By: Jerome Brookshire

The United States government is mounting a sweeping effort to overhaul the nation’s organ transplant system, a response to mounting evidence of dangerous lapses in safety, integrity, and fairness. At the center of the reforms is the Department of Health and Human Services (H.H.S.), which has begun investigating several of the nonprofit organizations responsible for arranging organ donations, while also drafting new rules intended to restore public faith in a system that saves thousands of lives every year but has recently come under unprecedented criticism.

The push follows a cascade of revelations, congressional hearings, and investigations spurred largely by the reporting of The New York Times, which in recent months has chronicled cases of bungled or premature organ retrievals, troubling conflicts of interest, and systemic deviations from established allocation rules. The exposure of such failures—often hidden from public view—has shaken confidence in one of the most celebrated pillars of modern medicine: the ability to match donated organs with patients in desperate need.\

The immediate spark for the federal intervention was a disturbing report concerning the Kentucky Organ Donor Affiliates, one of the 56 federally designated organ procurement organizations (OPOs) across the country. According to findings released by Congress and covered extensively by The New York Times on Thursday, the group had ignored critical signs of patient responsiveness in individuals being prepared for organ donation.

Unlike traditional donors who are declared brain-dead, these patients fell into the category of “circulatory death donation,” a practice in which patients on life support who are not expected to recover are removed from mechanical assistance. After their hearts stop, surgeons quickly recover viable organs. But as experts and officials told The Times, such procedures demand extraordinary precision, since they hinge on medical judgments that can easily be misapplied.

In Kentucky’s case, regulators found evidence that staff had misinterpreted or disregarded patient responses—decisions that might have led to near-fatal errors in organ retrieval. One congressional aide summarized the conclusions starkly: “They were not only negligent but dangerously cavalier.”

Dr. Raymond Lynch, chief of transplantation at the Health Resources and Services Administration (HRSA), an arm of H.H.S. that oversees the transplant network, said in an interview that his agency was broadening the inquiry nationwide. “We want to make sure that people continue to have faith in the public good that is organ procurement and transplant,” he said, according to The New York Times. “We will make it safe and reliable.”

The Kentucky case was hardly an anomaly. As The New York Times reported last month, more than a dozen cases have surfaced in which patients endured bungled or premature attempts to recover organs. One woman in New Mexico was nearly operated on before she unexpectedly regained consciousness. In another case in Alabama, doctors reportedly began surgical incisions before realizing the patient was still alive.

Such revelations have rocked both the medical community and the broader public, raising existential questions about whether the transplant system—long celebrated as a medical miracle—remains worthy of the trust placed in it. “Faith in the system is everything,” one transplant surgeon told The Times. “Without it, donations collapse.”

Congress has taken note. In addition to the House hearing convened earlier this summer, multiple committees are now investigating organ procurement organizations, with the Senate Finance Committee scheduled to question Health Secretary Robert F. Kennedy Jr. about oversight failures next week.

The political fallout has already translated into worrying real-world consequences. According to Donate Life America, which maintains national donor registration statistics, more than 20,000 Americans withdrew from donor registries in the past month alone—a sudden and alarming reversal after decades of gradual expansion. Earlier this year, there were 174 million registered donors.

Although families can still authorize donations even if a loved one is not officially registered, officials worry the trend could spell disaster for the more than 100,000 Americans waiting for life-saving organs. “Fewer people registering their lifesaving decision to be an organ, eye and tissue donor may mean more deaths of patients waiting,” Donate Life America warned in a statement.

This erosion of trust has become one of the government’s central concerns. In an attempt to calm fears, H.H.S. has created a specialized working group to establish national rules for circulatory death donation, expected to be finalized by late November. Officials told The New York Times that the group will impose stricter neurological testing requirements, new training protocols, and closer supervision of OPOs nationwide.

The Kentucky organization at the heart of the controversy has already enacted reforms, including mandatory neurology evaluations for potential donors, in an effort to stave off further sanctions.

Beyond the safety scandals, another issue bedeviling the transplant system is fairness. As The New York Times reported in February, procurement organizations have increasingly skirted regulations by bypassing patients at the top of transplant waiting lists. Federal data showed that in 2024 nearly 20 percent of organs were allocated to patients lower on the list, six times more frequent than just a few years earlier.

OPOs claimed these deviations were often necessary to prevent organs from expiring in transit or to expedite placement. But The Times uncovered evidence that many of these decisions were driven by convenience—sending organs to hospitals with whom OPOs had comfortable relationships, or to reduce staff workloads.

Such practices undermine the carefully designed national system intended to ensure fairness and medical need dictate allocation, not geography or connections. As The New York Times report emphasized, the principle of impartiality is foundational to maintaining public confidence.

Following the February report, HRSA has stepped up enforcement. In recent weeks, the agency issued formal warnings to OPOs reminding them that repeated deviations from the waitlist would be punished. Regulators have also begun publishing data online showing how frequently each organization bypasses patients—a transparency measure applauded by patient advocates.

Interestingly, data since the exposé suggests some improvement. According to a New York Times analysis, list deviations fell below 18 percent in the second quarter of 2025. Several organizations spotlighted in the original reporting, including those in Miami, Minnesota, and Cleveland, appear to have sharply reduced their frequency of skipping patients. Lifebanc, the Cleveland-based OPO, even ended a controversial arrangement with the Cleveland Clinic after whistleblowers described troubling favoritism.

The transplant industry, however, is not accepting these changes quietly. The Association of Organ Procurement Organizations, a powerful trade group, insists that “skipping” rules allow OPOs flexibility to place organs that might otherwise go unused. The group has criticized H.H.S. for canceling pilot programs aimed at testing faster allocation methods, arguing that tighter oversight could paradoxically reduce organ usage.

Yet the data, as The New York Times report highlighted, shows the opposite: despite reduced deviations from the list, organ utilization has actually increased. More organs are being transplanted, not fewer, suggesting that stricter adherence to fairness rules enhances rather than diminishes efficiency.

Political leaders are now weighing in. While some Republicans have seized on the scandals as evidence of systemic bureaucratic incompetence, Democrats have emphasized the need for new oversight frameworks rather than dismantling the existing system altogether. Secretary Kennedy has positioned himself as a reformer, pledging to make “transparency, accountability, and safety” the pillars of a new transplant era.

The stakes could hardly be higher. Each year, more than 40,000 transplants take place in the United States, offering a second chance at life for patients suffering from end-stage organ failure. But for every success story, thousands more languish on waiting lists. The average wait time for a kidney, the most commonly transplanted organ, is three to five years. For hearts and livers, the margins are even narrower, with survival dependent on precision logistics and public generosity.

The recent scandals have threatened that delicate balance. As The New York Times has observed in editorials, the transplant network is one of the few arenas where public altruism directly fuels medical progress. Eroding trust risks triggering a vicious cycle: fewer donors, fewer transplants, and more preventable deaths.

For now, the government’s strategy combines immediate enforcement with long-term reform. HRSA is investigating multiple OPOs, though officials have not yet named which groups are under review. At least one organization in West Virginia is reportedly facing penalties, according to two individuals familiar with the process cited by The New York Times.

Meanwhile, the forthcoming rules on circulatory death donation promise to standardize practices that have until now been subject to wide interpretation. Federal officials say the aim is to prevent tragedies like those in New Mexico and Alabama from ever occurring again.

Transparency is also emerging as a cornerstone. By publishing bypass data online, regulators hope to give patients, families, and watchdog groups the tools to hold procurement organizations accountable in real time.

The U.S. organ transplant system stands at a crossroads, grappling with both scandal and opportunity. The exposure of grievous errors, brought to light by The New York Times, has catalyzed a reckoning long overdue. For patients on waiting lists, the stakes are existential; for donors and their families, trust is everything.

H.H.S. officials insist that reforms will restore credibility and safety. “We will make it safe and reliable,” Dr. Lynch vowed in his interview with The Times. Whether the government can succeed in repairing the system’s image while simultaneously increasing its capacity will define the next chapter of American transplantation.

What remains clear is that the very legitimacy of the nation’s transplant system now depends on accountability—ensuring that the gift of life is never again tainted by negligence, favoritism, or avoidable error.