Update on Lung Continuous Distribution Policy

Teresa Randall
State of Residence: Washington

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 am a relative of a high risk double lung recipient in 12.2024. He would not be alive today with the new allocations in place. It is sad to see the transplant process go backwards and worry more about the bottom line than the transplant success rate of the actual recipient. Health scores are much more important than location and they provide a much higher chance of a successful transplant to those whose needs are critical.

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,
Teresa Randall

This follow-up comment reflects a partial revision of my prior submission dated May 24, 2026, based on further reflection and review of subsequent public comments.
I write to clarify and, in part, revise my prior position regarding the OPTN Board’s November 20, 2025 emergency action modifying the Lung Composite Allocation Score (CAS).
On further consideration, I believe HRSA may be moving in the correct strategic direction, particularly in increasing the weight of placement efficiency from 10% to 15%. My prior comment emphasized the equity costs of reweighting, but I now think that framing underappreciated the potential of placement efficiency as a structural lever to mitigate acuity escalation.
There is precedent in complex policy settings for expert committees to converge on suboptimal decisions through unintentional group reinforcement rather than deliberate error. It is therefore reasonable to allow for the possibility that HRSA’s intervention reflects a corrective response to such dynamics. In that context, transplant professionals and patients should extend a measured benefit of the doubt while continuing to evaluate outcomes rigorously.
I now view the increase in placement efficiency weight as a meaningful and potentially high-impact intervention. Its primary stated purpose is to reduce allocation out of sequence (AOOS) and improve policy compliance, but it may also help slow acuity runaway by reducing incentives to list and maintain candidates at extreme acuity. Over time, that could help avoid loss of cumulative survival from the onset of lung disease and reduce suffering among patients who present to transplant programs responsibly during a timely phase of illness.
This is especially relevant given the apparent increase in the proportion of candidates hospitalized at the time of transplant, which may serve as a surrogate marker of systemic drift toward higher acuity at allocation. There may be a short-term increase in waitlist mortality as the system re-equilibrates, and that should be monitored closely in forthcoming HRSA data releases. The longer-term effect, however, may be a net gain in cumulative survival from time of disease onset, a clinically meaningful outcome not captured in standard allocation metrics, along with a reduction in the duration of suffering among patients who present responsibly during a timely phase of illness.
I would also correct my earlier position regarding the proportional reduction in biological disadvantage, urgency, and post-transplant outcome weights. On reflection, the shift from 45% to 50% total allocation weight redistributed across attributes is unlikely to be materially important in isolation because the relative relationships among attributes are preserved. I therefore no longer view that proportional reweighting as a central concern, provided key structural protections, including CPRA, height, and blood type considerations, remain in place and are monitored for unintended effects.
I remain concerned, however, that blood type O candidates continue to languish longer than other blood groups on the waitlist despite prior corrective action. This suggests that the September 2023 adjustment may have been incomplete, and cumulative modeling of all ABO-related policy changes remains essential before further modification.
As noted in my prior comment, if further increases in placement efficiency weighting are considered, pediatric priority remains a logical source of marginal reallocation. Even at reduced levels, pediatric priority still confers a decisive and clinically appropriate advantage. This adjustment could enable additional efficiency gains and, if desired, further reduction in acuity escalation.
I also want to re-emphasize that allocation policy changes alone may not be sufficient to produce the intended reduction in acuity if the broader ecology has shifted since the 2017 continuous distribution era. The threshold for aggressive bridging interventions appears to have drifted in a system where interventions during the pre-transplant phase of care may be undertaken before waitlisting is secure in an already marginal candidate. For that reason, HRSA should advocate to CMS for reimbursement structures linked to meaningful long-term outcomes rather than procedural volume alone, encourage publication of center-level or program-level bridging metrics in relation to listing, transplant, and post-transplant outcomes, and strengthen informed-consent expectations so that patients and families understand the full pathway from bridging procedure to recovery, listing, transplantation, and meaningful survival. Without attention to that upstream ecology, allocation reform alone may not generate the degree of acuity moderation policymakers intend.
After reviewing additional perspectives, I also suggest considering reduction of the post-transplant survival horizon in CAS from 5 years to 4 or potentially 3 years. A shorter horizon may improve access for older candidates whose expected benefit is not fully captured under a 5-year model. This change would require careful modeling but may represent a pragmatic refinement of the current framework.
My revised view is that the November 2025 changes, particularly the increase in placement efficiency, should not be dismissed as a misstep, but instead evaluated as a potentially constructive intervention in a system struggling with persistent acuity escalation.
I appreciate the opportunity to revise my perspective and contribute to this ongoing policy discussion.
I am an employee of an OPTN member institution, but this comment is submitted in my personal capacity.

This follow-up comment reflects a partial revision of my prior submission dated May 24, 2026, based on further reflection and review of subsequent public comments.
I write to clarify and, in part, revise my prior position regarding the OPTN Board’s November 20, 2025 emergency action modifying the Lung Composite Allocation Score (CAS).
On further consideration, I believe HRSA may be moving in the correct strategic direction, particularly in increasing the weight of placement efficiency from 10% to 15%. My prior comment emphasized the equity costs of reweighting, but I now think that framing underappreciated the potential of placement efficiency as a structural lever to mitigate acuity escalation.
There is precedent in complex policy settings for expert committees to converge on suboptimal decisions through unintentional group reinforcement rather than deliberate error. It is therefore reasonable to allow for the possibility that HRSA’s intervention reflects a corrective response to such dynamics. In that context, transplant professionals and patients should extend a measured benefit of the doubt while continuing to evaluate outcomes rigorously.
I now view the increase in placement efficiency weight as a meaningful and potentially high-impact intervention. Its primary stated purpose is to reduce allocation out of sequence (AOOS) and improve policy compliance, but it may also help slow acuity runaway by reducing incentives to list and maintain candidates at extreme acuity. Over time, that could help avoid loss of cumulative survival from the onset of lung disease and reduce suffering among patients who present to transplant programs responsibly during a timely phase of illness.
This is especially relevant given the apparent increase in the proportion of candidates hospitalized at the time of transplant, which may serve as a surrogate marker of systemic drift toward higher acuity at allocation. There may be a short-term increase in waitlist mortality as the system re-equilibrates, and that should be monitored closely in forthcoming HRSA data releases. The longer-term effect, however, may be a net gain in cumulative survival from time of disease onset, a clinically meaningful outcome not captured in standard allocation metrics, along with a reduction in the duration of suffering among patients who present responsibly during a timely phase of illness.
I would also correct my earlier position regarding the proportional reduction in biological disadvantage, urgency, and post-transplant outcome weights. On reflection, the shift from 45% to 50% total allocation weight redistributed across attributes is unlikely to be materially important in isolation because the relative relationships among attributes are preserved. I therefore no longer view that proportional reweighting as a central concern, provided key structural protections, including CPRA, height, and blood type considerations, remain in place and are monitored for unintended effects.
I remain concerned, however, that blood type O candidates continue to languish longer than other blood groups on the waitlist despite prior corrective action. This suggests that the September 2023 adjustment may have been incomplete, and cumulative modeling of all ABO-related policy changes remains essential before further modification.
As noted in my prior comment, if further increases in placement efficiency weighting are considered, pediatric priority remains a logical source of marginal reallocation. Even at reduced levels, pediatric priority still confers a decisive and clinically appropriate advantage. This adjustment could enable additional efficiency gains and, if desired, further reduction in acuity escalation.
I also want to re-emphasize that allocation policy changes alone may not be sufficient to produce the intended reduction in acuity if the broader ecology has shifted since the 2017 continuous distribution era. The threshold for aggressive bridging interventions appears to have drifted in a system where interventions during the pre-transplant phase of care may be undertaken before waitlisting is secure in an already marginal candidate. For that reason, HRSA should advocate to CMS for reimbursement structures linked to meaningful long-term outcomes rather than procedural volume alone, encourage publication of center-level or program-level bridging metrics in relation to listing, transplant, and post-transplant outcomes, and strengthen informed-consent expectations so that patients and families understand the full pathway from bridging procedure to recovery, listing, transplantation, and meaningful survival. Without attention to that upstream ecology, allocation reform alone may not generate the degree of acuity moderation policymakers intend.
After reviewing additional perspectives, I also suggest considering reduction of the post-transplant survival horizon in CAS from 5 years to 4 or potentially 3 years. A shorter horizon may improve access for older candidates whose expected benefit is not fully captured under a 5-year model. This change would require careful modeling but may represent a pragmatic refinement of the current framework.
My revised view is that the November 2025 changes, particularly the increase in placement efficiency, should not be dismissed as a misstep, but instead evaluated as a potentially constructive intervention in a system struggling with persistent acuity escalation.
I appreciate the opportunity to revise my perspective and contribute to this ongoing policy discussion.
I am an employee of an OPTN member institution, but this comment is submitted in my personal capacity.

Patricia Wagner
State of Residence: Iowa

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 received a bilateral lung transplant in 1999. At that time, there was no scoring system, but there also was no medical center in my state that performed lung transplants. I was fortunate that I was able to have my transplant at the University of Minnesota, which is at least a 4-hour drive from my home. The recent changes to the CAS system make me fearful for people who do not live near a major medical facility and who may encounter longer, more harmful wait times.

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,
Patricia Wagner

We write as medical and surgical directors of lung transplant programs in California and Washington to oppose the emergency amendment to the lung Composite Allocation Score (CAS) implemented by the OPTN on May 7, 2026. This change raised the weight of geographic placement efficiency from 10 to 15 points and adopted a steeper distance-weighting function. We are concerned this change was made without sufficient deliberation and will harm lung transplant candidates throughout the country, including reducing access to lung transplantation for patients in our states. The amendment does not advance the goals it is meant to achieve in a manner sufficient to justify these harms. We urge the OPTN to suspend this amendment and to reconsider any change of this kind through its normal modeling and public-comment process.
Our first concern is the process by which this change was made. Continuous distribution and the CAS were adopted in 2023 in large part to reduce geographic disparities in donor lung allocation and to prioritize medical urgency, expected benefit and access for biologically disadvantaged candidates. The May 2026 emergency amendment moves in the opposite direction, increasing the prioritization of geography, in conflict with the Final Rule. Yet, the amendment was implemented without public comment, over the opposition of the OPTN Lung Transplantation Committee, and despite concerns expressed by the lung transplant community that this change would worsen geographic disparities in lung transplant waitlist outcomes. A change of this magnitude, which contradicts the established principles of donor organ allocation, should have been subject to the full scrutiny of the standard vetting process.
Second, the consequences of the amendment, which were not transparently reported prior to implementation, are likely to cause significant harm to lung transplant candidates across the country, and especially so in California and Washington. A recently published analysis by Valapour and colleagues (Chest 2026 May 22:S0012-3692(26)00652-5. doi: 10.1016/j.chest.2026.05.019) highlights and quantifies these consequences. They find that access to compatible donors was already strongly shaped by geography even before the emergency amendment was implemented, with West Coast centers having approximately 30% lower adjusted donor availability than those in the Midwest. Applying the emergency amendment’s parameters decreases donor availability in every region. Further, it more than doubles the already significant gap between the best- and worst-geographically positioned centers. This negative impact disproportionately affects lung transplant centers in California and Washington, leaving our patients with the worst adjusted donor supply in the nation and at a significant disadvantage for undergoing life-saving lung transplants. Patients in California and Washington are as deserving of access to lung transplantation as patients elsewhere in the country.
Our third concern is the lack of clarity on whether the amendment will even achieve its intended goals, and that any putative benefits with respect to these goals were not balanced against the foundational principles of donor organ allocation as stated in the Final Rule. We recognize the burden of long-distance procurement and understand that allocation out of OPTN sequence (AOOS) is a real and pressing problem. However, improvements in organ preservation technology and logistics are already diminishing the negative impacts of distance on efficiency, and the potential efficiency benefits of the amendment remain undefined and unproven. The emergency amendment is a blunt instrument that may or may not reduce AOOS or improve efficiency, while the potential harms to lung transplant candidates in California, Washington and across the country have now been clearly quantified. These conflicting priorities should have been defined, analyzed and debated prior to the implementation of any change.
Untested efforts to promote efficiency and reduce AOOS should not come at the cost of worsened waitlist outcomes for lung transplant candidates. This is especially true when there are disproportionate negative impacts on patients who happen to live further from the geographic center of the country. By prioritizing donor lung allocation based on geography rather than medical considerations, the emergency amendment operationalizes the happenstance of geography into reduced access, longer waiting times and more waitlist deaths. This is precisely the type of disparity that continuous distribution was created to remedy.
We therefore ask the OPTN to:
(1) revoke the May 7, 2026 amendment; and
(2) subject any future change in placement-efficiency weighting to full modeling and public comment, with transparent reporting of anticipated regional and center-level effects on waitlist outcomes before any changes are implemented.
We make these requests out of our sense of responsibility to the patients we serve and who will be harmed by this new policy, and we welcome the opportunity to work with the OPTN as this issue is reconsidered.
Respectfully,
Kamyar Afshar, DO
Medical Director, UC San Diego Lung Transplant Program

Abbas Ardehali, MD
Surgical Director, UC Los Angeles Lung Transplant Program

Gundeep Dhillon, MD, MPH
Medical Director, Stanford Lung Transplant Program

Sivagini Ganesh, MD
Medical Director, University of Southern California Lung Transplant Program

Eugene M. Golts, MD, MBA
Surgical Director, UC San Diego Lung Transplant Program

Steven Hays, MD
Medical Director, UC San Francisco Lung Transplant Program

Jasleen Kukreja, MD, MPH
Surgical Director, UC San Francisco Lung Transplant Program

Erika Lease, MD
Medical Director, University of Washington Lung Transplant Program

John W. MacArthur, MD
Surgical Director, Stanford Lung Transplant Program

Dominick Megna, MD
Surgical Director, Cedars-Sinai Lung Transplant Program

Michael S. Mulligan, MD
Surgical Director, University of Washington Lung Transplant Program

Reinaldo Rampolla, MD
Medical Director, Cedars-Sinai Lung Transplant Program

David M. Sayah, MD, PhD
Medical Director, UC Los Angeles Lung Transplant Program

Jonathan Singer, MD, MS
Associate Medical Director, UC San Francisco Lung Transplant Program