Comments

New England Organ Bank | 03/13/2024

NEDS wants to highlight numerous comments already submitted fully supporting the separation and creation of an independent OPTN Board, while emphasizing it is critical that HRSA first ensure that the OPTN is established as a distinct legal corporation. The implementing regulations (42 C.F.R. § 121.3(c)) to NOTA require that the OPTN be a private, not-for-profit entity. It is not effective to create an OPTN Board without a legally recognized entity to serve as the OPTN. Accordingly, the first step in creating an independent OPTN Board is establishing an independent corporate structure for the OPTN. This is a necessary precondition to a fully functional OPTN Board appointed with the required membership set forth in 42 C.F.R. § 121.3(a) that can then act as a fiduciary of the OPTN. The creation of a corporate entity supports several table stakes for the OPTN including appropriate liability protection (and D&O insurance) for the volunteer board members, appointment of an Executive Director (who can be employed by the OPTN), the ability to maintain and direct funds, and a reporting structure for OPTN Committees that protect the work (including for example, the MPSC).

As for the members of the independent OPTN Board, it is important to keep in mind that the OPTN is specifically designed under NOTA to be a public-private partnership and not a subagency of HHS. This key feature makes the OPTN unusual and distinct from other national policy making bodies within HHS. The OPTN Board is not an advisory board nor is it solely a policymaking board. The language in NOTA clarifies that the OPTN Board is the governing board of a private nonprofit organization. As such, the current Board members have full legal authority to act on behalf of the OPTN within the confines of the OPTN bylaws and in accordance with NOTA. Although its been suggested, it is unclear how currently elected OPTN Board members could be replaced with new members appointed by HRSA without either the Board itself voting to do so, amending the OPTN bylaws or legislative and regulatory changes to federal law. As fiduciaries of a nonprofit organization, the OPTN Board members are legally bound by the duty of care and loyalty to the OPTN (this is yet another protection afforded by structuring the OPTN as a legal entity). These well-established legal guardrails for Board governance are in-line with all private nonprofit organizations.

Calvin Henry | 03/13/2024

I strongly support the separation of OPTN and OPTN contractor boards. The issue of real or perceived conflicts has been well documented already. I am cautious of an exemption for the OPTN Executive Director (as a contractor employee) due to those same real or perceived conflicts. Ethical standards typically err on the side of ensuring that potential conflicts of interest with nonprofit organization staff/board members won’t be called into question so that the integrity of the organization is not challenged. At minimum, the executive director should have non-voting privileges if in a dual role of an employee of the contractor and an OPTN executive director but, optimally, I believe they should also be separate. I would also urge that HRSA be extremely transparent with their plans for a “smooth transition” on 3/29 and detail their implementation plan which currently doesn’t have the officer/volunteer protections normally afforded to one under an incorporated entity.

Neshea Harrison | 03/13/2024

My daughter is a liver transplant recipient, and the system has been a blessing to our family as well as to others. While in time separating the boards could be beneficial, but those things take time and planning. Moving too quickly can cause destruction oppose to helping.

Brittany Munn | 03/13/2024

As a mother of a liver transplant recipient, who received his second chance at life at 6 months old, I am mostly concerned with how quickly things are being pushed through without the needed clarity in the proposals to properly move forward with this OPTN Modernization Initiative. I am for separating the boards, but how that process moves forward without potential conflicts is currently unknown. I truly feel like this will be an unnecessary domino effect that will have a terrible consequence for those currently on the waitlist, especially for our kids who are waiting. I’m also concerned about the proposal to hold special elections in replacing the current Board members. This proposal is unclear about who would actually vote in this kind of election, and I truly believe (with all the talk about protecting this process against potential conflicts of interest) that with this not being clear enough, there could easily be conflicts of interest established within this new proposal. I strongly believe the OPTN Board members should continue to be elected by the transplant community, primarily by patients, caregivers and physicians who are a part of this community for benevolent reasons. Also, I do agree with what others have suggested in that the Board should be an incorporated entity to provide them legal protection while they volunteer their time to serve our community.

Katy Ter Weele | 03/13/2024

There is not enough clarity in the process. How is safety and continuity of the transition being prioritized?

It is important the OPTN board be represented by direct members of the transplant community. Patients, caregivers, and members of the transplant team understand the mental, physical, and emotional intricacies that are involved with organ transplantation. It is vital that transplant community voices (pediatric and adult) be directly involved in the process or you risk failing to represent the community whom you serve.

We need to ensure the integrity and altruistic aspect of the organ transplantation system continues during and after this transition.

Anonymous | 03/13/2024

As the parent of a pediatric transplant patient who is eagerly watching to see how our transplant system will change in the next few years, I don't think now it the time to be asserting this separation.

While I generally do support better accountability and reduction in conflicts of interest in decision making about organ allocation, I do not think the current Board make-up presents a conflict of interest; rather, the current Board is a respected, committed group of people who are doing their best to do what is best for the transplant community given the current state of OPTN.

Forcing this separation during a time in which the future of the OPTN contractor is so clearly unknown will only create more confusion, concern, and distrust in the overall organ allocation process.

Federation of American Scientists | 03/13/2024

It is critical that the OPTN boards and the boards of any contractors be separate, and that the inherent conflict of interest that currently exists in having OPTN and UNOS have identical boards be removed.

The OPTN final rule itself calls for the OPTN to be an independent entity, something that the current OPTN contractor (UNOS) has never respected and put into practice, which is an indication of a persistent disregard by the contractor for operating in patients’ interests versus corporate interests.

At the same time, it is critical that the OPTN board be composed of members operating in patients’ interests, without hidden or distorting financial conflicts of interest. Any potential financial conflict of interest of a prospective OPTN board member should be disclosed, and no prospective OPTN board member should have had any financial or fiduciary relationship with any OPTN contractor for a minimum of one year before being considered for the OPTN board. This would be in keeping with analogous federal government ethics rules, and help rebuild confidence in the system. These board members can no longer be dictated by industry and operating in industry interests over patients’ interests.

While these reforms are urgent, it is also critical that UNOS/OPTN work with HRSA in good faith to ensure that the appropriate steps are put in place for transition. The report “Lives Are at Stake” by the United States Digital Services (USDS) details that: “HRSA has tried many things over the years to encourage more transparency and accountability from UNOS through the OPTN contract. All of these attempts have been met with hostility from the contractor – UNOS has at times even threatened to walk away and continue operating the OPTN without a contract, despite the fact that it would be illegal for them to operate such a network independent of a government contract.”

Such tactics should never have been used by the OPTN contractor in the past, and cannot be allowed to persist now. Therefore, when it comes to timelines, where extension of particular services are required as part of the Modernization Initiative, these should be complied with in good faith by UNOS/OPTN on a timeline that best serves patients and the transition to more accountable, transparent, de-conflicted services and systems.

Even the tight timing of this comment period raises questions of whether the OPTN contractor is operating in good faith given HRSA is endeavoring to conduct a first-ever competition contracting cycle for OPTN-related functions, breaking up UNOS’s ~40 year monopoly on the system.

For too long, the OPTN contractor has called the shots and patients have borne the cost of its focus on corporate interests over patients’ interests. HRSA and bipartisan Members of Congress are clearly trying to right this wrong.

OPTN board members (who are still, let us be clear, UNOS board members) should in no way stand in the way of federal actions designed to bring more accountability to the OPTN and its critical life-and-death functions, and should make every effort to comply with seamless transitions to new ways of functioning and new contractors.

Jennifer Erickson

Senior Fellow, The Federation of American Scientists

Emma Long | 03/13/2024

As a parent of a child who has received a liver transplant, I want to express my deep concern about the proposed changes to the OPTN structure. I worry about the potential for disruption in the transplant system due to the timing and scope of the proposed changes. The possibility of significant changes during a time of transition is alarming, as any interruptions could have life-or-death consequences for those awaiting transplants, as well as for families like mine who must remain prepared for the possibility of needing another transplant in the future. It is imperative to prioritize the stability and effectiveness of the transplant system over arbitrary deadlines.

I am also concerned about maintaining the integrity of the OPTN Board, particularly in light of the HRSA proposal to hold a special election to replace the current board members. What are the details of the proposed special election? And without any legal protection, how will people continue to volunteer to serve on the board? We risk losing valuable expertise from professionals who may be deterred from participating due to potential personal and professional liabilities. It is crucial that the board includes experts in the field who are committed to the best interests of patients and their families, and that there is a focus on including diverse perspectives, perhaps from outside the transplant community but with experience in organizational governance, to ensure a more well-rounded approach to decision-making.

Finally, I find assertions of corruption within the OPTN board to be both inappropriate and unhelpful in this forum. While I am not aware of the specific process for submitting ethical concerns regarding OPTN board members, I strongly believe that a formal procedure should be in place and encouraged for addressing such complaints. This would ensure a more constructive and accountable process, rather than engaging in unproductive public attacks.

As a mother who has experienced the life-changing impact of organ transplantation, I urge those responsible for implementing changes to the OPTN structure to proceed with the utmost caution and consideration for their broader implications, particularly on vulnerable populations like children, such as my son. We must remember that behind every decision are real people, families like mine, who rely on a stable and effective transplant system. Every disruption has the potential to cause heartache and uncertainty for those awaiting transplants and for families who have already been through so much. In light of the potential consequences, we must ensure that all necessary elements for a smooth transition are firmly in place before implementing any changes.

Anonymous | 03/13/2024

First, I support the separation of the OPTN Board from the OPTN Contractor. HRSA wants this. UNOS wants this. The transplant community wants this. Let's make this happen. But we should be thoughtful in HOW this change occurs so that the transplant system continues to provide life-saving organs to patients desperately in need of them.
One of the great things about our democracy is the freedom of speech. It allows all of us to speak our minds. However, it also allows people to spread misinformation. Unfortunately, that happens too frequently in today's charged environment.
I feel that somebody must address some of the misinformation stated regarding the OPTN Board. Reviews of OPO finances have nothing to do with the operation of the OPTN. And removing people with knowledge of the OPTN and transplant system - or requiring a cooling off period - from the governance of the transplant system is an invitation for chaos that will ultimately harm patients. The transplant system is complex and requires the expertise of those who know it best.
Some have called for HRSA to appoint the OPTN Board. That would be a fatal error - not to mention a legally questionable action. What makes organ transplant so special and successful is that Congress (through NOTA) charged the transplant community with developing its own standards. Congress rightfully chose not to make the OPTN an administrative agency and instead created one of the most unique public-private partnerships in the country. This independence and inclusion of experts from the community is a strength of the system - not a weakness.
So yes, the OPTN and OPTN Contractor Boards should split. But the transplant community - including patients and donor families - must continue to self govern as envisioned by NOTA.

Rianna Modi | 03/13/2024

On behalf of the Organ Donation Advocacy Group (ODAG), we are writing to provide feedback related to the Organ Procurement & Transplantation Network (OPTN)’s Proposal to Address the Relationship of the OPTN and OPTN Contractor Boards. ODAG is committed to performance improvement and innovation with the goal of optimizing donation and transplant, and we have worked collaboratively with both the Health Resources and Services Administration (HRSA) and OPTN in furtherance of this goal. We are composed of fourteen organ procurement organizations (OPOs), that collectively serve over 113 million people in 30 states, 2,002 donor hospitals, and 83 transplant centers and, although ODAG members include 25% of the OPOs, we coordinated 33% of all deceased donors in the U.S. in 2023.

The proposal at hand seeks to minimize conflicts by removing the requirement that the OPTN Board of Directors be identical to the OPTN Contractor’s Board of Directors and by prohibiting members of the former from serving as an employee or Director of any organization contracted to support the OPTN. The proposed changes, if adopted, would become effective in less than a month, on March 30, 2024. As such, while we are not providing comment on whether or not OPTN should adopt this proposal in general, we are offering feedback regarding the practical effects of the proposal, assuming it is adopted, that must be considered before any changes are effective.

Critically, if OPTN establishes a separate OPTN Board of Directors from the OPTN Contractor Board of Directors, the former board will not be operating under any legal organization. A new corporation would have to be established under which the separate new OPTN Board would operate. Otherwise, the OPTN Board is not actually a fiduciary of anything and leaves the OPTN without any legal identity. This is contrary to the legal requirement under the National Organ Transplant Act of 1984 (NOTA) implementing regulations (42 C.F.R. § 121.3(c)) which explicitly require that the OPTN be a private, not-for-profit entity. Any existence of the OPTN Board as an unincorporated, amorphous entity is inconsistent with current regulations requiring the existence of the OPTN as a legal entity.

Among other things, this would ensure that there is an adequate corporate structure to account for potential legal exposure and protect the volunteers who serve on the OPTN Board. Currently, the United Network for Organ Sharing (UNOS) provides liability insurance coverage and indemnification to the members of the OPTN Board, as they serve dually on the OPTN Board and UNOS Contractor Board. However, if the proposed changes are implemented as currently contemplated, members of the OPTN Board will be left without any protection from legal liability, because the members will lose the protections they hold through UNOS. This loss of legal protection is unreasonable given the potential legal risk associated with managing the country’s complex organ donation and transplantation system and could result in resignations from the current OPTN Board and could disincentivize qualified and essential experts from joining the Board in the future.

As such, should the OPTN adopt this proposal, it is imperative that OPTN/HRSA establish the OPTN as a distinct non-profit, private corporate entity with a governing board, which will provide structure to the OPTN as directed by NOTA and legal protection to those serving on the OPTN Board. This legal entity should be established on a timeline that does not leave OPTN Board members facing a lapse in legal protection – i.e., the legal entity ought to be in place before the OPTN Board and Contractor Board are separated. Doing so will minimize any disruption to the donation and transplant ecosystem and system during the time of Board separation, especially given the number of concurrent changes occurring in the near future.

Thank you for the opportunity to provide comment and we look forward to continuing to engage on the development of an optimized donation and transplant system.

American Society for Histocompatibility & Immunogenetics (ASHI) | 03/13/2024

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the proposal to address the relationship of the OPTN and OPTN contractor boards. ASHI fully supports the proposal of separating the OPTN board of directors from the board of directors of any existing or future OPTN contractor. This proposal prohibits any current member on the OPTN board of directors from serving on the board of any OPTN contractors to mitigate the perception of conflicts of interest from the partners and stakeholders in the donation and transplantation community as well as the public. ASHI recommends that the separation of the OPTN and contractor board of directors occurs in a timely manner that will not compromise the function of the OPTN to manage the national transplant system. Further clarification of the separation by developing specific non-compete clauses with a defined timeline is also recommended.

Organize | 03/13/2024

Organize strongly supports the separation of the OPTN board with the boards of any OPTN contractor(s), which would be a meaningful step towards mitigating both real and perceived conflicts of interests. (As a point of context, HRSA attempted to mandate this separation as far back as 2018, which UNOS fought vigorously against — including filing an unsuccessful protest with the Government Accountability Office.)

Further, all OPTN board members should be required to publicly disclose all financial interests in or with any organization(s) which, in any way, would be influenced by the outcome of OPTN policies (e.g., financial relationships with medical device companies; tissue processors; consultancies; or aviation companies).

There has been a lot of misinformation peddled by opponents of reform related to the recent Congressional legislation and the OPTN Modernization Initiative. Contrary to industry fearmongering, for-profit companies will not be able to create self-benefitting policies, and the system itself is not being “privatized.” What both the legislation and the Modernization Initiative enable is competition in patients’ interest, and an end to an almost 40 year monopoly on controlling the U.S. organ donation system.

The best way to address the real concerns regarding the influence of profiteering interests in national organ donation policy — as are currently being investigated by the Senate Finance Committee in its September 5th, 2023 oversight letters to 8 OPO CEOs) — is to remove both structural and financial conflicts of interests through:

1) Separating the OPTN board from the boards of any OPTN contractor(s);

2) Openly publishing of all financial interests for all OPTN board members in all entities with any financial stake in OPTN policymaking; and

3) Moving to a HRSA-appointed OPTN board, rather than an industry-elected board, in line with other national policymaking bodies.

In addition to prohibiting members of the OPTN Board of Directors from serving as an employee of, or serving on the Board of Directors of, any organization contracted to support the OPTN, also requiring a cooling off period similar to federal ethics rules whereby individuals who had a fiduciary or financial relationship with any OPTN contractor could not serve on the OPTN board a minimum of one year.

Additionally, and especially in light of recent revelations of a federal — and potentially criminal — investigation into the organ procurement industry, HRSA would be best served by allowing law firms with expertise in corporate governance to compete for the OPTN Board Support contract.

Respectfully submitted,

Greg Segal

Organize, CEO

Note: The industry lobbying line that recent reforms will allow for-profits to take over policymaking activities and engage in profiteering activities is complete nonsense, and is in no way possible given existing regulatory and statutory constraints which no one has proposed changing. All that will change is that HRSA will have a larger pool of potential competent bidders to perform various functions (e.g., technology, logistics, and data analysis), which will also help guard against the vendor lock-in dynamic that entrenched UNOS for decades to the detriment of patients.

In fact, such recent reforms actually further strengthen the government’s leverage in holding its contractors accountable, including specifically to combat any inappropriate behavior or profiteering activity. (As ever, and counter to some industry-fueled misinformation, the National Organ Transplant Act, NOTA, explicitly prohibits the receipt of “valuable consideration” in exchange for a human organ; this has not changed.)

As a related fact-check, Organize, a mission-driven, non-profit patient advocacy organization, is not involved in any attempts to win any OPTN contracts, nor does Organize financially profit in any way from any organ donation reforms. Repeated industry suggestions to the contrary are categorically false.

American Society of Transplantation | 03/13/2024

The American Society of Transplantation (AST) supports the OPTN bylaw change proposed in, “Proposal to Address the Relationship of the OPTN and OPTN Contractor Boards.”

Society of Pediatric Liver Transplantation | 03/13/2024

The Society of Pediatric Liver Transplantation (SPLIT) appreciates the opportunity to comment on the relationship between the OPTN board and OPTN contractor boards. We see the purpose of – and are generally supportive of – creating an OPTN Board of Directors that is independent from the contractors
However, we are concerned about lack of liability protection for OPTN Board Members. Without this, the board would only be able to serve in a purely advisory role, or risk being sued personally. This is most concerning for the safety/feasibility that parents, patients and others that may not have institutional or organizational “backing” in their role as a transplant professional, but also for transplant professionals particularly those representing smaller, lower-resourced populations like pediatrics.

These plans seem somewhat incomplete, not only from the indemnity aspects but we do not see details about how the OPTN Board will be administered and financed separate from the contractors. Also, will the prohibition of members of the OPTN Board serving in meaningful positions for contractors just apply while they are active with the contractor or will it apply for some time after the individual has stopped working with the contractor? Will the prohibition also apply to individuals working with SRTR? We also question the HRSA proposal to hold special elections to replace current Board members – the rationale for this remains unclear and is different from what was previously proposed.

We also question the HRSA proposal to hold special elections to replace current Board members – the rationale for this remains unclear and is different from what was previously proposed. There are no details on who would vote in this election. With so much unknown, replacing an entire board during time of transition significantly risks disruption to our transplant system and ultimately risks the lives of our patients.

Riki Graves | 03/13/2024

The insinuation that the current Board is conflicted misrepresents the time and dedication many of these volunteer members have given to the transplant community. While separation of the contractor board and OPTN board is warranted, the timing of this proposal without any real plan to protect the board members legally, is a mistake.

I participated in a regional meeting where HRSA was questioned on the OPTN Modernization Initiative and no thoughtful answers were given regarding this issue and their proposed strategy initiatives. My concern is that the current board members may resign if they are not legally protected after the board split.

The Executive Director role being exempt from serving as an employee of a contractor or on a contractor's board seems to be an extreme conflict of interest, especially if the ED is a voting member of the board. This further proves that HRSA has not fully thought out this process and needs to take a step back to review the public's comments on this policy proposal.

American Society of Nephrology | 03/13/2024

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National Kidney Foundation | 03/13/2024

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Beth Bartlett | 03/13/2024

I'm writing as a heart transplant recipient.

I'm concerned about the Board's plan to change the by-laws and separate the OPTN and UNOS boards by March 29, which could threaten the stability and governance of the transplant system.

Without protocols in place for oversight, coordination, and communication between the OPTN Board and UNOS, separation is likely to impact the governance and smooth functioning of the OPTN. It is important the separating these two should not take place until a system for oversight, coordination and communication is firmly in place.

In addition, there are concerns about liability. As things currently stand, separation will unnecessarily result in OPTN Board members and committee volunteers losing liability insurance coverage they currently receive from UNOS, leaving them open to lawsuits. Some Board members and volunteers have said they are likely to resign as a result which could destabilize the OPTN.

Instead of rushing to separate the Boards which puts volunteers at risk of potential lawsuits for their actions on behalf of OPTN and is likely to result in disruptive resignations, the Board members should work to bring the negotiations to extend the UNOS contract to fruition and then develop a plan for an orderly separation of the Boards that includes another source of insurance to protect OPTN Board members and committee volunteers from liability.

Thank you.

Joseph Hillenburg | 03/12/2024

What problem are we trying to solve here? Nearly everyone who serves on the OPTN and UNOS Boards does so to serve the OPTN, not UNOS. Therefore, the answer is not to:

* Dismiss the entire board just because you claim they are "conflicted," despite the fact that UNOS (or even the OPTN) has never compensated them. This is doubly true for P&DA reps from outside the industry.

* Appoint a political lackey from outside the community to serve as the executive.

* Deny the OPTN board legal protections.

* Create a new board or executive at the behest of for-profit actors who are shielded behind the guise of being non-profit.

* Continue this process in any way behind closed doors.

* Rush a solution before presenting the community with a solid transition plan. As has been stated by HRSA at regional meetings, they do not yet have a plan. No should be set before the plan is presented to the community.

The foremost danger here is not that transplantation will stop if the Boards are separated prematurely. It is that no emergency actions can be taken because the members will fear the consequences of doing so. History has shown that the legal perils are real, as there are some who would rather enact change to the OPTN in the courts rather than through deliberation.

Do this correctly, carefully, and with consensus.

Amber Hildreth | 03/12/2024

As a pediatric transplant hepatologist, I appreciate the opportunity to comment on this proposal. I am in favor of a separation of the boards, but am not in favor of doing so immediately. Our transplant system is in a vulnerable state of transition, and I fear we risk harm to our patients by making too many changes at one time.

In addition, I am personally offended by some of the comments written alluding to the corrupt nature of the OPTN board. As a transplant physician, my whole-hearted goal is to provide care and advocate for my pediatric patients. This goal is shared by many of my colleagues who currently volunteer their time to serve on the OPTN board. OPTN board members should continue to be elected by the transplant community, not appointed by the government.

Finally, I agree with other's comments that the OPTN board should be an incorporated entity, providing legal protection to all board members who are volunteering their time to serve out transplant community.

Leanne Cook | 03/12/2024

The government is not requiring separation of the UNOS and OPTN Boards by March 29.

While the UNOS contract expires on March 29, the government is negotiating with UNOS to extend the contract to insure that there will be no disruption to the transplant system while the modernization plan is being implemented.

The Board is proposing to separate the OPTN Board now while UNOS still maintains its role in overseeing all the operations of the OPTN. There are no protocols in place for oversight, coordination and communication between a separate OPTN Board and UNOS. Separation is, therefore, likely to negatively impact the governance and smooth functioning of the OPTN. The separation should, therefore, not take place until a system for oversight, coordination and communication is firmly in place.

As things currently stand, separation will unnecessarily result in OPTN Board members and committee volunteers losing liability insurance coverage they currently receive from UNOS. Members of the OPTN Board have acknowledged this.

Volunteers will have potential exposure to lawsuits without any indemnification or insurance.

Some Board members and volunteers have said they are likely to resign as a result which could destabilize the OPTN.

Instead of rushing to separate the Boards which puts volunteers at risk of potential lawsuits for their actions on behalf of OPTN and is likely to result in disruptive resignations, the Board members should work to bring the negotiations to extend the UNOS contract to fruition and then develop a plan for an orderly separation of the Boards that includes another source of insurance to protect OPTN Board members and committee volunteers from liability.

Mary Anne Razim-FitzSimons | 03/12/2024

I support the separation of the OPTN and UNOS boards. My concern right now is that although the UNOS contract expires on March 29th, all the mechanisms for a smooth transition, including protocols for coordination, communication, and oversight between a separate OPTN board and UNOS, are not yet in place. Forcing the separation on a specific date, regardless of whether all the pieces for a successful separation are in place, risks the stability of the transplant system. The potential resignation of some board members and volunteers who may otherwise lose liability and indemnification coverage during a premature transition is a major concern. All this could easily add up to a disruption in the smooth provision of organs for those who need lifesaving transplants during the transition period. These risks are agonizingly real for potential transplant recipients, transplant professionals, and donor families.

There are good reasons for separating the two boards - this has already been discussed extensively. But separating the boards prematurely, before all elements are in place for the seamless transition that will achieve the purpose of separating the boards while also protecting patients, transplant professionals, and everyone else involved in the transplant system, risks undermining the benefits that separating the boards is intended to achieve. No one wants that.

My daughter is a transplant recipient, as is one of her close friends (a friendship developed through their shared transplant experience), so this issue is extremely personal to me. Much as I believe the two boards should be separated, no artificial deadline is more important than the lives and health of the people who this system was set up to serve. Let's make sure that all the elements necessary for a smooth transition are up and running before we make changes to a system that affects real lives every day. Thank you.

Association of Organ Procurement Organizations | 03/12/2024

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Luke Preczewski | 03/12/2024

I support the separation of the OPTN and UNOS boards. As with all the coming changes, I strongly urge care in the timing. Much of this process feels rushed, and I am concerned about disrupting the world's most effective transplant system by making changes too hastily, without sufficient safeguards, and without an assessment of potential unintended consequences.

For both the OPTN and UNOS boards, I strongly urge that the new boards include representatives comprising a minority of the board from outside the transplant community with experience in organizational governance. That is the best practice in board structure, as those voices will ask good and tough questions from the outside perspective.

I am an employee of an OPTN member, but my comments are submitted on behalf of myself as a transplant professional, not on behalf of my employer nor any other organization.

American Society of Transplant Surgeons | 03/12/2024

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Gift of Life Michigan | 03/11/2024

We support the proposed change and urge a seamless transition to an independent board with a sole focus of optimal functioning of the OPTN consistent with the best interests of patients and donor families. Clear expectations, delineation of roles, and legal protection, for all board members should also occur.

North American Transplant Coordinators Organization | 03/11/2024

NATCO strongly supports the concept of avoiding conflict of interest in governance of the OPTN. This proposal, to separate the Board of Directors of the OPTN from the Board of Directors or employees of any contractor, may serve to reduce the appearance of any conflicts of interests, and will align the OPTN Bylaws with HRSA's stated objectives in their OPTN Modernization Initiative to create an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight. However, it stops short of addressing important implications to the individuals of the OPTN Board of Directors charged with overseeing this unique public-private partnership. It stops short of addressing the lack of an entity structure that will provide liability protection for normal business and governance risks. We suggest that this issue is of prime importance in the creation of an independent Board of Directors. Until such time that the establishment of a corporate entity can be assured, NATCO believes it is premature to address alignment of the language within the bylaws.

Diane Ellis | 03/11/2024

I believe the two boards should eventually separate. However, doing so in a rushed manner is defeating the purpose of trying to improve the processes. This would cause many more problems than they would improve. The deadline of March 29 does not impact this separation of boards and hopefully, time will be taken to put good processes in place for a smooth transition.

TRAIPAG | 03/11/2024

The TRAIPAG Steering Committee and I are writing to you regarding the proposed OPTN bylaw change that would require separation of the OPTN Board from the UNOS board. After speaking with both HRSA’s Associate Administrator Dr. Suma Nair and with a board member at UNOS/OPTN, , TRAIPAG opposes this change for the reasons identified below.

This hasty change could threaten the stability of the entire transplant system and its governance.

The government is not requiring separation of the UNOS and OPTN Boards by March 29.

While the UNOS contract expires on March 29, the government is negotiating with UNOS to extend the contract to insure that there will be no disruption to the transplant system while the modernization plan is being implemented.

The Board is proposing to separate the OPTN Board now while UNOS still maintains its role in overseeing all the operations of the OPTN. There are no protocols in place for oversight, coordination and communication between a separate OPTN Board and UNOS. Separation is, therefore, likely to negatively impact the governance and smooth functioning of the OPTN. The separation should, therefore, not take place until a system for oversight, coordination and communication is firmly in place.

As things currently stand, separation will unnecessarily result in OPTN Board members and committee volunteers losing liability insurance coverage they currently receive from UNOS. Members of the OPTN Board have acknowledged this.

Volunteers will have potential exposure to lawsuits without any indemnification or insurance.

Some Board members and volunteers have said they are likely to resign as a result which could destabilize the OPTN.

Instead of rushing to separate the Boards which puts volunteers at risk of potential lawsuits for their actions on behalf of OPTN and is likely to result in disruptive resignations, the Board members should work to bring the negotiations to extend the UNOS contract to fruition and then develop a plan for an orderly separation of the Boards that includes another source of insurance to protect OPTN Board members and committee volunteers from liability.

Jef Kinney | 03/10/2024

I am a kidney transplant recipient from a living donor. My donor, and the transplant process, literally saved my life. For this I am forever grateful. I also support modernization of the system; however, I worry that the current proposed timeframe for some items may endanger the smooth running of the process and cause a disruption that would negatively impact transplantation and potential recipient lives.

Specifically the proposed by-law changes that would separate the UNOS/OPTN board(s) by March 29th seems premature and has the potential to impact donors, recipients and the OPTN Board and volunteers. The separation, as I understand, of the two boards will remove the insurance coverage currently provided to OPTN Board members and committee volunteers such that they will have personal exposure to lawsuits. If this comes to fruition I have head from volunteers that they will have no choice but to resign in order to mitigate potential legal exposure. It would seem prudent to push back the March 29 date for separation until an orderly, well-communicated plan can be developed and implements to ensure that there are no gaps in insurance coverage or other critical functions.

Thank you for your consideration.

Transplant Recipients and Immunocompromised Patient Advocacy Group (TRAIPAG) | 03/10/2024

Transplant Recipients and Immunocompromised Patient Advocacy Group (TRAIPAG) strongly opposes this bylaw change because making this change at this point in time will be disruptive to the continued smooth functioning of the nation’s transplant infrastructure. TRAIPAG fully supports the modernization effort, but believes the creation of separate OPTN and UNOS boards must be done in a thoughtful, deliberate manner. There is no reason, statutory or otherwise, that the boards of UNOS and OPTN must be separated on the date of the UNOS contract expiration.

Contract extension discussions are underway between UNOS/OPTN and HRSA. We believe both parties should work diligently and in good faith to extend the contract. With an extension, UNOS can continue to provide liability insurance and operating and legal support to the OPTN board and its many volunteers who are critical to the functioning of the network. Separation can take place at a later date after arrangements are made to provide liability insurance and support to an independent OPTN board and the OPTN volunteers. Foremost is to ensure that patients come first and that there be no disruption to the organ transplant infrastructure during the transition to the new structure and contractors which will likely result from the modernization process.

Laura Burns | 03/09/2024

If you want to disrupt the transplant system, this premature separation of the boards might do so. If you don’t want to disrupt the transplant system, separate the boards at such time as the new system is being activated.

I received a bilateral lung transplant in 2016 and was helped enormously throughout the process by volunteers. I was so impressed by Darnell Wuan, who was on the Patient Affairs Committee, that I myself have been considering volunteering as my way of paying back. However, a separation of of the boards before a smooth, functioning transition is in place gives me pause, especially as volunteers would lose the liability insurance coverage and indemnification they currently receive from UNOS. If this by-law takes effect March 29, I very definitely will not be volunteering.

Donna Kaiser | 03/09/2024

Transplantation saves lives. The processes, policies, and entire system that provides the magical 'gift of life' must be protected to ensure the system continues to function smoothly to continue to save lives before, during, and after this transition. Patient's lives must be prioritized and no aspect of the transplantation engine must suffer while policies, procedures,and a more robust governance are established. Thoughtful coordinated action to provide a more robust framework in the future can be performed all the while keeping the current system intact and functioning in a parallel effort.

Adding a rushed deadlines for a transition where the plan has not been fully and openly communicated and vetted may distrupt the current system, leading to endangering lives. This should never happen. People's lives must be prioritized above all with smoothly operating system. In addition, volunteer board members must be protected from adverse legal action throughout their voluntary service- these folks generously donate their time, energy, and passion to support transplantation and should have liability insurance or immunity.

Do the right thing for patients, families, donors allowing 'the gift of life' transplantation system to continue without abrupt disruption, and in parallel communicate thoughtful planning activities and solicit feedback for establishing a better more robust governance system in the future.

Any adverse outcome from rushed activities with inadequate planning will likely disrupt the transplant system leading to poor outcomes for patients, which can also add negativity to the public perception regarding donation. Donation saves lives; please protect and enhance our transplantation system so that more lives- not fewer- can be saved.

Thank-you for your time and consideration.

Anonymous | 03/09/2024

I am in favor of creating a separate board structure, but strongly oppose HRSA's plan to include board members who are not part of the transplant community. Without the insight and experience of individuals who understand the complex challenges of the transplant journey (this including patient and donor representation), we will lose crucial knowledge and “best in class” expertise which is essential for the safety and well-being of patients.

Anonymous | 03/09/2024

This may be a good change in the long run, but it is being done too quickly without comprehensive and careful planning. The danger is critical to the many individuals for whom the US transplant system is the only source of, literally, the ability to continue to live and not die. Congressional hearings already exposed weak areas in our transplant system, and changes are needed. However, changes among the Boards of OPTN and its contractor Boards should be undertaken with careful planning taking into account exactly how the transition will occur - spelled out in detail.

For example, the proposal does not fully define the relationships of the new board and OPTN, nor does it contain a meaningful system for oversight of the newly separated board. Detailed plans should be in place for the working relationship and authorities between the two boards, necessary and/or required coordination, responsibility overlap or oversight, coordination of decisionmaking, criteria (if any) for membership, and minimum protection (such as payment of expenses, member insurance and the like) should all be spelled out and open for stakeholder comment.

Other feedback here indicates that there is no U.S. government regulatory requirement for board separation by the 29th, so I oppose it until there is adequate time for thorough planning, stakeholder comment and a fair process for final decisionmaking on how this will work.

Transplant Families | 03/09/2024

Although we support HRSA's stated objectives in their OPTN Modernization Initiative to "creat[e] an OPTN Board of Directors independent from other OPTN contractors to strengthen accountability and oversight," we encourage HRSA to take this one step further and create a pathway for the OPTN to be its own incorporated structure, separate of the contractor. This would create a space for a truly autonomous and empowered board of dedicated transplant advocates, patients, families, donors, clinicians, and OPOs, and pave the way for an educated and experienced electorate to help guide future contractor(s). We urge HRSA to make this pathway an urgent priority because there is currently a gap in legal indemnification for the current dedicated board and committee members. As these member are volunteers, this would leave them open to legal risk if they do not have Director and Officers liability insurance OR legal protections that would be afforded to them as an independent entity. In cases, these are members of the general public who receive no compensation for any of their service to the transplantation community. We consider this omission to be a gross oversight.

In addition, we are deeply offended by comments made elsewhere in this forum which insinuate that OPTN Board members are conflicted their duties. Patient/donor representatives, in particular, are typically uncompensated and often spend their own money to advance the cause of donation and transplantation.

Furthermore, although we as the OPTN have historically had the Executive Director also serve the same role with the contractor, we find it interesting that there is such a call for separation. Yet, the future role of Executive Director is very nebulous and could be from a separate contractor that could change often and would be the de facto leader of the reimagined OPTN.

Patients and families rightfully demand that there continue to be continuity of care in our transplant healthcare system. Lives are at stake.

Anonymous | 03/08/2024

OPTN should stay attached to UNOS. UNOS is currently in a renewal phase. The relationship should not change until the renewal is over and a plan to continue to support OPTN is in place.

Kenny Laferriere | 03/08/2024

I understand the desire to remove any potential or perceived conflicts, but it does not seem appropriate to be separating the Board during this time of uncertainty. There is so much anxiety about all the changes from HRSA that is bringing great concern to patients and their families. It appears that there is a rush to separate the Board without thinking about the immediate impact and possible disruption of the current system. Additionally, how do we know that separation of the Boards is the right thing to do?

In my opinion, the community and HRSA need to better understand the changes that are coming as directives of HRSA so all aspects are considered to ensure continuity of donation and transplant. The members of the community with the expertise must to be a part of the modernization effort process. It is these people that have contributed to the success of the current system - which I might add has a proven track record of increases in both donors and transplants for 13 years in a row. I cannot understand the reasoning to charge full steam ahead with all these changes without due process.

Let's be smart about this and work collaboratively to ensure we get this right. No one is saying we don't want to improve, but I ask what is the harm in reviewing the proposals HRSA is bringing forward first and then establishing a strategic plan to coordinate all the changes in a well defined and transparent method? It is always better to get it right the first time, then have to rehash the process again to correct any negative effects resulting from the expedited changes.

The members of the OPTN have the responsibility of ensuring any changes/improvements will actually lead to an increase in number of transplants. This isn't something that we can trial to "see what works" because if we get this wrong, it will have devastating consequences for the lives of the patients that we serve.

Global Liver Institute | 03/08/2024

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View attachment from Global Liver Institute

Leora Herrmann | 03/08/2024

Several members of my chosen family are transplant recipients. I strongly oppose this by-law. Although I also strongly support the eventual separation of the OPTN and UNOS boards, this should not be done now. Separation needs to be done in an orderly and thoughtful fashion and not rushed into effect by March 29.

The government’s modernization plan will require that the OPTN Board be separate from any contractor’s Board, but there is no legal requirement that the OPTN and UNOS Boards separate by March 29. This date appears to have been selected by the Board because it is when the current UNOS contract expires. But this is not a reason to separate the Boards on that date. The government and UNOS are negotiating an extension of the UNOS contract so the transplant system can continue to function as the modernization plan called for by Congress is implemented and a smooth transition is made.

Members of the OPTN Board themselves have pointed out that separation on March 29 will leave OPTN Board members and committee volunteers without any protection from legal liability for their actions on behalf of the OPTN – a serious concern in light of prior litigation – because they will lose the liability insurance coverage and indemnification they currently receive from UNOS. Some OPTN Board members and committee members have said they will resign if they lose this insurance coverage. The members of the OPTN and UNOS Boards are the very same people. By choosing to separate into two separate Boards by March 29, they are unnecessarily placing those who remain on the OPTN Board and all OPTN volunteer committee members in jeopardy and causing many to consider resignation from their positions.

In addition, before the OPTN and UNOS Boards can be separated, it is essential that policies and procedures be put into place to ensure adequate communication and coordination between an independent OPTN Board and UNOS during the contract extension period. To suddenly separate the Boards before carefully considering and crafting these policies and procedures will negatively impact the governance and smooth functioning of the transplant system.

Instead of rushing to separate, I believe the members of the UNOS/OPTN Boards should support the contract extension negotiations between the government and UNOS and work to bring them to a conclusion. At a later date, an orderly separation of the Boards can take place that includes policies and procedures to guarantee adequate coordination and communication between the independent OPTN Board and UNOS as well as liability insurance for OPTN Board and committee members.

Fred Kolkhorst | 03/07/2024

The UNOS contract is obviously going to be extended as it will take significant time to have the new contractors in place and operational. Picking an arbitrary date in a few weeks when the current UNOS contract expires appears disruptive and inappropriate.

Patty Adair | 03/06/2024

Please ensure that the system continues to provide transplants to save lives without any interruption or disruption throughout the transition. Please also establish metrics to provide visibility to allow a smooth transition of operations.
Thank you.

Rebecca Baranoff | 03/05/2024

I support the idea of a separate board EXCEPT I disagree with HRSA's idea of having board members who are not associated with the transplant community. Without having individuals who are aware of the trials and tribulations of the transplant process, the patients and the national system we are at risk for losing vital information and expertise. And it feels unlikely we will have a smooth transition and no interruption for the patients who are currently waiting their life-saving organs

Nancy Marlin | 02/28/2024

The plan that was shared earlier included establishing OPTN as a separate legal corporation, which seems like a necessary first step. Has that been done?

Steven Weitzen | 02/28/2024

I have the following comments:

1. I may be reading the language of the bylaw amendment incorrectly – apologies, if so – but the new language seems incomplete or garbled. Perhaps the end portion is intended to read more along the lines of “no member of the OPTN Board of Directors can be an employee of, or serve on the Board of Directors of, any organization which is awarded or granted contracts or cooperative agreements to support the OPTN”? Whatever the case, unless I am misreading the new language, a modification of the new language would seem to be appropriate.
2. I believe this bylaw amendment is premature. We have been told for quite some time – and MANY times -- after the Modernization Initiative was enacted that there would be a smooth transition and that no organs or patients would be affected. It seems that this proposed bylaw amendment should not be happening until such time as the new and revised organ transplant system is in place and stable. As of right now, there is only a draft RFP for the organization of a new OPTN and committee system. Because of this, it would appear that the final RFP and the finalization of the contract thereunder would not occur for at least many months – if not longer.

That being said, if the proposed amendment were finalized, we would have the OPTN and UNOS boards separate, a contract to soon expire for UNOS which would leave OPTN as an unincorporated association without the protection of UNOS (UNOS, I have been told, is an entity which has provided insurance protection to the Boards of each of UNOS and OPTN and the volunteers of OPTN) and seemingly no support for OPTN by any governmental or other body – therefore, leaving the volunteer members of OPTN without any security, since the UNOS insurance support would be gone.

With no insurance, you may have a mass exodus of volunteers of OPTN. Without the framework of OPTN in place with its volunteers – including its volunteer Board – would the organ transplant system be able to function?

Now, I am TOTALLY in support of separate OPTN and UNOS Boards, but why don’t we delay this bylaw amendment and keep UNOS and OPTN together until such time as we have a new system in place that is stable? Were we not promised a smooth transition?
A system where many members (if not all) of the OPTN Board resigns and where there is a similar reaction by the hundreds of OPTN volunteers (i.e., including members of OPTN committees) would not seem wise or stable. This could help bring about the collapse of the organ transplant system.

Therefore, I would oppose this bylaw amendment until such time as there is stability in the organ transplant system pursuant to the Modernization Initiative that we have been promised.