The OPTN policy development process incorporates public comment feedback on policy and bylaws proposals before they go to the OPTN board of directors for approval. The public comment process occurs twice each year.

The Legislative and Regulatory Affairs Committee (LRAC) reviewed the policy proposals and decided that it was appropriate for AOPO to comment on the policy proposals listed below. A subgroup of the LRAC drafted the comments.

Proposed policy comments:

The Association of Organ Procurement Organizations (AOPO) supports any policy changes that decrease the risk to transplant the precious gift of a human organ. In May of 2021 the Organ Procurement and Transplantation Network (OPTN) implemented an emergency order to require nucleic acid testing (NAT) on lower respiratory specimens for all lung donors. The members of AOPO quickly adapted and implemented this change. We are in support of this policy change being made permanent because it clarifies the definition of a lower respiratory specimen and requires the results of the NAT to be available before donated lungs are transplanted. This would support the ongoing efforts of every Organ Procurement Organization (OPO) to provide recipients a successful second chance at life.

AOPO supports DTAC’s proposal to add fields in DonorNet and the Deceased Donor Registration (DDR) to better track donor risk criteria for HIV, HBV, and HCV. This proposal increases efficiency and standardizes documentation of critical information by eliminating the need to document PHS risk criteria in various open test fields and relying solely on attaching criteria to the donor record.

AOPO recognizes the importance of clear definitions when collecting data and is supportive of the proposed guidance regarding the classification of citizenship status. The primary focus of this data collection is to enable an analysis of transplant tourism as identified through trends in citizenship, residency, and country of origin for patients seeking care for transplantation in the United States. Collecting such data for deceased donors does not carry the same potential ethical concerns nor implicate transplant tourism in the same manner as compared to living donors or recipients and thus, the same specificity and verification of data collection for deceased donors is not needed. Due to the sensitive nature of information related to immigration status, particularly at the time of family donation conversations, it is highly likely that information on deceased donors that are non-citizen residents is underreported. Asking donor families a question on citizenship or residency status could create a barrier to donation that negatively impacts donation authorization.

In addition, we would caution that any analysis examining rates of non-citizen resident (NCR) and non-citizen nonresident (NCNR) transplant for equivalency with NCR/NCNR donation should recognize that each deceased donor on average provides 3 organs for transplant so the impact on the overall pool of available organs is triple the number of NCR and NCNR donors. Any inevitable analysis that compares deceased donor citizenship or residency with transplant recipient citizenship or residency should recognize these differences.

The guidance recommends that OPOs obtain the country of origin and the date of entry into the U.S for deceased donors that are non-citizens. The guidance also recommends OPOs understand source documentation and verification processes of citizenship status. These recommendations are problematic given the context under which OPOs are interacting with donor families and is not necessary to support the goals of this data collection. Date of entrance to the US, while important in transplant candidate evaluation, is immaterial from a deceased donation perspective and does not contribute to an understanding of transplant tourism. AOPO recommends data collection be limited to the country of origin for deceased donors and that the guidance eliminate any reference to OPOs checking source documentation or verifying citizenship status of deceased donors. AOPO also recommends that the guidance clarify use of the term “donor” in the document which is used interchangeably to indicate living donors and deceased donors. There are very different considerations for living versus deceased donors related to this guidance and the data collection.

AOPO appreciates the opportunity to comment on the update to the concept document for implementation of continuous distribution for kidney and pancreas allocation. We continue to support this framework as an effective way to incorporate and balance multiple medical and efficiency-based factors in a manner that is patient-focused. Continuous distribution will also provide future flexibility by allowing the OPTN to be responsive in its ability to adjust and change the relative rating of variables over time as organ distribution evolves.

AOPO strongly urges the OPTN to consider all relevant factors when developing components of the allocation score for kidney and pancreas allocation. AOPO appreciates the ability to participate in the policy development process and views the ultimate goal of this work as ensuring fair distribution of available organs while maximizing transplantation for the patients most in need.

Finally, AOPO would like to stress the importance of the OPTN continuing its work through the identified strategic policy priority to develop and implement policies, process, and systemwide tools designed to improve the efficiency of the matching process. This work towards a more efficient system is crucial to support the full value of any allocation framework by facilitating maximum utilization of transplantable organs.

AOPO congratulates the Lung Committee on its work and development of this groundbreaking proposal to implement continuous distribution for the allocation of lungs. As stated in its previous comment to the concept document, AOPO views the continuous distribution framework as an effective way to incorporate and balance multiple medical and efficiency-based factors in a patient-focused manner. Continuous distribution will also provide future flexibility by allowing the OPTN to be more nimble in its ability to adjust and change the relative weighting of attributes over time as conditions for organ distribution evolve. AOPO will focus its response on the following questions posed by the Committee.

    • Should waitlist survival and post-transplant outcomes be equally weighted, or should waitlist survival receive twice as much weight as post-transplant outcomes?

AOPO supports the proposal’s assignment of a one-to-one weighting for waitlist and post-transplant survival. As reported by the Committee, this weighting maximizes both patient survival on the waitlist and survival post-transplant. AOPO believes this outcome, aligned with maximizing the ethical principle of utility, should be imperative in lung allocation. The allocation system should be designed in a manner that clearly reflects good stewardship. From the OPO’s perspective, one of the most important outcomes for donor families is for gifted organs to save lives. The proposed weighting prioritizes this outcome – lives saved – to the extent the data modeling is predictively accurate. This is an analysis that should be reviewed critically post-implementation and adjusted if needed. Importantly, we recognize that these two attributes are assigned 50% of the total available points in the composite allocation score (CAS). As a result, equity and efficiency factors are combined with this utility calculation to support a balanced allocation framework.

    • Is 10% the correct weight for efficiency with a 1 to 1 on travel and proximity?

AOPO agrees with the proposal’s incorporation of efficiency attributes to ensure “smarter” distribution by distributing organs over further distances with increased costs and lower efficiencies only for significant clinical differences. Specifically, AOPO supports the travel efficiency measure with assignment of maximum points for travel within 45nm and a steep decline thereafter where travel of lungs will likely be by air. The proximity factors use the same inflection point (45nm) but a different shape curve recognizing that efficiency gains are modest at a point once flights are involved until very significant distances/time is involved.

However, AOPO urges the Committee to consider whether both travel and proximity are needed in the CAS. Because the travel score, although designed to be a proxy for costs, is directly tied to distance, proximity is already factored into the travel attribute. The travel and proximity curves are most notably different at long distances (over 1000nm) and are very similar at 0-90nm. Travel time, if and when it could be accurately calculated, would be a better paired attribute with travel distance to deliver both cost and other efficiency proxy factors. If the Committee does not want to combine travel and proximity attributes, AOPO would suggest a more significant percent of the available points be assigned for travel over proximity.

AOPO also recommends the Committee consider how donor factors impact the efficiency calculation. Longer travel times combined with clinically complex donor organs will create different behaviors (turn downs) as compared to longer travel times with less complex donor organs. To that end, we urge the Committee to consider future incorporation of an attribute related to ex vivo devices that are rapidly improving the ability to utilize previously non transplantable lungs and are changing the ability for lungs to travel long distances.

The overall 10% weighting for efficiency is a reasonable starting point, although AOPO suggests that the Committee ensure that this weighting does not contribute to geographic disparities in candidate access to lung transplant that the system is working to eliminate. We also want to ensure that the weighting is significant enough to support the efficient management of the system and avoid wastage which could result if organs are crossing other organs in the air without delivering meaningful clinically different outcomes for lung candidates as measured at the system level.

    • Multi-Organ: Does the proposal need to be adjusted to allow OPOs more discretion to offer from the heart list before offering the heart to candidates in need on the lung list who have a composite allocation score of at least 28?

AOPO supports language that provides OPOs more discretion in allocation in general, and in particular, in the early implementation of continuous distribution. Providing OPOs discretion to allocate from the heart list before allocating from the lung list for patients with composite allocation scores of 28 will allow OPOs to address circumstances unique to donor situations that may arise. While the committee has done an admirable job of attempting to factor in all variables that might impact the relative priorities of the two lists, logistical challenges or unique circumstances will arise in which OPO discretion will be essential to maximize the benefit of donated organs. For example, OPOs may be faced with a deadline for recovery while simultaneously facing clinical circumstances requiring significant lung “recruitment” in donor management. In such a circumstance, because the heart team usually requires time to mobilize a team to perform the heart recovery, delaying heart placement while attempting to improve lung function could result in the heart not being utilized.

AOPO appreciates the opportunity to provide input on the Regional Review Project and agrees that now is the right time to review the definition and purpose of the OPTN regions and how they factor into other OPTN structures including Board membership, Committee membership, public comment review and best practice sharing. AOPO believes that there are elements of each model as described in the study that could be combined to best support the goals of different organizing functions. For example, for best practice sharing, communities of common interest could be most effectively leveraged to ensure that types of members have an opportunity to interact collectively beyond geographic boundaries. This may also be productive and important for some types of policy and public comment review. For example, OPOs would benefit from having a collective opportunity to review OPTN policy proposals that directly impact OPOs rather than the current structure, where OPOs comprise a minority number of the OPTN membership in each Region and, therefore, the discussion of such polices through regional structures maybe less robust.

AOPO urges the OPTN to consider whether it would be valuable to have certain types of policy proposals reviewed both in units organized by community of practice as well as through geographic units. For example, some of the efficient matching policy proposals would benefit from regional review as the units of members that will be working together most frequently to implement these policies, as well as review by communities of common interest such as OPOs, transplant administrators, etc., that would provide a focused perspective. For other types of policy proposals, it may make the most sense to only have communities of practice review, such as Histo- compatibility tables reviewed by Histo programs or VCA program requirements reviewed by VCA Program members. And yet, for other policy proposals, the review might be most valuable through geographic regional structures (such as policy proposals involving geographic components that will impact a geographic area in a collective manner).

As for how the geographic regions are defined, AOPO recognizes that currently the regions are not drawn in a consistent manner as to size whether measured by population, number of OPTN members, number of waitlist candidates, or volume of donors or transplants. This should be considered and perhaps re-defined for more equitable representation of members to the extent geographic units continue to be utilized as the basis for representation on the Board and Committees, which AOPO supports maintaining at this time. While we recognize that alternative governance models could be effective, AOPO recommends that such discussion be deferred into the future after full implementation of the continuous distribution framework at which time members may be more comfortable considering a non-geographic based governance and committee structure model. In the interim, the OPTN could consider organizing regional units in a more equitable manner as identified above, as well as in a manner better aligned with current organ distribution (250nm circles) – however recognizing that overlapping areas make it difficult to accomplish. Alternatively, OPTN members could be invited to join more than one region for purposes of policy review meetings and best practices.

AOPO recommends that the OPTN be careful to retain those components of the system that are currently functioning well, including the use of hybrid representation on Committees and the structure of the Policy Oversight Committee with representational membership from each Committee, to ensure the ability to effectively coordinate policy development systemwide. AOPO recommends that the OPTN approach any changes to the use and definition of regional units in a manner that ensures increased equity for all OPTN member types, facilitates increased options for more focused input and collaborative participation, and minimizes stakeholder disruption.

AOPO supports the Heart Transplantation Committee proposal to clarify status requirements to eliminate questions raised by transplant programs. This proposal aims to eliminate gaps and inconsistencies in listing criteria which is essential to allocating organs in a fair and trustworthy manner.

AOPO is in favor of any policy that ensures the equitable allocation of life-saving organs to all potential transplant recipients, regardless of their ethnicity. The use of Glomerular Filtration Rate (GFR) is a key tool in the evaluation of when a patient should be placed on the renal transplant waiting list. While there are several methods of measuring a patients GFR, the test utilized should not provide results influenced by the potential recipient’s ethnicity.

AOPO supports the new data elements proposed by the Operations and Safety Committee. Organ check-out, Organ check-in, and time of first anastomosis are good markers to evaluate transportation logistics and to inform future policy development. AOPO applauds the committee’s commitment to data collection efficiency with the modification or elimination of some data elements and Organ Not Recovered Codes.

AOPO supports the Ethics Committee’s work in the Ethical Considerations in Continuous Distribution and recognizes the value of this document as a tool to assist the OPTN Board and Committees in developing and evaluating factors in continuous distribution (CD) framework in a manner that ensures alignment with the ethical principles of organ allocation. AOPO agrees that CD as a points-based framework has the potential to better facilitate the balancing of ethical principles at both the patient and systemwide level as compared to the prior classification system with hard boundaries.

AOPO understands the use of the Lung Committee’s work as illustrative of how the delineation of factors and weighting can be accomplished under CD consistent with ethical considerations. However, AOPO suggests that some of the sections be revised to be less descriptive of the Lung Committee’s work and rather use examples from the Lung Committee to support the discussion of how CD frameworks should be developed consistent with ethical principles of allocation. See in particular the following sections: “Changes in the value weights associated with the measurements”, “Addition of New Measures” and “Using Desired Outcomes” which read like a description of what the Lung Committee has done rather than leading with what the concepts/principles are that should be considered and then describing how the Lung Committee approached that work. For example, the addition of new measures section could describe the type of factors that should be considered (height weight, living donor status, etc.) and why (ethical principles that apply like access/equity linked to height) and then describe what the lung Committee did to incorporate those factors into the CD framework. This would improve the paper as a tool in the future as other organ systems transition to CD and as a white paper reference that is more than a contemporary description of current work underway.

AOPO also suggest that the section on Normative Justification be moved to the beginning of the paper as it lays out the ethical requirements for an allocation system and the alignment the CD framework provides. This sets the context for the details to follow such as weights, additional measures and identifying desired outcomes. AOPO appreciates the acknowledgement of the OPO’s role in identifying “the most economical and intelligent decision-making tools when solving the many, and often distinctive, distribution and matching problems which a complex allocation system in a big population of stakeholders precipitates” and agrees that this is an important component to operationalizing the CD allocation framework to deliver on the ethical principles it is designed to achieve. To that end, AOPO would suggest that the document emphasize a responsibility for all members of the system to work together to realize the ethical benefits of the CD framework. The “rules and tools” (so to speak) that transplant programs and OPOs must follow become critical to the ethical analysis because, without them, the system will not be able to deliver for patients the benefits that can be achieved through a CD framework. Finally, AOPO agrees with the point in the section on equity that donation serves all those in need not just those who are close by. We would however suggest that this section misconceives the current environment in reference to a “circle of concern” to the extent that’s a reference to DSA or 250nm. AOPO believes that the greatest wish and priority for deceased donors and their families is that their gift of life will positively impact someone that they do not know but know are in need. There are no boundaries on this priority.

Finally, AOPO appreciates the attention to the anticipated challenges and the need for transitioning to CD in a manner that minimizes disruption to patients, programs, and OPOs and in particular, attention to pragmatic concerns, many of which will fall on OPOs to resolve once CD is implemented. The issue of clinician behavior is one which has already been identified with the 250nm allocation frameworks and OPTN projects to address this (such as mandatory filters, clarification of provisional yes and other tools) are in process, but AOPO would urge the Ethics Committee to reference this work as critical to being able to maximize the ethical benefits that CD could provide (per point made in paragraph above). It is unclear in this section of the document what is being referenced as “outside threats to communication and technological systems” (line 1136) and AOPO would generally suggest revisions to this section as it makes references to terms like “imports” that are not defined in the document and may be confusing to broader readership. This section also seems to conflate expense and logistics which are related but not always directly correlated (for example there is a reference to the cost of shipping however this may or may not be increased through CD on either a systemwide or OPO-specific basis). AOPO would be pleased to offer some edits to this section.

AOPO strongly supports the MPSC’s efforts to enhance the transplant program monitoring systems. The development of transplant programs metrics that better align with the new CMS performance metrics for OPOs will facilitate significant systemwide performance improvement. The timing of the OPTN’s work on this is critical. With the national focus on increasing transplantation through the Kidney Health Initiative and AOPO’s own initiative to achieve 50,000 transplants by 2026, it is important that metrics between all components of the system are developed in a manner that will synergistically generate the most growth possible to serve waiting patients.

AOPO appreciates the attention the MPSC took to define the principles of a metric and agrees with the proposal that these components are essential for a valuable metric: (1) Measures aspects of care that are clearly within the authority of the OPTN; (2) Measures aspects of care that the transplant program can impact; (3) Has a clear desired outcome (3) Does not require collection of new data or development of a new metric; (4) Measures a discrete aspect of transplant care provided by transplant programs; (4) Is risk-adjusted; and (5) Incentivizes behaviors that will increase transplantation. AOPO anticipates future OPTN metrics that may be developed for other members like OPOS will follow these same principles.

AOPO notes that while the transplant rate is not solely within the control of a transplant program, it is also not solely within the control of OPOs, but nonetheless, OPO are accountable to a transplant rate under both the CMS metric and the OPTN yield measures. Multiple factors impact an OPO’s transplant rate that are outside of the OPO’s control such as type of organ donor (DCD v DB), offer acceptance practices of programs, donor conditions unknown at time of organ placement, and ultimately the transplant itself. AOPO suggests that the MPSC reconsider a transplant rate for transplant programs. Transplant rate could potentially be a shared performance metric evaluated for both OPOs and Transplant Programs recognizing that the calculation of such a rate will measure different aspects of the process as between different member types but that nonetheless some sort of aligned and shared accountability is required to result in the desired performance (increased transplants).

The metrics selected by the MPSC in the proposal are supported by AOPO as measuring important and distinct aspect of transplant program patient care: (1) waitlist mortality rate measuring waiting list patient care, (2) offer acceptance rate measuring offer acceptance practices, (3) 90-day post- transplant graft survival measuring peri-operative care, and (4) 1-year post-transplant graft survival conditional on 90-day graft survival measuring post-operative care. The measurement of pre-transplant care through waitlist mortality is particularly important as the system shifts to a patient-centric understanding of risk-benefit which must evaluate the risk to a candidate of receiving an offered organ versus the risk to a candidate of not receiving the organ offered. This paradigm is incredibly important to support through aligned performance metrics if the system is intent on better utilizing the available organ pool which is increasingly from older and medically complex donors. AOPO believes that this measure (waitlist mortality rate) alone has the potential for reducing discards, which at 20% for kidneys is widely recognized as an area the system needs to improve upon to better serve patients.

AOPO is also very supportive of an offer acceptance metric to pair with the waitlist mortality rate to ensure that programs are not evaluating the risk of an offered organ versus the theoretical lower risk of a theoretic organ offer that may come in the future. The system cannot accelerate its growth in transplant without metrics that align with the goal of increasing organ utilization for both OPOs and transplant programs. AOPO also believes the offer acceptance rate metric will incentivize best practices regarding transplant program use of filters which will provide a needed efficiency improvement to organ placement efforts by OPOs. This is particularly urgent in the context of broader distribution and the increasing number of organs being recovered from older and medically complex donors.

AOPO recognizes that development of the specific flagging boundaries and process through the MPSC to improve performance are a critical part of the proposal and defers to transplant program colleagues with statistical expertise to answer some of the specific questions posed in the proposal but stands ready to partner with all transplant programs to align performance to deliver the highest performing system possible.