Greater Transparency, Policy Changes Needed to Drive More Kidney Transplants

Opening the “black box”

Many speakers at Kidney Week shared stories of patients who had undergone dialysis for years and thought that they were on the kidney transplant waiting list but were not. Rachel Patzer, PhD, MPH, president and chief executive officer of the Regenstrief Institute in Indianapolis, IN, noted that the proportion of patients on the waiting list has fallen 30% since 2013. As of 2020, only about 13% of patients living with kidney failure are on the waitlist. Patzer spoke during the Kidney Week session, “Kidney Transplantation in 2024: Change Isn't Coming, It's Here.”

Existing data show large geographic variations in transplant referral and evaluation, Patzer noted. For example, New England transplant centers evaluated 62% of referred patients within 6 months (1). By contrast, Ohio Valley region transplant centers had evaluated only about 46% of those referred within 6 months. “This variation suggests that there are inconsistent practices that are leading to disparities in treatment and poor access for some patients,” she said.

Patzer explained that the process of getting on the transplant waitlist is complicated for patients, and there are very little data about prewaitlisting practices, making it a black box for researchers. However, recent policy changes, including new Health Resources and Services Administration requirements for organ procurement transplant networks and mandatory Centers for Medicare & Medicaid Services data collection, may soon help fill these gaps.

There is also substantial variation in the way organs are procured and allocated throughout the country. Jesse Schold, PhD, MEd, MS, professor in the Department of Surgery and Epidemiology at the University of Colorado Anschutz Medical Campus in Aurora, presented the Christopher R. Blagg, MD, Endowed Lectureship in Kidney Diseases and Public Policy during the same session as Patzer. In the talk, Schold explained that donor service areas throughout the country resemble gerrymandered voting districts. For example, he noted that the 4000-square-mile donor service area covering New York has twice as many patients as a 184,000-mile service area covered by Colorado.

Organ procurement organizations (OPOs) may also follow widely different practices across the country. Schold noted that new and controversial rules from the Centers for Medicare & Medicaid Services are going to change the way OPOs are regulated, including requiring more objective data of potential donors and setting targets that the organizations must meet to remain certified, including holding them accountable for how many allografts are transplanted. But, he noted that this has led to greater out-of-order placement of organs on the waitlist through “expedited placements.” Additionally, he said that as many as 40% of OPOs could be reclassified under the rules, which will greatly impact the overall system.

Schold urged greater coordination of policies regarding all parts of the health care system, including value-based care initiatives. He said that getting the quality metrics right is critical because they greatly impact care. “They change the way we select patients; they change the way to select organs,” he said. “They have a significant impact on our care, which also suggests [that] if we get them right, they have incredible potential benefits.”

Declined organs

However, collecting more organs and enrolling patients on the transplant waitlist are not enough. There are currently about 100,000 people on the kidney transplant waiting list in the United States. Patients who do undergo a transplant may wait, on average, 6 years, and nearly one-third may die waiting on the list.

Spending time on the waiting list exacts a toll on patients psychologically, socioeconomically, and physically, noted Joyce Popoola, MBChB, MD, PhD, a consultant nephrologist and senior lecturer at St George's University of London, United Kingdom, during the Kidney Week session on declined kidney offers. She noted that patients’ illness, disability, and risk of death grow over time while waiting. For example, an 18-year-old waiting for 5 years has morbidity similar to that of a 50- to 60-year-old, she said.

A growing number of deceased donor organs are collected, totaling about 26,000 each year. But more than one in four are discarded, Cooper said. Many of the organs are from higher-risk donors with a higher kidney donor profile index. Some may have anatomic abnormalities, some may have acute kidney injury, or the donor may have a history of hepatitis C or HIV. “It is easy, in the middle of the night, to say no to an imperfect organ,” Cooper said. “[There have] been lots of data demonstrating [that] every time we predict that the next offer is going to be a better offer, [the] patient actually doesn't ever get that transplant, and they die waiting on the list.”

“[There have] been lots of data demonstrating [that] every time we predict that the next offer is going to be a better offer, [the] patient actually doesn't ever get that transplant, and they die waiting on the list.”

In fact, Syed Ali Husain, MD, MPH, MA, FASN, assistant professor and transplant nephrologist at Columbia University in New York, NY, conducted an analysis of US data on transplant offers. During the Kidney Week session on declined kidneys, he revealed findings that over 6000 deceased patients remained on the list, having received an average of four organ offers after their deaths, often more than 1 month after their passing (2). Husain said that the data show how little patient engagement is happening and how frequently centers do not even contact potential recipients about offers. The same data show that 30% of patients die or are removed from the waiting list before receiving a transplant after a center declined an allograft that was transplanted into a patient who was farther down the waiting list. On average, the deceased patients had received 16 total offers while on the waitlist before being removed, he said. “People start to accumulate organ offers pretty quickly after waitlisting that are routinely declined on their behalf,” Husain explained. “It's pretty consequential to have the patient's voice not heard in this process.”

Cooper emphasized that many discarded organs may be usable. For example, he noted evidence that biopsy data may not be a good indicator or outcome, that kidneys with acute kidney injury can recover, that hepatitis C can be cured, and that organs from a donor with HIV can be given to a recipient who is HIV positive. Dual organ transplant, in which two kidneys are transplanted at once, is another option, but there are few surgeons experienced with dual organ transplant, he said. As a result, long cold ischemic times when dual transplant-ready organs have been turned down repeatedly often render them unusable. “If we could find a way to get more efficient and get these allocated to the proper patients, we could probably utilize more of these organs as well,” Cooper noted. He and his colleagues have created a list of patients who might benefit from dual transplants and have developed a rapid transplant protocol for them.

Cooper said that new policies will require transplant centers to track and report data on their referral, evaluation, and transplant statistics. He also urged transplant surgeons to review outcomes for their patients after turning down an organ and to review the outcome of the donor allograft, as well as to benchmark their center's statistics against others. Popoola and her colleagues conduct such a quarterly review, and they have found that most of the patients who have received a declined kidney allograft offer are still waiting 1 year later. They also work collaboratively as a single system. There is only one waiting list for the entire United Kingdom, and different centers work to facilitate successful transplants for recipients by sharing facilities when needed. “The waiting list is not a safe place for patients,” Cooper said. “We have to educate our patients better about the data, the options, and outcomes.”

Out-of-sequence transplants

A growing practice of out-of-sequence transplants is exacerbating inequities in the US organ allocation system, according to an oral abstract presentation by Sumit Mohan, MD, MPH, FASN, professor of medicine and epidemiology at Columbia University School of Medicine. During Kidney Week, Mohan presented data from an analysis of all of the deceased donor kidneys placed out of sequence between 2020 and 2023 (3). He found a 9-fold increase in out-of-sequence allocations during this period, with one in six kidneys allocated out of sequence. He noted that the organs offered out of sequence span the kidney quality spectrum, with only a small fraction being higher-risk kidneys. “What [OPOs] have chosen to do is basically call a friend,” he said during a press briefing at Kidney Week. “They get to pick which friend, and the friend gets to pick which one of their patients they get to put a kidney in.”

Mohan noted during the press briefing that OPOs are sending most of these out-of-sequence kidneys to a small number of transplant centers without a clear reason. At some transplant centers, 60% to 70% of their transplants may be out of sequence. In some cases, he said, organs are being flown thousands of miles to Florida from densely populated areas in the Northeast, where many nearby patients could benefit from them. He noted that although it is good that an organ is getting used, patients who were in line to receive an organ are getting passed over and are sometimes not offered another allograft.

Growing numbers of out-of-sequence transplants are just one of many policy-related challenges facing the field of transplants. Husain noted that at every stage in the process, from organ procurement to allocation and transplant, there can be misaligned incentives and efforts to game the system in ways that do not benefit patients. “We have had the privilege of self-regulation, but we are losing that,” said Husain during the session Kidney Transplantation in 2024: Change Isn't Coming, It's Here.

Recognition of these problems is leading to greater outside regulation of the transplant process. Husain described his wishlist of changes that includes the realignment of incentives to promote good behavior, transparency about organ offers and placement, public records of Organ Procurement and Transplantation Network meetings and decision-making, expanded definitions of conflicts of interest, and new approaches to implementing policy changes.

A seat at the table

Jefferson advocated for greater patient involvement on the transplant center's patient-selection committees and in organ-offer decisions. “The care team actually gets together to discuss you, the patient, to see if you should be waitlisted, deferred, or just completely rejected,” Jefferson said. “Everyone is talking about you, but you are not even there.”

She said that engagement on the patient-selection committee would keep patients better informed of where they are in the process. It would also help them to understand and challenge potential reasons that they are not being listed. For example, it is inadequate when a committee concludes that a patient does not have a support system because the committee just does not accept the patient's support system.

Jefferson also advocated for greater transparency and education about the convoluted transplant process. The first time that she needed a transplant in 2003, she only joined the waitlist at one center because she did not know that she could join multiple centers’ waitlists. When her first allograft began to fail, she joined the waitlist at multiple centers in several states. She explained that the waitlist time where she lived in Texas was 10 years, whereas other states had much shorter waitlist times.

The complicated process can also contribute to reduced waitlisting for individuals with lower socioeconomic status or individuals from racial and ethnic minority groups, Jefferson said. She explained that patients with limited funds or restrictive insurance may not be able to pursue waitlisting in multiple states. For example, she had to travel to Iowa from Texas repeatedly before receiving her second transplant, and she had to stay in Iowa for 1 month after the transplant, which many people may not be able to afford.

Jefferson emphasized that a concerted effort by all stakeholders is needed to improve the process for patients to make it more equitable. She argued that better patient engagement in decision-making would build patient and community trust in the transplant system and improve patient engagement.

Husain indicated that the transplant system can be paternalistic about making decisions on a patient's behalf, often with very little information about what patients want. At his center, for example, a transplant surgeon may have only seen a patient once before beginning to consider offers on their behalf. Because the surgical team consists of five to six surgeons who review offers, in some cases, the person reviewing the offer may have never met the patient. “If centers are going to make these life-or-death decisions on behalf of a patient, hopefully, they at least know what patients want,” he said. “You hope they’re making decisions that reflect what a patient would make if they were making it on their own.”

However, preliminary results of a survey by Husain and colleagues found that one in five patients on the waiting list does not believe their centers understand their values and preferences, and one in four does not trust their center to make decisions on their behalf. To improve the situation, Popoola suggested that transplant center teams begin discussing and recording patient preferences regarding allograft offers at the first visit and explaining the pros and cons of different scenarios.

Husain recommended getting patients’ pretransplant teams involved in the educational process, noting that they may have a deeper relationship with the patient. He also suggested that patients receive updates on how many organs were declined on their behalf to facilitate shared decision-making. He suggested that the Organ Procurement and Transplantation Network could develop a patient portal that would allow patients to check their status on the list and review any offers made to them, giving patients control over how much information and how often they choose to receive it.

“We need to be included every step of the way because this is our life,” Jefferson said. “One of the things that I often say is [that] my lived experience with kidney disease is just as valuable, if not more valuable, than your learned experience with kidney disease.”