“Dedicated to the Future of Health Care in the Tri-State Area,” the sign declares. “May 11, 1981.”

More recent placards posted at the facility’s entryways are ominous, however. “Closed,” they say. “No Trespassing.”

The Keokuk hospital, which served rural areas of Iowa, Illinois, and Missouri, closed in October 2022. But new owners plan to reopen the hospital with the help of a new federal payment system. The Rural Emergency Hospital program guarantees hospitals extra cash if they provide emergency and outpatient services but end inpatient care.

“We’ve been without a hospital for over a year — and I don’t think anybody in Keokuk or the surrounding areas will be picky in any way, shape, or form,” said Kathie Mahoney, mayor of the town of about 9,800 people. She said residents would prefer to have a full-service hospital with inpatient beds, even though those types of beds had been used sparingly in recent years.

The revival of the Keokuk hospital would mark a small victory in the nationwide struggle to save rural hospitals, which continue to close due to staffing shortages, low reimbursement rates, and declining patient numbers. The new federal program, which went into effect in January 2023, is meant to stem the closures. But there have been growing pains, said George Pink, deputy director of the North Carolina Rural Health Research Program, which tracks hospital closures and conversions.

Just 18 of the more than 1,700 eligible rural hospitals nationwide have applied for and won the new designation. Many hospitals are reluctant to give up inpatient services entirely, and some are concerned about how other payment streams could be affected, rural health leaders say. The new designation’s unclear definition of “rural” has also caused confusion.

“We are still in an era of rural hospital closures,” Pink said. Nine hospitals closed in 2023, and that number could rise in 2024, he said. An influx of federal relief funds during the pandemic kept struggling hospitals afloat, but now that money is largely gone.

The Rural Emergency Hospital program is the first new federal payment model for hospitals since 1997. Dora Hughes, acting chief medical officer of the Centers for Medicare & Medicaid Services, said the new model’s criteria are outlined by statute and “hospitals should consider specific circumstances before making the decision to apply.”

The federal agency is providing outreach to rural communities and welcomes feedback, Hughes wrote in an email to KFF Health News.

Now, rural health leaders and federal lawmakers are working quickly to tweak the new program to attract more applicants, said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association.

Currently, facilities that convert to rural emergency hospitals receive a 5% increase in Medicare payments, plus an average annual payment of about $3.2 million, in exchange for giving up their expensive inpatient beds and focusing solely on emergency and outpatient care. Rural hospitals with no more than 50 beds, like Keokuk’s, that closed after the law was signed on Dec. 27, 2020, are eligible to apply for the program and reopen with emergency and outpatient services.

More than 100 rural hospitals nationwide have inquired about converting, said Janice Walters, interim executive director for the Rural Health Redesign Center, which has a federal grant to provide technical assistance to hospitals that want to apply.

But only about a quarter of those inquiries are likely to become a rural emergency hospital, and persuading more troubled hospitals to make the leap would require regulators to make changes, Walters said.

Her advice? “Give them 10 beds to just take care of their community.”

In a journal article published last year, general surgeon Sara Schaefer worried about the unintended consequences of getting rid of rural inpatient beds. Schaefer, who spent six months of medical school at a small rural Idaho hospital, said she saw firsthand how difficult it was for the hospital to transfer patients to bigger facilities, which were often too full to take them.

“There has to be a better way,” said Schaefer, who is also a research fellow at the Center for Healthcare Outcomes & Policy at the University of Michigan.

The rural health association’s Cochran-McClain said lawmakers are considering changes that could allow the hospitals to:

• Keep overnight beds for patients who need moderate levels of care, such as those with pneumonia or in need of physical therapy after surgery.
• Allow participation in a federal drug discount program called 340B, which provides hospitals with extra revenue.
• Keep inpatient psychiatric or rehabilitation units open.
• Clarify eligibility, including which facilities qualify under the definition of “rural” and whether the hospitals that closed before the 2020 date in the law can apply.

Updates to the law could affect communities nationwide. In Fort Scott, Kansas, where the hospital closed in late 2018, Mayor Matthew Wells said the community wants the eligibility date pushed back. U.S. Sen. Jerry Moran (R-Kan.) introduced a bill in December that, if passed, would push eligibility back to 2015.

“This is a matter of life and death to my community,” Wells said. “I see a clear path, but the federal regulations in particular make that path nearly impossible.”

In Holly Springs, Mississippi, hospital chief executive Kenneth Williams said he doesn’t understand the federal definition of “rural.” His hospital, Alliance Healthcare Hospital, was one of the first to win the new Rural Emergency Hospital designation in early 2023. He laid off staff and shut down his inpatient beds. Then, CMS officials called to tell him they had made a mistake.

“And I said, ‘Wait a minute,’” Williams said. The hospital, which is about an hour south of Memphis, Tennessee, doesn’t meet the current criteria of rural, they told him. Williams, an internal medicine doctor, bought the hospital in 1999 and has been trying to keep it running since.

Federal regulators are now asking Williams to convert the facility into another type of Medicare payment model, such as the sole community hospital with inpatient beds that it was before. Williams said that would be difficult: “What kind of transition can I make, especially with reduced services?”

In Keokuk, the hospital fits the current requirements. Insight Health Group, the Michigan company that bought the shuttered facility last March, plans to apply for the new federal designation as soon as it obtains state permits under new Iowa regulations tailored to rural emergency hospitals. It would be the first such hospital in the state.

Like many other rural hospitals struggling to survive, Keokuk’s shuttered several key departments years ago, including its birthing and inpatient psychiatric units. In 2021, the last full year it was open, the hospital averaged fewer than three inpatients per night, according to data posted by the Iowa Hospital Association.

More than half of the three-story building would remain mothballed if the facility reopened under the new designation, but the emergency department could serve patients again as soon as late summer, said Atif Bawahab, Insight’s chief strategy officer.

Bruce Mackie has worked 32 years at the hospital, including 10 years as director of plant operations. The new owners kept him on to watch over the building. Beds, high-tech scanners, and lab equipment remain, but most of the clocks have stopped. “It’s spooky,” he said.

Even if the services are more limited than before, Mackie said, “everybody wants the hospital to reopen. This city needs an ER.”

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“I was just trying to make a living,” said Brady, 56, a dealer and supervisor at Borgata in that New Jersey resort city. “You don’t think, you know, that you’re going to get sick at your job.”

Some casinos continue to allow indoor smoking even as the share of Americans who smoke fell from about 21% in 2005 to 12% in 2021 and smoking is banned in at least some public spaces in 35 states, the District of Columbia, and U.S. territories. Still, 13 of the 22 states and territories that allow casino gambling permit smoking in at least part of their facilities.

Brady is among the casino employees, anti-smoking advocates, and public health experts who argue it is long past time to snuff out casino exemptions from smoking bans, given the dangers of secondhand smoke. But they’ve faced stiff pushback from some gambling industry leaders, including in Missouri, Louisiana, Kentucky, and New Jersey, who argue that smoking bans drive gamblers away — especially in places where patrons can go instead to a casino in a nearby jurisdiction that allows them to light up.

The covid-19 pandemic renewed this fight and sharpened the arguments on both sides — on the dangers of particulate matter for the anti-smoking side and the vulnerability of revenues for the casino industry, even as the American Gaming Association reported record-breaking revenues in 2022 for in-person casino gambling beyond the growth of sports betting and online gambling.

Casinos were shut down for several months in spring 2020 as part of the nationwide effort to mitigate the spread of the coronavirus. Rules governing reopening, including masking and physical distancing requirements and bans on smoking, varied by state and, in some cases, by casino operator and community.

After suffering pandemic-era losses, some casino executives, and at least one union representing workers, leaned into a 2021 report commissioned by the Casino Association of New Jersey to combat efforts to ban or restrict smoking at their properties. Using data from 2019, the report suggests that as many as 2,500 Atlantic City casino workers could lose their jobs and tax revenue could fall by as much as $44 million in the first year if smoking is banned in New Jersey but not in neighboring Pennsylvania. Both states considered prohibitions on casino smoking in 2023; New Jersey lawmakers didn’t pass their bill and Pennsylvania’s remains in limbo.

Brian Christopher, a social media influencer specializing in casinos and gambling, said he has heard the arguments about lost business before — and is unconvinced. “People are not driving or flying to a casino to have a cigarette,” he said.

Still, officials in some places are persuaded by arguments about depressed tax revenue. Last spring, Shreveport, Louisiana, officials repealed a 2020 ban on smoking in casinos. Those pushing the repeal said local gambling taxes fell when gamblers left for nearby casinos where they could smoke. The new ordinance allows smoking on 75% of the casino floor.

And Churchill Downs Inc. announced in June it was moving a gambling facility planned for empty mall space in Owensboro, Kentucky, to a location outside the city limits. Though the company declined to comment for this article, the city’s mayor told the Messenger-Inquirer newspaper that a primary reason for the move was the city’s long-standing voter-approved smoking restrictions, which do not exempt casinos.

Kanika Cunningham, director of the St. Louis County Department of Public Health in Missouri, was part of an effort last year to end a casino loophole in her county’s 2011 indoor smoking ban. But after pushback from the gambling company Penn Entertainment, a compromise was reached allowing smoking on 50% of a casino’s floor.

“It’s a balance and one that we feel the marketplace should determine, particularly in such a competitive environment with other gaming facilities nearby and in neighboring states,” said Jeff Morris, Penn Entertainment’s vice president of public affairs and government relations.

Penn Entertainment employs “state of the art ventilation systems, extremely high ceilings,” and “adequate separation of smoking and non-smoking areas,” he wrote in an email to KFF Health News.

The problem, Cunningham said, is that secondhand smoke cannot be contained to a single location in a big room.

“There’s no safe amount, and trying to restrict it to a certain area isn’t going to work,” she said.

Filtration systems can remove much of the visible smoke, as well as the odor, from indoor spaces even when lots of people are smoking, creating the impression of clean air. But existing technology does not eliminate the dangerous particulates in cigarette smoke, according to a 2023 report from the American Society of Heating, Refrigerating and Air-Conditioning Engineers, or ASHRAE.

A study published in 2023 for the National Institutes of Health evaluated particulate matter at eight Las Vegas casinos that allowed smoking and one that did not. In casinos where smoking is allowed, particulate levels were significantly higher — even in areas designated as nonsmoking — than at the nonsmoking casino.

And in ventilated casinos where indoor smoking is allowed, one study showed, workers can have nicotine levels as much as 600% higher than employees exposed to smoking in other workplaces.

Secondhand smoke can cause coronary heart disease, stroke, lung cancer, and other diseases. Some studies have shown a link to breast cancer, although more research is needed, according to the National Cancer Institute.

The pandemic raised awareness of the dangers of airborne particulates, giving smoking bans fresh momentum, said Andrew Klebanow, co-founder of the independent industry consulting group C3 Gaming, which produced a report in 2022 largely refuting the economic risk of casinos going smoke-free.

Indeed, more than 1,000 U.S. casinos and other gambling properties now ban smoking, including more than 140 tribal casinos, according to Americans Nonsmokers’ Rights Foundation.

New Mexico’s tribal leaders collectively agreed to maintain smoking bans when pandemic restrictions were lifted, said Denis Floge, chief executive of Acoma Business Enterprises and Sky City Casino in North Acomita Village. Employee health has improved, he said, qualifying the casino for rebates on its insurance premium. Cleaning and replacement costs for carpets and equipment fell, he said, and the tribes “haven’t missed a beat” on revenues.

Some guests have grumbled about having to go outside to smoke, Floge said, but that’s about it. “We don’t have anybody who jumps up and down, or throws a fit and says, ‘I’m leaving and never coming back!’” he said.

Casino executives who oppose smoking restrictions overlook people who want to enjoy the “great food and the great entertainment, but won’t step foot in a casino because they get hit by a blast of smoke as soon as they step in,” said Pete Naccarelli, a Borgata dealer and one of three co-founders of the advocacy organization Casino Employees Against Smoking’s Effects.

He said they founded the group, which has chapters in New Jersey, Kansas, Pennsylvania, Rhode Island, and Virginia, after his casino put out ashtrays at 12:01 a.m. the day the pandemic-related smoking ban officially ended. Borgata did not answer requests for comment.

The industry-commissioned report on New Jersey suggests that while more nonsmokers might frequent casinos once smoking is banned, they probably would not make up for the revenue lost if smokers choose other venues or when smokers take breaks from gambling to light up.

But Brady, now cancer-free after chemotherapy and a full mastectomy, believes that if policymakers spent some time breathing the same air she and her co-workers do they’d act more quickly to ban smoking in casinos, rather than prioritize tax revenues. “Our lives are more important,” she said.

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The added services would provide care to patients who live in largely rural eastern Iowa, including some of the hundreds previously treated at a University of Iowa clinic, saving them half-day drives to clinics in larger cities like Chicago and Minneapolis.

By June, The Project of the Quad Cities, as the Illinois clinic is called, had hired a provider who specializes in transgender health care. So, Andy Rowe, The Project’s health care operations director, called the clinic’s insurance broker to see about getting the new provider added to the nonprofit’s malpractice policy.

“I didn’t anticipate that it was going to be a big deal,” Rowe said. Then the insurance carriers’ quotes came. The first one specifically excluded gender-affirming care for minors. The next response was the same. And the one after that. By early November, more than a dozen malpractice insurers had declined to offer the clinic a policy.

Rowe didn’t know it at the time, but he wasn’t alone in his frustrating quest.

Nearly half the states have banned medication or surgical treatment for transgender youth. Independent clinics and medical practices located in states where such care is either allowed or protected have moved to fill that void for patients commuting or relocating across state lines. But as the risk of litigation rises for clinics, obtaining malpractice insurance on the commercial marketplace has become a quiet barrier to offering care, even in states with legal protections for health care for trans people. In extreme cases, lawmakers have deployed malpractice insurance regulations against gender-affirming care in states where courts have slowed or blocked anti-trans legislation.

Five months after starting his search for malpractice insurance, Rowe said, he received a quote for a policy that would allow The Project to treat trans youth. That’s when he realized finding a policy was only the first hurdle. He expected the coverage to cost $8,000 to $10,000 a year, but he was quoted $50,000.

Rowe said he hadn’t experienced anything like it in his 20 years working in health care administration.

Insurance industry advocates argue that higher premiums are justified because the rise in legislation surrounding gender-affirming care for minors means clinics are at increased risk of being sued.

“If state laws increase the risk of civil liability for health professionals, premiums will be adjusted accordingly and appropriately to reflect the level of financial risk incurred by the insured,” Mike Stinson, vice president of public policy and legal affairs at the Medical Professional Liability Association, an insurance trade association, said in an emailed statement. If state laws make an activity illegal, then insurance will not cover it at all, he said.

Only a few states have passed laws preventing malpractice insurers from treating gender-affirming care differently than other care. Massachusetts was the first, when lawmakers there passed legislation that says insurers could not increase rates for health care providers for offering services that are illegal in other states.

Since then, five other states have passed laws requiring malpractice insurers to treat gender-affirming health care as they do any other legally protected health activity: Colorado, Vermont, New York, Oregon, and California (similar legislation is pending in Hawaii).

“This was a preventative measure, and it was met with full acceptance by both the insured and the insurers,” said Vermont state Sen. Virginia “Ginny” Lyons, a Democrat who co-sponsored the state’s law. She said lawmakers consulted with both physicians and malpractice insurance companies to make sure the language was accurate. Insurers just wanted to be able to clearly assess the risk, she said.

Lyons said she hadn’t heard of any providers in Vermont who had trouble with their malpractice insurance before the law was enacted, but she was concerned politics might get in the way of doctors’ ability to offer care. In March 2022, The Texas Tribune reported that one Texas doctor had stopped offering care because his malpractice provider had stopped covering hormone therapy for minors.

Lawmakers in some states have gone further and revised malpractice provisions to restrict access to gender-affirming care, often while bans on offering that care to trans youth are stalled in court. In 2021, Arkansas became the first state to ban gender-affirming care for trans children. When that ban was held up in court last year, the governor signed a new law allowing anyone who received gender-affirming care as a minor to file a malpractice lawsuit up to 15 years after they turn 18.

Similar laws followed in Tennessee, Florida, and Missouri, all extending the statute of limitations on filing a malpractice claim anywhere from 15 to 30 years. (Another was introduced but not passed in Texas that would have stretched the statute of limitations to the length of the patient’s life.) Typically, malpractice suits must be filed within one to three years of injury.

The civil liability that those laws created has forced at least one clinic to stop offering some treatments. The Washington University Transgender Center in Missouri said the law subjected the clinic to “unacceptable level of liability.”

Alejandra Caraballo, a civil rights attorney and clinical instructor at the Harvard Law School Cyberlaw Clinic, said there has been “a concerted effort on the part of anti-trans activists to utilize malpractice insurance as a means of eliminating care.”

She likens the strategy to laws that have long targeted abortion providers by increasing “legal liability to chill a certain type of conduct.”

Anti-trans activists have drawn attention to a small number of “detransitioners,” who have filed lawsuits against the doctors who provided them with gender-affirming care, she said. She believes those lawsuits, filed in such states as California, Nebraska, and North Carolina, will be used to lobby for longer statutes of limitations and to create the perception that liability for providers is increasing.

For independent clinics, like The Project in the Quad Cities, and small medical practices that purchase their malpractice insurance on the commercial marketplace, those tactics are restricting their ability to offer care. Many providers of gender-affirming care are protected from rising premiums such as health centers that receive federal funding, which are covered under the Federal Tort Claims Act, or academic medical centers and Planned Parenthood clinics, which are self-insured. But a small number of independent clinics have been priced out.

In Albuquerque, New Mexico, a state that, like Illinois, has protected access to gender-affirming care, family medicine physician Anjali Taneja said the clinic where she works is running into the same trouble getting coverage.

Casa de Salud, where Taneja is the executive director, has provided gender-affirming care to adults for years, but when the clinic decided to start offering that care to younger patients, insurers wouldn’t issue a malpractice policy. The clinic was quoted “double what we paid a few years ago,” just to cover the gender-affirming care it offers to adults, Taneja said.

The red tape both Casa de Salud and The Project are encountering has prevented treatment for patients. When Iowa’s ban on gender-affirming care took effect Sept. 1, officials at The Project had hoped to offer services to the transgender youth who previously sought care an hour west at the University of Iowa’s LGBTQ Clinic. Instead, Rowe said, patients are making the difficult decision between going without treatment or commuting four hours to Chicago or Minneapolis.

After months of fundraising, The Project has almost enough money to pay for the $50,000 malpractice policy. But, Rowe said, “it’s a tough swallow.”

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An infusion of reliable federal funding, advocates say, could allow these nonprofits to expand their reach to more residents most at risk of being shot — or of shooting someone.

So far, California, Colorado, Connecticut, Illinois, Maryland, New York, and Oregon have passed laws approving the use of Medicaid money for gun violence prevention, said Kyle Fischer, policy and advocacy director for The Health Alliance for Violence Intervention, which has lobbied for the federal and state Medicaid policy changes allowing this spending. More states are expected to follow.

“These are concrete things that we can do that avoid the debates around the Second Amendment,” Fischer said.

With gun control legislation stalled in Congress, the Biden administration has opened up federal Medicaid dollars to violence prevention as one of the ways states and cities can combat firearm violence. President Joe Biden announced the novel approach in April 2021, and now the money is starting to flow to interested states.

But the process to unlock the funding has been lengthy, and it’s unclear how much money will ultimately be spent on these programs. Because Medicaid, which provides health care for low-income and disabled residents, is a state-federal program, states must also approve spending the money on violence prevention.

In Illinois, which two years ago became one of the first states to approve Medicaid spending for violence prevention, Chicago CRED hopes to get approval for its program this spring. Arne Duncan, the former U.S. education secretary who leads the violence prevention group, said getting paid by Medicaid will be worth the wait and that he hopes his state’s experience will make it more expeditious for others.

“We’re trying to build a public health infrastructure to combat gun violence,” Duncan said. “Having Medicaid start to be a player in this space and create those opportunities could be a game changer.”

In 2020, many cities around the country confronted a rise in shootings and homicides after officials responding to the pandemic shut down schools, businesses, and critical social services. That same year, police murdered George Floyd, a Black man, in Minneapolis, sparking nationwide protests and calls to cut police funding. Americans, already armed to the hilt, rushed to buy more guns.

While the pandemic has receded and homicide rates have dropped nationally, homicides haven’t gone down in some cities. The number of gun purchases is historically high in the United States, which is estimated to have more guns than people. Programs that worked a few years ago in places like Oakland, Calif. — which had won acclaim for slashing its gun violence — can’t keep up. Memphis in November broke its record for homicides in a year.

“We have a uniquely high prevalence of firearm ownership in the United States,” said Garen Wintemute, a professor of emergency medicine and chair in violence prevention at the University of California-Davis. “We have more guns in civilian hands than we have civilians, with something on the order of 400 million guns in the United States.”

“Guns are tools, and you put a tool in somebody’s hands, they’re going to use it,” he added.

Gun violence also brings a hefty price tag. Studies from the Government Accountability Office and Harvard Medical School have shown that the cost of caring for gunshot survivors ranges from $1 billion in initial treatments to $2.5 billion over the 12 months post-injury. And it’s not only gunshot victims who need medical help.

“The patients that we see, there’s a lot of grief. Parents losing their children, grandparents losing their grandchildren. That impacts people’s health tremendously,” said Noha Aboelata, founding CEO of Roots Community Health Center in Oakland. “Entire neighborhoods have ongoing stress and trauma.”

Despite the long and often bureaucratic process, Medicaid dollars are incredibly attractive for community organizations that have historically relied on philanthropic donations and grants, which can vary year to year.

“Medicaid is reliable,” Fischer said. “If you’re doing the work, you’re qualified for it, and you are taking care of patients, you get reimbursed for the work that you do.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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Since 2010, about 150 rural hospitals have shuttered and hundreds more have slashed services, leaving a growing number of America’s 60 million rural residents in health care deserts.

In this 2020 encore episode of the “Tradeoffs” podcast, Dan Gorenstein talks with KFF Health News chief rural health correspondent Sarah Jane Tribble about her yearlong effort to document the collapse of one rural Kansas community hospital. Nearly six years later, the residents of Fort Scott, Kansas, still live without a local hospital, a reality visited upon dozens more small towns in the years since.

“We’re talking about millions of lives affected by the kind of health care delivery that’s in these communities,” Tribble said. “Rural America, on a whole, is poorer, sicker and older than urban America. People whose lives are affected daily by chronic health issues.”

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That’s because, after KFF Health News sent questions to Nix’s insurance company, Blue Cross Blue Shield of Illinois, it retroactively approved $36,000 worth of treatments she thought she owed. Even better, she also learned she would qualify for the infusions moving forward.

Good news all around — except it didn’t last for long. After all, this is the U.S. health care system, where even patients with good insurance aren’t guaranteed affordable care.

To recap: For more than a decade, Nix, of Statesville, North Carolina, has suffered from autoimmune diseases, chronic pain, and fatigue, as well as a condition called trigeminal neuralgia, which is marked by bouts of electric shock-like pain that’s so intense it’s commonly known as the “suicide disease.”

“It is a pain that sends me to my knees,” Nix said in October. “My entire family’s life is controlled by the betrayal of my body. We haven’t lived normally in 10 years.”

Late in 2022, Nix started receiving intravenous immunoglobulin infusions to treat her diseases. She started walking two miles a day with her service dog. She could picture herself celebrating, free from pain, at her daughter’s summer 2024 wedding.

“I was so hopeful,” she said.

But a few months after starting those infusions, she found out that her insurance company wouldn’t cover their cost anymore. That’s when she started “raising Cain about it” on Instagram and Facebook.

You probably know someone like Sally Nix — someone with a chronic or life-threatening illness whose doctor says they need a drug, procedure, or scan, and whose insurance company has replied: No.

Prior authorization was conceived decades ago to rein in health care costs by eliminating duplicative and ineffective treatment. Not only does overtreatment waste billions of dollars every year, but doctors acknowledge it also potentially harms patients.

However, critics worry that prior authorization has now become a way for health insurance companies to save money, sometimes at the expense of patients’ lives. KFF Health News has heard from hundreds of people in the past year relating their prior authorization horror stories.

When we first met Nix, she was battling her insurance company to regain authorization for her infusions. She’d been forced to pause her treatments, unable to afford $13,000 out-of-pocket for each infusion.

Finally, it seemed like months of her hard work had paid off. In July, Nix was told by staff at both her doctor’s office and her hospital that Blue Cross Blue Shield of Illinois would allow her to restart treatment. Her balance was marked “paid” and disappeared from the insurer’s online portal.

But the day after the KFF Health News story was published, Nix said, she learned the message had changed. After restarting treatment, she received a letter from the insurer saying her diagnoses didn’t actually qualify her for the infusions. It felt like health insurance whiplash.

“They’re robbing me of my life,” she said. “They’re robbing me of so much, all because of profit.”

Dave Van de Walle, a spokesperson for Blue Cross Blue Shield of Illinois, said the company would not discuss individual patients’ cases.

“Prior authorization is often a requirement for certain treatments,” Van de Walle said in a written statement, “and BCBSIL administers benefits according to medical policy and the employer’s benefit.”

But Nix is a Southern woman of the “Steel Magnolia” variety. In other words, she’s not going down without a fight.

In September, she called out her insurance company’s tactics in a Change.org campaign that has garnered more than 21,000 signatures. She has also filed complaints against her insurance company with the U.S. Department of Health and Human Services, U.S. Department of Labor, Illinois Department of Insurance, and Illinois attorney general.

Even so, Nix said, she feels defeated.

Not only is she still waiting for prior authorization to restart her immunoglobulin infusions, but her insurance company recently required Nix to secure preapproval for another treatment — routine numbing injections she has received for nearly 10 years to treat the nerve pain caused by trigeminal neuralgia.

“It is reprehensible what they’re doing. But they’re not only doing it to me,” said Nix, who is now reluctantly taking prescription opioids to ease her pain. “They’re doing it to other patients. And it’s got to stop.”

Do you have an experience with prior authorization you’d like to share? Click here to tell your story.

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Determining a baby’s size during a 28-week obstetrical visit is routine. But Magloire, a family physician trained in obstetrics, knows that finding the mother’s uterus and, thus, checking the baby, can be tricky for inexperienced doctors.

“Sometimes it’s, like, off to the side,” Magloire said, showing a visiting medical student how to press down firmly and complete the hands-on exam. She moved her finger slightly to calculate the fetus’s height: “There she is, right here.”

Evans smiled and later said Magloire made her “comfortable.”

The 21-year-old had recently relocated from Louisiana to southeastern Georgia, two states where both maternal and infant mortality are persistently high. She moved in with her mother and grandfather near Cairo, an agricultural community where the hospital has a busy labor and delivery unit. Magloire and other doctors at the local clinic where she works deliver hundreds of babies there each year.

Scenes like the one between Evans and Magloire regularly play out in this rural corner of Georgia despite grim realities mothers and babies face nationwide. Maternal deaths keep rising, with Black and Indigenous mothers most at risk; the number of babies who died before their 1st birthday climbed last year; and more than half of all rural counties in the United States have no hospital services for delivering babies, increasing travel time for parents-to-be and causing declines in prenatal care.

There are many reasons labor and delivery units close, including high operating costs, declining populations, low Medicaid reimbursement rates, and staffing shortages. Family medicine physicians still provide the majority of labor and delivery care in rural America, but few new doctors recruited to less populated areas offer obstetrics care, partly because they don’t want to be on call 24/7. Now, with rural America hemorrhaging health care providers, the federal government is investing dollars and attention to increase the ranks.

“Obviously the crisis is here,” said Hana Hinkle, executive director of the Rural Training Track Collaborative, which works with more than 70 rural residency training programs. Federal grants have boosted training programs in recent years, Hinkle said.

In July, the Department of Health and Human Services announced a nearly $11 million investment in new rural programs, including family medicine residencies that focus on obstetrical training.

Nationwide, a declining number of primary care doctors — internal and family medicine — has made it difficult for patients to book appointments and, in some cases, find a doctor at all. In rural America, training family medicine doctors in obstetrics can be more daunting because of low government reimbursement and increasing medical liability costs, said Hinkle, who is also assistant dean of Rural Health Professions at the University of Illinois College of Medicine in Rockford.

In the 1980s, about 43% of general family physicians who completed their residencies were trained in obstetrics. In 2021, the American Academy of Family Physicians’ annual practice profile survey found that 15% of respondents had practiced obstetrics.

Yet family doctors, who also provide the full spectrum of primary care services, are “the backbone of rural deliveries,” said Julie Wood, a doctor and senior vice president of research, science, and health of the public at the AAFP.

In a survey of 216 rural hospitals in 10 states, family practice doctors delivered babies in 67% of the hospitals, and at 27% of the hospitals they were the only ones who delivered babies. The data counted babies delivered from 2013 to 2017. And, the authors found, if those family physicians hadn’t been there, many patients would have driven an average of 86 miles round-trip for care.

Mark Deutchman, the report’s lead author, said he was “on call for 12 years” when he worked in a town of 2,000 residents in rural Washington. Clarifying that he was exaggerating, Deutchman explained that he was one of just two local doctors who performed cesarean sections. He said the best way to ensure family physicians can bolster obstetric units is to make sure they work as part of a team to prevent burnout, rather than as solo do-it-all doctors of old.

There needs to be a core group of physicians, nurses, and a supportive hospital administration to share the workload “so that somebody isn’t on call 365 days a year,” said Deutchman, who is also associate dean for rural health at the University of Colorado Anschutz Medical Campus School of Medicine. The school’s College of Nursing received a $2 million federal grant this fall to train midwives to work in rural areas of Colorado.

Nationwide, teams of providers are ensuring rural obstetric units stay busy. In Lakin, Kansas, Drew Miller works with five other family physicians and a physician assistant who has done an obstetrical fellowship. Together, they deliver about 340 babies a year, up from just over 100 annually when Miller first moved there in 2010. Word-of-mouth and two nearby obstetric unit closures have increased their deliveries. Miller said he has seen friends and partners “from surrounding communities stop delivering just from sheer burnout.”

In Galesburg, Illinois, Annevay Conlee has watched four nearby obstetric units close since 2012, forcing some pregnant people to drive up to an hour and a half for care. Conlee is a practicing family medicine doctor and medical director overseeing four rural areas with a team of OB-GYNs, family physicians, and a nurse-midwife. “There’s no longer the ability to be on 24/7 call for your women to deliver,” Conlee said. “There needs to be a little more harmony when recruiting in to really support a team of physicians and midwives.”

In Cairo, Magloire said practicing obstetrics is “just essential care.” In fact, pregnancy care represents just a slice of her patient visits in this Georgia town of about 10,000 people. On a recent morning, Magloire’s patients included two pregnant people as well as a teen concerned about hip pain and an ecstatic 47-year-old who celebrated losing weight.

Cairo Medical Care, an independent clinic situated across the street from the 60-bed Archbold Grady hospital, is in a community best known for its peanut crops and as the birthplace of baseball legend Jackie Robinson. The historical downtown has brick-accented streets and the oldest movie theater in Georgia, and a corner of the library is dedicated to local history.

The clinic’s six doctors, who are a mix of family medicine practitioners, like Magloire, and obstetrician-gynecologists, pull in patients from the surrounding counties and together deliver nearly 300 babies at the hospital each year.

Deanna Buckins, a 36-year-old mother of four boys, said she was relieved when she found “Dr. Z” because she “completely changed our lives.”

“She actually listens to me and accepts my decisions instead of pushing things upon me,” said Buckins, as she held her 3-week-old son, whom Magloire had delivered. Years earlier, Magloire helped diagnose one of Buckins’ older children with autism and built trust with the family.

“Say I go in with one kid; before we leave, we’ve talked about every single kid on how they’re doing and, you know, getting caught up with life,” Buckins said.

Magloire grew up in Tallahassee, Florida, and did her residency in rural Kansas. The smallness of Cairo, she said, allows her to see patients as they grow — chatting up the kids when the mothers or siblings come for appointments.

“She’s very friendly,” Evans said of Magloire. Evans, whose first child was delivered by an OB-GYN, said she was nervous about finding the right doctor. The kind of specialist her doctor was didn’t matter as much as being with “someone who cares,” she said.

As a primary care doctor, Magloire can care for Evans and her children for years to come.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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That money has gone from an emerging funding stream for which people had lofty but uncertain aspirations to a coveted pot of billions of dollars being invested in real time to address addiction.

Altogether, the companies are expected to pay more than $50 billion to state and local governments over nearly two decades.

Meanwhile, more than 100,000 Americans have died of drug overdoses annually in recent years, underscoring the urgent nature of the crisis.

KFF Health News has been tracking the funds all year and covering the windfall’s mixed impact in communities across the country. Here are five things we’ve noticed in 2023 and plan to keep an eye on next year:

1. The total amount of settlement money state and local governments expect to receive is a moving target.

Before the start of the year, national settlements were in place with at least five companies, and several other deals were in the final stages, said Christine Minhee, founder of OpioidSettlementTracker.com.

Today, most states are participating in settlements with opioid manufacturers Johnson & Johnson, Teva Pharmaceutical Industries, and Allergan; pharmaceutical distributors AmerisourceBergen, Cardinal Health, and McKesson; and retail pharmacies Walmart, Walgreens, and CVS. Many are also settling with the national supermarket chain Kroger.

Several of these deals began paying out in the second half of this year, leading to bumps in states’ opioid settlement pots.

But there have been dents and slowdowns too.

Mallinckrodt Pharmaceuticals, a manufacturer of generic opioids, originally agreed to pay $1.7 billion as a result of its 2020 bankruptcy filing to state and local governments, as well as people directly affected by the crisis. But the company filed a second bankruptcy in August, slashing $1 billion from that figure.

Purdue Pharma, perhaps the best known of all the companies for its creation and marketing of OxyContin, had agreed to pay $6 billion as part of its bankruptcy proceedings. But the Biden administration objected to the deal this summer, and the case now lies in the hands of the Supreme Court. At its core is the question of whether it’s legal for the Sackler family to gain immunity from future civil cases about the opioid crisis under the company’s bankruptcy deal when they have not filed for bankruptcy as individuals.

The Supreme Court heard arguments in December and is expected to rule on the case next spring or summer. Until then, no Purdue money will flow.

2. Most states still aren’t being transparent about how the money is used.

In March, KFF Health News and Minhee published a comprehensive investigation showing that only 12 states had promised to publicly report how they were using all their settlement dollars.

Since then, that number has inched up to 16.

But 15 states still have not committed to publicly reporting anything at all, and others have promised to publicize only a portion of their spending.

Many people aren’t happy about the secrecy.

In Ohio, a local advocacy group, Harm Reduction Ohio, sued the OneOhio Recovery Foundation, which controls most of the state’s settlement dollars, for violating public records and open-meeting laws. Although a judge ruled in favor of the advocacy group, it became a moot point in July, when the state passed a budget that included language exempting the foundation from such requirements.

In Michigan, the Department of Health and Human Services came under fire for not publicly reporting how it was spending upward of $40 million in settlement funds. In October — just hours before a legislative subcommittee hearing in which lawmakers asked critical questions about the money — the department launched a website, displaying a breakdown of organizations to which it had awarded funds.

At the national level, a dozen Democratic lawmakers have raised concerns about a lack of transparency and oversight via a Sept. 25 letter to the Office of National Drug Control Policy, which is leading the federal government’s response to the opioid crisis.

“We urge the Biden administration to closely track opioid settlement fund spending, to ensure that populations in need of additional support receive it,” the lawmakers wrote.

The Office of National Drug Control Policy responded this month that it did not have the statutory authority from Congress to do so.

“Currently, no mechanism exists that would allow ONDCP to require states to disclose their spending,” the office wrote in a letter obtained by KFF Health News. “ONDCP cannot effectively monitor how states use these funds.”

3. Nationwide, money is being spent in several common areas.

Although there is no national data on how settlement dollars are spent, piecemeal tracking by journalists and advocates has surfaced some favorites.

One of the biggest is investing in treatment. Many jurisdictions are building residential rehab facilities or expanding existing ones. They’re covering the cost of care for uninsured people and trying to increase the number of clinicians prescribing medications for opioid use disorder, which have been shown to save lives.

Another common expense is naloxone, a medication that reverses opioid overdoses. Wisconsin is spending about $8 million on this effort. Kentucky has dedicated $1 million. And many local governments are allocating smaller amounts.

Some other choices have sparked controversies.

Several governments used settlement dollars to purchase police patrol cars, technology to help officers hack into phones, and body scanners for jails. Supporters say these tools are critical to crack down on drug trafficking, but research suggests law enforcement efforts don’t prevent overdoses.

People are also divided over school-based programs to prevent kids from developing addictions. While they agree on the goal, some people favor programs that teach kids about the dangers of drugs — like D.A.R.E. in the ’80s — while others prefer programs focused on improving mental health, resiliency, and communication skills.

Perhaps the most contentious use, though, is shoring up county budgets and paying back old bills. Even if it’s legal, many people directly affected by the epidemic say this misses the goal of the settlement money, which is to address today’s ongoing crisis.

4. The settlements required companies to change problematic business practices, but that has had unintended consequences.

As part of their settlements, manufacturers like Allergan and Johnson & Johnson agreed not to sell opioids for 10 years and curb marketing and promotion activities. Pharmaceutical distributors were required to step up efforts to identify suspicious orders from pharmacies, under the oversight of an independent third-party monitor. Retail pharmacy chains must conduct audits and site visits to their pharmacies, as well as share data with state agencies about problematic prescribers.

The goal of these stipulations is to prevent further misuse of prescription opioids. But some people see unintended consequences.

Distributors have placed stricter limits not only on pharmacy orders of opioids, but on many drugs considered potentially addictive, known as “controlled substances.” As a result, orders for these medications are being canceled more often and some pharmacies are hesitant to fill prescriptions for new patients. That has left people struggling to obtain medications for chronic pain, anxiety, attention-deficit/hyperactivity disorder — and, ironically, even medication that treats opioid addiction.

Bayla Ostrach, a researcher in North Carolina who studies substance use and health policy, said buprenorphine, which is considered a gold-standard treatment for opioid use disorder, was already difficult to obtain at many community pharmacies and in rural areas. But the settlements appear to be making it worse.

Instead of increasing access to treatment — which is critical to stemming the number of overdoses — “I really worry the settlements may be having the opposite effect,” Ostrach said.

5. Many places haven’t decided what to do with the money yet.

Several states, including Montana and Hawaii, have yet to spend any of the settlement funds controlled by their state agencies. In Maine and West Virginia, councils overseeing the lion’s share of funds are still in the process of identifying priorities and developing processes to award grants.

Across the nation, some county officials say they need more guidance on appropriate uses of the money. Others are surveying residents on what they want before making decisions.

The slow pace has frustrated some advocates, who say there should be greater urgency at a time when the drug supply is becoming increasingly deadly. But others say the money will continue arriving through 2038, so setting up thoughtful processes now could pay off for years to come.

It’s a trade-off between putting out current fires and preventing future ones, said Shelly Weizman, project director of the addiction and public policy initiative at Georgetown University’s O’Neill Institute. She’s hopeful officials will strike the right balance.

“Is there a vision in each state about where we’re going to be when the settlement monies are done?” she said. “My hope is that 18 years from now we’re not still where we are today.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life threatening or may result in death.”

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

• Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.
• Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
• Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.
• And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

‘Too Little, Too Late’

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to Market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

3,000

Approximate number of low- to moderate-risk devices cleared every year through 510(k). 

30

Approximate number of devices receiving original approval from the FDA each year through stricter premarketing requirements. 

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm Bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late Warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

10%

Approximate number of reports in which more than a year or two elapsed from when a death or serious injury occurred to when the FDA received the reports 

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private Eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

Related Links

• Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half. Dec 5, 2023
• Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail. Oct 10, 2023

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

‘Exciting Features’

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

Legal Barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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These sparsely populated communities can have trouble sustaining ambulance services, if small patient volumes and low reimbursements rates don’t cover operating costs.

They also struggle with staffing. Most medics across the country are paid, but 75 percent of those who do volunteer are based in rural areas. However, their ranks are aging, and the younger generation isn’t showing enough interest in volunteering.  

Why do ambulance deserts matter? Even though rural Americans are older and sicker than urban Americans, they have less access to health care. They have a higher risk of dying from certain diseases, like strokes and cancer, and are more than twice as likely to suffer accidental deaths, such as fatal car crashes and opioid overdoses.

And they’re way more likely to get gored by bison.

“What does Chuck Norris say? ‘Always expect the unexpected.’ Well, I didn’t do that. I didn’t expect the unexpected,” South Dakota rancher Jim Lutter told me. 

Bill, a 3-year-old bison Lutter had always considered docile, attacked him last December, inflicting a 4-inch-deep puncture wound, a fractured collar bone, 16 broken ribs and a partially torn off scalp. Lutter benefited from a technology showing up in a smattering of ambulance services nationwide: video telehealth.

Ed Konechne, a volunteer medic, treated Lutter with the help of Katie DeJong, an emergency medicine physician who watched and spoke with Konechne and Lutter inside the ambulance from 140 miles away in a Sioux Falls office building. 

“I firmly believe that Jim had the best care anyone has ever received in the back of a basic life-support ambulance,” the medic told me.  

The video technology, Konechne said, lets him focus 100 percent of his time on his patients. 

Just as rural Americans can live far from ambulance bases, they can also face long drives to the nearest hospital, which are struggling to survive in remote areas. 

So during Lutter’s ambulance ride, DeJong made sure the rancher would get help as soon as possible by arranging a helicopter transport and telling the receiving hospital how to prepare.  

The technology doesn’t directly address the financial and staffing strains that lead to ambulance deserts. But by improving treatment, speeding up care and handling logistics, the remote provider may help rural medics reach their next patient more quickly.  

DeJong thinks the technology could also help with recruitment: people in rural areas might be more interested in volunteering as emergency medical technicians if they know they’ll have remote backup.

Ambulance-based telehealth programs recently launched in parts of Texas and Minnesota, but South Dakota officials say their program appears to be the nation’s only statewide effort. It’s funded with $2.7 million in state and federal pandemic relief money, state officials said.

But when funding dries up, ambulance services that want to continue using the technology will need to foot the bill. An official with South Dakota’s contractor, Avel eCare, says there is “not a standard cost” for its service.

Another increasingly popular idea to address ambulance deserts is to declare EMS an “essential service,” like police and fire departments, so states or municipalities have to fund them. Other recommendations include creating new reimbursement models and for the federal government to offer grants to designated ambulance deserts.

Lutter was fortunate. And bison gorings, thankfully, are uncommon. But more deaths in rural America could be prevented if ambulances and emergency departments were more accessible.

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