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.
At 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.
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
Status: Public Comment
Sponsoring Committee: Lung Transplantation Committee
Strategic Goal: Provide equity in access to transplants
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.
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
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.
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.
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.
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
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)
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.
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?