Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
This article first appeared May 29, 2017 on ProPublica.
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
But what makes maternal health care in other affluent countries look so different than the U.S.? Among other things, midwives. Midwives in the U.S. participate in less than 10 percent of births. But in Sweden, Denmark and France, they lead around three-quarters of deliveries. In Great Britain, they deliver half of all babies, including all three of Kate Middleton’s. So if the midwifery model works for royal babies, why not our own?
Check out the video above to find out how midwives have been at the center of a culture war that’s deeply rooted in race and class in America.
Today we see vestiges of that history in states with restrictive midwifery laws and barriers to entry for midwives. Earlier this year, one study was the first systematic look at how and where they practice, offering new evidence that empowering them could significantly boost maternal and infant health. Many of the states with poor health outcomes and hostility to midwives also have large black populations. And with black mothers three to four times more likely to die in pregnancy or childbirth, the study raises the possibility that greater use of midwives could reduce racial disparities in maternal health.
This story makes up the eighth installment in Vox’s collaboration with ProPublica. You can find this video and all of Vox’s videos on YouTube. Subscribe and stay tuned for more from our partnership.
Patients may think their insurers are fighting on their behalf for the best prices. But saving patients money is often not their top priority. Just ask Michael Frank.
This article first appeared May 25, 2017 on ProPublica.
Michael Frank ran his finger down his medical bill, studying the charges and pausing in disbelief. The numbers didn’t make sense.
His recovery from a partial hip replacement had been difficult. He’d iced and elevated his leg for weeks. He’d pushed his 49-year-old body, limping and wincing, through more than a dozen physical therapy sessions.
The last thing he needed was a botched bill.
His December 2015 surgery to replace the ball in his left hip joint at NYU Langone Medical Center in New York City had been routine. One night in the hospital and no complications.
He was even supposed to get a deal on the cost. His insurance company, Aetna, had negotiated an in-network “member rate” for him. That’s the discounted price insured patients get in return for paying their premiums every month.
But Frank was startled to see that Aetna had agreed to pay NYU Langone $70,000. That’s more than three times the Medicare rate for the surgery and more than double the estimate of what other insurance companies would pay for such a procedure, according to a nonprofit that tracks prices.
Fuming, Frank reached for the phone. He couldn’t see how NYU Langone could justify these fees. And what was Aetna doing? As his insurer, wasn’t its duty to represent him, its “member”? So why had it agreed to pay a grossly inflated rate, one that stuck him with a $7,088 bill for his portion?
Frank wouldn’t be the first to wonder. The United States spends more per person on health care than any other country. A lot more. As a country, by many measures, we are not getting our money’s worth. Tens of millions remain uninsured. And millions are in financial peril: About 1 in 5 is currently being pursued by a collection agency over medical debt. Health care costs repeatedly top the list of consumers’ financial concerns.
Experts frequently blame this on the high prices charged by doctors and hospitals. But less scrutinized is the role insurance companies — the middlemen between patients and those providers — play in boosting our health care tab. Widely perceived as fierce guardians of health care dollars, insurers, in many cases, aren’t. In fact, they often agree to pay high prices, then, one way or another, pass those high prices on to patients — all while raking in healthy profits.
ProPublica is examining the bewildering, sometimes enraging ways the health insurance industry works, by taking an inside look at the games, deals and incentives that often result in higher costs, delays in care or denials of treatment. The misunderstood relationship between insurers and hospitals is a good place to start.
Today, about half of Americans get their health care benefits through their employers, who rely on insurance companies to manage the plans, restrain costs and get them fair deals.
But as Frank eventually discovered, once he’d signed on for surgery, a secretive system of pre-cut deals came into play that had little to do with charging him a reasonable fee.
After Aetna approved the in-network payment of $70,882 (not including the fees of the surgeon and anesthesiologist), Frank’s coinsurance required him to pay the hospital 10 percent of the total.
When Frank called NYU Langone to question the charges, the hospital punted him to Aetna, which told him it paid the bill according to its negotiated rates. Neither Aetna nor the hospital would answer questions about the charges.
Frank found himself in a standoff familiar to many patients. The hospital and insurance company had agreed on a price and he was required to help pay it. It’s a three-party transaction in which only two of the parties know how the totals are tallied.
Frank could have paid the bill and gotten on with his life. But he was outraged by what his insurance company agreed to pay. “As bad as NYU is,” Frank said, “Aetna is equally culpable because Aetna’s job was to be the checks and balances and to be my advocate.”
And he also knew that Aetna and NYU Langone hadn’t double-teamed an ordinary patient. In fact, if you imagined the perfect person to take on insurance companies and hospitals, it might be Frank.
For three decades, Frank has worked for insurance companies like Aetna, helping to assess how much people should pay in monthly premiums. He is a former president of the Actuarial Society of Greater New York and has taught actuarial science at Columbia University. He teaches courses for insurance regulators and has even served as an expert witness for insurance companies.
The hospital and insurance company may have expected him to shut up and pay. But Frank wasn’t going away.
Patients fund the entire health care industry through taxes, insurance premiums and cash payments. Even the portion paid by employers comes out of an employee’s compensation. Yet when the health care industry refers to “payers,” it means insurance companies or government programs like Medicare.
Patients who want to know what they’ll be paying — let alone shop around for the best deal — usually don’t have a chance. Before Frank’s hip operation he asked NYU Langone for an estimate. It told him to call Aetna, which referred him back to the hospital. He never did get a price.
Imagine if other industries treated customers this way. The price of a flight from New York to Los Angeles would be a mystery until after the trip. Or, while digesting a burger, you’d learn it cost 50 bucks.
A decade ago, the opacity of prices was perhaps less pressing because medical expenses were more manageable. But now patients pay more and more for monthly premiums, and then, when they use services, they pay higher co-pays, deductibles and coinsurance rates.
Employers are equally captive to the rising prices. They fund benefits for more than 150 million Americans and see health care expenses eating up more and more of their budgets.
Richard Master, the founder and CEO of MCS Industries Inc. in Easton, Pennsylvania, offered to share his numbers. By most measures MCS is doing well. Its picture frames and decorative mirrors are sold at Walmart, Target and other stores and, Master said, the company brings in more than $200 million a year.
But the cost of health care is a growing burden for MCS and its 170 employees. A decade ago, Master said, an MCS family policy cost $1,000 a month with no deductible. Now it’s more than $2,000 a month with a $6,000 deductible. MCS covers 75 percent of the premium and the entire deductible. Those rising costs eat into every employee’s take-home pay.
Economist Priyanka Anand of George Mason University said employers nationwide are passing rising health care costs on to their workers by asking them to absorb a larger share of higher premiums. Anand studied Bureau of Labor Statistics data and found that every time health care costs rose by a dollar, an employee’s overall compensation got cut by 52 cents.
Master said his company hops between insurance providers every few years to find the best benefits at the lowest cost. But he still can’t get a breakdown to understand what he’s actually paying for.
“You pay for everything, but you can’t see what you pay for,” he said.
Master is a CEO. If he can’t get answers from the insurance industry, what chance did Frank have?
Frank’s hospital bill and Aetna’s “explanation of benefits” arrived at his home in Port Chester, New York, about a month after his operation. Loaded with an off-putting array of jargon and numbers, the documents were a natural playing field for an actuary like Frank.
Under the words, “DETAIL BILL,” Frank saw that NYU Langone’s total charges were more than $117,000, but that was the sticker price, and those are notoriously inflated. Insurance companies negotiate an in-network rate for their members. But in Frank’s case at least, the “deal” still cost $70,882.
With a practiced eye, Frank scanned the billing codes hospitals use to get paid and immediately saw red flags: There were charges for physical therapy sessions that never took place, and drugs he never received. One line stood out — the cost of the implant and related supplies. Aetna said NYU Langone paid a “member rate” of $26,068 for “supply/implants.” But Frank didn’t see how that could be accurate. He called and emailed Smith & Nephew, the maker of his implant, until a representative told him the hospital would have paid about $1,500. His NYU Langone surgeon confirmed the amount, Frank said. The device company and surgeon did not respond to ProPublica’s requests for comment.
Frank then called and wrote Aetna multiple times, sure it would want to know about the problems. “I believe that I am a victim of excessive billing,” he wrote. He asked Aetna for copies of what NYU Langone submitted so he could review it for accuracy, stressing he wanted “to understand all costs.”
Aetna reviewed the charges and payments twice — both times standing by its decision to pay the bills. The payment was appropriate based on the details of the insurance plan, Aetna wrote.
Frank also repeatedly called and wrote NYU Langone to contest the bill. In its written reply, the hospital didn’t explain the charges. It simply noted that they “are consistent with the hospital’s pricing methodology.”
Increasingly frustrated, Frank drew on his decades of experience to essentially serve as an expert witness on his own case. He gathered every piece of relevant information to understand what happened, documenting what Medicare, the government’s insurance program for the disabled and people over age 65, would have paid for a partial hip replacement at NYU Langone — about $20,491 — and what FAIR Health, a New York nonprofit that publishes pricing benchmarks, estimated as the in-network price of the entire surgery, including the surgeon fees — $29,162.
He guesses he spent about 300 hours meticulously detailing his battle plan in two inches-thick binders with bills, medical records and correspondence.
ProPublica sent the Medicare and FAIR Health estimates to Aetna and asked why they had paid so much more. The insurance company declined an interview and said in an emailed statement that it works with hospitals, including NYU Langone, to negotiate the “best rates” for members. Frank’s claims were correct given his coverage, the billed services and the Aetna contract with NYU Langone, it wrote.
NYU Langone also declined ProPublica’s interview request. The hospital said in an emailed statement it billed Frank according to the contract Aetna had negotiated on his behalf. Aetna, it wrote, confirmed the bills were correct.
After seven months, NYU Langone turned Frank’s $7,088 bill over to a debt collector, putting his credit rating at risk. “They upped the ante,” he said.
Frank sent a new flurry of letters to Aetna and to the debt collector and complained to the New York State Department of Financial Services, the insurance regulator, and to the New York State Office of the Attorney General. He even posted his story on LinkedIn.
But no one came to the rescue. A year after he got the first bills, NYU Langone sued him for the unpaid sum. He would have to argue his case before a judge.
You’d think that health insurers would make money, in part, by reducing how much they spend.
Turns out, insurers don’t have to decrease spending to make money. They just have to accurately predict how much the people they insure will cost. That way they can set premiums to cover those costs — adding about 20 percent to for their administration and profit. If they’re right, they make money. If they’re wrong, they lose money. But, they aren’t too worried if they guess wrong. They can usually cover losses by raising rates the following year.
Frank suspects he got dinged for costing Aetna too much with his surgery. The company raised the rates on his small group policy — the plan just includes him and his partner — by 18.75 percent the following year.
The Affordable Care Act kept profit margins in check by requiring companies to use at least 80 percent of the premiums for medical care. That’s good in theory but it actually contributes to rising health care costs. If the insurance company has accurately built high costs into the premium, it can make more money. Here’s how: Let’s say administrative expenses eat up about 17 percent of each premium dollar and around 3 percent is profit. Making a 3 percent profit is better if the company spends more.
It’s like if a mom said told her son he could have 3 percent of a bowl of ice cream. A clever child would say, “Make it a bigger bowl.”
Wonks call this a “perverse incentive.”
“These insurers and providers have a symbiotic relationship,” said Wendell Potter, who left a career as a public relations executive in the insurance industry to become an author and patient advocate. “There’s not a great deal of incentive on the part of any players to bring the costs down.”
Insurance companies may also accept high prices because often they aren’t always the ones footing the bill. Nowadays about 60 percent of the employer benefits are “self-funded.” That means the employer pays the bills. The insurers simply manage the benefits, processing claims and giving employers access to their provider networks. These management deals are often a large, and lucrative, part of a company’s business. Aetna, for example, insured 8 million people in 2017, but provided administrative services only to considerably more — 14 million.
To woo the self-funded plans, insurers need a strong network of medical providers. A brand-name system like NYU Langone can demand — and get — the highest payments, said Manuel Jimenez, a longtime negotiator for insurers including Aetna. “They tend to be very aggressive in their negotiations.”
On the flip side, insurers can dictate the terms to the smaller hospitals, Jimenez said. The little guys, “get the short end of the stick,” he said. That’s why they often merge with the bigger hospital chains, he said, so they can also increase their rates.
Other types of horse-trading can also come into play, experts say. Insurance companies may agree to pay higher prices for some services in exchange for lower rates on others.
Patients, of course, don’t know how the behind-the-scenes haggling affects what they pay. By keeping costs and deals secret, hospitals and insurers dodge questions about their profits, said Dr. John Freedman, a Massachusetts health care consultant. Cases like Frank’s “happen every day in every town across America. Only a few of them come up for scrutiny.”
In response, a Tennessee company is trying to expose the prices and steer patients to the best deals. Healthcare Bluebook aims to save money for both employers who self-pay, and their workers. Bluebook used payment information from self-funded employers to build a searchable online pricing database that shows the low-, medium- and high-priced facilities for certain common procedures, like MRIs. The company, which launched in 2008, now has more than 4,500 companies paying for its services. Patients can get a $50 bonus for choosing the best deal.
Bluebook doesn’t have price information for Frank’s operation — a partial hip replacement. But its price range in the New York City area for a full hip replacement is from $28,000 to $77,000, including doctor fees. Its “fair price” for these services tops out at about two-thirds of what Aetna agreed to pay on Frank’s behalf.
Frank, who worked with mainstream insurers, didn’t know about Bluebook. If he had used its data, he would have seen that there were facilities that were both high quality and offered a fair price near his home, including Holy Name Medical Center in Teaneck, New Jersey, and Greenwich Hospital in Connecticut. NYU Langone is one of Bluebook’s highest-priced, high-quality hospitals in the area for hip replacements. Others on Bluebook’s pricey list include Montefiore New Rochelle Hospital in New Rochelle, New York, and Hospital for Special Surgery in Manhattan.
ProPublica contacted Hospital for Special Surgery to see if it would provide a price for a partial hip replacement for a patient with an Aetna small-group plan like Frank’s. The hospital declined, citing its confidentiality agreements with insurance companies.
Frank arrived at the Manhattan courthouse on April 2 wearing a suit and fidgeted in his seat while he waited for his hearing to begin. He had never been sued for anything, he said. He and his attorney, Gabriel Nugent, made quiet conversation while they waited for the judge.
In the back of the courtroom, NYU Langone’s attorney, Anton Mikofsky, agreed to talk about the lawsuit. The case is simple, he said. “The guy doesn’t understand how to read a bill.”
The high price of the operation made sense because NYU Langone has to pay its staff, Mikofsky said. It also must battle with insurance companies who are trying to keep costs down, he said. “Hospitals all over the country are struggling,” he said.
“Aetna reviewed it twice,” Mikofsky added. “Didn’t the operation go well? He should feel blessed.”
When the hearing started, the judge gave each side about a minute to make its case, then pushed them to settle.
Mikofsky told the judge Aetna found nothing wrong with the billing and had already taken care of most of the charges. The hospital’s position was clear. Frank owed $7,088.
Nugent argued that the charges had not been justified and Frank felt he owed about $1,500.
The lawyers eventually agreed that Frank would pay $4,000 to settle the case.
Frank said later that he felt compelled to settle because going to trial and losing carried too many risks. He could have been hit with legal fees and interest. It would have also hurt his credit at a time he needs to take out college loans for his kids.
After the hearing, Nugent said a technicality might have doomed their case. New York defendants routinely lose in court if they have not contested a bill in writing within 30 days, he said. Frank had contested the bill over the phone with NYU Langone, and in writing within 30 days with Aetna. But he did not dispute it in writing to the hospital within 30 days.
Frank paid the $4,000, but held on to his outrage. “The system,” he said, “is stacked against the consumer.”
Over decades, Bud Frazier has played a leading role in the development of mechanical heart pumps and an artificial heart. Out of public view, he's been accused of putting his quest to make history ahead of the needs of some patients.
This article first appeared May 24, 2017 on ProPublica.
By Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle
There's a story Bud Frazier tells often. It was around 1966, and Frazier, now one of the world's most celebrated heart surgeons, was a medical student at Baylor College of Medicine.
An Italian teenager had come to Houston for an aortic valve replacement, but at some point during or after the surgery, the teen's heart stopped. Doctors told Frazier to reach in and start pumping the failed organ by hand.
As he did so, the teen lifted a hand to Frazier's face, and in that moment, just before the patient died, he says he realized his life's calling.
"As long as I was massaging that kid's heart, he would wake up," Frazier, now 78, said last year. "I thought then, and I've often returned to this: If my hand can keep this kid alive, why couldn't we make a device to do the same?"
In the five decades since, Dr. O.H. "Bud" Frazier has obsessively pursued that goal, contributing to many breakthroughs in the long and unfinished effort to develop a permanent mechanical replacement for the human heart. Today, devices he tested at Baylor St. Luke's Medical Center and its research partner, the Texas Heart Institute, are credited with extending the lives of thousands of people worldwide each year.
But out of public view, Frazier has been accused of violating federal research rules and skirting ethical guidelines, putting his quest to make medical history ahead of the needs of some patients, an investigation by ProPublica and the Houston Chronicle has found. Reporters reviewed internal hospital reports, federal court filings, financial disclosures and government documents. The records and interviews with former St. Luke's physicians show:
Frazier and his team implanted experimental heart pumps in patients who did not meet medical criteria to be included in clinical trials, according to a hospital investigation a decade ago. The findings, which have never been disclosed publicly, prompted St. Luke's to report serious research violations to the federal government and repay millions of dollars to Medicare.
A former top St. Luke's cardiologist said he believes that Frazier favored experimental heart pumps over more proven treatments and that Frazier was reluctant to acknowledge when the devices led to serious complications. Two other doctors made similar observations. In one instance, one of them said Frazier discouraged publication of research that found a high rate of strokes in the first group of patients implanted with a pump he championed.
Frazier has often failed to publicly disclose consulting fees and research grants — and in one case, stock options he received and later transferred to his son — from companies that made the pumps he tested. Most medical journals require such disclosure so that other scientists and the public can judge whether personal interests may have influenced research findings.
And a former St. Luke's nurse alleged that Frazier allowed a researcher who was not licensed to practice medicine in Texas to treat heart failure patients in his program. Her 1994 lawsuit, which was backed by patient records, testimony and secret recordings of hospital employees, revealed that Frazier's signature stamp was sometimes used to authorize the researcher's improper medical orders.
Over time, several St. Luke's and Texas Heart executives were made aware of many of these allegations. But for years, they took little or no action to rein in a doctor whose work continues to earn the hospital international acclaim, according to records and interviews.
Frazier continued to operate on patients well into his 70s, and during those latter years, his Medicare outcomes ranked among the worst in the country. From 2010-15, about half of the traditional Medicare patients who received an implantable heart assist device from Frazier died within a year, nearly double the national mortality rate for such patients, according to a ProPublica analysis of federal data.
In a phone interview in April and subsequent written responses to questions, Frazier denied any wrongdoing and said his patients were sicker and higher risk than those treated at other hospitals.
He disputed the accuracy of a report commissioned by St. Luke's that described "serious and repeated" research violations in his program. He said he never discouraged the publication of negative research findings about heart pumps. He said he could have cashed in on his work with medical device makers, but he never did. And Frazier's lawyer maintained that the unlicensed physician who worked under him more than two decades ago did not treat patients.
"It's sort of discouraging," Frazier said, "to be impugned after working so hard to keep these patients alive."
Officials at St. Luke's and Baylor College of Medicine, where Frazier remains on the faculty, hailed him as a great surgeon and a pioneer. Frazier stopped operating full time in 2015, at the age of 75, but remains in a prominent role at Texas Heart, seeing patients and working toward his ultimate goal of a permanent artificial heart.
Supporters defend his actions, arguing that he followed the example of Michael DeBakey and Denton Cooley, the pioneering cardiac surgeons under whom he trained. Both tried untested techniques when the field of heart surgery was in its infancy; Cooley famously obtained an artificial heart from DeBakey's lab without his approval and implanted it in a patient, becoming the first in the world to do so.
Like his mentors, Frazier was willing to try promising but unproven medical devices to help desperate patients, his allies say. If he broke rules, they say it was to give dying people a shot at survival, a mission that consumed his life. Frazier was so committed to the work, he was known to roam the hospital late into the night checking on patients and often slept on a leather sofa in his office.
Dr. Billy Cohn, a longtime Texas Heart surgeon who has worked closely with Frazier since 2004, defended Frazier's approach to clinical research: "He had a different view of the world. If he had had the modern view, this field wouldn't exist, and tens of thousands of patients wouldn't be alive."
Dr. Frank Smart, Texas Heart's top transplant cardiologist between 2003 and 2006, sees it differently. Smart said he admired Frazier's commitment to developing lifesaving heart pumps, but he believed it led him to surgically implant the devices into some patients who were not yet sick enough to justify what was, at the time, an experimental treatment.
Frazier's drive likely moved the field forward, Smart said, but he and others worried that it sometimes came at the expense of individual patients.
"In the old days of medicine … that's the way these guys did things," said Smart, now the chief of cardiology at Louisiana State University School of Medicine. "It was, ‘Well, I have an idea, and I'm the one that knows best, and by golly, I'm going to do it.' And did that advance the field? Maybe. Is it the right thing to do? Absolutely not."
By the early 1990s, after decades of failed attempts to create an artificial heart, researchers in Houston and around the world had shifted their efforts to the development of internal pumps that would do the work of the heart's largest chamber, easing the organ's pumping burden without replacing it entirely. The devices were known as left ventricular assist devices, and Frazier was among their most vocal advocates.
Early milestones drew national media attention, including in 1992, when a 34-year-old patient walked out of St. Luke's a year after receiving a battery-powered LVAD, the first in the world to do so.
It was the dawn of a new era in heart care, and Frazier was at the center of it.
But even then, his program was accused of crossing serious ethical lines: An unlicensed physician had been illegally treating heart failure patients, according to a 1994 federal lawsuit filed by former St. Luke's nurse Joyce Riley. The hospital and Frazier "participated in a scheme" to unnecessarily admit patients in order to move them higher on the national heart transplant waiting list, the lawsuit alleged.
Although Frazier and others considered Branislav Radovancevic, or "Dr. Brano," a leader in the field of transplant research and aftercare, the Serbian-trained physician had failed at least twice to pass licensure exams, making it illegal for him to practice medicine in Texas.
Yet following the conclusion of his medical fellowship at Texas Heart Institute in 1987, Radovancevic routinely issued orders for patients in Frazier's program, prescribed drugs, took resident medical students on rounds, helped harvest organs for transplant and provided post-surgical patient care. The activity is described in patient medical records, transcriptions of secret recordings of St. Luke's employees and pleadings filed as part of Riley's lawsuit.
Riley, who died in 2017, reported sharing her concerns about these practices with supervisors. When that did not lead to changes, she sued in U.S. District Court in Houston under a provision of the False Claims Act that allows whistleblowers to try to recover damages on behalf of the government. The hospital, she alleged, had fraudulently billed Medicare for unnecessary medical treatments.
The litigation dragged on for more than a decade, with little publicity. Lawyers for Riley presented medical records of five patients — example cases intended to prove the larger conspiracy — who spent weeks in the intensive care unit at St. Luke's, despite being well enough to walk around the hospital. One received a second heart transplant from Frazier just days after physicians concluded his health troubles were not heart related and he could likely go home, an amended complaint alleged.
At the time, admission to intensive care and orders for certain medications automatically moved patients higher on the transplant wait list.
"Dr. Frazier knew of, directed, and personally participated in the fraudulent conduct and false claims described herein," the lawsuit alleged.
Lawyers representing St. Luke's, Texas Heart and Frazier vigorously denied the allegations in court filings. Threeprominentphysicians reviewed medical records and wrote reports on behalf of the hospital, saying the care provided to the five patients was appropriate, that Riley and her lawyers did not seem to understand the complexity of such medical cases and that Radovancevic appeared to have served only in an advisory role.
Nevertheless, after the lawsuit was made public in 1996, the hospital instructed Radovancevic to stop seeing patients, and he complied, Frazier testified in an October 2007 deposition.
During the deposition, one of Riley's lawyers introduced medical records in which nurses took verbal direction from "Dr. Brano" at the bedsides of patients and then stamped Frazier's signature onto the orders — including some that were recorded when Frazier's calendar showed he was in France and Russia. Frazier dismissed the orders as record-keeping errors and blamed others for the mistakes, according to a partial transcript of the deposition filed in court.
The lawyer, Jim Perdue Jr., asked Frazier why a nurse would have stamped his signature on medical orders that Radovancevic apparently gave at the bedside of a patient.
"I mean, I don't know why," Frazier said. "You have to ask the nurse why she would do that."
Radovancevic remained an active partner in Frazier's research until his death in 2007 at the age of 55. Frazier wrote a tribute at that time, and in response to questions for this article, he wrote that "‘Brano' was and, even after his death, remains one of the most highly regarded individuals in the history of heart transplant" with modern immunosuppressant drugs.
Two years later, in 2009, St. Luke's, Texas Heart, Frazier and other defendants agreed to settle the case, attracting no media attention. The terms — including the total payment and whether the defendants acknowledged any wrongdoing — remain secret.
A spokeswoman for the U.S. Justice Department said the federal government's share was $500,000, but that does not include the amount paid to Riley — between 15 and 30 percent of the total settlement — as a reward for bringing the case forward, or the significant legal fees repaid to her lawyers.
A St. Luke's spokeswoman noted that the hospital changed ownership in 2013, and its current leaders wouldn't comment about events before then.
As the lawsuit was drawing to a close, hospital executives were working to address other issues in Frazier's program.
Dr. Frank Smart joined Texas Heart Institute as medical director of the transplant and LVAD program in 2003 and quickly grew troubled by what he saw. During his tenure, he said, he witnessed things "that I just couldn't imagine."
The overarching frustration that drove him to complain to a top St. Luke's executive before leaving in 2006: Smart believed the program, under Frazier's guidance, was putting LVAD research ahead of what was best for patients.
Smart has never spoken publicly about his concerns. He agreed to do so now, he said, because he believes patients deserved better.
His arrival at Texas Heart came at a critical time in the evolution of LVADs, which had shown promise but remained ineffective as a long-term treatment, in part because of inevitable malfunctions. At about 100,000 beats per day, no mechanical pump simulating a human heart rhythm could run indefinitely without breaking down.
When Smart got there, the program was beginning to test a new generation of pumps designed to propel blood continuously, without a pulse, minimizing the number of moving parts and making the devices far more durable. Frazier had long championed the idea and maintained that the new LVADs could do more than just keep patients alive long enough to receive a new heart. He believed they could, over time, help restore strength to diseased hearts, possibly avoiding the need for transplants.
The method has since been shown effective in a small percentage of patients, but Smart believed Frazier's desire to prove his theory caused him to recommend the devices to patients who were not yet sick enough to justify them.
Smart recalled a troubling pattern: A patient would come to St. Luke's with symptoms of heart failure. Smart or another cardiologist would make recommendations for treatment, such as prescribing drugs used to improve heart function, a common first step in attempting to control the disease and delay the need for a transplant. But soon after, before that initial therapy had time to work, the patient would be told he or she had days or weeks to live and then "whisked off for an LVAD," Smart said.
Some patients thrived with the device; others did not.
In 2005, more than half of the 34 patients who received heart assist devices at St. Luke's died without leaving the hospital, slightly higher than the national average, according to a Chronicle analysis of Texas data on patients discharged from the hospital that year. The survival rate steadily improved in the years that followed, but at the time, Smart believed many patients would have benefited from more conventional treatments.
"There were patients who walked into the hospital for an elective measurement of the pressures in their heart," Smart said. "Now, they had heart failure and they needed to be looked at, but laying down on the cath table was the last time their feet ever touched the floor."
In other cases, once a patient received an LVAD, Smart said Frazier often turned down high-quality donor hearts for them. That led Smart to believe that Frazier and others on his team were more interested in demonstrating how well the devices performed over longer periods.
"Unfortunately," Smart said, "that meant that some people didn't get transplantation when that was probably a better option for them."
As the medical director of the program, Smart said, he felt powerless. He recalled growing so frustrated that, on a few occasions, he yelled at Frazier. Sometimes, Smart and other cardiologists resorted to "hiding patients" — moving them to other parts of the hospital to prevent Frazier from recommending experimental LVADs, buying the patients time to recover with less invasive treatments or receive a transplant instead. Two other former St. Luke's staffers confirmed the highly unusual practice.
"I can think of this one young girl we moved four or five times," Smart said.
Late in his tenure, Smart said he took his concerns about patient care to the hospital's leadership, but he said nothing came of it.
In a written response to questions, Frazier praised Smart as an "excellent director" and said if Smart had concerns about the program, "he never expressed them to me." He said he and Smart both "were trying to do the best we could for the patients," and any disagreements were settled during weekly meetings.
Frazier denied implanting LVADs in patients who did not require them, writing that all patients were evaluated extensively to assess the risks and benefits of the procedure "and were presented to a multi-disciplinary review board and had to be approved before they could be electively implanted."
He also said patients who needed transplants received them when suitable donor hearts became available. "If the patients could [be] treated medically the cardiologist would never refer them to our service," he wrote.
In early 2006, not long after Smart said he voiced his concerns, he received a job offer in New Jersey. Although he had come to Texas Heart planning to spend many years at the program, he decided to take it.
He took pride in small changes he made to improve patient care at St. Luke's — "I made more people go out vertical instead of horizontal," he said. But in the end, Smart concluded there was nothing he could do to stop what he considered improper research in the LVAD program.
He didn't know, until told by a reporter, that a couple of years after he left, St. Luke's executives raised similar concerns.
Jan. 20, 2010, was a big day for Frazier and Texas Heart Institute: The Food and Drug Administration approved, for the first time, a continuous-flow LVAD for use as a permanent treatment for advanced heart failure. The HeartMate II had proved more durable than its predecessors, and far fewer patients died in the hospital after receiving one. That opened the possibility for people to survive several years or longer with the device alone.
Frazier was a lead researcher in the pump's key clinical trial.
"This is a huge accomplishment, ushering in a new era of hope for thousands of people," Frazier was quoted as saying in a Texas Heart news release.
Not mentioned in the announcement: In 2008, the hospital had learned of "serious and repeated" problems associated with its participation in that trial.
Based on multiple reviews summarized in the report to hospital board members, St. Luke's executives concluded that Frazier and his team had implanted the experimental HeartMate II and another LVAD, the Jarvik 2000, in 30 patients who were enrolled in government health plans and for whom the medical need for the devices and compliance with trial parameters "could not be documented by the patient's medical record." The patients had been enrolled in the trials "without justification," the summary said.
In one of the reviews commissioned by the hospital, a prominent Cleveland Clinic cardiologist, Dr. James Young, concluded that St. Luke's heart failure program "pushes the limits," according to the summary document. "Dr. Young found the documentation to be poor and noted that Dr. Frazier was not up-front."
Executives at the hospital — known at the time as St. Luke's Episcopal prior to its 2013 acquisition by Catholic Health Initiatives — were troubled by what they were learning. They contemplated which scenario would be worse for the hospital's bottom line and reputation: cutting ties with Texas Heart, the famed research organization founded 46 years earlier by Cooley, or continuing to be associated with the institute should the public ever learn about its research violations.
"Should the affiliation be dissolved, the impact to St. Luke's market position is unclear," executives wrote, according to the summary report. "It is likely that such news would generate national attention and negatively impact our standing in the US News & World Report rankings."
Top officials at St. Luke's and Texas Heart reported the research violations to the federal Office for Human Research Protections in July 2008, and they pledged a host of reforms, according to a letter obtained by ProPublica and the Chronicle through the Freedom of Information Act.
St. Luke's and Texas Heart said they would audit every ongoing study for which Frazier was the lead researcher, to find and report any additional research deviations. And, according to the report to St. Luke's board, the hospital planned to give back between $3.4 million and $5.4 million in payments that Medicare had made on behalf of patients who received unjustified surgical treatments.
At one point, St. Luke's executives questioned whether Texas Heart and its leaders, including then-president Dr. James Willerson, were taking the allegations seriously. Texas Heart "evidenced no concern" that the hospital would need to repay millions of dollars to Medicare, according to the summary.
"Since Dr. Willerson's position was ‘Stop trying to run off Bud,'" the report said, "it was believed that he was not conveying the seriousness of the issues to THI's board."
Reached by phone in April, Willerson initially said he did not remember any allegations of research violations against Frazier. Weeks later, after a reporter informed Willerson that his signature appeared on a letter disclosing the violations to federal regulators, he said, "I've signed a lot of things."
"If you got a signed document with my signature on it, then obviously I did it," said Willerson, now Texas Heart's president emeritus. "But I really don't have any specific recollection of that."
During a phone interview in April, Frazier said no one ever informed him that he had been accused of violating research rules, and it was "totally false" that patients received LVADs without medical justification.
In subsequent written answers to detailed questions, David Berg, a lawyer representing Frazier, said the hospital based its findings on a "deeply flawed" two-day review by a health-care consulting firm known as the Anson Group. Berg described its findings of research violations as "defamatory," and he said all of the actions the hospital took as a result were "questionable."
Berg said the Anson Group, which did not interview Frazier, inappropriately faulted him and his team for implanting LVADs in mortally ill patients who qualified for humanitarian exemptions to the research protocols. "There is no mention [in the Anson report] of the exemptions, the fact that the FDA conducted unannounced audits of the program, and that the sponsor and the FDA were fully informed about these cases," Berg wrote.
He described two cases in which young patients received LVADs and are still alive a decade later. The Anson report, completed in early 2008, identified them as "prime examples of noncompliance," Berg wrote, adding: "That is not noncompliance. That is miraculous."
St. Luke's said it doesn't have a copy of the Anson Group report, and Navigant, a consulting firm that acquired the Anson Group, said it doesn't either. Berg also did not provide the report when reporters asked for it.
As for Young, the Cleveland cardiologist who found problems in the program, Frazier said he "was always jealous of me." Berg noted that Young has subsequently praised Frazier's contributions to the field. Young declined to comment.
When asked about Frazier's contentions, David Pate, St. Luke's CEO through 2009, said he stood by the hospital's decision to report research violations to the federal government. In emailed answers to questions, Pate said he took the research violations seriously, though he said the problems were technical and he did not believe patients were harmed. The hospital took appropriate corrective actions, he said, including repaying Medicare.
None of this was disclosed when the results of the HeartMate II trial were published in the prestigious New England Journal of Medicine in 2009, with Frazier listed as an author. A spokeswoman for the journal said editors were not aware of the issues until reporters asked in April and are now seeking more information.
Abbott, which now owns the company that makes HeartMate II, said the "study was conducted in accordance with the highest research standards, all patients were enrolled and followed per study protocol, and all data was fully audited and vetted prior to publication and submission to the FDA."
In June 2009, an FDA inspector reported finding some deficiencies in Frazier's handling of the HeartMate II trial but determined they did not rise to the level of violating the U.S. Food Drug and Cosmetic Act.
As a result of the episode, Pate said he and other executives concluded that Frazier needed to be replaced as head of the transplant and LVAD program. He praised him as a visionary surgeon but said he failed to adapt to modern research requirements.
"The culture needed to change with the evolving times," Pate, now CEO of a hospital in Idaho, wrote to reporters. "It was time for a new leader, who could build on the great foundation Dr. Frazier laid."
But for several years, that did not happen.
About the same time that St. Luke's reported the research violations, some cardiologists at Texas Heart Institute were concerned about another aspect of the HeartMate II study. They had observed a troubling side effect in some patients who received the device, and they believed the finding deserved attention.
About a quarter of the first 71 patients implanted with the LVAD at St. Luke's had suffered strokes.
Two physicians familiar with the research told reporters that they believed those findings should have been published in a medical journal, but they were not. One of the doctors said Frazier argued against it because doing so would "kill the field" of mechanical heart pumps.
Cohn, the surgeon who worked closely with Frazier after joining the program in 2004, recalled the disagreement. He said doctors had already figured out a way to more accurately measure patients' blood pressure and, as a result, better manage the pump settings to reduce the risk of brain bleeding.
Frazier didn't want to needlessly "freak people out" with research showing a high rate of serious complications, Cohn said.
"That would just pour water on the smoking ember of this new important field," Cohn said, adding that, in hindsight, the team "probably should have" published the stroke findings alongside their solution.
Dr. Biswajit Kar, the former St. Luke's cardiologist who led the effort documenting the high rate of strokes, declined to comment.
In a written response, Frazier said he did not recall any effort to turn the stroke research into a paper and "never opposed [Kar] publishing anything."
Frazier said he was the first to diagnose hemorrhagic strokes in patients who had received HeartMate II devices, years earlier in 2006, and he recalls organizing a meeting in Chicago with leading cardiologists from other hospitals and the device's maker to discuss the issue. "I recommended to the company that they require that blood pressure be controlled and that all new implanting centers be required to do the same."
Nevertheless, the initial stroke findings were never published.
Kar presented a summary of the report at a 2009 cardiology conference, with Frazier listed among the authors of the presentation. But other than a short abstract included in the conference program — which is not available online — there is no public record of the research.
By Frazier's own accounting, he has had a hand in developing nearly every cardiac pump in use today. But unlike many of his peers, he said, he never made money from his work on behalf of device makers.
"My efforts have never been for personal financial gain," Frazier wrote in response to written questions, adding that he "freely shared the mechanics of my heart flow pump with all comers, including two companies that later sold for billions of dollars."
Berg, Frazier's lawyer, recounted how the head of one major device maker told Frazier, "Bud, I'll give you … the credit, but I'll keep the cash."
Over the years, however, some of the companies have reimbursed him for travel, and paid him consulting and lecture fees; others supported his research with grants. One device maker rewarded him with stock options, corporate filings show.
He has often failed to disclose these potential conflicts.
The issue has come up before. The 2008 report to St. Luke's board noted Frazier's "failure to accurately complete the conflict of interest form." The hospital had apparently attempted to address the issue, according to the report, but "Dr. Frazier still doesn't understand."
ProPublica and the Chronicle reviewed the past 100 papers on which Frazier was listed as an author, dating to 2010. Frazier disclosed conflicts of interest in less than 10 percent, and those disclosures often were inconsistent and incomplete.
For example, Frazier served for years as chairman of the medical advisory board of HeartWare International, which was developing a continuous-flow pump with Frazier's help.
A 2008 Securities and Exchange Commission filing shows that HeartWare awarded Frazier options to purchase the equivalent of 7,142 shares in its newly formed U.S. company at a pre-set price. Frazier said he held the options until March 2009, when he transferred them to his son, Todd, a musician. Todd Frazier exercised the options between 2010 and 2011, collecting proceeds totaling $130,813, according to financial documents provided by Berg.
HeartWare's stock more than doubled in value between early 2009 and the end 2011 as physicians tested the device in a pair of key clinical trials. The elder Frazier played a leading role in the research, implanting the pumps in numerous St. Luke's patients in those years and speaking glowingly of them in HeartWare's corporate press releases. But when those studies were published in 2012 and 2013, Frazier disclosed no conflicts, even as some of his fellow authors did.
"There were no conflicts to report in 2012 and 2013," Frazier wrote to reporters, pointing out that neither he nor his son had any financial interests in the company by then. "It never occurred to me that Todd's having owned and sold the options (by 2011) was a conflict."
Most major medical journals require researchers to disclose financial conflicts, including stock options, dating back three years from the time a paper is submitted for publication.
In the years that followed, from mid-2013 through 2016 — the only period for which federal data is available — device makers paid Frazier more than $44,000 for travel, meals and work on their behalf. He was listed as the primary investigator on research grants that brought in another $56,000 to St. Luke's and Texas Heart in 2015 and 2016, according to payment data compiled by the Centers for Medicare and Medicaid Services.
But more often than not, Frazier did not disclose those payments in related research papers.
After reporters asked the New England Journal of Medicine about Frazier's omissions in twospecific studies and a letter, editors at the journal contacted Frazier for a response. Journal spokeswoman Jennifer Zeis later said Frazier agreed to submit revised disclosure forms, which will be posted online.
"We expect the disclosures reported by authors to be complete and accurate," she wrote in an email.
Frazier said he doesn't know which companies paid for his travel or consulting fees.
"I have personally never sent a bill," he wrote, "and don't know what is charged for anything I do."
In 2010, two years after the hospital became aware of questionable research practices in Frazier's program, Frazier turned 70 and, he said, began to transition into a new role, continuing to direct research at Texas Heart Institute while allowing younger physicians to take the lead on most transplants and pump implantations.
But even as Frazier dedicated more time to his goal of developing an artificial heart, he continued operating on patients. During those years, his LVAD outcomes lagged far behind those of his peers, Medicare data shows.
From 2010-15, Frazier implanted long-lasting left ventricular assist devices in 63 Medicare patients, according to a ProPublica review of federal data. Some 31 of those patients — nearly half — did not survive a year, one of the highest mortality rates in the nation.
That was nearly double the 25 percent one-year mortality rate for Medicare patients who received LVADs from other St. Luke's surgeons during the same period; the national rate for Medicare was 28 percent. (See how we conducted our analysis.)
Frazier took issue with ProPublica's analysis, saying it was "grossly unfair" to focus only on Medicare patients rather than the larger pool of patients the hospital treats, though he did not provide data showing his overall outcomes. "I implant devices in people, not ‘Medicare patients,'" Frazier wrote. "I have never known what insurance carrier any patient has."
Researchers commonly compare outcomes using Medicare data because it represents tens of millions of patients and because data for privately insured patients is not publicly available.
Frazier also said he was rarely the lead surgeon during his final five years operating, but when asked about this contention, St. Luke's said it stood behind the accuracy of the numbers it submitted to Medicare.
Frazier said the decision for him to stop operating full time in 2015 was his and had nothing to do with surgical outcomes. At the age of 75, he said, he was ready to slow down. It was a quiet exit from the operating room for a surgeon who had reportedly performed more heart transplants and implanted more LVADs than anyone in the world; there was no public announcement.
Three years later, Frazier is still called upon at times to assist with complicated operations, and he continues to be featured in St. Luke's marketing materials. His staff bio on Texas Heart's website calls him a "living legend."
Frazier's supporters say he has devoted his life to helping patients. Many in Houston and across the country, they say, would not be alive if not for Frazier's willingness to take the most difficult cases.
Doug Shonkwiler counts himself among them. He was so grateful, he gave his son the middle name Frazier.
In 2005, Shonkwiler, then a 37-year-old aerospace engineer in Fort Worth, drove himself to St. Luke's seeking help for persistent heart troubles. After some initial tests, he remembers a Texas Heart cardiologist telling him, "You only have a few hours to live."
Shaken by that prognosis, Shonkwiler agreed to let Frazier implant a HeartMate II in him, and he is glad he did. A year later, Frazier removed the device after concluding it had worked as he'd long predicted, relieving the strain on Shonkwiler's diseased heart and allowing it to recover. Shonkwiler remained in good health for another decade before returning to St. Luke's in 2016 to receive a transplant.
If not for Frazier, Shonkwiler, now 50, believes he would be dead: "Dr. Frazier has been really good to us," he said. "I can't imagine what our life would be like without him."
In the April phone interview, Frazier said he was disappointed to learn from a reporter that colleagues and administrators had questioned his methods over the years. He said Cooley, the famed surgeon who was his mentor, once told him there is a price to pay for rising to the top of your field.
"People were always attacking him for one thing or another," Frazier said of Cooley. "He said, ‘Any time you're at the top of your profession, people are going to take a shot at you all the time.' I guess that may have been the case."
In recent years, Frazier has collected numerous honors for his work developing implantable heart pumps, including in April, when he traveled to Nice, France, to receive a lifetime achievement award from the International Society for Heart and Lung Transplantation.
In a video interview played during the ceremony, Frazier acknowledged that his breakthroughs came at a cost: When the field of heart pumps was in its infancy, his first 26 LVAD patients died.
Those losses were painful, he said, but "absolutely necessary."
"Courage is grace under pressure," Frazier said in the video, quoting Ernest Hemingway. "I think that's the one thing you have to have. You have to be able to do things that may or may not result in a favorable outcome, calmly and as accurately as you can — that may in fact result in the death of a patient."
After the video ended, Frazier was invited onto the stage. There, he posed for photos while the world's leading heart and lung transplant surgeons stood and applauded.
Baylor St. Luke's in Houston was known for handling complex heart transplants. But when Travis Hogan was a patient there, he didn't know that the program was undergoing a series of dramatic changes. He never got his heart.
This article first appeared May 16, 2017 on ProPublica.
By Mike Hixenbaugh, Houston Chronicle, and Charles Ornstein, ProPublica
In early 2014, when Travis Hogan’s malformed heart was failing, his longtime doctors at Texas Children’s Hospital referred him to Baylor St. Luke’s Medical Center, long recognized as one of the best in the country for complicated heart transplants.
Hogan, then 29 and living at his family’s home in Pasadena, Texas, didn’t know it, but the iconic program was undergoing a series of dramatic changes.
Two years earlier, the transplant program slipped into turmoil when several top physicians left for a competitor. In the years that followed, patients at St. Luke’s waited significantly longer than the regional or national average for new hearts.
In 2015, as Hogan’s health declined after more than a year on the list, he was dealt two additional blows. First, hospital staff took him off the active transplant waiting list in November 2015, citing his worsening liver as cause for concern, which his mother, Georgeann Hogan, said she did not know until told by a reporter this week.
Then, around that same time, hospital staff explained that Dr. O.H. “Bud” Frazier, the 75-year-old surgeon who initially agreed to treat her son, was no longer operating. Frazier had been planning to implant a ventricular assist device to aid Hogan’s failing heart and allow his liver to recover until he could receive a transplant, Georgeann Hogan said.
She said nobody told her family why Frazier had stopped operating; Frazier told reporters in an interview in April that he was getting old and was ready to stop.
The change stunned Hogan’s family.
They did not realize that earlier in the year, several patients died shortly after receiving transplants at St. Luke’s, leading the hospital to scrutinize the heart program and adopt a more conservative approach.
It also hired a new lead surgeon, Dr. Jeffrey Morgan, who arrived in early 2016. Hospital staff told the Hogans that Morgan would pick up where Frazier left off with his plans for a ventricular assist device, Georgeann Hogan said.
But after Travis Hogan was admitted to the hospital in February 2016, St. Luke’s Heart Transplant Medical Review Board decided he “would not likely survive a combined heart and liver transplant,” the hospital said in a statement. Morgan sent word via Hogan’s cardiologist that he would not be operating, Hogan’s family said, not even to implant the heart assist device.
“That was devastating,” said Hogan’s sister, Regina Tran.
In past decades, patients born with a heart defect such as Hogan’s came from around the country to be treated at St. Luke’s, which was known for its willingness to take the most difficult cases. But in 2016, according to publicly available data, the hospital did not add a single patient with a congenital heart defect to its transplant waiting list; meanwhile, other high-risk patients, such as Hogan, were removed from the list.
Dr. Andrew Civitello, the transplant program’s top cardiologist, remembered a handful of difficult conversations with critically ill patients that year, though he did not refer specifically to Hogan: “‘We wanted and still want to transplant you,’” he said, recalling how the conversations played out, “’but given the current environment, we unfortunately can’t take the risks.’”
Hogan’s family scrambled to find an alternative. Another St. Luke’s physician urged the family to transfer to nearby Houston Methodist hospital, his mother said.
The process took weeks as the family fought to get the insurance company to approve the transfer. At Methodist, doctors implanted a balloon pump to help Hogan’s heart pump blood while he awaited a transplant.
One did not come in time. Hogan died a few weeks later, on May 26, 2016, at the age of 31.
In a written statement, St. Luke’s said Hogan spent 486 days on the active heart transplant list before he was made inactive and later removed, and that the median wait time for a heart transplant in its region for a patient with Hogan’s blood type was 537 days. “Mr. Hogan’s choice to be treated at [St. Luke’s] did not adversely influence his likelihood of obtaining a heart transplant,” the hospital said.
Tran acknowledges that her brother was very sick. But she sometimes wonders whether he might still be alive if he hadn’t spent two years waiting for a heart at St. Luke’s.
“We went there because we were told St. Luke’s was the place to go for help with the most difficult heart conditions,” Tran said. “But when it finally came time for my brother to receive a new heart, they turned us away.”
The hospital and its legendary surgeon Denton Cooley performed some of the world's first heart transplants back in the 1960s. In recent years, though, it has had some of the worst heart transplant outcomes in the country.
This article first appeared May 16, 2017 on ProPublica.
By Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle
The anonymous letter reached Judy Kveton in March 2017. Nearly two months earlier, her husband’s failed heart transplant at Baylor St. Luke’s Medical Center had led to a week of follow-up surgeries, a pair of devastating strokes and then, his death. The donor heart that doctors had implanted in David Kveton was “just not acting right,” Judy remembers the surgeon, Dr. Jeffrey Morgan, telling her hours before she decided to remove her husband from life support.
The letter mailed to her home in nearby Fort Bend County — one page, single-spaced and folded into an envelope with no return address — told a different story.
It said St. Luke’s has had some of the worst heart transplant outcomes in the country. It said other physicians had specifically voiced concerns about Morgan, the program’s lead surgeon. And it said, despite “numerous complications, deaths, and poor outcomes,” administrators had not done enough to correct the problems.
“I feel that David was not given the opportunity he deserved after struggling with his disease for so long.”
Signed, “Concerned.”
The note left Judy in tears. Although it didn’t specify what went wrong with her husband’s transplant, it made her doubt the reasons she and her husband chose St. Luke’s more than a decade earlier, when his heart began to fail. The Houston hospital, which is affiliated with Baylor College of Medicine and the Texas Heart Institute, has long held itself out as one of the best in the world for heart surgery.
But in recent years, the famed program has performed an outsized number of transplants resulting in deaths or unusual complications, has lost several top physicians and has scaled back its ambition for treating high-risk patients, all the while marketing itself based on its storied past, an investigation by ProPublica and the Houston Chronicle reveals.
St. Luke’s heart transplant survival rate, the most important measure of a program’s quality, now ranks near the bottom nationally, according to the most recently published data. Among St. Luke’s patients who received a new heart between the summer of 2014 and the end of 2016, just 85 percent survived at least one year, compared to 91.4 percent nationally.
Put another way, twice as many St. Luke’s patients died within a year as would have been expected, taking into account patient characteristics and illnesses.
In January, the federal Centers for Medicare and Medicaid Services cited the heart transplant program for its significantly worse-than-expected outcomes and threatened to cut off Medicare funds in August if the problems were not fixed, according to a letter obtained by ProPublica and the Chronicle. The program has since submitted a plan of correction and avoided the loss of federal funds.
Many of the program’s troubles are spelled out in data published by the Scientific Registry of Transplant Recipients, which is funded by the U.S. Department of Health and Human Services to track and analyze transplant outcomes. SRTR reports, released twice a year, serve as a scorecard for transplant programs, capturing and presenting data on patient survival that spans a rolling 30-month period.
The hospital says it made changes when outcomes began to decline. After a string of transplant patient deaths in 2015, the program hired Morgan as its surgical director and became more conservative, removing some higher-risk patients from its waiting list. It is also more selective than its peers in its acceptance of donor hearts. Since then, program leaders said, the survival rate has improved.
But the program has struggled in other ways.
In one of Morgan’s first transplant surgeries at St. Luke’s, in early 2016, he sewed shut one of two major veins that carry blood back to the heart, and the patient died a few weeks later, according to six medical professionals familiar with the case.
In another patient’s transplant a year later, Morgan stitched through the other major vein, according to the patient’s cardiologist, though Morgan said the man’s previous cancer treatments complicated the case. After the initial surgery, the blocked vein caused blood to pool in the patient’s head, leading to an emergency repair, weeks of follow-up operations, a three-month hospital stay and ongoing health struggles, including kidney failure.
Then, in January of this year, a heart defibrillator malfunctioned in the operating room during a critical stage of a patient’s transplant. Although the hospital said “a backup defibrillator was nearby and readily available,” the surgeon in that case, Dr. Masahiro Ono, described it differently. He said in an interview that the backup was not easily accessible, forcing him to pump the man’s new heart by hand for nearly 10 minutes.
“I cannot control that part as the surgeon,” Ono said of the device failure, which he said led to an internal investigation. “I tried my best to preserve the function of the heart, but it couldn’t make it.”
The 52-year-old patient died in March after undergoing more than a dozen operations and suffering numerous complications, including strokes, serious infections and organ failure.
Meanwhile, more St. Luke’s patients have lingered in the hospital for weeks or months following their transplants, a sign of slow recovery or possible complications, experts say. Between mid-2016 and mid-2017, half of the program’s heart recipients stayed in the hospital for 27 days or longer after transplant, compared to 16 days nationally. That ranked third longest of 125 programs in the country.
As the problems at St. Luke’s deepened, some doctors at the hospital raised concerns with administrators but said they were ignored. Some even began referring transplant patients to other programs.
Several top doctors have left in recent years, and later in May, Ono plans to leave for a leadership post at a smaller program in San Antonio. The losses have further diminished care, longtime staffers say.
A few months after David Kveton’s death, the hospital posted a video online of Morgan touting the center’s excellence: “I truly believe that patients here get first-rate care that’s unmatched by any other institution locally, regionally, nationally or internationally,” he said, before asserting that the program had performed the most heart transplants in the country, which is not true, and that it had above-average outcomes. The hospital’s website also featured charts that provided a misleading picture of the program’s recent performance.
The video and charts were removed a day after reporters questioned hospital administrators about them in January.
In an interview that month and in response to subsequent written questions, transplant program leaders acknowledged the poor outcomes but said the spike in patient deaths was confined to 2015, during a time of transition.
Transplant program leaders provided data showing that the one-year survival rate for patients who underwent transplants since Morgan’s arrival in 2016 was about 94 percent, though the numbers do not capture the plight of patients who survived after having serious complications.
“We only have had one year with below-expected outcomes in the recent past, 2015, and that’s been corrected,” Morgan said.
Hospital officials said if St. Luke’s has lagged behind its peers in measures of quality — including survival rates — it is primarily because the program treats older, sicker patients compared to many other programs. They also said more of their patients lack insurance coverage or the means to pay for rehabilitation, leading to longer hospital stays, though publicly available data shows that their patients have similar coverage compared to other hospitals.
“Heart transplant patients often are very sick individuals who have undergone years of prior heart procedures, and sometimes even previous transplants or device implants to keep their heart beating, and often battle other illnesses and diseases — all of which can complicate a heart transplant,” the hospital said in a statement.
Officials said the same was true of each of the patients who suffered poor outcomes and whose families spoke to reporters for this story.
Other programs have found ways to post better results while performing transplants for critically ill patients.
Houston Methodist hospital, a short walk from St. Luke’s at the Texas Medical Center, performs transplants on heart failure patients who, overall, are older and in more dire condition than patients at St. Luke’s, according to SRTR data. Yet Methodist patients who received transplants from mid-2014 to the end of 2016 were significantly more likely to survive a year afterward.
“St. Luke’s and Texas Heart Institute really paved the way for complex heart surgery, particularly heart transplants, to become a routine lifesaving procedure,” said Dr. Tom MacGillivray, who took over as the lead heart transplant surgeon at Houston Methodist in 2016 after nearly two decades at Harvard University and Massachusetts General Hospital.
“To see them having trouble, that should be a concern for all of us.”
Judy Kveton (pronounced KWEET-on) remembers feeling awestruck by the history of St. Luke’s each time she entered the conjoined buildings it shares with the Texas Heart Institute. A museum near the entrance is filled with medical artifacts from past achievements.
It was here that famed surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s, and where his protégé, Dr. O.H. “Bud” Frazier, has pursued a lifelong quest to develop a complete mechanical replacement for the human heart.
Decades later, the hospital has continued to promote itself based on those triumphs.
That’s why, when David Kveton, a construction worker, had an opportunity to transfer to another hospital in 2012, he and his wife decided to stick with St. Luke’s. His cardiologist, Dr. Biswajit Kar, was part of a team of physicians — including two other cardiologists and a surgeon — hired away from St. Luke’s that year to start a heart transplant unit down the street at Memorial Hermann Heart & Vascular Institute.
“He tried to get us to come with him,” Judy said. “But we thought, ‘This is the best heart hospital in the world. Why risk transferring to someplace just getting started?’”
Many St. Luke’s patients made the opposite choice. In 2013, the year after the doctors left, St. Luke’s transplant cases dropped by more than half, to 25, as dozens of heart failure patients shifted to the new program.
Judy said she observed declines in her husband’s care at St. Luke’s in the years that followed, a period that coincided with other major changes at the hospital. A year after the team left for Memorial Hermann, St. Luke’s longtime owner, the Episcopal Diocese of Texas, sold the hospital to Catholic Health Initiatives, a Colorado-based nonprofit hospital chain.
In 2014, CHI entered into an ambitious agreement with Baylor College of Medicine to build a new medical campus, including a $916.8 million, 650-bed hospital to replace its aging facility in the Texas Medical Center.
CHI’s rapid expansion was too much, too fast, and the chain amassed deep debt, according to the nation’s two largest credit-rating services. Last year, they downgraded CHI’s debt, with one specifically citing the organization’s “weak (financial) performance” in Houston as a cause for concern. A series of layoffs, staffing changes and other cost-cutting decisions since then hurt patient care at the chain’s flagship Texas hospital, according to several current and former St. Luke’s physicians. More changes could be afoot: CHI is in the midst of merging with another chain to become one of the nation’s largest nonprofit hospital operators.
Gay Nord, the hospital’s president, denied that staff cuts affected care in the heart transplant unit, but in 2015, two years after the CHI purchase, the program took a dramatic fall. Among 14 patients who received a heart transplant in the first six months, five died in less than a year, far more than would be expected. The program slowed after that, performing just six transplants in the second half of the year; one recipient died. (Doctors performed another that year as part of a multiorgan transplant, which doesn’t count toward outcome figures.)
Muta Melton was among the deaths. She got a call on her 48th birthday, May 31, to let her know St. Luke’s was receiving a heart for her. After initial complications, the outlook seemed bright. Melton was moved out of intensive care and even started walking and putting on her own clothes. “She was so excited to come home,” said her mother, Sheila Cram. “She looked good.”
Melton never left the hospital. She died six weeks after her transplant of a raging infection. “Things went downhill very, very quickly,” said Melton’s daughter, Roseanna McLaren. “I was not expecting her to pass at all. It happened, I don’t know, in maybe 36 hours.”
Both McLaren and Cram said they were unaware of the program’s recent struggles until they spoke to a reporter. “I thought that was supposed to be the best hospital,” Cram said. “That’s what I was told. That’s what everybody says. But evidently not.”
Behind the scenes, the program was reeling. Dr. Hari Mallidi, one of its leading surgeons, left that summer for a position at Brigham and Women’s Hospital in Boston, a teaching hospital affiliated with Harvard Medical School.
Mallidi had come to St. Luke’s three years earlier, just before the team of doctors left for Memorial Hermann. When he started, he said, outcomes were “trending in the wrong direction,” but he instituted “some basic changes, and things got a lot better.” A review of SRTR data confirms that the program’s one-year survival rate improved during Mallidi’s tenure leading up to 2015.
The CHI acquisition in 2013 and the resulting transition, he said, caused “a lot of bumps in the road,” which he declined to specify. Mallidi said he concluded, even before the string of patient deaths in 2015, that “leaving was better for my own academic development.”
Around that same time, Frazier, the surgeon who started the transplant program in 1982 and had reportedly performed more transplants than anyone in the world, also stopped operating regularly.
At the start of 2016, a 42-year-old surgeon arrived from Detroit to take over.
Morgan was an unconventional pick to lead a heart and lung transplant program as prominent as St. Luke’s. Top programs typically seek surgical leaders who have elite skills in the operating room while also conducting groundbreaking research.
But Morgan was relatively early in his career, having been the lead surgeon on just 18 heart transplants in the previous five years at Henry Ford Hospital in Detroit, according to numbers provided by St. Luke’s. The program is smaller and less prestigious and had somewhat worse-than-expected outcomes toward the end of Morgan’s time there.
Before leaving, Morgan was assistant director for heart transplants and the primary surgeon for mechanical heart pumps.
The team at St. Luke’s saw potential. Dr. Billy Cohn, a longtime heart surgeon at St. Luke’s who now runs a medical device innovation lab for Johnson & Johnson at the Texas Medical Center, led the hiring committee that selected Morgan.
They chose him, he said, despite his relative lack of surgical experience, because he was “an academic superstar,” having published numerous studies about advanced heart failure and having served as a reviewer and editor for medical journals.
Cohn stopped operating full time by late 2016 but remains on staff at Texas Heart Institute and Baylor, and he is still called upon sometimes to assist with complex surgeries.
“It was a bold move for him to come in and take this job,” Cohn said of Morgan. “It was a bold move for us to offer it to him.”
Some of Morgan’s work in Detroit has been called into question. Since moving to Houston, he has been named in two malpractice lawsuits in Michigan’s 3rd Circuit Court.
In one, filed in March 2017, a widow alleged that Morgan made a fatal error during a December 2014 operation to implant a pair of mechanical heart pumps in her husband, leading to an embolism in his brain. The hospital agreed to settle the case for an undisclosed amount of money a month after it was filed. An attorney for the patient’s widow declined to comment.
In another, a patient accused Morgan of failing to properly perform his quadruple heart bypass in July 2015. Later, another physician determined the original bypass surgery by Morgan “was performed incorrectly” and needed to be redone, according to the complaint filed this January. Morgan has been dropped as a named party in the lawsuit, although the case centers on his actions and continues against the hospital. The hospital denied the allegations in a March 1 court filing. The patient’s lawyer declined to comment, as did the hospital.
“To the best of my knowledge, the medical care that I provided in these cases met or exceeded applicable standards,” Morgan wrote in response to written questions.
Cohn acknowledged Morgan has made surgical “errors” since coming to St. Luke’s, including in his first weeks on the job, when he stitched through a major vein while implanting a new heart in a patient, blocking the flow of blood. Cohn remembered how physicians tried to figure out what had gone wrong when the patient’s condition began to decline after the transplant.
The patient died a few weeks later.
“Was it because he was cavalier, or he didn’t care, or he wasn’t skilled?” Cohn said. “It was none of those things. He just cut in the wrong place.”
Morgan said federal patient-privacy requirements prevented him from discussing the case without the family’s approval.
Cohn and three other medical professionals also confirmed that Morgan stopped performing lung transplants not long after his arrival after some of his initial patients experienced complications. Dr. Steve Singh, another cardiac surgeon who has since left, and then Ono took over until a new lung transplant surgeon was hired a year later.
“Was it hubris for Jeff to say, ‘I’m going to do lungs?’ “ Cohn said. “We put him in that position and said, ‘You’re the chief, man. Go for it.’ We handed him the reins. Was that our error? Yeah, maybe we should have said, ‘Dude, you don’t have the [experience] to be a lung transplant guy. We’re going to shut the program down until we find somebody.’”
Although Baylor’s hiring announcement noted Morgan’s expertise in treating patients with lung failure, Morgan said in response to written questions that “it is rare for a surgeon to focus on both heart and lung transplants.”
Former St. Luke’s cardiologist Dr. Roberta Bogaev said she asked administrators to commission an external review toward the end of Morgan’s first year at the program, in late 2016, and she began referring some of her most challenging heart failure cases elsewhere.
“It becomes very ethically challenging to recommend transplant if you don’t have that confidence level in your surgeon,” Bogaev said.
Surgical leadership was not her only concern. She said the loss of many experienced nurses and specialists following CHI’s acquisition — including in infectious disease, critical care and pathology — likely led to poorer transplant outcomes. And the policies of new hospital leadership restricted physicians’ ability to pursue innovative research, she said.
Bogaev left the hospital in early 2017 after taking a job in Virginia, primarily to be closer to family.
“I can tell you I have patients who would not be alive today if not for the program at Texas Heart Institute, and I’m a better physician because of the time I spent there,” Bogaev said. “But there was a clear change in direction of the whole program and the spirit of the program. And certainly the staff felt it, the patients felt it, and I am confident it caused a lot of the physicians as well as patients” to leave.
Dr. Deborah Meyers, the medical director of the heart failure program at St. Luke’s until early 2017, also raised concerns both before and after Morgan arrived.
“I had multiple conversations with multiple medical administrators during my tenure who were unwilling to get an external review to address the problems and unwilling to make substantial changes,” she said. Meyers, who now practices cardiology in Salinas, California, said she also referred some of her patients in 2016 to other hospitals because of her concerns.
“I told a couple of the patients [whom] I just loved that, ‘I want you to go to other institutions. I don’t feel good about our program.’ That’s true. And that’s a terrible thing.”
She likened those conversations to “a mother saying somebody else is going to take better care of you than I can. It’s a heartbreaking situation.”
Dr. Todd Rosengart, the chair of surgery at Baylor College of Medicine, played a leading role in hiring Morgan and said he considers him among “a number of luminaries” of surgery he has recruited to Houston in recent years. Morgan, like most physicians who practice at St. Luke’s, is an employee of Baylor, where he is a professor and chief of cardiothoracic transplantation.
Dr. Paul Klotman, the medical school’s president and chief executive, said in a statement that Morgan “has proven to be a talented transplant surgeon with excellent outcomes.”
The hospital also agreed to put reporters in touch with heart transplant patients who were pleased with the care they received, including Karim Rashid, a 52-year-old investment banker. He received a transplant last Thanksgiving after suffering from a rare inflammatory condition that caused heart failure several years earlier.
“I have nothing but excellent things to say,” said Rashid, who credits Morgan and his other St. Luke’s physicians with saving his life.
Morgan said referrals to his program were up significantly in 2017 from a year earlier and are up again this year.
Despite the early problems, Cohn said he does not regret recruiting Morgan. He said Morgan’s “surgical skills have come a long way” over the past two years, and he believes hiring him will work out in the long run, even if he never becomes one of the best in his field.
“Is it possible that someday Jeff is one of the most distinguished and experienced heart surgeons in the country?” Cohn said. “I don’t think so. I don’t think he’s that guy. … Mainly because he is so focused on academia, and that takes a lot of time.
“Is it possible that he will be highly respected and run a big program and do a great job? I expect so.”
Judy Kveton knew nothing about Morgan’s background or the concerns raised by his colleagues when Morgan walked into a waiting room in the early-morning hours of Jan. 26, 2017, following her husband’s transplant.
“The surgery went well,” she remembers Morgan saying. “Everything is fine.”
Morgan recalls that conversation differently than Judy and three other family members who were in the room. “After the surgery, I thoroughly explained to Mrs. Kveton that her husband was critically ill and was on a lot of medication to keep his blood pressure up,” he wrote in response to questions.
A day later, David Kveton was taken back into surgery. Doctors connected him to a life-support machine that circulates oxygenated blood through the body, doing the work of both the heart and lungs, in an attempt to give the new heart time to strengthen.
It was the first of several follow-up procedures that week.
“Nobody really told us anything,” Judy said. “But at some point, after a few days of this, we realized something wasn’t right.”
The downward spiral is detailed in David’s medical records: On Jan. 28, doctors inserted a balloon pump into the donor heart, an attempt to increase its pumping strength, but improvement was marginal. Three days later, a CT scan revealed he had likely suffered a stroke, though family members say they were not told of bleeding in his brain.
Six days after the transplant, Morgan surgically removed David from the bypass machine, hoping the heart had grown strong enough. Soon after, he developed an irregular heart rhythm and had to be taken back to an operating room, where Morgan reconnected him.
Afterward, Morgan called Judy, who had gone home for the night to rest: “Everything went fine,” she remembers him saying. “But we’re going to have to take out this heart, and we’re going to have to put in an artificial heart until we get him another transplant.”
She was stunned. After all her husband had been through, would they really start over?
It was the last time she spoke to the surgeon. Early the next morning, a nurse called to tell her something had gone wrong and that she and her children should make their way to the hospital. Once they arrived, the nurse quietly told Judy her husband had suffered another stroke. Hours later, a neurologist confirmed David might never recover normal brain function. That’s when his family decided to withdraw life support.
“Turn him off,” Judy remembers saying. “My husband wouldn’t have wanted to live like this.”
He died on Feb. 2, 2017, at the age of 64.
That afternoon, back at home, Judy said she got a call from Frazier, the world-renowned transplant surgeon who remains active in research at Texas Heart Institute and whose image is prominent throughout St. Luke’s online marketing materials. He asked for permission for the hospital to perform an autopsy on her husband:
“Miss Kveton, we haven’t lost a patient this soon after a transplant like this since the ‘80s,” she remembers Frazier telling her. “This shouldn’t have happened. I would like your permission to go in, I want to take that heart out. I want to find out, did we twist something putting it in? Or was it not screened properly?”
In a written response to questions, Frazier said he recalls calling Judy but not the details of the conversation. He said it’s common to perform autopsies when patients die after receiving transplants to “learn as much as possible from our surgeries, no matter the outcome.”
Judy gave permission, then never heard back. Instead, she received a bill for more than $1 million for the transplant and her husband’s final week in the hospital.
For reasons unknown to her, Medicare was refusing to pay, and now St. Luke’s billing department was writing to collect.
Two days after David Kveton’s funeral, Morgan was at the helm of another transplant that went poorly.
Lazerick Eskridge had been on the heart waiting list at St. Luke’s since 2015, a little more than two years, when he and his wife, Lisa, received word the hospital had a heart for him on the night of Feb. 8, 2017.
Lazerick, a Navy veteran, also had been given an opportunity to transfer to Memorial Hermann years earlier when his cardiologist, Kar, left to start the transplant program there. Like the Kvetons, the Eskridges couldn’t imagine leaving a hospital as renowned as St. Luke’s.
Finally, it seemed, their patience was about to pay off.
The morning of the surgery, they were greeted by Ono, the surgeon who soon plans to leave St. Luke’s. He told them he would be performing the transplant. But later that night, after hours of surgery, it was Morgan — a doctor the Eskridges had never met — who emerged from the operating room. Ono, Lisa was told later, had been tapped for a lung transplant.
Morgan told her “everything was fine,” Lisa said. “I was so relieved and so thankful.”
Less than an hour later, a nurse arrived in the waiting room with a much different message: Something was wrong; her husband was back in surgery and in critical condition.
Although Morgan said he thoroughly explained the situation to the family, Lisa said she doesn’t remember anyone telling her specifically what had gone wrong that night. All she knew was that her husband’s new heart wasn’t pumping enough blood, and something had caused his head to swell grotesquely. Later, when she visited him in the intensive care unit, she said his eyes were bulging from his face.
“It didn’t even look like him,” Lisa said.
Over the next several days, Lazerick underwent a series of follow-up surgeries and procedures to remove excess fluid. Like David Kveton, he was put on the heart-lung bypass machine for several days while doctors worked — doing what, Lisa was not sure.
Finally, after a week, Lazerick emerged with a marginally functioning heart — but also suffering from kidney failure, multiple infections and an injured right diaphragm that now prevents his lung from inflating completely. He remained in the hospital for three months and lost more than 70 pounds.
The year since then has been a struggle, he said.
Lazerick, now 47, had long suffered from congestive heart failure — a side effect of chemotherapy treatments two decades ago — but his kidneys and lungs had always been fairly strong. Since his heart transplant, he has been in and out of the hospital with breathing difficulties, including in December, when he spent weeks connected to a ventilator. When he’s not in the hospital, his days are consumed with medical appointments.
He must undergo dialysis three times a week, a treatment that flushes toxins from his body — doing the work of his failed kidneys. The exhausting cycle leaves him bedridden half the week; the other days are spent at physical therapy sessions.
The Eskridges were surprised to learn from a reporter that the federal government had cited St. Luke’s for poor heart transplant outcomes. That prompted them last month, more than a year after the transplant, to ask Lazerick’s cardiologist, Dr. Joggy George, if he could tell them more about what had gone wrong.
A Chronicle reporter sat in on the appointment at George’s office in St. Luke’s medical tower, a short walk from the hospital. What the doctor said left Lisa in tears.
George, a private practice transplant cardiologist, had stopped by the operating room to check on Lazerick shortly after his transplant. The medical team, he said, was preparing to move him back onto the operating table and reopen his chest.
George said he was later told by others in the room that a major vein connected to the heart must have been stitched through during the transplant, effectively pinching the vessel shut and causing blood to back up in Lazerick’s head.
George explained that many of Lazerick’s problems since then — his kidney failure, his breathing struggles, his inability to keep food down — may trace back to the blocked vein and the string of emergency operations and complications that followed.
“I realize this is very difficult for you to talk about and think about,” George told the Eskridges, before handing Lisa a box of tissues. “This was probably the darkest hour of your lives.”
After it became clear that blood wasn’t flowing into Lazerick’s new heart, Morgan performed an emergency procedure, connecting a smaller vein directly to the donor organ and permanently bypassing his superior vena cava. Because the bypass vein is smaller, George said Lazerick is at a higher risk of developing clots and must take blood thinners daily.
“I personally have not seen that happen before,” George said, explaining that it’s unusual for a major vein to be sutured closed during a transplant.
Medical records that the hospital released to the family, more than 6,800 pages in total, corroborate much of what George said, though nowhere do they explain how the vein became blocked.
“It’s kind of a shock,” Lazerick said, “to learn something like this could happen to you and nobody tells you about it.”
In a statement, Morgan said the vein tissue was “severely abnormal” because of Lazerick’s past cancer treatments and also was distorted by wires attached to the cardiac devices in his chest. Morgan said he used sutures to reinforce the vein’s connection to the heart, but due to “concern for narrowing,” he performed the bypass, which continues to work.
In defending its continued promotion of the heart transplant program as a national leader, St. Luke’s officials provided data showing that patient survival rates rebounded after Morgan’s arrival.
In February, Lazerick marked the first anniversary of his transplant. Statistically, that made him one of the success stories.
For Judy Kveton, the past year has been a frustrating search for answers.
She has spent hours sifting through stacks of her husband’s medical records, more than 2,000 pages, searching for passages that might tell her why he died. It’s hard to make sense of any of it, she said, but there are clues.
On the night of the initial surgery, an anesthesiologist, Dr. Manu Sethi, wrote a report noting that he observed complications after the transplant: “Multiple attempts to come off pump,” Sethi wrote, then indicated David Kveton was receiving drugs to strengthen heart contractions and increase his blood pressure.
Two days later, a cardiologist, Dr. Ajith Nair, wrote a note in David’s electronic medical record that included a hypothesis about what was causing the transplant to fail: “Suspect primary graft dysfunction, possibly due to ischemic time,” Nair wrote, suggesting there may have been too much time between when the transplanted heart was removed from the donor and when it was implanted in David.
Nobody at St. Luke’s ever expressed that concern to Judy, she said, and the medical records released to her didn’t include any other information about the donor heart. She needed the help of a lawyer to get the hospital to release the autopsy Frazier had ordered. When she finally received a copy in October, it only seemed to raise more questions.
The St. Luke’s physician who conducted the autopsy reported signs of a heart attack in the donor heart at the tip of the left ventricle. But the report didn’t draw any conclusions about what factors may have led to David death.
Judy wondered: Was there something wrong with the organ before it went into her husband?
In the fall, after talking with a reporter, she asked the United Network for Organ Sharing for details about the donor heart. She wanted to know what condition it was in, how much time passed before it was stitched into her husband’s chest, how many, if any, other hospitals had rejected the organ before it reached David. The organ-sharing agency initially gave her guidance on how to request some of that information, then abruptly reversed itself, declining to provide records without a subpoena.
“I feel like the entire system is stacked against me,” Judy said in January, throwing her hands up in frustration.
At least she’s no longer burdened by the prospect of owing St. Luke’s more than $1 million. Medicare eventually, without explanation, agreed to pay a small fraction of that amount, relieving her of any obligation.
Still, when she re-reads the anonymous letter — the one that suggests her husband wasn’t given a fair shot — she grows angry that someone at St. Luke’s might know what went wrong but won’t tell her:
University of Illinois at Chicago officials on Tuesday told faculty, staff and students that research misconduct by one of the campus’ star faculty members was an anomaly and there are no systemic oversight problems at the institution.
Still, the university’s president and chancellor also acknowledged Tuesday in emails to ProPublica Illinois that the campus can improve oversight of research, especially when it involves children.
The message to the campus came after a ProPublica Illinois investigation last week revealed how the National Institute of Mental Health recently ordered the university to repay $3.1 million in grant money that it had received to fund one of UIC psychiatrist Mani Pavuluri’s studies on bipolar disorder among children.
NIMH demanded the refund in November after determining there was “serious and continuing noncompliance” by Pavuluri as well as failures by the university’s institutional review board, or IRB, a faculty panel responsible for reviewing research involving human subjects.
Pavuluri’s research remains under investigation by federal officials, according to the university.
“The case of Dr. Pavuluri’s research misconduct is believed to be an isolated event,” Mitra Dutta, the vice chancellor for research, and Anand Kumar, head of the psychiatry department, wrote in a campus-wide email. They said it was the only time in UIC history that grant funds were reimbursed due to human subjects noncompliance.
The university already had returned about $800,000 it had received for two of Pavuluri’s other federally funded studies.
Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adolescents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with the powerful drug lithium.
Pavuluri, a tenured psychiatry professor, violated terms of the federal grant by testing lithium on children younger than 13 although she was told not to. She also failed to properly alert parents of the study’s risks, failed to conduct required pregnancy tests on some girls, and falsified data to cover up the misconduct, records show.
In all, 89 of the 103 subjects enrolled in the study — 86 percent — did not meet the eligibility criteria to participate, records show. They were too young, had previously used psychotropic medication, or did not meet other guidelines to participate.
The ProPublica Illinois investigation revealed lax oversight throughout Pavuluri’s clinical trials. Among other issues, Pavuluri sat on a panel that was responsible for monitoring the clinical trial as it proceeded.
NIMH noted several problems with the university’s review of Pavuluri’s research protocol.
The IRB, according to records, conducted an “insufficient initial review” of Pavuluri’s plans, including not having the research protocol at the time of the review, and then approved an expedited review though it did not have adequate documentation.
The IRB also failed “to request or review the rationale for the change in age range” during the review of an amendment that lowered the age of eligible participants to 10 years old, the records show.
Nor did it identify omissions in consent forms provided to research subjects or their parents, including that lithium is not FDA-approved for children under 12. The forms also did not disclose alternative courses of treatment.
On Tuesday, UIC officials outlined steps they took after identifying problems with Pavuluri’s work when a child enrolled in the lithium study was hospitalized in January 2013. The university reported its findings to NIMH and other federal agencies, initiated an audit of Pavuluri’s research, stopped three of her studies, and alerted about 350 study subjects or their parents about the noncompliance, the statement said.
Following an internal investigation in 2015, UIC suspended Pavuluri’s research indefinitely.
University officials have declined to provide a copy of the investigative report to ProPublica Illinois as well as some of their communications with federal agencies, citing state and federal privacy laws and other reasons. They also have refused to say who participated in the audit or in the internal investigation, citing an ongoing federal investigation.
After reviewing the investigative report, however, Chancellor Michael Amiridis wrote in a letter that Pavuluri’s conduct reflected a “pattern of placing research priorities above patient welfare.”
He ordered a review of her clinical practice, barred her indefinitely from conducting research and directed her to retract several scientific journal articles based on the three studies. Three articles were retracted.
Yet she continued to treat or oversee the care of more than 1,200 patients after 2013, records show.
In Tuesday’s statement, university officials said a review of Pavuluri’s medical practice “demonstrated high quality patient care with appropriate clinical documentation.”
Pavuluri, who joined UIC in 2000, founded the Pediatric Mood Disorders Program for children with bipolar disorder, depression and other disorders, which draws patients from around the country.
She secured about $7.5 million in grant funding from the National Institutes of Health during her years at UIC.
Pavuluri, 55, plans to retire from UIC at the end of June. She made the decision after meeting with her supervisors in February to discuss the NIMH decision and demand for repayment. In an interview with ProPublica Illinois, she said she was shouldering too much of the blame when the university also was at fault.
“It was in their interest to kind of maybe see this as one person’s mistake [rather] than the responsibility of the IRB as well,” she said.
In the statement, university officials said there were no systemic issues of lax research oversight, citing a 2014 audit conducted by the U.S. Department of Health and Human Services. The UIC officials said the audit determined human subjects research “was performed upholding the highest standards in ethical and responsible research conduct.”
But federal agencies did, in fact, find problems beyond those in Pavuluri’s research after conducting an onsite evaluation of UIC’s system for protecting human research subjects in July 2014.
A letter sent by HHS’ Office of Human Research Protections to Dutta later that year said the agencies had determined that, in approving other research projects, university IRBs “sometimes lacked sufficient information to make the determinations required for approval of research.”
The letter cited a study — not a Pavuluri project — that the IRB approved before it had enough information and other studies for which research approval was expedited when it shouldn’t have been.
In emails to ProPublica Illinois on Tuesday, Amiridis, the Chicago campus chancellor, said officials will continue to review IRB processes, while University of Illinois President Timothy Killeen said he is confident the campus handled the matter appropriately.
“UIC takes these matters seriously and is committed to the highest standards of research integrity now and into the future—particularly regarding research issues involving minors,” Killeen wrote.
Doctors would see new mothers sooner and more frequently, and insurers would cover the increased visits, under sweeping new recommendations from the organization that sets standards of care for obstetrician-gynecologists in the U.S.
The 11-page “committee opinion” on “Optimizing Postpartum Care,” released today by the American College of Obstetricians and Gynecologists, represents a fundamental reimagining of how providers, insurers and patients can work together to improve care for women after giving birth. “To optimize the health of women and infants, postpartum care should become an ongoing process, rather than a single encounter, with services and support tailored to each woman’s individual needs,” the committee opinion states.
While an ACOG task force began rethinking its approach several years ago, the guidelines arrive at a moment of mounting concern about rising rates of pregnancy-related deaths and near-deaths in the U.S. As ProPublica and NPR have reported, more than 700 women die every year in this country from causes related to pregnancy and childbirth and more than 50,000 suffer life-threatening complications, among the worst records for maternal health in the industrialized world. The death rate for black mothers is three to four times that of white women.
The days and weeks after childbirth can be a time of particular vulnerability for new moms, with physical and emotional risks that include pain and infection, hypertension and stroke, heart problems, blood clots, anxiety and depression. More than half of maternal deaths occur after the baby is born, according to a new CDC Foundation report.
Yet for many women in the U.S., the ACOG committee opinion notes, the postpartum period is “devoid of formal or informal maternal support.” This reflects a troubling tendency in the medical system — and throughout American society — to focus on the health and safety of the fetus or baby more than that of the mother. “The baby is the candy, the mom is the wrapper,” said Alison Stuebe, who teaches in the department of obstetrics and gynecology at the University of North Carolina School of Medicine and heads the task force that drafted the guidelines. “And once the candy is out of the wrapper, the wrapper is cast aside.”
The way that providers currently care for pregnant women and infants versus new mothers exemplifies this difference. During the prenatal period, a woman may see her OB-GYN a dozen or more times, including at least two checkups during her ninth month. Her baby’s first pediatric visit usually occurs a few days after birth. But the mother may not have a follow-up appointment with her own doctor until four to six weeks after delivery — and in many cases, insurance only covers one visit. “As soon as that baby comes out, [the mom] is kind of an afterthought,” said Tamika Auguste, associate medical director of the MedStar Health Simulation Training & Education Lab in Washington, D.C., and a co-author of the ACOG opinion.
For working mothers, having to wait four to six weeks makes it harder to arrange a check-up.
Some 23 percent of mothers employed outside the home are back on the job within 10 days of giving birth, a 2014 report for the U.S. Department of Labor found; another 22 percent return to work within 40 days. Lack of childcare and transportation can also present significant hurdles to accessing care. According to ACOG, as many as 40 percent of women skip their postpartum visit; for low-income women of color, the rates are even higher.
“You may have a woman that has asthma, is having problems lactating, and is obese, and when they come to see you at six weeks, we have missed the boat here,” Auguste said.
Nor is a single visit enough time to address a new mother’s questions and concerns, especially if she had a complicated pregnancy or is suffering from chronic conditions such as hypertension, diabetes or a mood disorder. “We’re trying to address all of the issues that women are dealing with after having a baby in one 20-minute encounter,” Stuebe said. “And that’s really hard to do.”
Under the new ACOG guidelines, women would see their providers much earlier — from within three days postpartum if they have suffered from severe hypertension to no later than three weeks if their pregnancies and deliveries were normal— and would return as often as needed. Depending on a woman’s symptoms and history, the final postpartum visit could take place as late as 12 weeks after delivery and ideally would include “a full assessment of physical, social, and psychological well-being,” from pain to weight loss to sexuality to management of chronic diseases, ACOG says.
In another significant change, ACOG is urging providers to emphasize in conversations with patients the long-term health risks associated with pregnancy complications such as preterm delivery, preeclampsia and gestational diabetes. “These risk factors are emerging as an important predictor of future [cardiovascular disease],” the recommendations state. “ … [B]ut because these conditions often resolve postpartum, the increased cardiovascular disease risk is not consistently communicated to women.”
Earlier, more frequent and more individualized care could be a step toward addressing the stark racial disparities in maternal and infant health, said ACOG’s outgoing president, Haywood Brown, who has made reforming postpartum care one of the main initiatives of his term. Black mothers are at higher risk for many childbirth complications, including preeclampsia, heart failureand blood clots, and they’re more likely to suffer long-lasting health consequences. They also have higher rates of postpartum depression but are less likely to receive treatment. Regardless of race, for women whose pregnancies are covered by Medicaid, the postpartum period may be their best opportunity to get help with chronic conditions before they lose insurance coverage.
The new guidelines urge doctors to take a proactive approach, helping patients develop a postpartum care plan while still pregnant, including a team of family and friends to provide social and other support. According to ACOG, one in four new mothers surveyed recently said they didn’t even have a phone number of a health care provider to contact with concerns about themselves or their babies.
ACOG isn’t the only organization calling for a reinvention of postpartum care; patient-safety groups, researchers, nurses and midwives have also tackled the issue, recasting the three months after birth as akin to a “fourth trimester.”
“The postpartum period has become a priority,” said Debra Bingham, a professor of nursing at the University of Maryland and executive director of the Institute for Perinatal Quality Improvement who has participated in many of these initiatives.
Some providers, including Brown, who is affiliated with Duke University, are already incorporating some of ACOG’s ideas. Still, putting the reforms into common practice may take years. One of the biggest impediments is insurance reimbursement. Currently, payment for prenatal care, delivery and a single post-birth visit is bundled together into one global fee, creating a disincentive for doctors to see patients more than once, Auguste said.
The disincentives are greater for women on Medicaid, which pays for about half of U.S. births. What’s more, in many states Medicaid coverage ends at two months postpartum. The ACOG opinion didn’t estimate the cost of implementing its recommendations.
Brown agreed that revamping how postpartum care is reimbursed is critical, and insurance representatives — along with members of other medical specialties — were on the ACOG task force that drafted the new guidelines. “I want to make sure that I get some employee health plans and some health systems to adopt this nationally,” Brown said.
Indeed, although the guidelines are aimed at OB-GYNs, they would require changes throughout the maternal care system. That’s what ACOG is hoping for. “It’s really a societal call to action,” Stuebe said.
Much as the role of the addictive multibillion-dollar painkiller OxyContin in the opioid crisis has stirred controversy and rancor nationwide, so it has divided members of the wealthy and philanthropic Sackler family, some of whom own the company that makes the drug.
In recent months, as protesters have begun pressuring the Metropolitan Museum of Art in New York City and other cultural institutions to spurn donations from the Sacklers, one branch of the family has moved aggressively to distance itself from OxyContin and its manufacturer, Purdue Pharma. The widow and one daughter of Arthur Sackler, who owned a related Purdue company with his two brothers, maintain that none of his heirs have profited from sales of the drug. The daughter, Elizabeth Sackler, told The New York Times in January that Purdue Pharma’s involvement in the opioid epidemic was “morally abhorrent to me.”
Arthur died eight years before OxyContin hit the marketplace. His widow, Jillian Sackler, and Elizabeth Sackler, who is Jillian’s step-daughter, are represented by separate public relations firms and have successfully won clarifications and corrections from media outlets for suggesting that sales of the potent opioid enriched Arthur Sackler or his family.
But an obscure court document sheds a different light on family history — and on the campaign by Arthur’s relatives to preserve their image and legacy. It shows that the Purdue family of companies made a nearly $20 million payment to the estate of Arthur Sackler in 1997 — two years after OxyContin was approved, and just as the pill was becoming a big seller. As a result, though they do not profit from present-day sales, Arthur’s heirs appear to have benefited at least indirectly from OxyContin.
The 1997 payment to the estate of Arthur Sackler is disclosed in the combined, audited financial statements of Purdue and its associated companies and subsidiaries. Those documents were filed among hundreds of pages of exhibits in U.S. District Court in Abingdon, Virginia, as part of a 2007 settlement in which a company associated with Purdue and three company executives pleaded guilty to charges that OxyContin was illegally marketed. The company paid $600 million in penalties while admitting it falsely promoted OxyContin as less addictive and less likely to be abused than other pain medications.
Arthur’s heirs include his widow and grandchildren. His children, including Elizabeth, do not inherit because they are not beneficiaries of a trust that was set up as part of a settlement of his estate, according to court records. Jillian receives an income from the trust. Elizabeth’s two children are heirs and would receive bequests upon Jillian’s death. A spokesman for Elizabeth Sackler declined to comment on the Purdue payment.
Janet Wootten, a spokeswoman for Jillian Sackler, acknowledged that, as a result of a “protracted estate negotiation,” payments to Arthur Sackler’s estate “were made over many years through the mid-1990s.” She added, however, that there is no evidence that the note was paid with OxyContin profits.
“There is no differentiation in these documents of assets, profits, debts, or the like, among the various companies, let alone with regard to a specific pharmaceutical product,” she said. “In fact, nowhere do these documents identify the source of funds used to pay the note (or notes).”
Wootten said the Purdue documents “in no way substantiate any suggestion or claim that Dr. Sackler’s and/or his widow’s philanthropy has in any way been funded by OxyContin.”
The three Sackler brothers are deceased. Arthur died in 1987, Mortimer in 2010 and Raymond in 2017. The families of Mortimer and Raymond own 100 percent of privately held Purdue Pharma and form the majority of its board.
Purdue declined to answer questions about the note and the 1997 payment. The company pointed to an existing statement that says “recent news coverage has wrongly characterized the relationship” between Arthur and Purdue and that “neither he nor any of his descendants have ever had any involvement or financial stake in” the success of OxyContin.
OxyContin is one of the biggest-selling opioids in the U.S., with revenues peaking at $3.1 billion in 2010. Purdue promoted OxyContin by showering doctors with junkets and speaking engagements, according to an investigation by the U.S. General Accounting Office. Since 1999, four years after OxyContin was approved, fatal overdoses related to prescription opioids have skyrocketed fivefold to 17,087 deaths in 2016. Earlier data isn’t available, nor is it known how many of the deaths are linked to OxyContin.
The history of Purdue traces back to 1952 when the three brothers — all medical doctors — purchased the Purdue Frederick Co. in Manhattan. Arthur was both mentor and visionary. Arthur was inducted into the Medical Advertising Hall of Fame, which credited him with shaping “pharmaceutical promotion as we know it today.” He pioneered marketing directly to doctors and advertising pharmaceutical products in medical journals. One of his most successful marketing efforts was the promotion of Valium in the 1960s — an effort he directed from a company unaffiliated with Purdue Frederick.
Soon after Arthur died in 1987, his estate sold his one-third interest in the Purdue Frederick Co. to his brothers for $22.35 million, according to the 2003 book, “Pain Killer,” by New York Times journalist Barry Meier. The amount of the note carried on Purdue’s books is the same as the purchase price, indicating that the payment was not made up front. Before paying off the note, Purdue paid interest on it at a rate as high as 14 percent per year, according to the financial documents.
A portion of the note — $2.7 million — was paid to Arthur Sackler’s estate in 1994. It incurred a prepayment penalty of $300,000, likely because it was paid before the note came due in 1998. That left a balance of $19.65 million, according to Purdue records.
When Arthur’s estate settled in 1994 following a lengthy battle between his widow Jillian and his children, the agreement detailed that a note from the Purdue Frederick Company “of at least $19 million” would be included in the new trust.
In 1994, the year that the trust was established, profits of Purdue and its affiliated companies were just under $1 million, according to company documents. The next year, OxyContin was approved, and Purdue’s profits soared — to $11.5 million in 1996 and $32.8 million in 1997, the year that the note was paid off.
Purdue had other successful products before OxyContin, although none on its blockbuster scale. They included another opioid painkiller, MS Contin, as well as antiseptics and laxatives.
Wooten said the payment’s timing was not connected to OxyContin’s growing popularity. “Timing of payments had nothing to do with when funds were available,” she said, adding that it would be “absurd” to suggest that the company or Arthur’s brothers “had insufficient funds to make the estate payments following Arthur’s death in 1987.”
Long before OxyContin was introduced, the Sackler brothers already were notable philanthropists. Arthur was one of the world’s biggest art collectors and a generous benefactor to cultural and educational institutions across the world. There is the Arthur M. Sackler Gallery at the Smithsonian, the Arthur M. Sackler Museum at Harvard University, and the Jillian and Arthur M. Sackler Wing of Galleries at the Royal Academy of Arts in London.
His brothers were similarly generous. They joined with their older brother to fund the Sackler Wing at the Met, which features the Temple of Dendur exhibit. The Mortimer Sackler foundation was the principal donor of the Serpentine Sackler Gallery in London; the Sackler name is affiliated with prestigious colleges from Yale University to the University of Oxford as well as world famous cultural organizations, including the Victoria and Albert Museum in London. There is even a Sackler Rose — so christened after Mortimer Sackler’s wife purchased the naming rights in her husband’s honor.
Now the goodwill gained from this philanthropy may be waning as the Sackler family has found itself in an uncomfortable spotlight over the past six months. Two national magazines recently examined the intersection of the family’s wealth from OxyContin and its philanthropy, as have other media outlets across the world. The family has also been targeted in a campaign by photographer Nan Goldin to “hold the Sacklers accountable” for OxyContin’s role in the opioid crisis. Goldin, who says she became addicted to OxyContin after it was prescribed for surgical pain, led a protest last month at the Metropolitan Museum of Art, in which demonstrators tossed pill bottles labelled as OxyContin into the reflecting pool of its Sackler Wing.
While it doesn’t appear that any recipients of Sackler charitable contributions have returned gifts or pledged to reject future ones, pressure and scrutiny on many of those institutions is intensifying. In London, the National Portrait Gallery said it is reviewing a current pledge from the Sackler Trust.
Against that backdrop, Jillian Sackler, who was Arthur’s third wife, turned to Rubenstein Communications, which has been distributing a “fact sheet” to media reporting on the controversy.
The first item listed was that “Arthur M. Sackler, his widow and heirs, have never financially benefited from the sale of OxyContin.” It went on to say that “Prominent news media, including The New York Times, The Washington Post, TIME, Economist, CNN, the Associated Press, Agence France Press, The Guardian, Huff Post, Art News, etc., have published corrections and clarifications noting the distinction between Arthur M. Sackler and his heirs — who have had no financial interest in the sale of OxyContin — and other branches of the Sackler family.”
Public relations firm BerlinRosen in New York City represents Elizabeth Sackler, who has been openly critical of Purdue Pharma. She has said that none of her father’s descendants “benefited in any way” from the sale of OxyContin while adding: “I stand with all angry voices against abuse of power that harms or compromises any and all lives.”
Her charitable work, however, has received financial support from the side of the family that ran Purdue after her father’s death and earned profits from the sale of OxyContin. In 2011, Purdue Pharma donated $500,000 to a foundation named after Elizabeth’s uncle Mortimer, and the foundation gave the same amount to the Brooklyn Museum for the Sackler Family Curator at the Elizabeth A. Sackler Center for Feminist Art. Elizabeth Sackler is a trustee of the museum and the benefactor of the eponymous center, which is the permanent host of the Dinner Party, an installation by the artist Judy Chicago that features three large tables in the shape of a triangle. There are 39 place settings at the table for famous women, ranging from the mythical Fertile Goddess to the writer Virginia Woolf.
In 2012, the wife of the youngest Sackler brother, Raymond, contributed $5,000 to Elizabeth Sackler’s charitable foundation, which has provided substantial financial support to the feminist center at the museum. A museum spokeswoman and Elizabeth Sackler’s spokesman declined to comment about the donations.
As insurers ask consumers to pay a greater share of their drug costs, it may be cheaper to pay cash than use your insurance card. One expert estimates that consumers could be overpaying for as many as 1 in 10 prescriptions.
This article first appeared December 09, 2017 on ProPublica.
By Charles Ornstein, ProPublica, and Katie Thomas of The New York Times
Having health insurance is supposed to save you money on your prescriptions. But increasingly, consumers are finding that isn't the case.
Patrik Swanljung found this out when he went to fill a prescription for a generic cholesterol drug. In May, Swanljung handed his Medicare prescription card to the pharmacist at his local Walgreens and was told that he owed $83.94 for a three-month supply.
Alarmed at that price, Swanljung went online and found Blink Health, a start-up, offering the same drug — generic Crestor — for $45.89.
It had struck a better deal than did his insurer, UnitedHealthcare. "It's completely ridiculous," said Swanljung, 72, who lives in Anacortes, Washington.
In an era when drug prices have ignited public outrage and insurers are requiring consumers to shoulder more of the costs, people are shocked to discover they can sometimes get better deals than their own insurers. Behind the seemingly simple act of buying a bottle of pills, a host of players — drug companies, pharmacies, insurers and pharmacy benefit managers — are taking a cut of the profits, even as consumers are left to fend for themselves, critics say.
Although there are no nationwide figures to track how often consumers could have gotten a better deal on their own, one industry expert estimated that up to 10 percent of drug transactions involve such situations. If true nationwide, that figure could total as many as 400 million prescriptions a year. The system has become so complex that "there's no chance that a consumer can figure it out without help," said the expert, Michael Rea, chief executive of Rx Savings Solutions, whose company is paid by employers to help them lower workers' drug costs.
Pharmacy benefit managers, the companies that deal with drug benefits on behalf of insurers, often negotiate better prices for consumers, particularly for brand-name medications, Rea said, but that's not necessarily true for some generic drugs. Insurers' clients are frequently employers overseeing large numbers of workers, and the companies are focused on overall costs. So when insurers seek deals for generic drugs, they do so in batches, reaching agreements for groups of different drugs rather than getting the lowest price on every drug.
As a result of these complicated layers of negotiation, which are not made public, different insurers end up paying different prices for individual drugs. Further compounding confusion for consumers, some insurers require a set co-payment for each prescription — say, $15 or $20 — even when the insurer reimburses the pharmacy at a much cheaper rate.
Several companies have emerged to capitalize on consumer anger over the confusing variations in price. The players include not only Blink Health and its better-known competitor GoodRx, but also veteran businesses like the benefit manager Express Scripts, which recently helped to start a subsidiary aimed at cash-paying consumers. Amazon, the online behemoth, is also said to be considering whether to join the fray.
Last Sunday, CVS Health announced plans to merge with health insurer Aetna, a move that would create a corporate behemoth that many have said would have little incentive to serve the needs of regular people. Some consumers say their experience with CVS already demonstrates how easy it is to fall through the cracks. In one case, a customer whose plan was managed by CVS Caremark, the drug benefit manager, would have had to pay more for a drug through her plan at a CVS than what she ended up paying at the same store, with a coupon from GoodRx.
Representatives for insurers and pharmacy benefit managers say cases like Swanljung's are "outliers." "There are three to four billion generic scripts written a year, and in the vast majority of cases, they are going to get a better deal by using insurance," said Mark Merritt, chief executive of the Pharmaceutical Care Management Association, which represents benefit managers.
A spokesman for UnitedHealthcare, Swanljung's insurer, noted that while Swanljung got a lower price for generic Crestor by using Blink Health, he also takes four other prescriptions, for which he got a better deal through his insurance. (Swanljung gave UnitedHealthcare permission to discuss his situation.) Having insurance is clearly valuable, said the spokesman, Matt Burns. In addition, the co-payment for generic Crestor, also called rosuvastatin, in Swanljung's plan is set to decrease significantly in January, in large part because the price of the drug has dropped this year.
Consumers also may face penalties if they don't use their insurance and pay cash to save money. In many cases, insurers won't let them apply those purchases to a deductible or out-of-pocket spending maximum.
Still, many find that leaving their prescription card at home is worth it. Some have found a better deal even at pharmacies that are owned by their drug plan, like CVS.
Susan Thomson, 55, a university lecturer who lives in Summit, New Jersey, is covered by a high-deductible plan through her former employer. Her drug benefits are managed by CVS Caremark, a subsidiary of CVS Health. For at least a decade, she's been using a prescription lotion called sulfacetamide sodium to treat rosacea, a skin condition.
Last year, each time she filled her prescription at a CVS pharmacy, she paid $75.07. Checking the CVS Caremark website this year, she learned that the cost had gone up to $99.03 (or $81.51 if she used CVS's mail order service).
Investigating further, she found that GoodRx offered the same prescription at the same drugstore for $75.57, without her insurance. The prices were even lower at other pharmacies.
"It just doesn't seem right," she said. "I just feel that the pharmaceutical industry and health care industry are pulling these numbers out of thin air."
Michael DeAngelis, a spokesman for CVS, did not dispute the details of Thomson's experience, but said it is rare and attributed the price disparity to her high-deductible plan. Because consumers are responsible for their costs in those plans until they hit their deductible, DeAngelis said it would take them longer to reach it and they might end up spending more in the long run.
Prices can also vary widely from month to month when consumers pay cash, he said.
Drug-discount cards have been around for decades, and retailers like Walmart have also offered cheap generic drug programs, but both were mainly used by people without insurance.
That is changing. Even as more Americans have health insurance since the Affordable Care Act was passed, insurers are increasingly asking consumers to pay a larger share of their costs. In 2016, about five million people in Medicare hit a stage in which they had to pick up a greater share of their expenses.
Reporters at ProPublica and The New York Times examined whether they could get better prices on 100 of the most prescribed drugs, identified by GoodRx, without using their insurance. ProPublica's prescription claims are managed by OptumRx, a large pharmacy benefit manager owned by UnitedHealth Group; The Times's medication coverage for reporters is managed by Express Scripts.
Both reporters found lower prices on GoodRx for at least 40 drugs on the list (many were drugs that can be purchased for $4 at Walmart, without any coupon).
Blink Health also sometimes beat the insurance out-of-pocket costs, but less often than GoodRx. Blink Health recently suffered a series of setbacks when two of the largest drugstore chains, CVS and Walgreens, stopped accepting its discounts, along with a grocery chain, Publix. In November, Blink Health sued its pharmacy benefit manager, which negotiates its prices, claiming that the company, MedImpact, had violated their agreement. MedImpact has not yet formally responded to the allegations in federal court in New York.
GoodRx, a private company founded in 2010, displays the deals it has with nine pharmacy benefit managers, each offering different prices for different drugs.
"We said, let's see if we can gather all these prices and see if we can exploit the variation in these contracts," said Doug Hirsch, GoodRx's co-founder and co-chief executive, "to see if we can provide better value."
Dr. Brad Wainer, a family-practice doctor in Berwyn, Illinois, said he frequently shows patients their options on GoodRx to see if they can get a better price. "Most of them don't believe me until they go and they find it out for themselves," he said.
Consumers may also pay more if they are covered by plans that require them to pay a set co-payment, no matter the cash price. In some of those cases, the insurers require the pharmacies to send them the difference between what they collect from the consumer and what the insurers have agreed to reimburse the pharmacies.
After a New Orleans television station, WVUE, reported last year on this practice, known as a clawback, lawyers across the country filed lawsuits accusing the insurers — including Cigna, Humana and UnitedHealthcare — of overcharging consumers. The companies are contesting the suits.
Several independent pharmacists said there might be safety issues if consumers buy drugs at different pharmacies. If those prescriptions are filled without an insurance card, pharmacy systems may not catch dangerous drug interactions. "That, to me, is a recipe for disaster," said Craig Seither, who owns Fort Thomas Drug Center in Fort Thomas, Kentucky.
Faced with competition, some pharmaceutical companies are cutting deals with insurance companies to favor their brand-name products over cheaper generics. Insurers pay less, but sometimes consumers pay more.
Mary Furman, a retired medical social worker in Charlotte, North Carolina, takes the drug celecoxib, the generic version of Celebrex, to treat her rheumatoid arthritis. When she went to fill a 90-day prescription in April, her pharmacy told her she would owe $96.89 if she used her Medicare plan, offered by SilverScript, run by CVS Health.
Then the pharmacy offered her a deal — $72.25 if she paid cash, a price the worker said was the same the pharmacy would offer any customer. "I was flabbergasted," said Furman, who is 72.
Furman took the deal, and afterward, her husband, Nelson, called SilverScript to report what happened. The representative told Nelson Furman he was "not surprised."
The couple then reported the experience to a company hired by Medicare to investigate fraud, but a representative encouraged her to contact the health plan again.
After reporters sent details of Furman's case to CVS, Nelson Furman said they received a call from the SilverScript president. DeAngelis, the CVS spokesman, blamed the pharmacy for charging the couple more than what their share should have been using their insurance. (Medicare rules require that consumers always get the lower price of their set co-payment and a pharmacy's cash price.)
Now the Furmans are looking at drug coverage for next year, and once again, they see huge variation in prices for that drug and others.
"The prices are all over the map," Nelson Furman said.
Many states have laws that allow the donation of drugs, but they don't have programs that get the drugs safely from nursing homes to those who need them.
This article first appeared December 01, 2017 on ProPublica.
Inspired by a ProPublica story in April that described how nursing homes and their pharmacies nationwide throw away hundreds of tons of valuable medicines — and how one Iowa nonprofit successfully recycles them — two states are working to create similar programs.
Other states, including Vermont, are exploring the idea as well.
“All that medicine is perfectly good and perfectly safe,” said Rep. Nicholas Duran, D-Miami, who co-sponsored a bill in Florida modeled on the Iowa program. “Rather than being burned up, it could be put back to some great use.”
ProPublica’s story detailed how the nursing home industry dispenses medication a month at a time, but then is forced to destroy it after patients pass away, stop using it or move out. Some send the drugs to massive regional incinerators or flush them down the toilet, creating environmental concerns.
In Iowa, a program called SafeNetRx retrieves the excess medication, inspects it and dispenses it for free to needy patients. Almost 80,000 Iowans have used SafeNetRx to obtain medication — from cheap antibiotics to cancer drugs worth thousands of dollars per month.
The state funds the program for about $600,000 a year and in fiscal 2016 it recovered and distributed drugs valued at about $3.4 million. This year it’s on pace to hand out more than $6 million of reclaimed medicine.
Many states have laws that allow the donation of drugs, but they don’t have programs that get the drugs safely from nursing homes to those who need them.
After reading ProPublica’s story, Duran, who is also the executive director of the Florida Association of Free and Charitable Clinics, said he visited a long-term care pharmacy and saw firsthand how much valuable medication was being destroyed.
The people at Polaris Pharmacy Services, he said, told him they’d love to donate the medicine, but can’t legally. The new law would create a program to transfer the drugs so they can be dispensed free to patients, he said.
About $400,000 worth of the drugs Polaris dispenses each month are returned because they’ve been stopped for some reason, said David Rombro, the pharmacy’s chief executive. The drugs come back in the same sterile packaging, untainted and unexpired.
Polaris can get credit for about half the unused medication, but the remaining drugs — worth about $2.5 million a year — must be taken away for incineration, he said. Based on the size of his pharmacy and how many others exist in Florida, he estimates about $50 million worth are destroyed annually statewide.
“It’s perfectly good medication,” Rombro said. “There are people that need drugs that don’t have them.”
In New Hampshire, radio show host Arnie Arnesen became excited about the idea after featuring the ProPublica story and the executive director of SafeNetRx on “The Attitude with Arnie Arnesen.” She pitched the drug donation idea to New Hampshire Sen. Dan Feltes, D-Concord, urging him to make it happen in New Hampshire.
“This makes so much sense,” she recalled saying to the senator. “It even fits in with our thrifty values.”
Feltes is now the sponsor of a New Hampshire bill that would create a commission to research how to start a drug donation program like Iowa’s.
Vermont leaders also say the Iowa program would be a good fit for their state, where the “ethos” favors recycling, being environmentally conscious and improving access to medication, said Meg O’Donnell, director of government relations at The University of Vermont Medical Center. There’s a chance Vermont would even hire SafeNetRx in Iowa to run its program, she said.
“We can say pretty confidently there are some real opportunities,” O’Donnell said.
It costs money for nursing homes or pharmacies to properly dispose of the unused medication, Rombro said. Polaris employs two people full time to process the excess drugs, and pays about $5,000 a month to incinerate them.
Other companies and nursing homes simply flush them and trace amounts of pharmaceuticals have been found in water supplies throughout the country. In Florida, wastewater is treated and then pumped into the aquifer, or used to water lawns and golf courses, said Jay Sheehan, senior vice president of Woodard & Curran, a company that runs two utilities in the state. But Sheehan said the wastewater is not treated for possible pharmaceutical contamination.
“We have a problem and we need to collectively address it,” Sheehan said. “The more we can [donate excess drugs] the better we are as a holistic community, because everything is connected.”
