The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim.
"This is a significant step forward," said Peter Lurie, president and executive director of the Center for Science in the Public Interest and a former FDA associate commissioner. These tests have "always been one of the remaining gaping holes in the FDA regulatory structure. And it's great to see that the agency has taken concrete steps to close it."
The move comes after decades of debate and stalled legislation on LDTs, which also include certain cancer screenings as well as some tests for rare diseases. Because these tests are designed, manufactured and used in a single lab, they escape most federal oversight over marketing and accuracy.
A large coalition of labs, associations and academic medical centers have long pushed back on the prospect of increased FDA involvement in these tests. It would be too onerous, they've argued, and it jeopardizes patient access to health services.
One of nearly 7,000 comments submitted in response to the draft rule came from the Association for Molecular Pathology, representing a wide-ranging group of professionals associated with laboratory testing. The FDA's proposed changes "would result in laboratory professionals being treated as product manufacturers instead of board-certified healthcare providers," the association's president wrote, and it would "unequivocally hinder and harm patient care."
The agency's hands-off approach dates back to an era when these tests were a relatively small, low-risk sector of the health care system. Now, they are a much bigger player and include high-stakes tests made by commercial companies. While the Centers for Medicare and Medicaid Services reviews lab operations, it doesn't check whether the tests themselves are clinically valid. The tests aren't registered with the federal government, so nobody knows how many exist. In 2021, Pew Charitable Trusts estimated that 12,000 labs are likely to deploy them, many of which process thousands a day.
The ProPublica story on prenatal genetic screenings referenced by the FDA revealed how the agency didn't check the tests before they reached patients or evaluate marketing claims made by the companies that sell them. Companies aren't required to publicly report when a test gets it wrong, the investigation found, and no federal agency can recall faulty screenings. The story detailed how false positives, false negatives and indeterminate results can have painful consequences for expecting parents. (We also published a guide to the prenatal tests to help families with their questions.)
Our coronavirus investigation showed how a Chicago-based company with state and local contracts in Nevada sold testing services that were unreliable from the start. As it became clear that the lab was telling infected people that they had tested negative for the virus, company officials nonetheless expanded the reach of the lab's testing. The company declined to comment for ProPublica's previous stories on these problems.
The rule will go into effect over a four-year period. Within two years, test-makers will be expected to meet registration and listing requirements, among others, which is "a critical part of this rule," according to Cara Tenenbaum, a former FDA policy adviser whose consultancy has advocated for more active oversight.
"At least knowing what is out there will be huge," she said in an email.
High-risk tests will need to meet new FDA review requirements before reaching the marketplace starting in November 2027. Moderate-risk and low-risk tests will need to do the same starting in May 2028. It's unclear how prenatal screening tests would be categorized.
The agency generally will not enforce some or all requirements for certain LDTs, including tests that were first marketed before the rule was issued and have not since been modified or have been modified in certain limited ways.
The agency will also generally not enforce some or all requirements for tests used within the Veterans Health Administration or the Department of Defense, as well as certain tests that meet other narrow conditions.
Nonetheless, the rule marks a massive shift in the FDA's approach to a sector that touches millions. "The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work," FDA commissioner Robert Califf said in an agency news release.
The final rule, he added, aims to "help ensure that important health care decisions are made based on test results that patients and health care providers can trust."
The FDA tried to rein in the lab tests a decade ago, issuing a draft guidance in 2014. That prompted a two-year backlash from opponents. The agency ultimately dropped it.
Laurie Menser, chief executive of the Association for Molecular Pathology, said in an emailed statement that the association is "very disappointed" in the new rule.
"It's unfortunate the agency continues to overstep its authority and bypass the country's legislative process," Menser said. "AMP is currently reviewing the different aspects of the rule and assessing the many implications for our members and patient care."
Lurie, who was closely involved with the FDA effort to address the tests a decade ago, said the rule has been a long time coming. "People had identified this problem a very long time ago, and wanted to take action, but found themselves stymied by opposition," he said.
"I think that it shows real courage on the part of the agency, as well as commitment to the public health, to take this step," he added.
Anna.clark@propublica.org is a Detroit-based reporter for ProPublica, covering stories in Michigan and the Midwest. She is the author of "The Poisoned City: Flint's Water and the American Urban Tragedy.
Cigna tracks every minute that its staff doctors spend deciding whether to pay for healthcare. Dr. Debby Day said her bosses cared more about being fast than being right.
This article was published on Monday, April 29, 2024 in ProPublica.
In late 2020, Dr. Debby Day said her bosses at Cigna gave her a stark warning. Work faster, or the company might fire her.
That was a problem for Day because she felt her work was too important to be rushed. She was a medical director for the health insurer, a physician with sweeping power to approve or reject requests to pay for critical care like life-saving drugs or complex surgeries.
She had been working at Cigna for nearly 15 years, reviewing cases that nurses had flagged for denial or were unsure about. At Cigna and other insurers, nurses can greenlight payments, but denials have such serious repercussions for patients that many states require that doctors make the final call. In more recent years, though, Day said that the Cigna nurses' work was getting sloppy. Patient files that nurses working in the Philippines sent to her, she said, increasingly had errors that could lead to wrongful denials if they were not corrected.
Day was, in her own words, persnickety. If a nurse recommended denying coverage for a cancer patient or a sick baby, she wanted to be certain it was the right thing to do. So Day said she researched guidelines, read medical studies and scrutinized patient medical records to come to the best decision. This took time. She was clearing fewer cases than many of her peers.
Some of her colleagues quickly denied requests to keep pace, she said. All a Cigna doctor had to do was cut and paste the denial language that the nurse had prepared and quickly move on to the next case, Day said. This was so common, she and another former medical director said, that people inside Cigna had a term for these kinds of speedy decisions: "click and close."
In late 2020, Dr. Debby Day said her bosses at Cigna gave her a stark warning. Work faster, or the company might fire her.
That was a problem for Day because she felt her work was too important to be rushed. She was a medical director for the health insurer, a physician with sweeping power to approve or reject requests to pay for critical care like life-saving drugs or complex surgeries.
She had been working at Cigna for nearly 15 years, reviewing cases that nurses had flagged for denial or were unsure about. At Cigna and other insurers, nurses can greenlight payments, but denials have such serious repercussions for patients that many states require that doctors make the final call. In more recent years, though, Day said that the Cigna nurses' work was getting sloppy. Patient files that nurses working in the Philippines sent to her, she said, increasingly had errors that could lead to wrongful denials if they were not corrected.
Day was, in her own words, persnickety. If a nurse recommended denying coverage for a cancer patient or a sick baby, she wanted to be certain it was the right thing to do. So Day said she researched guidelines, read medical studies and scrutinized patient medical records to come to the best decision. This took time. She was clearing fewer cases than many of her peers.
Some of her colleagues quickly denied requests to keep pace, she said. All a Cigna doctor had to do was cut and paste the denial language that the nurse had prepared and quickly move on to the next case, Day said. This was so common, she and another former medical director said, that people inside Cigna had a term for these kinds of speedy decisions: "click and close."
"Deny, deny, deny. That's how you hit your numbers," said Day, who worked for Cigna until the late spring of 2022. "If you take a breath or think about any of these cases, you're going to fall behind."
In a written response to questions, Cigna said its medical directors are not allowed to "rubber stamp" a nurse's recommendation for denial. In all cases, the company wrote, it expects its doctors to "perform thorough, objective, independent and accurate reviews in accordance with our coverage policies." The company said it was unaware of the use of the term "click and close" and that "such behavior would not be tolerated."
During Day's final years at Cigna, the company meticulously tracked the output of its medical directors on a monthly dashboard. Cigna shared this spreadsheet with more than 70 of its doctors, allowing them to compare their tally of cases with those of their peers. Day and two other former medical directors said the dashboard sent a message loud and clear: Cigna valued speed. (ProPublica and The Capitol Forum found these other former Cigna doctors independently; Day did not refer them.) One of Day's managers in a written performance evaluation called the spreadsheet the "productivity dashboard."
Measuring the speed and output of employees is common in many industries, from fast food to package delivery, but the use of these kinds of metrics in health care is controversial because the stakes are so high. It's one thing if a rushed server forgets the fries with your burger. It's another entirely if the pressure to act fast leads to wrongful denials of payment for vital care. Walgreens in 2022 dropped measurements of its pharmacists' speed from their performance reviews after some alleged that practice could lead to dangerous mistakes.
ProPublica and The Capitol Forum examined Cigna's productivity dashboards for medical directors from January and February 2022. These spreadsheets tallied the number of cases each medical director handled. Cigna gave each task a "handle time," which the company said was the average amount of time it took its medical directors to issue a decision.
Day and others said the number was something different: the maximum amount of time they should spend on a case. Insurers often require approval in advance for expensive procedures or medicines, a process known as prior authorization. The early 2022 dashboards listed a handle time of four minutes for a prior authorization. The bulk of drug requests were to be decided in two to five minutes. Hospital discharge decisions were supposed to take four and a half minutes.
"Medical directors would message me and say, 'We can't do these cases in four minutes. Not if you want to do a good job,'" Day recalled.
As ProPublica and The Capitol Forum reported last year, Cigna built a computer program that allowed its medical directors to deny certain claims in bulk. The insurer's doctors spent an average of just 1.2 seconds on each of those cases. Cigna at the time said the review system was created to speed up approval of claims for certain routine screenings; the company later posted a rebuttal to the story. A congressional committee and the Department of Labor launched inquiries into this Cigna program. A spokesperson for Rep. Cathy McMorris Rodgers, the chair of the congressional committee, said Rodgers continues to monitor the situation after Cigna shared some details about its process. The Labor Department is still examining such practices.
One figure on Cigna's January and February 2022 dashboards was like a productivity score; the news organizations found that this number reflects the pace at which a medical director clears cases.
Cigna said it was incorrect to call that figure on its dashboard a productivity score and said its "view on productivity is defined by a range of factors beyond elements included in a single spreadsheet." In addition, the company told the news organizations, "The copy of the dashboard that you have is inaccurate and secondary calculations made using its contents may also be inaccurate." The news organizations asked what was inaccurate, but the company wouldn't elaborate.
Nevertheless, Cigna said that because the dashboard created "inadvertent confusion" the company was "reassessing its use."
Day was afraid to look at the dashboards. Anyone could see that by Cigna's measures, she was a laggard. In January 2022, only a third of her peers had lower scores, and in February 2022, it was just a quarter.
In a recorded phone call and in emails with supervisors, Day complained that Cigna's metrics failed to account for the quality of decisions. She said she and others asked higher-ups how often medical director decisions were overturned on appeal but nobody would say.
Day gave Cigna written permission to discuss her employment with ProPublica and The Capitol Forum.
The company described Day as a "disgruntled former employee" and said her "personal view is not an accurate representation of the work of the many medical directors and clinicians we employ." Cigna added that prior authorization requests are often time-sensitive and the company's "mission is to ensure our patients receive the right care as quickly as possible."
Cigna rejected the assertions that denying cases was an effective way of working faster. "Even if medical directors were incentivized to review more claims — which they are not — it makes no sense to suggest that this incentivizes denials; it would be far quicker to approve all claims," the company spokesperson wrote. The insurer said that denials take more time because they require a deeper review of clinical data, potentially requesting additional reviews by senior clinical directors, drafting denial letters and possibly phoning the treating physicians.
But another doctor who had worked at Cigna also said that denying a request for payment was far quicker than approving one since the nurses served up language that could be used to justify the denial. That former Cigna medical director said, "Sometimes you just have to accept the nurse and click and close if you had too much work." (That doctor asked not to be named because they feared repercussions if they commented publicly.)
When Debby Day got her job at Cigna in November 2005, she thought it was a godsend.
She had been working for a health insurance startup in North Carolina. The charismatic founder of the company, Day said, had told her and a handful of principal executives to expect a windfall when the company went public. That never happened, and Day was eventually left with no job and no severance.
When a recruiter mentioned the medical director job at Cigna, it sounded like a perfect fit. The job was based in North Carolina, but Cigna didn't mind that she was licensed in California, where she did her residency at Harbor-UCLA Medical Center. She was ready to leave the executive track, and the position allowed her to put her medical training to good use without the daily grind of working in a clinic.
The daughter of an ophthalmologist, Day had watched her father perform eye surgery when she was a child, and she found medicine fascinating. When Day started practicing, she learned quickly that while she enjoyed the intellectual challenges of medicine, the hands-on work of seeing patients drained her. As a medical director, she said, "I could really take care of patients without having to talk to them all day long."
Cigna, like all health insurers, makes patients get approval in advance for certain treatments. Day became one of the people who reviewed these prior authorization requests, deciding what to cover and what to deny. Everyone Day worked with was under one roof in Raleigh, North Carolina. The office buzzed with conversations among colleagues, and she was able to consult with specialists on complex cases.
She never felt pressure to do anything but make the right decision for the patient. At the same time, she said, she didn't hesitate to reject treatment she thought was improper.
Day describes herself as persnickety but feels that the time she spent reviewing case files was essential to reaching the right decision. Credit:Andrea Bruce for ProPublica
A couple years into her time at Cigna, Day noticed some doctors prescribing a costly treatment called intravenous immunoglobulin, or IVIG, that helps patients with weakened immune systems fight off infections. Only she found they were prescribing it in cases where it didn't make any medical sense. That wasn't good for patients or for Cigna. "Some of these guys were pouring it into every patient they could get their hands on and then making hundreds of thousands of dollars billing for it," she recalled.
At the time, Cigna didn't have a policy for when IVIG should be used, so Day developed one based on the scientific evidence available at the time. Day said this saved millions of dollars and that Cigna rewarded her with bonuses and stock options.
"In my head I truly believed that you could marry good health care with business," she said.
As Day neared the end of her first decade at Cigna, the company closed regional offices in favor of a nationwide review system, she said. With medical directors working from home, Day could no longer pop down the hallway to consult with doctors in other specialities.
Cigna had used a productivity dashboard for years, but by 2019, these metrics began playing a more prominent role in the company's evaluations of medical directors, Day said. Now, making a fast decision seemed more important than making the right decision, she said. In February 2019 emails to her managers, Day openly questioned this system.
Her boss responded: "We all understand that many cases are involved and take more time," he wrote. "We have tried to account for that additional time in the allotment allowed for certain cases."
Still, he made it clear that transaction volume — the metric on the dashboard that was similar to a productivity score — was one of the factors "we use to determine merit raises, bonus" and stock awards. When asked about this, Cigna said that "any assertion that our Medical Directors' compensation (cash or stock) is tied to denials or their handle time for cases is false."
In that same 2019 email, Day's boss added, "We want to assist every medical director who wishes to improve his or her efficiency."
Day shot back, "Some of our newer MDs are quite terrified of the 'counting,'" she wrote. "All ask — 'how is quality measured?'"
Soon, Day realized that her boss wasn't talking in the abstract about improving efficiency; he was talking about her. She learned that managers were going to help her pick up the pace of her reviews.
When bosses reached out, they didn't discuss whether she was making the right call, only how long it took her to decide, she said.
By then, Day said, Cigna had shifted much of the nursing work to the Philippines. She found mistakes in the case files that these nurses sent. In an email to Day, a fellow medical director lamented the amount of time it took to untangle one case and said the reports by "the overseas nurses" were "messes."
Some of the more astonishing problems that Day spotted have stayed with her. In a case involving a newborn who needed an epilepsy evaluation, Day noticed that a Cigna nurse had listed the mother's name as the patient, rather than the baby's. Day fixed that mistake, avoiding what certainly would have been a denial. In another case, a nurse recommended denying payment for an ultrasound of the neck because the treatment wasn't medically necessary. But the nurse had gotten the body part wrong. It was a hip that was injured, and the imaging was needed. An appeal that landed on Day's desk involved Cigna's decision to reject payment for a test because it wasn't medically necessary for a patient with a sexually transmitted disease. But Day figured out that the patient had toenail fungus, not an STD.
Day said her bosses didn't want to hear that she was catching errors. By October 2020, Cigna had placed Day on a performance improvement plan that required her to raise her "productivity level" — referring to the score on the dashboard — to at least 70%, which would be a significant jump for her but was slightly below the median for medical directors. The company made the consequences crystal clear: If she failed to successfully complete the plan, she could be terminated.
ProPublica and The Capitol Forum asked Cigna how it calculated that score, but the company wouldn't say. "Transaction volume helps gauge productivity and efficiency — the amount of work done, not the speed at which it is done," a Cigna spokesperson wrote. The company said this metric measured the time a medical director spent on tasks involving medical judgment versus other work, such as internal meetings or training.
On the early 2022 productivity dashboard, though, a different calculation could explain Day's score, and this math reflects how fast medical directors reviewed cases. ProPublica and The Capitol Forum multiplied the number of cases Day handled by the time Cigna allotted for each type of case, then divided that total by the hours she worked that month. The resulting percentage equaled her score. Medical directors who spent every available minute of their workdays clearing cases within the time constraints Cigna set would score at least 100%. Indeed, some medical directors had scores greater than 100%, meaning they cleared cases in even less than the allotted time. The newsrooms' formula accurately reproduced the scores of 87% of the Cigna doctors listed; the scores of all but one of the rest fell within 1 to 2 percentage points of the number generated by this formula. When asked about this formula, Cigna said it may be inaccurate but didn't elaborate.
Day said her bosses told her that the way to boost her score was to review more cases during her normal work hours.
Responding to questions, Cigna said the productivity dashboard was "primarily used to ensure that we have enough medical directors to perform the amount and type of work that needs to be done." It is not used, the company said, to evaluate the performance of medical directors or track the speed at which individual doctors do their work.
Cigna, however, later said of the dashboard that "in the unusual situation that a medical director is a significant outlier to peers performing similar types of reviews, managers might use this metric as one data point to understand and discuss the variance with the medical director." It also said Day was placed on a performance improvement plan "to help her meet the most basic standards to support patient care."
During the time Day spent on the performance improvement plan, she refused to change her approach, which she felt was necessary to make the right call.
In December 2020, she appealed to the human resources department, figuring that colleagues there would see that it was wrong to fire a medical director for taking care to decide critical medical questions.
She was wrong.
"You feel that the time constraints/metrics, which are in place to review these cases are unreasonable, for some cases are very complex consisting of multiple pages to review," a Cigna human resources employee wrote, summing up Day's feelings as the matter escalated.
And while Day's supervisor "appreciates your attention to detail," the human resources employee wrote, he "also realizes that there are metrics in place that he must hold everyone to."
When asked about this, Cigna said, "Dr. Day raised questions about her performance improvement plan through appropriate internal ethics channels available to all employees, and there was no wrongdoing found."
Eventually, the daily stress of being pushed to work faster coupled with the threat of being fired took a toll on Day. Sleepless and fighting depression, Day was at the breaking point.
"I actually sort of had a mental breakdown," she recalled.
On a recorded call with her boss about her lagging productivity score, Day brought the subject back to the quality of the decisions she was making. Her boss made it sound like Day was a broken record.
"We have the same discussion every time we talk," he said. While saying "nobody's asking you not to do quality work," her boss said, "you must know I just have to redirect our discussion."
But Day continued: "When there is no measurement of quality, then the discussion will continue to have that element to it."
The supervisor said he heard Day's concerns "loud and clear" but warned that "at the end of the day, we need to get your productivity up and we don't have a lot of time to do that."
The focus on metrics was proof Cigna was losing its way, Day told her boss. When she started working at Cigna 15 years earlier, there was a "commitment to quality and taking care of our customers." Day said that it was still important to her and other medical directors that "we go home at the end of the day and think we've done a good job for Cigna."
How Cigna Saves Millions by Having Its Doctors Reject Claims Without Reading Them
In a response to questions, Cigna said the supervisor, who works in California, was unaware that he was being recorded and that under that state's laws, it is illegal to record a private phone call without all parties' consent. Day said that she was in North Carolina during the call and that North Carolina law allows a person on a call to record without getting the consent of others.
Day took a monthslong leave from the job in mid-2021 that allowed her to work part time, and she found a therapist who helped her manage the depression. When she returned, Day said, it was more of the same.
In the late spring of 2022 she decided to retire from Cigna.
In a written response to questions, Cigna said its medical directors are not allowed to "rubber stamp" a nurse's recommendation for denial. In all cases, the company wrote, it expects its doctors to "perform thorough, objective, independent and accurate reviews in accordance with our coverage policies." The company said it was unaware of the use of the term "click and close" and that "such behavior would not be tolerated."
During Day's final years at Cigna, the company meticulously tracked the output of its medical directors on a monthly dashboard. Cigna shared this spreadsheet with more than 70 of its doctors, allowing them to compare their tally of cases with those of their peers. Day and two other former medical directors said the dashboard sent a message loud and clear: Cigna valued speed. (ProPublica and The Capitol Forum found these other former Cigna doctors independently; Day did not refer them.) One of Day's managers in a written performance evaluation called the spreadsheet the "productivity dashboard."
Measuring the speed and output of employees is common in many industries, from fast food to package delivery, but the use of these kinds of metrics in health care is controversial because the stakes are so high. It's one thing if a rushed server forgets the fries with your burger. It's another entirely if the pressure to act fast leads to wrongful denials of payment for vital care. Walgreens in 2022 dropped measurements of its pharmacists' speed from their performance reviews after some alleged that practice could lead to dangerous mistakes.
ProPublica and The Capitol Forum examined Cigna's productivity dashboards for medical directors from January and February 2022. These spreadsheets tallied the number of cases each medical director handled. Cigna gave each task a "handle time," which the company said was the average amount of time it took its medical directors to issue a decision.
Day and others said the number was something different: the maximum amount of time they should spend on a case. Insurers often require approval in advance for expensive procedures or medicines, a process known as prior authorization. The early 2022 dashboards listed a handle time of four minutes for a prior authorization. The bulk of drug requests were to be decided in two to five minutes. Hospital discharge decisions were supposed to take four and a half minutes.
As ProPublica and The Capitol Forum reported last year, Cigna built a computer program that allowed its medical directors to deny certain claims in bulk. The insurer's doctors spent an average of just 1.2 seconds on each of those cases. Cigna at the time said the review system was created to speed up approval of claims for certain routine screenings; the company later posted a rebuttal to the story. A congressional committee and the Department of Labor launched inquiries into this Cigna program. A spokesperson for Rep. Cathy McMorris Rodgers, the chair of the congressional committee, said Rodgers continues to monitor the situation after Cigna shared some details about its process. The Labor Department is still examining such practices.
One figure on Cigna's January and February 2022 dashboards was like a productivity score; the news organizations found that this number reflects the pace at which a medical director clears cases.
Cigna said it was incorrect to call that figure on its dashboard a productivity score and said its "view on productivity is defined by a range of factors beyond elements included in a single spreadsheet." In addition, the company told the news organizations, "The copy of the dashboard that you have is inaccurate and secondary calculations made using its contents may also be inaccurate." The news organizations asked what was inaccurate, but the company wouldn't elaborate.
Nevertheless, Cigna said that because the dashboard created "inadvertent confusion" the company was "reassessing its use."
Day was afraid to look at the dashboards. Anyone could see that by Cigna's measures, she was a laggard. In January 2022, only a third of her peers had lower scores, and in February 2022, it was just a quarter.
In a recorded phone call and in emails with supervisors, Day complained that Cigna's metrics failed to account for the quality of decisions. She said she and others asked higher-ups how often medical director decisions were overturned on appeal but nobody would say.
Day gave Cigna written permission to discuss her employment with ProPublica and The Capitol Forum.
The company described Day as a "disgruntled former employee" and said her "personal view is not an accurate representation of the work of the many medical directors and clinicians we employ." Cigna added that prior authorization requests are often time-sensitive and the company's "mission is to ensure our patients receive the right care as quickly as possible."
Cigna rejected the assertions that denying cases was an effective way of working faster. "Even if medical directors were incentivized to review more claims — which they are not — it makes no sense to suggest that this incentivizes denials; it would be far quicker to approve all claims," the company spokesperson wrote. The insurer said that denials take more time because they require a deeper review of clinical data, potentially requesting additional reviews by senior clinical directors, drafting denial letters and possibly phoning the treating physicians.
But another doctor who had worked at Cigna also said that denying a request for payment was far quicker than approving one since the nurses served up language that could be used to justify the denial. That former Cigna medical director said, "Sometimes you just have to accept the nurse and click and close if you had too much work." (That doctor asked not to be named because they feared repercussions if they commented publicly.)
When Debby Day got her job at Cigna in November 2005, she thought it was a godsend.
She had been working for a health insurance startup in North Carolina. The charismatic founder of the company, Day said, had told her and a handful of principal executives to expect a windfall when the company went public. That never happened, and Day was eventually left with no job and no severance.
When a recruiter mentioned the medical director job at Cigna, it sounded like a perfect fit. The job was based in North Carolina, but Cigna didn't mind that she was licensed in California, where she did her residency at Harbor-UCLA Medical Center. She was ready to leave the executive track, and the position allowed her to put her medical training to good use without the daily grind of working in a clinic.
The daughter of an ophthalmologist, Day had watched her father perform eye surgery when she was a child, and she found medicine fascinating. When Day started practicing, she learned quickly that while she enjoyed the intellectual challenges of medicine, the hands-on work of seeing patients drained her. As a medical director, she said, "I could really take care of patients without having to talk to them all day long."
Cigna, like all health insurers, makes patients get approval in advance for certain treatments. Day became one of the people who reviewed these prior authorization requests, deciding what to cover and what to deny. Everyone Day worked with was under one roof in Raleigh, North Carolina. The office buzzed with conversations among colleagues, and she was able to consult with specialists on complex cases.
She never felt pressure to do anything but make the right decision for the patient. At the same time, she said, she didn't hesitate to reject treatment she thought was improper.
A couple years into her time at Cigna, Day noticed some doctors prescribing a costly treatment called intravenous immunoglobulin, or IVIG, that helps patients with weakened immune systems fight off infections. Only she found they were prescribing it in cases where it didn't make any medical sense. That wasn't good for patients or for Cigna. "Some of these guys were pouring it into every patient they could get their hands on and then making hundreds of thousands of dollars billing for it," she recalled.
At the time, Cigna didn't have a policy for when IVIG should be used, so Day developed one based on the scientific evidence available at the time. Day said this saved millions of dollars and that Cigna rewarded her with bonuses and stock options.
"In my head I truly believed that you could marry good health care with business," she said.
As Day neared the end of her first decade at Cigna, the company closed regional offices in favor of a nationwide review system, she said. With medical directors working from home, Day could no longer pop down the hallway to consult with doctors in other specialities.
Cigna had used a productivity dashboard for years, but by 2019, these metrics began playing a more prominent role in the company's evaluations of medical directors, Day said. Now, making a fast decision seemed more important than making the right decision, she said. In February 2019 emails to her managers, Day openly questioned this system.
Her boss responded: "We all understand that many cases are involved and take more time," he wrote. "We have tried to account for that additional time in the allotment allowed for certain cases."
Still, he made it clear that transaction volume — the metric on the dashboard that was similar to a productivity score — was one of the factors "we use to determine merit raises, bonus" and stock awards. When asked about this, Cigna said that "any assertion that our Medical Directors' compensation (cash or stock) is tied to denials or their handle time for cases is false."
In that same 2019 email, Day's boss added, "We want to assist every medical director who wishes to improve his or her efficiency."
Day shot back, "Some of our newer MDs are quite terrified of the 'counting,'" she wrote. "All ask — 'how is quality measured?'"
Soon, Day realized that her boss wasn't talking in the abstract about improving efficiency; he was talking about her. She learned that managers were going to help her pick up the pace of her reviews.
When bosses reached out, they didn't discuss whether she was making the right call, only how long it took her to decide, she said.
By then, Day said, Cigna had shifted much of the nursing work to the Philippines. She found mistakes in the case files that these nurses sent. In an email to Day, a fellow medical director lamented the amount of time it took to untangle one case and said the reports by "the overseas nurses" were "messes."
Some of the more astonishing problems that Day spotted have stayed with her. In a case involving a newborn who needed an epilepsy evaluation, Day noticed that a Cigna nurse had listed the mother's name as the patient, rather than the baby's. Day fixed that mistake, avoiding what certainly would have been a denial. In another case, a nurse recommended denying payment for an ultrasound of the neck because the treatment wasn't medically necessary. But the nurse had gotten the body part wrong. It was a hip that was injured, and the imaging was needed. An appeal that landed on Day's desk involved Cigna's decision to reject payment for a test because it wasn't medically necessary for a patient with a sexually transmitted disease. But Day figured out that the patient had toenail fungus, not an STD.
Day said her bosses didn't want to hear that she was catching errors. By October 2020, Cigna had placed Day on a performance improvement plan that required her to raise her "productivity level" — referring to the score on the dashboard — to at least 70%, which would be a significant jump for her but was slightly below the median for medical directors. The company made the consequences crystal clear: If she failed to successfully complete the plan, she could be terminated.
ProPublica and The Capitol Forum asked Cigna how it calculated that score, but the company wouldn't say. "Transaction volume helps gauge productivity and efficiency — the amount of work done, not the speed at which it is done," a Cigna spokesperson wrote. The company said this metric measured the time a medical director spent on tasks involving medical judgment versus other work, such as internal meetings or training.
On the early 2022 productivity dashboard, though, a different calculation could explain Day's score, and this math reflects how fast medical directors reviewed cases. ProPublica and The Capitol Forum multiplied the number of cases Day handled by the time Cigna allotted for each type of case, then divided that total by the hours she worked that month. The resulting percentage equaled her score. Medical directors who spent every available minute of their workdays clearing cases within the time constraints Cigna set would score at least 100%. Indeed, some medical directors had scores greater than 100%, meaning they cleared cases in even less than the allotted time. The newsrooms' formula accurately reproduced the scores of 87% of the Cigna doctors listed; the scores of all but one of the rest fell within 1 to 2 percentage points of the number generated by this formula. When asked about this formula, Cigna said it may be inaccurate but didn't elaborate.
Day said her bosses told her that the way to boost her score was to review more cases during her normal work hours.
Responding to questions, Cigna said the productivity dashboard was "primarily used to ensure that we have enough medical directors to perform the amount and type of work that needs to be done." It is not used, the company said, to evaluate the performance of medical directors or track the speed at which individual doctors do their work.
Cigna, however, later said of the dashboard that "in the unusual situation that a medical director is a significant outlier to peers performing similar types of reviews, managers might use this metric as one data point to understand and discuss the variance with the medical director." It also said Day was placed on a performance improvement plan "to help her meet the most basic standards to support patient care."
During the time Day spent on the performance improvement plan, she refused to change her approach, which she felt was necessary to make the right call.
In December 2020, she appealed to the human resources department, figuring that colleagues there would see that it was wrong to fire a medical director for taking care to decide critical medical questions.
She was wrong.
"You feel that the time constraints/metrics, which are in place to review these cases are unreasonable, for some cases are very complex consisting of multiple pages to review," a Cigna human resources employee wrote, summing up Day's feelings as the matter escalated.
And while Day's supervisor "appreciates your attention to detail," the human resources employee wrote, he "also realizes that there are metrics in place that he must hold everyone to."
When asked about this, Cigna said, "Dr. Day raised questions about her performance improvement plan through appropriate internal ethics channels available to all employees, and there was no wrongdoing found."
Eventually, the daily stress of being pushed to work faster coupled with the threat of being fired took a toll on Day. Sleepless and fighting depression, Day was at the breaking point.
"I actually sort of had a mental breakdown," she recalled.
On a recorded call with her boss about her lagging productivity score, Day brought the subject back to the quality of the decisions she was making. Her boss made it sound like Day was a broken record.
"We have the same discussion every time we talk," he said. While saying "nobody's asking you not to do quality work," her boss said, "you must know I just have to redirect our discussion."
But Day continued: "When there is no measurement of quality, then the discussion will continue to have that element to it."
The supervisor said he heard Day's concerns "loud and clear" but warned that "at the end of the day, we need to get your productivity up and we don't have a lot of time to do that."
The focus on metrics was proof Cigna was losing its way, Day told her boss. When she started working at Cigna 15 years earlier, there was a "commitment to quality and taking care of our customers." Day said that it was still important to her and other medical directors that "we go home at the end of the day and think we've done a good job for Cigna."
In a response to questions, Cigna said the supervisor, who works in California, was unaware that he was being recorded and that under that state's laws, it is illegal to record a private phone call without all parties' consent. Day said that she was in North Carolina during the call and that North Carolina law allows a person on a call to record without getting the consent of others.
Day took a monthslong leave from the job in mid-2021 that allowed her to work part time, and she found a therapist who helped her manage the depression. When she returned, Day said, it was more of the same.
In the late spring of 2022 she decided to retire from Cigna.
In January, the Biden administration pledged to increase public access to a wide array of Medicare information to improve health care for America's most sick and vulnerable.
Some Medicare plans' lack of transparency "deprives researchers and doctors of critical data to evaluate problems and trends in patient care," said Xavier Becerra, the secretary of health and human services, in a statement.
So researchers across the country were flummoxed this week when the Centers for Medicare and Medicaid Services announced a proposal that will increase fees and diminish access to claims data that has informed thousands of health care studies and influenced major public health reforms.
More than 300 academics — a who's who of health economics researchers — have already signed a draft letter decrying the "catastrophic impact" the new proposal would have on health care research. Nearly half of all Americans are covered by Medicare, Medicaid and the Children's Health Insurance Program. Medicare and Medicaid claims contain detailed information about payments for medical care, including diagnoses, treatments and patient demographics.
The CMS data "is a national resource," said Anirban Basu, a professor of health economics at the University of Washington. "It's used for research that helps to develop public policy, that helps in health equality, that plays a role in legislation. Most importantly, such research translates to better health and access for the 160 million CMS beneficiaries."
CMS explained that the changes were aimed at better protecting people's health care records, citing "an increase in data breaches across the healthcare ecosystem." In its announcement, the agency did not cite any examples of unauthorized releases of information involving research organizations or universities. However, last year, hackers stole the personal medical information of more than 600,000 Medicare beneficiaries from a CMS contractor.
"Expanding user-friendly, secure access to CMS data continues to be a priority for the agency," said Jonathan Blum, the principal deputy administrator and chief operating officer of CMS, in a statement. He added that the agency "will carefully consider how to best meet stakeholders' data needs while protecting beneficiary data."
Under the current system, academics are able to request claims data for a one-time fee of as little as $20,000 — a price that can increase depending on the amount of information requested. The data is stored on university computers that meet data protection requirements and that allow access to multiple users for a small additional charge.
Researchers have used such data to conduct studies that influenced numerous public health care initiatives, including the development and evaluation of the Obamacare program. Just last month, Basu published a paper, using information from the CMS programs, that analyzed the cost-effectiveness of gene therapy treatment for sickle cell disease, a blood disorder that primarily affects people of African descent.
Researchers have also used the data to discover potential abuse and fraud in Medicare and Medicaid — the two programs together account for more than $1.7 trillion in government spending.
The new proposal, however, would force researchers to use a CMS-controlled computer platform to analyze data, instead of distributing it directly to universities and other institutions. Costs would start at an estimated $35,000 and would allow access to only one researcher and require annual renewal fees. Blum noted that researchers, however, would no longer have to bear the costs of storing and securing the data.
Research teams on complex projects can include dozens of people and take years to complete. "The costs will grow exponentially and make access infeasible except for the very best resourced organizations," said Joshua Gottlieb, a professor at the University of Chicago's Harris School of Public Policy. He has used the data to show that when Medicare increases its fees, private insurance companies follow by hiking their own.
One of the major concerns is that higher prices will shut down research by Ph.D. students and junior faculty, whose budgets typically wouldn't cover a single user fee. "Some important research would be reduced" if the proposal is implemented, Basu said.
Some researchers are also concerned about having to use a government-controlled system to conduct research that may be critical of CMS. Medicare Advantage — a program that allows private insurance companies to pay for health care services for the elderly — has come under increasing scrutiny for rising costs.
Another unanswered question is how the CMS computer platform would accommodate additional requests from the thousands of researchers who now use data stored on their own computers. Academics often perform complex statistical analyses on data that require extensive computer time to process.
"It seems crazy to me that given the value of human life and what we spend on healthcare as a country, that the administration would take a step to make research harder not easier," said Zack Cooper, a professor of public health and economics at Yale.
Do You Have Insights Into Dental and Health Insurance Denials? Help Us Report on the System.
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.
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn't account for the impact of long-term harm from tainted devices.
This article was published on Friday, February 9, 2024 in ProPublica.
Philips Respironics received thousands of complaints about a dangerous defect in its breathing machines but kept them secret for years as stock prices soared. The devices, including the popular DreamStation for sleep apnea, went to children, the elderly and veterans before the global giant announced a massive recall.
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In the winter of 2021, with its stock price plunging, lawsuits mounting and popular breathing machines pulled from the shelves, Philips Respironics made a surprise public announcement.
The company said the sleep apnea devices it had recalled only months earlier had undergone new safety tests and did not appear to pose a health threat to the millions of patients who relied on them to breathe.
It was a remarkable reversal for the global manufacturer, which had drawn headlines after admitting that an industrial foam placed inside the devices could break apart in heat and humidity and send potentially toxic and carcinogenic particles and fumes into the masks worn by users.
The new results, Philips said, found the machines were not expected to "result in long-term health consequences."
But a series of emails obtained by ProPublica and the Pittsburgh Post-Gazette show the Food and Drug Administration quickly rejected those safety claims, telling Philips that the new tests failed to account for the impact on patients who had used the devices for years. The FDA also said it still considered the machines a significant health threat that could inflict severe injury or even death.
"These tests are preliminary," the agency told Philips. "Definitive conclusions cannot yet be drawn in support of reduction in hazards."
The FDA did not publicize its assessment, even though patients across the country were at risk and an untold number continued using their recalled machines while they waited on Philips to send replacements.
At the time, the FDA made only one public reference to the dispute — on the fourth page of a 14-page letter to Philips in May 2022. To see it, customers would have had to find it on the agency's website and then wade through scientific language about "cytotoxicity failure," "novel continuous sampling" and other complex concepts.
Philips went on to publicize more test results, all playing down the potential health dangers. To this day, the FDA has said little about its ongoing disagreement with the company over whether the machines were safe.
The emails over the course of 2022 were obtained by ProPublica and the Post-Gazette through a public records lawsuit filed by the news organizations against the FDA. Taken together, the exchanges reveal a startling lack of transparency by both Philips and the government while patients and their doctors struggled to make sense of one of the largest and most tumultuous medical device recalls in years.
"The bottom line is that lives were at risk," said Dr. Bob Lowe, a former emergency room physician and public health advocate in Oregon who used one of the recalled machines. "People have a right to know and providers have a right, or really an obligation, to be fully informed. As a physician, if I don't know what the dangers are, then I can't protect my patients."
In the emails to Philips, the FDA described a litany of concerns, notably that the company's analysis did not consider the "real world" use of the devices, which send air directly into the noses, mouths and lungs of patients for hours at a time.
Philips had brought on independent testing labs to assess whether the chemicals and particles released into the masks of patients reached dangerous levels, but the government in its emails said the testing program was "limited in its utility and does not fully assess or account for all risks."
"FDA has not accepted the data or Philips Respironics' conclusions," Denise Hampton, with the FDA's Office of Health Technology, wrote to the company in one of the emails.
It wasn't until October 2023 — nearly two years after Philips started promoting the favorable test results — that the FDA released a public statement about its concerns, saying that testing and analysis were not "adequate" and that Philips had agreed to conduct additional studies.
Richard Callender, a former mayor in Pennsylvania who used his sleep apnea machine for six months after the recall, said patients should have been given details far earlier.
"We deserve that. If they had concerns they should have at least informed the public," he said. "Don't let everybody walk around saying, ‘Hey, I'm OK because [Philips] told me they think it's all right.'"
The FDA defended its handling of the matter, saying it released the statement in October after completing an analysis of the company's test results. "Any health determination made by the FDA is science-driven and based on thorough analysis of the information presented to the agency," it said.
The agency said it "has been clear" about the government's concerns with the foam in public alerts and other communications and has maintained its position about the potential health risks.
Lowe, however, said the FDA waited far too long to publicly challenge Philips as the company repeatedly told patients that the devices were safe.
"It's not full disclosure," he said.
Philips did not respond to specific questions from ProPublica and the Post-Gazette, but it has previously said that the tests found the foam caused no "appreciable harm" to patients and that the company would continue to carry out additional tests.
In its emails to the FDA, Philips said that the favorable findings were based on the "worst-case chemical release" and that testing had found particles from the foam did not exceed safety levels.
While Philips continues to defend the safety of the devices, the company late last month announced it would not sell any new sleep apnea machines and other respiratory devices in the United States under an agreement with the federal government.
Days later, the FDA said it had received 561 reports of deaths associated with the machines since 2021.
From the outset of the recall, there was little debate that Philips had a serious problem: Noise-reducing foam that the company had fitted inside the devices years earlier was crumbling.
Both Philips and the FDA at the time described potential health risks for patients exposed to the material, including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects.
Philips, however, began to walk back its warnings in December 2021, six months after the recall began. And by the following year, the company made multiple announcements about the new test results.
In email exchanges, the FDA challenged the "significant limitations" of the company's testing program as well as efforts to change an earlier evaluation of the health risks conducted by about a dozen company officials. The 2021 internal assessment was damning, describing the deteriorating foam and dangerous chemicals and declaring the risk to patients who used the machines "unacceptable."
Months later, Philips turned in a modified evaluation to the FDA, lowering the threat level from "crucial" to "marginal."
Inside Philips, scientists and others were also alarmed, criticizing the company for minimizing the health risks without carrying out comprehensive testing to determine whether the machines could inflict serious harm, according to interviews and internal communications obtained by ProPublica and the Post-Gazette.
The dispute reached the company's highest levels. Medical director Hisham Elzayat broke ranks and refused to sign the evaluation that downgraded the risk level, according to court testimony and the internal communications.
"I haven't seen or heard anything that makes me decide acceptable risk," he wrote at the time.
In another message, he noted about the evaluation, "There is nothing I can do about it."
He also wrote, "If only all this effort is steered towards fixing the problem instead of hiding it."
Elzayat, a cardiothoracic surgeon who still works for Philips and whose differences with the company were described in a federal court hearing in October, declined to comment.
According to the court testimony, after Elzayat refused to endorse the new evaluation, he was removed from the team inside Philips that was handling the crisis and stripped of his access to data about the foam.
Another company supervisor also raised concerns, complaining about the company's push to change the evaluation, internal communications show.
"They desperately want to make changes," the supervisor wrote. "I am trying to limit what they are doing."
ProPublica and the Post-Gazette are withholding the supervisor's name because of fear of reprisals.
Another official at Philips cited similar concerns, writing about the actions by a company manager to ensure that a testing lab reported favorable results. "You wouldn't believe the magic he worked to ensure that compound was labeled a non-risk," the official wrote.
The debate was captured in internal communications, some of which have been turned over to the Department of Justice. The DOJ has been carrying out a criminal investigation, according to sources familiar with the probe and a document reviewed by the news organizations.
Philips, which has said it is cooperating with authorities, declined to answer questions about Elzayat's role in the controversial evaluation of the foam.
ProPublica and the Post-Gazette have reported that the company held back more than 3,700 complaints about the foam degradation from customers and the government before announcing the recall. The news organizations recently obtained more records from the FDA that identified an additional 1,100 complaints that Philips did not turn over to the government before the recall.
Federal law requires medical device makers to submit reports about malfunctions, patient injuries and deaths to the FDA within 30 days. Philips has said the company reviewed the complaints on a case-by-case basis and gave them to the FDA after the recall out of an "abundance of caution."
The private debate about whether the machines were safe played out as hundreds of thousands of people were left to decide whether to continue using their recalled devices while waiting for a replacement from Philips. Many reached out to members of Congress, who forwarded a series of complaints to the FDA, records show.
"Having to choose whether to continue using a life-saving device and risk further health complications or to stop using them altogether and risk death is an unthinkable decision to make," Rep. Brian Fitzpatrick, R-Pa., wrote to the agency in 2022. "It is imperative that patients and healthcare providers have the best guidance."
The back-and-forth between federal regulators and Philips also unfolded as longtime users of the devices and their relatives stepped forward to report illnesses, including throat, lung, esophageal and nasal cancers. Some described deaths of wives, husbands and other family members.
ProPublica and the Post-Gazette previously identified reports that described nearly 2,000 cases of cancer, 600 liver and kidney illnesses, and 17,000 respiratory ailments.
Medical experts interviewed by ProPublica and the Post-Gazette say that it may take years to determine the health consequences but that early findings are worrisome. The devices tested positive numerous times for genotoxicity, the ability of a chemical to cause cells to mutate, a process that can lead to cancer, company records show.
The biggest challenge, they said, is conducting more comprehensive testing, including an epidemiological analysis that tracks the health of people who used the machines over years.
"You would want more than lab tests to really confirm that these devices are safe," said Kushal Kadakia, a public health researcher at Harvard Medical School who has written about the recall. "You'd want data from patients over multiple years."
Mike Wereschagin of the Pittsburgh Post-Gazette contributed reporting.
The agency has rolled out sweeping changes to target end-of-life care providers that were billing for unneeded services, but some fraud hot spots continue to evade scrutiny.
This article was published on Thursday, January 25, 2024 in ProPublica.
The year 2023 was a banner one for hospice reform. Spurred by media reports, letters from Congress and pressure from lobbying groups, the Centers for Medicare and Medicaid Services increased oversight of end-of-life care. It retooled inspections to focus on quality of care. It made ownership data public for the first time. And, kicking off a plan to visit every hospice provider in the country, its staff made appearances at 7000 sites. Following the tour, the Medicare billing privileges for 46 nonoperational hospices were revoked.
In July, the agency also rolled out a special enforcement program to target hospices in Arizona, California, Nevada and Texas — states with alarming spikes in the number of providers. The increase in hospice numbers had raised concerns inside and outside the agency about fraudulent bills for unneeded services and market oversaturation. During its "period of enhanced oversight," the agency said, it would scrutinize the claims from new hospices in these states before paying them.
These reforms, however, have done little to slow the region's hospice boom. CMS data from last year shows that these four states continued to drive most of the growth of new Medicare-certified hospices in the country, with two-thirds of all certifications taking place there. The nation's leading trade groups for end-of-life care have repeatedly recommended that Medicare impose a moratorium on certifying new hospices in counties that have seen an explosion in questionable startups. This would prevent bad actors from draining Medicare funds, the groups contend, while regulators can investigate fraudulent networks. In response to questions about this recommendation, CMS told ProPublica in a written statement that "if state officials believe there is a hospice issue in their state, they can pursue a state-based hospice license moratorium under their state laws/regulations such as what was done in California."
California, however, offers an example of why this approach may not be working: Last year, the state temporarily banned new hospice licenses altogether after its auditors found evidence of "a large-scale, targeted effort to defraud Medicare," with providers charging for patients who did not need hospice care or, in some cases, did not exist. But without a federal moratorium on certifications, the large crop of licensees that were established in the past three years can continue to bill Medicare. "The Department of Public Health is doing a fantastic job of trying to clean it up here in California, but they can't clean it up fast enough if CMS keeps allowing new hospices to charge for patients," said Sheila Clark, the president of the California Hospice and Palliative Care Association, a trade group for providers.
Indeed, the agency's data shows that last year it continued to certify hospices located in buildings that have been flagged by auditors and journalists as potential fraud hot spots. In 2023, Medicare certified 15 more hospices at a two-story building in Los Angeles that is home to more than 100 hospices. It also certified three new hospices last year at a Phoenix address that purportedly houses dozens of providers, all of which have materialized in the past two years.
CMS said that without "evidence of sanctions" that would authorize it to deny certification, the agency cannot prevent these hospices from entering the program. In a recent blog post it added that "we take our role as stewards of the Medicare Trust Funds seriously, and we work to ensure that taxpayer dollars are spent on high-quality, necessary care for each beneficiary."
Hospice fraud doesn't just drain Medicare reserves. It also harms patients who are not actually dying, since enrollment cuts them off from curative care. Karen Joy Fletcher, communications director at California Senior Medicare Patrol, which runs a hotline for patients and families, said that hospice fraud continues to be a big problem in the state despite the moratorium.
A few weeks ago, for instance, the hotline received a call from Anna Duran, whose mother has been in a nursing home in Los Angeles County since 2010. Duran was surprised to discover that her mother was unable to get her pacemaker checked because she'd recently been enrolled in hospice by a doctor she'd never heard of. Duran, who holds power of attorney for her mother, determined that no one at the nursing home had enrolled her mother — or thought, for that matter, that she was about to die. She had dementia and high blood pressure, but she was still walking. Each time Duran called the number for the hospice business, no one picked up. An analyst from Medicare has now been assigned to untangle the case, but so long as Duran's mother is still on hospice, she no longer qualifies for her regular physical therapy appointments. Medicare, meanwhile, has paid the hospice more than $7,500. "Nobody knows how this happened," Duran said.
Ava Kofman is a reporter on ProPublica's national desk.
Doctors working for health insurers can rule on 10,000 or more requests for care a year. At least a dozen were hired by major insurance companies after being disciplined by state medical boards or making multiple or outsized malpractice payments.
This article was published on Friday, December 15, 2023 in ProPublica.
By Patrick Rucker, The Capitol Forum, and David Armstrong and Doris Burke, ProPublica.
When Shawn Murphy's wife died in 2009 after a botched gallbladder surgery, he presumed the doctor who performed the operation would be forced out of medicine for good.
Dr. Pachavit Kasemsap, a former Air Force surgeon, had cut Loretta Murphy's aorta during that common procedure, according to a database of malpractice payments kept by Florida insurance regulators. She never left the hospital and died just shy of her 40th birthday. Shawn Murphy was left to raise their two daughters, then 13 and 17, on his own.
During the weeks that Murphy prayed for his wife to recover and the months that he fought Kasemsap in circuit court in Brevard County, Florida, he didn't know that other families had complained that their loved ones had suffered under the same doctor's care.
Kasemsap has settled five malpractice cases for a total of $3 million, according to the Florida malpractice payment database. That includes $1 million paid to the Murphy family. In one of the cases Kasemsap settled, a patient said the doctor negligently stapled and stitched her rectum to her vagina. Kasemsap denied doing that, and in legal filings in all five cases, the doctor denied that he was negligent.
The doctor's LinkedIn profile says his last job as a surgeon ended in December 2012, months before he settled the last of those five cases. But there was one industry ready to welcome him regardless: health insurance.
Kasemsap got a job as an insurance company medical director, where suddenly he had the power to impact the lives of far more patients than he would ever have seen in the operating room.
For most policyholders, the inner workings of their health insurer are a black box: Requests to cover treatment or pay claims go in, and approvals or rejections are spit out.
The pivotal gatekeepers inside the box are medical directors like Kasemsap. They can, without ever seeing a patient, overrule the judgment of the doctor who did and deny payment for a recommended procedure, test or medicine.
Insurers say medical directors steer patients away from unnecessary or risky care and expensive treatments for which there are less costly, equally effective alternatives. Patients and their physicians complain that insurance company doctors routinely, and wrongly, deny payment for critical lifesaving treatments because they are expensive.
The stakes are high: A refusal to pay for treatment can drive families into bankruptcy. Some patients, facing the cost, forgo care altogether. And a single medical director can rule on 10,000 cases a year, according to court testimony in a case involving Aetna. Some Cigna doctors have ruled on more than 10,000 cases in a month without opening the patient file, as ProPublica and The Capitol Forum have reported.
Despite the key role insurers' medical directors play in the lives of patients, their identities and backgrounds, and their qualifications for making such life-altering assessments, remain largely hidden.
Many states require medical directors to be licensed physicians, but beyond that it is generally up to insurers to determine which medical professionals are fit for the job.
Patients and the doctors who treat them don't get to pick which medical director reviews their case. An anesthesiologist working for an insurer can overrule a patient's oncologist. In other cases, the medical director might be a doctor like Kasemsap who has left clinical practice after multiple accusations of negligence.
As part of a yearlong series about how health plans refuse to pay for care, ProPublica and The Capitol Forum set out to examine who insurers picked for such important jobs.
Reporters could not find any comprehensive database of doctors working for insurance companies or any public listings by the insurers who employ them. Many health plans also farm out medical reviews to other companies that employ their own doctors. ProPublica and The Capitol Forum identified medical directors through regulatory filings, LinkedIn profiles, lawsuits and interviews with insurance industry insiders. Reporters then checked those names against malpractice databases, state licensing board actions and court filings in 17 states.
Among the findings: The Capitol Forum and ProPublica identified 12 insurance company doctors with either a history of multiple malpractice payments, a single payment in excess of $1 million or a disciplinary action by a state medical board.
One medical director settled malpractice cases with 11 patients, some of whom alleged he bungled their urology surgeries and left them incontinent. Another was reprimanded by a state medical board for behavior that it found to be deceptive and dishonest. A third settled a malpractice case for $1.8 million after failing to identify cancerous cells on a pathology slide, which delayed a diagnosis for a 27-year-old mother of two, who died less than a year after her cancer was finally discovered.
None of this would have been easily visible to patients seeking approvals for care or payment from insurers who relied on these medical directors.
When patients look for doctors, they can first check the physicians' education, experience and qualifications. Most states allow consumers to see if doctors have been sanctioned by a medical board for providing substandard care, and many also provide some information about malpractice payments. But that kind of up-front scrutiny isn't possible with medical directors because patients typically don't learn their identity until a denial arrives.
Kasemsap's history of malpractice payments was no secret before Cigna hired him in 2019. Two years earlier, he was the subject of a front-page story in the South Florida Sun Sentinel headlined "Dangerous Doctors." In addition to handling appeals for the insurer, Kasemsap obtained a certification through a Cigna physician leadership program and oversees the work of 13 other medical directors there, according to his LinkedIn profile. Cigna CEO David Cordani posed with him and others in a photo at a recent company leadership event.
When told Kasemsap was working in this critical role, Murphy was shocked. "This guy should not be deciding medical questions," he said. "I don't care if it's an earache."
Kasemsap wrote in an email to ProPublica and The Capitol Forum: "Please know that I carry every patient outcome with me, and those experiences reinforced my commitment to being a compassionate, detail-oriented, dedicated colleague who puts our members at the center of everything I do." Kasemsap said he was responding on his own behalf, not Cigna's. He did not answer other questions about his malpractice cases or his role at the insurer.
Cigna, in a statement, said all of its medical directors are board-certified, credentialed physicians and the company holds its medical directors to the same standard as doctors who participate in its network. "We use a comprehensive suite of materials and discussions to assess how our medical directors support patients efficiently and effectively," a company spokesperson wrote.
In another statement, the spokesperson wrote, "As I'm sure you're aware, malpractice claims against physicians are common, particularly in high-risk specialties such as surgery, and the settlement of malpractice claims does not necessarily mean that malpractice occurred."
"I can say in my 35-plus years doing this that this is the most unskilled surgeon I have ever seen in a case," said Mac McLeod, a malpractice attorney who represented two plaintiffs who sued Kasemsap, including the woman who said Kasemsap connected her rectum to her vagina.
When asked about McLeod's assertion, Kasemsap wrote, "This is a mischaracterization of a highly complex medical case that occurred more than 15 years ago." Kasemsap did not say what was mischaracterized.
A Doctor Goes Sleuthing
A few days before Christmas in 2021, Terrold Dance was loaded down with electrical tools when he slipped on some ice at a worksite and went to a Colorado hospital for help. An MRI later showed that Dance had torn his rotator cuff, the muscles and tendons that surround the shoulder joint and keep the upper arm bone in the socket.
Workers' compensation paid for the scan and some physical therapy, but that didn't fix the problem. By the next Christmas, Dance was still in pain and couldn't fully raise his arm over his head. A Colorado orthopedic surgeon, Dr. Braden Jones, examined Dance and concluded that he needed surgery.
"The guy had not gotten better for a year," Jones recalled. "It was a pretty clear-cut case for surgery."
Pinnacol Assurance, the workers' compensation company that handled Dance's policy, required that the surgery be authorized in advance, and the company hired a medical reviewer named Dr. Jon Erickson to scrutinize Dance's request and medical records. Like a medical director, a contract medical reviewer for Pinnacol evaluates whether a surgery is medically necessary. In a letter to a case manager, Erickson concluded that steroid injections and some physical therapy would likely be enough to fix Dance's problem. Pinnacol denied the request for surgery.
"I believe the mechanism of injury is somewhat questionable," Erickson wrote, "and we would be best served by considering a program of nonoperative care which involves injections."
The letter baffled Jones. It downplayed Dance's shoulder injury and brushed aside the MRI report, Jones said. Erickson didn't cite any published research or medical society guidelines to explain why an operation was not needed. Jones said that the letter was such a break from accepted orthopedic practice that he wondered if Erickson had ever been a surgeon.
So Jones decided to check. The Colorado medical board had a copy of Erickson's medical license and an explanation for why he hadn't set foot in an operating room in many years.
A disciplinary report from the medical board said Erickson had performed a "substandard" hip replacement surgery in 2013 that led to irreparable harm to a patient. Erickson tried in three additional operations to fix it, the disciplinary report said, but the patient had to undergo a fifth surgery elsewhere and will always walk with a limp.
That wasn't all. The report criticized Erickson for another faulty hip replacement six months after the first. The surgery had taken place on a Friday, and by Monday the same patient was back on the operating table with a broken hip. Erickson performed a second surgery but something was wrong. An X-ray showed the problem.
Erickson had put the hip in backwards.
In a 2017 settlement with the Colorado medical board, Erickson was allowed to keep his license as long as he never performed any kind of orthopedic surgery again. As a doctor reviewing cases for an insurer, though, Erickson has the power to decide that orthopedic operations are not medically necessary, when he himself is not allowed to perform them.
In an interview, Erickson defended his decision to deny Dance's surgery and his work overall. "This was a relatively clear-cut case," Erickson said. He added, "What we do at Pinnacol when we review these cases is prevent a lot of inappropriate care, and we save a lot of money for our clients."
In a statement, Pinnacol said Erickson was contracted as an independent reviewer and that he did not work directly for Pinnacol. "He is not and has never been an employee," a spokesperson wrote, adding that Pinnacol no longer uses Erickson to review cases. "Our mission as a not-for-profit, state-chartered carrier is to serve the workers and employers of Colorado, and we would never, nor do we support denying necessary medical care ‘to save our clients money.'"
The company said its claim denial rates are "roughly half the state average." While Pinnacol is a nonprofit insurer, it does typically return money to its customers in the form of an annual dividend.
For Jones, the experience confirmed all of his worst suspicions about medical directors.
"If you have ever seen a Lego, you know which way the hip goes," Jones said. "I always considered these medical directors to be sellouts, but I thought an insurance company would have more dignity than to hire someone like this."
After Jones complained to Pinnacol about Erickson's history and the wrongheaded nature of the denial, the insurer approved Dance's rotator cuff surgery, which he underwent earlier this year. Dance has since regained full strength and motion.
Jones was so disturbed by what he discovered that he complained to the medical board. Chief among Jones' beefs: If Erickson is not allowed to perform orthopedic surgery due to the board action, why is he allowed to rule on insurance cases that affect what orthopedic surgeons in good standing can do? The medical board acknowledged to Jones in a September letter that his complaint remained open but declined to comment to ProPublica and The Capitol Forum. Erickson said he thought Jones' decision to file a complaint with the medical board "was a little bit overkill."
Trouble With Medical Boards
Doctors turn to health insurance company work for many reasons. Some do it after burning out on clinical care or a change in circumstance, such as starting a family or retiring from a practice. Many find the work rewarding, saying they can help patients by flagging care that is unnecessary or even dangerous.
The job offers good pay with potential bonuses and a set schedule without weekend work or night shifts. The median pay for medical directors at insurers like UnitedHealthcare, Cigna and Elevance is around $300,000 a year, with the high end of the salary range over $400,000, according to the job site Glassdoor.
Despite this, ProPublica and The Capitol Forum found, insurance companies still wind up employing doctors who state medical regulators have rebuked for providing shoddy care or being dishonest.
A unit of Cigna called eviCore has employed Dr. Lorraine Driscoll as an associate medical director from 2006 through at least March 2022, according to records filed with the Maryland Insurance Administration. The New Jersey medical board in 2013 found grounds for disciplining Driscoll for "dishonesty, deception, and misrepresentation and/or … for engaging in professional misconduct."
The board reprimanded Driscoll, an obstetrician-gynecologist, for altering patient records in ways that could help her fight a 2004 malpractice case involving a child born with Down syndrome. That case, which wound up settling for $700,000, was one of six that Driscoll settled, according to her application to be certified as a medical director by the Maryland Insurance Administration. (Maryland officials approved her application.) She did not respond to calls, emails or a letter with detailed questions sent via FedEx.
Other insurers, including Aetna and UnitedHealthcare, hire eviCore to determine whether certain treatments are medically necessary.
When asked if Driscoll still works for eviCore, a company spokesperson declined to answer. In a written statement, eviCore said its medical directors are all board-certified physicians "who are dedicated to ensuring that patients receive safe, effective care guided by the latest clinical evidence." The company added that its doctors "are held to the same legal, licensing and education requirements that physicians treating patients are held to."
Aetna has on its in-house team Dr. Beth Ann Binkowski, an internal medicine physician who was censured and reprimanded by the New York state medical board in 2015 for failing to appropriately prescribe medications for five patients at Syracuse University with mental health conditions. Binkowski referred a reporter to Aetna for comment. A company spokesperson said all Aetna medical directors are licensed and board certified and that the company follows accreditation requirements and state and federal regulations.
UnitedHealthcare hired Dr. Dolores Rhymer-Anderson as a medical director in 2015 despite the fact that the Georgia medical board had previously reprimanded her for care related to the delivery of a baby born with severe neurological damage in 2000. She settled a related malpractice lawsuit for $2 million. In a legal filing in that malpractice case, Rhymer-Anderson denied that she was negligent and said she exercised the appropriate degree of care and skill ordinarily employed by doctors in the same circumstance.
A peer reviewer appointed by the medical board faulted Rhymer-Anderson for failing to conform to the minimum standard of acceptable and prevailing medical practice. As part of an agreement with the board in 2006, she was required to complete 20 hours of continuing medical education and pay a fine of $1,500. The board order stated Rhymer-Anderson did not acknowledge any impropriety and agreed not to contest the allegations to avoid protracted litigation.
Rhymer-Anderson excluded obstetrics from her practice before the board order, blaming the move on her experience with the lawsuit, according to a regulatory filing. She said she hoped to avoid another legal action.
But in 2008 she was sued again and settled the case for $1 million. That lawsuit faulted her work during a diagnostic procedure to evaluate a patient's uterus. The patient went into respiratory distress and suffered a brain injury from lack of oxygen. The patient spent a month in the hospital before being transferred to a long-term care facility. The lawsuit accused Rhymer-Anderson of incorrectly administering anesthesia, failing to properly supervise a nurse assisting and failing to secure an airway by endotracheal tube.
In her application to be certified as a medical director in Maryland, Rhymer-Anderson said she settled because the plaintiff was estimating the cost of future care at $16 million, which exceeded her malpractice insurance, and she was concerned a jury award could put her personal assets at risk. She said in the Maryland filing that three expert witnesses concluded that she met the standard of care in the case. In a court filing in that case, Rhymer-Anderson said she acted within the standard of care in treating the patient and did not commit any act of negligence that resulted in injuries. (Maryland officials approved her application.)
Settlements of $1 million or more, referred to as catastrophic claims, are rare. Only 7.6% of claims saw settlements that large in a study of malpractice cases filed nationwide from 1992 through 2014. The same study found the average malpractice payment by doctors in Rhymer-Anderson's specialty was $432,959.
Rhymer-Anderson did not respond to phone calls, emails and a letter with detailed questions sent via FedEx.
A UnitedHealth Group spokesperson said Rhymer-Anderson left the company last year. The spokesperson also wrote, "Medical directors go through a rigorous hiring process, to ensure they are qualified for the roles for which they are being considered." He added, "We review individual performances regularly and provide ongoing training to help them with their various responsibilities."
'Cranking Out Denials'
When an insurer shoots down a request to pay for care, the patient's doctor can call the insurance company's doctor to make the case for why it should be approved. This is known as a peer-to-peer review.
But doctors often complain they're not actually speaking with peers when they call an insurer. They get exasperated when an orthopedic surgeon weighs in on a procedure to treat an irregular heartbeat or a pediatrician questions an oncologist's plan for an adult with lung cancer.
In a survey conducted by the American Medical Association, only 2% of the doctors who responded said that health insurance medical directors were "always" appropriately qualified to assess the requested treatment. More than a third said health plan doctors were "rarely" or "never" qualified.
When Orrana Cunningham's doctor at the MD Anderson Cancer Center in Houston asked her insurer to approve the use of expensive proton beam therapy to attack her cancer, the decision on whether to pay for the care fell to an Aetna doctor who had not treated patients in more than 20 years, according to records from a lawsuit the Cunningham family brought against Aetna.
Dr. David Massman, a medical director at Aetna, denied coverage of the treatment, ruling that it was "experimental or investigational."
Cunningham's radiation oncologist, Dr. Clifton Fuller, then requested a peer-to-peer call so that he could explain why proton beam therapy was the best method for treating Cunningham's stage IV nasopharyngeal squamous carcinoma, a rare cancer located at the base of her skull. Proton beam therapy was needed, he said, because it could precisely deliver radiation to the cancer site while avoiding devastating side effects, such as loss of sight and memory, that could occur with other radiation treatments.
It was a complex procedure. Fuller wanted someone with a background in treating cancer to be on the call. Instead, he was paired with Massman, a family medicine physician who had never worked in radiation oncology and had never seen a proton beam machine.
Massman went to work for health insurers two decades ago after his Illinois medical license was placed on a four-year probation for issues related to a drug addiction, according to state licensing records. His license is in good standing now.
In their peer-to-peer call, Fuller testified in a sworn deposition, Massman acknowledged Fuller may be right that proton beam therapy was a safe treatment for Cunningham but said he "can't do anything about it" because the therapy did not comply with an Aetna clinical policy guideline.
Appeals of the decision failed. In all, three Aetna medical directors reviewed the treatment request and subsequent appeals. None of them were radiation oncologists.
As the appeals dragged on, Cunningham grew sicker. Out of options, her husband decided to mortgage the family home and sell other assets to pay for the $92,000 treatment.
Cunningham underwent the procedure in April 2015, four months after her doctors first asked Aetna to approve it. When she returned home in May, she started to behave strangely. She didn't recognize her husband or son. She was diagnosed with herpetic encephalitis, a disease that her family's attorney contended was unrelated to the cancer treatment and triggered by stress. She died later that month.
Cunningham's husband sued Aetna in Oklahoma state court, alleging that the insurer breached its contract with his wife, acted in bad faith and inflicted emotional distress.
At the trial, Massman testified that he could not recall details of his peer-to-peer call with Cunningham's radiation oncologist, but he said that he would never tell a treating physician that they were right about a treatment Aetna was denying.
In his closing arguments at the trial, Cunningham's lawyer, Doug Terry, condemned Aetna's medical directors: "These doctors were not properly qualified to know the first thing about the medical issues involved here. None of them had any experience with radiation oncology or proton therapy. They were cranking out denials as fast as they could."
Aetna's lawyer countered that the company was proud of the medical directors who denied Cunningham's care for "standing up for what is right." Massman and other Aetna medical directors involved in denying Cunningham's care sat in the front row as the company's lawyer made his closing argument, said Terry.
The jury in 2018 awarded Cunningham's estate and her husband $25.6 million. After Aetna appealed the jury verdict, the parties settled the case under confidential terms in 2021.
Massman did not respond to calls, emails and a letter with detailed questions sent via FedEx.
In a statement, Aetna said its "sympathies continue to be with the Cunningham family." It said that today any clinical reviews or peer-to-peer conversations related to proton beam therapy are conducted by board-certified radiation oncologists. The company did not answer a question about efforts more generally to match specialists to the treatment requested.
'Frequent Flyers'
A small group of doctors — about 2%, termed "frequent flyers" by one study author — are responsible for 40% of medical malpractice claims in the country.
In 2013 Dr. John Stripling stopped working as a urologist, according to a deposition he gave in a product liability case. Around that time he faced medical malpractice lawsuits from patients in two states who alleged he botched enlarged prostate procedures.
In total, Stripling settled cases with 11 former patients between 2014 and 2017 with a combined payout of $3.6 million, according to Florida Department of Health records. After receiving "malpractice information," the Arkansas State Medical Board told Stripling in 2015 that he would have to appear before the board if he wanted to renew his license, which was expiring. He never did.
Stripling was able to maintain his license in Florida, state records show, and he began working for health insurers in 2016, according to his LinkedIn profile. His most recent job, his profile said, was as a medical director for naviHealth, a unit of UnitedHealth Group's Optum business, where he weighed in on placements of patients released from the hospital. A UnitedHealth Group spokesperson said Stripling left naviHealth in March.
A 2014 lawsuit filed in Arkansas state court by Larry Stanley, a patient of Stripling's, alleges that dozens of the doctor's patients in that state and Mississippi experienced severe and unacceptable complications when the doctor performed a procedure known as transurethral laser ablation of the prostate, or TULAP. The procedure uses a laser to treat an enlarged prostate, which can otherwise cause problems with urinating.
The lawsuit alleged that a nurse who worked with Stripling reported to another urologist that 40 of Stripling's patients who underwent the TULAP procedure experienced "unprecedented complications." The office manager and head nurse in Stripling's practice were so alarmed by the high rate of complications that they went directly to the chief executive officer of the company Stripling worked for, according to Stanley's lawsuit.
After Stanley's TULAP procedure with Stripling in 2010, he was left incontinent, had to use catheters to drain his bladder and underwent additional surgeries, according to Stanley's suit. In a court filing in that case, Stripling denied that he was negligent or at fault. The lawsuit was dismissed after both sides said they had resolved the matter, but the court records don't provide any additional detail. Stanley died in 2019. His son Greg recalled his father received about $300,000 in a settlement.
A steelworker in his younger years, Larry Stanley had later owned and operated a sawmill for 40 years. Greg Stanley said his father was a changed man after the surgery. He rarely left home, worried he would have wet spots on his clothes.
"This doctor butchered him," Greg Stanley said.
In a 2012 deposition in a malpractice case in Mississippi, Stripling said he stopped doing the laser prostate operation on Dec. 7, 2010, when he had a "coming-to-Jesus meeting" with himself and concluded "this is it." At least eight of the settlement payments made in his malpractice cases involved incidents that occurred in 2010, according to the licensing records.
Stripling said in the deposition that too many of his patients "were doing poorly" after their operations. "There was something flawed in what was being done; and I didn't have a clear answer, but it was time to make a decision," he said. He testified that he went back to performing an older procedure that didn't involve a laser.
That Mississippi case later settled for $305,000, according to Florida state medical licensing records. In a court filing, Stripling said he complied with the standard of care and was not negligent in his treatment of the patient.
Stripling did not respond to phone messages, emails and letters with detailed questions sent via FedEx. The UnitedHealth Group spokesperson reiterated that the company's medical directors go through a rigorous hiring process, that their performance is regularly reviewed and that the company provides ongoing training.
Another "frequent flyer" was Cigna's Kasemsap, who settled five malpractice suits after denying in court filings that he was negligent.
It was in November 2006, during a colostomy reversal surgery, that Kasemsap allegedly connected a 42-year-old woman's vagina to her rectum, according to a malpractice complaint filed in state court in St. Augustine, Florida. The mistake caused air and feces to pass through the vagina, and the patient had to undergo three more surgeries, according to the complaint.
A month later, according to allegations in another lawsuit, Kasemsap mistakenly cut a patient's common bile duct and an artery during a gallbladder surgery. A jury found him negligent in that case and awarded the patient $600,000. Kasemsap and the patient subsequently agreed to settle the case.
Kasemsap's malpractice insurer made another payment to a patient who said in a lawsuit that he had suffered from a mild case of hemorrhoids that Kasemsap wrongly diagnosed as a far more serious case. The doctor then negligently performed a 2007 surgical procedure that left the patient with "constant, severe physical pain and suffering, incontinence and irritation," the complaint said.
Kasemsap settled two more malpractice cases for incidents in 2009, including one filed by Loretta Murphy's family after her death, court records show.
Kasemsap started working for insurers in 2013, according to his LinkedIn profile, which boasts about his contributions to companies' financial health.
As a senior medical director at Highmark, a Blue Cross Blue Shield plan, he claimed credit for saving $3 million a year by removing high-cost specialty drugs from automatic authorization, his profile said. He also said he saved the company $15 million by initiating step therapy in the treatment of macular degeneration. Step therapy generally requires patients to try less expensive treatments before more expensive ones. (When asked about Kasemsap's profile, a spokesperson for Highmark wrote, "We can't speak to how Dr. Kasemsap categorizes his work. Medical directors use evidenced-based guidelines and the unique clinical picture of each member's case to render medical necessity decisions only, which is agnostic of cost.")
Since late 2019, Kasemsap has worked at Cigna, where he not only has reviewed treatment requests but has also managed other medical directors who handle Medicare Advantage requests for care, according to his LinkedIn profile. Kasemsap has thrived in his role at Cigna, and the company made him part of its Physician Leadership Development Program, which provides business and leadership skills.
Kasemsap's success at Cigna came as a bitter surprise to the Murphy family.
When Loretta Murphy's daughter Amanda Cain was young, her mother would play beauty parlor with her. Murphy would do Amanda's hair like she learned in cosmetology school, and Amanda would paint her mother's nails — purple with pink and white flowers.
"Her favorite flower was hibiscus, so I would always try that on the toes," said Cain, who ended up pursuing her own career in cosmetology.
Cain was a junior in high school when her mother went to Kasemsap to get her gallbladder removed. The procedure was only supposed to take about an hour. When more than an hour passed, Cain started to get nervous. Her grandparents were in the waiting room and eventually took her home to look after her younger sister.
The next time Cain saw her mother, she was lying in a hospital bed with a machine helping her breathe.
Murphy died a year before Cain graduated from high school. It was just one of many life events her mother never got to witness, including the birth of Cain's two children.
That Kasemsap has any say in the well-being and health of vulnerable people is maddening, Cain said.
"What do you say about anyone that would hire this guy knowing what they know?" she asked. "How, how would they still hire him?"
Do You Have Insights Into Dental and Health Insurance Denials? Help Us Report on the System.
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.
Giant insurers are imposing fees on doctors and hospitals for electronic payment. Now a bipartisan group of lawmakers has introduced a bill to end the practice.
This article was published on Tuesday, December 12, 2023 in ProPublica.
By Cezary Podkul
A bipartisan group of six U.S. representatives has introduced a bill that would prohibit insurers and their intermediaries from levying fees on doctors for paying them electronically. The legislation comes in the wake of a ProPublica investigation that detailed the toll of such fees, which add up to billions of dollars that could be spent on care but are instead funneled to insurers and payment processors.
The charges are akin to having an employer deduct 1.5% to 5% to provide a paycheck electronically if an employee prefers to receive a payment directly into their bank account rather than via a paper check. Yet that's the choice many insurers are increasingly forcing on doctors.
"We don't tolerate paying fees to receive direct deposit of a paycheck, likewise, doctors and patients should not be forced to pay predatory fees on electronic payments on essential health services," the bill's lead sponsor, Republican Rep. Greg Murphy of North Carolina, said in a statement announcing the legislation. Murphy's bill would effectively force the Centers for Medicare & Medicaid Services, the federal government's chief regulator on health care payments, to prohibit the fees.
As it happens, that would bring the giant agency back to its original position. CMS prohibited fees for electronic funds transfers until it was lobbied by a payment processor called Zelis. The agency changed its position in 2018, then went even further in 2022, explicitly stating that such fees are not prohibited. A spokesperson for CMS said the agency does not comment on proposed legislation. Zelis did not reply to a request for comment on Murphy's bill, but the company previously told ProPublica that its services remove "many of the obstacles that keep providers from efficiently initiating, receiving, and benefitting from electronic payments."
CMS's about-face was detailed in copious internal records meticulously collected by a New York City urologist, Dr. Alex Shteynshlyuger, who has made it his mission to fight the costly fees. His crusade now appears to have found a sympathetic ear in Congress: Like Shteynshlyuger, Murphy is a urologist, and he co-chairs the House GOP Doctors Caucus. Three Democrats and two Republicans thus far have signed on as co-sponsors of his bill.
The proposed legislation has the backing of the American Medical Association, whose policymaking body voted last month to adopt a new resolution opposing "growing and excessive" fees on electronic funds transfer payments. Shteynshlyuger, who has spent six years trying to convince CMS to ban the fees, introduced a proposal at New York state's medical society that then made its way to the AMA. He said of the new federal bill: "I'm happy that the legislators got involved."
Administrators at small medical clinics are hoping the bill will bring them relief from the fees, which are "doing nothing for us but costing us money," said Rebecca Hamilton, who manages an arthritis and rheumatology clinic in Wichita, Kansas.
Often, it's independent clinics like Hamilton's that suffer the most from such fees, since medical practices collect the vast majority of their revenues through EFT payments, according to the Medical Group Management Association. The winners are the recipients of the fees: large insurers and payment processors like Zelis.
One form of electronic fee is not addressed by Murphy's bill: charges for use of so-called virtual credit cards, which Shteynshlyuger has also been campaigning against. Virtual credit cards are temporary card numbers that are typically used for one payment. Fees for VCC use run as high as 5% versus a typical 2.5% for other kinds of electronic payments.
ProPublica's investigation showed how Matthew Albright, a lobbyist for Zelis, used a combination of cajoling, argument and the threat of litigation to get CMS to withdraw a 2017 notice prohibiting fees for electronic payment. CMS had posted the notice, which was based on a federal rule from 2000, on its website after hearing complaints from doctors. Internal CMS emails detailed how Albright repeatedly demanded that CMS withdraw and revise the notice, and when CMS ultimately refused, a law firm representing Zelis threatened to sue the agency. Within days, CMS removed the notice. It later stated that fees are allowed.
CMS previously told ProPublica that it reversed its position because it concluded that it had no legal authority to "flat-out prohibit fees."
Albright, like CMS, has changed his public position on the fees. Before he joined Zelis, Albright worked for the federal agency, where he wrote the rules implementing electronic health care payments. Shortly after his time at CMS, at a 2015 conference for health care business managers in Las Vegas, Albright expressed unequivocal opposition to fees for electronic payments. When Albright outlined the agency's rules, audio of the event shows, the mere mention of virtual credit cards prompted some members of the audience to cry, "Evil!" Albright asked if that sentiment was unanimous, prompting a wave of yeses.
Doctors Shouldn't Have to Pay to Get Paid
Before he became an industry lobbyist, Matthew Albright expressed opposition to electronic payment fees at a conference in Las Vegas in 2015.
Laughter ensued, and Albright, who has a master's degree in divinity, joked that he was preaching to the choir. His sermon? "What other industry does not get paid for the services they're doing, and when they do get paid, they have to pay for getting paid? What other industry, right? It's ridiculous!"
Reached by telephone for comment, Albright said, "I can't speak to you."
Cezary Podkul is a reporter for ProPublica who writes about finance. cezary.podkul@propublica.org @Cezary
ProPublica sought to better understand how often physicians were using atherectomies on patients with questionable need for it.
This article was published on Tuesday, December 12, 2023 in ProPublica.
By Annie Waldman, ProPublica, with data analysis by Alma Trotter and Fred Trotter, CareSet
Four years ago, researchers warned the Centers for Medicare and Medicaid Services that some doctors were overusing — potentially even abusing — invasive vascular procedures, increasing patients' chances of complications, which include amputation or even death.
They handed the federal agency a list of outlier physicians they found in the government insurer's own data. But the agency has done little to stop the practice and instead continues to pay doctors who exhibit this behavior millions of dollars a year.
The names of the doctors were never publicly revealed.
ProPublica is shedding new light on the problem.
Working with data journalists from the health analytics group CareSet, and in consultation with experts, ProPublica sought to better understand how often physicians were using one particularly controversial procedure, the atherectomy, on patients with questionable need for it. Over the past year, ProPublica has chronicled the rise of these procedures along with horror stories of patients who lost their legs from complications.
Their cases and many others, plus dozens of interviews with patients, healthcare providers and medical device representatives, have laid bare a thriving industry of strip-mall clinics and outpatient vascular centers where elderly patients are being exploited for multimillion-dollar Medicare payouts.
As part of the procedure, doctors use a laser or bladed catheter to remove plaque from the patients' vessel walls. For treatments conducted in outpatient clinics, Medicare pays generous reimbursements to doctors, who can charge tens of thousands of dollars for procedures done in a single visit. Experts recognize atherectomies are appropriate for severe vascular disease, but they told ProPublica that the majority of patients with milder symptoms like leg pain while walking, a condition known as claudication, should start with treatments like medication and exercise.
ProPublica sought to better understand how often physicians were using one particularly controversial procedure, the atherectomy, on patients with questionable need for it.
Some doctors stood out because of the money they made. Dr. Amiel Moshfegh, a Beverly Hills radiologist, received $45 million from Medicare over five years for performing thousands of atherectomies, according to public Medicare records. Most of his Medicare patients were older Latinos, according to federal data, who were warned in Spanish-language advertisements that poor circulation could lead to amputation. About 15% of his patients who underwent a first-time atherectomy, 170 of them, appeared to have milder disease based on their diagnosis for claudication, according to the data.
Other doctors stood out because a large portion of their patients who underwent atherectomies had just claudication, raising questions about the necessity of the procedures. That was the case for Dr. Christopher LeCroy, who works for a chain of vascular clinics across the Florida panhandle; about half of his first-time atherectomy patients appeared to have milder disease based on their diagnosis, according to the data.
And while over 5,000 physicians who provide vascular care rarely intervened on patients who appeared to have milder vascular disease based on their diagnoses, ProPublica and CareSet found that about 170 other doctors performed half or more of their first-time atherectomies on these kinds of patients.
"It's concerning that we may be doing unnecessary procedures and spending unnecessary healthcare dollars," said Dr. Caitlin Hicks, an associate professor of surgery at Johns Hopkins University School of Medicine and a leading researcher on procedure overuse. "We know that aggressive interventions for claudication may give short-term relief, but in the long term, patients are the same as they started or even worse."
His colleague Dr. Colbert Perez, who was also high on this list with 37% of his first-time atherectomy patients having only claudication according to the data, said that their practice, Caprock Cardiovascular Center & Cath Lab, had been marking their patients with incorrect diagnosis codes in Medicare billing claims for several years, which made their patient population appear to have milder disease. While billing errors can occur, CMS mandates that physicians "are responsible for ensuring that claims submitted" under their name are "true and correct."
Perez said that he rarely intervenes on patients with mild disease, following best practices, and said the center, which outsources its coding and billing to another company, was looking into the billing issue and was in contact with CMS for corrections and changes. He did not provide details on the federal investigation into Kurdi but told ProPublica that his colleague was "going through a separation" with the practice.
In all, experts who reviewed ProPublica's analysis called the findings alarming and validating. They called on government insurers to do something about the fact that a quarter of all patients who got first-time atherectomies — enough to fit in a sports arena — may not have needed them. CMS told ProPublica that it monitors claims data for outliers and can act when it identifies problems, by denying claims, suspending payment or referring questionable providers to law enforcement.
"When we see patterns that are beyond the boundaries of reasonable according to respected peers in the field," Makary said, "that is a signal that there should be a closer review."
Doctors named in our data objected to being portrayed as part of the problem.
Moshfegh, for example, noted he had no malpractice claims or blemishes on his license. "Atherectomies ultimately can save the government and taxpayers millions of dollars by avoiding amputations," he said. He did not respond to ProPublica's questions on his clinic's use of advertisements, the treatment of patients with milder vascular disease or why he had received more Medicare reimbursements for atherectomy than any other physician in the country. (Read his full statement here.)
LeCroy did not directly respond to ProPublica's questions sent by email, but the clinical director at his practice said he doesn't conduct procedures on patients with mild disease unless they have lifestyle-limiting pain and have already tried exercise and medication therapy. "This endovascular work is preventing patients having bypasses or amputation," said Cherlynn Hecker. Others echoed these points.
Several portrayed the mounting concerns about overuse as part of a debate, not settled science, and said they should be trusted to decide whether their patients can benefit from atherectomies. Private practice doctors also explained that their high reimbursement payments are meant to cover their total business expenses and do not lead to excessive personal profit. Some rebuffed ProPublica's analysis, taking issue with the use of claims data, which they said does not provide key details on patient symptoms and critiquing the focus on claudication, which they said can have a range of severity. While Medicare claims data has limitations, academics across the country and even government fraud detectives use it to examine trends and identify outliers.
Johns Hopkins surgeon and researcher Dr. Marty Makary said these kinds of outlier analyses are crucial to protecting patients. "Most of the public is flying blind," said Makary, who also leads the organization Global Appropriateness Measures, which uses similar medical data to address outliers and curb overuse. "The moral dilemma that the medical community is now facing is that we can see practice patterns in big data that are inappropriate. Do we have a duty to act? I think we do."
Using the research of Hicks, Makary and their colleagues as a springboard, ProPublica has spent the past year examining Medicare data for vascular care to answer some basic questions: Which doctors are making the most money off a single procedure? Who are they treating? And what is happening to their patients?
Relying on public Medicare data, we found that about 200 doctors are responsible for a majority of atherectomies conducted across the country. Over five years, from 2017 through 2021, this small cadre of mostly vascular surgeons, interventional radiologists and cardiologists has earned nearly $1.5 billion dollars, conducting almost 200,000 procedures. At the top of the list sits Moshfegh, the Beverly Hills radiologist who raked in almost double the reimbursements of any other doctor in America, for over 7,000 atherectomy procedures.
This highlighted doctors like Dr. Juan Kurdi of Lubbock, Texas; nearly half of his first-time atherectomy patients appeared to have milder disease based on their diagnosis, according to the data. Kurdi did not directly respond to ProPublica's emailed questions or phone messages, and his lawyer declined to comment. Kurdi's currently the target of a criminal investigation by the Department of Justice, according to court filings; he has not been charged. The government and his lawyers are discussing a potential pre-indictment resolution, according to case filings.
His colleague Dr. Colbert Perez, who was also high on this list with 37% of his first-time atherectomy patients having only claudication according to the data, said that their practice, Caprock Cardiovascular Center & Cath Lab, had been marking their patients with incorrect diagnosis codes in Medicare billing claims for several years, which made their patient population appear to have milder disease. While billing errors can occur, CMS mandates that physicians "are responsible for ensuring that claims submitted" under their name are "true and correct."
Perez said that he rarely intervenes on patients with mild disease, following best practices, and said the center, which outsources its coding and billing to another company, was looking into the billing issue and was in contact with CMS for corrections and changes. He did not provide details on the federal investigation into Kurdi but told ProPublica that his colleague was "going through a separation" with the practice.
In all, experts who reviewed ProPublica's analysis called the findings alarming and validating. They called on government insurers to do something about the fact that a quarter of all patients who got first-time atherectomies — enough to fit in a sports arena — may not have needed them. CMS told ProPublica that it monitors claims data for outliers and can act when it identifies problems, by denying claims, suspending payment or referring questionable providers to law enforcement.
"When we see patterns that are beyond the boundaries of reasonable according to respected peers in the field," Makary said, "that is a signal that there should be a closer review."
Editor's Note
We excluded physicians who conducted first-time atherectomies on fewer than 50 patients on average per year to focus on practitioners who have a higher use of the procedure over time. We defined milder vascular disease based on a diagnosis of claudication at the time of the initial atherectomy procedure within our study period.
This highlighted doctors like Dr. Juan Kurdi of Lubbock, Texas; nearly half of his first-time atherectomy patients appeared to have milder disease based on their diagnosis, according to the data. Kurdi did not directly respond to ProPublica's emailed questions or phone messages, and his lawyer declined to comment. Kurdi's currently the target of a criminal investigation by the Department of Justice, according to court filings; he has not been charged. The government and his lawyers are discussing a potential pre-indictment resolution, according to case filings.
ProPublica reached out to every doctor named in our story through multiple emails and phone calls, providing questions to the physicians, clinics, hospitals or lawyers. The following doctors, their offices or lawyers did not respond to ProPublica's questions for this story at the time of publication: David Burkart, Ian Cawich, Thomas P. Davis, Pablo Guala, Omar Haqqani, Syed Hussain, Juan Kurdi, Moinakhtar Lala, James McGuckin, Jim Melton, Rajiv Nagesetty, Daniel Simon, Pushpinder Sivia and Harold Tabaie. Dr. Bhaskar Purushottam and Monument Health, where he works, both declined to comment. Riverside Healthcare in Illinois, where Hussain has worked since September 2022, also declined to comment on the doctor's practice.
In addition to the doctors quoted in the story, the following doctors responded to ProPublica's findings.
Maryland vascular surgeon Dr. Samer Saiedy told ProPublica that Medicare claims data doesn't include enough details to provide a full picture of why he may have treated a patient with an invasive procedure. At his practice, patients are only given the option of invasive procedures, he said, if they have severe pain and have already tried less aggressive approaches first. "If you look at atherectomy only, and you narrow down, yes, I'll be an outlier because I do a lot of claudicants for severe symptoms after we do the medical treatment," he said. "They cannot walk through the pain, they're already on blood thinners, they're already on this and already on this. We're going to do something."
Saiedy also said the Medicare reimbursement data is misleading. Saiedy, who has made about $23.5 million from Medicare in reimbursements for atherectomy procedures over five years, according to federal data, said the payments cover all clinic expenses and are not going to him directly. "You have to look at the overhead of the practice," he said. "That includes nurses, anesthesia, leases for the equipment, rent."
California interventional radiologist Dr. Malwinder Singha, who received $23.8 million in Medicare reimbursements for atherectomy procedures over five years according to federal data, echoed Saiedy's concerns. "It is devoted to running of the [office-based laboratory] and only a tiny fraction is earned by the operator," he wrote in an email to ProPublica. "I have to pay my employees and expenses for all the supplies (wires, balloons, stents, atherectomy catheters, etc.), imaging equipment, [electronic medical records], facilities rent, etc."
Singha also took issue with the use of claims data to identify clinical outliers. "It does not take into account the patient population I see and the severity of their disease," he said. He added that outpatient facilities are safe, and their patients are satisfied with their care. "What I and my colleagues do is safe and effective," he said. "There are hundreds of office based labs who treat thousands and thousands of patients. The adverse event rate is miniscule."
Interventional radiologist Dr. James McGuckin, who received $17.2 million in Medicare reimbursements for atherectomy procedures over five years, treats "a significantly high-risk patient base" who are at-risk for amputation, said his attorney, David Heim, in an email this past August. Earlier this year, the Department of Justice sued McGuckin for submitting false claims to the federal healthcare programs for "medically unnecessary invasive peripheral artery procedures," allegations that Heim had called "provably wrong." His lawyers have moved to dismiss the case.
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A Michigan law requires coverage of cancer drugs. One insurer came up with a 'defensible' way to avoid paying for treatments that offered Forrest VanPatten his last chance for survival. 'We crossed the line,' says a former executive.
This article was published on Wednesday, November 25, 2023 in ProPublica.
By Maya Miller and Robin Fields
Forrest VanPatten was 50 and strong after years as a molten-iron pourer when he learned in July 2019 that a hyperaggressive form of lymphoma had invaded his body. Chemotherapy failed. Because he was not in remission, a stem cell transplant wasn't an option. But his oncologist offered a lifeline: Don't worry, there's still CAR-T.
The cutting-edge therapy could weaponize VanPatten's own cells to beat back his disease. It had extended the lives of hundreds of patients who otherwise had no chance. And VanPatten was a good candidate for treatment, with a fierce drive to stay alive for his wife of 25 years and their grown kids.
VanPatten didn't know it, but he also had the law on his side. His home state of Michigan had long required health insurers to cover clinically proven cancer drugs.
He and his family gripped tight to the hope that the treatment promised.
Then, his insurance company refused to approve it.
Across the country, health insurers are flouting state laws like the one in Michigan, created to guarantee access to critical medical care, ProPublica found. Fed up with insurers saying no too often, state legislators thought they'd solved the problem by passing hundreds of laws spelling out exactly what had to be covered. But companies have continued to dodge bills for pricey treatments, even as industry profits have risen. ProPublica identified dozens of cases in which plans refused to pay for high-stakes treatments or procedures — from emergency surgeries to mammograms — even though laws require insurers to cover them.
Companies can get away with this because the thinly staffed state agencies that oversee many insurers typically don't open investigations unless patients file complaints. Regulators acknowledge they catch only a fraction of violations. "We are missing things," said Sebastian Arduengo, an assistant general counsel for Vermont's insurance department.
In the 34 years since Michigan began to require cancer coverage, regulators there have never cited a company for violating the law.
Like most policyholders, VanPatten had no insight into the decision made by his insurer, a nonprofit called Priority Health that covers about a million Michigan residents.
He didn't know that around the time the therapy won the Food and Drug Administration's approval, executives at Priority Health had figured out a way to weasel out of paying for it.
Through interviews with former employees and a review of company emails and VanPatten's medical records, ProPublica was able to crack through the usual secrecy and expose the health insurer's calculations.
Former employees said the decision not to cover this treatment and a related one was driven almost entirely by their high price tags — up to $475,000. Side effects that could land a patient in the hospital can push the bill over $1 million. Priority Health number crunchers calculated to the penny the monthly cost per policyholder if the company shifted the expense to them: 17 cents. But executives didn't raise premiums or absorb the extra cost. They decided to save that money.
Patients' needs weren't part of the equation, recalled Dr. John Fox, then Priority Health's associate chief medical officer. "It was, ‘This is really expensive, how do we stop payment?'"
Over Fox's objections, fellow executives came up with a semantic workaround: These cancer drugs aren't technically drugs, they argued, they're gene therapies. All Priority Health had to do was to exclude gene therapies from its policies, and it could say no every time.
Priority Health said in a written statement to ProPublica that it provides compassionate, high-quality, affordable coverage and spends 90 cents of every premium dollar on member care.
"We are committed to making medical innovations available to members as quickly as possible, regardless of cost, as soon as they have been proven to be safe and effective," Mark Geary, a spokesperson, wrote. The company said it initially didn't cover CAR T-cell therapy because there was a "lack of consensus" about the treatment's effectiveness.
"Major life-threatening complications and side effects were common, with a high rate of relapse," the statement said.
At the time of VanPatten's denial there was, in fact, already substantial consensus about the medication. In December 2017, the National Comprehensive Cancer Network, then an alliance of 27 leading U.S. cancer treatment centers, spelled out in its guidelines for B-cell lymphomas which patients should receive the therapy and when. VanPatten's doctor said he met the criteria.
VanPatten's family signed a privacy waiver giving Priority Health permission to discuss his case with ProPublica. Nevertheless, Priority Health did not respond to questions about his case or whether the company had violated Michigan's mandate to cover cancer drugs when it refused to pay for his therapy.
VanPatten was disappointed but tried to remain optimistic after the first denial in January 2020. He and his wife, Betty, who worked in medical billing, knew it often took an appeal to coax the insurer to approve care.
In early February, Dr. Stephanie Williams, then the head of the blood and marrow transplant program for Spectrum Health, came to see VanPatten in his hospital room on Grand Rapids' Medical Mile. It had been more than six months since his diagnosis.
He was sitting up in bed hooked up to an IV. His face, once framed by reddish eyebrows and a signature goatee, was hairless and drained of color. Betty pasted on a tight smile.
Priority Health had denied the treatment again, Williams told them, though she vowed to keep fighting.
When she left the room, VanPatten swung his legs over the side of the hospital bed. He had remained resilient and good-humored through his illness. But at that moment, he felt like Priority Health was treating him like an expense, not a person. It got to him, the idea that the insurer he dutifully paid each month knew this was his only chance and was holding it just out of reach.
He grabbed a tissue box from a tray and hurled it against the wall.
Fox, whom Willams described as the "conscience of the company," had long been the point person for oncology in Priority Health's medical department. In his earlier life as a practicing physician, he had trained at the Centers for Disease Control and Prevention as a chronic disease epidemiologist. When he joined Priority Health in 2000, he admired the company's focus on preventive care and the fact that his bosses encouraged him to build deep relationships with local hospitals and doctors.
CAR T-cell therapy was a breakthrough more than 20 years in the making, and Fox had tracked clinical trials and talked to oncologists about it. By genetically reengineering patients' own white blood cells, then infusing them back into the body to fight cancer, the treatment helped most participants in clinical trials get into remission within three months.
He knew this would be a game changer for patients. He also knew the law. So when news of the FDA's approval of the first CAR-T medication, Kymriah, hit his inbox in August 2017, he recalled, "I said, ‘You know, we're required to cover this. This is a treatment for cancer.'"
But the culture at Priority Health had shifted over the previous year under new leadership to focus on cost savings, Fox and four other former employees said in interviews. The company brought in a new chief medical officer, Dr. James Forshee, in late 2016 from Molina Healthcare, an insurer known for wringing profits out of Medicaid managed care plans.
In conversations about the new treatment, several former Priority Health employees recall, Forshee pointed out that the law required covering cancer "drugs," and he argued that the new treatment actually wasn't a drug; it was a gene therapy. (Through a company spokesperson, Forshee declined to comment for this article.)
Fox thought this was ridiculous. He pressed company lawyers for an opinion. Priority Health's filings with the state "indicate that we have to cover FDA approved cancer drugs," Fox wrote to two members of the legal department in a September 2017 email.
Senior counsel John Samalik responded, bolstering Forshee's position that Priority Health didn't have to cover Kymriah: "I believe legally we have a defensible argument that Kymriah is a gene therapy and not a drug." (Samalik declined to comment through a company spokesperson.)
Fox pointed out that the company already covered another gene therapy. He told ProPublica that he suggested asking state regulators whether the cancer-drug mandate applied to Kymriah, but Forshee and at least one other executive refused.
"My inference being that, if we ask the state, they would say yes, so let's not ask," Fox said. Two other former Priority Health employees involved in the discussions confirmed Fox's recollections.
The FDA approved a second CAR T-cell medication, Yescarta, seven weeks after the first approval.
When ProPublica asked if the FDA considered CAR T-cell therapies drugs, an agency spokesperson said yes. She wrote in an email that they have been regulated as gene therapies, and that they "are biological products and drugs under the Public Health Service Act (PHS Act) and the Federal Food, Drug and Cosmetic Act."
Fox continued to push Priority Health to cover them; Forshee didn't budge.
As they often did for new therapies, Priority Health's actuaries calculated the price tag. They estimated that each year, one patient would need Yescarta and one Kymriah. If spread across the company's members, the therapies would cost an extra 17 cents per member per month — 8 cents for Yescarta and 9 cents for Kymriah, emails show.
If the company had chosen to absorb the cost rather than raise premiums, the extra expense — potentially more than $1 million for each patient receiving the therapy — could have hurt its bottom line. Other insurers had also balked at the cost of CAR-T and were slow to cover it.
Priority Health made a slight tweak to its 2018 filings to state regulators, one with life-changing implications for patients like VanPatten. As it had in the past, the company said it covered drugs for cancer therapy "as required by state law." But the insurer slipped in a new sentence more than a dozen pages later: Gene therapy was "not a Covered Service."
Meanwhile, regional and national health plans began approving the drugs. Kaiser Permanente started covering them within months of the FDA's approvals. Blue Cross Blue Shield of Michigan — the state's biggest health plan and Priority Health's main competitor — paid for a cancer patient to receive CAR T-cell therapy in December 2017. (A spokesperson said in an email that the plan added coverage based on the treatments' efficacy, without considering whether Michigan's mandate applied. "We would have covered these drugs irrespective of the law," she said.)
When the national Blue Cross Blue Shield Association made an announcement about CAR-T coverage later in 2018, employees at Priority Health forwarded it to one another. It was an I-told-you-so moment for Fox.
At a meeting that December, Fox made the case again that Priority Health should ask the state whether Michigan's law required covering the new cancer treatments.
Forshee bristled. "You don't trust our legal counsel?" he responded, according to Fox and another executive who attended.
His own temper rising, Fox considered what would happen if the company maintained its position. Patients who needed these therapies would likely die. Fox and his team would have to sign the denial letters, knowing the despair and anger they would sow.
After working at Priority Health for more than 18 years, Fox had once thought he'd retire there. He left that meeting certain he had to move on.
"Health plans have a right to make money; we're providing a service," Fox said. "But we have to do that honestly and fairly, putting patients first, not profits or premiums first. To me, that's where we crossed the line."
About seven months later, on a sticky night in July 2019, Forrest and Betty VanPatten were sipping beers with friends at the local club of the Fraternal Order of Eagles.
When they'd moved to Sparta, a small Michigan town known for its apple orchards, this was where they'd found community. The club had hosted countless charity raffles and fundraisers, including a "pink night" for the American Cancer Society for which Forrest squeezed into a hot-pink minidress Betty sewed for him. (There wasn't much off-the-rack that could fit his almost 6-foot-8-inch frame.)
They were expecting biopsy results at any moment. Forrest had gone to the emergency room the previous weekend with intense pain. He'd made it through two previous bouts of lymphoma and suspected he was about to face another.
Forrest's phone rang. It was the office of his primary oncologist, Dr. Brett Brinker. Oncologists meet hundreds of patients and their families, but Brinker had grown deeply fond of the VanPattens. Forrest was the guy who could talk to anyone, who made the party worth attending. Betty was his perfect foil. Their laughter and candor left a lasting impression.
The news was bad. Forrest had something called Richter's transformation. It made his lymphoma significantly more aggressive and less likely to respond to conventional chemotherapy. After hanging up, Forrest typed Richter's into his phone. Almost immediately, he proclaimed, "This is a death sentence."
Betty needed to clear her head. She walked around the block, passing a restaurant where Forrest's name was on the wall for completing a taco-eating challenge. When she got back, she urged Forrest to snap out of his defeatism.
He had just celebrated his 50th birthday and was determined to be around for his 51st. His kids, Donovan, 23, and Madison, 22, were in serious relationships, and he wanted to be there for their weddings.
"So we went in and got a game plan," Betty said. Forrest would begin with chemotherapy, and, if the cancer went into remission, they would try for a stem cell transplant. If the cancer didn't go into remission, Brinker made it clear they weren't out of options. He told them about CAR-T.
It felt reassuring at the time.
By January 2020, CAR-T was all they had left. Brinker said he thought the treatment could at least bring Forrest's disease under control for a few years. "It's hard to use the word ‘cure' when it's acting like that," he said of Forrest's cancer. But if they won some extra time, he said, "there's always something in the wings you can hope for."
On Jan. 28, Williams, the doctor who ran the transplant program, worked with her team to submit a request for coverage to Priority Health. Williams knew the company's policy on CAR-T but thought the insurer might relent when faced with an actual patient who was certain to die without the treatment. Plus, by that point, the federal government was covering the therapies for Medicare patients, and insurers often follow its lead.
Knowing it could take weeks to grow the cells used in the treatment, his doctors prepared to extract his white blood cells. "These are diseases where we don't have a lot of time to waste," Williams said.
Then Williams' office found out that Priority Health had denied the request. Forrest's doctors appealed but were turned down again, prompting Forrest to throw the tissue box at the wall.
Williams felt it, too. "I was deflated. I was angry," she recalled. "We kept trying to work it out, and we kept hitting roadblocks."
The VanPattens didn't have the money to pay out of pocket, and Forrest didn't want to saddle his family with medical debt. His medical team filed a third and final appeal, this one to an independent reviewer.
As that went forward, the VanPattens received a letter from Priority Health explaining its reasons for denying Forrest's treatment. CAR-T cell therapy "is not a covered benefit," and "therefore, we are unable to approve this request," the letter stated. Somehow, seeing the words in writing conveyed a different finality, sending Forrest into a downward spiral.
Their son, Donovan, took to social media to blast Priority Health for its decision, hoping to shame the company into a last-minute about-face. He included a screenshot of a text message from Forrest, who knew his insurer was an outlier. "It should be noted that Blue Cross and Blue Shield of MI pays for Car T Cell!" it read.
A reporter for Fox 17, a local TV news station, interviewed Forrest on Feb. 13 in the suede recliner he'd long claimed as his chair in the family's living room.
Days later, Forrest was back in Butterworth Hospital with shortness of breath. "He is in acute distress," an emergency room doctor noted when he was admitted.
The following night, his heart stopped beating. Betty retreated to the back of the room as doctors and nurses swarmed in. Donovan sat in a chair outside, his head in his hands.
Madison raced through Grand Rapids' snow-covered streets to join them. When she reached her father's room, a member of the medical team was still pushing down on his chest. But, she recalled, "it was clear he wasn't there anymore." The family told his doctors to end the resuscitation effort.
Forrest died on Feb. 17, before the independent medical reviewer had a chance to weigh in. Three weeks had passed since Williams and her team had asked Priority Health to cover the therapy.
Williams said that if Priority Health had approved the first request, Forrest could have received the infusion. It's unknowable whether the treatment would have given him more time, she said, but if he'd had that chance, "anything is possible."
Not long after Forrest died, his family received a handwritten card from a clinical coordinator who cared for him.
"I am so so so sad that we didn't get the chance to put the rest of our plan into motion," she wrote. "In honor of your kind (+very funny) husband, dad, friend, I promise to continue to push for Priority Health to cover CAR-T and to bring hope to all who need it."
In Priority Health's statement, Geary, the spokesperson, wrote that the company began covering the therapy "after extensive clinical work improved the treatment." The company would not say when it began paying for the treatment or whether Forrest's death influenced its decision.
"It is devastating when a disease takes a member's life," the statement said. "We recognize the deep pain of losing someone you love."
To former state Sen. Joe Schwarz, now 86 and retired, the story of Priority Health and Forrest VanPatten is a painful echo of a problem he thought he'd fixed.
More than 30 years ago, Schwarz helped write the Michigan law requiring insurers to pay for cancer drugs. Schwarz, a physician, still recalls what drove him to action: Insurance companies were refusing to pay for drugs given to make chemotherapy more effective, arguing they weren't themselves chemotherapy. An op-ed in the Wall Street Journal by the head of the Association of Community Cancer Centers confirmed that insurers nationwide were denying coverage for cancer patients.
At a Senate hearing, Schwarz accused health plans of abandoning their policyholders based on a "play on words." When ProPublica told Schwarz about Priority Health's gene-therapy argument, he let out a mirthless "hah," scoffing at the wordplay.
"You shouldn't split hairs between the term gene therapy and the term chemotherapy or the term radiation therapy or the term surgical therapy," he said. "They're all cancer therapies and they should all be covered."
ProPublica gave Michigan's Department of Insurance and Financial Services a detailed description of VanPatten's case, as well as Priority Health's contention that it didn't have to cover CAR T-cell cancer therapies. We asked if Priority Health broke the state law on cancer treatments. Laura Hall, the department's communications director, wouldn't say. The agency can investigate if it spots a pattern of improper denials, but "in general," she said, it only acts if a patient or their representative files a complaint.
The VanPattens didn't do that. And they didn't know about the Michigan law until ProPublica told them about it.
In the months after her husband died, Betty VanPatten was too weighed down by grief and anger to tangle with Priority Health through state insurance regulators. The days were a blur. Donovan and his partner, McKenzie, moved in with Betty, who threw herself into her job.
"I'd get up at 4, and I'd have my laptop and I just worked until about 9 or 10 o'clock," Betty said. "And a lot of times I'd just sit there and the tears are just running down my face."
The VanPattens still struggle with the sense that Forrest suffered an injustice and that Priority Health got away with it.
"They lost sight of the patient," Betty said at a family dinner this July. Madison agreed.
"Insurance is meant to protect people," she said, "not to make them fight through the last day to get what they should."
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After ProPublica and New York Magazine revealed how the school ignored warnings about Robert Hadden, Columbia announced a number of major initiatives, including a settlement fund for survivors and an independent investigation.
This article was published on Monday, November13, 2023 in ProPublica.
In a stunning shift, Columbia University announced on Monday a sweeping series of changes to address the school's failures to protect patients who were sexually assaulted by a Columbia doctor.
A ProPublica investigation, published in collaboration with New York Magazine, found that Columbia had failed to act on years of warnings as Robert Hadden, an OB-GYN, abused at least hundreds of patients during his 25-year career at the university. In 2012, administrators allowed Hadden to continue seeing patients even after he was arrested for assaulting a patient.
The story prompted waves of criticism toward Columbia. State Assembly members held a press conference on campus. A unanimous resolution by the university senate said that the Hadden revelations have "shaken our community to the core."
In Monday's announcement, the university said it would commit to an external investigation to examine systemic failures that allowed Hadden's abuse to continue. It also said it would notify nearly 6,500 former Hadden patients about his crimes. Columbia will also open a $100 million survivors' settlement fund for those who don't want to go through the court system.
The university had long sought to distance itself from the scandal, placing blame solely on Hadden. Columbia had refused demands from survivors that the school notify all of Hadden's patients. It hadn't commissioned an external investigation and had aggressively fought lawsuits filed by survivors.
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Hadden was convicted in federal court of sex crimes in January, and he is now serving a 20-year prison sentence. More than 600 patients have so far come forward to allege abuse.
"Columbia failed these survivors, and for that we are deeply sorry," President Minouche Shafik and Columbia University Irving Medical Center CEO Katrina Armstrong said in a statement on Monday.
Columbia's announcement comes just ahead of a looming deadline for survivors to file suit against the university. The Adult Survivors Act, put into law in New York last year, opened a one-year lookback window, during which survivors can file civil suits against perpetrators of sexual abuse, or institutions that protected them, even if they are past the statute of limitations. The deadline closes on Nov. 23.
The university has previously settled civil suits with 226 patients for $236.5 million.
Marissa Hoechstetter, a former Hadden patient who pushed for the Adult Survivors Act, said she was glad Columbia finally acted.
"This is what we've been asking them to do," Hoechstetter said. "This is good. But we need to continue to hold them accountable and see what comes of this and continue to support survivors."
Still, Hoechstetter said, the $100 million figure will likely be too low. "We don't yet know the full extent of his crimes," she said.
Bianca Fortis was an Abrams Reporting Fellow at ProPublica