our likelihood of accepting organs that we would not have transplanted in the past due to the likelihood of having a poor outcome. With a wider hazard ratio of observed to expected, more patients on our waiting list are more likely to be transplanted without the fear of being flagged by the MPSC.

Sami Alasfar | 09/17/2024

Speaking on the kidney transplant side, I agree with the proposed changes and making the threshold more liberal. Since post-transplant outcomes measure both donor quality and recipient health, this adjustment would encourage programs to not only accept higher-risk donor organs but also list higher-risk recipients without fear of immediate scrutiny. The proposed change also supports efforts to encourage programs to focus more on patient needs rather than potential performance penalties, which could result in more efficient use of available organs. The balance here between encouraging more transplants while maintaining robust monitoring standards is key.

Anonymous | 09/17/2024

I agree that changing the threshold for MPSC review of adult 90-day and 1-year conditional on 90-day graft survival from 50% probability that the transplant program’s hazard ratio is greater than 1.75 (75% higher than expected) to 50% probability that the transplant program’s hazard ratio is greater than 2.25 (125% higher than expected), will allow organizations to accept and transplant more complex donor organs