Liver policy updates

System notice: Clarification of pre-existing liver disease implemented March 1

March 1, 2020

Audience:

Liver transplant program directors, surgeons, physicians, administrators, clinical coordinators, compliance and quality managers

Implementation date:

March 1, 2020

At-a-glance

On Sunday, March 1, 2020, clarifications were made to policy requirements for adult and pediatric Status 1A listing. The updated language clarifies that a candidate diagnosed with liver disease prior to a previous liver transplant can qualify as a Status 1A for re-transplantation due to fulminant liver failure, provided that the candidate is not diagnosed with liver disease following the initial transplant. The goal of the clarification is to ensure that candidates for re-transplant who are experiencing fulminant hepatic failure receive the same access to organ transplant as other similar candidates with fulminant hepatic failure.

Details of the policy are contained in this policy notice.

What you need to do

Please familiarize yourself and your clinical staff with the clarified qualifications for candidate listing. While this is an important clarification, it is expected to apply in only a rare number of instances.

These updates do not change any details relating to the sequence of matches for candidates or to the OPTN Member Evaluation Plan.

Questions?
If you have questions relating to implementation, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

System notice: Access for urgent liver candidates in Hawaii and Puerto Rico implemented Feb. 18

Feb. 18, 2020

Audience: Liver and intestine transplant program directors, surgeons, physicians, administrators, clinical coordinators, data coordinators and clinical support staff; OPO executive directors and procurement directors/managers; compliance and quality managers

Implementation date: February 18, 2020

At-a-glance

On Tuesday, Feb. 18, a variance was implemented to improve timely access to donors for liver candidates listed as Status 1A, Status 1B, or with a MELD or PELD score of 37 or higher in Hawaii and Puerto Rico. It establishes additional geographic units of 1,100 nautical miles for candidates listed in Puerto Rico and 2,400 nautical miles for candidates listed in Hawaii. Details of the policy are contained in this policy notice.

Implementation details

These additional distribution units only apply for candidates listed in Hawaii or Puerto Rico who are in urgent need of a liver transplant.  The additional classification follows other distribution sequences in the acuity circle liver policy for urgent candidates listed at transplant hospitals within a radius of 500 nautical miles of the donor hospital. The additional classifications does not apply to any candidates in Hawaii or Puerto Rico with a MELD or PELD score below 37.

The variance will be evaluated annually and will expire after five years. It may be more likely to affect OPOs in areas geographically closest to the transplant programs in Hawaii or Puerto Rico, although the overall number of candidates expected to be affected by the variance is anticipated to be low.

What you need to do

Match runs for liver and liver-intestine offers follow the updated sequence.  Continue to follow the match run process as usual.

Resources and education

Access policy and system training in UNOS Connect from the course catalog; Liver category

  • LIV101-D: Access for Urgent Liver Candidates in Hawaii and Puerto Rico

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

Webinar to address NLRB effective practices

Feb. 12, 2020

The Organ Procurement and Transplantation Network Liver and Intestinal Organ Transplantation Committee will sponsor a webinar to discuss effective practices regarding the National Liver Review Board on Monday, Feb. 24, from 2-3 p.m. EST. You may register for the webinar here.

The webinar will also be archived, and a recording will be available following the event.

The webinar will address common issues and questions both for transplant program staff submitting extension requests and for NLRB members. This will include key components of the review submission process, recommendations on effective ways to write and read narratives, and reminders for NLRB members in the review process.

Access for urgent liver candidates in Hawaii and Puerto Rico to be implemented Feb. 18

Feb. 11, 2020

Audience:

Liver and intestine transplant program directors, surgeons, physicians, administrators, clinical coordinators, data coordinators and clinical support staff; OPO executive directors and procurement directors/managers; compliance and quality managers

Implementation date: Feb.18, 2020

 At-a-glance

On Tuesday, Feb. 18, a variance will be implemented to improve timely access to donors for candidates listed as Status 1A, Status 1B, or with a MELD or PELD score of 37 or higher in Hawaii and Puerto Rico. It will establish additional geographic units of 1,100 nautical miles for candidates listed in Puerto Rico and 2,400 nautical miles for candidates listed in Hawaii. Details of the policy are contained in this policy notice.

The UNOS Secure EnterpriseSM system, which includes UNetSM and other transplant applications such as WaitlistSM, DonorNet®, TIEDI® and KPDSM, will be unavailable for a brief period of time the morning of Feb. 18, beginning at 7 a.m. Eastern standard time, to allow for implementation.

Implementation details

These additional distribution units will only apply for candidates listed in Hawaii or Puerto Rico who are in urgent need of a liver transplant.  The additional classification will follow other distribution sequences in the acuity circle liver policy for urgent candidates listed at transplant hospitals within a radius of 500 nautical miles of the donor hospital.  The additional classifications will not apply to any candidates in Hawaii or Puerto Rico with a MELD or PELD score below 37.

The variance will be evaluated annually and will expire after five years. It may be more likely to affect OPOs in areas geographically closest to the transplant programs in Hawaii or Puerto Rico, although the overall number of candidates expected to be affected by the variance is expected to be low.

What you need to do

As of the implementation date, match runs for liver and liver-intestine offers will follow the new sequence.  Continue to follow the match run process as usual

Resources and education

Access policy and system training in UNOS Connect from the course catalog; Liver category

  • LIV101-D: Access for Urgent Liver Candidates in Hawaii and Puerto Rico

Questions? If you have questions relating to implementation, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

New national liver and intestinal organ transplant system in effect Feb. 4, 2020

Feb. 4, 2020 – The Organ Procurement and Transplantation Network (OPTN) has implemented a new liver and intestinal organ distribution system to improve the process of matching life-saving organs to candidates in greatest need of them. This new policy will save more lives annually by providing more transplant access for the most urgent candidates.  It also is expected to increase the number of pediatric liver transplants, making this a national policy that will work more efficiently and fairly for patients across the entire country.

The new system replaces the use of decades-old geographic boundaries of 58 donation service areas (DSAs) and 11 transplant regions. It emphasizes the medical urgency of liver transplant candidates and the distance between the donor hospital and transplant hospitals.

Livers from all deceased donors will first be offered to the most urgent liver transplant candidates (Status 1A and 1B) listed at transplant hospitals within a radius of 500 nautical miles of the donor hospital. Following offers to the most urgent candidates, livers from adult donors will be offered to candidates at hospitals within distances of 150, 250 and 500 nautical miles of the donor hospital. These offers are grouped by medical urgency.

The OPTN Board of Directors approved the policy in December 2018. It was implemented briefly in May 2019, then reverted to the prior system of DSAs and regions while a federal court considered a legal challenge to the new system. A court ruling issued Jan. 16, 2020 allowed the re-implementation to proceed.

Statistical modeling of the new policy projects that it will save more lives, with fewer patients dying while waiting for a liver transplant. It also makes the system fairer by providing more equitable access to a transplant based on medical need for the benefit of all patients. The policy also is expected to increase the number of liver transplants for children under the age of 18 by increasing their priority for organs from donors who are also younger than 18.  The benefits of the system are projected to have similar effects across various socioeconomic groups and population types, such as urban, rural and suburban.

The policy was developed by transplant and donation experts, recipients and donor families from around the country, with consideration of more than 1,200 public comments.

The new policy takes effect at a time of sustained increase in organ donation and transplantation in the United States. Nearly 40,000 total transplants were performed nationwide in 2019, setting an annual record for the seventh year in a row. Of that total, 8,372 liver transplants were performed involving deceased donors, an increase of 6.7 percent over the 2018 total.

Learn more about the implementation here.

Pre-implementation notice: Liver and intestinal organ distribution policy based on acuity circles to be implemented Feb. 4, 2020

Jan. 20, 2020

Audience:

Liver and intestine transplant program directors, surgeons, physicians, administrators, clinical coordinators, data coordinators and clinical support staff; OPO executive directors and procurement directors/managers; compliance and quality managers; member representatives

Implementation date: February 4, 2020

At-a-glance

On Tuesday, Feb. 4, the liver and intestine distribution systems based on acuity circles will begin operation. This will also include a conversion of each transplant hospital’s median MELD at transplant (MMaT) score to reflect transplants performed at hospitals within a radius of 250 miles. 

A federal court ruling issued Jan. 16, 2020, removed the potential for an injunction that may delay implementation of this policy, approved by the OPTN Board of Directors in December 2018.

The acuity circle policy replaces donation service area (DSA) and regional boundaries currently used in liver and intestinal organ distribution with a system based on distance between donor hospital and transplant hospital.  This policy notice addresses details of the policy. Simulation modeling suggests the policy should reduce pre-transplant deaths, increase pediatric transplantation and reduce geographic variation in medical urgency scores at the time of transplant.

The UNOS Secure EnterpriseSM system, which includes UNetSM and other transplant applications such as WaitlistSM, DonorNet®, TIEDI® and KPDSM, will be unavailable for approximately one hour the morning of Feb. 4 beginning at 7 a.m. Eastern standard time to allow for implementation. 

A separate variance will be implemented Tuesday, Feb. 18, 2020, to address transplant access for medically urgent liver candidates listed at hospitals in Hawaii and Puerto Rico. This variance was approved in a teleconference of the OPTN Executive Committee on Jan. 16, 2020 and was supported in a recent special public comment period.

Implementation details

The sequence of offers is likely to change in many areas. The system will first prioritize livers from adult deceased donors for compatible Status 1A and 1B candidates listed at transplant hospitals within 500 nautical miles of the donor hospital. Following that, it will prioritize candidates of similar groupings of medical urgency within 150, 250 and 500 nautical miles from the donor hospital. The new system will also increase priority for pediatric candidates relative to adult candidates for liver offers from donors younger than age 18.

As of the time of policy implementation, candidates with an existing MELD exception score based on the MMaT of their DSA will have their scores converted to a MMaT based on transplants performed at hospitals within a radius of 250 miles. The new MMaT scores to be used for each transplant program are available here. (As reference, the MMaT values currently based on DSA are available here.) PELD exception scores based on the median PELD at transplant (MPaT) will not change, since the MPaT is calculated on a national basis.

Variances affected by the new policy

As noted above, a new variance will be implemented Tuesday, Feb. 18, 2020, addressing access for urgent liver transplant candidates in Hawaii and Puerto Rico.

Also, as approved by the OPTN board at its December 2019 meeting, an existing Region 8 split liver variance will convert at the time of policy implementation to align with the acuity circles distribution policy. Keep in mind that if your OPO places a liver with a transplant hospital that is participating in the variance, it will need to offer the second segment to candidates with a MELD or PELD of at least 33 within 500 nautical miles instead of candidates with a MELD or PELD of 35 or higher in the region.

A closed variance for allocation of livers recovered in Region 9 will also be dissolved at the time of implementation. The policy notice addresses this change.

Resources and education

  • Various resources are available in the implementation toolkit. These include links to relevant policies and supporting information, as well as educational resources for transplant clinicians and transplant candidates.
  • Access policy and system training in UNOS Connect from the course catalog; Liver category*
    • LIV110: Liver and Intestine Allocation
    • LIV111: Liver and Intestine Allocation Town Hall
    • LIV110-D: More Than One Way to Split a Liver
    • LIV107: NLRB Policy: MELD/PELD Exception Scoring

An additional offering is in development and will be available Feb. 4, 2020:

    • LIV101-D: Access for Urgent Liver Candidates in Hawaii and Puerto Rico

 

Questions?If you have questions relating to implementation, contact UNOS Customer Service at 800-978-4334. For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

 

Updated liver and intestinal organ allocation policy to be implemented Feb. 4, 2020

Jan. 18, 2020 – A federal court considering a legal challenge to the liver and intestinal organ allocation policy based on acuity circles has determined, in a ruling issued Jan. 16, 2020, not to issue an injunction on policy implementation. As a result, the OPTN plans to implement the policy on Feb. 4, 2020 to allow for computer programming and notification of members.

Further details relating to policy implementation will be forthcoming soon.

Public comment sought; Liver access for urgent candidates in Hawaii and Puerto Rico

Dec.5, 2019 – The OPTN Liver and Intestinal Organ Transplantation Committee seeks public comment on a proposed variance to liver allocation policy for urgent transplant candidates listed at hospitals in Hawaii and Puerto Rico. The proposed variance would create special distribution units for the state and the territory to ensure they continue to have access to non-local livers upon future implementation of the acuity circles distribution policy.

This proposal is posted to the public comment section of the OPTN website for a special one-month comment period, closing January 9, 2020.

National webinar to present details of the Hawaii and Puerto Rico proposal

During the public comment period, there will be a national webinar to discuss details of the proposal on Wednesday, December 18th from 2:00-2:30 p.m. ET.

Register for the webinar here.

After registering at the above link, participants will receive a confirmation email containing additional information about joining the webinar.

For questions or additional information, send an e-mail to liver@unos.org.

Special public comment session open through Nov. 14

Oct. 15, 2019 – The OPTN Liver and Intestinal Organ Transplantation Committee seeks public comment through Nov. 14, 2019, on a proposed change to a closed variance for allocation of the second segment of split livers. The proposed amendment would align the geographic distribution area within the variance to the geographic distribution units currently in use, as well as those to be used upon future implementation of the acuity circles distribution policy.

This proposal will be posted to the public comment section of the OPTN website for a special one-month comment period, closing Nov. 14, 2019 at midnight Eastern time. The special public comment period will allow the OPTN Board of Directors to take action on the proposal at its December 2019 meeting.

For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

Update: Appellate court ruling regarding liver distribution policy

Sept. 26, 2019 – 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.

We will keep you informed of additional key developments.

For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

NLRB update: MMaT calculation now based on DSA of transplant hospital

May 24, 2019Key updates and actions:

  • MMaT now calculated by DSA of liver transplant hospital
  • Scores converted as of 10:15 p.m. EDT May 24
  • Waiting time may be adjusted upon request if MELD exception score increased
  • Median PELD at transplant (MPaT) is not affected

Note: To see the most up-to-date information on the OPTN website, make sure you always refresh your browser or clear your cache. You can accomplish this by pressing Ctrl F5 on your keyboard.

Effective May 24, 2019, at 10:15 p.m. EDT, the median MELD at transplant (MMaT) scores for liver candidates with exception scores are now based on recent liver transplants performed at liver transplant hospitals within the donation service area (DSA) where the candidates are listed.

When the National Liver Review Board (NLRB) was implemented on May 14, 2019, at the same time as the acuity circles distribution model, the basis of the MMaT calculation was recent transplants at all liver transplant hospitals included in a 250 nautical mile radius of the hospital listing the exception candidate.  With the reversion to a donation service area (DSA) and region-based liver allocation system effective May 23, some DSAs had different MMaT scores among liver programs within their area.  This in turn could create disparities affecting candidates’ transplant access within the local DSA of the donor.

The OPTN Executive Committee, by teleconference May 24, unanimously approved basing the MMaT calculation on DSA to address unintended consequences of the reversion to DSA-based liver allocation.

The conversion has been made within UNetSM for all liver transplant candidates who had an exception score based on MMaT within a 250 nautical mile radius.  Please refer to this table for the MMaT score for each liver transplant program based on DSA.  If you wish to compare it to the MMaT based on 250 nautical mile circles, this table lists the previous scores.

Many individual candidates’ MMaT will remain the same under the conversion as it was under the previous calculation.  Other candidates will have their exception scores either increase or decrease.

You may apply to UNOS to have a candidate’s waiting time adjusted only if the candidate experiences an increase in their MELD exception score as a result of this action.  The waiting time adjustment will include time the candidate had at a lower exception score from the May 14 initiation of NLRB up until this action. To request a waiting time adjustment for a candidate, please submit a Waiting Time Modification form.  These forms are located in UNetSM; navigate to the WaitListSM, then on the top menu select “Resources”, then select “Forms/Tools.”

Median PELD at Transplant (MPaT) is unaffected by this action.  MPaT is the same for all transplant programs with PELD exception candidates and will remain at 35.

As always, transplant programs may request individual exception scores for candidates by the procedure set forth in OPTN Policy 9.4 (MELD or PELD Score Exceptions).

If you have questions about data or information systems, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

OPTN liver allocation policy reverted to DSA and regions

May 23, 2019 – OPTN Policy 9 (Allocation of Livers and Liver-Intestines) has reverted to use of the donation service area (DSA) and regional distribution boundaries in effect prior to May 14, 2019. This action complies with a federal court order dated May 17, 2019.

The National Liver Review Board (NLRB) remains in effect. Candidates’ currently assigned exception scores did not change. As always, transplant programs may request individual exception scores for candidates by the procedure set forth in OPTN Policy 9.4 (MELD or PELD Score Exceptions).

Resources

The updated liver allocation policy is available in the Policies section of the OPTN website.

Online help documentation covering UNetSM functionality is also available.

Questions? If you have questions about data or information systems, contact UNOS Customer Service at 800-978-4334. For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

Pre-implementation notice: OPTN liver allocation policy to revert to DSA and regions May 23, 2019

May 21, 2019 – On May 23, 2019, OPTN Policy 9 (Allocation of Livers and Liver-Intestines) will revert to use of the donation service area (DSA) and regional distribution boundaries in effect prior to May 14, 2019. This action is being taken in compliance with a federal court order dated May 17, 2019.

The UNOS Secure EnterpriseSM system, which includes UNetSM and other transplant applications such as WaitlistSM, DonorNet®, TIEDI® and KPDSM, will be unavailable for a brief period the morning of May 23 to allow for implementation. These services will be offline from 7:00 a.m. EDT until approximately 8:00 a.m. EDT. Please save all data prior to this time.

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.

The National Liver Review Board (NLRB) will remain in effect. Candidates’ currently assigned exception scores will not change.

Resources

The allocation policies in effect as of system implementation will be posted to the Policies section of the OPTN website.

Online help documentation covering UNetSM functionality is also available.

Questions? If you have questions about data or information systems, contact UNOS Customer Service at 800-978-4334. For policy-related questions, send an e-mail to questions@unos.org or call 844-395-4428.

Liver policy to revert to DSA-based system due to court order

May 17, 2019 – 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.

We understand that these events are unfolding rapidly. We will continue to keep you informed of new developments.

Court order cease and desist on further liver policy implementation

May 15, 2019 – 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.

Liver policy changes and National Liver Review Board in place

May 14, 2019 – 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. Additional details about the policy are available on the liver distribution page on the UNOS website.

Learn more about the liver distribution policy approved by the OPTN Board of Directors in December 2018.

Learn how liver candidates are prioritized for transplant and about the national liver review board (NLRB)

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