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Incorporating COVID-19 Related Organ Failure In Candidate Listings

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This is a special public comment proposal because it was issued on August 31, after public comment opened on August 4, 2020. The special public comment period will close on October 1, 2020.

eye iconAt a glance

What is current policy and why change it?

Currently, there is no way to indicate a patient is in need of a lung transplant due to damage caused by a COVID-19 infection. This means there is no way to identify trends among these patients. Collecting this information now will help the OPTN decide if the Lung Allocation Score (LAS) needs to be updated in the future to better classify these patients.

Incorporating COVID-19 Related Organ Failure in Candidate Listings

Elizabeth Miller, UNOS Policy Analyst, reviews the policy proposal Incorporating COVID-19 Related Organ Failure in Candidate Listings.

Terms you need to know

  • Lung Allocation Score (LAS): In the OPTN lung allocation system, every lung transplant candidate age 12 and older receives a lung allocation score. The LAS is used with blood type and the distance between the candidate and the donor hospital to determine priority for receiving a lung transplant. The score is made up of factors that help determine a candidate’s waitlist urgency and post-transplant survival, including disease diagnosis.

Click here to search the OPTN glossary

What’s the proposal?

  • Add two new options to LAS Group D restrictive lung disease in lung allocation policy:
    • COVID-19: acute respiratory distress syndrome (ARDS)
    • COVID-19: pulmonary fibrosis
  • These diagnoses would be included in the drop down menu in UNetSM

What the anticipated impact of this change?

  • What it's expected to do
    • Help identify trends in these patient populations that could inform future policy changes
  • What it won't do
    • Change the diagnosis group for these candidates

Themes to consider

  • Other diagnoses caused by COVID-19 that could result in lung transplant
  • Organ transplant candidates outside of lung who are being listed due to COVID-19
  • Adding COVID-19 diagnoses codes for other organs

Overview

Status: Implemented

Sponsoring Committee: Lung Transplantation

Strategic Goal: Provide equity in access to transplants

Contact:

Sara Rose Wells

Documentation

View the policy notice (PDF; 10/2020)

Comments

Sam Dey | 10/01/2020

Yes, it must be accomodated.

OPTN Data Advisory Committee | 10/01/2020

The Data Advisory Committee (DAC) thanks the OPTN Lung Transplantation Committee for their efforts in developing this public comment proposal, Incorporating COVID-19 Related Organ Failure in Candidate Listings. DAC strongly supports this proposal as written for lung and heart. DAC cautioned adding this for other organs if there are not clear data on the impact of COVID-19 as a direct cause of organ failure for other organs. DAC questioned why the OPTN wasn’t collecting more detailed information on candidate/recipients related to COVID testing results and infection. DAC suggested member education encouraging utilization of both primary and secondary causes of death data collection to show complete impact of COVID-19 on recipient outcomes.

Region 11 | 10/01/2020

Region 11 vote: 11 strongly support, 8 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Several attendees supported collecting the data for all organ types. One attendee added that more information should be gathered prior to other proposals being developed. Two attendees commented that they would be interested in more data and guidance around recovering and transplanting organs from donors who had COVID in the past.

Region 9 | 10/01/2020

Region 9 vote: 9 strongly support, 4 support, 4 abstain/neutral, 1 oppose, 0 strongly oppose. Comments: A member said they are interested in having COVID-19 added as both a cause of listing for kidney and cause of kidney allograft failure. Another member said all organ should have this code if COVID-19 caused the organ failure. One member commented that not enough is known about the efficacy of lung transplant in COVID-19 patients.

OPTN Pancreas Transplantation Committee | 10/01/2020

The Pancreas Transplantation Committee thanks the OPTN Lung Transplantation Committee for their efforts in developing this public comment proposal, Incorporating COVID-19 Related Organ Failure in Candidate listings. While the Pancreas Committee supports the proposal, the committee does not believe that COVID-19 diagnosis codes are needed for pancreas.

Association of Organ Procurement Organizations | 10/01/2020

The Association of Organ Procurement Organizations (AOPO) supports the Lung Transplantation Committee’s proposal to add additional diagnosis codes to capture COVID-19 related lung disease diagnoses as the indication for lung transplantation and to thereby enhance the community’s knowledge of the impact of COVID-19. As the pandemic continues to unfold, it is reasonable to expect additional lung transplant candidates resulting from the impact of the virus on infected patients. Initiating tracking of this impact now will allow a more informed and complete picture for future analysis.

Region 5 | 10/01/2020

Region 5 Vote: 2 Strongly Support; 1 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments or questions.

Liver & Intestinal Transplantation Committee | 10/01/2020

The OPTN Liver and Intestinal Organ Transplantation Committee supports the effort of the Lung Transplantation Committee to include COVID-19 related organ failure in candidate listing. The Liver Committee does not believe that COVID-19 diagnosis codes are needed for liver or intestine candidates.

UF health- Shands | 09/30/2020

Agree it is important to be able to add COVID-19: acute respiratory distress syndrome (ARDS) COVID-19: pulmonary fibrosis

Ken Bodziak | 09/30/2020

I agree with incorporating the diagnosis of COVID-19 related organ failure in the listing for lung transplantation exclusively.

Region 4 | 09/30/2020

Region 4 Vote: 1 strongly support; 3 support; 0 neutral/abstain; 0 opposed; 0 strongly oppose. Comments: One attendee commented that it would be prudent to track COVID-19 candidates over all organs.

The Ad Hoc Disease Transmission Advisory Committee | 09/30/2020

The Ad Hoc Disease Transmission Advisory Committee (DTAC) is supportive of this proposal. The diagnosis group (A-D) that a candidate’s diagnosis falls within directly impacts their LAS. These points are calculated based on the predicted likelihood of waiting list survival and post-transplant survival. An additional benefit is that including these diagnoses will allow the lung transplant community to compare the outcomes of patients with COVID-19 related lung complications that underwent a lung transplant to other transplanted patients. The DTAC would also recommend adding similar diagnosis for other solid organ transplant types, specifically heart.

American Society of Transplant Surgeons | 09/29/2020

The American Society of Transplant Surgeons (ASTS) supports the concept of incorporating COVID-19 related organ failure in candidate listings. We do caution bundling the COIVD-19 diagnosis with other diagnoses in group D and wonder how that might affect the LAS for COVID-19 patients. We are concerned that the community does not currently understand the waitlist survival or post-transplant survival for patients carrying a diagnosis of COVID-19 and that we should not assume similar survivals as for other diagnoses in group D. We would support a neutral impact for COVID-19 diagnosis on the LAS until further data is available. In this manner, the LAS for COVID-19 patients would, for now, be governed by other measures of function that comprise the LAS equation until further information is available. We do support the OPTN establishing COVID-19 related diagnosis codes for other organs in particular heart and kidney.

Region 10 | 09/29/2020

Region 10 vote: 7 Strongly Support; 17 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: • An attendee commented that the diagnosis code should be more broad-based than just COVID-19, maybe viral induced pulmonary failure. In the past there was SARS and swine flu, and there might be others in the future. There should be another way to indicate viral etiology with an option to specify instead of just saying ARDS; it is unknown how long COVID-19 will need to be tracked. • Another attendee voiced support in making the policy more general in order to decrease the bureaucratic activity to make changes or additions in the future. • Another attendee noted that proper definitions and criteria will be essential. • One attendee supports adding diagnosis codes for lung patients, but does not support adding codes for other organs. • Several other attendees disagreed and see benefit in adding the diagnosis codes to other organs, especially for kidney patients. There has been evidence of multi-organ failure as a result of COVID-19.

Region 6 | 09/29/2020

Region 6 vote: 16 strongly support; 17 support; 6 neutral/abstain; 1 oppose, 0 strongly oppose. Comments: One attendee said this is an important measure to help track the effects of COVID-19 nationally. No members identified any instances of a patient receiving a kidney transplant due to COVID-19. One member commented that acute kidney injury has been seen in the sickest patients, but he hasn’t seen any chronic kidney disease in these patients yet. Another member said that while they are in favor of tracking COVID-19 related transplants, they have hesitation that these patients are being listed with the same medical urgency as others on the list, even though very little is known about their expected survival. One member opposed the proposal and said we need to know more about multi organ failure and organ recovery rates in patients severely affected by COVID-19. A member also said that an important question moving forward is whether there is a need to track patients whose long term disease progression is effected by COVID-19. Members also discussed the issue of whether COVID-19 should always be a contraindication to transplant, even if candidates are asymptomatic. One member suggested an all-organ symposium to discuss this, while another suggested a survey to find out if programs are transplanting any asymptomatic COVID-19 positive patients, as well as look into members’ thoughts about when donors can be considered if asymptomatic or recovered.

Region 2 | 09/25/2020

Region 2 vote: 14 Strongly Support, 13 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: • One attendee noted that they think the new diagnosis codes should only apply to lung candidates, but others disagreed. Two attendees see some benefit to include the diagnosis codes for kidney candidates. • Another attendee noted that there might be some benefit to adding diagnosis codes for heart candidates given pathology research in Europe. Is the committee considering looking at other information like inflammatory markers?

Region 1 | 09/24/2020

Region 1 vote: 4 Strongly Support, 7 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: Region 1 supports this proposal. One member stated that this is a once in a lifetime medical occurrence and any data collected will be useful.

American Society of Transplantation | 09/24/2020

The American Society of Transplantation is supportive of this proposal in concept and supports collecting data on COVID-19 diagnoses as they relate to transplant candidates. We do not think the medical community has yet identified all of the potential sequelae of COVID-19 infection. We also suggest caution regarding rushing to transplant, especially in the ill patient on ECMO, since the disease can have protracted course with ultimate recovery. We believe it is important to collect data in transplant candidates moving forward to further our understanding of the impact of COVID-19 on the transplant community. The AST believes it would be helpful to prospectively identify information that could impact understanding of the COVID-19 pandemic along with other pandemics that may arise in the future. In particular, the Society notes that we currently exclude potential donors who test positive for SARS-CoV-2/COVID-19. However, we feel it important to emphasize our commitment to individuals who develop end stage organ failure from COVID-19 and ultimately require a transplant. The system will benefit everyone from having data collected. We believe there may also be opportunity to capture information such as ICD-10 codes that could be retrospectively evaluated to provide insight into the impact of this pandemic situation. The Society shares the following comments for consideration: In response to specific questions posed by the Lung Committee: For lung, are there diagnoses other than ARDS and pulmonary fibrosis that would be caused by COVID-19 and require lung transplantation? • Regarding lungs, we suggest ARDS and chronic fibrosis are two distinct groups with different risks and thus should be clarified in the diagnosis list. • In addition, multi PE resulting in CTEPH be considered a possible diagnosis. Likewise, you may wish to consider adding: COVID-19 related pulmonary thromboembolism. • It will be important to update information as we continue to learn about this novel virus as other COVID-19-related lung diagnoses may arise over time. Are candidates for other organs being listed due to COVID-19 related organ failure? • As the COVID-19 pandemic progresses we may find more types of organ failures due to SARS-CoV-2. Currently, the impact has been limited but we are less than a year into the pandemic. Specific comments are noted below. • Since COVID-19 myocarditis is a recognized entity and can lead to terminal heart failure and need for transplantation, we believe this should be added as an option for the etiology of the heart failure. This information will help the transplant community track and determine its prognosis and potential impact on post-transplant survival. • Our liver community of practice does not believe there are enough data to currently support liver-related COVID diagnoses at this stage. Overwhelmingly, it was felt that any COVID-19 related liver failure/decompensation would either be characterized and qualified as an Acute Liver Failure diagnosis or would be an insult on top of some underlying disease (ACLF), with appropriate diagnosis codes already available for the underlying diagnoses. However, other community of practices noted the potential benefit of having COVID-19 specific diagnoses to track the overall impact of this novel virus on transplantation. • We are not aware of other specific examples; however, this remains theoretically plausible as COVID-19 is a systemic infection with multi-system effects and can be monitored over time. Accordingly, many felt that having a code for COVID-19 specific organ failure would be beneficial. Should the OPTN establish COVID-19 related diagnosis codes for other organs? • Yes. See below for specific examples. The Lung Committee is seeking feedback on whether COVID-19 diagnoses should be collected on heart candidates. • Yes. The option to list COVID-19 related cardiomyopathy as a diagnosis should be available. The Lung Committee is seeking additional feedback on whether COVID-19 diagnoses should be collected on kidney candidates. • Yes. The option to list COVID-19 related kidney disease as a diagnosis should be available. The Lung Committee is seeking additional feedback on whether COVID-19 patients could need a liver or intestine transplant as a result of damage from COVID-19. • Yes. Given the thrombotic potential of SARS-CoV-2, acute thrombotic events, such as hepatic artery thrombosis resulting in liver failure, or bowel/mesenteric thrombosis, could result in injuries that would lead to a need for a liver or intestine transplant. The Lung Committee is seeking feedback on whether COVID-19 diagnoses should be collected on pancreas or VCA candidates. • At this time, it is unclear if there is damage from COVID-19 that would result in need for pancreas and/or VCA transplant. While not covered in this proposal, we also suggest that the following be added to data collected on all solid organ transplants to better understand the impact, if any, that SARS-CoV-2 infection may have on the overall post-transplant outcomes • Has the patient ever had COVID-19? (If so, when was it diagnosed?) • Does the patient currently have COVID-19? (While we suspect this will be rare, it could be included under “ever had COVID-19” question (as noted above)

Heart Transplantation Committee | 09/24/2020

The OPTN Heart Committee thanks the OPTN Lung Transplantation Committee for its expeditious effort in developing the Incorporating COVID-19-related Organ Failure in Candidate Listings public comment proposal. The Committee expresses its support in collecting data to track COVID-19 related diagnoses that result in the need for transplant as well as historical patient data if diagnosed with COVID-19 prior to transplant but expresses concern for the creation of excessive burden related to data collection. The Heart Committee is collaborating with the Lung Committee to add the following heart related COVID-19 diagnoses to this proposal in order to track volume, best methods of care, and outcomes associated with candidates diagnosed with COVID-19: • Dilated myopathy: COVID-19: active myocarditis • Dilated myopathy: COVID-19: history of myocarditis

Region 8 | 09/22/2020

Region 8 vote: 3 strongly support, 12 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose Comments: A member asked the committee to consider adding COVID-19 as a secondary diagnosis and a follow up comment was made that primary and secondary diagnoses may be a good idea, however, the committee should consider the controversy around the completion of death certificates to inform the discussion. Another member recommend revising the current approach for gathering diagnosis data for patients listed for lung transplant to proactively gather data on new diagnoses which could include the option for including a Group A-D “other” category with "other" filled out by the transplant center and to consider revising the current list of diagnoses to align with ICD-10 diagnoses. One member agreed with the proposal as data collection and not a weighted factor for outcomes.

OPTN Vascularized Composite Allograft Transplantation Committee | 09/18/2020

The Vascularized Composite Allograft (VCA) Transplantation Committee does not believe that COVID-19 related diagnosis codes are needed for VCA. Members are not aware of VCA organs (face, limbs, etc.) failing due to COVID-19.

Anonymous | 09/16/2020

Having been on the front lines as an emergency department director and serving on the transplant committee, I am familiar with the devastation of Covid-19 and the working of the transplant system.

Region 3 | 09/15/2020

Region 3 vote: 3 Strongly Support; 16 Support; 6 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose: Comments: A member commented that COVID can have symptoms on organs because of hemodynamic instability or hypoxia, which can lead to other comorbidities, but that the main damage would be in the lungs and would advocate for patients being listed for single organ transplants rather than multi-organ transplants and that in regards to lungs there are no other diagnoses that should be added. It was also stated that you need to ensure that the patient would be able to recover after transplant. An additional comment was made that OPOs are discussing if and when it is appropriate to use organs from a donor who previously tested positive for COVID. Additional comments submitted online during meeting: • The documentation of a positive COVID test MUST be included. Too many hospitals are listing deaths related to COVID when that is not always the case. • Continue to collect data regarding pts affected by COVID

Region 7 | 09/10/2020

Region 7 vote: 10 Strongly Support, 5 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 7 supported the proposal and had the following comments: • An attendee commented that PHTS is collecting COVID-19 data for pediatrics. • An attendee added, that we do know if there is cardiac damage that comes along with COVID-19. Chronic effects need to be looked at and adding these codes could help with outcomes analysis.