Update on Lung Continuous Distribution Policy

Laura Bailey
State of Residence: Oregon

Relationship to Lung Transplant: Living Organ Donor, Caregiver/Community Member

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 of two factors. Firstly, I am the spouse and caregiver of a lung transplant recipient. My husband was dying of lung disease, with no discernable cause. He had none of the usual causes of lung disease. And yet, he was dying. His only hope was a lung transplant. He did everything "right" to go through the assessment process and be added to the transplant waiting list at the University of Washington Medical Center. We managed our lives around his illness and around our hope that he would remain alive and strong enough to receive a transplant. We trusted in the process that would ensure he was properly prioritized on the waiting list, and that when his time came to receive a donor organ, his medical team's decisions would be based on actual need of all patients on the waiting list. We trusted that the most needy patients would be prioritized to receive donor lungs. We trusted that there was no arbitrary system working against us in the background that would instead unduly prioritize geographic considerations. With the transportation and technology available in the United States, geographic efficiencies, we trusted, would have little or no impact on when he would be offered donor lungs. With everything else going on in our lives to keep him alive, we HAD to trust because we were powerless to have any control whatsoever over the allocation process running in the background of our lives. Patients and their families deserve to be able to trust in these background processes being based on greatest need, grounded in medical & clinical factors.

Secondly, I am also a registered organ donor, and I hope that some day my healthy lungs (and other organs/tissues) may help others. I need to trust that when that time comes, my donations will be made available to recipients based on solid medical, clinical, and FAIR procedures. I can envision no reason why geographical convenience or "efficiency" should factor into the distribution of my donations. This nation's transportation network, and the technology for supporting donated organs & tissues during transport from one corner of the US to the opposite corner are so sophisticated that my donations from Oregon can safely make their way to needy patients in any corner of the US. So, geographic considerations should not factor unduly into where my donations will be going.

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,
Laura Bailey

State of Residence: Michigan

Relationship to Lung Transplant: Caregiver/Community Member

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 love someone who is need of a lung 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.

Beth Cooper
State of Residence: North Carolina

Relationship to Lung Transplant: Living Organ Donor, Caregiver/Community Member

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 We desparately need to restore the CAS to its previous point and ratio allocation. Lives depend on it.

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,
Beth Cooper

The Cystic Fibrosis (CF) Foundation appreciates the opportunity to comment on the Organ Procurement & Transplantation Network’s (OPTN’s) Update on Lung Continuous Distribution Policy proposal. The Foundation recognizes the importance of reducing lung allocation out of sequence (AOOS) and identifying mechanisms to improve the lung continuous distribution framework more broadly. However, we have significant reservations about both the process and substance of the OPTN policy change and are deeply concerned about the implications for both lung transplantation and the entirety of the organ procurement and transplantation system. For that reason, the Foundation strongly opposes this policy proposal and urges its immediate discontinuation.

Use of the Emergency Action Pathway Without Sufficient Rationale:

The CF Foundation recognizes that OPTN must have the ability to respond rapidly when urgent issues arise, and that the Emergency Action pathway is critical for doing so. However, given the information that OPTN has provided publicly, it is unclear how the Lung Continuous Distribution Policy proposal met the threshold for implementation through a mechanism designed for situations that require immediate intervention.

Per the OPTN Management and Membership Policies manual, the Emergency Action pathway is only appropriate if the policy proposal under discussion meets at least one of three criteria:

1. The proposal is necessitated by a pending statutory or regulatory change.
2. The proposal is required due to an emergent public health issue or patient safety factors.
3. The proposal is necessitated by a new medical device or technology that affects organ allocation.

In the full proposal document, OPTN states several times that emergency action was warranted for this policy change. However, it has not provided an explanation that justifies the use of the emergency action pathway based on the criteria listed above. The CF Foundation is extremely concerned that the use of the Emergency Action pathway without a clearly demonstrated need, as appears to have occurred in this case, may set a precedent for moving future policy changes forward before sufficient evidence to support those changes is available. Critically, it also denies stakeholders with the opportunity to meaningfully engage in the process, which may result in policies that negatively impact the community and a lack of confidence in OPTN decision-making.

Failure to Provide Adequate Time for Analysis of the Proposed Change:

Based on publicly available information, the Lung Transplantation Committee appears to have been given approximately one month to analyze potential changes to lung allocation and provide accompanying recommendations to OPTN. OPTN acknowledged the limitations that this deadline placed on the Lung Transplantation Committee several times during the discussion about the update to the continuous lung distribution policy; the meeting included multiple instances in which, due to the time constraint imposed by OPTN’s deadline, the Committee did not have the data necessary to answer specific questions—the answers to which may have impacted deliberations—from the OPTN Board.

OPTN has not adequately explained what made the implementation of this policy urgent enough that OPTN could not provide the Lung Transplantation Committee with the time necessary to perform the appropriate analyses—and, instead, pressed the Committee to select the “best” of several potential policy changes that the Committee was required to develop specifically as backup options should the OPTN choose to act.

Additional Evidence Needed for Consideration of the Proposed Change:

The Lung Transplantation Committee unanimously recommended that OPTN make “no change to lung placement efficiency at this time pending a monitoring period of trends in lung AOOS and identification of drivers of lung AOOS.” Though this is likely based at least in part on the time constraints imposed on the Committee, it is also unclear whether the available clinical evidence supports the need to implement a change to lung allocation as it currently stands.

The proposal cites AOOS as a key justification for increasing the weight assigned to placement efficiency from 10% to 15%. While reducing AOOS and promoting efficient organ placement are important goals, the data presented do not clearly demonstrate that the current weighting structure is the primary driver of AOOS or that the proposed change will meaningfully improve patient outcomes. Additionally, national data from the Scientific Registry of Transplant Recipients (SRTR) suggest a more nuanced picture of recent AOOS trends . Available data indicate that AOOS increased following implementation of lung continuous distribution but subsequently declined over time, with recent rates trending downward from peak levels.

While AOOS should continue to be monitored and addressed when appropriate, these trends raise important questions about whether permanent changes to geographic weighting are necessary. The CF Foundation believes that additional evidence is needed to demonstrate both the existence of a persistent problem and that the proposed solution will improve outcomes without adversely affecting patient access to transplantation.

Impact of the Proposed Change on Access for Biologically and Geographically Disadvantaged Candidates:

In providing its recommendation, the Lung Transplantation Committee was particularly concerned about the “unknown potential impact of change on lung AOOS compared to expected negative impact on candidates facing transplant rate disparities under the current system (e.g., short statured candidates).” The CF Foundation shares these concerns. Patients with characteristics that make donor matching more difficult—including blood type O candidates, sensitized candidates, and candidates with uncommon size-matching needs—may be adversely affected if geographic considerations receive greater weight in allocation decisions.

The CF Foundation is further concerned about the potential impact that increasing geographic prioritization by placing greater weight on donor-recipient proximity will have on the CF community. While improved placement efficiency may provide operational benefits, geographic prioritization can affect access for patients who already face challenges in obtaining suitable donor organs. Individuals with CF frequently require highly specialized transplant care and may depend on access to donor offers across broader geographic areas.

Continuous distribution was designed to balance multiple priorities while minimizing inequities in access to transplantation. Before permanently increasing the influence of geographic efficiency, the CF Foundation believes that OPTN should carefully assess the potential effects on access, equity, waitlist mortality, transplant opportunities, and outcomes.

In Summation:

For individuals with CF and other patients awaiting lung transplantation, allocation policy decisions can directly affect access to life-saving donor organs. Given procedural concerns regarding the use of the Emergency Action pathway, the lack of opportunity for the Lung Transplantation Committee to perform comprehensive analyses, available data on declining AOOS rates, and the risk of disproportionate impact on recipients who already face obstacles related to transplantation, the CF Foundation opposes this policy proposal and its permanent adoption.

Should this proposal remain under consideration, we strongly urge OPTN to allow the Lung Transplantation Committee to complete and publicly release the requested analyses; comprehensively evaluate the impact of this policy on patient access to transplantation, particularly for disadvantaged candidates; and provide stakeholders with an opportunity to review and provide additional commentary on further iterations of the proposal. Such transparency is essential to ensuring that allocation policy changes are evidence-based, equitable, and in the best interests of patients awaiting transplant.

Sincerely,

Mary Dwight
Senior Vice President and Chief Policy and Advocacy Officer
Cystic Fibrosis Foundation

Albert Faro, MD
Senior Vice President and Chief Medical Officer
Cystic Fibrosis Foundation

My friend’s son is diagnosed with Hermansky Pudlak Syndrome. One day, he will develop pulmonary fibrosis and require a double lung transplant to save his life. It is critical that he and everyone needing new lungs have an equal opportunity to lungs available for transplant. This little boy is full of life and see the greatness in everything. We’d love to see a great future for him.