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.
Money and lobbying help shield lab-developed tests, including prenatal screenings, from heightened federal scrutiny.
A number of tests used by patients to make major healthcare decisions have once again escaped regulation by the Food and Drug Administration, following intensive lobbying on behalf of test-makers, professional associations and academic medical centers.
ProPublica recently published an investigation about popular prenatal screenings that fall into this category, which one expert described as an unregulated "Wild West." Upwards of half of all pregnant people now receive one of these prenatal screenings. (We also have put together a guide for expecting parents.)
Congress was on the cusp of finally creating a pathway for the FDA to scrutinize these tests, as it does for many other common commercial tests. For much of 2022, the VALID Act seemed on track for passage — and then, in the final weeks of the year, legislators backed away.
The VALID Act, which had bipartisan support, had been developed after nearly a decade of debate among stakeholders about ways to close a regulatory loophole and clarify the FDA's role in overseeing the testing industry. The legislation had momentum thanks, in part, to Theranos' fraudulent blood-testing scandal and the coronavirus pandemic, both of which revealed the possible consequences of unchecked tests reaching patients.
But lawmakers left VALID out of a must-pass end-of-year bill that dealt with a range of spending priorities.
Opponents argued that VALID would have created burdensome regulations for lab-developed tests, or LDTs, stunting essential innovation and flexibility while limiting patient access to healthcare.
The current approach to lab-developed tests goes back to 1976, when Congress revamped the regulation of medical devices. At the time, the tests were considered low-risk and were not in wide use. Since then, the FDA has effectively exempted this type of lab test from its requirements.
Today, the number and complexity of lab-developed tests has grown. A study by the Pew Charitable Trust said there's no way of knowing how many are used on patients each year because there are no tracking measures. But Pew estimated that 12,000 labs are likely to use LDTs, many of which process thousands of patient samples each day.
"The needs were getting bigger and bigger, and also the potential risks get bigger and bigger, too," said Mark McClellan, who served as the head of both the FDA and the Centers for Medicare and Medicaid Services during President George W. Bush's administration. He had urged Congress to pass the bill.
Several people involved in bill negotiations told ProPublica that concern over how it would affect academic labs is what killed it.
Bucshon pointed to the Association of American Medical Colleges and the Association for Molecular Pathology as particularly influential forces that persuaded his colleagues to leave VALID out of the end-of-year bill. According to disclosure forms, AAMC spent at least $300,000 on lobbying activities that included the VALID Act in 2022, while AMP spent at least $189,000. Since 2018, AMP spent at least $957,000 on lobbying activities that included VALID.
AMP had also urged academic lab leaders to reach out to elected officials about this issue. It shared sample letters for them to sign and send, and it organized a "Virtual Advocacy Day," where AMP scheduled meetings between members and their representatives in Washington, providing them with talking points, background information and best practices.
"Here's the thing," Bucshon said. "The academic medical centers, and big medical centers, are in every state." They employ a lot of people and have significant economic impact in every lawmaker's turf, he said, "and so that gives them a pretty big voice."
Heather Pierce, AAMC's senior director for science policy and regulatory counsel, said that many academic medical centers make and use a number of lab-developed tests, and they typically don't have the infrastructure or staff to handle the type of FDA oversight set out by VALID. FDA review, she said, would also add time to the process of developing tests for patients with urgent needs.
The makers of prenatal screening tests weighed in on the bill, too. Illumina, for example, spent more than $3 million over two quarters of 2022 on lobbying activities that included provisions of the VALID Act. And since 2019, Invitae paid at least $950,500 on lobbying activities that included VALID.
"While we support efforts to make sure that lab-developed testing is high quality, Invitae believes that the VALID Act would increase the cost of testing, slow innovation, and force consolidation in the industry while imposing many requirements that do little to improve patient care," said a spokesperson in an email.
While some proponents of the bill still hold out hope for the VALID Act, others said it's unlikely to get traction again anytime soon. Several of those involved said they anticipate the FDA, which has long claimed jurisdiction over the tests, will try to use its current powers to take direct action, though that will likely take more time and could face litigation from opponents.
"While we stand ready to work with Congress, we are considering all options," an FDA press officer said in a statement. "One of those options is administrative action, which could include rulemaking."
Speaking at a trade conference in October, FDA Commissioner Robert Califf said that going it alone is "not something we want to do, because having a clear law passed leads to the best situation." But, he said, if nothing passes, "we also can't stand by."
Current and former FDA officials have expressed befuddlement at how difficult it has been to regulate these tests. "There's almost a point of, what do I need to do?" Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said to a trade journal in October. "Do I need a pile of dead bodies before somebody says enough is enough?"
Some opponents of VALID acknowledge that lab testing reform is needed. But they said it should be done without involving the FDA. AMP's proposed policy, for example, would update the existing oversight system under the Centers for Medicaid and Medicare, which reviews lab operations.
Sen. Rand Paul, a Republican from Kentucky and a former physician, introduced an alternative bill that would do just this, dubbed the VITAL Act. An aide to Paul said the issue came to his attention after AMP approached him about it several years ago. Paul is expected to re-introduce the VITAL Act this year.
While the Centers for Medicaid and Medicare monitor the quality standards in labs, no federal agency checks to make sure lab-developed tests work the way they claim to before they reach patients; similarly, no agency vets the marketing before the tests are sold. Companies aren't required to publicly report so-called adverse events — incidents that happen when the tests get it wrong. And no federal agency has recall authority.
The VALID Act would have phased in the FDA review process over time, with the agency evaluating only high-risk tests — ones where an inaccurate result could lead to serious harm.
Momentum for VALID began to stall in the summer, with a push for an amendment that would exempt academic medical centers.
"I do think that the fact that we couldn't get it done in July and August really created this opportunity for people to poke holes in the boat, as it were," said Cara Tenenbaum, a former FDA policy adviser. "This protracted process allowed people who maybe were not otherwise engaged, or fully engaged, to have an outsized effect that I don't think was in the interest of patients."
Pew declined to comment on the proceedings. Tenenbaum lobbied in support of VALID on behalf of Pew.
Bucshon said he understands the concerns of regulatory skeptics. "Include me in that category, if it's unnecessary and inappropriate regulation that stymies innovation and technology advancements," Bucshon said. "This isn't one of those situations, in my opinion."
Medicare's COVID-19 testing costs reached over $2 billion in 2022. The growing costs concern some experts, who say financial incentives and a lack of regulation early in the pandemic led to fraud and overspending.
This article was published on Saturday, December 30, 2022 in ProPublica.
As the COVID-19 pandemic continues to churn, Medicare spending on testing for the virus continued to increase in 2022 and is outpacing the two prior years.
Through Oct. 31, Medicare had spent $2 billion on COVID-19 tests in 2022, an amount that will surpass last year's total as claims are filed, according to new data provided to ProPublica by CareSet, a research organization that works to make the healthcare system more transparent.
That compares to $2 billion for all of 2021 and $1.5 billion in 2020, a recent analysis by the Department of Health and Human Services' Office of Inspector General shows.
Fraud and overspending are contributing to the increases, experts say, because federal money for COVID-19 testing is not subject to some of the same financial and regulatory constraints as other tests covered by Medicare, the government insurance program for people 65 and older and the disabled.
The growing costs concern some of these experts, who say the need for financial incentives to expand the availability of testing has passed.
Early in the pandemic, testing was both critical to slowing the spread of the virus and in short supply. So the federal government enacted measures to make it more profitable to get in the COVID-19 testing business. Good for the duration of the public health emergency, which has not yet expired, the measures include a generous Medicare reimbursement rate, requirements for private insurance to cover testing — even compelling insurance plans to pay whatever cash price is demanded by out-of-network labs — and a hefty fund for testing those people who didn't have insurance.
The measures succeeded in drawing new and existing labs into the COVID-19 business and helped ensure most people had access to testing, even if some faced excessive waits to get their results. But the incentives also attracted price-gougers, fraudsters and people with no experience in the laboratory business. The result was a chaotic approach that ranged from bungled testing programs and confusion over new requirements to outright fraud.
"It was an unprecedented wave of fraud," said Michael Cohen, an operations officer with the HHS Inspector General, which investigates crimes involving federal healthcare programs.
This year, ProPublica detailed how one Chicago-based lab, Northshore Clinical, used political connections in Nevada to speed its licensing and generated tremendous volume through agreements with school districts, universities and local governments. The story also detailed questionable billing practices that one insurance expert described as fraudulent. A study of Northshore's testing on the University of Nevada Reno campus found the company missed 96% of COVID-19 cases during December 2021.
The company submitted 600 pages of documentation to state regulators to support its claim that it fixed deficiencies noted by inspectors, but it ultimately asked the state to close its license and pulled out of Nevada before the investigation was finished. Northshore repeatedly declined to comment to ProPublica.
The OIG, which had been investigating Northshore in Illinois, expanded its probe to Nevada after ProPublica published its report.
Cohen said OIG investigators have faced challenges responding to the onslaught of suspected fraud — from a lack of additional resources to constantly evolving policies.
In April, the Department of Justice announced criminal charges against people in eight states who allegedly submitted more than $149 million in COVID-19 false billings to federal programs. The OIG has also performed analyses on Medicare data, including for a report released this month that found 378 labs had billed Medicare for expensive add-on tests at "questionably high levels" after testing individuals for COVID-19.
Attorneys general in a handful of states have taken action against labs for forging results, charging fees for "expedited results" that arrived days later and deceptive marketing practices.
Programs to pay for COVID-19 testing aren't the only pandemic assistance funds that have attracted people seeking to profit. Paycheck Protection Program loans went to fake businesses or were spent on luxury goods instead of keeping people employed, ProPublica and other news outlets have reported. Expanded state unemployment programs also saw unprecedented fraud that a partial accounting estimates is $57.3 billion.
Tolerating some fraud is a necessary trade-off to attain legitimate public policy goals, said Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy. But once the incentives and loose regulations boosted the availability of testing, they could have been revised to prevent abuse and overspending, he argued.
"We were in a very different world in April 2020," Adler said. "We needed to overpay because we needed more capacity. Once we scaled up, it was no longer necessary. We could've saved a lot of taxpayer money."
According to the data provided by CareSet, more than 2,300 new labs have enrolled as Medicare providers since the pandemic began and have been billing for COVID-19 testing, evidence of the increased capacity generated by the federal measures.
Total Medicare spending on COVID-19 testing is a small fraction of the $4 trillion federal response to the pandemic. That figure includes not only testing and treatment but also direct support for individuals, businesses, schools and local governments. Adler said that may be why lawmakers haven't revisited the incentives.
Still, testing — as funded by Medicare, private insurance and other federal assistance programs — was a lucrative corner of the pandemic response for many providers.
Labs with troubled operations reaped millions from Medicare, the CareSet data shows.
Northshore Clinical, for example, submitted $6.2 million in Medicare claims for COVID-19 testing between Jan. 1, 2021, and Nov. 30, 2022. Doctors Clinical Laboratory, which is facing lawsuits filed by attorneys general in three states, billed $252,000 in 2021. Doctors Clinical did not respond to requests for comment.
Curative Labs, one of the largest COVID-19 testing providers in the country, has billed Medicare $32 million for testing since Jan. 1, 2021. Curative, launched in California by a 25-year-old college dropout, tapped political connections to land a no-bid contract to test in Colorado's nursing homes, according to the Colorado Springs Gazette. But the state's decision to use Curative tests on individuals without symptoms — a use the tests had not been authorized for — led to unreliable results, as Colorado's nursing home death rate was the highest in the nation, according to CPR News. The FDA later revoked authorization for Curative tests and the state canceled its contract with the company.
"During the pandemic, Curative provided millions of Americans with a safe, accessible and reliable way to test for the virus, including when it was extremely difficult to obtain a COVID-19 test," a Curative spokesperson said. "Our teams deployed tests in an efficient manner, helping to prevent the spread of outbreaks in communities across the state of Colorado and throughout the country."
The spokesperson also pointed to a Colorado legislative committee's decision not to audit the procurement process as an exoneration of Curative's operations in the state. The request for the audit failed in a tied vote along party lines after a state official testified she made the decision to use Curative based on the best science available at the time.
"Nomi Health was one of the first partners to provide open accessible testing at scale on behalf of our partners," Nomi's co-founder and chief operations officer Joshua Walker said in a statement. "We remain one of the few providers in the markets we serve providing important access to this needed service."
Walker said Nomi continues to provide free tests for uninsured individuals despite the end of the federal program that paid for those tests. "We still feel strongly that open and easy access is an important part of keeping our communities safe and helping to drive our economy forward."
The OIG's Cohen said the most common crime investigated by his agency was identity theft. Nefarious labs would snag Medicare beneficiaries' information and use it to bill for services not provided or expensive and unnecessary add-on tests.
"They would take it all. ‘We need your Medicare number. We need your Social Security number. Oh, we need credit card information.' People were giving up just tons of information because people were understandably clamoring for tests," Cohen said.
Medicare wasn't the only government program targeted for laboratory fraud.
healthcare providers found quick access to money in the federal fund for testing people without insurance. The program, run by another federal agency, the Health Resources and Services Administration, was designed to get money out fast and with few restrictions. "Bad actors bled the program for as much as they could," Cohen said.
The program was initially funded by Congress with $2 billion. It ended up paying out $11 billion in testing claims. Congress opted not to allocate any more money into it and HRSA stopped accepting claims in March 2022 — leaving many uninsured individuals on the hook for COVID-19 care.
An HHS official said safeguards against fraud were put in place and any providers caught abusing the program could be subject to enforcement measures.
"The COVID-19 Uninsured Program was designed to ensure that every person in the United States had access to COVID-19 testing, treatment and vaccines — regardless of insurance status — and has been successful in getting care to the most vulnerable among us," the official said.
As the pandemic has evolved, how people test for the virus has changed too. Now, instead of getting lab tests, many patients opt to use at-home rapid tests. And that has opened up another opportunity for fraud, experts say.
While the public health emergency is underway, Medicare is covering up to eight over-the-counter COVID-19 tests per member each month. Some providers are trying to design "subscription" services in which they mail eight tests every month whether the beneficiary needs them or not, Cohen said.
Indeed, the CareSet data shows a dramatic shift in spending for over-the-counter tests and away from PCR laboratory tests beginning in April.
And as investigators try to stay atop new scams, they're busy investigating the old ones.
"We are still finding entities that defrauded us of just enormous amounts of money," Cohen said.
New documents show that St. Jude Children's Research Hospital's reserves grew to $7.6 billion, as other children's cancer nonprofits struggled to raise cash.
This article was published on Wednesday, June 8, 2022 in ProPublica.
In July 2021, St. Jude Children's Research Hospital announced to fanfare that it had just finished raising $2 billion in donations, a single-fiscal-year record for the nation's largest healthcare charity. "Solving pediatric cancer is a global problem — a multi-trillion, multi-year problem," Rick Shadyac, chief executive of St. Jude's fundraising arm, told the Associated Press at the time. "The way we look at it is: If not St. Jude, then who?"
Financial disclosures newly released by St. Jude, however, show $886 million of the hospital's record $2 billion-plus in revenues last fiscal year went unspent. Those surplus dollars instead flowed to the hospital's reserve fund, which helped it grow to $7.6 billion by the end of June 2021. That's enough money to run St. Jude's 77-bed hospital in Memphis at last year's levels for the next five years without a single additional donation.
The impressive growth in fundraising raises new concerns about the amount of money that the charity has put aside for its rainy day fund.
Last year, ProPublica reported that St. Jude had accumulated billions of dollars while many families of young patients treated at the hospital struggled financially. Parents told ProPublica that they'd exhausted savings and retirement accounts and borrowed from family and friends, despite St. Jude's much-publicized pledge to alleviate many of the costs associated with treatment "because all a family should worry about is helping their child live." St. Jude said they provided generous benefits to families, but cannot cover all financial obligations that a family experiences during a child's illness. In response to the story, St. Jude significantly increased its benefits for families, including more support for travel and housing.
Some researchers, oncologists, healthcare advocates and families of patients complain that St. Jude's fundraising makes it more difficult for other pediatric hospitals to raise money for their operations. St. Jude competes for fundraising dollars directly against other children's hospitals, some of which have significant numbers of patients in clinical trials and their own research divisions focused on pediatric cancer care. To visualize just how much St. Jude outstrips its competitors: In 2020, U.S. News and World Report's ranked the nation's best children's cancer centers. St. Jude's, ranked tenth, pulled in more than the combined total of the nine hospitals ranked above it , according to financial records filed with the Internal Revenue Service.
"Donors all want to get the biggest bang for their buck," said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. "It's time for St. Jude to respect donors' preferences and stop hoarding. Effectively and sufficiently spending money on the core mission is the only way to deserve donors' trust and sustain their generosity."
In a statement, St. Jude said the large reserve was a prudent cushion against swings in the stock market as well as the economic uncertainties created by global crises like the war in Ukraine. It said it expects the yearly cost of operating the hospital and making capital improvements to increase from a total of $2 billion in fiscal 2023 to $2.2 billion by fiscal 2026. At that point, according to the statement, contributions may not keep pace with spending and the hospital may need to tap the reserve fund. The hospital said it expects to spend a total of $12.9 billion over the six-year period beginning with fiscal 2022.
St. Jude said it cannot be fairly compared to any other hospital because its operating model relies disproportionately on public donations.
"Our reserves allow us now, and in the years ahead, to treat patients and continue research projects — no matter what happens to the economy or in the event of a disaster," the statement said.
St. Jude said it is also expanding its work internationally, including a plan to spend $200 million over five years to help thousands of children in the Middle East, Africa and other parts of the world receive free chemotherapy drugs. In recent months, the hospital has also helped pediatric cancer patients in Ukraine continue receiving care.
"Having a responsible reserve fund is critical to fueling this comprehensive, global strategic plan," St. Jude wrote.
The Better Business Bureau's Wise Giving Alliance, which sets standards for charitable spending, advises charities to avoid accumulating funds that could instead be used for current programs. It says a charity's unrestricted net assets available for use should not be more than three times the past year's expenses or the current year's budget. The alliance deducts assets like land and buildings from its calculations and combines the expenses of the hospital and its fundraising arm. The alliance calculation puts the reserve fund at 3.05 times higher than the current year budget of the hospital and ALSAC, which the charities provided to the alliance. Though St. Jude itself is slightly above the limit, the alliance said it remains in compliance.
St. Jude's fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, spent $626 million in fiscal 2021, about 35% of the organization's total expenses, the financial disclosures show. That figure includes fundraising and educating the public about childhood cancers. St. Jude spent $1.2 billion on treatment for children with major illnesses, laboratories and clinical trials and hospital administration. St. Jude said its fundraising and marketing expenses were well within industry standards.
The record-breaking $2 billion in contributions to St. Jude represented a 16% increase over the previous year. St. Jude said that it benefited from investment gains in a hot stock market in addition to the increase in contributions in fiscal 2021.
One key driver of the boost in donations was bequests, in which donors name St. Jude as a beneficiary in their wills. Such donations increased 24% from the prior year to $478 million, or almost one in four dollars donated to St. Jude.
The bequest program, while one of the most successful in the country in terms of dollars raised, has also led to disputes with donors' family members and allegations the hospital is too aggressive in seeking monies from inheritances. St. Jude says that it operates with the highest ethical standards in carrying out donors' intents.
St. Baldrick's Foundation is one of the largest funders of childhood cancer research in the country. Its wide-ranging programs pay for clinical trials to test new treatments and provide training for new doctors and researchers entering the field.
The charity primarily raises money through events where people shave their heads to solicit contributions. When COVID-19 triggered quarantines in March 2020, St. Baldrick's had to cancel scores of events and lost millions of dollars in donations, said Kathleen Ruddy, the organization's chief executive.
In the fiscal year before the pandemic began, St. Baldrick's financial disclosures show it raised more than $36 million. Total donations last fiscal year, ending in June 2021, were about $18 million — a 49% drop. The charity had to close several research grant programs and lay off staff, Ruddy said.
People often ask if St. Baldrick's is part of St. Jude, Ruddy said, but in fact St. Jude applies for, and sometimes receives, research grants from St. Baldrick's.
St. Jude is one of a number of deserving charities serving kids with cancer, Ruddy said.
"We have funded about $9.3 million worth of research at St. Jude" since the foundation launched in 2004, Ruddy said. "But we've funded over $300 million at other hospitals. So it tells you that no institution has a monopoly on talent and innovation and ideas."
She said St. Baldrick's fundraising has begun to recover and the charity plans to restore one of its shuttered research grants next fiscal year.
Most Americans know St. Jude Children's Research Hospital through television advertisements featuring Hollywood celebrities asking for contributions or the millions of fundraising appeals that regularly arrive in mailboxes across the country.
But a select group of potential donors is targeted in a more intimate way. Representatives of the hospital's fundraising arm visit their homes; dine with them at local restaurants; send them personal notes and birthday cards; and schedule them for "love calls."
What makes these potential donors so special? They told St. Jude they were considering leaving the hospital a substantial amount in their wills. Once the suggestion was made, specialized fundraisers set a singular goal: build relationships with the donors to make sure the money flows to the hospital after their deaths.
The intense cultivation of these donors is part of a strategy that has helped St. Jude establish what may be the most successful charitable bequest program in the country. In the most recent five-year period of reported financial results, bequests constituted $1.5 billion, or 20%, of the $7.5 billion St. Jude raised in those years. That amount, both in terms of dollars and as a percentage of fundraising, far outpaces that raised by other leading children's hospitals and charities generally.
While a financial boon to St. Jude, the hospital's pursuit has led to fraught disputes with donors' family members and allegations that it goes too far in its quest for bequests.
St. Jude is a major research center with a 73-bed hospital in Memphis, Tennessee, that primarily treats kids from the Mid-South. Its bequest operation has a broad reach, with fundraisers based across the nation and a willingness to challenge families in court over the assets their loved ones leave behind. These battles can sometimes be lengthy and costly, spending donor money on litigation and diminishing inheritances. Family attorneys who specialize in such fights say that St. Jude can be especially aggressive, often pursuing cases all the way to state supreme courts.
"At the end of it, there is very little to hold on to feel good about," said Vance Lanier, of Lafayette, Louisiana, who won a yearslong legal battle with St. Jude over his father's estate but not before both sides spent heavily on the case.
"Think of all the fees for lawyers that didn't go to St. Jude, not one child, not one cancer patient," Lanier said. "Where is the sanity in all this?"
The nonprofit even courts those who aid in estate planning and drawing up wills, sponsoring conferences where attorneys, financial advisers and estate professionals gather. On at least one occasion it offered attendees a chance to win a golf trip.
The prospective donors wooed by St. Jude are often people like Nona Harris: elderly, childless women with substantial wealth. Harris notified the charity in 1996 that she was considering leaving it a bequest. St. Jude spent the next two decades cultivating Harris. An internal database, built to collect information on donors, tracked nearly 100 calls and other contacts between Harris and the charity's fundraisers during that time — an average of almost once every two months. It also noted information Harris shared with fundraisers.
By the time she died in 2015, the charity knew just about everything there was to know about her. It knew about the health problems of her husband, J.D., from the medicines that he took to the heart defibrillator that needed to be replaced. St. Jude knew that J.D.'s mother died when he was 13 and that one of Nona's relatives had a rare tongue cancer. It knew the couple owned a condominium in Tulsa, Oklahoma, and a ranch with cattle and horses in Kansas.
Most importantly, the charity knew the couple planned to leave their nearly $6 million estate to St. Jude. But Nona died before J.D., and after he changed his estate plan — reducing St. Jude's payout by about $2.5 million — the charity went to court, triggering an expensive, drawn-out legal battle that pitted the hospital against several of J.D.'s family members.
Estate matters can be contentious, and many nonprofit organizations, including ProPublica, seek donations in people's wills.
But St. Jude's pursuit of such donations stands out. Bequests to St. Jude, as a percentage of total contributions, are more than double the national average of 9% as calculated by Giving USA.
And it receives more than other children's hospitals that list bequest donations. Boston Children's Hospital reported that estate and trust donations ranged from 3% to 6.5% annually during the three-year period of 2014 through 2016. Donations from estates to Children's Hospital Colorado Foundation represents 3.5% of total giving at that hospital, according to its website. Nationwide Children's Hospital in Columbus, Ohio, said its bequest giving was aligned with national benchmarks such as the 9% figure from Giving USA.
For such organizations, any decision about waging legal fights with family members often comes down to a public relations decision.
"A legal fight could mar the reputation of a charity," said Elizabeth Carter, a law professor at Louisiana State University who specializes in estate planning. "A lot of charities decide it is just not worth it; we don't need that bad press. Occasionally you will see them fighting it, but not often because of the bad PR that comes from it."
In a statement issued through its fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, St. Jude said its bequest program "operates with the highest ethical standards and with bequest program best practices like other large charities."
But it declined to answer specific questions about its bequest program, including how many cases are in litigation, or to respond in detail to questions about individual cases in which it has contested wills.
In 2017, Fred Jones, the ALSAC lawyer who oversees bequest matters, told an Oklahoma court that the charity was involved in more than 100 legal fights over disputed estates. Jones said many of those involved other parties challenging an estate in which St. Jude had an interest, but that it did pursue legal action on its own in some cases. Jones said St. Jude received about 2,000 new bequests in the fiscal year ending June 30, 2017. In a statement, ALSAC said it litigates less than less than 1% of the thousands of estate donations that it receives.
Jones told the court that neither St. Jude nor ALSAC "is in the business of trying cases," in part because such efforts are funded with donations for the treatment of sick children. As a result, Jones said, St. Jude only initiates cases in which due diligence reveals substantial evidence to support a claim. "In effect, we're using donor dollars — which we very carefully protect — in those cases where we believe that there has been a curtailment of the donor's actual intent," he said. Jones did not respond to a request for comment. St. Jude declined to provide further details on the use of donor funds to pay legal costs. In some jurisdictions, courts allow winning parties in a case to seek legal fees from the losing side and legal costs are sometimes reimbursed as part of settlement agreements.
To make the case that estate proceeds should go to St. Jude, the charity sometimes argues that relatives are not entitled to any proceeds from their family's estates.
"Where I think the line is crossed is when they promote the disinheritance of children or families," said Cary Colt Payne, a Las Vegas attorney representing a son who is battling St. Jude over his father's estate.
In its statement, ALSAC said ProPublica's reporting on bequests was "highly selective and flawed as it focused on a small handful of contested cases over several years out of the many types of these donations received each year. These contested estate matters often cover complex and sensitive family matters, include multiple charities, and involve local lawyers advising ALSAC/St. Jude."
St. Jude's responsibility, according to the statement, is "to carry out the clear written intent of a donor, typically stated in a written will or trust drafted by an independent lawyer, most often witnessed and notarized. These are beautiful legacy gifts with enduring impact, enabling us to remain focused on our mission: Finding cures. Saving children."
"Love Calls"
St. Jude, founded by the entertainer Danny Thomas, makes a unique promise as part of its fundraising: "Families never receive a bill from St. Jude for treatment, travel, housing or food — because all a family should worry about is helping their child live."
That pledge, and the ubiquitous appeals for donations that accompany it, has helped St. Jude become the country's largest healthcare charity. Recent years have seen record-breaking fundraising gains. The hospital raises so much money that between 2016 and 2020, it annually steered an average of $400 million into a growing reserve fund that totaled $5.2 billion as of June 30, 2020 — the most recent figures publicly available.
To raise money, St. Jude depends on the related nonprofit ALSAC, which conducts the hospital's fundraising and awareness campaigns.
ALSAC's interactions with Nona Harris provide a window into the techniques used by the charity to encourage bequests and cultivate those who express an interest in making them.
In January 1996, Nona called St. Jude to let the hospital know she was considering making a large bequest, which at that time she said could be up to $500,000.
Phone calls from potential donors like Harris are just one of the ways ALSAC learns of potential bequests. Other times, the hospital is alerted by a financial planner or estate lawyer of plans by clients to leave money to St. Jude. Most times, proceeds from bequests just show up with no prior notice after a person has died. The charity also solicits them in fundraising materials, encouraging anyone open to considering St. Jude in their will to notify it using an enclosed information card and envelope.
Harris, after notifying St. Jude of the potential bequest, then asked that no one contact her. That request was apparently ignored as an ALSAC staffer was tasked with getting in touch with Nona a few months after her call, according to a printout of a computerized log of interactions with Nona filed in court.
ALSAC bequest specialists maintain a "portfolio" of estate donors who are ranked by importance, according to current and former ALSAC employees. The size and range of the ALSAC bequest operation gives it the advantage of being able to meet in person with donors anywhere in the country.
ALSAC sent Nona handwritten birthday and holiday cards, and in one case, just a note to say, "I thought of you today." The cards were often followed by phone calls around the holidays to check in with her.
On four occasions — in 2000, twice in 2001 and in 2005 — Nona was listed for what were described in the log as "love calls." St. Jude declined to provide details on what such calls entailed.
The ALSAC staff invited the Harrises to special events, including a 50th anniversary gala party in Los Angeles, as well as asking them repeatedly to come to Memphis and visit the hospital. "I will be sure to be at the front door waiting for your arrival," a staffer wrote in 2007. Family members do not believe the Harrises ever visited.
One hint in the notes of why Nona chose St. Jude as a beneficiary of her estate was a comment she made in 2004 that she "was thrilled to do it since St. Jude is her patron saint." Although the hospital is named after the saint, it does not have any religious affiliations. J.D. also had a fondness for the children's hospital, according to family members, and would occasionally wear a St. Jude baseball cap sent to the couple by fundraisers.
The Harrises were different from other large bequest donors in one significant way. It doesn't appear anyone from ALSAC ever visited them at their home.
Former ALSAC employees who worked on bequests said they would visit some donors dozens of times. They said some of those were older donors who were lonely and enjoyed the companionship. Internally, the jobs came to be known as "the tea and cookie positions" since that's what many visits to donors involved. One staffer said he became so close to one donor that he attended holiday dinners at the family's home.
An ALSAC employee based in Rhode Island said she would meet in person with 150 to 200 people a year throughout New England and upstate New York who indicated they planned to leave money to St. Jude or were considering it, according to testimony she gave in 2015 in a New Hampshire estate dispute.
The employee, Maureen Mallon, was an estate lawyer in private practice for 20 years before joining ALSAC as a philanthropic adviser in 2010.
"Part of my role is to connect them, to build a relationship with them, to give them more information about the hospital," she said of visiting potential donors.
Mallon testified about her relationship with one donor, whom she visited at her home in person five times, usually for an hour or more. The woman — who was elderly, widowed and did not have children — would have lunch ready for the two of them and always sent Mallon home with baked goods. One time she called to make sure Mallon made it home safely. Mallon said the woman discussed details of her estate and shared family histories and relationships. She confided that certain relatives would be unhappy if they learned she planned to leave her home to the Memphis hospital. The visits and notes about what was discussed were recorded in a database, according to the testimony. Attempts to contact Mallon were unsuccessful.
The Harrises were private people who had retired to their ranch in Kansas following years of traveling the world as part of J.D.'s work in the oil industry. They used their Tulsa condo when they came for medical care in the city.
On the ranch, J.D. would rise early each day to drive the foreman around the 320-acre property to feed the scores of cattle and horses. He typically dressed in blue jeans, black cowboy boots with his initials on them, a cowboy hat and a white oxford shirt with two pockets that he used to carry a small notebook, a pencil and his checkbook.
J.D. was plainspoken and frank, friends recalled, while Nona was described as a generous person who was always impeccably dressed.
After Nona died on the day after Thanksgiving in 2015, J.D. became closer with his remaining family members, including two nieces and a nephew, according to court testimony.
J.D. was particularly fond of his great-nephew Brent Neitzke, who lived in Indiana and visited him at the ranch on a regular basis after Nona's death. Most Sunday nights, J.D. and Neitzke would talk for hours on the phone. Neitzke said they discussed politicians, happenings in the world and J.D.'s travels. He said J.D. also talked about his estate and his plans to split it.
J.D. told his accountant that the estate plan he formed after Nona's death was something of a compromise. He would still be honoring Nona's wish to help St. Jude while at the same time taking care of his family.
When J.D. called ALSAC two months after Nona died to share the news that his wife had passed away, he told the staffer who was the main contact for Nona that he wanted "to talk to me at length about his codicile (sic) to their will," according to court records. A codicil modifies or revokes parts of a will.
Later, the ALSAC staffer tried to set up a meeting with J.D. at his home, but J.D. said that it was too soon for a visit and that he wanted to speak to his attorney first, according to notes of the conversation recorded by ALSAC.
For ALSAC, the next step was the courtroom.
Court Battles
That's where Vance Lanier found himself when St. Jude fought him over the distribution of his father's estate.
Lanier is a financial planner in Lafayette, Louisiana, who helps clients with estate and trust matters. His father, Eugene, died in December 2015. His will directed that $100,000 from the proceeds of the sale of his home go to St. Jude.
But there was a problem. The elder Lanier did not own his home, according to his son. More than a decade earlier he had placed it in a trust, along with other assets, to benefit his three children.
To Lanier, it was a simple matter. St. Jude was not entitled to any money from the house sale. "He had given away his assets to put into a trust," Lanier said. "My dad did not own it. He could have changed that while he was alive, but he didn't."
Still, recognizing that his father did want to make a donation to St. Jude, and hoping to avoid spending money on legal fees, Lanier said he offered St. Jude $25,000 to settle the matter. The offer was rejected, according to Lanier and his attorney, and St. Jude instead pursued the matter in a yearslong court fight. St. Jude argued that the elder Lanier, through his will, "clearly directed the sale" of the property and that $100,000 of the proceeds should go to the hospital.
A trial court ruled in favor of Vance Lanier. St. Jude appealed that ruling but eventually lost. The charity then asked the state Supreme Court to reverse that ruling, but the request was denied, ending the matter.
Lanier said the legal dispute was expensive for both sides. He spent $50,000 in lawyer fees. Even if St. Jude had won the case, he said, much of the money it would have received from the elder Lanier's estate would have been wiped out by legal costs. St. Jude did not respond to questions about how much it paid its lawyers.
Lanier said he wrote to the chief executive of St. Jude complaining that the legal fight was a waste of time and the charity's resources.
Before the estate dispute, Lanier said he and other members of his extended family were supporters of St. Jude and had collectively donated thousands of dollars to the Memphis hospital. That is no longer the case, he said.
"After this and seeing the waste, I don't want anything to do with them," he said.
Influence and Attorneys
One sign of the significance of bequests to St. Jude is that it frequently underwrites conferences for estate lawyers and financial planners, who can help clients determine which charities to leave money to in their wills.
In some cases, it is the only charity involved. Typical sponsors are mostly banks, trust companies and consultancies.
St. Jude has been a top-level diamond sponsor for the past several years of the Heckerling Institute on Estate Planning, an annual conference that typically draws more than 3,000 attendees.
The $30,000 cost of a diamond sponsorship allows St. Jude to bring as many as 10 employees to work at its deluxe suite on the exhibit hall floor. St. Jude also gets a list of all attendees and their emails and expanded networking times with conferencegoers.
At the 2017 conference, St. Jude raffled off a free trip to attend a PGA Tour golf event in Memphis.
The winner, estate and tax adviser Jack Meola, of New Jersey, said that in addition to attending the golf event, he and his wife were taken on a tour of St. Jude. "It's a very emotional experience," he said.
At the Heckerling conference the next year, ALSAC asked him to give a luncheon talk to attendees about St. Jude, Meola said.
He said he shares his experience of visiting the hospital with his clients when they are considering charities as beneficiaries.
"I always talk to clients and give them the example," Meola said. "They may not end up choosing St. Jude, but I give them the emotional side."
St. Jude's relationship with a Las Vegas estate lawyer ensured it learned about a lucrative estate case in time to fight for the bequest all the way to the state Supreme Court, and it raised ethical questions about whether the lawyer had been fully transparent with her client.
The lawyer, Kristin Tyler, drafted a will in October 2012 for Theodore Scheide Jr. that directed his estate go to St. Jude. But after Scheide died in 2014, the original of that will could not be located. A guardian who served as the administrator of Scheide's estate concluded that he destroyed it, rendering it null and void, and determined his money should go to his son.
In 2016, just as a court was on the verge of finalizing the passing of Scheide's $2.6 million estate to his son, Tyler learned of the plans for the money and alerted Jones, the ALSAC attorney. Tyler knew to call Jones because in addition to Scheide she had another client: St. Jude.
Tyler was vague about what prompted her to look into the matter at the last minute, writing in one email at the time that "for some reason I recently thought about Theo Scheide." She was certain, however, that the money should go to St. Jude and not Scheide's son. The two were estranged and Tyler said Scheide was adamant about disinheriting his son.
After calling Jones, Tyler then contacted a partner at a prominent Las Vegas law firm that worked with the charity. In an email, she advised the partner that St. Jude would be reaching out to him and "you need to jump on this quick." She offered to help, writing, "I want to make sure this estate goes 100% to St. Jude and not to Theo's estranged son." She wrote that it would be "a shame" for the money to go to the son.
Tyler later testified that she had represented the hospital in at least two, and perhaps three, estate matters. She testified that she was unsure if she was working for St. Jude at the same time she helped Scheide draft his will. In any event, she said that it wouldn't have been necessary to tell Scheide about her work for St. Jude because the interests of the two parties were not opposed to each other — meaning there was no conflict of interest. St. Jude did not respond to questions about its relationship with Tyler.
Legal experts said the need to disclose the relationship with St. Jude would depend on the nature and extent of Tyler's dealings with the charity. Tyler declined to comment.
A district court judge, after a hearing, ruled that the estate should go to the son as there were not two independent witnesses who could vouch for the existence and substance of the missing original will. St. Jude appealed that decision to the state Supreme Court, which overturned the lower court in 2020 and ruled in favor of the charity. Appeals in the case continue.
Key to the supreme court ruling were affidavits from Tyler and her assistant testifying to the legitimacy of the missing will, saying that they witnessed Scheide sign it and that, to their knowledge, he had not intentionally destroyed or revoked it.
For Scheide's son, Chip, the most painful part of the legal fight with St. Jude was not potentially losing out on his father's estate but the way he was characterized by the charity and years of uncertainty over the potential inheritance. In appealing the case to the state Supreme Court, St. Jude repeatedly referred to Chip as a "disinherited" son and claimed his father had "no interest" in contacting him. He called it "intentionally hurtful."
Chip acknowledges an estrangement from his father but says it was not rooted in anger or a dispute. Instead, Chip said, it was the result of a decision his father made in the wake of his parents' divorce to remarry and move from Pittsburgh to Florida when Chip was 11 or 12. After he moved away, Chip only saw his father a few times.
"He made a choice," Chip said of his father and the distant relationship between the two. Still, he said, the two stayed in touch. They regularly exchanged holiday cards and just a year before he died, Theodore sent Chip a congratulatory card and a check when he married for a second time.
Chip was in Las Vegas about a year before his father died and tried to contact him, without success. Later he learned his father was in the hospital at that time.
Despite the contention of St. Jude that Theodore did not want to contact Chip, Diane Prosser, a case manager for the guardianship service that managed Theodore's affairs, said in an interview with ProPublica that Theodore talked frequently about his son toward the end of his life.
"I know towards the end, he mentioned his son a lot," Prosser said. "I remember saying, should we be looking for his son?" Prosser said she discussed the matter with her boss but doesn't remember any effort by the guardianship service to find Chip before Theodore died on Aug. 17, 2014.
"He Knew Exactly What He Wanted to Do"
J.D. Harris was admitted to the hospital for a heart valve procedure on Dec. 15, 2016, a little over a year after his wife died. During the operation, his kidneys failed, according to court testimony. Doctors told J.D. that if he didn't begin dialysis he would die within days. J.D., who was 92, told the doctors he wasn't interested in the treatment.
By this point, J.D. had not yet made the changes to his estate that he talked about during the previous months. On Dec. 19, he called his longtime accountant, Dwight Kealiher, from the hospital and told him he wanted to rework his trust and will.
Attorney Jerry Zimmerman, a well-known Tulsa estate lawyer, met twice with J.D. at the hospital on Dec. 21. Zimmerman questioned J.D. to make sure he was competent, asking him personal questions and inquiring about his assets. He said in court testimony that J.D. was lucid and accurately recalled details of his estate and his existing trust.
Zimmerman said J.D. told him he wanted to change his estate plan to split it between St. Jude and four family members, including Neitzke. J.D. also wanted $100,000 to go to Jim Tibbets, the foreman of his ranch, whom he considered a friend, Zimmerman testified.
Zimmerman returned to the hospital the next day with the reworked estate documents, but J.D. said he wanted Kealiher to be there to review them and didn't sign. A day later, on Dec. 23, Zimmerman came back with Kealiher, who had just been released from a different hospital.
J.D., however, was in no condition to sign, according to his medical records. A hospital notary said he was "laboring" and might be confused. A nurse, concerned that J.D. was too weak to sign and incoherent, eventually asked everyone to leave the room.
Tibbets slept in J.D.'s room that night and said that J.D. woke up several times asking about the estate documents and requesting that Zimmerman come to the hospital so he could sign them. Tibbets explained it was the middle of the night and that wasn't possible, court records show.
The next day was Christmas Eve and Zimmerman was not available to come to the hospital, court records show. He gave the papers to be signed to Tibbets. Overnight, Tibbets said J.D. again woke up and asked about the estate documents as well as inquiring about the animals on his ranch.
"He was adamant about it," Tibbets said in an interview of J.D.'s desire to finalize his estate plans. "His mind was still sharp right until he passed away."
Tibbets said he put a piece of cardboard underneath the papers and that J.D. meticulously signed each letter of his name, understanding the importance of the moment. When he finished, he told Tibbets he was "glad" it was done. He died later on Christmas Day.
Six months later, St. Jude began the court fight seeking to overturn a district court finding that the restated trust was properly executed and requesting a new trial on the matter.
The hospital said that it didn't receive proper notice of the nature of the district court hearing on J.D.'s estate and that it was unfairly denied a chance to introduce medical records showing that J.D. was often incoherent, comatose or otherwise incapable of decision-making at the times he was asked to sign the reworked estate plan. The charity did not contest that J.D. signed the documents.
"He talked to his lawyer. He talked to his accountant. He talked to his family. He talked to his ranch hand, who was family to him," Tulsa District Court Judge Kurt G. Glassco said in a ruling, which found that J.D.'s reworked estate plan was valid. "And he knew exactly what he wanted to do."
After Glassco denied St. Jude's request for a new trial, the charity then appealed to the state Supreme Court, which delegated the matter to the Court of Civil Appeals.
As the case dragged on, J.D.'s nephew Doug Holmes, who was one of the family members named as a beneficiary in the restated trust, wrote a letter to the St. Jude board of directors.
"The continued unfounded litigation has caused significant pain to family members, as we repeatedly have to relive the final days of our dear uncle," he wrote in December 2018. "With each of St. Jude's legal filings, the attorney fees increase, sapping precious dollars that could go to St. Jude families."
In December 2019, the appeals court upheld the lower court ruling. In 2020, more than three years after J.D.'s death, his family members finally received their shares of his nearly $6 million estate.
Neitzke said his family remains mystified as to why St. Jude challenged the distribution of J.D.'s trust. The charity was still being granted a generous, multimillion-dollar bequest and J.D. even told the charity to expect a change from what Nona had promised before she died, he said.
Neitzke said he had been a supporter of St. Jude, but the litigation had changed his view.
"I thought this was a waste of time and money," he said. "I will never give them another dime."