In recent months the Trump administration has taken a closer look at the organ transplant system. In September it announced investigations into state organ procurement groups for safety lapses, including cases in which attempts were made to remove organs from terminally ill patients who were still alive.
Of course, such serious mistakes should be investigated, and accountability demanded for any errors.
But the government’s emphasis on these rare events is misdirected. The focus should be on a larger problem that more seriously undermines fairness and equity in our transplant system.
This problem has become rampant since 2018, when a new system of rules was created for how hearts should be distributed for transplantation in the United States. The six-tier system, developed by the Organ Procurement and Transplantation Network (OPTN), a nonprofit that operates under a federal contract, replaced an older system in effect since 2006 that lumped patients into three tiers. The new classification system is more granular, spelling out more precisely the criteria for judging how sick a patient is, and thus in theory better at assessing his or her urgency for heart transplantation. The highest priority is reserved for patients in the top two tiers. The goal is to get the sickest patients transplants faster, thus saving lives.
But since the system went into effect, this goal has been subverted by practices that could be described as gaming. For example, patients have been given invasive treatments that their conditions may not have warranted to push them higher on the waitlist. Applications to boost transplant status without following the rules — so-called exception requests —have also proliferated.
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The strict rules in the new system were actually designed to decrease gaming. However, as with the previous allocation system, there is a loophole.
Disease severity and therefore waitlist priority is judged primarily by the therapies doctors used to treat patients, not some intrinsic measure of how sick they are. Receiving more aggressive interventions, such as surgically implanted heart pumps, pushes patients to the highest tiers, while treatment with medications alone leaves patients with lower status. The rationale was that patients requiring pumps are at the highest risk of dying and therefore should receive the highest priority. However, an incentive was built into the system to use invasive treatments to make patients appear as sick as possible.
This incentive has altered treatment patterns. For instance, a 2020 study published in Transplantation Direct found that the use of a particular mechanical device called an intra-aortic balloon pump changed dramatically within the new system, increasing from just 3% of waitlisted patients in 2017 to 45% under the new allocation system. There is nothing to suggest that transplant candidates after 2018 were any sicker to justify the increased use of the pumps.
Furthermore, the waitlist mortality rates of patients with these pumps in Tier 2 has been found to be comparable to that of patients treated with medications alone in Tier 3, again suggesting no difference in disease severity and therefore no justification for a difference in transplant priority.
The conclusion is inescapable: The current organ allocation system incentivizes invasive treatments that aren’t always medically necessary but may be used to move less-sick patients up the waitlist.
These findings raise serious ethical questions. The desire by doctors to get their patients transplanted more quickly is not inherently unethical, to be sure. One-third of patients die waiting for a heart transplant. Doctors naturally want to do the best for those in their care, and they are subject to the incentives of the system in which they work.
But there’s a distinction between legitimate advocacy and the sort of waitlist manipulation that may be happening. With a scarce resource like donor hearts, improving one patient’s status necessarily comes at the expense of another. In fact, treatment escalation to game the waitlist has become so widespread in the field that colleagues at other centers admit to feeling compelled to participate to not disadvantage their own patients.
Complicating the ethics of this issue is that doctors could also be motivated by a desire to increase their center’s transplant volume. More transplants mean more money as well as a greater chance to improve the outcomes that regulatory bodies scrutinize. Gaming through treatment escalation is also wasteful and can harm patients by creating complications.
Perhaps the designers of the new system could have anticipated the effect of the incentives built into it, but they did not. Now, it is incumbent on the transplant community to restore equity and fairness in the organ allocation system.
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As a first step, we must standardize the criteria for exception requests outside of the published rules so that they can be applied to all patients, not just those at centers that have the time and resources to submit and advocate for them. Exception status now applies to about 30% of waitlisted patients and significantly increases the chance of their getting a transplant. The decisions of regional boards that review these requests should also be examined to monitor for waitlist manipulation.
But more importantly, we need a system that assesses medical urgency for transplantation independently of the interventions doctors use to treat their patients. In fact, transplant doctors working with OPTN have been trying to devise such a system: a “score” based largely on objective test results that would replace the rigid tiers — and therefore the incentive to manipulate — of the current and previous systems. Such a score has been used for lung transplants and has significantly decreased gaming in that field.
However, federal agencies have directed transplant organizations to pause work on developing this score to channel scarce resources into investigating rare organ procurement mistakes and other allocation issues. This is a grave mistake. Waitlist gaming more seriously undermines safety and equity in our organ transplant system and affects many more lives.
Correction: An earlier version of this essay misstated the organization that redesigned the organ transplant system.
Sandeep Jauhar is the author of “Heart: A History” and a cardiologist at Northwell Health.
