Update on Lung Continuous Distribution Policy

Thank you for the opportunity to provide comment on this vital issue — literally one of life and death — for lung transplant candidates/recipients.

I respectfully urge the Board of Directors of the Organ Procurement and Transplant Network (OPTN) of the Health Resources and Services Administration (HRSA) to return the Continuous Allocation Score (CAS) point allocation and ratios to the pre-November 20, 2025, vote levels. This requires the OPTN Board to reverse the decision it made on November 20, 2025, when it removed five points from categories describing a recipient's medical condition and reallocated them to the efficiency category.

I am calling for this reversal for three reasons:
- First, the entire spectrum of the lung transplant community — professionals, candidates/recipients and their families, and other community members — have consistently and unanimously opposed the Board’s changes to the CAS.
- Second, two nieces of my nieces have cystic fibrosis, and although they have been fortunate not to need a lung transplant so far, if such a need were to arise, the OPTN Board’s decision on November 25, 2025, would adversely affect them.
- Third, beyond my nieces, it’s the right thing to do for all lung transplant candidates/recipients.

Please restore the CAS to its previous point and ratio allocation!

Thank you again for this opportunity to provide comment.
Suzy Pelican

Ira Hecht
State of Residence: Oregon

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 this decision has decreased the probability of favorable patient outcomes.

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,
Ira Hecht

Kathy Wery
State of Residence: Oregon

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 my husband received a double lung transplant 7 years ago. He would not be alive today without his miracle transplant. I can only imagine that the redistribution of points in the lung allocation system may have been detrimental to his transplant listing, and ultimately receiving his transplant in time for his survival. I feel strongly that the time and effort of the Lung Committee in reviewing, vetting, and supporting the CAS allocation system should remain in place. Let the experts on the Lung Committee evaluate and recommend any enhancements to the CAS scoring. I do not agree with the decision to change the allocation points for AOOS without review and approval of the Lung Committee. Please reverse the OPTN Board decision.

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,
Kathy Wery

I have been involved with the lung transplant community for over 10 years as a caregiver to my wife who is currently waiting for her second lung transplant. During these 10 years, I have always felt that the medical community had my wife's best interest in mind, but this is no longer the case. On May 7th, when the new allocation scoring went into effect, I watched in horror as her score decreased while her symptoms continue to worsen. This is unacceptable.

OPTN implemented the CAS new system without using adequate scientific modeling available to measure the potential impacts the new policy could have on patient biological factors, wait times and wait list mortality. While you chose to abandon the scientific rigor that these changes demand, these factors were taken into consideration in a soon to be published paper by Dr. Maryam Valapour, et. al, in CHEST (Valapour M, Gunsalus PR, Rose J, Lehr CJ, Baker SL, Dalton JE, Geography as a Determinant of Lung Transplant Access in the United States, Chest (2026), doi: https://doi.org/10.1016/j.chest.2026.05.019). The findings from this research show, after running the new CAS parameters through the modeling, that the amended CAS policy was likely to increase geographic disparities, and significantly more so for high risk candidates with O blood type, with the strongest negative impact affecting people who are listed on the West Coast. The evidence of disparity was not subtle, it was striking. Your new CAS system will put lives at risk, lives that were previously safeguarded under the previous CAS parameters.

In addition, your proposal states that AOOS is the problem and the reason for the CAS change. However, by your own admission, the new CAS system is not expected to “completely alleviate AOOS.” In fact, the OPTN Board has never identified what the goal AOOS rate is, and at what point it becomes a problem. As you know, it is not reasonable to assume that the AOOS rate would ever be zero. And, as Dr Hartwig clearly stated in his presentation before the vote was taken, AOOS had self corrected and was approaching pre 2023 levels. This calls into question why the change in the CAS system was needed in the first place. The HRSA website states that your expected impact is on travel distance, logistical complexity, and policy compliance. It does not escape me that these factors are linked to dollar amounts. Cost. While the Congressional Senate Finance Committee renewed the funding for transplantation, it has changed how the money is allocated and given that task to HRSA. It has occurred to me that HRSA is highly motivated to decrease the cost of organ transport and perhaps has tasked the OPTN board to save money as part of its modernization initiative. If true, I have no problem with creating a more streamlined system, however, making these changes before a new system has been created and scientifically vetted for its human impact makes no sense. This crash and burn approach, or destroying a system before you are ready to replace it, is absurd and reckless and it comes at the expense of human lives.

I ask you to fight with, not against the community that you have been a part of for years. I ask that you stand up for our community, not kowtow to HRSA’s pressure to change the CAS as a prerequisite for green-lighting the transition to Continuous Distribution for other solid organs. Reverse the new CAS scoring system back to its 2025 status and find another way. Fight for our community, not against it. During the OPTN Town Hall meeting, I watched OPTN board members use language such as “this will be a difficult transition.” For whom, I ask? Having my loved one die on the waitlist because of your new unfounded policy is not “a difficult transition.” It is unconscionable, and it is avoidable by using the science that is already available to make informed decisions. My wife's life deserves more than a “wait and see” approach.

In conclusion, I strongly oppose the recent changes to the CAS system which allocates 5 points to the efficiency category by taking away points from biological factors. I’m asking that you reverse your decision and return the CAS system to its previous structure. I’m asking that IF there is a need to change the CAS system in the future, you maintain the 2025 system until you thoroughly run any new scenario through the scientific rigors and medical modeling that this type of decision deserves and that you honor the recommendations made by your medical colleagues and advisory boards. I ask that you take our communities' overwhelming dissent to your new CAS system seriously. A “wait and see” approach to decisions that have life and death implications is totally unacceptable and a complete betrayal to our transplant community. Do the right thing. Change the CAS system back! Do better.

Anne Fairbrother, DVM, PhD
State of Residence: Oregon

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 my friend's daughter is on the recipient list. Like many others who require a lung transplant, it is imperative that the criteria used to allocate organs be based on biological need, not ease of transport. The Lung Board professionals were unanimous in their rejection of the proposed changes, and it is not clear why their opinion was dismissed out of hand. Further information from the OPTN Board about why the proposed change will be beneficial to potential recipients is needed. If there is no scientific support for predicting better outcomes, the proposed change should be rejected.

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,
Anne Fairbrother, DVM, PhD