How was the policy developed?
Adopted by the Organ Procurement and Transplantation Network (OPTN) Board of Directors in December 2018, the policy re-calibrates how geography is considered when matching donated livers with transplant recipients based on experience gained with the previous, decades-old system. That system has relied heavily on the arbitrary geographic boundaries of Donation Service Areas (DSAs) and transplant regions.
The new system eliminates those map-based boundaries and corrects inequities that emerged over time within the old policy that led to unfair advantages and disadvantages based on where liver transplant recipients live.
This transformative policy is the result of more than five years of work and was developed by transplant experts, organ recipients and donor families from around the country, with consideration of more than a thousand public comments.
Pathway to the policy
Increasing transplants, equitably
News and system notices that led to policy implementation
- Oct. 21: Changes made to liver Status 1A and 1B justification forms
- Oct. 7: Updated NLRB exception requirements effective October 7
- Sept. 17: Updated Median MELD at Transplant scores take effect September 29
- Sept. 17: Updated NLRB exception requirements effective October 7 (Pre-implementation notice)
- Sept. 15: Updated 15–month monitoring report available for liver, intestine policy
- June 30: OPTN Board approves liver allocation refinements
- Apr. 13: Updated 12-month monitoring report available for liver, intestine policy
- Mar. 25: Expedited Liver Placement policy implemented
- Mar. 25: New policy establishes expedited placement of livers
- Feb. 26: Expedited Liver Placement policy implementation begins March 25, 2021
- Feb. 25: Expedited Liver Placement: Phase 1 implementation underway
- March 1: System notice: Clarification of pre-existing liver disease implemented March 1
- Feb. 18: System notice: Access for urgent liver candidates in Hawaii and Puerto Rico implemented Feb. 18
- Feb. 12: Webinar to address NLRB effective practices
- Feb. 11: Access for urgent liver candidates in Hawaii and Puerto Rico to be implemented Feb. 18
- Feb 4: New national liver and intestinal organ transplant system in effect Feb. 4, 2020
- Jan 20: Pre-implementation notice: Liver and intestinal organ distribution policy based on acuity circles to be implemented Feb. 4, 2020
- Jan 18: Updated liver and intestinal organ allocation policy to be implemented Feb. 4, 2020
- Dec 5: Public comment sought; Liver access for urgent candidates in Hawaii and Puerto Rico
- Oct 15: Special public comment session open through Nov. 14
- Sept. 26: Update: Appellate court ruling regarding liver distribution policy: An appellate court ruling issued September 25 is a significant step toward application of the national acuity circles liver distribution policy. It does not mean that policy implementation will immediately follow. UNOS is assessing current developments and will provide all members a minimum of 14 calendar days advance notice of any implementation date. The ruling by the 11th Circuit Court of Appeals unequivocally affirmed the organ allocation policy development process that has been consistently used for more than 20 years. We believe the decision is very positive for our efforts to make liver allocation more equitable for all candidates. The court ruling remands certain questions to the district court for further consideration. We remain confident that the December 2018 liver allocation policy was legally and appropriately adopted after extensive analysis and consideration of feedback from the transplant community and the public. As soon as we have further guidance on whether UNOS will be able to re-implement the acuity circles policy, we will provide members with at least 14 days’ advance notice before any reprogramming takes effect.
- May 24: NLRB update: MMaT calculation now based on DSA of transplant hospital
- May 23: OPTN liver allocation policy reverted to DSA and regions
- May 21: Pre-implementation notice: OPTN liver allocation policy to revert to DSA and regions May 23, 2019
- May 17: Liver policy to revert to DSA-based system due to court order: The Health Resources and Services Administration (HRSA) has instructed UNOS, as the OPTN contractor, to revert to the liver distribution policy in place prior to May 14, 2019, utilizing boundaries based on donation service areas and regions, consistent with a federal court order. For further information, refer to a HRSA letter to UNOS and UNOS’ reply to HRSA on May 17, 2019. In all instances, organ procurement organizations and liver transplant programs should continue to follow the match run generated in UNetSM for liver donors and potential recipients.
- May 15: Court order cease and desist on further liver policy implementation: UNOS received an Order from a federal court in Atlanta not to do further work implementing the new liver allocation policy approved by the OPTN Board of Directors in December 2018. As the policy has already been implemented, we are seeking clarification from the judge. In the meantime, OPOs and transplant centers should follow the match runs that UNet generates. If we make changes to UNet, we will notify the community.
- May 14: Liver policy changes and National Liver Review Board in place: Today, a federal court in Atlanta denied a request to delay implementation of the liver distribution policy approved by the OPTN Board of Directors in December 2018. The plaintiffs have indicated an intent to appeal that ruling and as of this message, no injunction has been ordered that would further delay implementation of the policy. As a result, the new policy will go into effect on May 14. Implementation of the National Liver Review Board (NLRB) will also go into effect on the same date, and the planned conversion of exception scores for most candidates who have current exceptions will take place at that time. The transplant community, including a committee comprising transplant experts, organ recipients, and donor families from around the country and the OPTN Board of Directors—with extensive input from the public—came together to develop and approve the new policy. Simulation modeling of the new policy suggests it will be fairer to patients nationwide, save more lives by reducing pre-transplant deaths, and improve transplant access for children in need of a transplant.
letters from leaders
Making transplant opportunity more equitable
By Brian Shepard, CEO (former), United Network for Organ Sharing
“Many transplant experts from around the country served on our committee that led the development of policy options, and thousands of public comments were received and considered as part of the process.”
Read Shepard's full letter
April 24, 2019
It has been a lengthy, five-year process to adopt and prepare to implement a much-needed, updated distribution policy for donated livers. Many transplant experts from around the country served on our committee that led the development of policy options, and thousands of public comments were received and considered as part of the process. Like any policy adopted by the Organ Procurement and Transplantation Network, it must be one that comports with all applicable laws and regulations, and it must be one that can work for patients across the entire country. This new policy meets these criteria.
The organ transplantation community is making great strides. Last year, we hit a new milestone for the most organ transplants in a single year in the U.S., our sixth consecutive record-breaking year. Despite this, however, the reality is that, on average, three people with end stage liver disease die every day in the U.S. while waiting for a liver transplant. A total of 1,155 lives were lost last year alone.
This new policy is projected to reduce waitlist mortality by roughly 100 fewer deaths each year and allow more children to receive life-saving transplants. It will also correct an inequity that had emerged over time within the previous policy that led to unfair advantages and disadvantages based on where liver transplant recipients live. These are all significant benefits to patients and the liver matching system overall.
Unfortunately, there simply are not enough donated organs to altogether do away with transplant waiting lists. This is precisely why transplant matching must be as fair as possible, influenced by only the most objective factors. Our system is built first and foremost to match donor organs with those patients who are sickest and most in need.
Geography is part of the matching equation to ensure that we minimize the amount of time organs must be preserved between recovery and transplant. The arbitrary boundaries established between donor and transplant hospitals when the current distribution policy was developed in the 1980s were less of a factor then, as there were fewer patients in need. Over time, however, due to different patterns in organ donation and the concentration of transplant hospitals, differences began to emerge in patients’ chances of receiving a transplant in different regions of the country.
The new policy will treat equally sick patients the same, wherever they live or wish to seek a transplant. Patients will no longer have to try to get on more than one wait list because they live in an area where they have less access than others. The matching process will be a simpler measure of distance from the donor hospital to their transplant hospital, and it will continue the practice of prioritizing based on the medical need of candidates.
Simply put, the new policy restructures the outdated transplant map and makes liver distribution fairer for all. The patients who are both most in need and closest to the donor will get offers first. This will not change the life-saving benefit of organ donation, nor the dedication of organ donation and transplantation professionals who work daily to make transplants happen.
Again, statistical modeling projects the new policy will result in about 100 fewer waiting list deaths each year. But even if this new policy results in just one more life saved, it will be worth it.
A look at how the policy was developed
A message from Sue Dunn, past president, Board of Directors
“I know that as a community we will continue to work together to address the new system so that we make the best use of the gifts entrusted to us and provide the greatest benefit to those who need our services.”
Read Dunn's full letter
Dec. 18, 2018
By now you may have heard about the decisions and actions our Board of Directors took at its December 2018 meeting relating to liver distribution. I’d like to provide you a bit more context about the vote, and offer information about how the Board made this decision.
The Board weighed at length a number of options. We heard the recommendations of the Liver and Intestinal Organ Transplantation Committee and the primary themes of public comment. We considered a number of alternatives and amendments brought by our Board members representing their constituencies.
We heard and shared strongly held views while maintaining a civil tone and discourse. (Listen to a recording of the liver proposal discussion here.) Crucially, our patient and donor family members reminded us that these discussions do not just involve impersonal “supply” or “demand,” but that the people we serve both enable and are affected by our actions.
The Board voted to support an acuity circles approach, one of the two approaches considered by the Liver Committee, modeled by the SRTR and distributed for public comment this fall. (More detail about how the sequence operates can be found here.)
Some key arguments in support of its ultimate adoption included the fact that it retains more local priority for candidates at similar levels of medical urgency. It is also potentially more responsive to geographic differences in area or population, as some areas of the country may not have liver programs within 150 or 250 miles of the donor location. Issues of concern include the potential effect on flight travel of recovery teams and the associated increase in costs, as well as the potential for lengthier time to organ recovery in some instances.
It is fair to say that any fundamental change creates new challenges we must face. The Board discussion provided us with a good sense of what the donation and transplant community must monitor closely going forward and address on an ongoing basis.
We all depend on the gift of organ donation and the contributions of one another to save and enhance the lives of transplant candidates. I know that as a community we will continue to work together to address the new system so that we make the best use of the gifts entrusted to us and provide the greatest benefit to those who need our services.
As always, thank you for your interest and participation in our national system. We all benefit from full, civil and informed discussion of the challenges and opportunities our community needs to address.