By Michelle Crouch
A lawsuit filed earlier this month seeks to stop Atrium Health from taking control of organ donation services at partner hospital Wake Forest Baptist Medical Center in Winston-Salem.
For 40 years, Wake Forest Baptist relied on HonorBridge, an independent organ procurement organization that serves 75 percent of North Carolina, to handle the hospital’s life-saving organ donations and get them to transplant recipients.
But after joining the Atrium Health system, Wake Forest Baptist petitioned the federal government to switch to LifeShare Carolinas, Atrium’s in-house organ procurement service.
Citing LifeShare’s higher donation and better transplant rates, Atrium said the change would lead to increased efficiency, more organ donations and cost savings.
Federal regulators approved Atrium’s request in December, and LifeShare made plans to take over in April.
But on March 11, HonorBridge sued to block the change, arguing that federal regulators overstepped their authority. HonorBridge said the decision ended a 40-year relationship without cause and will disrupt organ recovery and transplant in the region, placing lives at risk.
Further, it said the change will cause “irreparable harm” to HonorBridge and the hospitals it serves — including UNC Health and Duke Health — by cutting the organization off from its largest provider of organs.
“We have been embedded in the community here for 40 years and have established collaborative practices based on trust,” said Chuck Heald, director of advocacy and marketing for HonorBridge. “Now we see Atrium cherry-pick this high-performing hospital where they can receive a lot of reimbursement from the number of organs they will be able to recover and transplant.”
Although organ procurement groups are nonprofits, they generate revenue by collecting fees for each organ they recover — on average, about $31,659 for a liver and $36,000 for a kidney.
Atrium Health did not respond to multiple requests from The Charlotte Ledger/NC Health News for comment about the lawsuit.
The legal battle underscores the problems with the nation’s organ transplant system and the flaws in the federal government’s plan to revamp it, said Renée Landers, a professor of law at Suffolk University in Boston who served on a panel at the National Academies of Science, Engineering and Medicine commissioned by Congress to investigate the organ donation system’s problems.
Landers said the most controversial aspect of the government’s effort at reform is a new ranking system for organ procurement organizations, with a plan to eliminate the lowest-performing ones by 2026 — a system that HonorBridge’s lawsuit challenges.
A hearing on HonorBridge’s request for a preliminary injunction motion is scheduled for 2 p.m. on March 28 in Wilmington.
Recent changes to the organ transplant system
More than 104,000 Americans are on the waitlist for organs — mostly for kidneys — including 8,120 people in North Carolina.
Organ procurement organizations, known as OPOs, play a vital role in moving people off that waitlist. When a hospital patient is near death and identified as a potential donor, the organizations communicate with the potential donor’s family, coordinate with the medical team, match the organ with a recipient and oversee the organ’s transfer — all within a short time to maximize the chances of a successful transplant.
Under the current system, each of the country’s 56 organ procurement organizations has a designated service area where it operates without competition.
However, in 2021, amid mounting criticism over the system’s inefficiency, inequality and high numbers of unused organs, the federal government gave hospitals the option to request a waiver to switch to a different organization. It said the switch could be granted as long as the change would increase organ donation rates, assure equitable treatment of patients and improve cost-effectiveness and quality.
Landers said she knows of only one other hospital, Renown Health in Nevada, that has asked to work with a different organ collection group.
That request also led to a lawsuit, with one procurement group accusing a neighboring one of trying to elbow in on their hospital relationship by offering a $6 million kickback — another example of the fierce competition among the organizations.
Wake Forest Baptist: LifeShare has better performance
In requesting the switch to LifeShare, Wake Forest Baptist said that because it is now part of the Atrium system, the change would lead to cost and operational efficiencies.
Atrium also said it is better able to provide the support, resources and additional donors needed for Wake Forest Baptist’s research initiatives.
But a large part of the hospital’s case was that LifeShare’s transplant rate is 42 percent better than HonorBridge’s, while its donation rate is 26 percent better. Those statistics put LifeShare in the top tier of the government’s three-tiered rating system, while HonorBridge is in the bottom tier.
LifeShare’s higher tier is evidence that the switch “will result in additional organ donors, organs transplanted and lives saved,” Wake Forest Baptist wrote in its request. “This move would also support the (government’s) legislative efforts to reward higher performing OPOs and increase the number of lives saved through organ donation.”
In granting the waiver request, the federal Department of Health and Human Services also cited LifeShare’s higher tier.
HonorBridge: Federal ranking system is flawed
Heald said he believes Wake Forest Baptist’s decision to change groups came from hospital administrators, not its medical staff — an indication, he said, that HonorBridge’s performance was not the issue.
“When the waiver was first requested, the hospital staff did not even know that the hospital had done that,” he said. “We had to tell them, and they weren’t happy about it.”
In its lawsuit, HonorBridge said the government should not have used the federal ranking system to justify the change, because the rankings are “interim” based on a single year of post-pandemic data and weren’t meant to be used to grant waivers.
HonorBridge also argues the rankings are additionally flawed because they fail to account for demographic differences across each organization’s service area, Heald explained.
While Atrium serves the Charlotte metro area and western North Carolina, he said, HonorBridge’s territory spans the rest of the state, including more rural areas where residents are significantly more likely to have health conditions that make their organs difficult to transplant.
Hospitals may reject less-than-perfect organs
Another problem with the new rankings is that half of an organization’s score is based on the percentage of organs they procure that are successfully transplanted into recipients. However, Heald says HonorBridge has little control over how many of its organs hospitals choose to accept.
Hospitals are evaluated based on survival rates after a transplant, Landers, the law professor, explained, so they are incentivized to reject “medically complex” organs even if these organs would save a patient’s life.
“A lot of organs are declined for patients on the waiting list because the doctors are waiting for an organ they think will be better or keep their statistics high,” Landers said.
A person who dies on the waitlist for a kidney has, on average, been offered 16 organs, according to a large study published in JAMA Network Open. In most cases, those patients are never made aware that an organ was available, Landers said.
A 2022 National Academies report recommended changes to improve the system, including revising how the federal government evaluates transplant centers to encourage greater use of organs.
It also suggested that rankings of organ procurement organizations go beyond transplant and donation rates and also consider factors such as a region’s demographics and the medical complexity of potential organs.
Concerns over new rules
Under the current rules, organ procurement organizations compete against each other rather than being measured against fixed performance metrics, Landers said. This discourages them from sharing best practices and increases the likelihood of lawsuits like the one involving HonorBridge.
Because the system ranks the groups relative to one another, some will always end up in the bottom tier, regardless of their actual performance, she explained. Under the rules, the organizations in the bottom tier in 2026 will lose their contracts with the federal government.
The Association of Organ Procurement Organizations, a trade group representing OPOs, has warned that this would result in 42 percent of its members losing certification, “risking severe disruption to the donation and transplant system.”
Landers shares those concerns, saying a mass decertification could leave some rural areas without a lead organization for organ procurement.
She said she is hopeful federal health officials will reconsider the policy before 2026 and consider the recommendations in the National Academies report.
“The system is not perfect, as our report said, but actually in any given year, it is either best performing or second-best performing in the world,” she said. “There is a real danger of breaking what’s working here.”
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