Comments

Justin Wilkerson | 10/16/2024

Great work that I strongly support! The Expeditious Taskforce continues to attack the most pressing issues in transplantation. Reducing the flagging threshold will enable some centers to take a broader approach to kidney transplants. Increased acceptable risk will enable the utilization of challenging organs and will save the lives of the those in most desperate need who might not compete for organs going to those higher on the list. This proposal will likely not negatively affect anyone higher on the TX list but will likely benefit many who not otherwise receive an offer in time. Thank you for stepping forward to advance this proposal!

Colleen O'Donnell Flores | 10/16/2024

Thank you for the opportunity to provide public comments on important aspects impacting transplant patients and programs. I urge MPSC to consider the increase in offer acceptance thresholds, only after further development of existing offer filters, especially non-renal filters.

Gabriel Loor | 10/16/2024

Dear OPTN policy makers,

As you know, transplant is a lifesaving procedure for many patients with end organ failure but despite all best efforts, the outcomes can be unpredictable. In order to make the outcomes more predictable, transplant programs can elect to offer this life saving therapy to patients with the lowest risk profile possible. Features of this profile include younger age, limited comorbidities, no prior surgeries, and many more. Similarly, donor selection can be made more conservative to include only younger donors with limited comorbidities. The expected result is a predictable post-transplant outcome that is better than it otherwise would be if other patients were offered the same therapy. This practice leads to many patients being denied a life saving opportunity and many donor organs going to waste.

However, this practice of remaining selective with recipients and donors has been necessary for many programs because of the national standards imposed upon transplant programs. Any relaxation of that national standard by way of increasing flagging criteria, is sure to lead to a greater effort to transplant more patients in need and save more lives.

It is also possible that early outcomes will be worse than they currently are on average. It is equally possible that centers will learn how to take better care of sicker patients and learn how to improve the outcomes associated with higher risk transplants. Internal quality review boards will help institutions navigate the new landscape and develop best practices for success.
Costs can also be a concern. If outcomes suffer then costs per transplant can increase. Yet the cost of a single life saved is priceless and the costs associated with suffering without a transplant can be astronomical. As centers gain experience they will improve transplant outcomes while reducing their costs. Overall, despite the potential downsides, the upsides associated with an increase in the national flagging criteria would be a monumental push forward for the field of transplant and for patients living with end stage irreversible end organ disease. The patients in our country deserve the best outcomes and they deserve a chance.

International Society for Heart and Lung Transplantation | 10/16/2024

attachment

View attachment from International Society for Heart and Lung Transplantation

American Society of Nephrology | 10/16/2024

Please see attachment.

View attachment from American Society of Nephrology

St. Louis Children's Hospital at Washington University Medical Center | 10/16/2024

attachment

View attachment from St. Louis Children's Hospital at Washington University Medical Center

American Society for Histocompatibility and Immunogenetics (ASHI) | 10/16/2024

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the proposal to expand the criteria for post-transplant graft survival transplant performance metrics. The proposal aims to incentivize the consideration of more complex transplants, including those on biologically/immunologically challenged recipient candidates (e.g. highly sensitized patients) and the use of transplantable organs from more suboptimal donors.

ASHI supports this proposal. ASHI supports excluding pediatric patients in this consideration. This proposal will, hopefully, be the first step leading to more access to transplantation by improving organ utilization and reducing organ discards.

Heart Failure Society of America | 10/16/2024

attachment

View attachment from Heart Failure Society of America

Cystic Fibrosis Foundation | 10/16/2024

On behalf of the Cystic Fibrosis (CF) Foundation, we appreciate the opportunity to provide feedback on the Organ Procurement and Transplantation Network Membership and Professional Standards Committee (MPSC)’s proposal to update criteria for post-transplant graft survival metrics.

The CF Foundation has previously recommended OPTN consideration of several measures to mitigate disincentives for transplant programs to accept extended donor criteria organs and medically complex recipients. We therefore support the MPSC’s proposal to change 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 to 50% probability that the transplant program’s hazard ratio is greater than 2.25. We agree that increasing the flagging threshold for these metrics may reduce transplant program concern and uncertainty regarding MPSC performance review, encourage transplant programs to consider more marginal donor organs and more medically complex recipients, and support increased organ utilization and transplants.

With our previous recommendations in mind, we would also like to note that, though the MPSC’s proposal specifically refers to the anticipated impact on transplant program acceptance of extended donor criteria organs, we are optimistic that the proposed changes would also encourage transplant programs to consider transplanting more medically complex organ recipients. This is especially important of the context of CF, given the inherent multiorgan complications of CF including malnutrition, diabetes, and liver disease as well as chronic (and frequently multidrug-resistant) infections, potential for prior transplantation, and other complicating factors that may be present in cases of CF patients requiring lung transplantation.

Finally, the CF Foundation emphasizes that the proposed changes in the flagging threshold for adult 90-day and 1-year conditional on 90-day graft survival do not diminish the need for, or value of, existing OPTN programs designed to improve performance through education, coaching, and peer mentoring, such as the Individual Member-Focused Improvement program. Though voluntary, we believe that such programs are immensely useful for OPTN member transplant programs and may even mitigate some concern about raising the flagging threshold.

Inova Fairfax Hospital | 10/16/2024

Inova Fairfax strongly supports the proposed policy change to raise the established post-transplant graft survival outcomes threshold. This adjustment is essential for several critical reasons:

1. Enhancing Organ Utilization: The current restrictive outcomes threshold limits the use of available organs, resulting in fewer transplant opportunities for patients at higher risk. By adjusting the threshold, we can promote effective organ utilization to ensure every gift is maximized and increase transplantation rates for those who need it most while decreasing discards, further supporting the OPTN Expeditious Task Force’s bold aim of 60,000 successful deceased donor organ transplants by 2026.

2. Improving Access to Transplantation: The existing outcomes threshold disproportionately affects candidates with complex medical conditions, restricting their access to life-saving transplants. Making this change would likely impact transplant programs' decision-making by minimizing risk-averse behaviors and increase acceptance of complex donors and complete more complex transplants.

3. Addressing Variability in Outcomes: Year-over-year variability, driven by changing patient populations, unforeseen events, and wide confidence intervals in 90-day and 1-year graft survival metrics, means that MPSC reviews may not be reflective of current program performance, especially for smaller volume programs. This variability can lead to inappropriate penalization for programs delivering quality care.

4. Adapting to the Evolving Transplant Landscape: The shift towards continuous distribution and new performance measures necessitates a change in threshold. OPOs are also faced with competing performance measure interests, further complicating the system. Adjusting the threshold will allow transplant programs to participate in this evolving landscape.

5. Increasing Regional Access for Sicker Patients: By adjusting the threshold, we can provide greater access to transplantation for patients who currently travel outside their regions due to their local programs' inability to take on additional risk. This change would enhance health equity and ensure that sicker patients have improved access to transplantation within their own communities.

In conclusion, adjusting the post-transplant graft survival outcomes threshold is a vital step towards improving access and equity in transplantation. In addition, we also encourage and emphasize the inclusion of other key players for full alignment, particularly payors and expansion of the determination of 'Centers of Excellence' designation. Otherwise, programs may face decreasing payors and patient referrals, and it will not have the desired effect of increasing access to transplant. We encourage HRSA and the OPTN to use their influence to communicate the significant benefit this will create for more patients.

Anonymous | 10/16/2024

I support this proposal as it may lead to increase in transplantation and reduce discard. However, there should be clear guidance provided on patient selection to include urgency and, patient characteristics, ( ie ABO blood group, cPRA, time on waitlist)). Discussion and education of transplant candidates and evidence supporting an effort to provide equal care should be included. I also support excluding pediatric patients in this consideration.

Anonymous | 10/15/2024

I do not agree with the proposal to increase the threshold for MPSC review. The reason the change is suggested is that the current system stifles innovation and leads programs to be risk averse. This is wrong. The real reason programs are underperforming and not transplanting patients with good outcomes is poor leadership. This change by UNOS will simply allow programs with poor leadership to keep harming patients.

At my current institution, we have a Section Chief of Heart Failure and Transplant who does not show up for work and provides no leadership. She has no basic knowledge of transplantation. The Medical Director lacks basic understanding of immunosuppression management. Our Surgical Director is essentially absent - has not done a transplant in over a year, contributes nothing of value in selection meeting, and provides zero input in QAPI meetings. Our hospital leadership refuses to make any changes or to demote any of these individuals. The prospect of a MPSC review or a CMS audit is our only hope for meaningful change.

Anonymous | 10/15/2024

If the recommendation passes, I suggest a change to the MPSC review process. The MPSC should require a conversation with the hospital and program leadership. A letter from hospital leadership and written program response, may not be enough.

Gabriel Loor | 10/15/2024

Transplant is a lifesaving therapy for many patients with end organ failure but despite all best efforts, the outcomes can be unpredictable. In order to standardize results and ensure the best possible outcomes, transplant programs can set thresholds to ensure that only the best candidates are considered for transplant. To do so they can, and often do, elect to offer transplant to patients with the lowest risk features possible. Such features include younger age, limited comorbidities, no prior surgeries, and many more. Similarly, donor selection becomes more conservative to include only younger donors with limited comorbidities. The expected result is a post-transplant outcome that is better than it otherwise would be. Yet, unfortunately, many patients are denied a life saving opportunity and many donor organs are going to waste.

However, the practice of remaining selective with recipients and donors has been necessary because of the national standard imposed upon transplant programs. Any relaxation of that national standard by way of increasing flagging criteria, is sure to lead to a greater effort to transplant more patients in need and save more lives.

It is possible that early outcomes will be worse than they currently are on average. It is equally possible that centers will learn how to take better care of sicker patients and learn how to improve the outcomes associated with higher risk transplants. Internal quality review boards will help institutions navigate the new landscape and develop best practices for success.
Costs can also be a concern. If outcomes suffer then costs per transplant can increase. Yet the cost of a single life saved is priceless and the costs associated with suffering without a transplant can be astronomical. As centers gain experience they will improve transplant outcomes while reducing their costs. Overall, despite the potential downsides, the upsides associated with an increase in the national flagging criteria would be a monumental push forward for the field of transplant and for patients living with end stage irreversible end organ disease. The patients in our country deserve the best outcomes and they deserve a chance.

American Nephrology Nurses Association | 10/15/2024

ANNA agrees with increasing the threshold for monitoring for review of post-transplant graft survival. We support increased access to transplant, increased utilization of organs, and a decreased discard rate. We feel this will remove barriers and encourage transplant centers to accept and transplant more complex organs to help achieve the goals of the OPTN and the transplant community while still protecting patients with monitoring standards.

View attachment from American Nephrology Nurses Association

UC San Diego Center for Transplantation | 10/15/2024

The UC San Diego Health Center for Transplantation applauds the OPTN Membership and Professional Standards Committee for their swift action in rectifying this quality measure which the community has identified as a contributing factor to risk averse behavior, based on the perception that the potential for MPSC review for post-transplant graft survival outcomes. We strongly support the removal of barriers and the decrease of disincentives to the acceptance of high-risk candidates for transplant and the transplantation of high-risk but transplantable organs as we believe that the ability for transplant programs to take such calculated risks when they deem it clinically appropriate to do so is in line with the strategic goals of increasing access to transplantation and decreasing organ non-utilization rates.

We stress the importance of any proposed changes aligning with the SRTR as the SRTR bar rating has long been a recognized benchmark for assessing the quality and effectiveness within the community. 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 program approvals and inclusion in insurance networks.

We also agree with the American Society for Transplant Surgeon’s insight that that revision will streamline the workflow of the MPSC and thus allow it to focus on the small number of programs with actual performance improvement needs and the urgent system issues the community is experiencing at the moment, including but not limited to the staggering increase in out of sequence allocations.

North American Transplant Coordinators Organization (NATCO) | 10/15/2024

The North American Transplant Coordinators Organization (NATCO) supports the proposal, “Update Criteria for Post-Transplant Graft Survival Metrics” released during a special public comment period. We believe that it will increase the utilization of more organs by decreasing the fear of flagging by the MPSC, thereby supporting the overall mission of the Expeditious Task Force. Transplant centers can accept more complex donor organs, especially smaller centers that end up taking higher risk due to lower numbers. In addition, the number of reviews for MPSC will be decreased, leaving them to focus on other important work.

Wasim Dar | 10/15/2024

I support the proposal to change the MPSC threshold from 1.75 to 2.25 O/E. The goal of transplant centers is to help patients with end stage organ disease through organ transplantation. By proposing and implementing this change in MPSC center performance thresholds, it sends the message that the OPTN and HRSA reaffirm that getting patient's transplanted is the primary goal for patients, transplant centers, OPO's and the OPTN.

Association of Organ Procurement Organizations (AOPO) | 10/14/2024

attachment

View attachment from Association of Organ Procurement Organizations (AOPO)

Anonymous | 10/14/2024

While the goal of increasing transplants is admirable, it cannot come at the potential expense of patient safety. I am not adverse to monitoring and as a patient, question programs who complain of it. Patient safety should be the first consideration. As a recipient of course I want as many transplants performed as possible. I know all too well the uncertainty while waiting for an organ and because of this it should not be solely the decision of the transplant center whether to take a complex organ. Patients should be involved in the decision making process. I imagine we as a whole would side with utilizing the organ but we should have a voice. MPSC should continue to act as a patient safety monitoring entity. I would surmise that this proposed change will necessitate more monitoring as centers opt to take riskier organs. Patient safety must not be sacrificed to increase transplant numbers.

UW Health Transplant Center | 10/14/2024

UW Health Transplant Center strongly supports the O/E ratio increase from 1.75 to 2.25, echoing similar sentiments as AST and others. This change is imperative to centers becoming less risk-averse by decreasing the likelihood of flagging, increasing organ utilization, and increasing the likelihood of more patients getting transplanted with lifesaving organs.

Anonymous | 10/10/2024

I believe there should be greater oversight of transplant programs, not less. During my career, I have witnessed first-hand many suboptimal heart transplant programs with less than optimal outcomes. This has not been the result of "bad luck" but rather due to poor leadership. Poor and absent leadership from the medical and surgical aspects of the program will lead to poor outcomes. And hospital leadership is often reluctant to make programmatic changes. Only the external influence of UNOS or CMS can affect change.

Robert Cannon | 10/10/2024

I am strongly in favor of updating post-transplant survival flagging thresholds to a hazard ratio of 2.25. My only critique is that this proposal does not go far enough.

There is a wealth of literature suggesting that punitive regulatory measures based on these metrics act against the best interests of patients and increase organ discard by discouraging transplant of high-risk patients and medically complex organs. There are many patients denied transplant despite the fact that they would have an expected survival benefit because their anticipated outcome does not reach the standards currently mandated by graft survival metrics. There are many donor organs which are discarded despite the fact that they would provide an expected survival benefit over remaining listed ("better than dialysis kidneys," for example) becuase they would not allow post transplant graft survival outcomes to remain "in range" if used in large numbers by a single program. This status quo is harming patients and is untenable.

Furthermore, MPSC members note in their meeting minutes that noting that "the vast majority of programs with serious issues were not identified through review of post-transplant outcomes, but rather through avenues such as patient safety reports"

If these metrics don't help the MPSC identify the vast majority of programs with patient safety issues, why do we persist in clinging to them when there is evidence that they are harming patients?

While I'd rather see the OPTN follow the lead of CMS in removing survival metrics from conditions of membership, I support this proposal as a step in the right direction.

Respectfully,

Robert M. Cannon, MD
Surgical Director for Liver Transplant
University of Alabama at Birmingham

American Society of Transplantation | 10/10/2024

The American Society of Transplantation (AST) supports the proposal, “Update Criteria for Post-Transplant Graft Survival Metrics” released during a special public comment period. The AST supports the proposed flagging threshold change to 2.25 for 90-day and 1-year conditional on 90-day graft survival as this change is anticipated to increase transplant programs’ willingness to accept more complex donor organs and perform more complex transplants, while also providing a secondary benefit of streamlining the MPSC’s work. The AST supports the goal of this proposal and encourages the OPTN to pursue other considerations that will likely have a more significant impact on which organs will be accepted by transplant programs. Specifically, the SRTR five-tier rating system needs to be better aligned with the OPTN bylaws outcomes thresholds, as it is used by payors and hospital administrators and ultimately has greater influence over transplant programs’ decisions. Additionally, better risk adjustment for recipient factors is needed; similar to donors, transplant recipients are also becoming more “complex.” Without working to address these two important considerations, the AST expects the proposed OPTN bylaws change to have a minimal impact on transplant program acceptance behavior.

The AST agrees with applying this change only to adult transplants at this time. The AST requests that the OPTN perform similar analyses of flagged pediatric transplant programs. It would be useful to determine if pediatric transplant programs might also benefit from an increased threshold for outcome reviews in order to reduce the number of reviews resulting from “false positives” and the associated administrative burden.

The AST is supportive of the OPTN exploring an increase to the organ offer acceptance rate ratio only after multi-criteria offer filters are implemented for each organ, programs have been allowed sufficient time to understand and optimize offer filters for their patients, and there is convincing data that supports increasing the organ offer acceptance rate threshold will yield increased utilization of organs for transplant.

Finally, the AST remains concerned about the OPTN’s usage of special public comment periods. There is value in having robust community discussions about changes to OPTN policies and bylaws, especially those held at the OPTN regional meetings. The AST is concerned that truncating the public comment process without any prior announcement or awareness of these special comment periods limits the discussion of these proposed changes and increases the likelihood of unintentional consequences.

Allegheny Health Network Transplant Institute | 10/09/2024

We strongly support increasing the flagging threshold for 90-day graft survival and 1-year conditional to a hazard ratio of 2.25. This will support the expeditious task force bold aim of 60,000 DDKT by 2026. Modifying risk adjusted post-transplant graft survival metrics will help avoid risk-adverse practices by encouraging transplant programs to accept more complex donor organs.

This proposal would reduce the risk of unfairly penalizing programs that may be performing adequately. By raising the threshold, the system would be less likely to flag programs who currently have a high organ acceptance rate with outcomes that are skewed using the existing rate ratio. According to Donate Life, 5,600 people in the United States die each year while on the transplant waiting list. Increasing organ utilization will allow us to decrease wait list mortality and restore patient’s quality of life.

Barnes-Jewish Hospital | 10/08/2024

We strongly support the change proposed to 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. We believe this change will lead to improved organ utilization through transplantation of complex patients.

It is imperative to gain alignment of performance metrics across the transplant landscape for transplant centers and OPOs. Expanding the threshold for review should result in a review of SRTR quality measures and payer” centers of excellence” designations to encourage centers to take the additional risk necessary to increase access to transplantation.

We also encourage a thorough review of fair pricing of machine perfusion technologies. The increased use of complex organs with complex patients necessitates the use of machine perfusion. In the current state, these technologies can be cost prohibitive for centers to offer in their procurement options, creating additional constraints in organ utilization and disparity in patient access to transplantation.

Vanderbilt University Medical Center | 10/08/2024

On behalf of Vanderbilt Transplant Center, we appreciate the opportunity to provide feedback on potential changes to the post-transplant performance metrics. We do not support this current proposal as it is written. Patient safety is our top priority and must be the most important priority for the OPTN and the MPSC. While changing the hazard ratio threshold from 1.75 to 2.0 or 2.25 will reduce the number of programs flagged for post-transplant graft survival, it is still unclear how this change will affect patient safety and long-term outcomes. We feel that there has been a lack of consideration in this proposal in an effort to dramatically increase transplant volume nationwide. We feel that there are other initiatives that could increase transplant volume without sacrificing patient safety that should be considered.

Anonymous | 10/08/2024

I would like to supplement comments I made on October 4, 2024. I need to mention two other factors for my support of this proposal.

When I had my transplant in 2020, I was asked if I was willing to accept an organ from a donor who had Hepatitis C. I had some concerns, but the transplant team provided materials addressing how we could treat Hepatitis C and verified my insurance coverage. They resolved any concerns I had.

Ultimately, my donor did not have Hepatitis C, but I was willing to accept that risk if I had to, based on the information provided by my team. This is why providing information to the candidate about risks and mitigation strategies is important so they can make an informed decision.

I also watched the presentation on this proposal. While the outcome metrics will be changed, there will be other metrics in place that will identify centers that may have performance issues that are not due to taking on higher risk transplants. This is an important factor in my decision to support the proposal.

Thank you for considering the input of candidates, recipients and others outside the medical community.

OPTN Transplant Administrators Committee | 10/08/2024

The OPTN Transplant Administrators Committee thanks the OPTN Membership and Professional Standards Committee for their work on this proposal. The Committee is in full support of this effort and agrees with the direction to change the flagging threshold.

John Vella | 10/08/2024

This is a long overdue initiative that will reduce the risk of transplant programs being penalized for transplanting higher risk individuals.

Richard Gilroy | 10/07/2024

the proposal will lead to an increase in total transplants. I strongly support all initiatives that drive to this position. I recommend that the MPSC consider creative ways monitor the outcome of this change and to evaluate for any unexpected consequences that might have a negative impact at the patient level.

The George Washington University Transplant Institute | 10/07/2024

The George Washington University Transplant Institute thanks the OPTN Membership and Professional Standards Committee (MPSC) for their work on this proposal. We strongly support this proposed change, as it will allow for additional flexibility and less penalty for transplant programs. This will increase transplant program willingness to accept marginal organ offers, and will in turn, allow for more transplants to be performed. By changing the threshold of 2.25 to 1.75 for 90-day and 1-year conditional on 90-day graft survival, our center would be more willing to accept more medically complex donor organs and perform more complex transplants. We believe that an increase in the threshold for the offer acceptance ratio would be beneficial, not just for our program, but on the transplant system as a whole. The current system makes discourages centers from accepting higher-risk organs and higher-risk patients out of fear of punitive action, which leads to high rate of discards and more deaths on the waitlist. With the passage of this proposal, we would expect increased organ utilization, increased in transplants, decrease in candidate pre-transplant mortality, and decreased organ non-use. This would allow transplant centers to make more patient-centric and less outcome-centric decisions. We believe this proposal will be beneficial to transplant centers, and most importantly, our patients.

Anonymous | 10/07/2024

This is a much needed change given current waitlist criteria. It will no doubt help transplant programs give more opportunities to more patients.

Anonymous | 10/07/2024

Updating the criteria will allow us to help more patients reach transplantation.

Anonymous | 10/04/2024

I am a transplant recipient. When a candidate opts to proceed with being put on the wait list, they know they will be assuming some level of risk by having the transplant because they have been advised of the risks.

I believe some and perhaps many candidates on the waiting list will be willing to accept an organ from a higher risk deceased donor.

But proceeding with using a higher risk deceased organ should be conditional upon advising the recipient of the scope of the risks, as well as any strategies to mitigate those risks. This is a critical step in the informed consent process which exists to protect both recipients and the transplant center and to strengthen a relationship built on trust.

Gift of Life Michigan | 10/04/2024

We appreciate the work the Committee has put into this recommendation to change the threshold for OPTN Membership and Professional Standards Committee (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 to 50% probability that the transplant program’s hazard ratio is greater than 2.25. While record numbers of donor organs have been given over the last several years, and transplants continue to save lives, tens of thousands of patients do and will need transplants. We respect and appreciate the responsibility of transplant centers not only to get their patients transplanted, but to do so with a lifesaving outcome and restoration of a normal life.

As some have observed, transplant centers are already held to exceptionally high outcome expectations, and the thresholds currently in place have become risk-averse at all levels out of concern for negative affects on their center's standing with the OPTN and/or MPSC. This undoubtedly impacts a center's likelihood of accepting more complex organs, and ultimately results in fewer transplants.

Myriad factors contribute to a patient's and transplanted organ's condition after transplant. We believe the proposed change to the threshold is a better reflection of more possible factors than simply the 90-day and one-year status, and gives centers and patients greater ability to reasonably consider organs from complex donors.

Milton Mitchell | 10/03/2024

Thanks to a generous Donor Family, I am 10 years plus and enjoying my second chance at life. I am Forever Grateful.

I strongly belive Pre Transplant Patient should be educated and informed always regarding "High Risk" offers. Including the treatment followup necessary. I believe this will help with underutilization, personally.

Thankfully, my transplant center asked me if I was willing to consider accepting a "High Risk " organ(s). I unequivocally said "yes". Loudly and clearly because I wanted to live. Get up, out and Go on with my life, even if for a limited time. Yes, I jumped at the option.

Further, I believe every pre transplant patient should be asked and informed if willing to consider accepting "High Risk" organs Like I did. Some patients are gravely ill and see their options extremely limited. Some may say yes and some may say no. But they should be asked.

Furthermore, lying there just knowing your health is overall declining but a "Hiigh Risk" organ(s) could get you up and out of the transplant center/hospital is another option - that's good. Any patient will give serious consideration to that - most may accept


More importantly, I believe most gravely ill pre transplant patients would accept High Risk organs. For various and personal reasons.
But ask, inform and educate. Patient Voice.

Milt

Ira Copperman | 10/03/2024

In general, I support a change which removes disincentives from the decision for transplantation. The factor that continues to be overlooked in this process is the patient voice. The transplant team should be required to explain to the waiting recipient the risks involved with each and every offer. There may be good medical reasons not to accept a kidney for transplant, but those reasons should be just one factor, albeit a very important factor, in the reason not to accept an organ. A patient may be very willing to accept a higher risk offer, even if it means just one additional year of life free from dialysis or other disease treatments. These patients will, I am sure, be very compliant patients, welcoming the need to accommodate to followup visits, potential complications from immunosuppressive drugs, or return visits to clinic as part of the post-transplant regimen.

So include the patient voice, and I think acceptance rates will increase.

Anonymous | 10/03/2024

If I understand this correctly, does this proposed program include cases, such as if the donor had diabetes? If so, how are the risks assessed? Additionally, how are the risks explained to the upcoming recipients and/or family members?

LifeShare Transplant Donor Services of Oklahoma | 10/03/2024

Our OPO strongly supports the MPSC-proposed change in post-transplant graft survival metrics. With a current kidney (2024 YTD) non-utilization rate of 25%, and historic annual rates of as high as 30%, despite employing hypothermic machine preservation in 85% of kidneys and despite making hundreds of thousands of placement attempts on non-utilized kidneys, we are acutely aware that our transplant center colleagues' decision making to accept or decline an offer is impacted in no small part by the performance metrics they are measured by. Providing some additional flexibility to those metrics will, we believe, increase utilization of available organs and thereby increase both the positive impact of donors' gifts and increase access to transplant for patients in need.

Julie Heimbach | 10/03/2024

This proposal will be very beneficial in allowing more patients to be able to access transplantation. Thank you for bringing this forward

Kidney Donor Conversations | 10/03/2024

The best treatment for kidney failure is a living donor transplant. Yet, OPTN continues to focus on deceased donor transplants. Please consider removing barriers to increasing the number of living donor transplants also.

Consider distributing resources to include supporting living donors and helping patients receive the best treatment, a living donor transplant.

I am a Nephrology Nurse, my husband has received 2 living donor transplants, and I donated my kidney to a stranger in 2017.

Tracy Giacoma | 10/03/2024

The burden on transplant centers to choose metrics that change day to day over saving the lives of patients needs to stop. This will help improve transplant organ acceptance rates and get more patients their lifesaving transplants.

Anonymous | 10/03/2024

Strongly Support

Kevin Cmunt | 10/02/2024

As a member of the OPTN Expeditious Task Force, Faculty Member for the CMS ETCLC, former OPO CEO and passionate advocate for donor families and honoring the gift of donation, I strongly support the proposed change. Underutilization has reached unthinkable levels. In 2024 we are on pace to discard 9400 kidneys, a 270% increase since 2018. While the total number of these kidneys that should have been used is open for debate, there is no question that the number is in the thousands and very likely north of 5,000. Not only are we disadvantaging thousands of waiting patients, we are not living up to our obligation to fulfill our implicit promise to donor families that we will do everything we can to honor their gift by using it to save lives. Additionally, these discarded kidneys are costing the transplant system over $250,000,000 per year as the costs of recovering these organs are included in the fees charged for those organs transplanted.
In addition to this action, it may also be helpful to re-educate the transplant community on how MPSC evaluates programs with regard to >85 KDPI transplants. My understanding is programs are only flagged if both their risk adjusted outcomes for all kidney transplants and all kidney transplants 85 KDPI kidneys can only help a program's risk of flagging.
There are many other changes to policy that may help including:
-Modifying the SRTR Tier ratings to emphasize increase in transplants, time to transplant and use of all available organs

-Increased reimbursement for kidney transplants with better than dialysis kidneys (high KDPI, higher biopsy, longer CIT, Hard-to-Place etc)

-Incentives for growth (IOTA model except with 10X the $$s)

-Education of C-Suites at transplant programs on the need for more resources to increase transplant

Last, I would highly encourage you to act as Expeditiously as possible. We are discarding a kidney every hour we don't take action.

Patrick McGlone | 10/02/2024

This would, in theory, help to remove the trepidation that Centers feel prevents them from accepting more complex transplantation cases and/or organs. This would absolutely aid in the goal of performing more transplants.
However, there is still the question of insurer "requirements" causing such cases to not be considered. For example, requiring an insurance "Center of Excellence" designation before approving a patient to list at a specific program, may skew the results as it would prevent the patient and program from even investigating the complex transplantation to begin with. The fear of losing such a designation would cause programs contracted with that insurer to reroute high risk patients / Tx to another program. This would skew the numbers. Parity in requirements would also be required in order to ensure consistency in reporting/results.

Anonymous | 10/01/2024

In theory, adjusting the hazard ratios will allow programs to be more aggressive and utilize more marginal organs - not sure realistically, however, that this will improve behavior when OPTN efforts are not coordinated with CMS reporting and, more importantly, with insurers who can set contract requirements for whatever hazard ratios they want. We need alignment!

Neeraj Sinha | 09/29/2024

I serve as medical director of an adult lung transplant program, however following comments are in my personal capacity:

Would a change to a threshold of 2.25 from 1.75 for 90-day and 1-year conditional on 90-day

graft survival increase your willingness to accept more complex donor organs and perform more

complex transplants?

Yes.

• Do you support a change to the alternative threshold of 2.0 considered by the MPSC rather than

the proposed 2.25 threshold?

No. 2.25 would be appropriate threshold.

• Would you support an increase in the threshold for the offer acceptance rate ratio to identify

more programs and incentivize programs to accept more organs?

Yes, from 0.3 to 0.35.

• Should the change in threshold be applied to pediatric transplants in addition to adult

transplants?

No comments.

• Are patients supportive of the change in threshold which aims to increase access to more

complex organs?

From lung patients' perspective, I can imagine that they would likely welcome the proposed 2.25 threshold as they would only have a tiny dip in the large longevity gain that they get if they get transplanted when compared to if they don't. Benefit from increase in transplant rate will far outweigh the tiny dip in longevity gain. However, I would imagine that they would like a patient-experience centered quality metric added to the existing metrics, eg total number of days spent in hospital system in the first year post-transplant (index event plus all subsequent readmissions within first year, including days spent in acute rehab and LTACH).

One word about median length of stay (LOS) versus mean LOS: As outliers matter a lot more than the central values when it comes to LOS (either index event or for the entire year), programs should be judged based on mean LOS, not median LOS. A program can have an excellent median LOS, but can still get flagged for survival as it is the LOS outliers who tend to have mortalities. Insurances also pay attention to mean LOS, not median LOS.

To summarize, mean within-first-year LOS can be added as an additional metric to flag a program.

Andrew Kao | 09/27/2024

I think this proposal will go a long way towards increasing program willingness to accept more medically complex donor organs that would likely work well but program may be hesitant due to perceived higher risk leading to worse program outcomes. Support the 2.25 threshold rather than 2.0. Would support also altering the pre-transplant acceptance threshold to monitor whether programs are more aggressive in acceptance donor organs.

Baylor Scott & White Health | 09/26/2024

On behalf of Baylor Scott & White Health and our 3 multi-organ transplant centers, Baylor University Medical Center, Baylor Scott & White All Saints Medical Center and Baylor Scott & White Temple, we appreciate the opportunity to provide feedback on changes to the threshold for transplant center flagging for patient outcomes. We strongly support the graft flagging criteria described in the proposal. Benefits of this change include improved access to transplant, decreased pre-transplant mortality, and increased organ utilization. It will decrease the disincentives to transplanting sicker candidates, allow increased access to transplant for more patients, and allow the focus to remain on a smaller number of transplant programs with performance needs.

Sumeet Asrani. MD
Chief of Hepatology and Liver Transplantation

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

Attachment

View attachment from National Kidney Foundation

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

Attachment

View attachment from American Society of Transplant Surgeons

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