Update on Lung Continuous Distribution Policy

INFINITE LEGACY COMMENT – UPDATE ON LUNG CONTINUOUS DISTRIBUTION POLICY

Infinite Legacy (IL) appreciates the opportunity to provide comments on the Update on Lung Continuous Distribution Policy and the emergency revisions to the Lung Composite Allocation Score (CAS). Infinite Legacy is supportive of the OPTN’s efforts to improve allocation efficiency and reduce allocation out of sequence (AOOS) rates. However, we offer the following input on several critical aspects of the proposal.

First, IL expresses concern that the primary rationale for changing allocation policy centers on AOOS, rather than on medical status or urgency of deaths on the lung waitlist. Efficiency points should not come at the expense of medical urgency. According to the OPTN Benchmark report, IL has a large distribution of medical urgency points at 10.81% compared to 6.48% nationally. We are concerned that the proportional reduction in waitlist survival and post-transplant outcome weights from 25% to 23.6111% will negatively affect our local lung waitlist patients who rely on those medical urgency considerations.

Second, IL expresses concern that the weights for post-transplant survival were adjusted and decreased for our local lung waitlist patients. According to the OPTN Benchmark report, a snapshot of active lung candidates waiting on March 31, 2026, shows that active lung candidates with post-transplant survival points of less than 20 account for 72.9% of IL's waitlist, compared to 72.08% nationally. These patients stand to be disproportionately impacted by reductions in the weight assigned to post-transplant outcomes.

Third, IL expresses concern that limited modeling exists such that the full impact of this policy change cannot currently be adequately assessed. Modeling is important in policy development so that changes that negatively impact recipients are considered prior to policy implementation, rather than reactively after changes have been made. Initial modeling reported by the Lung Committee showed that some of these changes would increase waitlist mortality. The completed simulations also showed potential risks for Blood group O, short-statured patients, and pediatric patients. Additional analysis on the impact on waitlist mortality in these groups should be considered before full adoption.
IL believes that late or intraoperative declines by transplant centers contribute to AOOS. Accordingly, we recommend that the OPTN add decline codes to capture the frequency and scope of such declines. This data would further identify and guide policy changes that support timely organ acceptance and limit AOOS at its source, rather than solely adjusting the CAS weighting. IL also suggests evaluating lung waitlist removals due to patients becoming too sick to transplant, as well as lung non-use rates, in the context of this policy change. These additional metrics would provide a more complete picture of whether the policy revision is achieving its goals without unintended harm to patients.
The Decision Project®, a community engagement initiative of IL, also supports efforts to improve allocation efficiency and policy compliance while encouraging the OPTN to also consider the impact these changes may have on public trust in the transplant system. Through community-based focus groups and ongoing engagement in historically underserved communities, we consistently hear concerns regarding fairness, transparency, and equity in organ allocation. Many community members believe that geography, wealth, race, or influence affect who receives a transplant. Whether accurate or not, these perceptions remain significant barriers to donor registration and willingness to participate in donation.

As implementation moves forward, we encourage the OPTN to:
• Include public trust and community confidence as part of its evaluation of policy success;
• Develop plain-language educational materials explaining why allocation changes are made and how equity is maintained;
• Share post-implementation findings in a way that is accessible to patients, donor families, and the public, not solely transplant professionals; and
• Engage community organizations, patient advocates, and trusted local partners when evaluating future allocation policy changes.

Operational efficiency and policy compliance are important goals, but long-term success also depends on maintaining public confidence in the fairness and transparency of the allocation system. Community perspectives should remain an important component of future policy development and evaluation.

July 3, 2026

RE: Public Comment on the Update on Lung Continuous Distribution Policy

LifeLink® of Puerto Rico appreciates the opportunity to provide public comment on the Update on Lung Continuous Distribution Policy. As an organ procurement organization, LifeLink of Puerto Rico supports efforts to strengthen allocation integrity, reduce unnecessary barriers to organ placement, and mitigate avoidable organ non-use in a manner that honors donor families and best serves patients awaiting a life-saving transplant.
LifeLink of Puerto Rico recognizes that Allocation Out of Sequence (AOOS) is a concern that warrants thoughtful attention. The integrity of the allocation system depends on a shared commitment among OPOs, transplant programs, the OPTN, HRSA, and other stakeholders to support efficient, equitable, and policy-compliant organ allocation while preserving appropriate safeguards against organ non-use.
Our comment is focused on the policy development and governance process, particularly the apparent disconnect between the recommendation of the OPTN Lung Transplantation Committee and the final decision made by the OPTN Board of Directors. LifeLink of Puerto Rico acknowledges the concern reflected in many public comments that stakeholders do not fully understand why the Board proceeded with a policy change that did not align with the recommendation of the organ-specific committee charged with bringing clinical and technical expertise to lung allocation policy.
LifeLink of Puerto Rico respects the authority and responsibility of the OPTN Board to make final policy decisions, including decisions that require balancing clinical, operational, ethical, and system-level considerations. At the same time, when the Board reaches a decision that differs from the recommendation of an expert committee, it is important for the Board to clearly acknowledge that recommendation, explain the rationale for departing from it, and identify how the committee’s expertise will continue to inform implementation, monitoring, and future policy refinement.

The OPTN committee structure is a critical mechanism for incorporating specialized clinical knowledge, patient-centered considerations, operational experience, and real-world transplant system expertise into national policy. Organ-specific committees are uniquely positioned to evaluate how changes may affect medically complex candidates, biologically disadvantaged candidates, pediatric candidates, transplant program behavior, offer acceptance practices, and the broader balance of system equity and utility. Their recommendations should therefore be treated as a central part of the policy record and visibly accounted for in Board deliberations and decisions.
LifeLink of Puerto Rico encourages the OPTN Board to take seriously the concerns raised by the Lung Transplantation Committee and by members of the broader transplant community. In particular, LifeLink of Puerto Rico encourages greater transparency regarding the evidence considered, the rationale for the selected policy approach, the reasons for not adopting the Lung Committee’s recommendation, and the safeguards or monitoring that will be used to assess unintended consequences.
This is especially important when a policy change affects the relative weight of placement efficiency compared to other allocation factors. Efforts to improve efficiency and address AOOS should be carefully balanced against the need to preserve patient-centered allocation principles, including medical urgency, expected post-transplant benefit, pediatric priority, biological disadvantage, and equitable access to transplant.
LifeLink of Puerto Rico remains committed to supporting allocation integrity, improving organ placement, and engaging constructively with HRSA, the OPTN, OPOs, transplant programs, patients, donor families, and other stakeholders to ensure that allocation policy is evidence-based, transparent, equitable, and worthy of public trust.
Thank you again for considering these comments and for the continued work to advance a safe, ethical, and trusted donation and transplantation system. We remain appreciative of the volunteers and OPTN staff who steward policy development and implementation, often under complex clinical and operational realities. We would welcome the opportunity to support further discussion or provide additional operational perspective as the OPTN finalizes this proposal.

Cordially,

Guillermina Sánchez, MBAHCM
Executive Director
LifeLink of Puerto Rico

RE: Public Comment on the Update on Lung Continuous Distribution Policy

LifeLink® of Georgia appreciates the opportunity to provide public comment on the Update on Lung Continuous Distribution Policy. As an organ procurement organization, LifeLink of Georgia supports efforts to strengthen allocation integrity, reduce unnecessary barriers to organ placement, and mitigate avoidable organ non-use in a manner that honors donor families and best serves patients awaiting a life-saving transplant.

LifeLink of Georgia recognizes that Allocation Out of Sequence (AOOS) is a concern that warrants thoughtful attention. The integrity of the allocation system depends on a shared commitment among OPOs, transplant programs, the OPTN, HRSA, and other stakeholders to support efficient, equitable, and policy-compliant organ allocation while preserving appropriate safeguards against organ non-use.

Our comment is focused on the policy development and governance process, particularly the apparent disconnect between the recommendation of the OPTN Lung Transplantation Committee and the final decision made by the OPTN Board of Directors. LifeLink of Georgia acknowledges the concern reflected in many public comments that stakeholders do not fully understand why the Board proceeded with a policy change that did not align with the recommendation of the organ-specific committee charged with bringing clinical and technical expertise to lung allocation policy.

LifeLink of Georgia respects the authority and responsibility of the OPTN Board to make final policy decisions, including decisions that require balancing clinical, operational, ethical, and system-level considerations. At the same time, when the Board reaches a decision that differs from the recommendation of an expert committee, it is important for the Board to clearly acknowledge that recommendation, explain the rationale for departing from it, and identify how the committee’s expertise will continue to inform implementation, monitoring, and future policy refinement.

The OPTN committee structure is a critical mechanism for incorporating specialized clinical knowledge, patient-centered considerations, operational experience, and real-world transplant system expertise into national policy. Organ-specific committees are uniquely positioned to evaluate how changes may affect medically complex candidates, biologically disadvantaged candidates, pediatric candidates, transplant program behavior, offer acceptance practices, and the broader balance of system equity and utility. Their recommendations should therefore be treated as a central part of the policy record and visibly accounted for in Board deliberations and decisions.
LifeLink of Georgia encourages the OPTN Board to take seriously the concerns raised by the Lung Transplantation Committee and by members of the broader transplant community. In particular, LifeLink of Georgia encourages greater transparency regarding the evidence considered, the rationale for the selected policy approach, the reasons for not adopting the Lung Committee’s recommendation, and the safeguards or monitoring that will be used to assess unintended consequences.

This is especially important when a policy change affects the relative weight of placement efficiency compared to other allocation factors. Efforts to improve efficiency and address AOOS should be carefully balanced against the need to preserve patient-centered allocation principles, including medical urgency, expected post-transplant benefit, pediatric priority, biological disadvantage, and equitable access to transplant.

LifeLink of Georgia remains committed to supporting allocation integrity, improving organ placement, and engaging constructively with HRSA, the OPTN, OPOs, transplant programs, patients, donor families, and other stakeholders to ensure that allocation policy is evidence-based, transparent, equitable, and worthy of public trust.
Thank you again for considering these comments and for the continued work to advance a safe, ethical, and trusted donation and transplantation system. We remain appreciative of the volunteers and OPTN staff who steward policy development and implementation, often under complex clinical and operational realities. We would welcome the opportunity to support further discussion or provide additional operational perspective as the OPTN finalizes this proposal.

Hope Weed, RN, BSN, CPTC
Executive Director
LifeLink of Georgia

Rosha Poudyal
State of Residence: Massachusetts

Relationship to Lung Transplant: Lung Transplant Candidate/Recipient

Regarding the November 20, 2025 OPTN Board meeting vote to alter the Lung Transplant Continuous Allocation Score (CAS) points and ratios in order to address concerns about Allocation out of Sequence (AOOS).

I am writing to express my strong desire for HRSA/OPTN Board to reverse the decision voted on during the November 20, 2025 Board meeting to remove five points from categories describing a recipient's medical condition and reallocating them to the efficiency category, returning the CAS point allocation and ratios to the pre November 20, 2025 vote levels.

This matters to me because I am a young individual whose life depends on being able to receive a transplant.

Additionally, I share the concerns expressed by the Lung Transplant Foundation letter directed to HRSA and the OPTN Board of Directors, submitted via the Critical Comments and Directives Pathway on April 13, 2026, and signed on to by seventeen distinct lung disease patient advocacy organizations, identifying the following primary concern areas as reasons to oppose this change to the CAS:

- Bucking decades of protocol, no prospective public comment period occurred before this major policy change, and no clinical evidence was supplied justifying the use of the emergency pathway at the time of the vote.
- No clinical rationale was given for ignoring the recommendation of the Lung Committee, which unanimously opposed this change to the CAS, and no solutions were proposed to address the concern that initial modeling suggested that these changes would increase the waitlist mortality for high-risk individuals.
- The change in protocol from extensive modeling before policy changes are implemented to minimal modeling with an intention of catching problems after they occur will endanger lives unnecessarily.
- Patient voices and specialized lung transplant expert opinion should be centered at every stage of OPTN policy development, including the identification of problems, proposed solutions, and the implementation of new policy geared at addressing identified problems.

Thank you again for the opportunity to comment. I sincerely hope that, based on the consistent and unanimous dissent from lung transplant professionals, lung transplant candidates/recipients, and community members, HRSA and the OPTN Board of Directors will reverse the November 20, 2025 vote and restore the CAS to its previous point and ratio allocation.

Sincerely,
Rosha Poudyal

Keep it the same