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Making allocation more fair and flexible

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Summer 2020 public comment was open Aug. 4 – Oct. 1

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Public comment is a critical forum for national discussion on organ transplant policy. When public comment has closed, OPTN volunteer committees analyze the themes and concerns voiced by the community as they review proposals and continue the policy development process.

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Project

Update on the Continuous Distribution of Organs Project

What is the purpose of this project?

The current system allocates lungs by placing candidates into categories that are considered and prioritized in sequence. When reviewed in sequence, sometimes candidates are placed on the side of a hard boundary that would stop them from being prioritized further on the match run. This proposed framework will consider multiple patient factors all at once with an overall score. This overall score includes not only medical urgency and patient outcomes, but also factors such as biologic match and efficiency of organ transport. This paper is an update from the Lung Committee and a request for community feedback through an exercise that will help inform the Committee’s work.

Read more about continuous distribution.

Read about continuous distribution

What could this project accomplish?

This project could accomplish:

  • Provide a more complete approach to matching candidates and donors
  • Remove hard boundaries that prevent candidates from being prioritized further on the match run
  • Establish a system that is flexible enough to work for each organ type on the match

What this project wouldn’t do:

  • This paper is not a proposed policy change

Key themes to consider: 

  • Attributes identified to be included in score
  • Additional attributes that should be included
  • Weight of attributes in final score

“Coming from a lung recipient family, this is a step toward a welcome change to removing hard geographic boundaries from lung allocation, and this will be especially beneficial for highly sensitized patients. The current allocation exceptions for highly sensitized patients aren’t sufficient, and incorporating CPRA would help ensure access.”

Anonymous 

OPTN public comment

“Would give more weight to patient acuity and equal to the remainder.”

Anonymous 

OPTN public comment

“Laudable concept. The various weights attributed to the goals that form the composite allocation score will be critically important and debate over this will likely be contentious. Of the composite elements, placement efficiency seems to be the least important and should be given the least weight. The aura concept seems extremely problematic, and the committee’s apparent lack of favor at this time for the aura approach to allocation is noteworthy and correct. As the committee has noted, the aura approach is in violation of a long held paradigm of placing organs with candidates, not with programs, and the committee should be lauded for discarding the aura approach.”

Anonymous 

OPTN public comment

“LifeGift supports the continuous distribution concept and its framework of the 5 goals in order as written in the proposal material. It reduces the impact of accidents of geography and is generalizable to all organs. It will be important to consider the increasing presence of new preservation devices and modalities in the fifth goal. These devices allow for longer preservation times if the organ is transported on device and thus distance attribute points assignments will need to be modified for this welcomed advancement in organ preservation.”

LifeGift

OPTN public comment

Proposal

COVID-19 Emergency Policies and Data Collection

What actions were taken?

The following actions were implemented to assist the transplant community and promote patient safety during the COVID-19 pandemic:

 

  • Updating Candidate Data During 2020 COVID-19 Emergency
  • Relaxing Data Submission Requirements for Follow-up Forms
  • Modifying Wait Time Initiation for Non-Dialysis Kidney Candidates
  • Incorporating COVID-19 Infectious Disease Testing into DonorNet®

What feedback is requested?

The OPTN would like feedback on actions taken to help the transplant community during the pandemic while still promoting patient safety. For all of these, the Executive Committee would like to know:

 

  • Were these the right actions?
  • How long should they stay in effect?
  • Do you support use of the emergency action pathway for these changes?
Read the proposal and view more comments.

“CASD applauds the OPTN’s efforts to partner with transplant centers and OPOs across the country during these unprecedented times. In direct response to the requested feedback relating to the emergency actions takes, CASD offers the following: o We strongly support each of the initiatives taken by the Executive Committee aimed at reducing unnecessary risk posed by the potential spread of COVID19 and barriers in accessing timely transplant related care. o Initially these actions were set to expire within a 12 month timeframe. In light of the constantly changing environment and daily updates to national recommendations in best practices, CASD support the Board of Directors delegating the responsibility of continuing to monitor the situation and proposal of additional policy modifications and repeal of these emergency actions to the Executive Committee. It is imperative that COVID-19 infectious disease testing remain in DonorNet, and we would recommend that until the community has more reliable information available on the potential impact of the virus on our patient population these fields should require a response. We do not support the OPTN requiring retrospective data entry on the follow-up forms given amnesty status. This would create a significant and costly administrative burden on institutions that are already struggling due to the impact COVID19 has had on operations and finances. We would agree that the emergency policy process utilized by the OPTN was an appropriate way to respond in this event and would support a similar process for future incidents. The initial communications to members regarding these emergency actions were very confusing. While UNOS and the OPTN typically do not provide recommendations on how centers should translate policy to practice, it would have been very helpful to have had clearer guidance in these instances. MPSC and the survey teams should most certainly be involved in the development of such guidelines. Although CASD was not subject to a virtual audit, it seems contradictory that UNOS would continue routine surveys when federal agencies suspended theirs.”

UC San Diego Center for Transplantation, CASD

OPTN public comment

“COVID-19 Emergency Policies and Data Collection The Operations and Safety Committee thanks the OPTN Executive Committee for their efforts in developing this special public comment proposal for the COVID-19 Emergency Policies and Data Collection. The Committee agreed that the Executive Committee took appropriate action and that tracking this data is important. The Committee agreed that COVID-19 infectious disease testing should remain in DonorNet®, but that it should not be a mandatory field, as it could stifle the allocation process.”

OPTN Operations and Safety Committee 

OPTN public comment

Proposal

Further Enhancements to the National Liver Review Board

What is the purpose of this proposal? 

The National Liver Review Board (NLRB) reviews requests from transplant programs for candidates whose model for end-stage liver disease (MELD) score or pediatric end-stage liver disease (PELD) score does not accurately reflect their medical urgency for transplant. The NLRB can approve or deny the request. If the NLRB denies the request, the transplant program can appeal the case.

The NLRB uses policy, guidance documents, and operational guidelines to inform their decision to approve or deny a request. Based on feedback and lessons learned, the committee wants to update those documents so the process works better for programs and candidates. The proposal includes changes to policy, operational guidelines, and guidance documents.

Read the proposal and view more comments.

What’s the anticipated impact of this change?

What it’s expected to do: 

  • Provide updated clinical requirements in policy for transplant programs submitting an exception request for a candidate with portopulmonary hypertension (POPH)
  • Provide a more effective process for reviewing Post-Transplant Explant Pathology forms for candidates listed with hepatocellular carcinoma (HCC)
  • Provide more guidance for National Liver Review Board (NLRB) members when reviewing exception score requests for candidates with polycystic liver disease (PLD)
  • Create a pediatric specific Appeals Review Team (ART) to review appeals for pediatric candidate exception requests
    Add a member of the Liver and Intestinal Organ Transplantation Committee as the ART leader

What it won’t do:

  • This proposal will not impact how liver candidates are prioritized on the match run to receive a potential transplant

Key themes to consider:

  • Additional National Liver Review Board (NLRB) improvements

“PSC patients are unfairly forgotten when livers are available due to lower MELD scores. Doctors should be allowed to give at least 3 discretionary points for these patients as they suffer greatly but it’s not reflected in the MELD score. My husband is a PSC patient and I was fortunate to be a match for living liver donation. Because his kidneys worked perfectly, he more than likely would not have made it to the top of the list for a deceased donor before developing cholangiocarcinoma. Many PSC patients don’t have a living donor option and suffer from hepatic encephalopathy, ascites, jaundice, severe fatigue, insomnia and so much more for years. They often become so sick that they can’t be transplanted. The MELD score should account for PSC patients and the suffering they endure despite the lower MELD. Please help PSC patients!”

Deven Daehn

OPTN public comment

“The ART “Leader” for the Pediatric NLRB should be an experienced UNOS certified Pediatric physician or Surgeon and not “just a Liver Committee member” which is most likely to be an adult liver physician or surgeon. Ruling out other causes of POHP can be difficult due to patients who have multiple risk factors.”

OPTN’s Region 4 

OPTN public comment

“Please adjust the proposal to include adding exception points for patients with PSC and PBC. The MELD score does not accurately reflect level of sickness and quality of life of these patients. The common scenario in these patients is that kidney function remains high despite extremely deteriorated liver function, which means patients are much, much sicker before they have a high enough score for transplant. Please consider adjusting for this disparity by allowing exception points in patients with these diseases.”

Anonymous 

OPTN public comment

“I am so thankful for my SPLIT community for advocating for children on the waitlist. In response to the pediatric specialty ART: this NLRB enhancement is sorely needed. Our transplant team has seen so many comments regarding denials of our pediatric non-automated exception score submissions that seemed to indicate that there was a lack the core pediatric knowledge needed for the review. Our team welcomes feedback from NLRB, but it must be constructive and from peers that know pediatrics. This change will make the scoring on a more even playing field for kids. Currently we are relying on those who are not trained in the field of pediatrics to make decisions for pediatric listed patients, and it is resulting in very inconsistent voting among reviewers that we can tell from the comments are adult specialists with limited to possibly no pediatric experience.”

SPLIT 

OPTN public comment

Proposal

Guidance and Policy Addressing Adult Heart Allocation

What is the purpose of this proposal? 

In 2018, adult heart allocation policy was changed to better sort candidates based on their medical urgency. The Heart Committee (formerly the Thoracic Committee) monitored the impact of the changes and identified opportunities for improvement. This proposal will provide clearer information for transplant programs submitting exception requests. It also gives improved guidance to regional review board members who evaluate these requests. Additionally, it changes policy to make clear when certain data need to be submitted and provides more consistent timeframes for how long statuses last. The goal is to further clarify current adult heart status criteria.

Read the proposal and view more comments.

What’s the anticipated impact of this change?

What it’s expected to do:

  • Help ensure that candidates with similar medical urgency are treated equally
  • Provide transplant programs more information on what they need to include in their exception requests
  • Create more consistency with Review Board decisions on exception requests

Themes to consider: 

  • What the volume of Status 2 exception requests suggests about adult heart statuses in policy
  • Usefulness of guidance for Status 2 exception requests
  • Appropriateness of proposed timeframes within adult heart statuses

“Agree with the timeframe for patients on inotropes and the creation of criteria/document for status 2 patients. In regards to Status 1 patients and changing the time frame to 7 days. These are the sickest of the sick, usually on ECMO or biventricular support. There is very little chance that their condition would improve in 7 days without transplantation, to the point of being downgraded. Therefore, having the timeframe decreased to 7 days would only add additional work on the transplant center instead of truly benefitting or even increasing the patient’s chances of receiving an acceptable offer, especially in patients with O blood group.”

University of Alabama at Birmingham

OPTN public comment

Proposal

Align OPTN Policy with U.S. Public Health Service Guideline, 2020

What is the purpose of this proposal? 

In June 2020, the U.S. Public Health Service (PHS) updated the Guideline for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection due to improved testing and risk assessment methods. The OPTN must change its policies to be consistent with the updated Guideline.

Read the proposal and view more comments.

What’s the anticipated impact of this change?

The proposal will:

  • Increase number of transplants and minimize risk of transmission of HIV, HBV and HCV
  • Provide a framework for discussion of risks and benefits of accepting and declining organs from donors with risk criteria for acute HIV, HBV, and HCV infection
  • Promote early identification and treatment for HIV, HBV and HCV

It will not:

  • Eliminate the need to inform candidates that organs have risk criteria for HIV, HBV, and HCV transmission
  • Eliminate the absolute risk of disease transmission events

Key themes to consider:

  • Potential changes to organ use
  • Length of time required for living donor sample storage
  • Removal of hemodilution as a risk criteria
  • Feasibility of collecting additional data related to HBV vaccination status

“This proposal is long overdue. This policy will help assayed patient and provider concerns about infectious risk transmission through transplant by reducing the “labeling” effect, will likely lead to increased utilization of these currently “labeled” organs, and reduce compliance regulatory burden for transplant centers around special consents, non-uniform consenting processes for patients, and so on. I strongly support this proposal.”

Amit K. Mathur, MD

OPTN Public comment

“While I support the effort to create a safer system for recipients, I am concerned with the testing requirements for recipients. Having to do NAT testing on a 3 month old prior to transplant and in the post transplant timing just does not make any sense to me. I am unaware of any babies getting an infectious disease from a transplant. That aside why would we test again when the donor was negative and the pre-transplant testing was also negative. The burden on transplant centers for post testing will be difficult for larger centers and also does not make sense if both the donor and pre-transplant recipient testing indicate a negative result. This seems to be a solution for a problem that does not exist particularly in the pediatric world.”

William Pelley

OPTN Public comment

“Given a negative deceased donor NAT, the likelihood of disease transmission (HIV, HCV, HBV) to the recipient is roughly one in a million (Source, DTAC presentation to MPSC, 8/20/2020). We do roughly 23,000 deceased donor kidney transplants a year in this country. We would need to transplant patients for over 40 years to get one true positive test result. So, this policy proposes to require transplant programs to test every recipient despite the vanishingly low likelihood of a positive test due to the transplant? I am concerned that the significant resources needed to obtain all these negative tests, enter, store, and access the data, and make that data available for surveyors could be better spent advancing the strategic initiative of transplanting more patients in need. The community may need clarification on that.”

Steven Potter 

OPTN Public comment

What is public comment?

Public comment is a crucial part of policy development. It's a time for donor families, transplant candidates, organ recipients, donation and transplant professionals and the general public to provide feedback and engage in debate about policies that govern organ matching and allocation. To make the nation’s organ donation and transplantation system fair and equitable for all, many voices are needed and every view matters.

Please see the resources listed here to learn more about how UNOS convenes the organ donation and transplant community and the public in this twice yearly forum.

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