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."
It's been a heavy lift for lawmakers in both parties who are trying to balance the competing needs of powerful stakeholders, factions within their ranks and consumers stuck with high bills.
This article was first published on Tuesday, December 17, 2019 in Kaiser Health News.
After months of hearings and negotiations, millions of dollars in attack ads, full-court press lobbying efforts and countless rounds of negotiations, Congress appeared to be moving toward a solution to the nation's surprise medical bill problem. Sort of.
Surprise bills, the often-exorbitant medical bills that come when a patient doesn't realize they've been seen by a provider outside their insurance network, have in recent months been viewed as public enemy No. 1 on Capitol Hill.
Two committees, the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee, have been working on plans and announced a compromise Dec. 8. Later that week, the House Ways and Means Committee followed suit by announcing its solution, though details are few.
It's been a heavy lift for lawmakers in both parties who are trying to balance the competing needs of powerful stakeholders, factions within their ranks and consumers stuck with high bills. With an election year fast approaching and polls consistently showing health care costs are a high priority for voters, the push for action has intensified.
Time Is Not Of The Essence
Despite the rushed way some committee members announced the agreement Dec. 8 — issuing a press release on a Sunday before any official bill text was released — it's now unlikely that Congress will consider the package before it wraps up work for the year.
HELP Committee Chairman Lamar Alexander (R-Tenn.) signaled as much Monday in a press release in which he promised to do everything he could to keep the surprise medical bill issue at the top of the congressional to-do list for 2020 — until it's solved. "The only people who don't want this fixed are the people who benefit from these excessive fees," he said.
Still, the recent signs of progress are significant, even if final passage happens early next year, said Loren Adler, the associate director of USC-Brookings Schaeffer Initiative for Health Policy, a research group.
Even if Congress punts it to February or March, "there's a decent shot of getting it done," Adler said. "It would be pretty darn embarrassing if Congress doesn't pass it after talking about it this long and it being such an egregious problem."
Compromise Bill
The HELP/Energy and Commerce legislative outline shows movement toward compromise on several fronts, from omitting the controversial "all-payer claims database" ― a federal repository for health-pricing information ― to adding more public health provisions.
It includes Senate protections against surprise bills from air ambulances, while adopting most of the House's approach to hospital bills, down to preserving the House's title for that section.
"A sign of a compromise is that nobody particularly loves it," Adler said.
Over the past few months, the biggest debate around remedies for surprise bills has centered on how to determine payment for out-of-network doctors and hospitals. One group wanted an arbitration process while the other sought a benchmark system. It seems neither side got exactly what they were seeking.
Under benchmarking, the government would set a compensation rate for providers when they see out-of-network patients. The most popular proposition was one that paid a "median in-network" rate, when doctors are paid in the middle of the range of what others in the area are paid by insurance companies for the same service.
The other idea was independent dispute resolution, or arbitration. The provider and insurer bring their best offer to a third party, who chooses between the two.
Generally, employers and consumer advocates favor benchmarking. Hospitals and doctors' groups, especially those backed by private equity firms, pushed for arbitration.
The compromise approach tracks closely with legislation advanced by the House Energy and Commerce Committee: a median in-network benchmark with an arbitration "safety valve" where either side can bring a bill to arbitration if it's more than $750. Previous versions allowed arbitration only for charges over $1,250.
"I think what we've seen come out recently is probably what a reasonable bettor would have predicted," said Benedic Ippolito, a research fellow in economic policy studies at the American Enterprise Institute.
This proposal is seen as more favorable than earlier HELP Committee drafts to providers because it allows them to go to arbitration for more bills, but to these stakeholders, it's not enough.
"Without an arbitration mechanism that applies to a legitimate number of claims, the concerns raised by the provider community will persist," read a statement from Envision Healthcare, a physician staffing firm. A large number of surprise bills are generated by physicians employed by such staffing companies, which are often backed by private equity firms. The business model allows these doctors ― often specialists including emergency medicine and radiology, among others ― to set their own rates because they don't work for the hospital.
To be fair, plenty of groups have come out in support of the compromise. A message from the Energy and Commerce Committee noted 27 patient and consumer advocate groups that signed a letter of support.
James Gelfand, a senior vice president at the ERISA Industry Committee, which represents large employers, said the compromise isn't what his constituents would have written to solve surprise medical billing, but he thinks it's still important to pass, and parties who keep demanding changes are just trying to stall.
"We hate arbitration, and we believe the changes made to please 'team arbitration' will raise costs tens of billions of dollars," Gelfand said. "But we support the bill. We want to get it across the finish line."
The blueprint offered by the Ways and Means Committee is considered friendly to providers because it lays out a system similar to arbitration and favors a go-slow approach. A press release from panel Republicans indicated that stakeholders need to "stay at the table and debate these ideas" into the new year.
To some, it felt like a delay tactic.
"We know that pushing legislative action into 2020 pushes the work into a difficult presidential election year and makes it harder for Congress to act. This would dramatically increase the odds that Congress will fail to enact meaningful legislation to ban surprise medical bills and fail our nation's families," Frederick Isasi, executive director of the advocacy group Families USA, said in a written statement.
Money And Momentum
Political muscle could also factor into the measure's momentum.
Money from private equity has been flowing into the debate, from millions of dollars spent on commercials and online ads, to campaign donations.
According to Open Secrets data, Rep. Richard Neal (D-Mass.), the chairman of the Ways and Means Committee and one of the voices calling for more time on surprise billing, received $29,000 this year from Blackstone Group, the private equity firm that owns TeamHealth, a physician-staffing firm. This was the first year ever that Blackstone was in Neal's top five donors.
Rep. Kevin Brady (R-Texas), that panel's ranking member, received $45,000 from Welsh, Carson, Anderson and Stowe, the private equity firm that owns several staffing companies, including US Acute Care Solutions, U.S. Anesthesia Partners and US Radiology Specialists. U.S. Anesthesia Partners was one of Brady's top contributors last year as well, giving $56,250 in the 2017-18 cycle.
Sen. Bill Cassidy (R-La.) has been one of the strongest proponents of arbitration on the HELP Committee. He received $68,900 from Blackstone and $66,300 from Welsh, Carson, Anderson and Stowe.
Much of what we accept as legal in medical billing would be regarded as fraud in any other sector.
I have been circling around this conclusion for the past five years, as I've listened to patients' stories while covering health care as a journalist and author. Now, after a summer of firsthand experience — my husband was in a bike crash in July — it's time to call out this fact head-on. Many of the Democratic candidates are talking about practical fixes for our high-priced health care system, and some legislated or regulated solutions to the maddening world of medical billing would be welcome.
My husband, Andrej, flew over his bicycle's handlebars when he hit a pothole at high speed on a Sunday ride in Washington. He was unconscious and lying on the pavement when I caught up with him minutes later. The result: six broken ribs, a collapsed lung, a broken finger, a broken collarbone and a broken shoulder blade.
The treatment he got via paramedics and in the emergency room and intensive care unit were great. The troubles began, as I knew they would, when the bills started arriving.
I will not even complain here about some of the crazy-high charges: $182 for a basic blood test, $9,289 for two days in a room in intensive care, $20 for a pill that costs pennies at a pharmacy. We have great insurance, which negotiates these rates down. And at least Andrej got and benefited from those services.
What I'm talking about here were the bills for things that simply didn't happen, or only kind-of, sort-of happened, or were mislabeled as things they were not or were so nebulously defined that I couldn't figure out what we might be paying for.
To be clear, many of the charges that I would call fraudulent — maybe all of them — are technically legal (thanks sometimes to lobbying by providers), but that doesn't make them right. And no one would accept them if they appeared on bills delivered by a contractor, or a lawyer or an auto mechanic. There were so many of these charges that I came up with categories to keep track of them:
1. Medical Swag
In the trauma bay, someone slapped a hard brace around Andrej's neck until scans confirmed that he had not suffered a grievous spinal injury. It was removed within an hour.
The medical equipment company that provided that piece of plastic billed $319. Our insurer paid $215 (90% of its discounted rate of $239). We were billed $24, our "patient responsibility."
Companies are permitted by insurers to bill for "durable medical equipment," stuff you receive for home use when you're in the hospital or a doctor's office. That yields some familiar marked-up charges, like the sling you can buy at Walgreens for $15 but for which you or your insurer get a bill for $120 after it is given to you at urgent care. The policy has also led to widespread abuse, with patients sent home with equipment they don't need: My mom's apartment, for example, holds an unused wheelchair, a walker and a commode paid for by Medicare, by which I mean our tax dollars. It's as if you were given a swag bag at a conference and then sent a bill for hundreds or thousands of dollars.
At least with swag, you get to keep it. My husband's hardly worn neck brace didn't even come home with us as a souvenir.
2. The Cover Charge
The biggest single item on Andrej's ER bill was a $7,143.99 trauma activation fee. What was that for, since every component of his care had been billed and billed handsomely?
Among the line items: $3,400 for a high-level emergency room visit. $1,030 for the trauma surgeon. Between $1,400 and $3,300 for five purported CT scans. And I say "purported" because one trip into a scanner examined the head, upper spine and maxillofacial bones but was billed as three separate things. There was also an administration fee of more than $350 each for four injections.
Trauma activation fees have been allowed since 2002, after 9/11, when the Trauma Center Association of America, an industry group, convinced regulators that they needed to be compensated for maintaining a state of "readiness."
Wait. Isn't the purpose of an ER to be "ready"? Isn't that why the doctors' services and scans are billed at higher rates when they are performed in an emergency department?
Despite scrutiny from researchers about whether trauma fees are deserved, trauma activation fees have only grown in size, 15% annually in recent years, and can reach into the tens of thousands of dollars. (On average, Medicare pays a fee of about $1,000.) Some have likened trauma activation fees to a cover charge for being wheeled into an ER with major trauma. But does a cover charge typically cost more than the meal?
3. Impostor Billing
We received bills from doctors my husband never met. Some of these bills were understandable, like for the radiologist who read the scans. But others were for bedside treatment from people who never came anywhere near the bed to deliver the care.
Andrej had a small finger fracture with a cut that needed some stitches, which a resident, a surgeon-in-training, sutured. But the $1,512 billed came in the name of a senior surgeon, as if he had done the work.
Physicians and many other health professionals are allowed to bill for the work of "extenders" — stand-ins with less training who see patients and work under the supervising doctor. These might be residents, physician assistants or nurse anesthetists, for example. For billing purposes, this allows the senior providers to be in two, three, sometimes more than half a dozen places at once, often even when they are physically miles away.
The resident did a fine job on my husband. But if an assistant did the work, shouldn't it be billed for less? At law firms, the hourly rates for paralegals and junior attorneys are lower than those for partners.
On a website called Clinical Advisor, a reimbursement expert himself seemed to wonder at the profession's luck that such billing is tolerated: "I hear people ask, 'How can I do that? The doctor never saw the patient, never had any interaction with the patient and yet I can still bill this service under the physician?'"
4. The Drive-By
The day before Andrej left the hospital, a physical therapist visited and asked a few questions. From that brief encounter, the therapist noted "ambulation deficits, balance deficits, endurance deficits, pain-limiting function, transfer deficits." That translated into a bill of $646.15 for what was recorded as a P.T. evaluation "1st session only (billable)." He said he was there for 30 minutes, but he was not. He said he walked Andrej up 10 steps with a stabilizing belt for assistance. He did not. There was no significant health service given. Just an appearance and some boxes checked on a form. It's a phenomenon called drive-by doctoring.
More shockingly, the drive-bys continued at our home, presaged by a call on Andrej's cellphone a day after he was discharged. A physical therapist from a private company wanted to visit him for at-home therapy. In his discharge instructions, no one had mentioned this service, and his injury was clearly too fresh to benefit. She came. She didn't know which body part had been injured and concluded he was in too much pain to participate.
The same company called twice more the following week to schedule visits. By the third time, I told Andrej not to open the front door. Nonetheless, our insurer was billed — and paid — for three visits.
It's as if Alexa noticed that my dishwasher makes too much noise (it does) and took it upon herself to send over a repair guy. But if I turned him away at the front door, saying I'm OK with the racket (I am), would I still be billed for the visit?
5. The Enforced Upgrade
One Monday when Andrej was in pain and out of pills, the trauma doctor suggested we meet in the emergency room, because the trauma clinic was open only from 8 to 10:45 a.m. on Wednesdays and Thursdays.
So we met the trauma doctors in the ER, and they talked to Andrej, who remained in his street clothes. They gave him a prescription. Because the interaction — which could have happened in the lobby — happened in the ER, it resulted in an ER visit charge of $1,330. But when the trauma clinic is open less than six hours a week, billing for an ER visit that doesn't tap into any of the emergency room resources feels like a scam. Is an ER visit determined by the content of the services rendered, or merely by the location?
Andrej had a similar experience when his broken finger was treated with a plastic splint that folded over his fingertip. He complained because the upper layer pressed on the fracture. At a follow-up visit, someone took a pair of scissors and cut off the upper half of the splint and taped the lower half back in place. That translated into a $481 charge for "surgery," in addition to the $375 charge for the office visit and a $103 facility fee. Doesn't surgery, by definition, involve cutting into flesh or an animate object — not a piece of plastic?
Sure, it sounds fancy to upgrade a meeting to an ER visit, or to call the tweaking of a splint "surgery," but if an airline overbooks my flight and puts me on another flight where the only seat available is in first class, it does not charge me for the more expensive ticket.
My insurer paid for most of these questionable charges, though at discounted rates. But even a discounted payment for something that never really happened or didn't need to happen or that we didn't agree to have happen is still, according to common sense, a fraud.
Why do insurers pay? Partly because insurers have no way to know whether you got a particular item or service. But also because it's not worth their time to investigate the millions of medical interactions they write checks for each day. Despite the advertised concern about your well-being, as one benefits manager enlightened me: They're "too big to care about you." Electronic records, which auto-fill billing boxes, have probably made things worse. For example, the birth of a baby boy may automatically prompt a bill for a circumcision; having day surgery may prompt a check for sedation.
So what is the appropriate payment for swag I didn't ask for, outrageous cover charges, stand-in doctors, drive-by visits and faux surgery? In some cases, zero; in others, far less than was paid. And yet, these are all everyday, normal experiences in today's health care system, and they may be perfectly legal. If we want to tame the costs in our $3 trillion health system, we've got to rein in this behavior, which is fraud by any other name.
Californians, be warned: A new state law could make you liable for a hefty tax penalty if you do not have health insurance next year and beyond.
But some of you need not worry: The law contains several exemptions that will allow certain people to avoid the penalty, among them prisoners, low-income residents and those living abroad.
"It will be really important that people get clear guidance and instruction to make sure they don't inadvertently pay a penalty when they are eligible for an exemption," says Laurel Lucia, director of the Health Care Program at the University of California-Berkeley's Center for Labor Research and Education.
Most types of insurance, including Medi-Cal, Medicare and employer-sponsored coverage, will satisfy California's coverage requirement. People who purchase insurance for themselves and their families, either through Covered California, the state's health insurance exchange, or the open market, will have until Jan. 31 to buy a health plan for 2020.
If you aren't covered and owe a penalty for 2020, it will be due when you file your tax return in 2021. The penalty will amount to $695 for an adult and half that much for dependent children. Some people with higher incomes instead will have to pay 2.5% of their income, which could make their penaltyquite a bit heftier.
Penalty payments are expected to raise $317 million in the first year they are collected, according to the state Legislative Analyst's Office. The money will help pay for new state subsidies intended to make insurance more affordable for some people.
You won't have to pay the penalty if you are uninsured for three consecutive months or less during the year, or if you are incarcerated or are Native American. Likewise, if you are in the U.S. illegally.
General hardship exemptions also are available if you are facing personal or family difficulties, including homelessness, domestic violence, bankruptcy, eviction or the consequences of a natural disaster.
And you're off the hook if your household income is below the threshold for filing a tax return. This was the most common exemption from the federal penalty, according to Internal Revenue Service data based on 2016 returns. It might be even more popular under the California law, since the state's filing threshold is higher than the federal one, Lucia says.
You can also claim an exemption if you would have to spend more than 8.24% of your income on insurance premiums in 2020. This so-called affordability exemption was also among the most common under the federal law.
How you claim an exemption depends on the type you are seeking.
Covered California will handle three types of exemptions: religious conscience, general hardship and affordability. Each will require filling out a different application, and the applications will be available starting in January, says James Scullary, an exchange spokesman.
For other exemptions, you'll need to apply when you file your 2020 return with the Franchise Tax Board in early 2021. A tax board spokeswoman promises that "our tax forms and instructions will include information for all exemptions claimed on the tax return."
You can also apply to the tax board for an affordability exemption when you file your return.
Gerald Kominski, a senior fellow at the UCLA Center for Health Policy Research, says the 8.24% threshold to qualify for the affordability exemption is too high and pushes many middle-class families to pay a penalty even when they are hard-pressed to buy insurance.
Steven Morelock, a resident of Los Angeles, paid hundreds of dollars in federal penalties for several years because he felt too financially stressed to plunk down $250 a month for a high-deductible health plan. He was already shelling out nearly half of his $2,500-a-month salary in rent alone.
"I would have had to change my habits very dramatically," says Morelock, 41, a labor organizer. "It would have cut the amount of money I had for non-fixed costs by about half." He finally got employer-sponsored insurance late last year.
Another exemption that has stirred some debate is for membership in a health care sharing ministry — an association of religiously like-minded people, primarily Christians, who cover one another's medical costs.
Legislators and others who opposed including this exemption in California's law argued that the ministries are subject to little regulatory scrutiny, the coverage they offer is limited, and it's not guaranteed. More recently, concerns have arisen about sham ministries engaged in deceptive business practices.
Dr. Dave Weldon, president of the Alliance of Health Care Sharing Ministries, acknowledges some of the limitations and says the organizations he represents "all counsel their members that this is not insurance, there's no contract, there's no obligation to pay."
Bob Stedman, 55, says he and his family were exempt from the federal penalty every year because of their membership in Samaritan Ministries International. The Lake Forest, Calif., resident plans to take the same exemption under the California law.
Stedman figures he's saving about $1,000 to $1,500 a month in premiums compared with regular insurance, and was pleased when the $50,000 bill he received following a stroke was heavily discounted by the hospital and then almost entirely covered by other ministry members. And knowing his money is not being used to finance abortions, which most commercial health plans in California are required to cover, gives him "the benefit of a clear conscience," he says.
Weldon says the exemption is warranted on those grounds alone. "This nation has a long history of religious accommodation," he says.
If you're not sure whether you might qualify for an exemption, you can get more information from Covered California or the tax board.
Contact Covered California atwww.coveredca.com or by phone: 800-300-1506. For the tax board, log on towww.ftb.ca.gov or call 800-852-5711.
But don't limit yourself to those two agencies. Insurance agents and tax preparers across the state are trying to master the details of the new law, and they can help.
For a list of insurance agents whose help is free, log on to the Covered California website and click on "find help" or go to the website of the National Association of Health Underwriters (www.nahu.org) and hit "find an agent." The California Society of Tax Consultants (https://www.cstcsociety.org/) and the California Society of CPAs (www.calcpa.org) can help you find a tax preparer.
ST. LOUIS — Dr. Laurie Punch plunged her gloved hands into Sidney Taylor's open chest in a hospital's operating room here, pushing on his heart to make it pump again after a bullet had torn through his flesh, collarbone and lung. His pulse had faded to nothing. She needed to get his heart beating.
She couldn't let the bullet win.
Bullets are Punch's enemy. They threaten everything the 44-year-old trauma surgeon cherishes: her patients' lives, her community, even her family. So, just as she recalled doing two years ago with Taylor, Punch has made it her life's mission to stem the bleeding and the damage bullets cause — and excise them if she can.
In the operating rooms at Barnes-Jewish Hospital, Punch treats gunshot victims, removing bullets that studies show can poison bodies with lead and fuel depression. And in her violence-racked community, she teaches people how to use tourniquets to stop bleeding, creating a legion of helpers while building trust between doctors and community members.
Punch feels a calling to St. Louis, a place with the nation's highest murder rate among big cities, where at least a dozen children were shot to death this summer alone, including a 7-year-old boy playing in his backyard. Punch believes all she's learned has prepared her for now, when gun violence kills an average of 100 Americans a day and mass shootings are so common that two this summer struck less than 24 hours apart.
To her, the battle is personal, in more ways than one.
Besides being a surgeon, she's a multiracial single mom living in Ferguson, Mo., just over a mile from where Michael Brown Jr., a black teenager, was shot and killed by a white police officer five years ago.
She has a son the same age as the little boy killed in the backyard in August. And she said, "I hear the gunshots echoing through my 2-acre backyard all the time."
The 23-year-old was brought to Punch's hospital last summer, shot seven times. While the nurses gave him blood, Punch said, she cut open his chest, trying to force life back into his body — to no avail.
"I watched his wife sink, as the floodwaters of vulnerability and risk came into her eyes, thinking about the life of her and her child and how they would live without him," Punch told the assembled lawmakers. "I watched his father rage. And I heard his mother wail."
Punch placed the black-and-yellow, blood-splattered Adidas sneakers she'd worn the day of the shooting on the table before her in the hearing room.
"I can't wash these stains out," she told lawmakers.
The trauma surgeon was adamant: Violence is a true medical problem doctors must treat in both the operating room and the community. Until they do that, she said, violence victims will continue to be vectors who spread violence.
"The disease that bullets bring does not yet have a name," she told Congress that day. "It's like an infection, because it affects more than just the flesh it pierces. It infects the entire family, the entire community. Even our country."
But healing also can be contagious — spreading among victims, families and the physicians themselves.
Punch, who regularly visits the neighborhoods where her patients live, attended an event last year for Saint Louis Story Stitchers, an artist and youth collective working to prevent gun violence. She remembers spotting a volunteer she knew — Antwan Pope, who'd been shot some years earlier but had found renewed purpose helping young people.
Punch told Pope about Hibler's case, and learned Hibler was Pope's cousin. Hibler's dad was at the community event, too, and he handed Punch a lapel pin with his son's picture.
She wore it on her white coat for months.
Two Worlds
Punch was born in Washington, D.C., the only child of a Trinidadian father and white Midwestern mother. They separated six months after her birth.
Until she was 7, Punch moved every year with her mom. They eventually settled with Punch's grandmother in the tiny town of Wellsville, Ohio, a close-knit but segregated community.
Classmates bullied her for being different, Punch recalls.
"I was different in every way because I wasn't black; I wasn't white," said Punch, who later came out as gay.
From the time Punch was 9, she took $2 piano lessons from Elizabeth Carter. The local music teacher had transformed former drug dens into places with music lessons, free clothes and meals, and put all the kids who sought her help to work. Punch's assignment was serving food.
"You show someone that they can help," Punch said, "it's revolutionary."
That lesson guided her life as a child and when Punch moved on to Yale University, the University of Connecticut's medical school and then the University of Maryland Medical Center in Baltimore, where poverty and trauma scarred many of her patients' lives.
Punch spent her early career in the shock trauma center in Baltimore, throwing everything she had into saving others.
After marrying a woman she met as a medical intern, Punch became pregnant with twins at 35.
The next few years were marked by highs and lows in her personal life and the unrelenting stress of dealing with the aftermath of violence at work.
She miscarried at five months. No one could tell her why.
Five months later, she became pregnant again, this time giving birth to a healthy boy, Sollal Braxton Punch. But not long later, she and her wife separated. Now she found herself as a single parent as the pressures of her job mounted.
One morning, three shooting victims arrived at the trauma center, quickly followed by a car crash victim who was pregnant. Punch's nanny texted her, saying Sollal had a fever of 102.3.
"I realized I can't do this anymore," Punch said. "I just can't."
The Call Of Community
So, she took a break from trauma for more than two years, focusing on general surgery at Houston Methodist Hospital in Texas.
But in 2015, a former colleague contacted her about a job as a trauma surgeon and educator at Washington University in St. Louis.
She feared going back to another troubled city. Michael Brown Jr. had been killed in Ferguson, Mo., a little more than a year earlier, triggering unrest and riots in that city just outside St. Louis.
Despite the area's well-known history of violence, she flew to St. Louis for interviews, then rode around Ferguson with Dr. Isaiah Turnbull, an assistant professor. He pointed out the spot on Canfield Drive where Brown's body had lain in the road for more than four hours.
"It was almost like seeing Ground Zero," Punch said. "This is where it all went down. And it went down because of deep structural realities that caused the experience of black and brown people in north St. Louis to be fundamentally different. I went from not wanting to go to wanting to be right in the middle of it."
And now she is.
On a recent hot summer evening, 20 people — some black, some white — gathered around Punch. A few feet away, a doctor, a trauma nurse and a medical student stood near tables stacked with "pool noodles," the long foam cylinders kids play with in swimming pools — these happened to be about the width of a human arm.
Punch told the class that a person can bleed to death in a minute, but an ambulance can take 15 minutes to arrive.
"If you can stop the bleed, you can save a life," she said. "Time is life and minutes matter."
Participants practiced packing wounds by pressing gauze into holes in the pool noodles. They tightened tourniquets — first on the foam cylinders, then on each other.
Punch knows one of the doctors who created the "Stop the Bleed" training sessions after the mass shooting at Sandy Hook Elementary School in Connecticut. She realized the same training could save lives after street shootings, too.
Since March 2018, she and her team have trained more than 7,000 community members in the St. Louis metropolitan area. Many come to a rented space she dubbed "The T," for trauma, tourniquet and time. But Punch's team has also held classes in schools, a juvenile detention center and a firing range.
"It's far more than teaching people what to do," Punch said. "They learn: 'I am not simply a victim or a perpetrator or an observer; I'm a helper. I have the capacity to help.'"
Contagious Healing
Two years ago, Sidney Taylor was shot outside his brother's comedy club in north St. Louis County while trying to help a friend who was drunk. When Taylor arrived at Punch's hospital, profuse bleeding had left his blood pressure dangerously low.
At one point, the father of four technically died on the operating table, but Punch and her team pulled him back.
After 10 days in intensive care, the longtime wrestling coach was still in physical and mental agony.
That's the point when many patients slip back to their communities unhealed. But Taylor, now 47, showed up in Punch's clinic a month after he had been shot, and they bonded during a 25-minute visit. Punch described to him how her team had removed part of his lung and inserted a breathing tube.
"Wow," he told her. "I have another chance at life."
Punch mulled a thought, then asked. "Would you ever want to share your story?"
Taylor agreed.
Punch recruited his hospital caregivers to create a video of their memories of saving him. When the taping finished, Taylor hugged each one.
Punch uses the video during talks, sometimes inviting Taylor to join her. Giving back to the community in that way has saved him a second time, he said.
After getting shot, "I could've basically turned to the dark side and done straight revenge," Taylor said. "But I didn't because of her."