Kathleen Hoechlin lost control as she crested a small jump on her final ski run of the day at California's Mammoth Mountain two years ago. She landed hard on her back, crushing one of the vertebra in her lower spine "like a Cheerio," she said.
An air ambulance flew Hoechlin, then 32, to an airport near Loma Linda University Medical Center in Southern California's Inland Empire. There she underwent emergency 12-hour surgery to remove bone fragments and replace the crushed vertebra with a metal cage that was fused to the rest of her spine with rods and screws to provide structure and stability.
Hoechlin was still in intensive care when her husband, Matt, got the bill for the 300-mile air ambulance ride. The total: $97,269. The company wasn't in their health plan's network of providers, and the PPO plan they had through Matt's job agreed to pay just $17,569.
The Hoechlins were on the hook for the $79,700 balance.
"It was just shocking," said Hoechlin, who worked as a business analyst project manager in Highland, California. "I was just focused on, 'Am I going to be able to walk again?' I thought I was going to have a heart attack when he told me."
A California law that took effect Jan. 1 aims to protect consumers from such enormous bills for out-of-network air ambulance services. The measure limits what consumers owe if they're transported by an air ambulance that's not part of their insurance network to the amount that they'd be charged if they used an in-network provider. The health plan and the air ambulance provider must then work out payment between themselves.
But the new law won't protect consumers like Hoechlin, whose health plan isn't regulated by the state. Matt's employer pays its workers' medical claims directly rather than buying state-regulated insurance, a common arrangement called "self-funding." Self-funded plans are regulated by the federal government and generally not subject to state health insurance laws.
In this regard, the new air ambulance law is like laws in California and other states that protect consumers from surprise medical bills: They don't apply to residents in federally regulated health plans. Those plans cover about two-thirds of people who get insurance through their jobs nationwide.
Federal legislation is the best solution for those consumers, experts say. One of the leading bills before Congress to address surprise medical bills includes air ambulance charges. But that, and other measures, are up in the air, although members of Congress say they are working to reach an accord this year.
Another legal wrinkle affects even consumers with health plans the state does oversee. Under the federal Airline Deregulation Act of 1978, states aren't permitted to regulate the "rates, routes, or services" of air carriers, including air ambulances. It's unclear whether the California law, which doesn't spell out a payment rate for a health plan, would be preempted by federal law if challenged in court, according to legal experts.
"It's a very big step in balance billing, but it's not a definitive one," said Samuel Chang, a health policy researcher at the Source on Healthcare Price and Competition, a project of the University of California-Hastings.
Although people rarely need to be transported by a helicopter or airplane for medical care, it's often an emergency when they do, and they're unable to shop for an in-network provider, even if their health plan offers one. According to a federal Government Accountability Office analysis of air ambulance private insurance claims, 69% of air ambulance transports were out of network in 2017.
The median price charged in 2017 was $36,400 for a transport by helicopter and $40,600 by plane, according to the report. If an insurer doesn't have a contract with an air ambulance provider, the air ambulance company may bill the consumer for whatever the insurer doesn't pay, a practice known as balance billing.
"The air ambulance issue is such a big deal because it's just such an eye-popping bill," said Yasmin Peled, the policy and legislative advocate at Health Access California, a consumer advocacy group.
Air ambulance providers defend their charges, saying the rates offered by commercial insurance companies barely cover their costs. And public insurance programs often pay even less.
"Seven out of 10 of our transports are Medicare, Medicaid or uninsured," said Doug Flanders, director of communications and government affairs at Air Methods, a large air ambulance company that provides services in 48 states, including California. Medicare pays Air Methods an average of $5,998 per transport, and Medicaid payments are typically half of that, Flanders said via email. That presents a "huge financial challenge," he said.
In recent years, Air Methods has focused on joining the networks of some major insurers, including Blue Shield of California and Anthem Blue Cross of California, Flanders said. In addition to protecting patients, being in network "stabilizes operations and eases the administrative burden of the claims processing procedures created by insurers," he said.
For the past several years, reimbursements by Medi-Cal, the state's Medicaid program, for air ambulance services have been bolstered by funds collected from penalties for traffic violations. But the penalty was slated to sunset in 2020. Under the new California law, the state will extend supplemental funding of Medi-Cal payments for air ambulance services until 2022. Without that agreement, the rates would have reverted to much lower 1993 levels.
With the higher Medi-Cal rates, the industry supported the bill, including the prohibition on balance billing. In fact, the California Association of Air Medical Services sponsored the bill, although it didn't respond to requests for comment.
In contrast, when other states have tried to prohibit air ambulance balance billing, the companies have often successfully challenged those laws on the grounds that the federal Airline Deregulation Act of 1978 prohibits state rate setting, according to Erin Fuse Brown, an associate law professor at Georgia State University who has studied air ambulance billing.
Legal experts say California's approach may thread the needle where other states have failed.
"I do think the state has a pretty tolerable argument here that they are not regulating rates," said Christen Linke Young, a fellow at the USC-Brookings Schaeffer Initiative for Health Policy. "They are telling the air ambulance providers who they can go to to get paid, but they're ultimately not telling the amount that is getting paid."
Kathleen Hoechlin and her husband, who now live in Riverside, California, eventually negotiated the amount they owed down to $20,000, arguing to the air ambulance firm that by tapping their savings and using money from a GoFundMe campaign, that was all they could afford.
She is now able to walk with only a slight limp. But she continues to deal with severe pain due to nerve damage. She recently underwent a fourth surgery to implant a spinal cord stimulator to interrupt the pain signal to her brain.
"When you look at the bigger picture, at the total amount, we're feeling very fortunate," she said.
Kristie Flowers had been sick with the flu for four or five days in July before the 52-year-old registered nurse from Genoa, Colo., acknowledged she needed to go to the ER.
At Lincoln Community Hospital, about 10 miles from her home on the Eastern Plains of Colorado, doctors quickly diagnosed her with pneumonia and sepsis. Her right lung had completely filled with fluid, and Flowers needed much more intensive care than the 15-bed hospital could provide.
Doctors stabilized Flowers and transferred her by ambulance about 80 miles away to St. Francis Medical Center in Colorado Springs. There, doctors put her on a ventilator for 10 days as they slowly nursed her back to health. After two weeks, she returned to Lincoln Community Hospital for another week of rehab before going home.
After her insurance plan had paid its share, Flowers owed $8,000 in medical bills. A big chunk represented the $3,500 deductible from her employer-sponsored health plan. Never one to let the bills pile up, Flowers went to the bank and took out an $8,000 loan to pay off her medical tab.Bottom of Form
Plans with annual deductibles of $3,000, $5,000 or even $10,000 have become commonplace since the implementation of the Affordable Care Act as insurers look for ways to keep monthly premiums to a minimum. But in rural areas, where high-deductible plans are even more prevalent and incomes tend to be lower than in urban areas, patients often struggle to pay those deductibles.
That has hit patients like Flowers hard as they grapple with medical debt when emergencies happen — but small rural hospitals like Lincoln Community are suffering, too. These facilities often stabilize critically ill patients and then transfer them to larger regional or urban hospitals for more definitive care.
But when the hospitals submit their claims, bills from the first site of care generally get applied to a patient's deductible. And if patients can't afford to cover that amount, those hospitals often don't get paid, even as the larger urban hospitals where patients were transferred get close to full payment from the health plan.
"As soon as we send them to the city, those things start being paid by the insurance company," said Kevin Stansbury, CEO of Lincoln Community, "while we're still chasing the patient around for collections."
The result is financial headaches for patients and a substantial rise in the amount of uncollectible "bad debt" written off by all hospitals during the past few years. According to the Healthcare Financial Management Association, hospital bad debt increased by $617 million to nearly $56.5 billion between 2015 and 2018. More hospitals, especially those in rural areas, are left teetering financially.
At least 120 rural hospitals nationwide have shut down in the past decade. Without changes, advocates say, more will close, leaving patients such as Flowers in remote areas far from access to immediate emergency care.
Shopping On Premiums
According to the nonprofit National Rural Health Association, bad debt for rural hospitals has gone up about 50% since the passage of the Affordable Care Act in 2010.
"People in rural America were buying plans maybe for the first time, but buying plans they couldn't afford," said Maggie Elehwany, the group's vice president for government affairs and policy. The plans "seemed to make sense at the time, until they got sick."
Part of the problem is that consumers primarily shop based on monthly premiums, and insurance plans can lower the monthly premiums they charge by increasing deductibles and copays. Some consumers take the gamble that they'll stay healthy and won't get stuck paying the high deductible. But others simply may not understand they are typically responsible for the full deductible before their insurance kicks in to cover the rest of their bills.
In many rural counties, consumers shopping on their state's health insurance exchange had little choice. This year, about 10% of enrollees, living in 25% of counties, many of them heavily rural, will have access to just one insurer in their local Affordable Care Act marketplaces, according to a Kaiser Family Foundation analysis. (KHN is an editorially independent program of the foundation.)
"The exchanges have never worked the way they were envisioned," Elehwany said. "The goal was you go on your computer and it's going to be like buying an airline ticket, and just shopping around for what makes sense for you. There's no shopping in rural America. You have one choice."
In Colorado, for example, the average deductible in 2017 was nearly $5,800 for a bronze-level plan. According to an analysis by the Colorado Center on Law & Policy, 1 in 4 Coloradans would not be able to afford to pay that deductible over the course of a year. The ability to pay was even worse in rural areas.
Mark Holmes, director of the North Carolina Rural Health Research and Policy Analysis Center, said that incomes are generally lower in rural areas than elsewhere, and that higher-income rural residents are more likely to travel to an urban hospital than to stay local. Lower-income rural residents, meanwhile, generally go to their local hospital, he said, but they are less likely to be able to meet a high deductible.
Rural residents are also less likely to be covered by employer-sponsored plans and, therefore, more likely to face high deductibles than their urban counterparts.
"They may never pay us," said Stella Worley, CEO of the 25-bed Keefe Memorial Hospital in Cheyenne Wells, Colo., near the Kansas line. "They get transferred onto high level of care and the other hospital gets paid. We get paid nothing — a lot."
Worley recalled one patient who had been treated and transferred to a larger hospital. Keefe Memorial wrote off $14,000 in total charges. The patient was billed $1,000 for his deductible and never paid it. Eventually, the unpaid bill went to a collection agency, which takes a 30% cut if it ever collects the fee.
For many rural residents, paying a monthly premium and still facing thousands of dollars in out-of-pocket costs can feel like having no insurance at all. As a result, patients avoid seeking primary care services that could solve minor problems before they devolve into major health issues with much higher costs.
"Some of the people I know in our community trying to get insurance for their employees had a $10,000 deductible, which is really catastrophic insurance," said Rob Santilli, CEO of Gunnison Valley Health, in Gunnison, Colo. "It's not going to help them, and it immediately puts them into bad debt with the first instance when they need coverage."
To be sure, non-rural hospitals have also seen an increase in bad debt. But most city hospitals are part of a larger health system and can weather the storm better than small, independent rural hospitals operating on razor-thin margins.
Colorado has so far avoided the rural hospital closures that have plagued other states. Nonetheless, 22 rural hospitals in Colorado operated in the red last year, according to Michelle Mills, CEO of the Colorado Rural Health Center. That's double the number in 2018.
"We're definitely at a tipping point," Mills said.
Finding Solutions
Hospital and rural health groups across Colorado are lobbying for changes in insurance plan designs to circumvent the impact from high-deductible plans. Lincoln Community's Stansbury suggested that primary care services, which help keep rural hospitals afloat and patients healthy, should be exempt from the deductible to encourage patients to keep up with their care.
Another option would be simplifying billing so insurance plans would pay hospital and doctor bills directly and send patients a single bill of what they owe. That approach would solve a common complaint from patients who struggle to reconcile multiple bills from various hospitals, doctors and other health care providers that stem from a single episode of care. It would also shift the burden of collecting the patient's portion of the bill to insurance companies, and protect the hospitals against uncollectible bad debt, leveling the playing field for the rural hospitals.
The Colorado Hospital Association is working with several state legislators to propose that sort of billing structure during the 2020 legislative session. Stansbury said the approach would also allow rural hospitals to focus on patient care rather than trying to collect payments.
"We just don't have the expertise for billing," he said. "We do it badly."
The National Rural Health Association favors requiring insurance plans that offer Medicare and Medicaid plans in rural areas to also offer exchange plans in those counties. If rural consumers had more options, they might be able to avoid high-deductible plans.
That could minimize bad debt for rural hospitals and pay dividends far beyond health care, Elehwany said.
"When you've got a small rural hospital and it closes, it's a nail in the coffin of that rural community," she said. "How are you going to attract a business? How are you going to keep your school if you don't have physicians? In rural America, health care is really part of the whole infrastructure of the community."
Improving health and lowering costs for the sickest and most expensive patients in America is a dream harder to realize than many health care leaders had hoped, according to a study published Wednesday by the New England Journal of Medicine.
Researchers tested whether pairing frequently hospitalized patients in Camden, New Jersey, with nurses and social workers could stop that costly cycle of readmissions. The study found no effect: Patients receiving extra support were just as likely to return to the hospital within 180 days as those not receiving that help.
"It's my life's work. So, of course, you're upset and sad," said Brenner, who now does similar work with health insurance giant UnitedHealthcare.
The model of care, pioneered in part by Brenner and profiled in a widely read 2011 article in The New Yorker, has inspired dozens of similar projects across the country and attracted millions in philanthropic funding.
"This is the messy thing about science," said Brenner, who won a MacArthur Foundation "Genius Grant" for his efforts. "Sometimes things work the way you want them to do work and sometimes they don't."
The Hope
Many hospital and insurance executives have pinned their hopes on this work because it promised to solve a common problem: when patients lives are so complicated by social factors like poverty and addiction that their manageable medical conditions, like diabetes and asthma, lead to expensive, recurring hospital stays.
Writer and physician Atul Gawande introduced Brenner as a brash visionary crusading on behalf of the "worst-of-the-worst patients" in the New Yorker piece, titled "The Hot Spotters." (Gawande, who now heads Haven, a joint venture of Amazon, Berkshire Hathaway and JPMorgan Chase, declined to be interviewed for this article.)
Brenner's prescription: Pair these people with front-line care workers who would shepherd them to the social and medical services they needed. Early evidence was promising, the anecdotes inspiring. Brenner boiled the model's potential down to four words and two tantalizing goals: better care, lower costs.
"Lots of organizations make claims that their programs work and they've never been rigorously tested," Brenner said.
Instead, Brenner took the unusual step of inviting the scrutiny of respected researchers.
In 2014, Massachusetts Institute of Technology economist Amy Finkelstein began a randomized controlled trial, the same rigorous method used to evaluate new drugs. Over four years, the coalition enrolled 800 patients, all who had been recently hospitalized and struggled with social problems. Half received the usual care patients get when leaving the hospital. The other half got about 90 days of intensive social and medical assistance from the coalition.
And the result: The 400 patients who received the intensive help were just as likely to return to the hospital as the patients who didn't. In both groups, nearly two-thirds of people were readmitted within 180 days.
So why did the coalition fail? Why did the savings touted in their early data, which Gawande had declared "revolutionary" in The New Yorker nearly a decade ago, disappear when put to this rigorous test?
'My Daily Routine'
Larry Moore, who has hypertension, alcohol addiction, chronic seizures and difficulty walking, was one of the first people to enroll in the coalition's trial.
Moore's experience serves as a road map for understanding why the coalition missed its mark.
His first months were promising: prescriptions filled, medical appointments attended, Social Security benefits claim in process. The 47-year-old even started to trust the team with the details of his deep-seated addiction, confiding how he would consume mouthwash, vanilla extract and even hand sanitizer at times.
"You couldn't keep anything with alcohol in it" around him, Moore recalled. "That's addiction."
But all the progress suddenly stopped when Moore seemed to disappear from the coalition's radar.
"We didn't see Mr. Moore after November," said nurse Jeneen Skinner. "We went to the house. We sent text messages. We [made] phone calls."
The coalition has learned that for people living in poverty and with poor health, a small hiccup — in Moore's case, a missed rent payment — can spiral into a major setback.
Moore spent the next 2½ years mostly homeless, completely out of touch with the coalition.
"I was going from place to place. I sleep on a bench or a rock until the next day when the liquor store opens," remembered Moore. "That was my daily routine."
Seventy emergency room visits and six hospital admissions later, Skinner reconnected with Moore.
He told her the one thing that would keep him out of the hospital: housing.
The 'Camden Coalition'
Too many times, during the trial, people ended up back in the hospital despite the intervention. But the coalition is convinced it didn't fail as much as the larger social safety net did.
"The bottom line is, we built a brilliant intervention to navigate people to nowhere," said Brenner.
Coalition staff and their patients usually knew what was needed — evidence-based addiction treatment, housing, mental health services — but resources were often in short supply.
Over the past three years, the coalition set out to fill in those gaps, undergoing a kind of metamorphosis.
"We think of ourselves now as the Camden Coalition" steering away from the "health care providers" part of the name, said Kathleen Noonan, who succeeded Brenner as head of the organization.
It has forged partnerships with jails, lawyers and legislators, and started its own housing program. Many of these efforts began as the clinical trial was ongoing — a sign the coalition had seen the writing on the wall.
'I Kid You Not'
"I would have never imagined this," said Moore, sweeping his arm around his one-bedroom apartment.
A green houseplant sits in the sunshine. A fluorescent-colored stuffed animal decorates the bed.
"When I first moved in here," Moore explained, "it took me about a month to even sleep in my bed. I slept on a couch."
Housing made it easier to face his other problem, choosing to try the drug naltrexone, a long-acting injection to treat alcohol addiction.
Moore is nearly two years sober today. He meets with a coalition support group on Wednesdays. He's becoming a deacon at his church. In the 22 months he has lived in the apartment, Moore's trips to the hospital have plummeted: just one admission and one ER visit.
"I kid you not, when I saw Mr. Moore probably a month ago, I was standing next to him and did not recognize him," said nurse Skinner. "He looked at me, and said, 'Jeneen, it's me. And I was like, 'My God, you look amazing!'"
Larry Moore's story is just that: one story.
Yet it represents a larger trend. Insurers — including UnitedHealthcare under Brenner's direction — hospitals and many state Medicaid agencies have begun spending millions to meet patients' social needs.
The new study, though, backs up the skepticism of other researchers that, when it comes to saving money at least, these approaches don't work well. For one, programs are expensive and hard to scale. The coalition's housing effort currently serves only 50 people and costs about $14,000 per person per year. Secondly, the data is lacking, cautioned Boston University economist Austin Frakt. "Despite what people would like to believe, there's not a lot of evidence you can reduce health spending by spending more in other areas."
Finkelstein said that as health care companies move further beyond the four walls of a hospital, the need for rigorous evaluation grows. "I think a lot of well-intentioned people in health care can't handle the truth," she said. "They're trying to do good, but they don't have the courage to say, 'Let's do a gut check on ourselves.'"
Dan Gorenstein is the creator and co-host of Tradeoffspodcast and Leslie Walker is a producer on the show, which features the study on the Camden Coalition in episode 7.
India Hardy has lived with pain since she was a toddler — ranging from dull persistent aches to acute flare-ups that interrupt the flow of her normal life.
Sitting in the afternoon heat on her mom's porch in Athens, Georgia, Hardy recollected how a recent "crisis" derailed her normal morning routine.
"It was time for my daughter to get on the bus, and she's too young to go on her own," Hardy recalled. "I was in so much pain I couldn't walk. So, she missed school that day."
Sickle cell disease affects red blood cells, which travel throughout the body carrying oxygen to tissues. Healthy red blood cells are shaped like plump and flexible doughnuts, but in people with sickle cell disease, the red blood cells are deformed, forming C-shaped "sickles" that are rigid and sticky.
These sickle-shaped cells can cause blockages in the blood vessels, slowing or even stopping normal blood flow. An episode of blockage is known as a sickle cell "crisis" — tissues and organs can be damaged because of lack of oxygen, and the patient experiences severe spells of pain.
'It's Like Torture'
Hardy tries to manage these crises on her own. She'll take a hot bath or apply heating pads to try to increase her blood flow. Hardy also has a variety of pain medications she can take at home.
When she has exhausted those options, she needs more medical help. Hardy would prefer to go to a specialized clinic for sickle cell patients, but the closest is almost two hours away, and she doesn't have a car.
So, Hardy often goes to the emergency room at nearby St. Mary's Hospital for relief. Until recently, the doctors there would give her injections of the opioid hydromorphone, which she says would stop her pain.
Then, some months ago, the emergency room changed its process: "Now they will actually put that shot in a bag which is full of fluids, so it's like you're getting small drips of pain medicine," Hardy said. "It's like torture."
It's the same for her brother, Rico, who also has sickle cell disease and has sought treatment at St. Mary's. The diluted medicine doesn't give the same pain relief as a direct injection, they say.
Striking A Balance
St. Mary's staffers explain that they're trying to strike a balance with their new treatment protocol between adequate pain treatment and the risk that opioid use can lead to drug dependence.
It's a local change that reflects a national concern. The U.S. is in the midst of an addiction and overdose crisis, fueled by powerful opioids like hydromorphone. That crisis has made medical providers more aware of the risks of administering these drugs. More than 47,000 Americans died in 2017 from an overdose involving an opioid, according to the Centers for Disease Control and Prevention.
That has prompted some emergency room leaders to rethink how they administer opioid medications, including how they treat people, such as Hardy, who suffer from episodes of severe pain.
"We have given sickle cell patients a pass [with the notion that] they don't get addicted — which is completely false," said Dr. Troy Johnson, who works in the emergency room at St. Mary's. "For us to not address that addiction is doing them a disservice."
Johnson proposed the ER's shift to intravenous "drip delivery" of opioids for chronic pain patients because of personal experience. His son has sickle cell disease, and Johnson said he has seen firsthand how people with the disease are exposed to opioids when very young.
"We start creating people with addiction problems at a very early age in sickle cell disease," Johnson said.
He brought his concerns to the director of the ER, Dr. Lewis Earnest, and found support for the change. Hospital officials say they also consulted national guidelines for treating sickle cell crises.
"We're trying to alleviate suffering, but we're also trying not to create addiction, and so we're trying to find that balance," Earnest said. "Some times it's harder than others."
St. Mary's says the new IV-drip protocol is for all patients who come to the emergency room frequently for pain, and most of their sickle cell patients are fine with the change.
Caught In The Crossfire
The national guidelines cited by St. Mary's also say doctors should reassess patient pain frequently and adjust levels of opioids as needed "until pain is under control per patient report."
Some people who work closely with sickle cell patients, upon hearing about the new approach to pain management at St. Mary's, called it "unusual."
It's more common for ERs to give those patients direct "pushes" of pain medication via injection, she noted, not slower IV drips.
People with sickle cell disease aren't fueling the opioid problem, Andemariam said. One study published in 2018 found that opioid use has remained stable among sickle cell patients over time, even as opioid use has risen in the U.S. generally.
"If anything, individuals with sickle cell disease in our country have really been caught in the crossfire when it comes to this opioid epidemic," Andemariam said.
She suggested that ER doctors and nurses need more education on how to care for people with sickle cell, especially during the painful crisis episodes, which can lead to death.
A study of some 16,000 deaths from 1979 to 2005 related to sickle cell found that men in the group lived to be only 33, on average. Women didn't fare much better, living to an average age of 37. The same study suggested that a lack of access to quality care is a factor in the short life spans of people with sickle cell disease.
Researchers who study sickle cell say the opioid epidemic has made it harder for patients with the condition to get the pain medication they need. The American College of Emergency Physicians isfocusing on the problem, asking federal health officials to speak out about sickle cell pain and fund research on how to treat it without opioids.
"We in the physician community are looking for ways to make sure they get adequate pain relief," said Dr. Jon Mark Hirshon, vice president of the group. "We recognize that the process is not perfect, but this is what we're striving for — to make a difference."
Considering A Move To Find Relief
In the meantime, India Hardy said she feels those imperfections in the process every time she suffers a pain crisis, and she's not alone.
In addition to her brother, Hardy said she has another friend in Athens with sickle cell disease, and that friend has also reported difficulty in finding pain relief at the St. Mary's emergency room.
"It's just really frustrating, because you go to the hospital for help — expecting to get equal help, and you don't," Hardy said, her voice breaking. "They treat us like we're not wanted there or that we're holding their time up or taking up a bed that someone else could be using."
Hardy filed a complaint with the hospital but said nothing has changed, at least not yet. She still gets pain medication through an IV drip when she goes to the St. Mary's emergency room.
At this point, she's considering leaving her relatives and friends behind in Athens to move closer to a sickle cell clinic. She hopes doctors there will do a better job of helping to control her pain.
This story is part of a partnership that includes WABE, NPR and Kaiser Health News.
Seema Verma, administrator for the Centers for Medicare & Medicaid Services, sat down for a rare one-on-one interview with Kaiser Health News senior correspondent Sarah Varney.
They discussed her views on President Donald Trump's plan for sustaining public health insurance programs, how the administration would respond if Obamacare is struck down by the courts in the future and her thoughts on how the latest "Medicare for All" proposals would affect innovation and access to care.
A portion of their conversation aired on PBS NewsHour on Dec. 23. A transcript follows, edited for length and clarity.
Sarah Varney: Thank you, Administrator Verma, for joining us. We really appreciate it. You spoke recently about this need to protect Medicaid as a lifeline, but also not to have people be entrapped, or trapped on, Medicaid and come to rely upon it too greatly. So, as I was mentioning, we were in Tennessee recently, and I know you can't speak to specific cases —
Seema Verma: Mmm, hmm.
Varney: But, we did find a number of families who had been disenrolled, and then found it quite difficult to get back on. And I just wondered if there is a danger in taking this approach where there's more frequent verification checks, a real focus on eligibility verification, that it could discourage some parents and kids who might be eligible for the program from signing up?
Verma: Well, our top priority is making sure that the beneficiaries in the Medicaid program have high-quality, accessible care, and we want to do everything that we can to improve the quality of their lives. In terms of the enrollment process, we also have an obligation to taxpayers to make sure that only the people that qualify for the programs are participating. And we also want to make sure that the programs are sustainable over the long term. I think there's a balance between making sure it's easy for people to apply, but we also have to make sure that we do the appropriate work to make sure that they qualify for the programs.
Varney: So, are you concerned, though, that there were a number of people, after the eligibility process kicked in again in 2017, after the ACA sort of put things on hold for a while, that there might have been families, though, that have been lost? That just don't want to come back, or can't come back? Or are hearing worries about the public charge rule, as well, and so are concerned about giving the government their information?
Verma: You know, our top priority is making sure that we focus on improving quality of care, high-quality care, accessible care, and making sure that we're improving the quality of life for individuals. You know, when I think of the Medicaid program, and in every decision we make, I try to keep in mind the actual beneficiary. In my time spent on the Medicaid program, I've met a lot of Medicaid beneficiaries. I met a gentleman, Richard, who was in Indiana. He was a quadriplegic and literally requires 24-hour care. I met some parents of a child on the Medicaid program. This child had cerebral palsy and so severe that they require 24-hour care, and you can imagine the impact on the entire family. This is a child that will never be independent, will always require help. And so, when we're creating our eligibility policies, we keep those individuals in mind. We don't want to make it harder for them to apply for the program.
And so, we try to come up with policies that don't put a lot of onerous requirements on the beneficiary, but we can have requirements for states that require them to do back-end processes, and back-end checks that don't actually burden the actual recipient or their families, but that also ensure that we are putting the appropriate protections in place for taxpayers, so the program is sustainable over the long term. And we have only the people that qualify for the program participating.
Varney: We know that more health coverage leads to longer life expectancy; I think this has been well established. And I wonder if whether or not the administration should be emphasizing more finding those children who are not enrolled, who are eligible but not enrolled, and perhaps focusing on outreach, which we haven't really heard your administration talk about?
Verma: Well, again. Our focus is on making sure, especially children, that they have access to high-quality health care. As a mom, I've got two kids, so I can personally attest to the fact that having health insurance is very important for children. Something very little, like an ear infection, can lead to deafness if it's not, you know, treated appropriately. So having that access to high-quality health care is very, very important to their development. The Trump administration is very committed to the Children's Health Insurance Program; the president signed legislation around that. Additionally, we have spent over $48 million on outreach efforts. We're very focused on working with states, so that they can identify the best practices to make sure that those individuals, children that qualify, can enroll in the program, that they're aware that this program exists.
Varney: Have you found that the reduction in the Navigator grants has made it more difficult to reach those families?
Verma: We, actually, we have not. If you look, the Navigator programs are really aimed at the Affordable Care Act programs and the exchange programs. So those are not aimed at children. Those are aimed at our adult population. And we have seen very minimal impact. What we have done is try to increase our digital communication, of, to help enrollment. And we've seen a very minimal impact on enrollment.
I think the issue around enrollment really comes back to affordability. Obamacare has had a direct impact on increasing premiums. Across the nation, we've seen premiums go up by 100%, 200%. [Editor's note: PolitiFact rated this claim by the Trump administration "false." ACA premiums were down by about 4% in 2019 compared with 2018.] And so the issue around enrollment is that health insurance has become so unaffordable for families that that's why they can't afford their coverage.
Varney: So we did hear from a number of federally qualified health centers that although the Navigator grants really were focused on, you know, ideally they were focused on exchanges, people buying private health insurance, that, in fact, there were a lot of people who came in, who became eligible for Medicaid and discovered that they were eligible for Medicaid in that way. So I wonder if there is additional outreach that needs to be done to those families, not just virtually or online, but some other way to reach those families?
Verma: The real problem around making sure that people have access to affordable coverage is really addressing the high cost of health care. And that's what the president is focused on. His health care agenda isn't just about putting out more subsidies and having the government pay more and more and creating unaffordable programs. But it is about addressing the underlying cost drivers in health care. That's why he's focused on prescription drug pricing, he's focused on transparency, price transparency, so that there's more competition in the market. We're also focused on getting rid of burdensome regulations that we know drive up the cost of care.
I think by addressing that, that is going to result in decreased premiums, which will result in more people having access to affordable coverage.
Varney: But all those things that you just mentioned — they don't necessarily affect the Medicaid population directly. Now, they may affect them indirectly by increasing overall health care costs, but in terms of the Medicaid population, really reaching out, ensuring that every single child who's eligible for Medicaid is enrolled?
Verma: So, our focus is also on addressing the economy. Under the president's leadership, we have a booming economy. We have one of the lowest unemployment rates. We have more people that are earning more money, and we have fewer people living in poverty. There's been a reduction in the number of people living in poverty by 1.4 million people. And so, we are seeing people coming out of the Medicaid program, and because the economy's doing so well. The issue is, though, they can't afford coverage. And so, even as we increase our outreach efforts, we spent over $48 million on outreach, the issue is around affordability. Obamacare has impacted the market in such a way that it's become unaffordable for people that don't have subsidies.
Varney: So, we're at this moment in our country and our national conversation where we're talking about how do we ensure that more and more people are insured? And I wonder what the administration is doing to move the needle, to stop the growth in the uninsured, particularly among children?
Verma: I think our focus has been about addressing affordability of health care. The underlying issue in people not being able to afford their health insurance is that it's too expensive. And the solution is not trying to throw more government money around subsidies, because that's just going to increase taxes for everybody. Our approach is to address the underlying issues. President Trump is addressing long-standing issues in health care that haven't been addressed by any administration. The blueprint that he put out on drug pricing was very historic. The work that he's done on price transparency. And the work that we're trying to do around the regulatory burden, getting rid of all kinds of unnecessary regulations that are actually increasing the cost of health care for providers. We spend over $200 billion on administrative costs every year. So what we're trying to do is address the cost of health care, but also make sure that we continue to have the high-quality, innovative health care system that Americans are used to.
Varney: So there are some people who are advocating for a Medicare for All type of solution to this, to say that much of those costs are because the marketplace, in a sense, doesn't work in health care. And I wonder what you say to people who are proposing that? Who are saying, this is all just, that the market doesn't work when it comes to health care?
Verma: So, when it comes to health care and it comes to the solutions around Medicare for All. … Medicare for All would strip Americans, 180 million Americans, of their private health insurance and put them on a government-run, bureaucratic program. If we look at the programs that we have today, our government-run programs, our Medicare program is not affordable. The Medicare Trustees have indicated in the next seven years they're gonna run out of money, they're gonna have trouble paying their bills. The Medicaid program is the No. 1, No. 2 budget item for many states. And you're hearing states every day — look at the situation in New York, where they can't afford their Medicaid programs. And so, our track record on government-run programs isn't strong. And I think our focus is on trying to unleash competition to drive down costs, but keep the innovation in the system. Our concern is that a government-run or more government is going to thwart innovation.
As the head of the Medicare program, I see every day that government regulations kind of stand in the way, that there are delays in our beneficiaries being able to access treatments. That's why the president put out the Medicare Executive Order, which was focused on making sure we can do better with this. But I think, you know, putting more people on a government program is actually going to threaten the sustainability of the programs that we have in place today.
Varney: And do you think through the measures that you're talking about, that you could reduce costs — 15%, 20% — in the health care system of the United States?
Verma: I think our goal is to try to reduce cost, and to make it more unaffordable [sic]. And we've had great success with this under President Trump's leadership. If we look at the Medicare Advantage Program, for example, under his leadership, premiums have gone down by over 23% since he came into office. In the Part D program, premiums are down by 13%, the lowest level in seven years. Going back to Medicare Advantage, that's the lowest level in 13 years. So, I think the president's policies are working, because we demonstrated that we can lower premiums.
Same thing on the individual exchanges. For the very first time, the individual market has been stabilized and premiums went down last year by a percent, this year by 4%, and they're still too high, there's a new class of uninsured being created by Obamacare, but President Trump's policies have actually resulted in more Americans, more seniors having money back in their pockets.
Varney: Now we're waiting for a ruling from the courts on the future of the Affordable Care Act. If it's struck down, what is your plan to replace it?
Verma: Well, the president's been very clear that he wants to make sure that individuals with preexisting conditions have protections. And we have prepared for a variety of scenarios, and we want to make sure that there's no disruption in coverage. And we'll work with Congress to make sure that Americans have access to high-quality, affordable coverage. That is not what they have today. People with preexisting conditions do not have those protections. Individuals that don't get subsidies and can't afford coverage really don't have those protections. And so the president wants to make sure that we're addressing those individuals, and that people with preexisting conditions have the appropriate protections that they don't have today.
Varney: But how do you guarantee those protections, also reduce costs and not lead to widespread uninsurance rates going up?
Verma: I think our focus is not just on costs, but it's also making sure that we preserve quality and innovation in the system. One of the initiatives that we've had is around trying to pay our providers differently. Right now, we're paying in a system where we just pay for people to get things done. And we want to change that paradigm, where we're holding providers accountable for providing quality care, improving the quality of life, preventing disease and keeping people healthy.
Varney: So, just my final question. There have been these reports of a rift, a growing rift between you and Department of Health and Human Services Secretary Alex Azar. And I wonder if people should be concerned about whether or not that's going to get in the way of the very ambitious slate of initiatives that you and President Trump have planned?
Verma: Well, Secretary Azar and I are both committed and have a shared goal around delivering on the president's agenda.
As happens when the tech industry gets involved, hype surrounds the claims that artificial intelligence will help patients and even replace some doctors.
This story was first published on Monday, December 30, 2019 in Kaiser Health News.
"There's nothing that I've seen in my 30-plus years studying medicine that could be as impactful and transformative" as AI, said Dr. Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.
Early experiments in AI provide a reason for caution, said Mildred Cho, a professor of pediatrics at Stanford's Center for Biomedical Ethics.
Systems developed in one hospital often flop when deployed in a different facility, Cho said. Software used in the care of millions of Americans has been shown to discriminate against minorities. And AI systems sometimes learn to make predictions based on factors that have less to do with disease than the brand of MRI machine used, the time a blood test is taken or whether a patient was visited by a chaplain. In one case, AI software incorrectly concluded that people with pneumonia were less likely to dieif they had asthma ― an error that could have led doctors to deprive asthma patients of the extra care they need.
"It's only a matter of time before something like this leads to a serious health problem," said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic.
Medical AI, which pulled in $1.6 billion in venture capital funding in the third quarter alone, is "nearly at the peak of inflated expectations," concluded a July report from the research company Gartner. "As the reality gets tested, there will likely be a rough slide into the trough of disillusionment."
That reality check could come in the form of disappointing results when AI products are ushered into the real world. Even Topol, the author of "Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again," acknowledges that many AI products are little more than hot air. "It's a mixed bag," he said.
Experts such as Dr. Bob Kocher, a partner at the venture capital firm Venrock, are blunter. "Most AI products have little evidence to support them," Kocher said. Some risks won't become apparent until an AI system has been used by large numbers of patients. "We're going to keep discovering a whole bunch of risks and unintended consequences of using AI on medical data," Kocher said.
None of the AI products sold in the U.S. have been tested in randomized clinical trials, the strongest source of medical evidence, Topol said. The first and only randomized trial of an AI system ― which found that colonoscopy with computer-aided diagnosis found more small polyps than standard colonoscopy ― was published online in October.
Few tech startups publish their research in peer-reviewed journals, which allow other scientists to scrutinize their work, according to a January article in the European Journal of Clinical Investigation. Such "stealth research" ― described only in press releases or promotional events ― often overstates a company's accomplishments.
And although software developers may boast about the accuracy of their AI devices, experts note that AI models are mostly tested on computers, not in hospitals or other medical facilities. Using unproven software "may make patients into unwitting guinea pigs," said Dr. Ron Li, medical informatics director for AI clinical integration at Stanford Health Care.
AI systems that learn to recognize patterns in data are often described as "black boxes" because even their developers don't know how they have reached their conclusions. Given that AI is so new ― and many of its risks unknown ― the field needs careful oversight, said Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin-Madison.
Yet the majority of AI devices don't require FDA approval.
"None of the companies that I have invested in are covered by the FDA regulations," Kocher said.
Legislation passed by Congress in 2016 ― and championed by the tech industry ― exempts many types of medical software from federal review, including certain fitness apps, electronic health records and tools that help doctors make medical decisions.
There's been little research on whether the 320,000 medical apps now in use actually improve health, according to a report on AI published Dec. 17 by the National Academy of Medicine.
"Almost none of the [AI] stuff marketed to patients really works," said Dr. Ezekiel Emanuel, professor of medical ethics and health policy in the Perelman School of Medicine at the University of Pennsylvania.
The FDA has long focused its attention on devices that pose the greatest threat to patients. And consumer advocates acknowledge that some devices ― such as ones that help people count their daily steps ― need less scrutiny than ones that diagnose or treat disease.
Industry analysts say that AI developers have little interest in conducting expensive and time-consuming trials. "It's not the main concern of these firms to submit themselves to rigorous evaluation that would be published in a peer-reviewed journal," said Joachim Roski, a principal at Booz Allen Hamilton, a technology consulting firm, and co-author of the National Academy's report. "That's not how the U.S. economy works."
But Oren Etzioni, chief executive officer at the Allen Institute for AI in Seattle, said AI developers have a financial incentive to make sure their medical products are safe.
"If failing fast means a whole bunch of people will die, I don't think we want to fail fast," Etzioni said. "Nobody is going to be happy, including investors, if people die or are severely hurt."
Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market "moderate-risk" products with no clinical testing as long as they're deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.
Instead, the FDA is using the process to greenlight AI devices.
Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity toimaging software approved 20 years earlier. That software had itself been cleared because it was deemed "substantially equivalent" to products marketed before 1976.
AI products cleared by the FDA today are largely "locked," so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA's Center for Devices and Radiological Health. The FDA has not yet authorized "unlocked" AI devices, whose results could vary from month to month in ways that developers cannot predict.
To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.
The FDA's pilot "pre-certification" program, launched in 2017, is designed to "reduce the time and cost of market entry for software developers," imposing the "least burdensome" system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.
Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products "is efficient and that it fosters, not impedes, innovation."
Under the plan, the FDA would pre-certify companies that "demonstrate a culture of quality and organizational excellence," which would allow them to provide less upfront data about devices.
Pre-certified companies could then release devices with a "streamlined" review ― or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products' safety and reporting back to the FDA.Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.
High-risk products, such assoftware used in pacemakers, will still get a comprehensive FDA evaluation. "We definitely don't want patients to be hurt," said Patel, who noted that devices cleared through pre-certification can be recalled if needed. "There are a lot of guardrails still in place."
But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. "People could be harmed because something wasn't required to be proven accurate or safe before it is widely used."
In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.
"The honor system is not a regulatory regime," said Dr. Jesse Ehrenfeld, who chairs the physician group's board of trustees.
In anOctober letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency's ability to ensure company safety reports are "accurate, timely and based on all available information."
When Good Algorithms Go Bad
Some AI devices are more carefully tested than others.
An AI-powered screening tool for diabetic eye disease was studied in 900 patients at 10 primary care offices before being approved in 2018. The manufacturer, IDx Technologies, worked with the FDA for eight years to get the product right, said Dr. Michael Abramoff, the company's founder and executive chairman.
The test, sold as IDx-DR, screens patients for diabetic retinopathy, a leading cause of blindness, and refers high-risk patients to eye specialists, who make a definitive diagnosis.
IDx-DR is the first "autonomous" AI product ― one that can make a screening decision without a doctor. The company is now installing it in primary care clinics and grocery stores, where it can be operated by employees with a high school diploma. Abramoff's company has taken the unusual step of buying liability insurance to cover any patient injuries.
Yet some AI-based innovations intended to improve care have had the opposite effect.
A Canadian company, for example, developed AI software to predict a person's risk of Alzheimer's based on their speech. Predictions were more accurate for some patients than others. "Difficulty finding the right word may be due to unfamiliarity with English, rather than to cognitive impairment," said co-author Frank Rudzicz, an associate professor of computer science at the University of Toronto.
Doctors at New York's Mount Sinai Hospital hoped AI could help them use chest X-rays to predict which patients were at high risk of pneumonia. Although the system made accurate predictions from X-rays shot at Mount Sinai, the technology flopped when tested on images taken at other hospitals. Eventually, researchers realized the computer had merely learned to tell the difference between that hospital's portable chest X-rays ― taken at a patient's bedside ― with those taken in the radiology department. Doctors tend to use portable chest X-rays for patients too sick to leave their room, so it's not surprising that these patients had a greater risk of lung infection.
DeepMind, a company owned by Google, has created an AI-based mobile app that can predict which hospitalized patients will develop acute kidney failure up to 48 hours in advance. A blog post on theDeepMind website described the system, used at a London hospital, as a "game changer." But the AI system also produced two false alarms for every correct result, according to a July study in Nature. That may explain why patients' kidney functiondidn't improve, said Dr. Saurabh Jha, associate professor of radiology at the Hospital of the University of Pennsylvania. Any benefit from early detection of serious kidney problems may have been diluted by a high rate of "overdiagnosis," in which the AI system flagged borderline kidney issues that didn't need treatment, Jha said. Google had no comment in response to Jha's conclusions.
False positives can harm patients by prompting doctors to order unnecessary tests or withhold recommended treatments, Jha said. For example, a doctor worried about a patient's kidneys might stop prescribing ibuprofen ― a generally safe pain reliever that poses a small risk to kidney function ― in favor of an opioid, which carries a serious risk of addiction.
As these studies show, software with impressive results in a computer lab can founder when tested in real time, Stanford's Cho said. That's because diseases are more complex ― and the health care system far more dysfunctional ― than many computer scientists anticipate.
Many AI developers cull electronic health records because they hold huge amounts of detailed data, Cho said. But those developers often aren't aware that they're building atop a deeply broken system. Electronic health records were developed for billing, not patient care, and are filled with mistakes or missing data.
A KHN investigation published in March found sometimes life-threatening errors in patients' medication lists, lab tests and allergies.
In view of the risks involved, doctors need to step in to protect their patients' interests, said Dr. Vikas Saini, a cardiologist and president of the nonprofit Lown Institute, which advocates for wider access to health care.
"While it is the job of entrepreneurs to think big and take risks," Saini said, "it is the job of doctors to protect their patients."
The American Hospital Association, the biggest hospital trade group, says it promotes "best practices" among medical systems to treat patients more effectively and improve community health.
But the powerful association has stayed largely silent about hospitals suing thousands of patients for overdue bills, seizing homes or wages and even forcing families into bankruptcy.
Atlantic Health System, whose CEO is the AHA's chairman, Brian Gragnolati, has sued patients for unpaid bills thousands of times this year, court records show, including a family struggling to pay bills for three children with cystic fibrosis.
AHA, which represents nearly 5,000, mostly nonprofit hospitals and medical systems, has issued few guidelines on such aggressive practices or the limited financial assistance policies that often trigger them.
In a year when multiple health systems have come under fire for suing patients, from giants UVA Health System and VCU Health to community hospitals in Oklahoma, it has made no concrete move to develop an industry standard.
"There could be a broader message coming out of hospital leadership" about harsh collections, said Erin Fuse Brown, a law professor at Georgia State University who studies hospital billing. "It seems unconscionable if they are claiming to serve the community and then saddling patients with these financial obligations that are ruinous."
Nonprofit hospitals are required to provide "community benefit," including charity care in return for billions of dollars in government subsidies they get through tax exemptions. But the rules are lax and vague, experts say, especially for bill forgiveness and collections.
The Affordable Care Act requires nonprofit hospitals to have a financial assistance policy for needy patients but offers no guidance about its terms.
"There is no requirement" for minimum hospital charity under federal law, said Ge Bai a health policy professor at Johns Hopkins. "You design your own policy. And you can make it extremely hard to qualify."
Practices vary sharply, a review of hospital policies and data from IRS filings show. Some hospitals write off the entire bill for a patient from a family of four making up to $77,000 a year. Others give free care only if that family makes less than $26,000.
The law does not substantially limit harsh collections, either. IRS regulations require only that nonprofit hospitals make "reasonable efforts" to determine if patients qualify for financial assistance before suing them, garnishing their wages and putting liens on their homes.
Gaping differences in both collections and financial assistance show up in the policies of health systems represented on AHA's board of trustees.
This year, AHA board chairman Gragnolati's Atlantic Health System, in northern New Jersey, sued patients for unpaid bills more than 8,000 times, court records show.
Atlantic Health sued Robert and Tricia Mechan of Maywood, N.J., to recover $7,982 in unpaid bills for treatment of their son Jonathan at the system's Morristown Medical Center.
Three of the Mechans' four children have cystic fibrosis, a chronic lung disease, including Jonathan, 18. Tricia Mechan works two jobs — full time as a manager at Gary's Wine & Marketplace and part time at Lowe's — to try to pay doctor and hospital bills that pile up even with insurance.
"I have bill collectors call me all the time," Tricia Mechan said. "You're asking me for more, and all I'm doing is trying to get the best care for my children. I didn't ask to have sick children."
She closed a savings account and borrowed money to settle Jonathan's bill for $6,000. Another son with cystic fibrosis, Matthew, owes Atlantic Health $4,200 and is paying it off at $25 a month, she said.
Marna Borgstrom, CEO of Yale New Haven Health, also sits on AHA's board. Yale almost never sues families like the Mechans.
"I have not signed off on a legal action since 2015" against a patient, Patrick McCabe, the system's senior vice president of finance, said in an interview. "People are coming to us when they are at their most vulnerable, and we truly believe we need to work with them and not create any additional stress that can be avoided."
Yale has treated Nicholas Ruschmeyer, 30, a Vermont ski mountain manager, for recurring cancer. He has been careful to maintain insurance, but a few years ago the hospital performed a $12,000 genetic test that wasn't covered.
"Yale completely absorbed the cost," said his mother, Sherrie Ruschmeyer. Yale is "wonderful to work with, not at all aggressive," she said.
Atlantic Health bars families from receiving financial assistance if they have more than $15,000 in savings or other assets. Yale never asks about savings. Even families who own homes without a mortgage qualify if their income is low enough.
Atlantic Health's policies including seizing patient wages and bank accounts through court orders to recoup overdue bills. Yale says it does not do this.
In some ways, Atlantic Health's policies are more generous than those of other systems.
It forgives bills exceeding 30% of a family's income in many cases, the kind of "catastrophic" assistance some hospitals lack. It also bills many uninsured patients only slightly more than Medicare rates. That's far less than rates charged by other hospitals in the same situation that are substantially higher than the cost of treatment.
"Atlantic Health System's billing policy complies with all state and federal guidelines," said spokesman Luke Margolis. "While we are willing to assist patients no matter their financial situation, those who can pay should do so."
After a reporter inquired about its practices, Atlantic Health said it "is actively engaged in refining our policies to reflect our patients' realities."
AHA also is considering changing its position on billing in the wake of recent reports on aggressive and ruinous hospital practices.
Previously AHA said billing offices should "assist patients who cannot pay," without giving specifics, and treat them with "dignity and respect." Queried this month, association CEO Rick Pollack said, "We are reevaluating the guidelines [for collections and financial assistance] to ensure they best serve the needs of patients."
Kaiser Health News found that the University of Virginia Health System sued patients 36,000 times over six years, taking tax refunds, wages and property and billing the uninsured at rates far higher than the cost of care. Richmond-based VCU Health's physicians group sued patients 56,000 timesover seven years, KHN also found.
In response, VCU pledged to stop suing all patients. UVA promised to "drastically" reduce lawsuits, increase financial assistance and consider further steps. Methodist erased debt for 6,500 patients and said it would overhaul its collections rules.
Yale's less aggressive policies also came in response to journalism — a 2003 Wall Street Journal report on how the system hounded one family. Yale still sends overdue bills to collections, McCabe said. But it balks at the last, drastic step of asking a court to approve seizing income and assets.
For patients with unpaid bills, he said, "if you're willing to play a game of chicken, you will win."
Hospitals say they see more and more patients who can't pay, even with insurance, as medical costs rise, family incomes plateau and out-of-pocket health expenses increase. In particular, they blame widespread high-deductible coverage, which requires patients to pay thousands before the insurance takes over.
"More consumers pay far more with fewer benefits," Pollack said.
Some states go beyond federal rules for charity care and collections. In California, patients with an income of less than $90,000 for a family of four must be eligible for free or discounted care. New Jersey requires Atlantic Health and other systems to give free care to patients from families of four with income less than $51,000.
The National Consumer Law Center, a nonprofit advocacy group, suggests all states adopt that standard for large medical facilities. Its model medical debt law also would require substantial discounts for families of four with income below $103,000 and relief for patients with even higher incomes facing catastrophic bills.
The AHA should consider similar changes in its own guidelines, NCLC attorney Jenifer Bosco said.
"I would be interested in seeing them taking a more active role in creating some standard for hospitals about what's too much," she said. "What's going too far? Given that this is a helping profession, what would be some appropriate industry standards?"
KHN senior correspondent Jordan Rau contributed to this report.
The FDA's registry exemption program makes key death data about heart devices inaccessible and can take up to two years for the public to see under open-records laws.
This article was first published on Tuesday, December 24, 2019, in Kaiser Health News.
The Food and Drug Administration continues to file thousands of reports of patients' deaths related to medical devices through a reporting system that keeps the safety data out of the public eye.
The system is similar to a vast program exposed earlier this year by KHN that kept device-injury reports effectively hidden within the agency. The FDA shuttered the program after the article about it was published and released millions of records.
The result of this remaining so-called registry exemption program is that key death data about heart devices sits in inaccessible FDA reports that can take up to two years for the public to see under open-records laws. Device-related death reports are typically open, allowing researchers to track and alert their peers about safety concerns.
The FDA carved out the exemption in 2010 and it covers six devices, a spokeswoman said. Doctors tend to report extensive data on patients for certain medical devices that are closely monitored in registries. Private medical societies tend to administer the registries and act as gatekeepers to the data.
The registry leaders, in turn, have reported data to device makers, who sent the FDA spreadsheets detailing what they know about more than 8,000 patient deaths. Those spreadsheets are also inaccessible to the public.
Under standard FDA reporting rules, the device maker is bound to investigate and send the agency a detailed public report about each patient death believed to be device-related.
Device makers say the registries strip key data they need to fully investigate each death, most of them related to heart valves threaded through a catheter and implanted in faulty hearts.
"It's crazy," said Diana Zuckerman, president of the National Center for Health Research. "I have to say, there's not a particular reason I can think of why you put [summary reports] behind some kind of firewall where no one can see it."
An FDA spokeswoman said the agency just got additional funding from Congress that it plans to use to make "more information readily available and easier to access."
"We agree that the public should have access to more information about reports of adverse events for medical devices," the agency said in an email, noting that its current public device database called MAUDE is outdated and "has limited functionalities."
Earlier this year, the FDA shut down other so-called exemptions to its device-reporting rules that put millions of device harm or malfunction reports out of public reach. Doctors, researchers and even device-safety experts were unaware that for 20 years the FDA accepted 5.7 million reports through its "alternative summary reporting" program.
The FDA released the data ― and the identity of 108 devices that had been quietly "exempted" from public reporting ― in June after KHN reported on the scope of the program.
The FDA also said in December that it is no longer accepting "litigation" summary reports, also highlighted in the KHN report, which makers of pelvic mesh and surgical robots used to file thousands of reports on spreadsheets straight to the agency.
The FDA said it left the registry exemption in place to support the massive datasets being built around certain devices. The registry data helps the agency "act quickly with manufacturers and health care professionals to make more timely, evidence-based decisions to mitigate device problems and keep patients safe," the statement said.
The FDA accepts hundreds of death reports on spreadsheets kept within the agency from the TVT Registry, which tracks valves threaded through a patient's vessel in a catheter and implanted in the heart.
The devices have been hailed as lifesaving for patients too fragile for open-heart surgery. They have also been controversial because they have created a need in some patients for an additional device ― a pacemaker ― compounding their risk. Experts have also questioned whether the devices will be durable, particularly as they're increasingly implanted in younger patients.
Such a heart valve made by Medtronic called CoreValve amassed the most reports, with more than 5,800 death incidents reported since 2014, according to Medtronic. The device was initially approved for patients too sick for open-heart surgery.
The device helped boost survival in fragile, elderly heart patients, with nearly three-quarters still alive and free of major strokes a year after the valve was implanted. It and a competing, similar valve have since been approved for use in younger, healthier patients.
The quarterly summary reports filed with the FDA note hundreds of deaths and thousands of injuries. They say the "anonymized" registry data did not have enough information for Medtronic to determine whether the event was previously reported to the company or the FDA's public device-injury database called MAUDE. The spreadsheet sent straight to the FDA includes "observations related to patient deaths."
Medtronic filed far fewer stand-alone public device-death reports, about 900, many summarizing valve-related deaths mentioned in published research. While device companies are required to report patient deaths to the FDA if they have enough information to investigate, doctors are not ― explaining some of the reporting gap.
Medtronic said in a statement that it strives to eliminate malfunctions in all of its devices, but, when they occur, "we make every effort to inform regulators, the healthcare community and the public in a timely … manner." The company said about 40% of deaths reported from the registry data list no cause, so it's unclear if they were related to the device.
The maker of the competing device approved in 2011, the Sapien 3 Transcatheter valve, also files death reports under the registry exemption. Edwards Lifesciences filed spreadsheets since 2016 reflecting 2,400 death incidents and individual reports on about 400 deaths.
Edwards' reports describe possible device-related deaths in patients who had too little or too muchcalcification in their hearts or whose deaths were attributed to fragility and age. Edwards also notes in its summary filings that "device information is not included in the data received from the registry."
Edwards spokeswoman Sarah Huoh said that 600,000 patients worldwide have benefited from transcatheter valve surgery. She noted that the Sapien 3 valve used in healthier, younger patients showed a "remarkably low" 1% death or disabling stroke rate a year after surgery.
Dr. Steven Nissen, chief academic officer at the Cleveland Clinic, said the number of deaths is not alarming, given the frailty of the patients initially undergoing the procedures. But he said the underlying data sent to the FDA should be open.
"To understand safety of devices, we need to have access to all of the data," he said.
The valve business is brisk and growing, with much of the money coming from the taxpayer-funded Medicare program. Edwards reported $700 million in sales for one quarter of this year for its Sapien valves and predicts a $7 billion market in 2024.
In all, the FDA said it has granted registry exemptions to six devices tracked in three registries. Makers of the MitraClip, which is also threaded in a catheter to clip together flaps in the heart, have filed spreadsheets reflecting more than 500 deaths.
The FDA said it has also given the registry exemption for a cardiac device called the Watchman and to Medtronic's Valiant Thoracic Stent Graft and a Medtronic catheter used to reopen blocked leg arteries.
It's been about a year since the hospital in Fort Scott, Kan., closed. The lessons for this community about meeting its residents' health needs could provide insights for the rest of the country.
This article was first published on Tuesday, December 24, 2019 in Kaiser Health News.
FORT SCOTT, Kan. ― Dr. Max Self grabbed a sanitary wipe and cleaned off the small flashlight in his hands. More than 20 years as a family doctor in rural Fort Scott, Kan., has taught him a few tricks: "I've got my flashlight. See? Look, you want to hold it?"
Two-year-old Taelyn's brown eyes grow round and her tiny hand reaches out. But, first, Self makes sure she opens her mouth wide and he peers down. Behind him sits another staff member ― a medical scribe. Self's scribe gives him the ability to "focus on people," rather than toggling between a computer screen and the patient. It's a new perk he didn't have when he worked at Mercy Hospital.
That beloved hospital closed one year ago and, in the passing months, the small town's anger and fear evolved into grief, nervousness and ― lately ― pragmatic hope. Most of the handful of physicians in town stayed, taking jobs at a regional federally qualified health care center that took over much of the clinic work from Mercy. The emergency department, after closing for 18 days, was reopened temporarily ― run by a hospital 30 miles south.
It's not "all gloom and doom, although we all wish we had a hospital ― no doubt about it," insurance agent Don Doherty said during the town's weekly Chamber of Commerce coffee on D
Nationwide, death rates have been higher in rural America compared with urban areas since the 1980s, and the gap continues to widen. More rural residents live with chronic conditions, like diabetes, that affect their daily lives, and there is a higher percentage of older residents. Rates of smoking and premature births are relatively high, and people often die younger here than the national average.
Since 2010, 120 rural hospitals have closed across the country ― 19 in this year alone, according to data from the University of North Carolina's Cecil G. Sheps Center for Health Services Research. Anational analysis of Medicare cost reports found that 21% of the nation's remaining rural hospitals are at high risk of closing.
"Frankly, it's not getting better," said Dr. Daniel DeBehnke, study co-author and a managing director with Navigant's health care practice.
A year ago, after Mercy gave a 90-day notice that it would close, City Manager Dave Martin said the betrayal felt by city leaders led to lawyers and calls with other health care systems about taking over the facility. Now, Martin has realized "we will not have ― or do we need ― a hospital."
But, if not a hospital to care for rural communities like Fort Scott with its 7,800 residents, what is needed? The answers to that question play out every day here and could hold lessons for the rest of the country.
'You Will Be Taken Care Of'
Self has cared for his share of struggling patients in this town, where 1 in 4 children live in poverty, and its main corridor ― U.S. 69 ― is lined with fast-food restaurants. But Fort Scott is "not far off" from what it needs to be healthy. Sure, residents have to travel south 30 miles to Pittsburg, Kan., or north 90 miles to the Kansas City, Kan., area to be hospitalized, but "you will be taken care of," he said.
Self's new employer is Community Health Center of Southeast Kansas, which as a federally qualified health center gets a higher level of government reimbursement for Medicare and Medicaid patients than Mercy did, said Jason Wesco, executive vice president at CHC.
The center can also gain grants to take care of the uninsured, which is important in states like Kansas that did not expand Medicaid, though Wesco said it has not received any for Fort Scott.
Wesco estimates 90-95% of the health care offered before the hospital closed is still available locally. And services have been added, including a much-needed therapist on-site for behavioral health and telehealth access to a psychiatrist and substance abuse services.
"Drive up there, go into the parking lot, you're like 'There's a lot of people here,'" Wesco said. CHC's Fort Scott facilities have filled more prescriptions and done more mammograms in a month than the hospital "ever did," he said.
Local residents like 28-year-old Eliza Oliver, whose daughter, Taelyn, easily passed her annual wellness check with Dr. Self, said it's much less expensive to get care and prescriptions at the new health center. That part is great, Oliver said, but she still worries about the future of emergency care in town and where people can deliver babies.
Another Catholic hospital chain, Ascension Via Christi, which has a facility 30 miles away in Pittsburg, Kan., stepped in at the last minute to operate Mercy's old emergency room, signing a two-year agreement. This was vital: While much of the rest of Mercy Hospital Fort Scott had been underused and patient rooms sat empty, the ER handled nearly 9,000 people the year before it closed.
Mercy Hospital delivered more than 230 babies between July 2017 and June 2018. A few months ago ― after the hospital closed ― Oliver drove a friend who was in labor across the Missouri border more than 20 miles to deliver. "We had to jet over there and even though we made it in time, it's nerve-wracking," Oliver said.
Another Catholic hospital chain, Ascension Via Christi, stepped in at the last minute
Not having a community hospital does require a new mindset. The community still has an obstetrician, but doctors send patients out of town to have their babies. By June this year, Ascension's Fort Scott ER staff had delivered three babies for expectant mothers who didn't leave enough time.
Randy Cason, president at Ascension's Pittsburg hospital, drove to Fort Scott to tell the weekly chamber coffee that doctors needed to "counsel and educate" mothers that it's no longer a 10-minute drive to the hospital.
Sherise Beckham, a former Mercy dietitian, was anxious on bed rest this spring while awaiting a baby. "You're on a two-lane highway; a lot of times you get behind a semi, behind a tractor," Beckham laughed. "Sometimes, you are lucky if you have cell service."
Beckham's delivery did not go as planned. After driving to Ascension's Pittsburg hospital to meet her family doctor, she had an unexpected cesarean section, and the baby, whose heart rate dropped dramatically, was transferred to a neonatal intensive care unit an hour away from home in Joplin, Mo. Now, eight months later, the baby is healthy though he continues to see a physical therapist who monitors his developmental progress.
Recent research by Katy Backes Kozhimannil, an associate professor at the University of Minnesota School of Public Health found that rural residents have a 9% greater chance of dying or suffering complications such as heart failure, stroke and the need for blood transfusions during childbirth compared with non-rural residents.
Federal policymakers have said they want to do better. President Donald Trump's administration this year set new Medicare payment policies that included more telehealth services and changed some payments for rural hospitals. Seema Verma, the administrator for the Centers for Medicare & Medicaid Services, also promised a new rural health payment model and "a lot of people are waiting with bated breath," said George Pink, a senior research fellow at UNC's Sheps Center.
CMS declined to comment on the timing of the proposal.
Congress, too, has made overtures to passing legislation. Maggie Elehwany, lead federal lobbyist for the National Rural Health Association, said the Affordable Care Act's promise that hospitals would have more insured patients and less bad debt "never really unfolded in rural America." The 14 states that have not adopted Medicaid expansion are largely rural and many are in the South, where the greatest number of hospitals have closed.
Catholic nuns founded the Fort Scott hospital more than a century ago and 89-year-old Fred Campbell still recalls a mantra etched in stone over the entrance of one old Mercy hospital building: "Dedicated to suffering humanity."
"We always felt that, man, come hell or high water, you're gonna be with us and you're not going to abandon us," Campbell said.
But exactly a year ago, its then-owner, St. Louis-based Mercy, a major health care conglomerate with more than 40 hospitals, declared it no longer financially viable.
Within weeks of Mercy closing, a newly built $9 million grocery store closed. A few weeks later, the cancer center closed and, by October, the town's dialysis center had closed, too. John Leatherman, professor for the department of agricultural economics at Kansas State University, said there's no doubt Bourbon County took "a big hit" when the hospital was shuttered.
Roxine Poznich lost her income when her job at Mercy ended. After more than 20 years at the hospital, the 73-year-old said she now finds herself paying for groceries with her credit card ― even though she is unsure whether she can pay the bill at the end of the month. "I'm scared," Poznich said.
But Fort Scott economic development director Rachel Pruitt said the loss of the hospital has not affected the city's sales tax revenue. Manufacturers like the community's largest employer, Peerless Architectural Windows and Doors, with its 400 jobs, continue to expand ― just down the road from where Mercy's 177,000-square-foot hospital building still stands.
City leaders say ideally the community would "right-size" its health care. That would include keeping the current outpatient clinics that provide primary care and an emergency department but also adding some inpatient beds, allowing residents with short-term hospitalization to stay local. Pruitt said there has even been talk of adding a wound center that could treat injuries among the town's industrial workers.
And, though the mostly empty Mercy Hospital building feels like a white elephant, that too may soon change: Mercy recently announced it would donate land in a repurposed corner of its property to Community Health Center. Health center leaders have hired an architect for a new building that will probably be about 30,000 square feet. Wellness, imaging, walk-in care, a women's health center, dental care and expanded primary and specialty care would be available.
ER operator Ascension declined requests for interviews, but spokeswoman Michelle Kennedy said the Pittsburg leadership team is "working on plans related to our presence in Fort Scott in the near future" but could not release details. City leaders say they are confident an ER will remain.
In the background, there is Reta Baker. Residents here denounced the former president of Mercy Hospital Fort Scott at the time of the closure. She sold her house and moved closer to her new job with CHC, at its headquarters in Pittsburg, Kan.
Baker, who started her career as a nurse at Fort Scott's hospital in 1981 and grew up nearby, said she continues to "be engaged in a lot of conversations" about the community's future. The next year will have growing pains, she said, but she believes the health care needed for residents is there.
"Now, we need to cement it," she said.
This is the fifth installment in KHN's year-long series, No Mercy, which follows how the closure of one beloved rural hospital disrupts a community's health care, economy and equilibrium. Coming in 2020, a podcast from KHN with more voices and stories from Fort Scott, Kansas.
Derek Lewis was working as an electronic health records specialist for the nation's largest hospital chain when he heard about software defects that might even "kill a patient."
The doctors at Midwest (City) Regional Medical Center in Oklahoma worried that the software failed to track some drug prescriptions or dosages properly, posing a "huge safety concern," Lewis said. Lewis cited the alleged safety hazards in a whistleblower lawsuit that he and another former employee of Community Health Systems (CHS) filed against the Tennessee-based hospital chain in 2018.
The suit alleges that the company, which had $14 billion in annual revenuein 2018, obtained millions of dollars in federal subsidies fraudulently by covering up dangerous flaws in these systems at the Oklahoma hospital and more than 120 others it owned or operated at the time.
The whistleblowers also allege that Medhost, the Tennessee firm that developed the software, concealed defects during government-mandated reviews that were supposed to ensure safety.
Both CHS and Medhost have denied the allegations and moved to dismiss the suit. The motions are pending. Last month, Department of Justice lawyers wrote in court filings that they were still investigating the matter and had not yet decided whether to take over the case.
The lawsuit is one of dozens filed by whistleblowers, doctors and hospitals alleging that some electronic health records (EHR) software used in hospitals and medical offices has hidden flaws that may pose a danger to patients — and that a substantial chunk of the $38 billion in federal subsidies went to companies that deceived the government about the quality of their products, an ongoing Fortune-KHN investigation shows. The subsidies were designed to persuade hospitals and doctors' offices to install software that would track the medical history of every patient and share the information seamlessly with other health care providers.
But the software makers allegedly gamed the system, repeatedly. Three major EHR vendors have made multimillion-dollar settlement deals — totaling $357 million — over Justice Department investigations which include allegations that they rigged or otherwise gamed the government's certification test. At least two other companies are under investigation.
Beyond those cases, federal officials have paid hundreds of millions of dollars in subsidies to doctors and hospitals that could not show they were even qualified to receive them, according to federal officials. Nearly 28% of doctors and 5% of hospitals who attested to meeting government standards later failed audits. Federal officials told Fortune and KHN that they have clawed back $941 million in improper subsidies.
"We're entering an entirely new area of health care fraud," John O'Brien, senior counsel with the Department of Health and Human Services Office of Inspector General, said in a July 2017 videoannouncing a $155 million False Claims Act settlement with eClinicalWorks, one of the nation's leading sellers of EHRs for physicians.
The concern is not just over wasteful spending of tax dollars. EHRs monitor the medicines people take and their vital signs, so software glitches that prevent doctors from accessing files quickly, that mix up patients or send vital test results to the wrong file can contribute to serious injuries, or even deaths.
In March, Fortune and KHN revealed that thousands of injuries, deaths or near misses tied to software defects, user errors and other problems have piled up in various government-sponsored and private repositories.
"Ultimately, it's about patients getting the right care," Andrew Vanlandingham, the HHS inspector general's senior counselor for health information technology, said in an interview. He said that investigators are "gearing up" for more scrutiny of the important industry, including closer monitoring to make sure that records software is safe.
Leaping Into The Digital Era
In 2009, Congress committed billions of dollars in economic stimulus funds to bring the era of paper medical records to a close. Officials hoped to cut down on medical errors caused by illegible paper records and draw on the power of massive troves of medical data to drive down the cost of health care and help develop improved treatments for disease.
The hastily devised plan offered Medicare doctors and other medical professionals up to $44,000 and $64,000 in subsidies if they bought the software and accepted patients on Medicaid, the federal health care program for low-income people.
The money was intended to help them pay vendors to install EHRs in their offices. Hospitals, which required more sophisticated and costlier software, could receive millions in subsidies, based on the number of inpatients treated. To give them a nudge, officials warned doctors and hospitals that failure to wire up would trigger gradual cuts in their Medicare payments. EHR vendors had to meet certification standards set by the HHS Office of the National Coordinator for Health Information Technology, or ONC.
Providers had to attest that their EHR software could perform a variety of functions, which the government described as making "meaningful use" of the technology.
Certification was essentially an open-book test in which the government gave vendors the questions in advance — for instance, the names of 16 or so drugs the system would have to prescribe electronically to pass. The Justice Department has alleged that some vendors simply doctored their software to pass the test — for example, programming the required codes for just the specified 16 drugs they would be tested on, rather than all medicines — as officials had expected.
Frank Poggio who recently retired from a 45-year career in health technology, saw the cases of fraud coming, he said, because the tests "were superficial, and if you wanted to game it, you could game it."
Poggio said there were many weaknesses in the system that allowed a vendor to show a "prototype" as opposed to live software.
Dr. Scott Monteith, a Michigan psychiatrist who served as an early certification juror, said he saw some limitations firsthand. He said one vendor took 30 minutes to produce a list of patients who had diabetes and also smoked, data he figured any computer program should be able to spit out in seconds. The vendor passed.
"That's an example of how poorly thought-out the whole thing was," said Monteith, who noted he was then, and still is, a big booster of EHRs.
Jeffery Daigrepont, a senior vice president at Coker Group, a firm that advises health providers on business decisions, said the government erred by handing out too much money in the early stages of the program, when many doctors and hospitals had not yet done much more than agree to participate.
"It was an upside-down pyramid," he said. "You got the bulk of the money for doing the least amount of effort."
Dr. John Halamka, a physician and Harvard Medical School professor who chaired the ONC standards committee, which wrote the certification rules, defended the process.
"The only problem [with certification] is that it presupposed that the product the vendor certified would be the same product they sold," Halamka said. "It presupposes that people will go into the certification process and participate in good faith."
That did not always happen in the rush to snatch up subsidy dollars, according to the whistleblowers' suits. The Justice Department case against eClinicalWorks, which has 130,000 providers, accused the company of rigging tests to win certification, claims the company has denied. The company did not respond to numerous requests for comment.
The government accused Greenway Health, a Florida-based EHR developer with 75,000 providers, of doing the same thing. The DOJ's complaint included a number of instant-message exchanges between Greenway employees in which they allegedly discuss their plan for gaming the certification process by "shortcutting some functionality" of the software. In February, Greenway Health settled with the government for just over $57 million without admitting wrongdoing.
The whistleblower case filed by Lewis and former co-worker Joey Neiman accuses the CHS hospital chain of submitting more than $385 million in false claims for EHR stimulus payments between 2012 and 2014.
Visiting the Oklahoma hospital as part of a troubleshooting team in June 2015, Lewis heard that physicians worried flaws in the system could result in patients being sent home "with the wrong drugs, doses or instructions," according to the suit.
Things got so bad that local doctors were threatening to admit patients elsewhere unless the hospital fixed the software problems, according to the suit.
In a statement, CHS said it had "complete confidence" in its records systems. "The allegations made in the lawsuit against our hospitals are completely without merit," the company said. Medhost denied its software has flaws, noting in itsstatement: "Hundreds of facilities have successfully used our software over the years and continue to do so today."
Few in the industry seemed surprised by such allegations. When news of the eClinicalWorks case broke, Farzad Mostashari, who led the ONC from 2011 to 2013, tweeted: "Let me be plain-spoken. eClinicalWorks is not the only EHR vendor who 'flouted certification/misled' customers. Other vendors better clean up."
The Electronic Health Record Association, a trade group that represents more than 30 vendors, did not respond to a request for comment. However, vendors have argued that they faced a tangle of regulations that required them to meet constantly shifting standards that government officials often could not explain.
ONC officials declined to answer written questions. But in a statement, ONC said it takes steps to ensure that products "are safe for patients and usable by providers."
System Glitches And Accusations Of 'Gaming' The System
While the ONC sets the standards, the federal Centers for Medicare & Medicaid Services (CMS) had the job of paying doctors and hospitals that attested to meeting the "meaningful use" criteria. As of September 2018, CMS had paid out $38.4 billion in these funds.
In 2012, CMS hired accounting firm Figliozzi and Co. of Garden City, N.Y., which audited almost 50,000 medical professionals. Nearly 28% failed, despite the fact that they had previously attested to meeting the standards. Hospitals did better, posting a 5% failure rate. CMS officials said they have recovered some $941 million in these improper payments. The losses to the Treasury are likely far higher because only 14% of the medical professionals and 40% of the hospitals receiving payments were audited.
Michael Arrigo, who has served as an expert witness in health IT-related fraud and medical malpractice cases, said that in some cases EHR vendors misled hospitals about the challenges of replacing paper records with computers.
Others rolled the dice, apparently hoping the program was so large and complicated that they were unlikely to be targeted for audit. "Sometimes [providers] got away with it until a whistleblower found out," Arrigo said.
Reviewing state and federal court filings, Fortune and KHN found more than two dozen cases, many filed by hospitals against vendors, which depict chaotic EHR installations and safety concerns as they pursued meaningful-use dollars.
Parrish Medical Center, a 210-bed public hospital on Florida's Space Coast, is one. In December 2010, the Titusville hospital contracted with McKesson's Enterprise Information Solutions. One of America's largest companies, McKesson said its product would be easy for doctors and nurses to learn and help them "deliver high-quality, safe patient care."
But the deal collapsed, prompting a bitter court battle in which the hospital repeatedly assailed McKesson's competence. For instance, the hospital alleged that bugs in the software caused it to create more than one record for the same patient, a flaw dubbed a "major safety issue."
An expert hired by Parrish said he contacted eight other hospitals, including three in Florida, which had dumped McKesson due to what he called "poor or unsatisfactory customer service."
The medical staff at one of those hospitals was "up in arms" because it took 63 mouse clicks to look up a patient's lab results, according to the expert's report.
Parrish later signed on with another EHR vendor and the suit has since been settled. Both Parrish and McKesson declined to comment for this story. McKesson sold its health IT business to Allscripts in October 2017. Earlier this year, Allscripts reported to the Securities and Exchange Commission that government attorneys have requested documents from the company as part of an investigation into McKesson's certification.
In another lawsuit, Weirton Medical Center, a hospital in West Virginia, stated in a court filing that it submitted "inaccurate" meaningful-use data to the government ― though it blamed the vendor. The hospital alleged the system failed to identify a patient who was critically ill and in the hospital. The hospital declined to comment to KHN and Fortune about the case, which has been settled.
Hamstrung By Technology?
ONC officials said they keep no log of complaints they receive.
A study published in JAMA this month found that 40% of the software that ONC singled out for post-marketing review had flaws that could lead to patient harm, including inaccurate drug codes, information displaying incorrectly and decimal points gone missing.
That's "a concerning number, and we have to do something to address that," said researcher Raj Ratwani, the director of the MedStar Health National Center for Human Factors in Healthcare and a co-author of the study. These systems were used in 786 hospitals and by 37,365 provider organizations, according to Ratwani, who said there's no way to know how many defects have been fixed.
ONC has"decertified" about 100 pieces of once-approved software products. But most were tiny market players that had few or no users and went out of business. PlatinumMD, which had just 48 "meaningful" users, is an example. In a 2014 whistleblower lawsuit, San Diego urologist Dr. Scott Brown alleged that PlatinumMD filed for $18,000 in subsidies on his behalf even though it had not yet fully installed his EHR. In February 2016, the defunct company's owners settled the case without admitting liability by paying the government $180,000.
Another 132 government-certified products have been flagged for corrective action due to "non-conformities." As for the technology that the government alleges was fraudulently certified, it's still used in health care settings across the country.
While those vendors faced multimillion-dollar settlements and now must operate under the oversight of a government monitor, their technology was not taken off the market. Nor were they dumped by many customers who, for the most part, however dissatisfied, were stuck with it.
ONC seemed to acknowledge that decertifying a large vendor would cause a major disruption, noting in an October 2016 regulation: "Our first and foremost desire would be to work with developers to address any problems."
In the regulations, ONC cited the costs medical providers would face should their EHR vendor shut down as ranging from $33,000 to as much as $650 million.
"It is very difficult to switch product," said Steve Waldren, chief medical informatics officer for the American Academy of Family Physicians. "You couldn't just go down the street and pick up another EHR, put it in and move your data over."
He noted that beyond the considerable cost of the technology, providers would have to take time to learn a new system.
"ONC does seem to have a stance that removing some of these players from the market would be very disruptive," said Brad Ulrich, a Tennessee health IT expert. "They are almost too big to fail."