A patient has needed a liver transplant for years, and one finally becomes available in her town. Instead, the organ is shipped by plane to someone hundreds of miles away. Because of a change in how donated livers are allocated, such a scenario could become common.

“There has been a lot of controversy over the proposed changes to liver allocation,” says Jared A. White, MD, FACS, associate professor and surgical director of liver transplant at Medical University of South Carolina.

The change resulted from a lawsuit against the Department of Health and Human Services. “Waiting times were different in different parts of the country. Some people thought this was inequitable and sued to change this,” says Keren Ladin, PhD, MSc, director of Tufts University’s Research on Ethics, Aging, and Community Health Lab in Boston. In their suit, hospitals and patients argued the new policy will waste viable livers.

The proposed allocation change went into effect for a brief period but then was placed on hold, reverting back to a version of the old system by court mandate. “I suspect it will not be long before another change is made,” White predicts. “And then we will have to await the unintended consequences of these policies.”

The United Network for Organ Sharing (UNOS) is tasked with devising criteria to allocate organs equitably across the county. “While UNOS sets policies, organ transplantation relies fundamentally on the public’s trust and support. It is unclear how they will interpret these changes,” says Leslie M. Whetstine, PhD, a bioethicist at Aultman Hospital in Canton, OH. Traditionally, UNOS distributed organs within the boundaries of its 11 geographical regions.

“This meant that someone in the Midwest, for example, where donation rates are often many times higher than on the coasts, would have a greater chance of receiving a transplant than someone who may have been sicker in another state,” Whetstine explains.

The revised allocation process is based on critical need. This means that an organ procured in Ohio might be sent to a recipient in New Jersey. “Some object to this new process, arguing that it exploits states that have higher donation rates,” Whetstine says.

This would negatively affect individuals in rural or underserved communities. “This change could also impact transplant centers if organs are exported outside their locations,” Whetstine adds.

This could harm the center’s financial viability and, ultimately, the populations served. Compounding the ethical complexities, donation rates vary widely across geographical areas. In Montana, 93% of residents are organ donors, compared to just 32% of New Yorkers.

“In the absence of an opt-out system where citizens are automatically enrolled as organ donors unless they expressly decline, allocation will remain problematic,” Whetstine laments.

Little Agreement

The waitlist for liver transplants is large and growing, with a relatively stable number of donor livers and liver transplants performed. States or regions report different prevalence of liver disease, population density, and organ donation rates. Performance of organ procurement organizations (OPOs) also varies. “Thus, the concept of ‘geographic disparity’ has been at the forefront of discussion,” White says.

There is little agreement on how to best allocate livers equitably from one state or region to the next. Officials in states like New York, California, and Massachusetts suggest that waitlists are so long that patients have to be sicker to receive a liver and die while waiting. Meanwhile, less-sick patients in the Southeast and other regions are receiving transplants. “What they are failing to show is that the rate and risk of death from liver disease is actually much higher in the Southeast,” White argues.

However, this is due in part to poor access to transplant centers in the Southeast. “An additional caveat is that some of the OPOs in these states that are speaking out the loudest in favor of allocation changes happen to be among the worst-performing in the country,” White notes.

If OPOs improved their performance to even a fraction of the national standard, more organs would be added into the system, according to White. Thus, more transplants would be performed overall, rather than simply rearranging where the current organs go.

“This has been a point of contention among all major liver transplant centers,” White adds. “Little compromise has been reached.”

Continued Debate

Modeling of the new policy suggested an overall decrease in total liver transplant volume. “‘Equalizing’ the so-called geographic disparity at the expense of millions of dollars of added cost to travel [can lead to]higher discard rates of organs and a number of other challenges yet to be seen,” White says.

The potential for fewer transplants is a serious ethical concern. The new system does not address the issue of optimizing organ donation, yield, and allocation at the OPO level.

“Enormous sums of money are predicted to be spent flying livers all over the country,” White explains. “In addition, some of the transplant programs in these OPOs aren’t optimizing the livers they do have.” For instance, some centers do not accept livers from older donors viewed as “marginal.”

“I have personally used several livers from the Northeast that were skipped due to ‘poor quality,’ and yet those livers worked just fine in the Southeast,” White reports.

Most of the focus has been on the differences in waitlist times. “Not enough has focused on outcomes of patients on the waitlist and causes of organ donor-eligible deaths and access to transplant nationwide,” Ladin says.

Additionally, there is disagreement on whether equalizing waiting times is actually equitable or whether it will in exacerbate disparities. “Patients in areas with long wait times often benefit from high market competition,” Ladin notes. This is a result of better access to healthcare, including transplantation. Thus, mortality is lower than in other regions with shorter wait times.

“Redistribution of organs across the country may mean worsening the situation of persons who are already worse off with respect to social protections and access to transplantation,” Ladin suggests. Higher mortality leading to greater availability of organs may result, in part, from disproportionate risks incurred at the local level, according to the authors of a recent paper.1

Although the new system is in the implementation phase, the transplant community remains divided. “As such, we are likely to see these issues continue to be debated,” Ladin predicts.

REFERENCE

  1. Ladin K, Zhang G, Hanto DW. Geographic disparities in liver availability: Accidents of geography, or consequences of poor social policy? Am J Transplant 2017;17:2277-2284.