James Eason, MD, who earned acclaim by operating on Steve Jobs, led the transplant center named in his honor at Methodist University Hospital in Memphis. An internal analysis by Eason's own team details the preventable deaths under his watch.
This article was published on Wednesday, June 14, 2023 in ProPublica.
On a brisk morning in the winter of 2019, at a standing-room-only reception, a procession of speakers lavished praise on the surgeon who more than tripled the size of the liver transplant program at Methodist University Hospital in Memphis. The lifesaving doctor was receiving an honor often reserved for the dead: Methodist's leaders announced that the hospital's new state-of-the-art transplant center would be named for Dr. James Eason.
Eason seemed to have reached the summit of what was then a 25-year career. A decade earlier, he had performed one of the highest-profile liver surgeries in recent history: the transplant that extended the life of Apple co-founder Steve Jobs by more than two years. That operation earned Eason the gratitude of Jobs' widow, who later donated a total of $40 million to the transplant center he helmed and the medical school where he worked as a professor. At age 58, Eason had become one of the country's highest-paid transplant surgeons, earning $1.7 million a year, more than anyone at Methodist but the head of its nearly 13,000-employee, six-hospital health system.
But for all the lives the liver transplant program saved, the hospital's leadership had growing concerns about the number of patients dying on Eason's watch. During the five years before the renaming ceremony, those deaths had sparked investigations from the federal contractor that oversees transplant centers. They also prompted multiple health insurers to remove the liver program from their preferred networks, according to internal documents.
In 2018, following the most recent investigation, Methodist hired a consulting firm to audit the program. The audit, conducted by peers from other transplant centers, found that numerous errors had contributed to patient deaths — and that to reduce the rate of failed liver transplants, Methodist likely would have to perform fewer transplants overall. But according to the audit, that would be difficult. Staffers felt "powerless to make change due to the resistance of leadership," who gave the employees the impression that "volume is king," the audit said.
In December 2018, Methodist University Hospital President Roland Cruickshank wrote a letter to the federal contractor acknowledging the transplant program's worrisome number of deaths. "The decline in our outcomes is of the utmost concern," he wrote, "and is not taken lightly." Weeks later, Cruickshank sat in the front row of the renaming ceremony and stepped up to unfurl a banner with the words "James D. Eason Transplant Institute."
ProPublica and MLK50: Justice Through Journalism obtained an extraordinary cache of internal records that reveal Methodist leaders failed to comprehensively fix problems with the liver program before the renaming ceremony. The records include the independent audit, detailed internal reviews of patient deaths and the hospital's correspondence with the federal contractor, a nonprofit called the United Network for Organ Sharing, or UNOS.
One of the documents was an internal analysis drafted at Eason's behest. In part of the analysis, one of his most senior colleagues determined that between late 2014 and mid 2018, 25 deaths — more than half of the program's 48 total fatalities — were preventable.
The analysis found that some liver recipients had died after their transplant as a result of "process/protocol issues." It also found that a portion of patients "should not have been listed" for transplant due to preexisting medical conditions.
Along with the documents, interviews with families of nearly two dozen liver transplant recipients who died over the past decade show that, in some cases, Methodist staffers didn't tell them about the extent of the problems that contributed to their loved ones' deaths.
Terry Green, a retired Army noncommissioned officer who donated a portion of his liver to his identical twin brother, did not know that Eason's team had, according to medical records and internal documents, failed to conduct enough testing to rule out the risks of cardiac and pulmonary complications before Eason himself performed the transplant. His brother died from cardiac arrest in the operating room.
Stacy Roberts was unaware that, following her father's transplant, Eason's team had identified major problems with the donated liver it had placed inside him, issues it may have been able to identify with further screening, internal records show. Methodist had accepted the liver from another hospital, which had failed to spot that the organ bore the early signs of cirrhosis. Days later, after her father experienced serious complications, Methodist providers conducted their own biopsy, discovering the full extent of the damage to the organ. Her father died about a month after the surgery. Hospital records show that transplant program leaders later required surgeons to more rigorously review liver donations before accepting those organs for patients.
For years, Tiffany Garrigus was haunted by the memory of watching her 59-year-old father die just several hours after his transplant. Unbeknownst to Garrigus, a nurse had reported concerns about internal bleeding to the surgical fellow on shift and noted that the doctor failed to quickly alert the attending surgeon. The miscommunication delayed potentially lifesaving care. The independent auditors later determined that Methodist's own review of Steve Garrigus' death was a "missed opportunity" to prevent similar issues in the future.
"They screwed up," Garrigus said after she learned about records that outlined Methodist's treatment of her father. "No one was held accountable and nothing changed."
Garrigus and five other families who spoke with ProPublica and MLK50 signed documents waiving their rights to privacy so Eason and Methodist could answer questions about their loved ones' deaths. Eason and Methodist declined to address those questions. The hospital and Eason also did not answer specific questions about the dozens of deaths detailed in the investigations, the findings in the audit of the transplant program or the correspondence between the hospital and UNOS.
Spokespeople for Eason and the hospital asserted that ProPublica and MLK50 singled out patients with negative outcomes. Methodist spokesperson Tabrina Davis also said in a statement that the news organizations had "settled on a clear narrative, one which we believe is a misleading and inaccurate portrayal of the institute." The statement went on to say that "the transplant institute is on a continuous journey of improvement, focused on providing the highest quality care for each patient."
Eason turned down multiple requests to be interviewed for this story but responded to questions in writing at various points. In one statement, he said that he and his team at Methodist "tried to give every patient the opportunity for transplant." He also said in that statement that while there were "2-3 unexpected deaths per year" between 2011 and 2018, "we also saved more than 100 lives each year, all of whom would have died without liver transplantation." Eason's lawyer, Elizabeth Sacksteder, said in a separate letter that "performing more transplants rather than fewer" and using "the best available organs rather than waiting for the perfect organ" are pivotal parts of Eason's approach to running a liver transplant program.
For more than a decade, Methodist liver recipients had a greater-than-expected chance that their liver would not be functioning one year after transplant, a metric used by UNOS to assess transplant centers' performance. Eason said in his statement that UNOS had overrelied on that metric without taking into account that programs like Methodist have accepted more high-risk patients who would otherwise die imminently. He added that Methodist has excelled at minimizing the extent to which patients die on the waitlist, a metric that is now part of how UNOS evaluates transplant programs.
"I would never choose to let a single high-risk patient die instead of giving that individual a good chance of living," Eason said in another statement.
Eason, however, is no longer making those choices at Methodist. This past August — after years of investigations and years of Methodist leaders celebrating Eason's accomplishments — hospital employees were unexpectedly pulled into a conference room at the transplant center. Standing at the front of the room, along with other top executives, was the head of the health system. He shared a brief message that caught employees off guard: Eason was no longer with the James D. Eason Transplant Institute.
Methodist's Liver Transplant Outcomes Drew Scrutiny From Investigators
The United Network for Organ Sharing launched two investigations over the past decade after Methodist University Hospital's liver transplant program performed worse than expected.
Transplant centers report data about their performance to UNOS, which examines whether the performance of transplant programs was worse than expected. To do so, UNOS analyzes the extent to which transplanted livers still functioned one year after a surgery.
Each percentage is based on outcomes over the prior 30-month period. For still-functioning transplants performed in the last six months of the study period, the chance of a liver continuing to function one year after the surgery is modeled after the outcomes of previous transplants in the study period.
The blue line shows the percentage of Methodist patients expected to have a functioning transplanted liver at one year, based on characteristics of the liver transplant program's prior recipients and donors. The yellow and gray lines show the chance of a patient having a functioning transplanted liver at one year, modeled after real-world outcomes.
Before his arrival at Methodist, Eason led another transplant center that was investigated for its poor performance during his tenure.
In the winter of 1998, Eason left his post as head of a San Antonio military hospital's transplant center to begin a new job. He now oversaw liver and kidney transplants at the Ochsner Foundation Hospital just outside New Orleans. Eason's team increased the number of liver transplants Ochsner performed from 23 in 1998 to 76 in 2001. But the rapid growth was followed by higher rates of deaths within a year of transplant, according to data from the Scientific Registry of Transplant Recipients.
One of Eason's colleagues, Dr. Ari Cohen, subsequently wrote in a presentation to a group of transplant experts that the rate of adult patients living for one year after their liver transplants at Ochsner became "significantly worse than expected" between July 2002 and December 2004.
In 2005, a UNOS committee began investigating the reasons behind poor outcomes at Ochsner, according to an article written by Ochsner doctors that was later published in the health system's academic journal. The article described the liver transplant program's culture prior to 2005 in a way that was similar to what Methodist's audit would turn up years later: A "feeling of fear" had left employees "unable to freely express their views" about the program's problems.
In response to the UNOS investigation, Ochsner put together a team that determined the transplant center's leadership was one of the biggest problems contributing to the liver program's poor patient outcomes.
UNOS spokesperson Anne Paschke said that the organization does not comment on specific investigations. Cohen, along with other Ochsner doctors who contributed to the article, did not respond to emails or phone calls. An Ochsner spokesperson declined to respond to ProPublica and MLK50's questions or make anyone available for an interview. Eason declined to comment on the UNOS investigation or his former colleagues' reflections on the program under his leadership. In his statement, he said that he came to Ochsner after the program had been "closed due to loss of leadership" and that the program "went from saving zero lives to saving more than 80 lives each year."
Before the UNOS committee completed its investigation, Eason accepted an offer that would allow him to return to his home state of Tennessee — and provide an opportunity to take another small liver transplant program and grow it even more dramatically.
In the five years following Eason's departure, his former colleagues addressed the problems, according to the journal article. They turned Ochsner's liver program into one of the top performers in the South, according to healthcare ratings organizations.
When Methodist announced Eason's hiring in 2006, Dr. Hosein Shokouh-Amiri was deeply concerned. The veteran Methodist surgeon said he had heard about the rapid expansion of Ochsner's transplant program and was worried that a similar approach might lead to higher rates of failed liver transplants for Methodist patients.
Amiri was afraid that Eason would override clinical decisions that Amiri or his colleagues had determined were in the best interest of patients. And so he decided to leave the transplant program shortly after Eason arrived. Before Amiri's final day at Methodist, Eason wanted to know if he would reconsider. Sitting in Eason's office, Amiri asked if Eason would ever require a surgeon to accept a donated liver that the surgeon would rather decline because of poor quality. Amiri recalled that Eason wouldn't answer at first. Amiri said that when he pressed for an answer, Eason told him that he would do so if he felt it was necessary.
As Amiri saw it, Eason's track record of boosting volume would "bypass the moral and ethical standard we had promised" to Methodist patients.
"He wanted my approval," Amiri said. "I resigned."
Eason did not respond to questions about Amiri's recollections and concerns. Eason's spokesperson, Stefan Friedman, wrote in an email that Amiri left Methodist "to go to a program that performed only 11 transplants last year with higher deaths on the waitlist and lower one-year survival rates." Amiri said that his liver transplant program had lower survival rates "because we took sicker patients." Federal health data confirms that Amiri's program accepted a higher percentage of patients at high risk of death from liver disease than Methodist.
During his early years in Memphis, Eason led the dramatic growth of Methodist's liver transplant program. The year before he started, in 2005, Amiri and his colleagues had performed 34 liver transplants. Over the next three years, Eason's team more than tripled the hospital's annual number of liver transplants, replacing 117 organs in 2008. Methodist leaders celebrated this growth as a historic achievement — one that allowed the liver transplant program to serve more patients in a majority Black city that had a higher poverty rate than the national average. Eason's lawyer said in a letter that the population of the Memphis region "disproportionately suffers from co-morbidities associated with poverty" that "heighten the inherent risks of liver transplant surgery."
By performing 126 transplants in 2009, Methodist became one of America's 10 largest liver transplant programs. As hospitals across the country expanded their transplant centers, they stood to profit from treating more patients suffering organ failure. According to a 2009 study published in Medical Care Research and Review, the average cost of a U.S. liver transplant and the subsequent days spent recovering in the hospital was about $163,000. Around that time, The Wall Street Journal reported that some hospitals charged nearly three times as much for the surgery. Friedman said in a statement that Eason did not receive additional compensation for performing more transplants, "nor was any aspect of his compensation based on such a metric." Methodist did not respond to questions about the program's finances.
The growth of Methodist's program was fueled in part by a special agreement with federal health officials that allowed the program to obtain livers across the entire state of Tennessee and parts of Arkansas and Mississippi. As the program grew, it began attracting more patients from beyond the greater Memphis area. A central Ohio minister received a liver transplant at Methodist in 2009 after being rejected by three other programs. He lived for another 12 years. A mechanic from San Juan, Puerto Rico, who experienced liver failure received a transplant at Methodist in 2010; in an interview translated by his wife, Carlos Acevedo Martinez told ProPublica and MLK50 that he had no complications and was grateful "Methodist gave him life again."
Near the end of his third year at Methodist, Eason was in touch with his friend George Riley, a Memphis native whose parents had been doctors at Methodist. Riley, a California lawyer, wanted to know if Eason might help his client. Steve Jobs faced a long wait to get a new liver in his home state of California. His wife, Laurene Powell Jobs, had learned that people could be simultaneously added to waitlists in multiple states. Since Jobs had a plane, he could fly to whichever transplant center was willing to accept him. Tennessee, it turned out, had a shorter waitlist.
One day in March 2009, before dawn, Eason waited for Jobs' plane at the Memphis airport. "I went to meet him and escorted him to the hospital," Eason later told WMC-TV. One of Jobs' biographers, Walter Isaacson, wrote that Eason closely oversaw Jobs' care after the transplant, assigned nurses solely to his recovery and "would even stop at the convenience store to get the energy drinks Jobs liked." Jobs later recovered in a 5,784-square-foot mansion in Memphis that Riley purchased through a shell company, according to The Commercial Appeal.
Weeks after Jobs returned home that spring, news broke of his surgery. Media outlets including CNN and TheNew York Times published articles that explored whether Eason gave preferential treatment to the billionaire. The surgeon pushed back: Jobs was the sickest, most deserving patient on the day that liver became available, he said. Starting that summer, Eason lived on and off in the mansion — a perk he didn't publicly disclose at the time. Two years later, in 2011, he bought the house from the shell company for $850,000, the same price the company paid for it in 2009. (Home sale prices in the greater Memphis area had fallen in the interim.) Eason did not respond to questions about living in or buying the home.
Around the time of Jobs' transplant, Methodist's liver recipients had a better estimated chance of their organs functioning at least one year after a transplant than the national average. But in the years after Jobs' surgery, Eason's liver transplant program began to struggle. The rate of failed liver transplants increased between July 2010 and December 2012. As a result, the UNOS committee that had scrutinized Ochsner's performance under Eason opened an investigation in early 2014. The committee's work is confidential, but ProPublica and MLK50 obtained records that described the investigation. (UNOS declined to confirm when the investigation ended.)
The UNOS committee, which is composed of several dozen transplant experts who volunteer to review their peers' programs, can recommend the discipline of transplant centers for their poor performance. But the committee rarely punished programs. In fact, the committee was so toothless that in 2018 the then-CEO of UNOS likened the committee's investigations to "putting your kids' artwork up at home."
"You value it because of how it was created rather than whether it's well done," the UNOS leader wrote of the investigative committee. "Only in this case, we persuade ourselves that it's well done anyway."
Though Eason now defends the program he led, he acknowledged in an April 2014 letter to the UNOS committee that Methodist's outcomes "were not as expected." He pledged to address the committee's concerns.
According to internal documents from June 2014, Methodist was anticipating potential financial fallout from those poor outcomes. A Centers for Medicare & Medicaid Services official had informed Methodist that its liver transplant program was out of compliance with federal standards because it had "significantly lower than expected" outcomes and did not have an adequate policy for evaluating the reasons behind its failed liver transplants. The official warned that CMS would terminate the liver program's participation in Medicare, which covered the costs for nearly a third of the liver transplants performed at Methodist, if it failed to correct those problems.
In its written plan outlining how it would fix the problems, Methodist told CMS that one way it would improve outcomes was through Eason encouraging a "higher scrutiny of patients" whose risks of complications outweighed the potential benefits of surgery. Methodist ultimately avoided termination from Medicare.
But records obtained by ProPublica and MLK50 show that Methodist kept accepting patients whose poor health increased the risk of complications after a transplant. Eason's team soon approved for transplant a 356-pound woman with a BMI of 66 and a woman who struggled so much with drinking alcohol that she only stopped after getting sick from liver failure. The team also signed off on a patient for transplant in spite of the fact that she was septic the day before the surgery. All three died within a year after their transplants.
Dr. Satheesh Nair, one of Eason's most senior colleagues, later determined in an analysis of patient deaths that Methodist should not have placed these patients on the transplant waitlist. Nair did not respond to questions. Eason did not comment on the findings of the analysis, but said that he asked for it to be done as part of his transplant program's efforts to improve its quality of care.
Davis, the Methodist spokesperson, also declined to comment on Nair's findings. She said in a statement that Methodist has turned away liver transplant candidates because they "do not meet the criteria to indicate they would have successful outcomes" after a transplant.
By the time Jerry Green arrived at Methodist in 2016, the 46-year-old minister from West Memphis, Arkansas, was experiencing symptoms of liver failure, including fatigue and jaundice. As Green underwent a battery of tests, the evaluation revealed potential signs of pulmonary hypertension, according to hospital records. That condition can increase the risk of death from a transplant.
Medical experts have written in journal articles that when a transplant candidate has signs of pulmonary hypertension, additional testing, including what's known as a right heart catheterization, should be done to more precisely determine the risk of complications during or after a transplant. If the risk is too great, liver transplant programs can either reject the patient or postpone the surgery until the patient receives care to improve their health. But "no further assessments were made," according to an internal analysis of Green's treatment that the liver transplant program later conducted.
Methodist doctors calculated that Green had a strong chance of surviving for three months without a transplant. But that also meant he was unlikely to get a liver from a deceased donor because he would be low on the waitlist. According to hospital records obtained by ProPublica and MLK50, Eason encouraged Green to get a transplant immediately the only way he could: by finding a living donor. Green was reluctant. But when he gave in, he asked his twin brother, Terry. He agreed.
In the summer of 2016, as the Green family packed inside Methodist to support the twins, a surgeon sliced open Terry's abdomen. It was one of the first living liver donor transplants ever performed at Methodist. Once they started Jerry's surgery, his pulmonary arterial pressure rose so much that surgeons considered halting the transplant. Methodist providers gave Jerry medication that lowered his pressure. According to an operative report from a surgical fellow, Eason "had extensive discussion with his family, where they strongly hoped to undergo the surgery with any possible measures." (Jerry's wife, Jacqueline Green, said that she was notified about the concerns over his pressure but did not have an in-depth discussion with Eason about the risks of proceeding with the surgery.) Eventually, surgeons began replacing his liver with a segment of Terry's.
Once Terry woke up, Eason stopped by to check on his abdomen. The surgeon then shared the worst news of Terry's life. Jerry's heart had suddenly stopped. The staff tried to revive him in the operating room but could not pull him back from the brink of death. "His heart wasn't strong enough," Terry remembers Eason saying. "What we learned here will help others in the future."
After the funeral, Jacqueline met with Eason to learn more about what went wrong. As Jacqueline asked questions about Jerry's death, Eason said that the liver transplant was successful. "It was just his heart" that failed, she recalled Eason saying.
The following year, Methodist enacted several new policies designed to more rigorously test patients' cardiac and pulmonary risks ahead of a liver transplant. In the program's internal analysis, Nair later determined that Green's death was preventable. Jacqueline said Eason never told her about that finding.
Not long after Jerry Green's death, Eason and nearly two dozen colleagues gathered for a confidential meeting. A familiar problem that had dogged the program was now resurfacing.
Four years earlier, in December 2012, CMS had announced it would cut off a crucial part of Methodist's organ supply from central and east Tennessee. Some transplant experts praised the decision because they felt Methodist had unfairly benefited from an old policy that provided access to more high-quality organs from a large geographic area. To avoid shrinking what had become the nation's fourth-largest liver program, Methodist accepted more livers that posed a higher risk of complications for their recipients. Eason's transplant quality director later wrote in a document responding to the UNOS committee's investigation that the strategy was justified as the country faced a chronic organ shortage. As the quality director explained, the additional risk was in "balance against the risk of candidate death on the waitlist."
At the confidential meeting, Eason and his staff focused on a case that exemplified the perils of such risk-taking. That July, Methodist had received a liver offer from a North Carolina hospital. The liver had belonged to a 34-year-old military veteran who had struggled for years with use of hard drugs and alcohol. The way that he died required that his liver be removed after his heartbeat stopped, known as a donation after circulatory death or DCD. Such donations involve an organ that has been deprived of sufficient oxygen between the time of death and the organ's removal. As a result, these donations can elevate the risks of complications for a recipient. That year, about 6% of U.S. liver transplants involved DCD organs, according to data from the Scientific Registry of Transplant Recipients. The data also showed Eason's team accepted DCD livers at a percentage nearly triple the national average.
The night that Methodist received the liver offer, one of Eason's surgeons described the donor's history to Eugene Willard, a 61-year-old grandfather who served as the mayor of his small town of Amagon, Arkansas. Willard wanted to reject the offer, according to his daughter, Stacy Roberts. Two weeks earlier, another Methodist doctor had determined Willard would be a "suitable candidate for liver transplantation providing he loses weight," records show. That doctor had encouraged Willard to slim down to lower his risk of complications whenever the transplant did happen. But with the offer on the table that night, the surgeon urged Willard to accept the liver, his daughter recalled. "If you don't do it, you're going to die," she remembered the surgeon saying. Willard followed the surgeon's advice and agreed to accept the organ.
After Willard's new liver showed signs of poor function, Methodist providers ordered another biopsy to better understand his complications. This time, they saw that the donated liver had so much scarring that the early stages of cirrhosis were present. He died about a month after the surgery.
At the confidential meeting, the team concluded that the North Carolina hospital's biopsy of the donated liver "may have been inadequate." Eason's team responded by approving a policy change that required surgeons to more rigorously examine biopsies before accepting livers. Nair's analysis later determined that Willard's death was preventable, citing "donor selection" issues.
Data from the Scientific Registry of Transplant Recipients shows that Methodist continued to accept DCD livers in 2017 and 2018 at rates higher than twice the national average. Eason's transplant quality director later explained in the response to UNOS that Methodist's surgeons accepted more high-risk livers because they had "access to fewer local organs than the national rate," leaving the program little other choice for saving patient lives. The quality director defended the practice as one that "represents our effort to provide care to an underresourced patient population."
"Most have no other opportunity or hope of transplantation," the quality director wrote.
Over the course of 2018, Methodist's transplant center leaders were confronting a new round of scrutiny. After a period of improved patient outcomes following the UNOS committee's investigation four years earlier, the liver transplant program's failure rate had again worsened. As a result, the UNOS committee opened another investigation.
Methodist responded with a step intended to help its struggling program. It hired the transplant consulting firm Guidry & East to conduct an audit of its liver transplant program's operations.
Five transplant experts — including doctors affiliated with medical schools at the University of California, San Francisco and Cornell University — traveled to Memphis in October 2018 for the two-day audit. They toured the center's halls, interviewed employees and reviewed liver transplant records. The experts wrote a 35-page report, a final draft of which was obtained by ProPublica and MLK50, that identified a list of problems that they said contributed to patient deaths.
The audit stated that Eason's program appeared to "maximize the number of transplants by disregarding flags" as to whether patients were suitable candidates for surgery and, according to one Methodist doctor, was "currently accepting less than ideal donor organs for transplantation." It also determined that the program had failed to thoroughly review the causes of patient deaths in order to prevent repeat mistakes with future patients, a problem previously identified during federal inspections.
To better protect patients, Eason would need to improve its policies in a way that would limit surgeons from operating on patients unlikely to survive long after transplant, in addition to limiting the number of high-risk organs the program accepted, the experts' audit determined.
The experts also flagged problems with the hospital's oversight of its liver transplant program. The audit noted the stark "disconnect" between Eason's team and hospital leadership. "There is a lack of transparency in what is reported," the experts determined.
After the audit, Methodist University Hospital President Cruickshank pledged in a letter to the UNOS committee that senior hospital leadership would "work closely" with Eason's team to adopt Guidry & East's recommendations. Those changes, Cruickshank said, would "once again allow us to meet the UNOS requirements and our own expectations of exceptional outcomes." (Cruickshank, who has since left Methodist, did not respond to multiple requests for comment.)
In February 2019, less than two months after Cruickshank's letter, Eason stood at the renaming ceremony before his supporters, including Laurene Powell Jobs, an internationally known philanthropist who has donated to a wide variety of causes. (Powell Jobs' social impact organization Emerson Collective contributes to numerous media organizations, including ProPublica and MLK50, and owns a majority stake in The Atlantic. Through a spokesperson, Powell Jobs declined to comment about her support of Eason and Methodist.) In the halls of Methodist's new $275 million nine-story tower, a portion of which would be home to the transplant center that had received her donation, Eason and Powell Jobs posed for a photo before a wood-paneled wall lettered with the surgeon's name on it.
Later that month, Methodist received a letter from the chair of the UNOS committee overseeing the investigation, whose members had met to review the Guidry & East audit. The letter stated that "recent outcomes do not seem to be improving."
In April 2019, as Methodist was about to welcome patients to its new transplant center, Eason wrote in a letter to the UNOS committee that the liver transplant program was headed in the right direction. To address the committee's concerns, Eason presented a detailed plan that outlined how Methodist was overhauling policies within its liver transplant program. He attached newly written guidelines that directed the program to be more stringent in accepting high-risk patients and livers. He also noted that transplant leaders were routinely holding conferences where staffers more thoroughly reviewed cases with bad outcomes, openly discussed medical mistakes and identified ways to prevent repeat errors.
"We believe our team has made tremendous progress in improving the outcomes of our Liver Transplant Program," Eason wrote.
Davis, the Methodist spokesperson, said in a statement that Methodist "considered every recommendation" from Guidry & East and enacted some of those policies "right away." Neither Eason nor Nair responded to questions about the Guidry & East report.
After the new transplant center facility opened that spring, the liver program's numbers did, in fact, begin to turn around. The program's rates of failed liver transplants continually improved in 2019 and 2020. But they did not improve enough to clear the threshold that the UNOS committee typically required to close an investigation.
In 2021, UNOS rewrote the rules for investigating transplant programs. Ian Jamieson, then the chair of the investigative committee, said that judging programs on post-transplant outcomes alone had created a "disincentive to transplantation." To remove that barrier, UNOS leaders decided, a program would have to have far worse rates of failed liver transplants before UNOS would automatically step in to investigate.
UNOS touted the policy as "a more holistic approach" to evaluating transplant programs, since the committee would now also consider the extent to which patients were dying on the waitlist. The changes were not universally praised: Critics worried that the policy would lead to fewer transplant programs being held accountable.
Around the time the new UNOS policy began to take effect last year, the committee ended its investigations into numerous transplant programs, including the liver transplant program at Methodist.
Eason and a spokesperson for Methodist said that the investigation was closed because the program's outcomes had improved. (UNOS declined to comment on the reason.) Eason said in his statement to ProPublica and MLK50 that UNOS' new policy was recognition that UNOS had been relying on a transplant metric that was "outdated and invalid." He sees that decision as part of a broader shift in which federal transplant policy is falling more in line with his philosophy to offer transplants to as many people as possible.
With outcomes improving and policy shifting, Eason seemed poised to keep leading his team at the center that bore his name. But one morning this past August, Methodist transplant center employees were unexpectedly summoned into a meeting down the hall from where the renaming ceremony had taken place. For the prior week, Eason hadn't made his usual rounds through the halls of the transplant center. His staff even had to postpone a living donor transplant because of his absence.
Once the seats were filled, Michael Ugwueke, the president and CEO of Methodist's six-hospital health system, asked for everyone's attention. He informed them that Eason was no longer with the transplant center. When staffers asked what happened, Methodist executives said they couldn't provide any details. As part of the decision, the transplant center suspended conducting liver transplants for living donors.
Methodist and Eason declined to answer questions about his departure. Methodist has scrubbed many mentions of Eason from its website. In the six months following Eason's departure, he remained employed as the director of the Transplant Research Institute at the University of Tennessee Health Science Center, the medical school affiliated with Methodist. In late February, he retired from his tenured position, according to emails obtained through an open records request. UTHSC spokesperson Peggy Reisser declined to comment on the retirement.
So far, no hospital has publicly announced that Eason will lead its transplant center. Medical board records show that he has obtained licenses in Ohio and Pennsylvania. When ProPublica and MLK50 asked about Eason's departure and search for a new job, his lawyer, Sacksteder, responded in a letter on March 15 that he is a "highly respected" liver transplant surgeon whose name still graces the transplant center he had helmed.
Just a few weeks later, Methodist employees noticed something had changed at the hospital. Workers had removed several signs throughout the facility. The words "James D. Eason Transplant Institute" are no longer affixed to the front of the building.
A new sign simply reads: "Methodist Transplant Institute."
The legislation, spurred by a news investigation, allows workers to be barred from healthcare jobs for obstructing investigations into staff misconduct.
This story was published on Tuesday, June 13, 2023 in ProPublica.
Illinois Gov. J.B. Pritzker signed a bill into law on Friday that strengthens the range of penalties that a state watchdog can mete out for healthcare employees who conspire to hide abuse or interfere with investigations by the state police or internal oversight bodies.
The legislation was introduced following an investigative series by Capitol News Illinois, Lee Enterprises Midwest and ProPublica into rampant abuses and cover-ups at Choate Mental Health and Developmental Center, a state-run institution in southern Illinois that houses people with intellectual and developmental disabilities and mental illnesses. The new law applies to employees at state-run institutions and at privately operated community agencies for people with developmental disabilities and mental illnesses that operate under the oversight of the Illinois Department of Human Services and its Office of the Inspector General.
The news organizations detailed how employees had lied to investigators, leaked sensitive investigative details, retaliated against people who reported abuse and sought to indoctrinate new workers into the cover-up culture. Employees who engaged in such actions made it difficult to pursue cases of patient abuse, yet they rarely faced serious consequences. IDHS Inspector General Peter Neumer suggested the change in law last year.
The new law allows the OIG to report workers who engage in such misconduct to Illinois' existing healthcare Worker Registry, which would bar them from working in any healthcare setting in the state.
The registry identifies any healthcare worker who has been barred from working with vulnerable populations in any long-term care setting, such as state-operated developmental centers or group homes. Under prior law, workers could be barred because they had been found to have engaged in financial exploitation; neglect that is considered "egregious"; or physical or sexual abuse. The new law adds "material obstruction" of an investigation to the list of findings that can be reported to the registry, which is maintained by the Illinois Department of Public Health.
Pritzker signed the bill on the same day the IDHS inspector general released a 34-page report that recommended a "top to bottom analysis" of all processes related to the reporting of abuse and neglect at Choate "because at the present time there appear to be fundamental problems with all aspects of that system."
The OIG report referenced the beating of a patient with a developmental disability by Choate staff in December 2014 that was covered by the news outlets. Four mental health technicians were charged with felonies in connection to the beating. Three of them pleaded guilty to failing to comply with abuse reporting laws for state employees, and one — Mark Allen, a mental health technician who had been originally charged with felony aggravated battery — pleaded guilty to felony obstruction of justice.
The report noted that at least eight people colluded to obstruct the state police and OIG investigation. Few staff members were forthcoming with details, even though they later told investigators it was the worst case of abuse they had ever seen.
"This was a textbook example of a code of silence, in which staff seek to protect each other from the consequences of their misconduct by remaining silent about what they witnessed or lying to protect their fellow employees," the new OIG report stated. While Allen was ultimately reported to the registry after the inspector general found him responsible for the abuse, the other three were not. Even though they were criminally convicted of failing to report what they'd witnessed, and the inspector general found that they had engaged in the cover-up, prior law did not include obstruction as a reportable offense.
The new law is a "necessary reform that will provide additional protection for residents and hold accountable any bad actors who violate the trust of a resident or patient," Alex Gough, a spokesperson for Pritzker, said in a statement.
"Governor Pritzker continues to take the longstanding problems at Choate very seriously, and he remains committed to providing a healthy, safe living environment for every single person residing in the state's care."
On Monday, Neumer said in a statement that he was pleased that the governor and legislators supported the measure, which passed both chambers unanimously, because it "serves as a strong deterrent to those who would engage in ‘code of silence'-type conduct, where employees lie or omit key facts to investigators in an effort to protect themselves and/or their fellow employees."
"When employees fully and completely cooperate with OIG's investigations, that also enhances OIG's ability to fact-find, which serves as an additional deterrent to misconduct," he said.
IDHS Secretary Grace Hou noted in a letter to Neumer, which was included in the inspector general's report, that she also had backed the legislative change. That is one of several steps her department has taken to address conditions at Choate and in the agency's 12 other developmental centers and psychiatric hospitals, the letter said.
In a statement, Marisa Kollias, a spokesperson for IDHS, said that a "system-wide transformation" of the agency's facilities is already underway.
In March, Pritzker and Hou announced that more than 120 residents of Choate — about half of the facility's population — would have to move out for their safety. The residents and their guardians were given up to three years to find an alternative placement, such as in a community group home or another state-run facility.
In addition to the relocation of some of Choate's residents, the department has also hired a chief resident safety officer and is implementing other safety enhancements.
Kollias noted that Hou asked the inspector general to conduct the review of Choate last September, the same month the news organizations published their first in a series of reports about Choate.
"IDHS leadership continues to be deeply concerned by the events investigated and reported on by the OIG," Kollias said. "The report underscores the importance of actions that IDHS has taken since the beginning of the administration, including substantially expanding training, hiring new staff and installing security cameras."
The inspector general has repeatedly called for the installation of security cameras at Choate and in other IDHS facilities, but the department had previously said that doing so was complicated by federal regulations. The department said late last week that the Centers for Medicare and Medicaid Services, which partially funds its institutional care, has provided new guidance that will allow for the installation of cameras in indoor, common area locations. The department, the statement said, "will be installing those expeditiously."
CMS data suggests that from 2017 to 2021 90 physicians billed for more than a third of all procedures and government payments, totaling nearly $1 billion.
This article was published on Wednesday, May 24, 2023 in ProPublica.
By Annie Waldman
In the suburbs of Maryland, Dr. Jeffery Dormu's presence is hard to miss. He's a regular on the local TV station, which has featured him and his practice five times over the past five years. And he smiles down from an electronic billboard outside a three-story vascular center he calls The Watcher. "It has a biblical reference, which is to watch over the community," he said at its 2018 opening. In response to the country's "tragedy of cardiovascular disease," the center trademarked the phrase "vascular devastation," a slogan frequently invoked in its marketing, along with a claim to have "saved over 34,000 lives and limbs."
Dormu and his group, the Minimally Invasive Vascular Center, have been a magnet for people with leg pain who worry they have peripheral artery disease, a condition that afflicts more than 6.5 million Americans and happens when fatty deposits narrow the arteries and block blood from flowing to the legs.
But Dormu's portrayal of his practice as a heroic refuge hid a distressing statistic: The vascular surgeon was performing an invasive leg treatment more often than almost any other doctor in the country, even when his patients didn't need it and even as evidence of harm mounted.
One man had to have his leg amputated after Dormu administered multiple invasive treatments for mild pain, according to legal filings. A 62-year-old grandmother bled out and died shortly after Dormu cut into her, according to another lawsuit.
Dormu's go-to procedure, the atherectomy, involved shaving blockages with blade-topped catheters. Best practices recommend that doctors hold off on invasive procedures like these, which can lead to complications including limb loss, on patients in the earliest stages of disease; doctors should first see how the patients do with exercise and medication. Dormu defaulted to atherectomies almost immediately, patient legal and medical records show.
Four years ago, leading researchers warned the Centers for Medicare and Medicaid Services that some doctors were potentially abusing interventions. The researchers implored the government insurer to scrutinize its own data to identify overuse, noting that some of the doctors could present an "immediate threat to public safety."
There is no public evidence that CMS meaningfully responded.
But a ProPublica analysis of CMS data suggests that if the agency had reviewed its own figures, it would have discovered that Dormu was part of a small pool of physicians performing a disproportionate number of treatments. From 2017 to 2021, the analysis shows, the top 5% of doctors conducting atherectomies — about 90 physicians overall — accounted for more than a third of all procedures and government payments, totaling nearly a billion dollars.
Near the top of the list sits Dormu, logging more atherectomies — and making more money from them — than almost every other doctor in America.
CMS paid Dormu more than $30 million in the past decade for vascular procedures he performed on hundreds of patients.
Dormu declined to be interviewed and did not respond to emailed questions.
But a chorus of experts told ProPublica that the federal government's decision to provide unconditional payments for vascular procedures — and then not pay attention to what happened — is a prime example of what's wrong with the American healthcare system.
"The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people," said Dr. Dipankar Mukherjee, a vascular surgeon and chief of vascular surgery at Inova Fairfax Hospital in Virginia.
CMS kicked off the problem 15 years ago, when it tried to rein in the swelling hospital costs for vascular care. Over the past few decades, advances in technology allowed patients with serious circulation problems to avoid open surgery and instead undergo minimally invasive treatment with cutting-edge devices. As they flocked to hospitals for these procedures, patients with clogged leg arteries became even more expensive than patients with clogged heart arteries.
In 2008, recognizing that the procedures could be done safely and more efficiently outside hospitals, CMS officials turbocharged payments to doctors' offices that deployed balloons and stents to widen arteries. And in 2011, they began to reimburse those offices for atherectomies.
Before the change, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800 respectively. But nothing compared to the payout for atherectomies conducted in offices: about $13,500 per procedure, as opposed to roughly $11,450 in a hospital.
Instead of saving money, the government started a boom.
Atherectomies increased by 60% from 2011 to 2014; Medicare's overall costs for peripheral vascular treatments climbed by nearly half a billion dollars, or 18%.
From 2013 to 2021, the most recent year of Medicare data, the number of atherectomies has doubled and payments to doctors have nearly tripled, totaling about $503 million in 2021.
"There's definitely places where atherectomy is very helpful," said Dr. Caitlin Hicks, an associate professor of surgery at Johns Hopkins University School of Medicine. "But it's definitely being used inappropriately, and that's when bad things happen."
Experts fear patients are being caught up in a new era of profit-driven procedure mills, in which doctors can deploy any number of devices in the time it takes to drill a tooth and then bill for the price of a new car.
The generous reimbursements have created a conflict of interest for doctors running their own practices, who are supposed to make unbiased medical decisions while also being responsible for a lease, overhead and staff. And unlike hospitals, which have panels and administrators who spot adverse events and questionable billing, these offices don't face such scrutiny.
CMS, experts say, should step up: It could reduce its reimbursements or even investigate doctors with outsized procedure patterns.
ProPublica reached out to CMS more than two weeks ago, listing the facts in this story, asking questions and requesting an interview. CMS did not make an official available to talk or provide any written answers.
"Vascular medicine now is the frontier of the Wild West," said Dr. Marty Makary, a professor of surgery and healthcare quality researcher at Johns Hopkins University School of Medicine. "People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible."
It was at the cusp of this lucrative new era in vascular medicine that Dormu, an ambitious young doctor from Washington, D.C., entered the scene.
After earning his medical degree at the New York Institute of Technology College of Osteopathic Medicine and completing an additional eight years of training in New York and New Jersey hospitals, including a residency in general surgery and two fellowships in cardiothoracic and vascular surgery, he received his license to practice medicine in Maryland in 2007. That year, he founded the Minimally Invasive Vascular Center.
"People in general are just afraid of surgery," he later told a local TV journalist. "They can get by with minimally invasive surgery, a needle puncture without having to be cut, without having to worry about an amputation. They walk in and within hours they walk out, and pretty much healed."
But according to public records and lawsuits, as his profile and his practice grew, so, too, did evidence of harm.
In March 2016, while he was performing an elective aorta repair at Providence Hospital, the patient began to hemorrhage, according to a District of Columbia Board of Medicine document on the incident. After trying to control the bleeding, Dormu transferred the patient to the intensive care unit for resuscitative efforts and then left the hospital for his private practice and other appointments.
He was gone for more than two hours, and in that time, hospital staff couldn't reach him. The hospital patient died in the recovery room from hemorrhage and organ failure, the report said. Six years later, the District of Columbia Board of Medicine would reprimand him for the incident alongside a $5,000 fine, finding that he abandoned a patient in need of further emergency care, "knowing the high risk of mortality and without adequate communication to other hospital staff."
The death of the patient did not interfere with his medical license or appear to slow his career.
Nine months later, a mechanic sought his care for mild leg pain. As the owner of his shop, Steve Rosenberg clocked long hours, six days a week, repairing anything with wheels or an engine. But as he reached his mid-50s, the long days of standing under vehicle lifts had begun to strain his legs.
His primary care doctor suggested that he see a vascular specialist and handed him a list of physicians to choose from. Dormu happened to have an office in the same plaza as Rosenberg's auto shop, between a jujitsu studio and a dentist's office.
He first visited Dormu's practice that December.
Instead of starting with more conservative treatment, Dormu deployed a trifecta of interventions on both of Rosenberg's legs within three months, widening his arteries with stents and balloons, and debulking his vessels with atherectomy devices, according to later legal filings.
Shortly after one of the procedures, Rosenberg's left foot grew numb and was cool to the touch. He went to the emergency room, where doctors discovered that one of his stents had clogged, hindering his vessel from carrying blood.
Dormu called him back to his office, where he repeated the procedures: shaving the blockages, ballooning the artery walls and installing another stent.
The next day, he repeated the procedures again, ballooning his vessels and installing yet another stent.
Dormu sent Rosenberg to Providence Hospital in Washington, D.C., for further treatment. Within a day, his left foot had grown cold, a sign that blood likely no longer flowed freely through his vessels.
According to the terms of a legal settlement in a malpractice suit against Dormu, Rosenberg cannot comment on his care. However, public documents filed in his case, including assessments from medical experts, illuminate the cascade of procedures and the outcome.
A vascular surgeon Dormu retained for his defense, Dr. Garry Ruben, said the interventions were warranted; he said Rosenberg had been prescribed an anti-platelet medication, which he did not consistently take. In legal filings, Dormu blamed Rosenberg's injuries on his preexisting medical conditions and circumstances outside his control.
However, after reviewing medical records and diagnostic studies, Dr. Christopher Abularrage, an expert retained by Rosenberg and a professor at Johns Hopkins who specializes in vascular and endovascular surgery, found several "breaches of the standard of care." Dormu had failed to prescribe conservative therapy and lifestyle modifications first, he found, and "persisted with unindicated, endovascular interventions in the face of persistently poor outcomes and diminishing returns."
In less than six months, Rosenberg had been transformed from a patient with mild leg pain to one with a high risk of limb loss, he concluded.
Rosenberg spent nearly a week at Providence Hospital, the life slowly draining from his leg, before he was transferred to Washington Hospital Center on April 8, 2017, according to records. By then, his left leg was gangrenous and had no pulse. All of the stents had become blocked.
Without better options, doctors amputated his leg.
Between 2013 and 2017, Dormu earned about $14.5 million from Medicare — more than 99% of other vascular surgeons across the country — for treating hundreds of patients a year, the vast majority of them in his clinics.
In 2018, he was able to afford an upgrade.
The Watcher was not like other surgical centers. In its entrance stood a juice bar that could serve organic cold-pressed drinks to patients. Crystal chandeliers adorned its hallways. Moist air was pumped through its vents. And more than a dozen original modern paintings lined its walls, making it feel like an art gallery. "We wanted it to give that shock and awe," Dormu said in a video interview from the facility's opening day.
His clinic provided a litany of medical services, including treatments for uterine fibroids, erectile dysfunction and varicose veins, as well as elective nonsurgical fat reduction.
The expansive facility boosted Dormu's earnings. From 2018 through 2021, he earned nearly $18 million in Medicare payments for all of his clinic's activities.
One procedure stood out from the rest: Nearly $12 million of that came from atherectomies, according to Medicare data.
He performed one on Alice Belton, a high school nursing teacher who sought help in 2018 for lower extremity pain, numbness and tingling. Her artery blood flow was normal; even Dormu noted that she didn't have severe leg pain, according to an ongoing lawsuit. And yet, he conducted multiple procedures over about a year, shaving plaque, ballooning her vessels, treating her veins and running invasive scans; the procedures were unnecessary, according to a medical expert retained in her case.
Belton says she has since developed permanent nerve damage in her leg, which has prevented her from working full time. In legal filings, Dormu denied the allegations and claimed that the alleged injuries were caused by preexisting conditions.
"The experience with Dr. Dormu has shaken my confidence in healthcare practitioners and more importantly in myself," she said. "I feel duped that this surgeon convinced me, a nurse, that my problems required such radical surgical interventions."
And then there was John Malinich, who had no leg pain but wanted to get his circulation checked in 2019 after he saw Dormu's billboard. At first, Malinich didn't question Dormu's treatments; the doctor's confident demeanor and lavish facility impressed him and put him at ease.
"After surgery on both of my legs, they wanted me to go back and do it over again," he said. "After that, I started getting suspicious."
He said he got a second opinion from another vascular surgeon who informed him that the prior procedures, which involved balloons, an atherectomy and a stent, had been unnecessary. To ensure his stent doesn't collapse or clog, doctors now have to annually monitor Malinich. He filed a lawsuit against Dormu, who has denied allegations of overtreatment. The case is ongoing.
"I trusted the guy," Malinich said. "But it was just to make money."
The next year, Heather Terry was looking forward to her mother's return home after a six-month stint rehabilitating in a nursing home. For years, Heather had helped take care of 62-year-old Linda Terry, who had debilitating epilepsy. After a fall down a flight of stairs and subsequent back surgery, Terry was left paraplegic and unable to walk.
Just before she was supposed to be discharged from the nursing home in August 2020, the staff told Heather Terry that her mother had leg pain and ulcers on her heels that needed treatment. According to her family, Linda Terry had no prior circulation issues. The procedure was simple, the staff said, and would be conducted in a clinic just down the road.
On Aug. 13, Terry was transferred to Dormu's center, where he started an atherectomy procedure, inserting the small tube capped with blades into her vessels to shave the plaque from her artery walls.
Less than 15 minutes into the treatment, her blood pressure began to drop.
With atherectomy, there's always a risk that the device may dissect the vessel, which would require immediate care.
Dormu aborted the procedure and brought Terry into the recovery area. She was drowsy and her blood pressure continued to waver, signs that she may have been bleeding internally, according to her family's attorney. Instead of being rushed to the emergency room, legal filings show, she was sent back to the nursing home, where she became unresponsive.
The nursing home called an ambulance, which ferried her to the emergency room at the University of Maryland Laurel Medical Center. Three hours later, she was pronounced dead, according to the lawsuit, a consequence of severe anemia due to internal blood loss.
For the aborted procedure, according to the family's attorney, Dr. Zev Gershon, Dormu charged her insurance about $20,000.
Heather Terry believes that if Dormu had treated her mother with appropriate care and transferred her directly to the hospital, she might have survived. "It went from ‘She's going to come home tomorrow' to ‘She's dead,'" said Terry, whose ongoing malpractice case against Dormu is set to go to trial this year.
In legal filings, Dormu denied any involvement in her mother's death. He said in a deposition that he did not see evidence of bleeding and that Linda Terry's anemia could have been due to a prior fall. He said he also gave a directive to send her to the hospital after the aborted procedure, despite EMS records obtained by the family's attorney showing that Terry was sent back to the nursing home.
"I trusted doctors," Heather Terry said, "but now I'm starting to think that maybe they shouldn't be as fully trusted."
By 2021, Dr. Kim Hodgson, a former president of the Society for Vascular Surgery, recognized that unfettered profiteering in his field was not just a threat to patients, it also stood to damage the credibility of his speciality. Notably, abuse in outpatient vascular facilities was the No. 1 complaint he had received from members. That August, the vascular surgeon stood before hundreds of doctors at the society's annual conference and made a plea.
"Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place," he said. "We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources."
In dozens of slides, he laid out evidence exposing the magnitude of the crisis: the Medicare incentive, the explosive growth of procedures in clinics and the potential for inappropriate treatment. Most critically, he warned about the risk of patient harm. In recent years, researchers have found that patients in early stages of vascular diseasehad less than a 2% risk of amputation after five years. However, with aggressive interventions, that risk could surge up to 5% or even 10%.
"The problem is that these behaviors — unindicated early interventions and overuse of unproven technologies — still have costs and more often than not, those costs are borne by our patients," he said. "We can and should do better, otherwise we are also enablers."
The issue has magnified into a crisis that has splintered the specialities that conduct these procedures, which include interventional radiologists, cardiologists as well as vascular surgeons. Some physicians do not view overuse as an urgent problem and feel the recent academic attention unfairly stigmatizes private practice doctors.
"The majority of operators are doing the right thing," said Dr. Jeffrey Carr, an interventional cardiologist and the founding president of the Outpatient Endovascular and Interventional Society, which represents physicians working in outpatient settings. "We need to call out the bad actors, but to cast a narrative that puts us all in the same arena is wrong."
Other doctors recognize a need for considerable reforms.
CMS could reverse the change that kicked off the entire problem, some experts said, by reducing its outpatient reimbursement rates. "If you shut off the money, the whole thing will stop tomorrow," Mukherjee, the Virginia vascular surgeon, said.
But such cuts might hurt doctors practicing responsibly and could even nudge the least scrupulous ones into higher gear to make up the financial difference. "You could incentivize people to do more procedures, and some of them may be inappropriate," said Dr. Peter Lawrence, the former chief of vascular and endovascular surgery at the University of California, Los Angeles, who developed an outpatient center connected to the university.
More critical than payment cuts, Lawrence said, is greater oversight of office-based facilities. Many states don't require doctors in those settings to have special vascular training or hospital privileges in case of complications, he said. "You could be a psychiatrist and do these procedures," he said.
Many physicians also support improved data collection, particularly for newer technologies like atherectomy, to ensure that they're not only safe but result in improved outcomes.
"Many of the vascular procedures that are done are relatively safe or can be done with good short-term results, but the failures are long term — it's what happens in two to five years," Lawrence said. "Unless you have a reimbursement system, which not only pays you for the initial procedure, but whether or not it's durable, you can have procedures done in our society that have great short-term results but have poor long-term results."
CMS could require physicians to participate in patient registries, said Dr. William Schuyler Jones, an interventional cardiologist and associate professor of medicine at Duke University School of Medicine. "That type of required reporting would make our system better," he said, "and would ultimately put the onus on all of us to do more appropriate care."
For Dormu, patients were the ones to prompt accountability, airing their grievances to the Maryland Board of Physicians. Among them was a woman who sought his care for excessive leg itching and said he tried to pressure her into an invasive artery scan. When she sought a second opinion, the doctor concluded that her itching likely stemmed from a reaction to an insect bite.
The medical board examined the records of 11 of Dormu's patients. Two peer reviewers, board certified in vascular surgery, independently concluded that Dormu had performed "medically unnecessary and invasive vascular procedures" and failed to meet appropriate standards of care for 10 of the 11 patients, "exposing them to potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient's circulation, and limb loss."
One patient who sought Dormu's care to evaluate blockages in their legs could walk a mile before treatment, but after the procedures, they could not walk at all.
"There exists a substantial likelihood of risk of serious harm to the public health, safety, and welfare in Dr. Dormu's continued practice," the board's executive director, Christine Farrelly, concluded.
Last October, the board found him in violation of state medical law, citing his overuse of procedures and his failure to uphold standards of care. It fined him $10,000, suspended him and put him under a two-year probation, during which he must be supervised and enroll in an ethics course.
Maryland Department of Health spokesperson Chase Cook said the agency's Office of healthcare Quality, which is responsible for oversight of the state's surgical centers and licensed Dormu's current facility, was not aware of his sanctions nor the allegations of harm. The office "will follow-up in accordance with federal and state regulations," Cook said.
Despite lacking an active license to practice medicine in Maryland, Dormu is still listed on his clinic's website as the lead vascular surgeon, "currently available for office visits and in-patient consultations."
When ProPublica called Dormu's office to inquire whether he was still practicing, the receptionist said he was no longer seeing patients and that "Dr. Seibles" was providing all the same services. According to the Virginia Board of Medicine's directory, Dr. Ayana Jonelle Seibles spends 20% of her time practicing at Dormu's center in Maryland.
An emergency medicine physician who does not have specialty training in vascular surgery, Seibles appears to have a close relationship with Dormu; according to county property tax records, they have owned a home together since at least 2017. Seibles did not respond to ProPublica's questions that were sent by email.
In a lawsuit deposition last month, Dormu said that he stopped doing surgery this year as a "personal choice." When asked the name of his supervisor, he stated that he couldn't recall it. He also couldn't recall how many times he had been sued for malpractice, any of the details of the cases, nor the names of the attorneys representing him. He also couldn't specify how many atherectomies he had performed, only estimating that he had done more than 100.
According to Medicare data, over the past decade, he has done at least 3,400.
For most of his life, Rosenberg trusted doctors; his own father was one. But the mechanic has lost faith in medicine. Memories of his 2017 amputation have been largely buried by the trauma, but he recalls lying in his hospital bed after the operation, the remnants of his left leg wrapped in a cloud of white bandages. "Life isn't supposed to turn out like this," he said.
He was discharged to his three-story colonial home, where two steps led to the front door and 13 steps gave way to the second floor; he could only ascend them by crawling backward. Eventually, he sold the house and his family moved into a flat, ranch-style home.
He tried to maintain his auto shop, relying on his wife and teenage stepson to help out. But with his limited mobility, first in a wheelchair and later maneuvering with his prosthetic and a cane, he could not repair cars like he used to and was forced to sell his business and retire.
Before, he could get dressed and out the door in less than 30 minutes; it now takes more than an hour. He used to prepare meals for his family, but after, his stepson had to learn how to cook. In the months following the surgery, he often fell asleep by 7:30 p.m., tired from carrying his body around all day. Discomfort would awaken him by 4 a.m.
Half of his days are now spent navigating the complex web of amputee providers, arguing with insurance agents, attending physical therapy and meeting with specialists to keep his vascular system in check.
Above all, managing the pain has remained a lingering burden. Even though he lost most of his left leg, its memory has been indelibly burned into his brain, haunting him like a phantom. Sometimes the bottom of his missing foot itches or a jolt surges down his absent calf.
"And there's nothing anyone can do about it," he said, "because it's not there."
Do You Have Experience With Peripheral Artery Disease? Have You Had a Procedure on Your Leg? Tell Us About It.
Some doctors may be overusing a procedure to clear out clogged arteries in legs, potentially leading to amputations. We need your help connecting with patients, including those who may not know they have had an atherectomy.
Annie Waldman is a reporter at ProPublica covering healthcare.
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Doctors told her she might die but she couldn't have an abortion under state law until she got sicker, documents show. The Biden administration says failing to act violates a federal law requiring hospitals to provide emergency care.
This article was published on Friday, May 19, 2023 in ProPublica.
Mylissa Farmer knew her fetus was dying inside of her. Her water broke less than 18 weeks into her pregnancy last August, and she was desperate for an abortion.
But according to federal documents, during three emergency room visits over two days in Missouri and Kansas, doctors repeatedly gave Farmer the same chilling message: Though there was virtually no chance her fetus would survive and the pregnancy was putting her at high risk for life-threatening complications, there was nothing they could do for her.
In the 11 months since the Supreme Court overturned Roe vs. Wade, similar stories have been reported in the 14 states where abortion bans have gone into effect. In Texas, five women are suing the state for denial of care, including one who went into septic shock and almost died.
Now, the Biden administration is employing one of the few tactics it has available to try to hold hospitals accountable for denying pregnant patients abortion care for high-risk conditions.
In April, a first-of-its-kind federal investigation found two hospitals involved in Farmer's care were violating a federal law that requires hospitals to treat patients in emergency situations. If the hospitals do not demonstrate they can provide appropriate care to patients in Farmer's situation, they stand to lose future access to crucial Medicare and Medicaid funding. Physicians who fail to treat patients like Farmer could incur fines, and patients may be able to sue for monetary damages, Farmer's attorney, Alison Tanner, said.
The investigation, conducted by the Centers for Medicare and Medicaid Services, documented that both Freeman Health System in Joplin, Missouri and the University of Kansas Health System breached their internal policies for complying with the Emergency Medical Treatment and Labor Act, and that their protocols continue to place patients in "immediate jeopardy" of serious health risks, the highest level of violation.
Investigators concluded that future patients in similar situations could face "serious injury, harm, impairment or death." The hospitals will remain under investigation while they come up with plans to ensure that patients in need of emergency abortion care are not turned away, federal officials said.
A "statement of deficiencies" from the investigation contains summaries of interviews with doctors, nurses and a risk manager involved in Farmer's care. They reveal the extent to which health care providers went against their own medical judgment to comply with new state laws or political pressure. They also provide an on-the-ground view of how strict state abortion bans have altered care for patients with high-stakes pregnancy complications.
The agency did not disclose whether it is pursuing other investigations related to abortion denials. A spokesperson declined to share the number of complaints the agency has received related to denials of abortion care.
Health and Human Services Secretary Xavier Becerra has sent letters to all hospitals that participate in Medicare, warning them that federal law supersedes state abortion bans. The Department of Justice has also sued and won a case in an Idaho federal district court, arguing the state's abortion law violates the Emergency Medical Treatment and Labor Act.
But experts say such efforts do not resolve the conflict. Last year, a Texas federal district court granted a preliminary injunction blocking Becerra's guidance, siding with the Texas attorney general's arguments that EMTALA does not cover abortions intended to prevent an emergency.
The court found "EMTALA creates obligations to stabilize both a pregnant woman and her unborn child, and it fails to resolve the tension when those duties conflict."
Texas law, the court pointed out, allows abortion only in cases "when the medical condition is life-threatening" and the patient's condition "pose[s] a serious risk of substantial impairment of a major bodily function."
That's a narrower range of circumstances than described in the federal government's EMTALA guidance, which calls for offering abortion care "when the health of the pregnant woman is in serious jeopardy" or when her condition "could … result in a serious impairment or dysfunction of bodily functions or any bodily organ," the court found. (The judge added italics for emphasis.)
"In addition to requiring a physical threat to life, [Texas law] requires both a greater likelihood and a greater severity than the Guidance's interpretation of EMTALA does," the judge wrote. As a result, EMTALA could not compel hospitals to offer abortions that would not be permitted under state law, the judge wrote.
Both cases are under appeal and may eventually make their way to the Supreme Court. In any case, it's unclear how much impact federal enforcement can have. Though the hospitals who denied Farmer care have been reprimanded, neither has faced sanctions so far.
In a case where providing an abortion would violate state law and failing to provide one would violate federal law, doctors face a lopsided set of potential legal repercussions, said Mary Ziegler, a leading historian of the U.S. abortion debate. The possible penalties for violating EMTALA include fines. The consequences for violating state abortion bans could include prison time and loss of license.
"If [hospitals] interpret EMTALA in keeping with the Biden administration's understanding of it, they could expose themselves to potentially very serious criminal charges," Ziegler said. "The incentive structure will be that doctors don't want to risk legal liability."
Farmer was told by doctors in two states that she had to wait to get seriously ill before they could terminate the pregnancy that was putting her at risk. Credit: Nathan Papes/Springfield News-Leader/USA Today Network
Farmer, whose story was first reported by the Springfield News-Leader, was considered a high-risk patient from the beginning of her pregnancy, according to her doctors. She was 41, had a history of blood clots, an irregular heart beat, polycystic ovary syndrome, past abdominal surgeries and a past miscarriage.
She was nearly 18 weeks pregnant on Aug. 2, 2022, when she felt liquid gush from her vagina and began cramping and bleeding, according to the investigation.
Doctors at Freeman Health System, a Level II trauma center, quickly determined she had suffered previable prelabor rupture of membranes, known as PPROM — her water broke too early and she had lost her amniotic fluid.
PPROM occurs in about 3% of pregnancies. When it happens before viability, which is generally agreed to start at about 23 or 24 weeks, the chances of the fetus's survival are extremely low because their lungs cannot develop without amniotic fluid. The chances of the pregnant patient developing a life-threatening infection are high.
The American College of Obstetricians and Gynecologists says the standard of care in these cases is to counsel patients on the risks and offer a choice between expectant management — waiting for the miscarriage to complete on its own or the patient to become sicker — or immediate delivery, by inducing labor or performing a dilation and evacuation surgery.
Being forced to wait can have dire outcomes. In Ireland, a woman with PPROM died from sepsis in 2012 after doctors refused her abortion care, prompting public outrage that eventually led abortion to be legalized in that country.
Anti-abortion activists say that state abortion bans include medical exceptions to allow abortions to protect the "life of the mother." But in most laws, the exceptions are written so broadly they can be interpreted to only cover the most urgent emergencies, and doctors could face stiff penalties for violating the law — up to life in prison in Texas, for example. According to media reports, few patients have been able to access abortions under those exceptions.
PPROM cases where the fetus still has cardiac activity are particularly difficult for hospitals to navigate under the laws, because a patient's health status can change from stable to life-threatening extremely quickly, said Dr. Chloe Zera, a maternal-fetal medicine specialist in Massachusetts. The laws do not clarify whether physicians can act to prevent an imminent health emergency instead of waiting for one to develop.
"There are [PPROM] cases that do OK. And there are cases where there is overwhelming infection or hemorrhage, or hysterectomy or ICU admission or death. And things can turn really fast," Zera said. "We just don't have great ways to predict who's going to get sick."
When a patient has PPROM at 18 weeks, she advises ending the pregnancy because the risks to the patient's health outweigh the chances of the fetus reaching viability. If Farmer had walked into her hospital in Boston, where abortion access has been expanded since Roe was overturned, Zera said Farmer would have been able to have the procedure right away if she wanted.
That's not what happened in Missouri or Kansas.
According to records, Farmer's OB-GYN at Freeman Health System and a maternal-fetal medicine specialist described in detail the severe risks Farmer faced if she continued the pregnancy: clotting, sepsis, severe blood loss, loss of her uterus and death. At the doctors' request, ProPublica is not naming them after they expressed concerns for their safety.
The maternal-fetal medicine specialist explained to Farmer that typical treatment options usually include abortion care, according to the documents. But when Farmer requested that labor be induced, the specialist told her it was not possible in Missouri.
"We discussed that the current Missouri law (188.015.7 RSMo) supercedes our medical judgement, and the MO law language states that we cannot intervene in the setting of a pregnancy with positive fetal heart motion unless there is a ‘medical emergency,'" the specialist wrote in Farmer's charts, according to the investigation. "She is currently medically stable. … Therefore contrary to the most appropriate management based my medical opinion, due to the legal language of MO law, we are unable to offer induction of labor at this time."
Missouri's abortion ban is one of the strictest in the country. It bans all abortions, except those that are necessary to save a pregnant patient's life. Even in those cases, doctors could still be charged with a crime. The exception is allowed as an affirmative defense, which puts the burden of proof on the doctor to show the abortion was necessary — similar to claiming self-defense in a homicide case.
The maternal-fetal medicine specialist told Farmer she could travel to another state for care or stay at the hospital for observation. "We discussed that awaiting a medical emergency may put her at further risk for maternal mortality," the documents say. The specialist and the OB-GYN declined to comment, and the hospital's media department did not respond to calls and text messages.
According to a complaint filed on Farmer's behalf by the National Women's Law Center, she called multiple hospitals, including two in Illinois and two in Kansas, both states where abortion is legal. She couldn't get through to some of them. Other hospitals said they were not big enough to provide the care she needed or could only handle miscarriages later in pregnancy. She tried two abortion clinics, but could not reach anyone there. Finally, one hospital recommended she go to the University of Kansas Health System, in Kansas City, Kansas, which has the largest out-of-state emergency room nearest to Farmer. She and her boyfriend drove nearly three hours.
In interviews with federal investigators, Farmer said that when she first arrived at the University of Kansas at 11:35 p.m., doctors confirmed she had no amniotic fluid left and discussed either inducing labor or providing a dilation and evacuation procedure. Farmer preferred to induce labor so she could hold her daughter, who she had named Maeve, but she told the doctors she would choose "whatever option to save my life." An OB-GYN resident suggested that inducing labor would be easier to get past the hospital's legal team, according to the documents. ProPublica is not naming the resident because the hospital expressed concerns for the person's safety.
The resident returned and said: "Unfortunately, due to the political climate, it was too hot and heated right now," Farmer told investigators. Earlier that same day, Kansans had voted on whether to protect their state's constitutional right to abortion. To the hospital's legal team, both procedures "resembled an abortion and it was too risky," Farmer recalled the resident saying.
At the University of Kansas Health System, investigators spoke to a nurse, an OB-GYN resident and a maternal-fetal medicine specialist involved in Farmer's care, as well as the chair of the OB-GYN department and a risk management coordinator. They all corroborated Farmer's account and said they believed they were not allowed to provide an abortion until Farmer's symptoms progressed or fetal cardiac activity ceased.
Unlike Missouri, Kansas does not have a sweeping abortion ban. Abortion remains legal up to 20 weeks, and on the day Farmer arrived at the hospital there, Kansans overwhelmingly voted to keep abortion rights in their state constitution.
But Republican lawmakers, guided by national anti-abortion groups, have worked for decades to chip away at abortion access in other ways. The hospital referred investigators to a statute from 1998 that specifically prohibits doctors at the University of Kansas from providing abortions except for in emergency situations.
Yet the statement of deficiencies points out that the University of Kansas Health System also has specific policies to advise physicians in emergencies, including guidance on how to care for patients with prelabor rupture of membranes.
That guidance warns that, after a patient's water breaks, the risk of complications, including infections, hemorrhage, oxygen deprivation and death, increase with time. For PPROM before 23 or 24 weeks, it directs physicians to offer immediate delivery as an option and to make the decision taking into account "the patient's wishes."
And the hospital's EMTALA policy states that the definition of an emergency medical condition is broad and is not limited to patients with traditional "urgent" conditions: "The phrase ‘immediate medical attention' has been applied to situations in which the need for medical assessment and care was in a time frame of days rather than hours."
Investigators also documented that less than two months earlier, a 40-year-old woman came to the same emergency room when her water broke at 15 weeks and received an abortion.
She was counseled on the same risks as Farmer. Her fetus still had cardiac activity and her condition had not yet progressed to an emergency. In fact, her condition was slightly more stable than Farmer's: She was not yet bleeding and still had some amniotic fluid left. Yet the patient was offered and received abortion care.
Under EMTALA, the hospital had a duty to transfer her to another facility if it could not provide care. Nothing in Kansas law would have prevented the hospital from transferring her to another hospital that could provide abortion care.
But Farmer, the documents make clear, was not given any of those options. The investigation found that the doctors did not even take Farmer's temperature or conduct a pain assessment, steps that are required under the hospital's triage policies and a critical tool in evaluating whether her condition was worsening.
The doctors on the medical team, Farmer told investigators, "were very clear about making sure that she knew she had a very serious situation and that she needed care" but only advised her to monitor her symptoms and told her to go back to her hospital in Missouri to deal with further concerns.
Farmer felt "pretty much abandoned at that point, that there was nothing they could do, and that [she and her boyfriend] were on their own," she told investigators. She worried about the cost of an abortion at an abortion clinic.
At 1:30 am, she was discharged.
Investigators also cited the hospital for a separate case: A 73-year-old man who arrived at the hospital's emergency room in September and had an abnormal electrocardiogram was left in the waiting room for nearly 90 minutes without a medical screening examination, until staff realized he had died.
ProPublica sent the University of Kansas Health System detailed questions about the violations cited in the documents. Jill Chadwick, a spokesperson for the hospital, declined an interview. In a statement about Farmer's case, Chadwick said: "The care provided to the patient was reviewed by the hospital and found to be in accordance with hospital policy. It met the standard of care based upon the facts known at the time, and complied with all applicable law."
If Farmer's treatment complied with hospital policy, the standard of care and the law, ProPublica asked, did that mean providing abortion care two months earlier to another patient with PPROM was a violation?
Chadwick said she could not provide further comment. In a later email, a spokesperson said "physicians can and do provide abortions" at the hospital "if there is an emergent need to save a patient's life, or to prevent serious and irreversible harm to a patient's major bodily function."
Farmer returned to Missouri and, later that evening, went back to the emergency room of Freeman Health System for her pain. Again, doctors counseled her on all the risks of continuing her pregnancy. Again, they told her there was nothing they could do until fetal cardiac activity ceased or she got sicker. They gave her Tylenol and anti-anxiety medication.
"The patient's medical record also indicated that the patient was exhibiting psychological distress associated with the situation and expressed that she perceived financial barriers to seeking further care on an outpatient basis," investigators wrote. They also found that medical providers did not reexamine Farmer's cervix to check how quickly she was progressing and whether she might soon go into labor.
According to her complaint, Farmer finally got connected with an abortion clinic in Illinois that agreed to provide the procedure as soon as possible because of the urgency of her condition. In the car on the way there, she began to experience contractions, but did not want to stop at any Missouri hospital for fear of being denied care again. Upon arrival, a physician performed surgery to end the pregnancy.
Because of their travel, both Farmer and her boyfriend missed work. She was docked a week's pay and he lost his job. Her insurance refused to cover her care at the abortion clinic, according to her complaint. Afterward, she continued to experience pain and doctors told her she had likely developed an infection during the ordeal. Farmer has since had a tubal ligation to ensure she can never get pregnant again, and she has shared her story with multiple media outlets, alerting federal officials and others to her case and prompting investigations. (She declined through her lawyer to speak with ProPublica because of the trauma of reliving the experience.)
"It was dehumanizing. It was terrifying. It was horrible not to get the care to save your life," she told The Associated Press. "I felt like I was responsible to do something, to say something, to not have this happen again to another woman. It was bad enough to be so powerless."
How Does EMTALA Intersect With Abortion Law?
What is EMTALA? The Emergency Medical Treatment and Labor Act requires hospitals that receive federal funding to treat and stabilize anyone who presents at their emergency department, regardless of their ability to pay. If the hospital is not equipped to provide treatment, it is required to arrange a transfer to a hospital that is.
Hospitals cannot delay medical screening or stabilizing treatment for any reason.
How does EMTALA apply to abortion care? Some patients experience pregnancy complications that put them at high risk for rapidly developing a life-threatening emergency. Since state abortion bans went into effect, patients in some states have reported being denied abortion care until fetal cardiac activity stopped or they got sicker.
The federal government says that hospitals must provide abortions in these cases, even if that directly conflicts with interpretations of state laws that outlaw abortions.
What do state laws say? Abortion bans have gone into effect in 14 states. Though the language varies, most state abortion laws do include exceptions for medical emergencies. But doctors say the definitions of what constitutes a medical emergency are too narrow and do not encompass the range of complications that can arise during pregnancy and endanger a patient's health. A doctor who provides abortion care risks prosecution and could face years in prison, fines and loss of their medical license.
This has caused some hospitals and physicians to interpret these laws in the strictest terms to mean that abortion care is not legal until fetal cardiac activity has ceased or the patient's condition has progressed to an immediate emergency. In the 11 months since Roe was overturned, most state officials have not clarified that interpretation. In Texas, the attorney general has argued that the medical exceptions granted under the ban do not apply to abortions intended to prevent an emergency.
How can I file an EMTALA complaint? The process for investigating hospitals to determine if they are complying with EMTALA is "complaint driven," a spokesperson with the Centers for Medicare and Medicaid Services said. Anyone can file an EMTALA complaint with their state's survey agency, which will investigate the issue and, when appropriate, verify that corrective action is taken to ensure the hospital is in compliance.
Beers family members built a 'conglomerate' by selling a Christian alternative to traditional health insurance. They're now scrambling for cash, even though they received millions in PPP loans that were later forgiven.
This article was published on Monday, May 15, 2023 in ProPublica.
In just a handful of years, members of a Canton, Ohio, family built a financial empire that included a boutique airline, a bank in the Missouri Ozarks, a chain of carpet stores, a marijuana farm in Oregon, and more than $20 million in real estate. The "conglomerate," as the Beers family calls it, was made possible by hundreds of millions of dollars collected from Americans who thought they had found an affordable alternative to medical insurance. Instead, many were saddled with debt.
The conglomerate, however, is showing signs of strain as the family downsizes its workforce and sells off some of its holdings. These moves will free up cash, said an attorney who represents several family members, and allow them to pay off a court settlement related to its alleged fraud. Now, another big debt has come their way: Several family members face liens placed against their properties for millions in back taxes.
A ProPublica investigation earlier this year revealed how Liberty HealthShare — the Christian nonprofit the family controlled and marketed as a cheap way to circumvent Obamacare requirements — paid at least $140 million to vendors owned by members and friends of the Beers family. Those family members and friends then funneled the money through a network of shell companies to purchase scores of businesses. As the family amassed wealth, Liberty's finances were depleted and thousands of members' medical bills went unpaid.
As part of the settlement with the Ohio attorney general's office in 2021, Liberty HealthShare severed all ties with the family.
Members of the family, including patriarch Daniel J. Beers, and their attorneys, have denied wrongdoing. They claim that the family-owned vendors — Cost Sharing Solutions and Medical Cost Solutions LLC — charged Liberty market rates or less for their services, which included running a call center and negotiating bill payments with doctors and hospitals.
In January, Cost Sharing Solutions laid off all but a handful of staff, according to current and former employees. "They have no money," said one source who asked to remain anonymous because of the nondisclosure agreements that the company required employees to sign. "It's all gone." From 2014 to 2021, Liberty paid Cost Sharing Solutions at least $90 million.
Last month, members of the family auctioned off more than 470 acres they owned outside of Canton. Those parcels constituted roughly half of the Lazy L Ranch, the compound where most of the family lives. "From its hilltop panoramic views to wooded valleys and open farm fields, this property will take your breath away," the auction notice read. Purchase prices and the identities of the buyers have not yet been made public.
The IRS has recently secured liens against parcels of the ranch that family members still own. Property records show that Beers' sons, Danny and Ronnie, owe $2.9 million and $1.1 million in federal income taxes for 2017 to 2021. Brandon Fabris, who also lives on the ranch and serves as chief operating officer of Cost Sharing Solutions, owes more than $700,000 in federal taxes.
Family members have also recently sold their controlling stake in Ultimate Air Charters, a small airline that caters to gamblers who travel from Canton to locales such as Atlantic City. Rick Arnold, the attorney who represents Beers and many of the companies that family members own, said the airline was sold to an entity outside of the family. He would not disclose its identity, which also has not been made public in Ohio business filings, and did not respond to questions about the federal tax liens on the Beers and Fabris homes.
In addition to the monthly dues that Liberty members paid for coverage of their medical bills, all of these ventures benefited from taxpayer money. Seven entities in the conglomerate received more than $6.3 million in COVID-19 relief funds, the vast majority of which was forgiven by the federal government, according to a ProPublica analysis of Paycheck Protection Program data. Cost Sharing Solutions, claiming it would save 168 jobs, obtained more than $1 million in April 2020 and another $1 million in January 2021. Ohio Lazy L Ranch LTD collected more than $80,000, and Ultimate Air Charters secured more than $2.9 million.
Arnold said the layoffs and sales are a way for his clients to pay $5 million in collective damages from the settlement with the Ohio attorney general's office. Although the agreement with the state calls for monthly payments, Arnold says his clients have negotiated a new deal to send a lump sum "within the next couple of months."
"It was part of a greater business plan," Arnold said of the recent transactions. "It also creates liquidity and allows them to pay the attorney general."
Beers and the two family-controlled vendors have missed several payments and are in arrears for $290,000 and $690,000, according to records from the attorney general's office. A spokesperson for the Ohio attorney general said the payment schedule and agreement have not changed, despite Arnold's claim.
In 2021, Liberty members whose medical bills languished and were referred to collections filed a class-action lawsuit against the Beers family, the ministry and the two vendors. The defendants have filed a motion to dismiss, which is pending.
J. David McSwane is a reporter in ProPublica's Washington, D.C., office covering health care, energy, federal contracts and land issues.
Ryan Gabrielson is a reporter for ProPublica covering healthcare.
Investigators cited the photos in order to begin the investigation into T. Denny Sanford, a South Dakota businessman. ProPublica fought for three years to get the records unsealed.
This article was published on Thursday, April 27, 2023 in ProPublica.
Investigators discovered photos of nude children, estimated to be as young as 8, in an email account they said was associated with South Dakota billionaire T. Denny Sanford, according to previously sealed records released Thursday.
The records — which ProPublica had been fighting to make public for almost three years — shed light on the origins of the child pornography investigation into Sanford, a credit card magnate and philanthropist who has donated vast sums to children's causes.
In 2020, ProPublica first reported that South Dakota authorities were investigating Sanford and had referred the matter to the U.S. Department of Justice. Last year, the South Dakota attorney general announced it closed its investigation without filing charges.
The status of a federal investigation into the matter remains unclear. A DOJ spokesperson declined to comment Thursday when asked whether the department's inquiry remains open.
The investigation of Sanford started after AOL's parent company sent a tip to the National Center for Missing & Exploited Children, which passed it on to authorities in South Dakota, according to the new documentation. The center is a private nonprofit that operates a tip line where people and companies can report images of suspected child sex trafficking and abuse. The organization's staff reviews the tips and refers them to law enforcement.
The material provided to the organization included 36 image files with child pornography in an AOL account that investigators linked to Sanford, according to the documents released Thursday.
Sanford's attorney, Stacy Hegge, released a statement Thursday that said various other people had access to Sanford's electronic devices and that prosecutors ultimately decided against filing criminal charges in the case.
"Mr. Sanford appreciates that after a thorough investigation the authorities concluded there exists no prosecutable offense. Here, because there is no prosecutable case or further action to be taken, the court records being released contain only allegations. These preliminary allegations were provided to law enforcement prior to law enforcement's exhaustive investigation and its realization that various individuals had documented access to the electronic devices at issue, including signs of hacking."
"While some claim releasing affidavits that reiterate these allegations constitute transparency, releasing preliminary allegations made prior to completing the full investigation only misinforms people and obscures the investigation's conclusions that no prosecutable offense occurred."
Sanford's lawyers did not respond to further detailed questions.
Investigators with the South Dakota attorney general's office obtained five search warrants in 2019 and 2020 for Sanford's email, phone and internet data. The newly released documents are investigators' sworn affidavits in support of those warrants.
According to the new records, agents believed they had found probable cause that a crime had occurred involving Sanford, who is one of the nation's leading philanthropists.
The affidavit said that while many of the images were duplicates, an agent had found three unique photos, all of nude girls. The agent estimated one to be between 8 and 12 years old, another to be between 12 and 15, and a third to be between 10 and 15.
The law enforcement records include descriptions of the images. One photo is of "a nude juvenile female standing facing the camera. Her breasts and vagina are visible in the image. There is snow in the background and her hair is brown. The estimated age of the juvenile is 8 to 12 years old."
The records seem to suggest Sanford's email account sent the emails with the images, but because of redactions, it's not clear. The identity of the email account receiving the message was also redacted. At least one of the images, according to the agent's description, appears to be a photo taken of another screen.
"I feel that the content of the image files described above fit the definition of child pornography as described in South Dakota Codified Law," an investigator wrote.
Geolocation data the agents reviewed pointed to locales where Sanford has homes, including La Jolla, a suburb in San Diego; Scottsdale, Arizona; and Sioux Falls, South Dakota.
ProPublica won access to the search warrants in the case and the affidavits detailing the cause for the warrants after litigation that reached the state's highest court. Sanford unsuccessfully asked the courts to block release of the records, which are supposed to be publicly accessible under state law, and constrain ProPublica's reporting on the case. He was represented during part of that time by South Dakota's ex-attorney general, whose former office launched the investigation, and who has since again been elected to the job again.
ProPublica's general counsel, Jeremy Kutner, lauded the release of the records: "We are delighted that the court has, for the second time, vindicated the public's essential rights to monitor law enforcement and the criminal justice system, rights clearly enshrined in law. But the baseless delays foisted on the public by Sanford and his attorneys throughout this case are a testament to how fragile those rights can be. This ruling is a reminder that the predilections of the powerful should never override the law."
A ProPublica analysis of FDA data reveals that the agency only inspected 6% of the overseas plants where drugs and their ingredients are produced in 2022.
This article was published on Wednesday, April 19, 2023 in ProPublica.
By Irena Hwang
For years, U.S. pharmaceutical companies have relied on drugs produced overseas to meet Americans' medical needs. And for years, it's been clear that federal drug regulators couldn't keep up with inspections of the plants that made those drugs.
But a series of recent deaths linked to eyedrops produced overseas that were tainted with bacteria points to just how seriously behind the Food and Drug Administration is. Three people died and eight others were blinded in the United States from the drops, which were made in a plant in the Indian state of Tamil Nadu that the agency had never inspected prior to the outbreak. Worse, public health officials say they have detected the drug-resistant bacterial strain, which had never been seen in the U.S., among patients who never used the eyedrops, meaning it has likely achieved community spread.
A ProPublica analysis of FDA inspection data as of April shows that the agency's inspections of overseas drug manufacturers, located mostly in India and China, has dropped precipitously even as the number of manufacturers has remained relatively steady. In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800. And in India, where the contaminated eyedrops originated, the FDA inspected only 3% of manufacturers in 2022 — significantly less than in 2019, when 45% of plants were inspected.
The FDA, which is tasked with ensuring the safety and efficacy of both prescription and over-the-counter drugs, has acknowledged that limited resources make it impossible to inspect every plant, whether in the U.S. or not, that makes drugs or their ingredients. But the agency has been slow to make improvements.
This is not the first time that American consumers have been injured or killed as a result of contaminated drugs produced overseas. In the 1980s, drugs manufactured in Italy intended to prevent seizures resulted in epileptic seizures and two deaths. In 2007 and 2008, hundreds had allergic reactions, some fatal, to a commonly used blood thinner, prompting an FDA investigation. Some of the cases were later linked to an ingredient produced in a facility in China that had never been inspected by the FDA.
The Government Accountability Office, a federal watchdog agency, has warned for decades that the number of overseas inspections was worryingly low. Just weeks before the first cluster of COVID-19 patients was reported in China at the end of 2019, the GAO reported that despite some improvements in how the FDA tracked and prioritized its efforts, inspections of both foreign and domestic drug plants were on the decline, due in large part to challenges retaining staff and filling vacancies.
"While our drug supply is generally safe, problems do occur, as evidenced by contaminated eye drops in the last few months," said Mary Denigan-Macauley, director of public health at the GAO. "No one wants to lose their vision or an eye simply from taking eyedrops to alleviate dry eyes."
Without a doubt, the COVID-19 pandemic slowed inspections to a trickle — in fiscal year 2021, according to the data, the agency inspected a mere 99 overseas sites, less than 4% of eligible foreign manufacturers. By comparison, 15% of domestic manufacturers were inspected that year. (Nearly three-quarters of manufacturers of U.S. drug ingredients, and more than half of producers of finished drugs, are located overseas.)
During the pandemic, the FDA began announcing domestic visits beforehand and paused surveillance visits overseas except for those deemed "mission critical," conducting most preapprovals of new drugs without visiting foreign manufacturing sites.
The FDA defended this decision in an email statement to ProPublica, saying it used "alternative inspectional tools such as remote interactive evaluations, record requests, and leveraging information from trusted regulatory partners."
Both the GAO and Rep. Sanford J. Bishop, a Georgia Democrat, say these remote interactions do not offer the same insight that in-person, unannounced inspections do. The FDA itself affirmed the utility of inspections in its latest annual report on pharmaceutical quality: "In the absence of inspections, many of these situations" that could result in defective products, "and possible public harm, could have gone undetected."
But three years after the pandemic started, the FDA has been slow to return to pre-pandemic inspection rates. The pandemic heightened the urgency surrounding the FDA's drug inspection process, as the need for more equipment, vaccines and antiviral medications, many of which are produced overseas, increased. Though routine domestic surveillance inspections resumed in July 2021, routine foreign inspections remained on hold until February 2022.
In December, President Joe Biden signed a year-end spending package that allocated $10 million for a pilot program to "increase unannounced foreign inspections" of drug makers. But that was just a tiny fraction of the $3.5 billion earmarked for all FDA drug quality oversight programs.
"We have got to be protective of the health, safety and welfare of the American people," said Bishop, who pushed for funding for overseas inspections in the House. "That is the job of the FDA."
Experts hope the pilot program will address standards surrounding those visits, which have drawn criticism for being too permissive. Unlike domestic inspections, foreign manufacturers were routinely given a heads-up before an inspection and allowed to provide their own translators, practices that FDA inspectors have admitted could make information gathered unreliable. The FDA said that it planned to use the additional $10 million to increase staffing for foreign inspections and to work on prioritizing inspections that the agency was unable to perform during the pandemic.
Among the foreign establishments never inspected was a Global Pharma Healthcare factory in Tamil Nadu that produced artificial tears sold by U.S. companies EzriCare and Delsam Pharma. As an over-the-counter product that does not require FDA approval, the eyedrops fell into another FDA regulatory blind spot. Though the FDA has the authority to inspect manufacturers of over-the-counter products before they are sold to consumers, there is no requirement that an inspection must occur prior to the sale — unlike for prescription drugs.
The FDA is asking Congress to require that manufacturers notify the FDA of their intent to distribute over-the-counter drugs well in advance of selling them, potentially providing the FDA a "feasible opportunity" to conduct inspections.
But even that requirement might not have made much of a difference. According to the GAO's 2022 report on FDA foreign inspections, a growing backlog of manufacturers slated for routine surveillance inspections is skewing in a concerning direction. The percentage of overseas manufacturers that hadn't been inspected within five years, or which have never once been inspected, has grown from 30% in 2020 to more than 80% in 2022. And if the FDA prioritizes sites that have not been inspected recently, that might come at the expense of inspecting sites identified by the FDA as posing the highest public health risk.
Preventing future public health risks, like the ongoing eyedrop outbreak, has to be a priority, said Denigan-Macauley of the GAO.
"These problems are not hypothetical. They are real," she said.
In the case of the imported tainted eyedrops, in January, the FDA and the Centers for Disease Control and Prevention traced back the Pseudomonas aeruginosa outbreak to the Global Pharma Healthcare-produced EzriCare Artificial Tears. That same month, the FDA requested records from the manufacturer regarding an unrelated issue and, concerned by Global Pharma's "inadequate response," placed it on an import alert, preventing its products, including the eyedrops, from entering the U.S. In early February, the FDA recommended a recall of the EzriCare and Delsam Pharma eyedrops, though it waited weeks to finally conduct an on-site inspection, only to find multiple sanitary and safety issues. The companies did not respond to a request for comment, though in a February press release EzriCare said that it was cooperating with the CDC and FDA. Global Pharma has said to The New York Times it is "fully cooperating with U.S. federal authorities."
Internal documents and former company executives reveal how Cigna doctors reject patients' claims without opening their files. "We literally click and submit," one former company doctor said.
This article was published on Friday, March 25, 2023 in ProPublica.
By Patrick Rucker, Maya Miller and David Armstrong
When a stubborn pain in Nick van Terheyden's bones would not subside, his doctor had a hunch what was wrong.
Without enough vitamin D in the blood, the body will pull that vital nutrient from the bones. Left untreated, a vitamin D deficiency can lead to osteoporosis.
A blood test in the fall of 2021 confirmed the doctor's diagnosis, and van Terheyden expected his company's insurance plan, managed by Cigna, to cover the cost of the bloodwork. Instead, Cigna sent van Terheyden a letter explaining that it would not pay for the $350 test because it was not "medically necessary."
The letter was signed by one of Cigna's medical directors, a doctor employed by the company to review insurance claims.
Something about the denial letter did not sit well with van Terheyden, a 58-year-old Maryland resident. "This was a clinical decision being second-guessed by someone with no knowledge of me," said van Terheyden, a physician himself and a specialist who had worked in emergency care in the United Kingdom.
The vague wording made van Terheyden suspect that Dr. Cheryl Dopke, the medical director who signed it, had not taken much care with his case.
Van Terheyden was right to be suspicious. His claim was just one of roughly 60,000 that Dopke denied in a single month last year, according to internal Cigna records reviewed by ProPublica and The Capitol Forum.
The rejection of van Terheyden's claim was typical for Cigna, one of the country's largest insurers. The company has built a system that allows its doctors to instantly reject a claim on medical grounds without opening the patient file, leaving people with unexpected bills, according to corporate documents and interviews with former Cigna officials. Over a period of two months last year, Cigna doctors denied over 300,000 requests for payments using this method, spending an average of 1.2 seconds on each case, the documents show. The company has reported it covers or administers health care plans for 18 million people.
In the four minutes and 49 seconds you've been on this page, Cigna's doctors could have denied 347 claims, according to company documents.
Before health insurers reject claims for medical reasons, company doctors must review them, according to insurance laws and regulations in many states. Medical directors are expected to examine patient records, review coverage policies and use their expertise to decide whether to approve or deny claims, regulators said. This process helps avoid unfair denials.
But the Cigna review system that blocked van Terheyden's claim bypasses those steps. Medical directors do not see any patient records or put their medical judgment to use, said former company employees familiar with the system. Instead, a computer does the work. A Cigna algorithm flags mismatches between diagnoses and what the company considers acceptable tests and procedures for those ailments. Company doctors then sign off on the denials in batches, according to interviews with former employees who spoke on condition of anonymity.
"We literally click and submit," one former Cigna doctor said. "It takes all of 10 seconds to do 50 at a time."
Not all claims are processed through this review system. For those that are, it is unclear how many are approved and how many are funneled to doctors for automatic denial.
Patients expect insurers to treat them fairly and meaningfully review each claim, said Dave Jones, California's former insurance commissioner. Under California regulations, insurers must consider patient claims using a "thorough, fair and objective investigation."
"It's hard to imagine that spending only seconds to review medical records complies with the California law," said Jones. "At a minimum, I believe it warrants an investigation."
Insurers deny tens of millions of claims every year. ProPublica is investigating why claims are denied, what the consequences are for patients and how the appeal process really works.
Within Cigna, some executives questioned whether rendering such speedy denials satisfied the law, according to one former executive who spoke on condition of anonymity because he still works with insurers.
"We thought it might fall into a legal gray zone," said the former Cigna official, who helped conceive the program. "We sent the idea to legal, and they sent it back saying it was OK."
Cigna adopted its review system more than a decade ago, but insurance executives say similar systems have existed in various forms throughout the industry.
In a written response, Cigna said the reporting by ProPublica and The Capitol Forum was "biased and incomplete."
Cigna said its review system was created to "accelerate payment of claims for certain routine screenings," Cigna wrote. "This allows us to automatically approve claims when they are submitted with correct diagnosis codes."
When asked if its review process, known as PXDX, lets Cigna doctors reject claims without examining them, the company said that description was "incorrect." It repeatedly declined to answer further questions or provide additional details. (ProPublica employees' health insurance is provided by Cigna.)
Former Cigna doctors confirmed that the review system was used to quickly reject claims. An internal corporate spreadsheet, viewed by the news organizations, lists names of Cigna's medical directors and the number of cases each handled in a column headlined "PxDx." The former doctors said the figures represent total denials. Cigna did not respond to detailed questions about the numbers.
Cigna's explanation that its review system was designed to approve claims didn't make sense to one former company executive. "They were paying all these claims before. Then they weren't," said Ron Howrigon, who now runs a company that helps private doctors in disputes with insurance companies. "You're talking about a system built to deny claims."
Cigna emphasized that its system does not prevent a patient from receiving care — it only decides when the insurer won't pay. "Reviews occur after the service has been provided to the patient and does not result in any denials of care," the statement said.
"Our company is committed to improving health outcomes, driving value for our clients and customers, and supporting our team of highly-skilled Medical Directors," the company said.
PXDX
Cigna's review system was developed more than a decade ago by a former pediatrician.
After leaving his practice, Dr. Alan Muney spent the next several decades advising insurers and private equity firms on how to wring savings out of health plans.
In 2010, Muney was managing health insurance for companies owned by Blackstone, the private equity firm, when Cigna tapped him to help spot savings in its operation, he said.
Insurers have wide authority to reject claims for care, but processing those denials can cost a few hundred dollars each, former executives said. Typically, claims are entered into the insurance system, screened by a nurse and reviewed by a medical director.
For lower-dollar claims, it was cheaper for Cigna to simply pay the bill, Muney said.
"They don't want to spend money to review a whole bunch of stuff that costs more to review than it does to just pay for it," Muney said.
Muney and his team had solved the problem once before. At UnitedHealthcare, where Muney was an executive, he said his group built a similar system to let its doctors quickly deny claims in bulk.
In response to questions, UnitedHealthcare said it uses technology that allows it to make "fast, efficient and streamlined coverage decisions based on members benefit plans and clinical criteria in compliance with state and federal laws." The company did not directly address whether it uses a system similar to Cigna.
At Cigna, Muney and his team created a list of tests and procedures approved for use with certain illnesses. The system would automatically turn down payment for a treatment that didn't match one of the conditions on the list. Denials were then sent to medical directors, who would reject these claims with no review of the patient file.
Cigna eventually designated the list "PXDX" — corporate shorthand for procedure-to-diagnosis. The list saved money in two ways. It allowed Cigna to begin turning down claims that it had once paid. And it made it cheaper to turn down claims, because the company's doctors never had to open a file or conduct any in-depth review. They simply denied the claims in bulk with an electronic signature.
"The PXDX stuff is not reviewed by a doc or nurse or anything like that," Muney said.
The review system was designed to prevent claims for care that Cigna considered unneeded or even harmful to the patient, Muney said. The policy simply allowed Cigna to cheaply identify claims that it had a right to deny.
Muney said that it would be an "administrative hassle" to require company doctors to manually review each claim rejection. And it would mean hiring many more medical directors.
"That adds administrative expense to medicine," he said. "It's not efficient."
But two former Cigna doctors, who did not want to be identified by name for fear of breaking confidentiality agreements with Cigna, said the system was unfair to patients. They said the claims automatically routed for denial lacked such basic information as race and gender.
"It was very frustrating," one doctor said.
Some state regulators questioned Cigna's PXDX system.
In Maryland, where van Terheyden lives, state insurance officials said the PXDX system as described by a reporter raises "some red flags."
The state's law regulating group health plans purchased by employers requires that insurance company doctors be objective and flexible when they sit down to evaluate each case.
If medical directors are "truly rubber-stamping the output of the matching software without any additional review, it would be difficult for the medical director to comply with these requirements," the Maryland Insurance Administration wrote in response to questions.
Within the world of private insurance, Muney is certain that the PXDX formula has boosted the corporate bottom line. "It has undoubtedly saved billions of dollars," he said.
Insurers benefit from the savings, but everyone stands to gain when health care costs are lowered and unneeded care is denied, he said.
Speedy Reviews
Cigna carefully tracks how many patient claims its medical directors handle each month. Twelve times a year, medical directors receive a scorecard in the form of a spreadsheet that shows just how fast they have cleared PXDX cases.
Dopke, the doctor who turned down van Terheyden, rejected 121,000 claims in the first two months of 2022, according to the scorecard.
Van Terheyden's denial letter from Cigna Credit: highlights and redactions added by ProPublica
Dr. Richard Capek, another Cigna medical director, handled more than 80,000 instant denials in the same time span, the spreadsheet showed.
Dr. Paul Rossi has been a medical director at Cigna for over 30 years. Early last year, the physician denied more than 63,000 PXDX claims in two months.
Rossi, Dopke and Capek did not respond to attempts to contact them.
Howrigon, the former Cigna executive, said that although he was not involved in developing PXDX, he can understand the economics behind it.
"Put yourself in the shoes of the insurer," Howrigon said. "Why not just deny them all and see which ones come back on appeal? From a cost perspective, it makes sense."
Cigna knows that many patients will pay such bills rather than deal with the hassle of appealing a rejection, according to Howrigon and other former employees of the company. The PXDX list is focused on tests and treatments that typically cost a few hundred dollars each, said former Cigna employees.
"Insurers are very good at knowing when they can deny a claim and patients will grumble but still write a check," Howrigon said.
Muney and other former Cigna executives emphasized that the PXDX system does leave room for the patient and their doctor to appeal a medical director's decision to deny a claim.
But Cigna does not expect many appeals. In one corporate document, Cigna estimated that only 5% of people would appeal a denial resulting from a PXDX review.
"A Negative Customer Experience"
In 2014, Cigna considered adding a new procedure to the PXDX list to be flagged for automatic denials.
Autonomic nervous system testing can help tell if an ailing patient is suffering from nerve damage caused by diabetes or a variety of autoimmune diseases. It's not a very involved procedure — taking about an hour — and it costs a few hundred dollars per test.
The test is versatile and noninvasive, requiring no needles. The patient goes through a handful of checks of heart rate, sweat response, equilibrium and other basic body functions.
At the time, Cigna was paying for every claim for the nerve test without bothering to look at the patient file, according to a corporate presentation. Cigna officials were weighing the cost and benefits of adding the procedure to the list. "What is happening now?" the presentation asked. "Pay for all conditions without review."
By adding the nerve test to the PXDX list, Cigna officials estimated, the insurer would turn down more than 17,800 claims a year that it had once covered. It would pay for the test for certain conditions, but deny payment for others.
These denials would "create a negative customer experience" and a "potential for increased out of pocket costs," the company presentation acknowledged.
But they would save roughly $2.4 million a year in medical costs, the presentation said.
Cigna added the test to the list.
'It's Not Good Medicine'
By the time van Terheyden received his first denial notice from Cigna early last year, he had some answers about his diagnosis. The blood test that Cigna had deemed "not medically necessary" had confirmed a vitamin D deficiency. His doctor had been right, and recommended supplements to boost van Terheyden's vitamin level.
Still, van Terheyden kept pushing his appeal with Cigna in a process that grew more baffling. First, a different Cigna doctor reviewed the case and stood by the original denial. The blood test was unnecessary, Cigna insisted, because van Terheyden had never before been found to lack sufficient vitamin D.
"Records did not show you had a previously documented Vitamin D deficiency," stated a denial letter issued by Cigna in April. How was van Terheyden supposed to document a vitamin D deficiency without a test? The letter was signed by a Cigna medical director named Barry Brenner.
Brenner did not respond to requests for comment.
Then, as allowed by his plan, van Terheyden took Cigna's rejection to an external review by an independent reviewer.
In late June — seven months after the blood test — an outside doctor not working for Cigna reviewed van Terheyden's medical record and determined the test was justified.
The blood test in question "confirms the diagnosis of Vit-D deficiency," read the report from MCMC, a company that provides independent medical reviews. Cigna eventually paid van Terheyden's bill. "This patient is at risk of bone fracture without proper supplementations," MCMC's reviewer wrote. "Testing was medically necessary and appropriate."
Van Terheyden had known nothing about the vagaries of the PXDX denial system before he received the $350 bill. But he did sense that very few patients pushed as hard as he had done in his appeals.
As a physician, van Terheyden said, he's dumbfounded by the company's policies.
"It's not good medicine. It's not caring for patients. You end up asking yourself: Why would they do this if their ultimate goal is to care for the patient?" he said.
"Intellectually, I can understand it. As a physician, I can't. To me, it feels wrong."
Clarification, March 27, 2023: This article was updated to clarify that a response from the Maryland Insurance Administration referred to medical directors in general.
An NIH report decried stillbirths as a 'major public health concern' and said the nation needed to do more to address the problem through research and prevention.
This article was published on Thursday, March 23, 3032 in ProPublica.
Federal officials have released a bleak assessment of the country's progress in understanding and preventing stillbirths, calling the rate "unacceptably high" and issuing a series of recommendations to reduce it through research and prevention.
The National Institutes of Health report, titled "Working to Address the Tragedy of Stillbirth," mirrored findings of an investigation by ProPublica last year into the U.S. stillbirth crisis, in which more than 20,000 pregnancies every year are lost at 20 weeks or more and the expected baby is born dead.
ProPublica's reporting found that a number of factors contributed to the nation's failure to bring down the stillbirth rate: medical professionals dismissing the concerns of their pregnant patients, a lack of research and data, and too few autopsies being performed. Additionally, alarming racial disparities in stillbirth rates have compounded the crisis.
"The extent of the problem is massive," said Dr. Lucky Jain, who served as co-chair of the Stillbirth Working Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Council, which issued the report last week. "All of my life, I have maintained that what I cannot measure, I cannot improve. And so if I don't have proper data, records, autopsy findings, genetics, the background information of why a fully formed baby died suddenly, how do I even begin improving things as a scientist?"
The working group concluded that barriers to lowering the stillbirth rate could not be traced to one federal agency or a single state health department or local hospital, Jain said, but to problems "at every level."
"The report has reinforced what you all have already been saying," said Jain, who is chair of pediatrics at Emory University School of Medicine and pediatrician-in-chief at Children's Healthcare of Atlanta. "ProPublica has emphasized the need for an autopsy, has emphasized the need for reporting stillbirths. There's plenty of overlap and the same type of concern that ProPublica has expressed around stillbirths."
ProPublica found that federal health agencies had not prioritized stillbirth-focused research, data collection or analysis, and that those agencies, along with state health departments, hospitals and medical providers, had done a poor job of raising awareness about stillbirth risk and prevention.
Although many people, including some medical providers, believe that stillbirths are inevitable, research shows that as many as 1 in 4 may be preventable.
The newly released report, which called stillbirth "a major public health concern," was the result of a congressional mandate that required the Department of Health and Human Services to develop a stillbirth task force. The working group was charged with examining health disparities and communities that face a higher risk of stillbirth; barriers to collecting data; the psychological impact of and treatment received after a stillbirth; and known risk factors.
Dr. Diana W. Bianchi, director of the National Institute of Child Health and Human Development, the branch of the National Institutes of Health that led the working group, said in an email that one of the agency's goals is to advance efforts to "better understand and ultimately prevent" stillbirths. Among its priorities, Bianchi said, is moving forward on the working group's recommendation to create a research agenda to "develop specific, actionable approaches to prevent stillbirth."
Work to implement the report's recommendations, she said, will begin this spring and summer.
In total, the working group issued 12 recommendations, the majority of which were aimed at the NIH and the Centers for Disease Control and Prevention. A CDC spokesperson said the agency is investigating risk factors and health disparities and is considering which existing CDC projects could be used for stillbirth research, such as those that already collect data on birth defects and pregnancy risks.
"Findings on factors associated with stillbirths will inform CDC's next steps, including further research and potential prevention efforts," the spokesperson said.
Several of the working group's recommendations were related to improving the quality of stillbirth data at the local, state and national levels. Specific changes included standardizing definitions, enhancing training for employees who collect data for fetal death certificates, and making it easier to amend that data when needed.
One of the reasons stillbirth data often is incomplete or inaccurate is that autopsies, placental exams and genetic testing are not uniformly performed. And even if one or more of those exams are carried out and do reveal a cause of death, that critical piece of information is typically not updated in state or federal databases.
ProPublica found that in 2020, placental exams were performed or planned in only 65% of stillbirth cases and autopsies were conducted or planned in less than 20% of cases. The federal report identified several of the same barriers that ProPublica had spotlighted.
"Many parents report that hospital staff discouraged them from requesting an autopsy of their stillborn baby because of cost, because it might be inconclusive, or because it would disfigure the baby," the working group concluded. "Doctors may also be worried about liability."
The report noted that while Medicaid covers a large portion of pregnancies and births, it does not cover the cost of an autopsy. Experts previously told ProPublica that they believed an autopsy after a stillbirth should be covered as a continuation of maternal care.
A spokesperson for the Centers for Medicare & Medicaid Services said autopsies are not covered because they do not fall "within the definition of medical assistance established by Congress."
The working group also suggested that states could model their policies for stillbirth autopsies after policies relating to sudden infant death syndrome. Many states, which have designated SIDS as a "public health emergency," pay for autopsies if a baby is suspected to have died of SIDS. In 2020, the number of stillbirths was 15 times the number of SIDS deaths.
The report also addressed the devastating psychological effects of a stillbirth. Many parents withdraw from the world and are at a higher risk of depression, post-traumatic stress disorder and anxiety, the working group found. Those feelings may be compounded if patients are dismissed or blamed for the stillbirth.
"It is not uncommon for individuals of color, in particular, to speak of healthcare providers who treated them with a dismissive attitude or who feel that there is no point in speaking up about certain concerns because they will not be heard and it will not make a difference," the report said.
Black women are more than twice as likely — and in some states close to three times as likely — as white women to have a stillbirth, according to 2020 CDC data. The national stillbirth rate for Black women that year was10.3 per 1,000 births, and for white women it was 4.7. But it's not just Black babies who are dying at a disproportionate rate. So are their mothers.
The same week that the NIH stillbirth report was released, the CDC issued a separate report on maternal mortality that found that the rate of mothers dying while pregnant or shortly after birth increased in 2021, while the rate of maternal mortality in Black women was more than double that of white women.
Sen. Jeff Merkley, a Democrat from Oregon, said the stillbirth report, coupled with ProPublica's reporting and the most recent CDC data on maternal mortality, "underscores the fact that stillbirths and maternal mortality are shockingly high in the United States compared with other similarly developed nations, and that Black women are paying the highest price."
Merkley, who last year had co-sponsored a stillbirth bill that did not ultimately pass, called for change and said one way to "stem the tide of these horrific outcomes" is to ensure that states use federal maternal health funding to implement stillbirth interventions, as he proposed doing in his legislation.
The American College of Obstetricians and Gynecologists, the nation's leading organization of OB-GYNs, supports the report's findings, particularly the need for additional research, said Dr. Christopher Zahn, ACOG's chief of clinical practice and health equity and quality. Many stillbirths, he said, remain unexplained.
Members of PUSH for Empowered Pregnancy, a New York-based nonprofit that works to prevent stillbirths, emerged as vocal advocates during the working group sessions. Samantha Banerjee, executive director of PUSH, said the organization forwarded ProPublica's reporting to the working group and pressed for families who've experienced a stillbirth to be included in the process. After a rocky start in the early sessions, she said, she and her team witnessed a shift in the way the group approached the issue.
Banerjee, whose email signature includes "Mom to Alana, born still in 2013," said the final report exceeded her expectations.
"This is the first time in over a decade that we have seen the U.S. take a substantial step in the right direction when it comes to ending preventable stillbirths," she said. "The dire landscape of stillbirth prevention is accurately described, and there are clear calls to action for systemic change intended to prevent stillbirths."
Duaa Eldeib is currently investigating issues related to health inequities and race. Send tips and documents her way.
After a college student finally found a treatment that worked, the insurance giant decided it wouldn't pay for the costly drugs. His fight to get coverage exposed the insurer's hidden procedures for rejecting claims.
This article was published on Thursday, February 2, 2023 in ProPublica.
By David Armstrong, Patrick Rucker and Maya Miller
In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.
United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.
But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis — an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue and life-threatening blood clots. His medical bills were running nearly $2 million a year.
United had flagged McNaughton's case as a "high dollar account," and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought McNaughton's disease under control after he'd been through years of misery.
On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that McNaughton's treatment was "not medically necessary." Her colleague, Dave Opperman, reacted to the news with a long laugh.
"I knew that was coming," said Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. "I did too," Kavanaugh replied.
UnitedHealthcare Employees Discuss the Denial of Chris McNaughton's Claim
David Opperman is an insurance broker who works for UnitedHealthcare. Victoria Kavanaugh is a nurse for United. In this recorded phone call from 2021, the two express relief that a doctor has turned down Penn State student Chris McNaughton's claim as "not medically necessary."
Opperman then complained about McNaughton's mother, whom he referred to as "this woman," for "screaming and yelling" and "throwing tantrums" during calls with United.
The pair agreed that any appeal of the United doctor's denial of the treatment would be a waste of the family's time and money.
"We're still gonna say no," Opperman said.
More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.
Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not "medically necessary."
When United refused to pay for McNaughton's treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America's leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.
As United reviewed McNaughton's treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering McNaughton's drug plan.
At one point, court records show, United inaccurately reported to Penn State and the family that McNaughton's doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for McNaughton's treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.
United declined to answer specific questions about the case, even after McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of McNaughton's treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company's guiding concern was McNaughton's well-being.
"Mr. McNaughton's treatment involves medication dosages that far exceed FDA guidelines," the statement said. "In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety."
But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with McNaughton. In emails, officials calculated what McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.
"This is just unbelievable," Kavanaugh said of McNaughton's family in one call to discuss his case. "They're just really pushing the envelope, and I'm surprised, like I don't even know what to say."
The Same Meal Every Day
McNaughton on the Penn State campus, where he first enrolled in 2020 Credit: Nate Smallwood, special to ProPublica
Now 31, McNaughton grew up in State College, Pennsylvania, just blocks from the Penn State campus. Both of his parents are faculty members at the university.
In the winter of 2014, McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team's games since the start of his sophomore year. He was majoring in psychology.
When McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.
A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. McNaughton's case was severe.
Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.
McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.
For two years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch and a similar meal for dinner, occasionally swapping in tilapia.
McNaughton at his home in State College, Pennsylvania. When he fell ill with ulcerative colitis he was forced to stop playing college basketball. Credit: Nate Smallwood, special to ProPublica
His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring McNaughton to Dr. Edward Loftus Jr. at the Mayo Clinic in Minnesota, which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.
For his first visit with Loftus in May 2015, McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.
Mornings were the hardest. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the five-minute walk from the hotel to the clinic. When they met, Loftus looked at McNaughton and told him that he appeared incapacitated. It was, he told the student, as if McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.
McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Loftus treated him.
In addition to trying to find a treatment that would bring McNaughton's colitis into remission, Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection and fatigue. McNaughton also experienced "moon face," a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.
In 2018, Loftus and McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases like colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year's supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.
McNaughton receives an infusion of medication to treat his ulcerative colitis at a medical facility in State College. After initially paying for his treatment, UnitedHealthcare began rejecting his insurance claims. Credit: Nate Smallwood, special to ProPublica.
McNaughton had tried individual biologics, and then two in combination, without much success. He and Loftus then agreed to try two biologic drugs together at doses well above those recommended by the U.S. Food and Drug Administration. Prescribing drugs for purposes other than what they are approved for or at higher doses than those approved by the FDA is a common practice in medicine referred to as off-label prescribing. The federal Agency for Healthcare Research and Quality estimates 1 in 5 prescriptions written today are for off-label uses.
There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Loftus has been paid to do consulting related to the biologic drugs taken by McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.
In cases of off-label prescribing, patients are depending upon their doctor's expertise and experience with the drug."In this case, I was comfortable that the potential benefits to Chris outweighed the risks," Loftus said.
There was evidence that the treatment plan for McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose — to reduce inflammation in the large intestine — but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.
As for any suggestion by United doctors that his treatment plan for McNaughton was out of bounds or dangerous, Loftus said "my treatment of Chris was not clinically inappropriate — as was shown by Chris' positive outcome."
The unusual high-dose combination of two biologic drugs produced a remarkable change in McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to three or four. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.
"If you told me in 2015 that I would be living like this, I would have asked where do I sign up," McNaughton said of the change he experienced with the new drug regimen.
When he first started the new treatment, McNaughton was covered under his family's plan, and all his bills were paid. McNaughton enrolled at the university in 2020. Before switching to United's plan for students, McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by McNaughton would be covered by United.
McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was "pending," something it did for his other claims that came in during the rest of the year.
McNaughton and his family were worried. They called United to make sure there wasn't a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.
In January 2021, McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer "pending." They were stamped "DENIED." The total outstanding bill for his treatment was $807,086.
When McNaughton's mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of "a high dollar amount on the claims," according to a recording of the call.
Misrepresentations
With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive McNaugton of treatment that they considered miraculous.
They turned to Penn State for help. Light and McNaughton's father, David, hoped their position as faculty members would make the school more willing to intervene on their behalf.
"After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated," Light wrote to a school official in February 2021.
In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that "supporting the health and well-being of our students is always of primary importance" and that "our hearts go out to any student and family impacted by a serious medical condition." The university, she wrote, does "not comment on students' individual circumstances or disclose information from their records." McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment "even if confidentiality has been waived."
The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was "a high likelihood they would no longer be effective."
During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for McNaughton's care through the end of the plan year that August. Penn State immediately notified the family of the "wonderful news" while also apologizing for "the stress this has caused Chris and your family."
Behind the scenes, McNaughton's review had "gone all the way to the top" at United's student health plan division, Kavanaugh, the nurse, said in a recorded conversation.
McNaughton had been on the treatment for three years and it had put his disease in remission with no side effects.
The family's relief was short-lived. A month later, United started another review of McNaughton's care, overseen by Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.
The nurse sent the McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.
Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.
"This school apparently is a big client of ours," she said. She then shared her opinion of McNaughton's treatment. "Really this is a case of a kid who's getting a drug way too much, like too much of a dose," Kavanaugh said. She said it was "insane that they would even think that this is reasonable" and "to be honest with you, they're awfully pushy considering that we are paying through the end of this school year."
On a call with an outside contractor, the United nurse claimed McNaughton was on a higher dose of medication than the FDA approved, which is a common practice known as "off-label prescribing."
MRIoA sent the case to Dr. Vikas Pabby, a gastroenterologist at UCLA Health and a professor at the university's medical school. His May 2021 review of McNaughton's case was just one of more than 300 Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.
In a May 4, 2021 report, Pabby concluded McNaughton's treatment was not medically necessary, because United's policies for the two drugs taken by McNaughton did not support using them in combination.
Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as McNaughton's, contain a provision that treatments and procedures must be "medically necessary" in order to be covered. The definition of medically necessary differs by plan. Some don't even define the term. McNaughton's policy contains a five-part definition, including that the treatment must be "in accordance with the standards of good medical policy" and "the most appropriate supply or level of service which can be safely provided."
Behind the scenes at United, Opperman and Kavanaugh agreed that if McNaughton were to appeal Pabby's decision, the insurer would simply rule against him. "I just think it's a waste of money and time to appeal and send it to another one when we know we're gonna get the same answer," Opperman said, according to a recording in court files. At Opperman's urging, United decided to skip the usual appeals process and arrange for Pabby to have a so-called "peer-to-peer" discussion with Loftus, the Mayo physician treating McNaughton. Such a conversation, in which a patient's doctor talks with an insurance company's doctor to advocate for the prescribed treatment, usually only occurs after a customer has appealed a denial and the appeal has been rejected.
When Kavanaugh called Loftus' office to set up a conversation with Pabby, she explained it was an urgent matter and had been requested by McNaughton. "You know I've just gotten to know Christopher," she explained, although she had never spoken with him. "We're trying to advocate and help and get this peer-to-peer set up."
McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.
In the peer-to-peer conversation, Loftus told Pabby that McNaughton had "a very complicated case" and that lower doses had not worked for him, according to an internal MRIoA memo.
Following his conversation with Loftus, Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels "is not established."
When Kavanaugh shared the May 12 decision from Pabby with others at United, her boss responded with an email calling it "great news."
Then Opperman sent an email that puzzled the McNaughtons.
In it, Opperman claimed that Loftus and Pabby had agreed that McNaughton should be on significantly lower doses of both drugs. He said Loftus "will work with the patient to start titrating them down" — or reducing the dosage — "to a normal dose range." Opperman wrote that United would cover McNaughton's treatment in the coming year, but only at the reduced doses. Opperman did not respond to emails and phone messages seeking comment.
McNaughton didn't believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Loftus who had upped the doses, leading to his remission from severe colitis.
The only thing that made sense to McNaughton was that the treatment United said it would now pay for was dramatically cheaper — saving the company at least hundreds of thousands of dollars a year — than his prescribed treatment because it sliced the size of the doses by more than half.
When the family contacted Loftus for an explanation, they were outraged by what they heard. Loftus told them that he had never recommended lowering the dosage. In a letter, Loftus wrote that changing McNaughton's treatment "would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective."
It would not be until the lawsuit that it would become clear how Loftus' conversations had been so seriously misrepresented.
Under questioning by McNaughton's lawyers, Kavanaugh acknowledged that she was the source of the incorrect claim that McNaughton's doctor had agreed to a change in treatment.
"I incorrectly made an assumption that they had come to some sort of agreement," she said in a deposition last August. "It was my first peer-to-peer. I did not realize that that simply does not occur."
Kavanaugh did not respond to emails and telephone messages seeking comment.
When the McNaughtons first learned of Opperman's inaccurate report of the phone call with Loftus, it unnerved them. They started to question if their case would be fairly reviewed.
"When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters," McNaughton said. "They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed."
A Buried Report
While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.
On May 21, 2021, United sent the case to one of its own doctors, Dr. Nady Cates, for an additional review. The review was marked "escalated issue." Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.
Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because "AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed." He transitioned to reviewing paperwork for the insurance industry, he said, because "I guess I was a chicken."
When he had practiced, Cates said, he hadn't treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.
He said his review of McNaughton's case primarily involved reading a United nurse's recommendation to deny his care and making sure "that there wasn't a decimal place that was out of line." He said he copied and pasted the nurse's recommendation and typed "agree" on his review of McNaughton's case.
Dr. Nady Cates, a United Medical Director, Explains That He Copied and Pasted the Text of His Decision to Deny McNaughton's Care
In the deposition, Cates tells McNaughton's lawyer that he copied the recommendation of Pamela Banister, a nurse for United, rather than writing his own decision.
Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer's guidelines, and if not, he denies it. United's policies, he said, prevented him from considering that McNaughton had failed other treatments or that Loftus was a leading expert in his field.
"You are giving zero weight to the treating doctor's opinion on the necessity of the treatment regimen?" a lawyer asked Cates in his deposition. He responded, "Yeah."
Attempts to contact Cates for comment were unsuccessful.
At the same time Cates was looking at McNaughton's case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Loftus warning of the life-threatening complications that might occur if the dosages were reduced.
On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.
Dr. Nitin Kumar, a gastroenterologist in Illinois, concluded that McNaughton's established treatment plan was not only medically necessary and appropriate but that lowering his doses "can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon."
Unlike other doctors who produced reports for United, Kumar discussed the harm that McNaughton might suffer if United required him to change his treatment. "His disease is significantly severe, with diagnosis at a young age," Kumar wrote. "He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case." He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be "broadly successful."
When Kavanaugh learned of Kumar's report, she quickly moved to quash it and get the case returned to Pabby, according to her deposition.
In a recorded telephone call, Kavanaugh told an MRIoA representative that "I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result." After further discussion, the MRIoA representative agreed to send the case back to Pabby. "I appreciate that," Kavanaugh replied. "I just want to make sure, because, I mean, it's obviously a very different result than what we've been getting on this case."
MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Pabby again rejected McNaughton's treatment plan. While noting it was "difficult to control" McNaughton's ulcerative colitis, Pabby added that his doses "far exceed what is approved by literature" and that the "safety of the requested doses is not supported by literature."
In a deposition, Kavanaugh said that after she opened the Kumar report and read that he was supporting McNaughton's current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Pabby for review.
Kavanaugh said she didn't save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. "I didn't because it shouldn't have existed," she said. "It should have gone back to Dr. Pabby."
When asked if the Kumar report caused her any concerns given his warning that McNaughton risked cancer or hospitalization if his regimen were changed, Kavanaugh said she didn't read his full report. "I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back," she said. Kavanaugh added, "I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer."
In a court filing, United said Kavanaugh was correct in insisting that Pabby conduct the review and that MRIoA confirmed that Pabby should have been the one doing the review.
The Kumar report was not provided to McNaughton when his lawyer, Jonathan Gesk, first asked United and MRIoA for any reviews of the case. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Kavanaugh mentioned a report number Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.
Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
A Sense of Hopelessness
McNaughton on the Penn State campus Credit: Nate Smallwood, special to ProPublica
When McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.
It was a striking contrast to the previous six years, which he had spent largely confined to his parents' house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn't talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.
United, in correspondence with McNaughton, noted that its review of his care was "not a treatment decision. Treatment decisions are made between you and your physician." But by threatening not to pay for his medications, or only to pay for a different regimen, McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.
The idea of changing his treatment or stopping it altogether caused constant worry for McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn't bend his leg or walk properly. There were daily migraines and severe stomach pain. "I was consumed with this situation," McNaughton said. "My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell."
McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.
McNaughton and his parents talked about him possibly moving to Canada where his grandmother lived and seeking treatment there under the nation's government health plan.
Loftus connected McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.
The psychologist, Tiffany Taft, said McNaughton was not an unusual case. About 1 in 3 patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.
"You get into hopelessness," she said of the depression that accompanies fighting with insurance companies over care. "They feel like ‘I can't fix that. I am screwed.' When you can't control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together."
In the case of McNaughton, Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. "It sends you immediately into panic about all these horrific things that could happen," Taft said. The physical and mental symptoms McNaughton suffered after his care was threatened were "triggered" by the stress he experienced, she said.
In early June 2021, United informed McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would only pay for a treatment plan that called for a significant reduction in the doses of the drugs he took.
United wrote that the decision came after his "records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan."
In August 2021, McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported McNaughton's claim for treatment rather than looking for ways to deny coverage.
United, in a court filing, said it did not breach any duty it owed to McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of McNaughton's treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Loftus, according to an email sent by United's lawyer.
The Cost of Treatment
An order form for medications given to McNaughton Credit: Nate Smallwood, special to ProPublica
It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the U.S. is expected to reach $505 billion in 2023, according to an estimate from Optum, United's health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.
A panel convened by ICER to review its analysis cautioned that insurance coverage "should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost." ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.
United officials did not make the cost of treatment an issue when discussing McNaughton's care with Penn State administrators or the family.
Bill Truxal, the president of UnitedHealthcare StudentResources, the company's student health plan division, told a Penn State official that the insurer wanted the "best for the student" and it had "nothing to do with cost," according to notes the official took of the conversation.
Behind the scenes, however, the price of McNaughton's care was front and center at United.
In one email, Opperman asked about the cost difference if the insurer insisted on only paying for greatly reduced doses of the biologic drugs. Kavanaugh responded that the insurer had paid $1.1 million in claims for McNaughton's care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.
United was keeping close tabs on McNaughton at the highest levels of the company. On Aug. 2, 2021, Opperman notified Truxal and a United lawyer that McNaughton "has just purchased the plan again for the 21-22 school year."
A month later, Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on McNaughton in the prior plan year.
United officials strategized about how to best explain why it was reviewing McNaughton's drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. "As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included" in order to "make healthcare more affordable for our members," Kavanaugh offered as a potential talking point in an April 23, 2021, email.
Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than two decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.
The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.
When discussing the case with Penn State, Light said, she told university administrators that United could pay for a year of her son's treatment using just minutes' worth of profit.
'Betrayed'
McNaughton looks out a window at his home in State College. Credit: Nate Smallwood, special to ProPublica
McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting McNaughton's claims into pending status.
McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.
In June 2021, just a week after United told McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.
In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators "have observed an unfortunate breakdown in communication" between McNaughton and his family and the university health insurance plan, "which appears from our perspective to have resulted in a standstill between the two parties." While she proposed some potential steps to help settle the matter, she wrote that "Penn State's role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance." The university's role "is limited," she wrote, and the school "simply must leave" the issue of the best treatment for McNaughton to "the appropriate health care professionals."
In a statement, a Penn State spokesperson wrote that "as a third party in this arrangement, the University's role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give — with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer."
Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.
When the McNaughtons first reached out to the university for help, they were referred to the school's student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that "I appreciate your trusting me to resolve this for you."
In April 2022, United began paying Klinger's salary, an arrangement which is not noted on the university website. Klinger appears in the online staff directory on the Penn State University Health Services webpage, and has a university phone number, a university address and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.
The university said students "benefit" from having a United employee to handle questions about insurance coverage and that the arrangement is "not uncommon" for student health plans.
The family was dismayed to learn that Klinger was now a full-time employee of United.
"We did feel betrayed," Light said. Klinger did not respond to an email seeking comment.
McNaughton's fight to maintain his treatment regimen has come at a cost of time, debilitating stress and depression. "My biggest fear is realizing I might have to do this every year of my life," he said.
McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.
He has been accepted to Penn State's law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.
He plans to reenroll in the United health care plan when he starts school next fall.