Assessing the financial and equity implications of the 2020 liver allocation policy change

The study by Ahmed et al. touches on legitimate concerns about the Organ Procurement and Transplantation Network (OPTN) policy change for liver allocation. The paper’s most notable claims were increasing travel costs, greater dry runs, overall hospital costs, and disparities. This commentary aims to provide context for the data reported by Ahmed et al. (1).

Before February 2020, liver allocation was based on donation service areas (DSAs) and OPTN regions, which tended to vary in population density and geographic distribution (2). The Final Rule by OPTN in 2000 sought to make the allocation based on the “best use of donated organs” and “sound medical judgment” (3). This meant that medical urgency was prioritized over geographic availability, but certainly, geographic limitations could interfere with medical urgency. The February 2020 policy change intended to decrease disparities associated with this (4). The policy change in February 2020 changed allocation from DSAs and OPTN regions to allocation circles. That is, donor livers could travel a maximum distance of 500 nautical miles from the hospital of the donor’s liver to that of the recipient, effectively the radial distance.

Despite OPTN’s allocation change, which was intended to reduce geographic disparities, several concerns among transplant centers quickly came to the forefront, which Ahmed et al.’s paper addresses. In this paper, 22 of 68 centers responded to provide information about two separate, 12-month periods, before and after the UNOS policy change. The paper reported a 6% decrease in the volume of liver transplantations (LTs) from 1,948 cases to 1,837, but an increase in overall hospital cost by 10.9% (P=0.94). There was a statistically significant increase in dry runs and imported fly-outs. The study also highlighted that transplant centers serving communities with a higher percentage of racial and ethnic minorities had an increase in cost of more than 90% for dry runs, imported livers, and fly-outs. Low-income states’ hospital and import costs increased by 12% and 94%, respectively (1,5). This written piece demonstrates legitimate concerns from the liver transplant community, but there are limitations that this commentary will address.

First, given the nature of the study, response bias is likely to be present; the centers that responded may have been those that were affected negatively enough to provide feedback. Additionally, the 6% decrease in LT volume among these centers may not be entirely representative, as the national LT volume increased during this period; deceased donor liver-alone transplants increased from 13,773 to 14,489 based on expanded 2-year outcomes before and after the start of acuity circles. The same monitoring report identified an increase in the transplant rate of patients with Model for End-Stage Liver Disease (MELD)/Pediatric End-Stage Liver Disease (PELD) scores greater than 29. The acuity circles also prioritized livers for Status 1A/1B patients over a greater region than the prior DSAs (6).

Another limitation of the study was that the post-policy period was too short, and it was further complicated by the COVID-19 pandemic and its impact on already limited hospital resources (7). Furthermore, the U.S. Food and Drug Administration approved the first ex-situ perfusion machine in September of 2021 for clinical use (8,9). With the widespread implementation of ex-situ machine perfusion technology in the U.S. for donor livers in recent years, expenditures were expected to increase due to the increased safe fly-out distance and the utilization of this new technology. For normothermic regional perfusion (NRP) of donation after circulatory death (DCD) organs, the average cost is approximately $10,000 per donor. In contrast, for normothermic machine perfusion (NMP), the estimated cost ranges from $40,000 to $80,000 per donor. Bakhtiyar et al. demonstrated that it would take 31 donor allografts procured via NRP to match the cost of a single allograft using NMP (4,10). With machine perfusion, DCD increased by more than 230% in 2022–2023 (7). Evaluating the last few years since the implementation of NMP in the U.S. would be informative given the increased LT volume and competing increased travel cost and machine cost.

Another consideration for cost, apart from the UNOS policy change, is an expanded list of indications for LT. Per Chu et al., LT is being performed more often now for cholangiocarcinoma, neuroendocrine liver metastasis, and colorectal liver metastasis. In addition, various criteria have been proposed for patients who do not meet the Milan criteria for hepatocellular carcinoma. Combined organ transplantation for multiple organ failure is also sometimes performed (11).

The impact on the cost for centers that serve a greater percentage of patients from racial and ethnic minority groups could potentially be due to the cutoff defined by Ahmed et al. for what constitutes low versus high. For example, Ladner et al. pointed out that the cutoff for the low percentage of non-Hispanic Black and Hispanic individuals was less than 18.2%, whereas the national percentage of non-Hispanic Black and Hispanic individuals was 30.8% (7).

Recommendations

Ahmed et al.’s study could be strengthened by a more comprehensive cost analysis since the implementation of machine perfusion technology, as there has been both an increase in LT DCD volume and costs associated with travel and machine use. Furthermore, involving more centers could enable sub-analyses based on whether the center is coastal or inland and rural or urban. The financial implications of remaining on the LT waiting list versus proceeding with LT by using machine perfusion or NRP should be included in the cost analysis, as remaining on the waiting list might incur costs related to increased hospitalization rates and requirements of higher medical expenses. Although not the focus of Ahmed et al.’s paper, including outcomes research before versus after the UNOS policy change in 2020 would have informed the balance between quality and cost. Ultimately, the paper would benefit from an extended period of data collection, further sub-analyses based on center location, greater center participation, and reporting outcomes research to bring quality of care into the discussion.

Supplementary

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Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.