Study raises doubts about affordability and fairness of revised American liver transplant guidelines
The modified liver transplant procedure has transformed the geographical criteria for selecting recipients of donated livers. Instead of operating within well-defined regional service regions, the latest strategy prioritizes the most critically ill liver patients listed at transplant facilities that are within a 500-nautical mile radius of the donor hospital. This change was implemented by the United Network for Organ Sharing in February 2020, which functions under the Organ Procurement and Transplant Network contracted by the United States federal government.
According to a recently published study, the introduction of this new method resulted in an 11% increase in liver transplant expenses. The hike in costs is mainly due to the increased costs associated with air travel to transport the donated livers. In the study which involved 22 transplant centers that represent approximately a quarter of the entire national volume, the overall number of liver transplant procedures dropped by 6%. The changes in transplant numbers when compared to donors point to an increase in lip transplant rejection rates.
"Transplant centers from low-income states, those serving populations with a higher percentage of racial and ethnic minorities, and those in states with less efficient healthcare systems are bearing higher expenses despite observing a decrease in the number of liver transplant recipients since the policy was implemented," the study's authors remarked.
Geographical disparity has always been a stumbling block for the transplant system, especially because liver transplants cannot remain viable as long as several other organs, such as the heart and lungs.
Rural areas already face many disadvantages when it comes to organ transplants, but this new liver transplant policy may incur additional disadvantages. The study found that rural centers demonstrated a significantly larger drop in the number of liver transplant surgeries, an increase in imported livers, and a big engagement in hospital and flight costs.
The University of Arkansas for Medical Sciences, for example, may have to send staff to Chicago, Houston or Nashville to collect a liver donation for a patient in Little Rock, which will significantly increase the overall expenses for the medical center.
"This is costly, but if it's the best way to help people undergo transplant surgery, we'll simply do whatever's right to respect the donors' gift," said Dr. Lyle Burdine, director of the solid organ transplant program at this university. "To prepare for the new liver transplant policy, we've gathered more staff to handle the logistical issues and engineered a program that keeps the organ viable during the transition between the donor and the transplant recipient."
The center, however, still couldn't adjust the reimbursement rates offered by hospital payers for this increased cost. "That's still in the late 1990s, and the financial pressure is really felt more prominently at the edges of healthcare," added Burdine.
Dr. Daniela Ladner, founding director of the Northwestern University Transplant Outcomes Research Collaborative, together with her team, published a related commentary on the same day in JAMA Surgery, urging a more comprehensive and long-term analysis before reaching any conclusions regarding the effectiveness of the new policy.
While it's clear that not all transplant centers can cope with the same resilience in the wake of national policy changes, the sample size of 22 centers used in the new analysis might not be reflective of the nation as a whole. The new policy was adopted during the peak of the Covid-19 pandemic, which may have caused some discrepancies in results and findings. The "field is evolving tremendously," they wrote, because of the advent of new technologies such as normothermic perfusion pumps which enable donor livers to travel longer distances.
Dr. Timothy Schmitt, the director of transplantation for the University of Kansas Medical Center, observed a drastic drop in liver transplant volume to 40% in the first two years of the new policy, a 15% hike in costs per transplant, and a decline in the number of local donor-gifted livers from about 90% to 15%.
Several of these changes were anticipated via projections of how the policy would evolve, but it also created a scenario where the liver transplant recipients are considerably sicker than before. "This has led us to change our practice," Schmitt said. "Now, some patients who would have been suitable candidates for liver transplants may not even be placed on the waitlist as they may not survive the waiting period."
Dr. Scott Biggins, the chair of the United States federal government's liver transplantation committee, observed positive nation-wide results after the initial year with the new policy: "Although we delve into regional and center effects, the essential thing is that we focus on the patients and the nationwide trend. This policy has managed to lower waitlist mortality, promote access to liver transplants across the United States, and did not cause a negative impact on post-transplant survival."
Over the past four years, the committee has initiated the development of an updated liver transplant policy aimed at making the allocation process less categorical and more continuous, according to Biggins.
At present, liver allocations are primarily driven by prioritizing the sickest patients with the highest individual scores on a model for end-stage liver disease. However, the new model would also prioritize improving the overall efficiency of the system, shifting away from solely relying on urgency.
These changes could potentially address some of Schmitt's concerns, as he would favor a more flexible "matrixed allocation scheme" that takes into account travel costs.
Still, the potential changes to transplant policy are in their early stages, and it will likely take several years before they're fully realized through public input and consultation with other stakeholders.
"Going forward, we have the opportunity to place the focus on the patients rather than profit margins," Biggins said. "Healthcare is a business, but we're committed to enhancing the lives and well-being of our patients—with the primary goal being to deliver organs to those in need."
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Despite the revised liver transplant guidelines leading to an increase in costs and a decrease in transplant numbers for certain centers, particularly those in rural areas and low-income states, proponents of the new policy argue that it promotes access to liver transplants across the United States and has reduced waitlist mortality.
However, critics are calling for a more comprehensive analysis and long-term evaluation before reaching conclusions on the effectiveness of the new policy, citing the potential impact of the Covid-19 pandemic on results and findings, as well as the possibility that the sample size used in the initial analysis may not be representative of the nation as a whole.
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