Liver policy updates

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Updated Median MELD at Transplant scores take effect September 29

Sept. 17, 2021 – Effective September 29, 2021, the median MELD at transplant (MMaT) for liver candidates with exception scores will be updated. The updated table lists the MMaT for each liver transplant hospital that will be in effect as of that date, as well as the details of the MMaT calculation.

If you wish to compare the new MMaT to the values current through September 28, this chart shows the current scores and those that will be updated.

The scores are updated twice a year. They are based on recent liver transplants performed at all liver transplant hospitals within a 250 nautical mile radius of the hospital listing the exception candidate, with exclusions based on certain candidates and procedure types.

Many individual candidates’ exception score will remain the same as it was under the previous calculation. Exception scores for other candidates will either increase or decrease. 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).

The Median PELD at Transplant (MPaT) was recalculated using updated data but results remained the same. The MPaT is a national calculation and is the same for all transplant programs with PELD exception candidates. It will remain at 35.

Updated NLRB exception requirements effective October 7

Sept. 17, 2021 – The OPTN will implement several enhancements to the National Liver Review Board (NLRB) on October 7, 2021. The OPTN Board of Directors approved some of these actions at its December 2020 meeting and another at its June 2021 meeting. These actions include:

  • Updated criteria for initial or extension standardized exception requests for candidates with portopulmonary hypertension
  • A new Appeals Review Team to address second appeals of exception requests for pediatric candidates
  • Procedural changes to NLRB operations to increase consistency between the NLRB and the National Heart Review Board (NHRB)
  • Updated qualifications for a standardized exception for liver transplant candidates with cholangiocarcinoma

For more detail, refer to the policy notices for the enhancements approved in December 2020 and June 2021, respectively.

An additional provision approved in December 2020 addressed improvements to the review of post-transplant explant pathology forms for candidates with hepatocellular carcinoma. This provision is subject to approval by the federal Office of Management and Budget prior to implementation and is not part of the October 7 release. You will be notified when this provision is set for implementation.

Liver transplant programs should be aware of the new features and requirements, as they may affect the qualifications for exception scores for some  transplant candidates. For the updated criteria regarding candidates with portoplumonary hypertension or cholangiocarcinoma, new data fields have been added to the exception request form.

Updated 15–month monitoring report available for liver, intestine policy

Sept. 15, 2021 – A data report is available in the Liver and Intestine section of Resources on the OPTN website. The report contains key measures of the new liver and intestinal organ allocation policy for the 15-month period from initiation in early February 2020 through early May 2021.

Given the impact of the COVID-19 pandemic on candidate listing and transplantation, the embedded tables and charts denote activity before and after the World Health Organization’s declaration of the pandemic on March 13, 2020, where relevant.

Since much of the post-implementation period has coincided with the pandemic, its effect on system performance should be considered. Keeping that in mind, several key trends are apparent:

  • More than 200 additional deceased donor, liver-alone transplants have been performed since the policy implementation as compared to the equivalent pre-implementation period. The increase has occurred in adult recipients, while the number of pediatric transplants has remained similar.
  • As intended in the policy, geographic variability in median urgency scores at transplant has decreased at the levels of donation service area, state and region. The national median score at transplant for adults remains unchanged at 28; the national median for pediatric recipients dropped from 35 to 30.
  • The great majority of liver transplant programs have experienced similar transplant volume before and after the policy change.
  • As expected, the median distance between donor hospital and transplant hospital has increased, particularly for recipients with higher medical urgency. More transplants are being performed at distances between 250 and 500 nautical miles. Median cold ischemic time increased only slightly (roughly 13 minutes for adult recipients; about 34 minutes for pediatric recipients).
  • While there were fewer deceased donors with a liver recovered (decreased utilization rate) since the policy came into effect, those that did have a liver recovered more often resulted in a transplant (decreased discard rate).
  • The total number of intestine transplants increased slightly since the policy took effect.

Subsequent monitoring reports will be posted on an ongoing basis.

OPTN Board approves liver allocation refinements

June 30, 2021 – The Board of Directors of the Organ Procurement and Transplantation Network, at a virtual meeting held June 14, approved 40 vascularized composite allograft (VCA) transplant programs across eight specialty categories. VCA transplants involve complex structures that may include organs, bone, muscle, skin, nerves, blood vessels and/or connective tissue.

“The fact that we now have these specialty programs is a reflection of how rapidly VCA transplantation has evolved in just the last few years,” said David Mulligan, M.D., president of the board. “We believe this will allow these programs to provide high quality of care and continue to advance successful treatment for VCA recipients.”

Each approved program has met previously approved OPTN minimum requirements, including specific training and experience of key personnel. The new, specialized VCA transplant program categories are:

  • Upper limb
  • Head (craniofacial allograft) and neck
  • Abdominal wall
  • Genitourinary organs
  • Glands
  • Lower limb
  • Musculoskeletal composite graft segment
  • Spleen

The searchable Member Directory on the OPTN website now lists approved transplant programs for each of the VCA specialties.

In a separate action, the Board voted to modify the OPTN living donor policy to incorporate requirements for living donor VCA transplants. This action will allow living donor VCA transplantation to be consistent with the overall requirements of OPTN living donor policy, with some specific provisions for VCA living donor procedures. Of the 32 uterine transplants performed in the United States between September 2016 and May 2021, 20 have involved living donors.

Liver allocation updates

The Board accepted modifications to the liver allocation policy concerning the calculation of median MELD at transplant (MMaT) scores for candidates who have exception scores. The MMaT calculation will now be based on transplants performed within a 150 nautical mile circle around the donor hospital; the MMaT is currently based on transplants performed within 250 nautical miles of the candidate’s transplant hospital.

The modifications will also change the order of sorting liver transplant candidates on organ match runs.  Pediatric candidates will appear on the match run before adult candidates when they have the same MELD or PELD score and the same compatibility with the donor’s blood type. In addition, transplant candidates without a MELD or PELD exception will appear on the match run before exception candidates when they have the same MELD or PELD score and the same compatibility with the donor’s blood type, and when they are in the same age category (pediatric or adult).

Strategic plan

The board approved a new OPTN Strategic Plan for 2021 through 2024. While the overall goals are similar to those in previous plans, the supporting objectives, tasks and priorities have been extensively restructured with input from the transplant community and public. A previous strategic goal of increasing efficiency of the OPTN has now been incorporated into the broader goal of increasing transplants. The new plan contains four strategic goals:

  • Increase the number of transplants
  • Provide equity in access to transplants
  • Improve waitlisted patient, living donor, and transplant recipient outcomes
  • Promote living donor and transplant recipient safety

Other actions

The board took additional actions as follows:

  • Approved clarifications to policies that address allocation of multiple organs (Sponsor: Organ Procurement Organization Committee)
  • Accepted updates to guidance used by the National Liver Review Board (NLRB) and a policy clarification regarding exceptions for candidates with cholangiocarcinoma (Sponsor: Liver and Intestinal Organ Transplantation Committee)
  • Endorsed updates to organ offer refusal codes (Sponsor: Data Advisory Committee)
  • Approved modifications to the Deceased Donor Registration form Sponsor: Organ Procurement Organization Committee)
  • Accepted requirements for member notification in cases where HLA typing of donors or transplant candidates has changed (Sponsor: Histocompatibility Committee)
  • Approved clarifications to policies and bylaws regarding VCA transplantation (Sponsor: Vascularized Composite Allograft Transplantation Committee)
  • Endorsed revisions to an OPTN Ethics Committee white paper addressing General Considerations in Assessment for Transplant Candidacy (Sponsor: Ethics Committee)

Discussion items

The Board was briefed on the OPTN Executive Committee’s resolution to sunset an emergency action related to listing non-dialysis kidney transplant candidates during the COVID-19 pandemic. The Board hosted additional discussion on the following initiatives:

  • An update and early data analysis relating to the revised kidney and pancreas allocation system implemented in March 2021
  • A presentation from the OPTN Network Operations Oversight Committee (NOOC), assessing a number of metrics regarding the organ matching system and implementation of Board-approved projects and describing upcoming IT system enhancements
  • A project in development by the OPTN Membership and Professional Standards Committee to improve metrics used in monitoring of transplant programs
  • Data analysis of the 12-month period since implementation of the acuity circles system for liver and intestinal organ transplantation
  • A feasibility study and potential data sources to analyze how social determinants of health may affect organ transplantation
  • Progress to date on a study of the OPTN regional structure, an initiative called for in the current OPTN contract
  • Progress to date on seeking nominees for open Board and committee positions for 2022
  • Updates on projects under review by the OPTN Policy Oversight Committee
  • An update from the OPTN Finance Committee on the status of the current fiscal year budget

Updated 12-month monitoring report available for liver, intestine policy

Apr. 13, 2021 – A data report is available in the Liver and Intestine section of Resources on the OPTN website. The report contains key measures of the new liver and intestinal organ allocation policy for its first 12 months of operation.

Given the impact of the COVID-19 pandemic on candidate listing and transplantation, the embedded tables and charts denote activity before and after the World Health Organization’s declaration of the pandemic on March 11, 2020, where relevant.

Since much of the post-implementation period has coincided with the pandemic, its effect on system performance should be considered. Keeping that in mind, several key trends are apparent:

  • As intended, the policy has begun reducing geographic variability in median MELD scores at transplant. This is more apparent for larger geographic areas such as region and state than by individual DSA or transplant programs.
  • As anticipated, the policy has increased transplant rates for more urgent MELD/PELD candidates and for pediatric candidates between the ages of 12 and 17.
  • Despite the effects of the pandemic, the number of livers transplanted in the post-policy era was essentially the same as before, with a slight increase in the number of livers used in multi-organ procedures and a slight decrease in liver-alone transplants.
  • The number of waiting list removals decreased for reasons of patient death or being too sick to transplant.
  • The great majority of liver transplant programs have experienced similar transplant volume before and after the policy change.
  • As expected, the median distance between donor hospital and transplant hospital has increased (72 to 141 nautical miles for adult transplants), particularly for adult recipients with higher medical urgency. The median cold ischemic time, however, increased only slightly (12 minutes for adult transplants).
  • There was no significant difference in 6-month patient survival.

Subsequent monitoring reports will be posted on an ongoing basis.

Notice of Implementation: Expedited Liver Placement policy

Mar. 25, 2021

Audience

Organ Procurement Organization (OPO)

    • Primary OPO Administrative Directors, Primary Data Coordinators
    • Organ Procurement Adms/Mgrs, Regulatory Affairs Coordinators/Managers, Compliance Officers, Data Coordinators, OPO Quality Managers/Coordinators, Quality Coordinators, Quality Directors/Managers, Organ Placement Coordinators, Organ Procurement Coordinators, Organ Procurement Adms/Mgrs

Transplant center (TXC)

    • Liver Primary Program Administrators, Primary Data Coordinators, Primary Physicians, Primary Surgeons
    • Liver TX Program Administrators/Managers, TX Program Directors, TX Program Medical Directors, Clinical Training Coordinators/Managers, TX Program – Clinical Coordinators, Support Staff-Clinical, Data Coordinators, Regulatory Affairs Coordinators/Managers, Compliance Officers, Quality Directors/Managers, Quality Coordinators, TX Program Surgical Directors, TX Surgeons

Implementation date: March 25, 2021

At-a-glance

To clarify expedited placement surrounding deceased donor whole livers, this release gives clarity surrounding how to place these organs when late turndowns occur, provide guidance for organ procurement organizations (OPOs) and transplant hospitals (TXC) when there is a need to utilize expedited placement, and provide a consistent process which can be practiced across the country and regulated by policy.  The policy was implemented March 25, 2021.

What you need to do

  • OPO
    • Staff may begin utilizing the expedited liver placement process. See the education and resources provided below to aid in this.
    • Start deciding when to initiate expedited placement on deceased donor livers when appropriate according to associated policy 9.10.B.
    • Report data to the OPTN within the workflow wizard in accordance with policy 9.10.B prior to sending expedited liver offers.
    • Enforce the new 30-minute evaluation time limit for expedited offers by applying a bypass to the transplant hospitals that have exceeded this time limit.
  • TXC
    • Continue updating Contact Management in DonorNet® with on call contacts to receive expedited organ offer notifications.
    • Continue evaluating liver candidates on a candidate-by-candidate basis to receive expedited liver organ offers.
    • Begin managing expedited organ offer notifications, this includes adhering to the new 30-minute evaluation time limit for expedited offers received.
    • See previous system notice for more information on the above transplant hospital details.

Additional details

Phase 1 implementation was released Feb. 25, 2021, and was intended to give transplant hospitals one month to complete the tasks listed in the previous notice.  This release, Phase 2, is the final release for this implementation. It gives OPOs the tools they need to initiate expedited liver offers. Both OPO staff and transplant hospital staff should be prepared to utilize these tools and respond to these offers respectively.

Education and resources

  • Look for the following course in UNOS Connect, accessible to UNetSM users through the resources tab on the Secure Enterprise (UNet) homepage.
    • SYS164: Expedited Liver Placement for OPOs and transplant hospitals – an interactive module with the following additional resources
      • Opting in job aid
      • System related FAQ (also found in DonorNet Online Help)
  • OPTN policy notice: Expedited Liver Placement
  • Toolkit: Expedited Liver Placement
  • Online help documentation covering UNet functionality available now. Access Secure Enterprise and then choose either WaitlistSM or DonorNet. On the Help menu, click Online Help. You may search for a specific help topic or use the table of contents to assist with your search.
  • Use our supported browsers to optimize functionality on the UNet system. Prepare for UNet to stop supporting the Internet Explorer web browser on Sept. 30, 2021. An email with more information was sent to UNet users and posted to Secure Enterprise on Nov. 30, 2020.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 800-978-4334 from 8 a.m. to 7 p.m. ET.

For policy-related questions, contact member.questions@unos.org.

New expedited liver policy in effect

Mar. 25, 2021

Effective March 25, 2021, the Organ Procurement and Transplantation Network implemented a new policy to establish a system for the expedited placement of deceased donor whole livers in the event of a late turndown by an intended candidate.

The new policy clarifies how to place these organs and provides requirements for organ procurement organizations (OPOs) and transplant hospitals when there is a need to expedite placement of deceased donor livers. It also provides a consistent process which can be practiced across the country and regulated by policy.

As a result of the new policy, OPOs must be aware that expedited liver candidates will be identified on the original liver match run. This will allow for advanced planning and communication for potential expedited offers.

Transplant hospitals have the opportunity to indicate their willingness to accept an expedited liver offer on a candidate-by-candidate basis, but in order to participate they are required to enter specific acceptance criteria in advance. They must also respond with a provisional “yes” to expedited offers within 30 minutes in order to be eligible to receive the liver for their candidate. After the 30-minute period, OPOs are required to place the liver with the candidate with a provisional “yes” that appears highest on the match run.

Previous OPTN liver allocation policy did not address the expedited placement of organs. The absence of policy language created a lack of transparency about how late turndowns are handled, and a lack of consistent guidance for OPOs and transplant hospitals. This could have ultimately affected a candidate’s access to a lifesaving liver transplant if they were bypassed on the match run.

Questions?

Find more details about the changes, including professional education and monitoring information, in the policy implementation toolkit in the Professional Education section of this website.

Learn more about the implementation here.

Expedited Liver Placement policy implementation begins March 25, 2021

Feb. 26, 2021

Audience

  • Organ Procurement Organizations
    • Primary OPO Administrative Directors, Primary Data Coordinators, Organ Procurement Adms/Mgrs, Regulatory Affairs Coordinators/Managers, Compliance Officers, Data Coordinators, OPO Quality Managers/Coordinators, Quality Coordinators, Quality Directors/Managers, Organ Placement Coordinators, Organ Procurement Coordinators, Organ Procurement Adms/Mgrs
  • Transplant Hospitals
    • Liver Primary Program Administrators, Primary Data Coordinators, Primary Physicians, Primary Surgeons, Liver TX Program Administrators/Managers, TX Program Directors, TX Program Medical Directors, Clinical Training Coordinators/Managers, TX Program – Clinical Coordinators, Support Staff-Clinical, Data Coordinators, Regulatory Affairs Coordinators/Managers, Compliance Officers, Quality Directors/Managers, Quality Coordinators, TX Program Surgical Directors, TX Surgeons

Implementation date: March 25, 2021

 At-a-glance

To clarify expedited placement surrounding deceased donor whole livers, this release aims to give clarity on how to place these organs when late turndowns occur and provides guidance for organ procurement organizations (OPOs) and transplant hospitals (TXC) when there is a need to utilize expedited placement. It also provides a consistent process which can be practiced across the country and regulated by policy.  All associated policies will be implemented March 25, 2021.

What you need to do 

  • OPOs
    • Will need to prepare staff to begin utilizing the expedited liver placement process. See the Education and Resources section below to aid in this training.
    • Upon release, will need to start deciding when to initiate expedited placement on deceased donor livers when appropriate according to associated policy 9.10.B.
    • Will need to report data to the OPTN, within the workflow wizard in accordance with policy 9.10.B, prior to sending expedited liver offers.
    • Will need to enforce the new 30-minute evaluation time limit for expedited offers by applying a bypass to the transplant centers that have exceeded this time limit.
  • TXCs
    • Will need to continue updating Contact Management in DonorNet® with on call contacts to receive expedited organ offer notifications. See previous system notice.
    • Will need to continue evaluating liver candidates on a candidate-by-candidate basis to receive expedited liver organ offers. See previous system notice.
    • Will need to begin managing expedited organ offer notifications. This includes adhering to the new 30-minute evaluation time limit for expedited offers received.
    • See previous system notice for more details on the above TXC details.

Additional details

Phase 1 implementation was released Feb. 25, 2021, and was intended to give the transplant hospitals one month to complete the tasks listed in the previous notice.  This release, Phase 2, is the final release for this implementation and will give the OPOs the tools they need to be initiating expedited liver offers.  Both the OPO staff and TXC staff should be prepared to utilize these tools and respond to these offers respectively.

Education and resources

  • The following training materials are available in UNOS Connect and accessible to UNetSM users through the resources tab on the Secure Enterprise (UNet) homepage:
    • SYS106-D: Opting in for Expedited Liver Offers
    • SYS164: Expedited Liver Placement for OPOs and TXCs – available March 8, 2021
    • System-related FAQ is attached as a resource to both courses above as well as in the DonorNet Online Help
  • OPTN policy notice: Expedited Liver Placement
  • Online help documentation covering UNet functionality will be available when the system updates go into effect. Access Secure Enterprise and then choose either WaitlistSM or DonorNet. On the Help menu, click Online Help. You may search for a specific help topic or use the table of contents to assist with your search.
  • resource toolkit is available on the OPTN website.

Additional OPO education and resources

To help you prepare for the release of expedited liver placement in March, we would like you to have an opportunity to log into a test version of the system to preview the new expedited liver placement tools.

The test site will be available from Tuesday, March 9 through Friday, March 12, and will be populated with blinded test data.  If you are interested in participating in this opportunity, please email the IT Project Lead, Darby Harris (darby.harris@unos.org), and provide a primary contact name, phone number and email address.

The deadline for submitting your OPO as a participant is Friday, March 5.  Login information and detailed instruction will be provided to your named contact on Monday, March 8. This test site will not be available after March 12.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 800-978-4334 from 8 a.m. to 7 p.m. ET.

For policy-related questions, contact member.questions@unos.org.

Expedited Liver Placement: Phase 1 implementation underway

Feb. 25, 2021

Audience (Please share this notice with anyone in your organization who would benefit from it.)

  • Transplant liver program directors, administrators, coordinators, compliance and quality officers, and clinical support staff
  • Primary data coordinators
  • Member representatives and alternate representatives

Implementation date

Feb. 25, 2021

At-a-glance statement

In preparation to receive expedited liver offers from deceased donors, transplant centers need to opt-in their candidates. This must be done on a candidate-by-candidate basis within the candidate’s liver registration in WaitlistSM. Transplant centers will need to designate an on call contact for their center within Contact Management in DonorNet®, this contact will receive the expedited liver organ offers.

What you need to do

  • Transplant centers need to evaluate liver candidates individually and either opt-in or opt-out to receiving expedited offers. To opt-in, the candidate record must be marked as “yes” to accept an expedited liver recovered by any procurement team. Those that have not opted-in will not qualify to receive expedited liver offers. Your candidate will be neither set as opted-in nor opted-out for expedited offers, your candidates will be set to a new status, “waiting for response.”  It is up to your program to either opt-in or opt-out for expedited offers on a candidate-by-candidate basis.  The new “waiting for response” status is included in Custom Report options and is intended to help your center manage the candidates who are neither opted-in nor opted-out for expedited liver offers.
  • Transplant centers need to specify who is on call to receive expedited organ offers, the same way contacts are set for local or import organ offers today. Transplant centers should consider designating the direct decision maker for organ offers as the new expedited offer contact, as these organ offers have a new evaluation time limit of 30 minutes.

Additional details

Phase 1 gives transplant centers one month to complete the tasks above, as Phase 2 implementation will give organ procurement organizations the tools they need to begin placing expedited livers. The tasks are necessary to complete in order to begin receiving expedited organ offers beginning on March 25, 2021, with Phase 2 implementation.

Education and resources

  • Look for the following training materials in UNOS Connect, accessible to UNet users through the resources tab on the Secure Enterprise (UNet) homepage.
    • SYS106-D: Opting in for Expedited Liver Offers – available now
    • SYS164: Expedited Liver Placement for OPOs and TXCs – available March 8, 2021
  • OPTN policy notice: Expedited Liver Placement
  • Online help documentation covering UNet functionality is now available. Access Secure Enterprise and then choose either Waitlist or DonorNet. On the Help menu, click Online Help. You may search for a specific help topic or use the table of contents to assist with your search.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at unethelpdesk@unos.org, or call 800-978-4334 from 8 a.m. to 7 p.m. ET.

For policy-related questions, contact member.questions@unos.org.

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.

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.

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.

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.

 

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.

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.

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.

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.

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.

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.

Making liver distribution more fair and equitable

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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United States Government Accountability Office (GAO) Report

Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs

Published October 2020 Congressional requestors asked the GAO to review changes to the OPTN's liver and lung allocation policies. In the past, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, after changes in 2017 and 2020, livers and lungs are now generally offered first to the sickest candidates based on distance. This report describes changes to the liver allocation policy. It examines the OPTN's processes for changing the liver and lung allocation policies, and describes federal oversight. Read full GAO report
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