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North Carolina’s largest organ procurement nonprofit is suing the Trump administration over a new rating system the group argues could upend the transplant system and risk lives.

Under the new rules, set to take full effect in August, the government will issue new ratings based on organizations’ relative performance and decertify the lowest-performing tier. Only the top-rated organizations will be guaranteed certification until the next rating round. 

HonorBridge, which serves 77 counties in North Carolina and one in Virginia, expects to be decertified—which is effectively a “death sentence,” the organization argues. Hospitals can’t contract with decertified procurement agencies if they want to keep federal funding. 

The Centers for Medicare & Medicaid Services (CMS) oversees the nation’s 55 organ procurement organizations, which function as regulated monopolies. 

These organizations, which are considered federal contractors, recover, match, and distribute as many transplantable organs as possible within their jurisdictions. They receive a flat fee per organ from Medicaid or hospitals to cover sourcing and coordination efforts. 

Last month, HonorBridge filed a federal lawsuit over the new rules against the U.S. Department of Health and Human Services and its secretary, Robert F. Kennedy Jr., and CMS and its administrator, Mehmet Oz. 

The suit comes as regulators grapple with how to govern organ agencies amid heightened scrutiny of their effectiveness, including how many healthy organs they’re able to procure and the rate of successful transplants. Federal health officials assert that injecting free-market principles into the industry will improve the performance of complacent organizations.

Several organizations say this defies the system’s intended design. 

Robert F. Kennedy Jr. and Mehmet Oz listen as President Donald Trump speaks in the Oval Office. (AP Photo/Evan Vucci)

Congress created rules for a nationwide organ transplant system in 1984, granting organizations exclusivity to procure organs in specific service areas. The idea was to prevent the organizations from encroaching on one another’s territory or engaging in profit-motivated decision making. 

Congress didn’t want the organizations vying for the same hospitals, hoping to drive up their metrics or revenue. For example, a hospital in an urban area with advanced equipment may generate more organs eligible for transplant, given the volume of patients and life-prolonging technology, compared to a hospital in a rural area. 

The Trump administration has taken the opposite approach. Through its new three-tiered rating system, CMS aims to “incentivize robust competition” in areas with low donation and transplant rates. Fearing complacency—or worse, abuse—by the organizations, the Trump administration says the overhaul is necessary. 

In its legal complaint, HonorBridge argues the federal health departments and their leaders are replacing “regional exclusivity with a cutthroat, iterative Hunger-Games-style competition,” referencing the dystopian book and movie series in which competitors must kill one another to survive. 

Several other organ procurement organizations are also suing the administration over the revamped rules, which the first Trump administration introduced in 2020. The Biden administration continued the rollout of those rules. Kennedy recently accused the previous administration of failing to act. 

Five organizations in Texas, Florida, and Georgia filed a similar complaint in August. And in December, the law firm representing HonorBridge also filed a suit on behalf of three organizations covering several northeastern states, Michigan, and South Carolina. 

The suits allege the administration is exceeding its authority by taking action beyond Congress’ intent for the program.

CMS and the federal health department did not respond to The Assembly’s inquiries. In defending its rules in the other cases, CMS has said it’s committed to holding organ procurement organizations accountable. In a statement, HonorBridge said metrics are essential to measuring system performance, but they must be fair and accurate.

Combined, the lawsuits offer insight into the delicate dance of organ transplants and unsettling allegations in a tug-of-war over one of life’s most sacred gifts.

Demand Outpaces Supply

The stakes are always high in organ donation and transplantation. Success hinges on dozens of decisions, people, and processes that must synchronize in a matter of hours. 

Demand for organs far outpaces the available supply, with only about 2% of deaths eligible to lead to donation. Typically, a donor’s death must be anticipated and take place in a hospital setting because organs rapidly deteriorate once deprived of oxygen. 

In North Carolina, nearly 4,000 people are waiting for organ donations, according to the Organ Procurement & Transplantation Network’s data as of late January. The vast majority—nearly 3,680—are awaiting kidney transplants. 

Last year, 101 people in North Carolina died while waiting. 

A file photo of donation paperwork. Last year, 101 people in North Carolina died waiting for an organ. (AP Photo/Whitney Curtis)

Given the supply-demand mismatch, stakeholders have sought to increase the organ supply. Between 2015 and 2025, the number of total organ transplants in the U.S. grew from nearly 31,000 to 49,000. CMS attributes the increase to “sustained regulatory pressure.”

CMS first imposed performance-based, survival-rate reporting requirements for organ procurement organizations in 2007, but the rules created unintended consequences. 

CMS acknowledged agencies were improperly incentivized to improve their metrics, which led to forgoing organs deemed less desirable, like those in older or medically complex patients, that could have been successfully transplanted. It also resulted in the firms deprioritizing matching organs with patients who were less likely to survive. 

In 2019, President Donald Trump ordered CMS to overhaul its rules “to establish more transparent, reliable, and enforceable objective metrics” to monitor the organizations. 

The government proposed a three-tier rating system to rank agencies’ performance against each other using two measurements: the rate of organs procured compared to how many potential eligible deceased donors were available, and the rate of procured organs actually transplanted (some organs are procured, but issues can arise in transportation, degradation, or matching). 

CMS has issued a few iterations of its tiered rankings. In new rankings, which are scheduled to be issued this summer, Tier 1 organizations will be automatically recertified and retain exclusive access to their territory. 

Geographic areas served by Tier 2 organizations will be opened for competition; both the existing organization and others could apply to control the territory. 

Organizations in Tier 3 will be nixed, leaving their territory up for grabs. Ten organizations are rated Tier 3 in the most recent ratings released last year. 

HonorBridge is ranked in Tier 2; it was previously ranked in Tier 3 between 2020 and 2022. 

Greg Segal, CEO of the New York-based Organize, founded the nonprofit to advocate for industry reform after his father waited five years for a heart transplant. Segal calls organ procurement organizations’ claims “distasteful fear-mongering.”

He said organ procurement organizations’ real concern is about the shift away from self-reported data, which was in place prior to the 2020 rule change, to government data. “They don’t like any world in which they can lose their contract,” he said. “That’s all this is about.”

Medical students watch as the liver and kidneys are removed from a donor in Jackson, Tenn. (AP Photo/Mark Humphrey)

Performance data varies considerably by demographic characteristics—the healthier and younger the donor base, the higher the transplant rate. This complicates comparisons between organizations. 

Researchers have warned that the government’s new classification system may be overly simplistic and unfairly punish procurement agencies operating in underprivileged areas. 

But regulators are keen to take action. In 2020 and 2021, the then-Democratic-led House Committee on Oversight and Government Reform sought documentation to investigate 17 organizations suspected of systematically overlooking organs that could have saved lives, and other wasteful practices. (HonorBridge was not among them.) 

And in July, the federal health department shared disturbing findings from its investigation of an organ procurement organization that operates in Kentucky, Ohio, and West Virginia. That probe identified at least 28 cases in which a patient may not have died prior to the initiation of organ procurement. “The entire system must be fixed,” Kennedy said at the time.

For procurement agencies across the country, the investigation was a nightmare—the supply of desperately needed organs is already scarce. The findings threaten the most important, intangible feature the complex system relies on: trust. 

Rating System Flawed?

HonorBridge is the state’s biggest player in the space, and helps orchestrate donor families, surgeons, pilots, organ matches, grief counseling, and more, all within a rapidly closing window of time. Last year, the organization helped recover 1,155 organs and its transplants saved 789 lives. 

The nonprofit’s operations are spread throughout the state with offices in Chapel Hill, Greenville, and Winston-Salem. Because it’s paid a flat fee per organ, HonorBridge makes a smaller margin salvaging organs from rural areas, where it costs more to operate. Nonetheless, it is still obligated to recover as many organs as is feasible. Its work in busy transplant centers effectively subsidizes its efforts in disadvantaged communities. 

HonorBridge is the state’s largest organization of this sort, with offices in Chapel Hill, Greenville, and Winston-Salem. (Carolyn de Berry for The Assembly)

As of December, more than 5.5 million North Carolina residents have the organ-donor-designation heart on their license or identification card. Last summer, state lawmakers passed legislation that HonorBridge helped craft that will add a question about organ donation to 2028 state income tax forms, which is expected to increase the donor pool.

Minorities are less likely to consent to organ donation. Research attributes this to a legacy of distrust in a medical system that can be imbued with discrimination. At the same time, minorities are overrepresented on transplant waiting lists. Black residents comprise 48% of the state’s organ waitlist but only 22% of the population.

HonorBridge argues in its lawsuit that this will punish organizations operating in under-resourced communities. It says the government’s rating system fails to acknowledge factors outside of an organ procurement organization’s control, like a population’s demographic characteristics and density, or the performance of the hospitals where the transplants take place. 

“The entire system must be fixed.”

Robert F. Kennedy Jr., Health and Human Services secretary

The round of tiered designations expected this summer will be based on 2024 data. HonorBridge argues “a single bad year could doom” an organization, and says CMS’s data is too “stale” to be used as the basis for shuttering effective operations. 

HonorBridge ranks 37 out of 55 agencies based on 2023 data.

Last week, CMS introduced more new rules to strengthen its oversight of the organizations. Among the proposals, CMS aims to incentivize the use of organs that may otherwise go to waste. It’s not immediately clear if these new rules will satisfy the organizations’ core complaints.

Atrium Makes a Move

The lawsuit filed last month marks HonorBridge’s second legal action against the Trump administration. 

The organization first sued CMS last year after the agency granted a waiver allowing Atrium Health to work with its own organ procurement agency at Atrium Health Wake Forest Baptist in Winston-Salem, the largest hospital in the region. 

HonorBridge got its start in the hospital in 1985, and for 14 years exclusively served it before branching out to work with other transplant centers across the state. Charlotte-based Atrium Health purchased Wake Forest Baptist in 2020, and filed its waiver request less than two years later. 

Atrium Health controls LifeShare Carolinas, which procures organs in 22 counties on the western side of the state, including Charlotte and Asheville. (A Virginia-based organization operates in one northeastern border county, Dare.) 

In its waiver application, Wake Forest Baptist cited LifeShare’s Tier 1 CMS rating as a reason the hospital should be allowed to break its contract with HonorBridge. Neither Wake Forest Baptist nor LifeShare responded to a request for comment.

In legal filings, CMS leaders defended granting the waiver to Atrium, and argued HonorBridge was simply facing the “consequences for poor performance.” HonorBridge argued the ratings comparisons weren’t fair, given each organization’s differing organ specialities and populations. 

Both accused the other of risking lives in attempting to secure the Wake Forest Baptist territory. 

HonorBridge also sued CMS last year after the agency granted a waiver allowing Atrium Health to work with its own organ procurement agency. (Carolyn de Berry for The Assembly

HonorBridge alleged Atrium had a conflict of interest and would prioritize its own business needs. Atrium argued that using its own agency would increase efficiency and save money. Organ acquisition costs per kidney were about $34,900 for LifeShare versus about $46,800 for HonorBridge in 2023, according to legal filings. 

HonorBridge asked the court to nullify Atrium’s waiver. Richard E. Myers II, chief judge for the U.S. District Court of Eastern North Carolina, declined the organization’s request for a preliminary injunction in March, allowing LifeShare to take over as Wake Forest Baptist’s organ procurement agency. 

Still, Myers left open the possibility that the deal could be unwound later on, and appeared persuaded by some elements of HonorBridge’s argument against the CMS tiered rating system. 

“If you are a public school teacher and you’re in the best district, you’re going to get higher test scores,” Myers said at a hearing in March. “If you’re in the worst district, you’re going to get lower test scores. Does it make you a worse teacher?”

A trial for that lawsuit is scheduled for December. CMS has yet to file its response to the latest suit. 

Johanna F. Still is a health care reporter for The Assembly. She previously worked for the Greater Wilmington Business Journal, where she reported on economic development. She is also a photographer, and was the assistant editor of Port City Daily.