Judgments against patients in these suits can derail someone's life but, according to experts, they don't bring hospitals much money. So why do they do it?
Some hospitals sue patients over unpaid medical bills in bulk, sometimes by the hundreds of thousands. The defendants are often already facing financial hardship or even bankruptcy.
Judgments against patients in these suits can derail someone's life but, according to experts, they don't bring hospitals much money.
Host Dan Weissmann investigates this practice with The Baltimore Banner and Scripps News and speaks to patients who've found themselves on the receiving end of such lawsuits.
Weissmann also speaks with Nick McLaughlin, an entrepreneur who’s making the business case for hospitals to stop trying to collect money from people who simply don't have it.
The money is part of the approximately $50 billion that states and local governments will receive nationwide in opioid settlement funds over nearly two decades.
This article was published on Wednesday, December 13, 2023 in KFF Health News.
Nearly a year after Montana began receiving millions of dollars to invest in efforts to combat the opioid crisis, much of that money remains untouched. Meanwhile, the state's opioid overdose and death counts continue to rise.
Opioid manufacturers and distributors are paying more than $54 billion in restitution to settle lawsuits about their role in the overdose epidemic, with little oversight on how the money is spent. We're tracking how state and local governments use — or misuse — the cash.
The money is part of the approximately $50 billion that states and local governments will receive nationwide in opioid settlement funds over nearly two decades. The payments come from more than a dozen companies that made, distributed, or sold prescription opioid painkillers that were sued for their role in fueling the overdose epidemic.
Many places have begun deciding where that money will go and making payments to schools, public health departments, and local governments. South Carolina, for example, has awarded more than $7 million to 21 grantees. Wisconsin has posted two years' worth of spending plans that total nearly $40 million.
Montana, West Virginia, and Hawaii are among the states moving slower.
Montana began receiving its first settlement payments in January, and, by fall, payments totaled roughly $13 million. As of early December, the Montana Opioid Abatement Trust — a private nonprofit created to oversee 70% of the state's share — had met once to agree to its rules of operation, and its money remained locked behind an inactive grant portal. The remainder, divided among the state and local governments, either hadn't been spent or wasn't publicly recorded.
Those charged with distributing the money say they're building a framework to spend it in ways that last. Meanwhile, some addiction treatment providers are eager to use the funds to plug gaps in services.
The tension in Montana reflects a nationwide push-pull. Those handling settlement dollars say governments should take their time planning how to use the enormous windfall. Others argue for urgency as the drug supply has become increasingly deadly. More than 100,000 Americans died of overdoses in 2022, surpassing the previous year's record-setting death toll.
Nearly 200 Montanans died of a drug overdose in 2021, the latest year state data is available. That number, likely an undercount, is roughly 40 more deaths than the year before. Emergency medical responders have continued to record an increasing number of opioid-related emergencies this year.
In Billings, the Rimrock Foundation, one of the state's largest behavioral health providers, has seen its number of clients with opioid use dependency more than triple since 2021. Like other treatment facilities, Rimrock has a waitlist, and addiction treatment providers worry about the limited community resources that exist for patients once they are discharged. "The result of not addressing this is a lot of deaths," said Jennifer Verhasselt, Rimrock Foundation's chief clinical officer.
Debbie Knutson, Rimrock's medical unit and nursing supervisor, said there is widespread confusion about how and when the state's settlement dollars can be used.
"It's very concerning if we have money available that we could use to help people that is just kind of sitting, waiting for somebody to decide where it should go," Knutson said.
Rusty Gackle, the Montana Opioid Abatement Trust executive director, said a lot of work has happened behind the scenes to get local governments ready to accept their initial payments and for regional leaders to form systems to request money from the trust. That included hosting a series of town hall-style meetings to share information about the process. He said many of those local regions are still finalizing their governance structures.
"I would love to progress a little bit faster," Gackle said. "But I'd rather do it right so that we're not having to go backwards."
Montana officials got a late start too, he added. Some states began receiving settlement dollars last year, but Montana was toward the tail end of the line.
Montana is dividing its money three ways: 15% to the state, 15% to local governments, and the rest to the Montana Opioid Abatement Trust, with some money set aside for attorneys' fees.
As of late November, the state hadn't begun spending the $2.4 million it had in hand for state agencies. Officials also aren't tracking how and when local governments spend their direct payments.
Similarly, West Virginia and Hawaii hadn't — by late November — begun spending the largest shares of their funding. In West Virginia, the makeup of the foundation board that will oversee roughly 70% of the state's settlement dollars was announced only in August, six weeks after the state's deadline, and the board is now sitting on more than $217 million.
Nationwide, state and local governments have received more than $4.3 billion as of Nov. 9. How much of that has been used remains uncertain due to states' lack of public reporting. But from what is known, it varies.
Colorado, whose spending plan is similar to Montana's but received its settlement money earlier, has allocated millions toward school and community-based programs, recovery housing services, and expanded treatment services.
Sara Whaley, a Johns Hopkins researcher who tracks states' uses of opioid settlement funds, said a slower start isn't inherently wrong. She prefers governments take time to spend the money well rather than fund outdated or untested practices. In some cases, governments are building entirely new systems to dole out the money. Several waited until the courts finalized the settlement amounts and details.
"There are definitely states that were like, 'We are going to get money at some point. We don't know how much or when, but let's start setting up our system,'" Whaley said. "Other folks were like, 'We have a lot going on already. We'll just wait until we get it and then we'll know what the settlement terms are.'"
Even once committees start meeting, it can take months for the money to reach front-line organizations.
Connecticut's opioid settlement advisory committee made its first allocation in November, eight months after it was formed. Maine's recovery council, which controls half the state's settlement funds, has been meeting since November 2022, but just recently voted on priorities for the more than $14 million it has on hand and still needs to establish a grant application process.
Tennessee's Opioid Abatement Council accepted grant applications this fall. Stephen Loyd, council chair, said the process — from picking awardees to processing payments — will take roughly six months. Within that time, he said, 2,808 Tennesseans are likely to die of drug overdoses.
As an interim step, Loyd proposed at an October meeting to award $7.5 million to an emergency six-month initiative to flood the state with naloxone, a medication that reverses opioid overdoses.
But his proposal was met with protests from council members, who pushed back on what they saw as a circumvention of the grant process they had spent months establishing. The council didn't vote on the emergency initiative but instead created an expedited review process to consider fast-tracking future applications.
Gackle said he doesn't think Montana is far behind others. Now that spending systems are almost in place, he said, things should move faster.
Lewis and Clark County, home to the state capital, Helena, has a yearlong plan and budget for opioid settlement funds. A cohort of 17 counties in rural eastern Montana defined its regional settlement decision-makers in November and, by early December, had yet to begin official talks about where the money should go.
Brenda Kneeland, CEO of Eastern Montana Community Mental Health Center and an advisory committee member for the Montana Opioid Abatement Trust, said eastern Montana has one inpatient treatment center for substance use disorders and zero detox facilities, so emergency rooms end up serving as a fallback resource.
Kneeland said local officials want to ensure they understand the rules to avoid trouble later and to stretch the funding.
"You don't get an opportunity to try to correct such a wrong very often," Kneeland said. "It's just a huge job at a county level. I've never seen an undertaking like this in my career."
The Montana Opioid Abatement Trust advisory committee will meet quarterly, meaning its next chance to review any submitted grants will be next spring.
GRAND RAPIDS, Minn. ― Myrna Peterson predicts self-driving vehicles will be a ticket out of isolation and loneliness for people like her, who live outside big cities and have disabilities that prevent them from driving.
Peterson, who has quadriplegia, is an enthusiastic participant in an unusual test of autonomous vehicles in this corner of northern Minnesota. She helped attract government funding to bring five self-driving vans to Grand Rapids, a city of 11,000 people in a region of pine and birch forests along the Mississippi River.
The project's self-driving vans always have a human operator in the driver's seat, poised to take over in complicated situations. But the computers are in control about 90% of the time, and they've given 5,000 rides since 2022 without any accidents, organizers say.
"It's been fun. I'm really sold on it," said Peterson, who used to rely on her power wheelchair to travel around town, even in winter.
Autonomous vehicles, which can drive themselves at least part of the time, are making news in urban areas, such as San Francisco, where extensive tests of the technology are underway.
Rural experiments have been set up in a few other states, including Iowa and Ohio. Peterson hopes the pilot projects help bring a day when fully autonomous cars and vans assist the estimated 25 million Americans whose travel is limited by disabilities.
Fully independent vehicles remain far from everyday options, as tech companies and automakers struggle to perfect the technology. Recently, for example, General Motors recalled all its self-driving cars after one struck and dragged a pedestrian who had been hit by another vehicle.
But Waymo, a corporate relative of Google, is forging ahead with fully autonomous taxi rides in multiple cities.
Peterson is among those who believe autonomous vehicles someday will become safer than human-driven models.
"Look at how many times the lightbulb failed before it worked," she said.
Unlike many smaller towns, Grand Rapids has public buses and a taxi service. But Peterson said those options don't always work well, especially for people with disabilities. The autonomous vehicle program, known as goMARTI, which stands for Minnesota's Autonomous Rural Transit Initiative, offers a flexible alternative, she said. She hopes it eventually will ease a national shortage of drivers, which tends to be especially acute in rural regions.
The project is funded through the spring of 2027 with more than $13 million from federal, state, and local sources, much of it coming from the 2021 federal infrastructure bill.
The project's distinctive Toyota minivans are outfitted by a Michigan company, May Mobility, which is backed by the Japanese auto giant and other investors. Slogans painted on the side invite the public to "Experience Self Driving in Minnesota's Nature." The vans bristle with technology, including cameras, radar, GPS, and laser sensors. Their computer systems constantly monitor surroundings and learn from situations they encounter, said Jon Dege, who helps manage the project for May Mobility.
Users arrange free rides via a smartphone app or the 211 social service telephone line.
On a recent chilly afternoon, a goMARTI van pulled up near Peterson's house. She soon emerged, bundled in a bright purple parka honoring her beloved Minnesota Vikings football team. She rolled her electric wheelchair to the van, up a ramp, and into the back. Van operator Mark Haase helped strap the wheelchair in, then climbed into the driver's seat for a demonstration.
As the van pulled onto the street, the steering wheel seemed to shudder, reflecting tiny adjustments the computer made. Haase kept his foot poised near the brake pedal and his hands cupped around the steering wheel, ready to take over if a complication came up. After moments when he needed to take control of the vehicle, he pressed a button telling the computer system to resume command. "It was weird at first, but it didn't take long to get used to it and trust the system," Haase said.
The Minnesota Department of Transportation helped direct federal money toward the Grand Rapids project, which followed a similar effort in the southern Minnesota city of Rochester. Tara Olds, the department's director of connected and automated vehicles, said her agency sought smaller communities that wanted to give autonomous vehicles a shot.
Neither kind of driver will ever be perfect, Olds said. "You know, humans make mistakes, and computers make mistakes," she said. But the public would understandably react differently if a fatal crash were caused by an autonomous vehicle instead of a human, she said.
Frank Douma, a research scholar at the University of Minnesota's Center for Transportation Studies, has analyzed the Grand Rapids project and other autonomous vehicle programs. He said running such projects in smaller towns isn't necessarily harder than doing so in urban areas. "It's just different."
For the foreseeable future, such services probably will need to run on predetermined routes, with regular stops, he said. It would be more complicated to have autonomous vehicles travel on demand to unfamiliar addresses out in the countryside.
Developers will need to overcome significant challenges before autonomous vehicles can become a regular part of rural life, he said. "But it's no longer something that can be dismissed as impossible."
A 2022 report from the National Disability Institute predicted that autonomous vehicles could help many people with disabilities get out of their homes and obtain jobs.
Tom Foley, the group's executive director, said a lack of transportation often causes isolation, which can lead to mental health problems. "There's an epidemic of loneliness, particularly for older people and particularly for people with disabilities," he said.
Foley, who is blind, has tried fully autonomous vehicles in San Francisco. He believes someday they will become a safe and practical alternative to human drivers, including in rural areas. "They don't text. They don't drink. They don't get distracted," he said.
For now, most riders who use wheelchairs need attendants to secure them inside a van before it starts moving. But researchers are looking into ways to automate that task so people who use wheelchairs can take advantage of fully autonomous vehicles.
The Grand Rapids project covers 35 miles of road, with 71 stops. The routes initially avoided parking lots, where human drivers often make unexpected decisions, Dege said. But organizers recognized the street-side stops could be challenging for many people, especially if they're among the 10% of goMARTI riders who use wheelchairs. The autonomous vans now drive into some parking lots to pick riders up at the door.
During the recent demonstration ride with Peterson and Haase, the van turned into a clinic parking lot. A lady in an orange car cut across the lot, heading for the front of the van. The computer driving the van hit the brakes. A split second later, Haase did the same. The orange car's driver smiled and gave a friendly Midwestern wave as she drove past.
The autonomous vans have gone out in nearly all kinds of weather, which can be a challenge in northern Minnesota. Grand Rapids received more than 7 feet of snow last winter.
"There were only three or four times when it was so snowy we had to pull it in," Dege said. The autonomous driving systems can handle snowflakes in the air and ice on the pavement, he said. They tend to get confused by snow piles, however. The human operators step in to assist in those situations while the computers learn how to master them.
The robot drivers can get stymied as well by roundabouts, also known as traffic circles. The setups are touted as safer than four-way stops, but they can befuddle human drivers too.
Haase took control each time the van approached a roundabout. He also took the wheel as the van came up on a man riding a bicycle along the right side of the road. "Better safe than sorry," Haase said. Once the van was a few yards past the bicycle, he pressed a button that told the robot to resume control.
Peterson takes the vans to stores, restaurants, community meetings, hockey games — "and church, of course, every Sunday and Wednesday," she said.
She said the project has brought Grand Rapids residents together to imagine a more inclusive future. "It's not just a fancy car," she said.
Jasen Gundersen never considered a career in business when he entered medical school nearly three decades ago to become a rural primary care doctor.
But, today, he isn't working in rural America and he doesn't do primary care. In fact, he no longer practices medicine at all.
As CEO of CardioOne, which provides back-office support to cardiologists, Gundersen is part of a growing trend: physicians and medical school students earning advanced business degrees to work the business side of the booming health care industry.
Just over 60% of medical schools now offer dual MD-MBA programs, more than twice the number two decades ago, a recent study shows. And researchers estimate the number of dual-degree graduates has nearly tripled. Still, it's difficult to know exactly how many physicians now have business degrees. While the medical school students who simultaneously earned both a medical and business degree represent almost 1% of the roughly 28,000 medical school students who graduate each year, that doesn't include physicians, like Gundersen, who later go back to school to pursue an executive MBA.
For years, some doctors have sought auxiliary degrees, including master's degrees in public health and law degrees. But more and more, doctors want to pair their clinical expertise with management skills and financial literacy as the American health system focuses on maximizing profits. Often that's so they can become business executives, especially as lucrative health tech startups proliferate and hospital systems, pharmacy benefit managers, and insurers have swelled into formidable companies.
However, this pursuit of advanced business degrees begs the question: Whom will these doctors end up serving more, patients or shareholders?
Long gone are the days when nuns ran many local hospitals. Now, many hospitals are part of multibillion-dollar systems, some of which, such as HCA Healthcare Inc. and Tenet Healthcare Corp., outrank some of America's most recognizable brands on the Fortune 500 list.
Still, it's one of the few sectors of the economy where the people who know the most about what's going on in their companies aren't the ones running them, said J.B. Silvers, a management professor at Case Western Reserve University who has been teaching business fundamentals to medical students and physicians for decades.
In the past, doctors rarely left medicine to join the ranks of management because they tended to earn more as practicing physicians. But that's changing, Silvers said, especially as new career paths emerge. The MBA can serve as the doorway to those new opportunities — and the potentially lucrative ownership stakes that can come from leading successful medical technology companies.
Physicians earn, on average, $350,000 a year, making them among the highest-paid workers in the U.S. Doctors in primary care tend to make less than that, while the top 1% of physicians can make more than $1.7 million annually.
"There's a lot of other ways to make more money now," said Rich Joseph, who, as an MD-MBA graduate from Stanford, is an example of the trend. Joseph, an outspoken critic of how U.S. doctors are trained, is chief medical officer for Restore Hyper Wellness, which offers cryotherapy and IV drips at locations across the country.
Doctors are considered the face of the health care system, but a lot of big decisions are made in the boardroom, said Folawiyo Laditi, a recent graduate of Yale's MD-MBA program and a urology resident at the University of Pittsburgh.
Laditi wants to leverage his business degree to tackle systemic issues in health care that sometimes don't always feel "fixable" as a doctor treating a single patient at a time. He hopes "to make changes that can affect a lot of patients and a lot of people at once."
Medical schools are selling the power that comes from the dual degree. "Ready to pair your clinical expertise with business best practices to transform your organization? Hone your business acumen to assume a greater scope of leadership," touts the website of the University of Tennessee's physician executive MBA program.
Harvard University says on its website that its dual-degree program is intended to "develop outstanding physician leaders, skilled in both medicine and management, to take positions of influence through which they will contribute substantially to the health and well-being of individuals and society."
Gundersen, the CardioOne CEO, who attended the University of Tennessee program and now lives outside of Denver, found it useful to practice medicine for years after he got his business degree, juggling executive and clinical work. He stopped treating patients nearly four years ago.
It helps to speak the language of physicians, Gundersen said while in Florida during a summer business trip to sell cardiologists on using his company's platform. He pitches alleviating a pain point for most doctors — the nondoctoring work — so they can focus on patient care. It's something he felt as a practicing physician.
Gundersen said the nation needs more doctors, especially ones who remain independent from sprawling health care companies. As he promotes that message to prospective cardiac doctors, Gundersen recognizes the irony. "We need more doctors, and here I am the doctor who doesn't doctor anymore," he said.
Colorado officials say their plan to import cheaper medicines from Canada has been stymied by opposition from drugmakers and inaction by the Biden administration, according to a state report obtained by KFF Health News.
The Dec. 1 report, prepared for the state legislature by Colorado's Department of Health Care Policy & Financing, says that state officials approached 23 drugmakers in the last year about an importation program. Only four agreed even to discuss the proposal; none expressed interest in participating.
"Generally, the challenges that remain are outside state authority and rely on action by FDA and/or drug manufacturers," the report reads.
Lawmakers in both parties, at the state and national level, have sought for decades to legalize importing drugs from Canada. Since 2020, when President Donald Trump's administration opened the door to Canadian drug imports with regulations issued just weeks before he lost reelection, only a few states have filed applications with the Food and Drug Administration to create importation programs.
The FDA hasn't yet ruled on any of them. Colorado filed its application in December 2022. Florida, which applied in 2020, has been waiting nearly three years for a decision from the Biden administration on its importation plan, pushed by Gov. Ron DeSantis, now a Republican presidential candidate.
FDA spokesperson Cherie Duvall-Jones said the FDA has not acted on states' importation applications because it has not determined whether they would save significant money for consumers without posing risks to public health.
U.S. consumers pay some of the highest prices in the world for brand-name pharmaceuticals. Drugs are generally less expensive in Canada, where the government controls prices.
Under Trump, the federal government declared that importing drugs from Canada could be done safely — satisfying for the first time a condition spelled out in a 2003 law.
But Colorado officials cited another catch: The rule didn't take into account that states would have to negotiate directly with drug manufacturers, which oppose selling their brand-name drugs in the United States at Canadian prices.
"As the federal Final Rule did not contemplate the need for this negotiation step, we have urged FDA to release further guidance regarding how states can operationalize the program with this in mind, but to date, no guidance has been released," the Colorado report said.
Unlike many other Trump administration health policies, Biden hasn't revoked or revised the importation rule. But his administration hasn't shown much support for the idea, either. Health and Human Services Secretary Xavier Becerra told KFF Health News last December that he wouldn't commit to the FDA ruling on any state application in 2023.
The president has repeatedly suggested that under his watch Americans would be able to import drugs from Canada.
During his 2020 campaign, Biden said he'd allow for the importation of drugs the government certified as safe. In 2021, he ordered the FDA to work with states to import prescription drugs from Canada. In a 2022 speech about how he planned to reduce drug prices, he cited Colorado estimates of how much people in the state could save through importation.
FDA officials responded to Colorado's application in March by asking for more information and a smaller list of drugs to target, to prove that importation could save money. Colorado's initial application listed 112 high-cost drugs. The state estimates residents and employers could save an average of 65% on the costs of those medicines, including drugs for diabetes, asthma, and cancer.
Colorado said it plans to submit an updated application early next year. By then, it's possible the FDA will have ruled on Florida's application.
The Colorado and Florida importation proposals differ. Colorado's program is intended to directly help consumers obtain cheaper medicines. Florida's plan aims to cut spending on drugs in government programs such as Medicaid, the prison system, and facilities run by the state Department of Children and Families.
The drug industry has argued the Trump administration didn't properly certify that drugs imported from Canada would be safe, jeopardizing Americans' health. Canada's government, too, has expressed concern that U.S. imports would lead to shortages and higher prices in its country.
Drug manufacturers "will do anything to protect their golden goose that is United States consumers and patients who pay the largest amount for drugs in the world," said Colorado state Sen. Sonya Jaquez Lewis, a Democrat, pharmacist, and leading advocate for drug importation.
The White House and Congress, she said, should force drugmakers to negotiate with states to start importation programs.
In its initial response to Colorado's application, the FDA listed several types of information it still needed, including plans on labeling and drug eligibility, according to a March letter from the FDA to the state. Another problem, the FDA said: The state planned to import medicines across the U.S. border in Buffalo, New York. The FDA said the only port of entry it allows for medicines is in Detroit.
Colorado officials told the FDA in March that without federal approval of its application, it was having difficulty securing commitments from drug manufacturers to obtain medicines.
"It has been made clear that potential partners will be more interested in committing to participate once our program has been approved by the FDA," Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, wrote to the FDA.
"While we understand the regulatory framework does not permit for a provisional approval, we know that showing progress towards an approved program will aid in our negotiations with drug manufacturers," she added.
Another complication is that the FDA's rule doesn't allow states to buy drugs directly from secondary drug wholesalers. Instead, they must purchase medicines directly from manufacturers, said Marc Williams, a spokesperson for the Colorado agency.
That's proven challenging because drug manufacturers have prohibited the export of products intended for sale in Canada to the U.S., Williams said.
"Without their permission and a supply agreement directly with a manufacturer, Colorado is unable to buy and import these lower-priced drugs that would save people money," he said.
The Biden administration plans to push states to boost oversight of the number of doctors, hospitals, and other health providers insurers cover in Obamacare plans, under rules proposed in November.
The annual regulatory proposal, known as the payment parameters rule, also seeks to expand access to adult dental coverage in Affordable Care Act marketplaces and would require states to hold open enrollment periods for Obamacare plans at the same time of year. It's likely one of the last major ACA policy efforts of President Joe Biden's first term — and, if he loses reelection, could represent his final touches on the landmark health program created when he was vice president.
Biden has been a staunch supporter of Obamacare and has taken steps during his own first term in the White House to expand the program through rules and legislation, including measures that increased premium subsidies. In part because of those subsidies, enrollment has increased steadily and hit records under his watch.
The proposal for 2025 would continue administration efforts to expand coverage, making it easier for states to offer plans that include adult dental care. The rules also set additional guardrails on the growing number of states that have chosen to run their own ACA marketplaces.
The rules need to be finalized in the spring and would affect plans starting in January 2025, not long before Inauguration Day.
So expect some controversy.
Already, the ACA has entered the political debate, with the current GOP front-runner, former President Donald Trump, taking to his Truth Social site on Thanksgiving weekend to call the failure of the GOP to repeal the ACA "a low point for the Republican Party."
Trump also said he was "seriously" considering alternatives, which harked back to his presidency when he frequently promised an Obamacare replacement was soon to be revealed. It never was.
Biden quickly seized on Trump's comments, saying on Nov. 27 that "my predecessor has once again — God love him — called for cuts that could rip away health insurance for tens of millions of Americans."
Many of the changes made during Biden's term, especially to rules that spell out how the law is to be implemented, could be altered if a Republican wins the White House — just as occurred in the transition from the Obama administration to the Trump term and, again, when Biden took office.
When Trump came into office, for example, he made a number of moves to roll back ACA rules set by the program's namesake, President Barack Obama, including sharply reducing funding for enrollment assistance, shortening the annual sign-up period, and allowing less expensive but less protective short-term plans to cover longer periods of time. Biden's team, in turn, expanded funding for enrollment, added special enrollment periods, and has a proposal awaiting final approval that would restore restrictions on short-term plans, which don't cover many of the benefits included in ACA plans and are often called "junk insurance" by critics.
"If the past is any guide, and the next administration is different, the first thing they will do is roll things back," said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University.
Politics may be one reason the administration's latest proposal doesn't include larger changes to the ACA. Doing anything more aggressive in an election year "might disrupt a program that Biden fully supports," said Joseph Antos, senior fellow at the American Enterprise Institute, a right-leaning think tank.
But the proposal from the Department of Health and Human Services does respond to concerns about "network adequacy," or whether insurers' doctor and hospital networks are large enough to meet demand. The rules would require states to set numerical standards, such as a maximum "time and distance" that patients must travel to access in-network care, that are at least as rigorous as federal limits that kicked in this year.
The proposal would affect the 18 states, plus the District of Columbia, that run their own ACA marketplaces.
While many of them already set some network parameters, the standards vary. The administration's latest proposal notes that 25% of existing state rules fail to set any quantitative requirements, such as how long or far a patient might have to drive to find a participating provider, or the acceptable ratio of the number of enrollees in a plan to the number of covered medical providers.
Requiring standards at least as tough as federal exchange rules across all states "would enhance consumer access to quality, affordable care," the document says.
Some states "may not be doing enough to ensure compliance," said Corlette. "States will have to step up their game."
States would also have to review insurer networks to see if they meet the standards before giving the go-ahead to sell their plans. While the federal marketplace will, beginning in 2025, require insurers to meet new rules aimed at limiting patients' wait times for appointments, especially for primary care and behavioral health, state marketplaces won't yet have to impose similar standards.
More prescriptive state requirements for ACA insurers might draw some pushback during the public comment period for the rules, which runs through Jan. 8. They could also be a target for change if the GOP wins the White House, said Chris Condeluci, a health law attorney who worked as counsel to the Senate Finance Committee when the ACA was drafted.
"On the one hand, it makes sense to have standardized rules so everyone is working off the same song sheet," said Condeluci. But he said there's support for the idea that state marketplaces were not "to be nationally run or overly prescriptive from a federal government regulatory perspective."
The HHS proposal also seeks to expand access to routine adult dental coverage by eliminating a prohibition against states including the care as an "essential health benefit" in their benchmark plans. The rules would also standardize open enrollment periods across all states, requiring them to begin Nov. 1 and run through at least Jan. 15. Most states already do that, although Idaho's period currently begins Oct. 15 and ends Dec. 15, and New York's begins Nov. 16 and ends Jan. 31.
The payment parameter notices, though dryly named, are a big deal not only for insurers, who plan their benefits and set their rates based in part on such rules, but also for consumers.
The ACA marketplaces "cover millions of people and it's very important to make sure they are working and people understand what they are buying," said Bethany Lilly, executive director of public policy at the Leukemia & Lymphoma Society.
Bradley Little, a physical education teacher in Arizona, was leading his class through a school hallway in 2017 when he collapsed. Little feared he was having a stroke. Or, in a sign of the times, that he'd been shot. He tried to stand, but his leg wouldn't move.
A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little's right leg had "suddenly and catastrophically structurally failed," according to a lawsuit Little would later file in federal court. The implant severed at its "neck" — a 2-inch-long titanium part linking Little's thigh to his torso.
"It looked like a laser went through it," Little said in an interview. "It was like someone just went in there and cut it right in the middle."
Profemur artificial hips were once considered innovative for a feature known as a "dual modular neck," intended to modernize total hip replacement surgery. Hundreds of thousands of Americans undergo hip implant surgery each year and devices are expected to last at least 20 years, according to the American College of Rheumatology. The Profemur necks, available in an array of lengths and angles, made it easier to customize the hip implants for patients.
But the neck also proved to be a weak point. Over the past two decades, more than 750 Profemur hips like Little's have fractured at the neck, an attorney for the manufacturer once said in court while defending the device as not defective. In interviews, patients said they were left unable to walk and in need of emergency surgery. Reports submitted to the FDA describe Profemur patients stranded in the midst of routine life, while hiking, golfing, bowling, mowing the lawn, lifting a potted plant, getting out of a chair, putting on pants, and leaning over to pick up a key.
After each break, patients endure an hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, according to three orthopedic surgeons who've performed such a procedure. The repair surgery, which can cost tens of thousands of dollars and may not be fully reimbursed by insurance, often requires a patient's femur to be cracked open to extract a metal stem that was inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.
"It's gruesome," said Lee E. Rubin, an orthopedic surgeon and expert on prosthetic hips at Yale School of Medicine. "There's no way around the fact that there's a failed or broken implant in that patient's thigh. We have to remove it."
Many Profemur fractures in patients' bodies could have been avoided if the manufacturer or the FDA responded to early signs of failure with more urgency, according to a months-long investigation by KFF Health News and CBS News. An FDA database shows reports of Profemur's titanium modular necks breaking inside U.S. patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all. Ten sizes of the titanium neck eventually were recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA. Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.
"This implant should have been pulled out of the market earlier," he said.
Profemur's original manufacturer, Wright Medical Technology, in 2009 switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy, FDA documents show. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market despite reports of corrosion causing the implants to fail, FDA documents show.
In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, according to FDA data and records.
Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s, according to the company website. Wright sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285 million in 2013, according to the Securities and Exchange Commission. Stryker Corp., one of the nation's largest device companies, paid about $4 billion for the rest of Wright in 2020.
Wright Medical declined to comment in an email from Stryker spokesperson Jon Zimmer. MicroPort did not respond to more than a dozen requests for comment sent to its attorneys, public relations firm, and U.S. offices. MicroPort still advertises Profemur hip implants with dual modular necks on its website, where the devices are listed as "not marketed/registered in United States."
The FDA declined to provide an official for an interview and did not answer written questions about why some Profemur sizes were not permanently recalled. In an email, FDA spokesperson Audra Harrison said medical device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency "monitors" this process and requests recalls only in "urgent situations." In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA "took action accordingly," the agency said.
For this investigation, journalists with KFF Health News and CBS News analyzed thousands of reports of Profemur complications submitted over the past two decades to the FDA's nationwide MAUDE database, which catalogs reports of medical device problems and malfunctions. MAUDE is unverified, incomplete, and imperfect — for example, not all device problems are properly submitted to the database, and a single issue may be reported more than once. However, the database still offers the best available perspective on medical device complications in the United States. The FDA has used MAUDE to identify device problems since the early '90s.
KFF Health News and CBS News also reviewed about 180 lawsuits filed in federal court in the past decade alleging Profemur modular necks broke or corroded. Plaintiffs have alleged severe pain, swelling, a "debilitating lack of mobility," and, in at least a few cases, nerve damage and neurological issues from cobalt and chromium ions leaking into their bloodstream.
Most of the lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, according to court filings. The remainder of the lawsuits are ongoing.
Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.
"A device fracture does not mean it is defective," Wright Medical attorney Tiffany Carpenter said in federal court in 2018, according to a hearing transcript. "Devices fracture all the time."
Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.
Some plaintiffs say they got Profemur implants in both legs — then they both ended up breaking.
Mark Feld, 75, of New Hampshire, who was an avid runner, said he was implanted with Profemur artificial hips in his right and left legs in 2005 and 2008, then the right hip fractured within 10 years, according to a lawsuit he filed. Wright Medical denied liability in court filings and settled out of court for an undisclosed amount.
Feld said that because he surrendered all claims against Wright in the settlement, he could not sue again when his left implant broke in 2020 as he was walking across a bridge near his apartment.
He crawled home to call 911, he said, and was rushed to the hospital.
"I couldn't walk across that bridge for a year," Feld said. He now has new hip implants made by another company, but his fear lingers. "To this day, I still feel like a ticking time bomb. … Nobody could confirm for me that it can't happen again."
Little, the Arizona teacher, also suffered a second Profemur break, four years after his first, according to his lawsuit, in which Wright Medical denied liability and settled out of court. Little said in an interview that this time he was teaching class on a tennis court when he felt a sensation in his left leg that reminded him of crushing an aluminum can. He said he narrowly avoided tumbling onto his students.
After his two broken hip implants and replacement surgeries, Little said, he had to stop coaching basketball and will retire from teaching at the end of this school year — four years earlier than planned. He still feels unsteady and is afraid to climb a stepladder to change a lightbulb, he said.
"I've been robbed of some things," Little said. "There should be accountability for it."
It is not publicly known how many Profemur hips have failed. According to a federal court transcript, Carpenter, the attorney for Wright Medical, said in court in 2018 that the company was aware of 768 fractures among about 353,000 Profemur necks sold. That's a fracture rate of about 0.2%.
Other sources report a much higher rate. The Profemur devices that were permanently recalled in 2020 had a U.S. fracture rate of 2.2% — 11 times what was described in court — according to FDA documents. Peer-reviewed studies estimate fracture rates as low as 1% and as high as 6% for some Profemur models.
Even the lowest estimates are "unacceptable," said Samo Fokter, an orthopedic surgeon and Profemur expert at University Medical Center Maribor in Slovenia.
Fokter has co-authored more than 10 peer-reviewed studies on the Profemur, including one this year, and said he implanted about 50 of them before they were known to fracture.
"This should not happen," Fokter said. "If you put too much force on any implant, it can fracture, of course, but this is very, very rare. Not approaching 1%. It should be less than one in 100,000, let's say."
‘Like a Black Hole Developed Under Their Foot'
The Profemur's problems originate from its "neck," which is a metal connector between the upper components in the hip socket to a lower "stem" that is inserted into a patient's thigh bone, according to peer-reviewed studies, court records, and expert interviews.
Historically, an artificial hip's stem and neck were a single piece of metal. The Profemur line added a junction at the top of the stem so the neck was separate. Because these dual modular necks detached on both ends, the size and angle could be changed to better fit a patient.
But the Profemur's additional junction was also its downfall. Rubin, one of the Yale experts, who also maintains an exhibit of the history of prosthetic hips at the university, said in some patients tiny cracks formed on the portion of the neck that slotted into the socket of the stem. Patients had no idea their implant was cracking until the neck snapped, he said.
"From a patient's perspective, they're walking around on what otherwise would seem like a successful hip implant," Rubin said. "And all of a sudden, as they took a step, they could not bear weight … like a black hole had developed under their foot."
The dual modular neck was developed by a European company, Cremascoli Ortho Group, in the '80s, then purchased by Wright Medical in 1999 to be introduced as the Profemur in the United States. The Profemur was cleared for sale by the FDA in 2000 through the 510(k) program, which permits new medical devices to be sold without extensive testing if they are deemed to have "substantial equivalence" to other devices already on the market. Through this process, new medical devices can piggyback on a single approval for decades.
Wright Medical told the FDA that the Profemur was substantially equivalent to five existing artificial hip systems, and the agency agreed, according to FDA documents obtained through a Freedom of Information Act request. However, of those five hip systems, at least three had significantly different necks than the Profemur, Rubin said. And one was later recalled because of its high failure rate, according to the FDA.
The FDA documents state that although the Profemur is different from the older hip implants that its approval was based on, those differences were "not expected to affect the device's safety and effectiveness." Spokesperson Harrison said in an email that the FDA "followed the statutory framework" when the Profemur was reviewed and cleared.
Once it was cleared by the FDA, Wright touted the Profemur's dual modular neck as a feature.
In a 2004 promotional document obtained by KFF Health News and CBS News, Wright guaranteed the "structural reliability" and "absence of fretting corrosion" at the junction of the stem and neck. Then Wright marketed the Profemur to people with an "active lifestyle," saying the product was for patients who wanted to return to activities like golf, tennis, karate, and wrestling after their hip replacements, according to at least two dozen lawsuits filed against the company.
Wright also hired Jimmy Connors, who was the world's top-ranked tennis player in the ‘70s, as a spokesperson.
"This hip has given me back my quality of life. It's allowed me to do anything I did before," Connors said on JimmysNEWHip.com, a website launched by Wright in 2006, according to screen captures of the site preserved by the Internet Archive.
When the website launched, Wright Medical knew of at least some reports of modular neck fractures. Multiple lawsuits allege the company was aware as of 2000 that some Cremascoli hips had fractured at the modular neck, and then became aware of more fractures in 2003 and 2004. The FDA database shows Wright was also aware of two Profemur implants that allegedly fractured at the neck and were returned to Wright in spring 2005.
In 2006, FDA data showed six reports of Profemur fractures that identified the neck as the part that allegedly broke. By 2007, there were 11 such reports. By 2008, there were 30.
Connors, reached on his cellphone, said Wright Medical did not inform him of Profemur fractures at the time of his endorsement or since. Connors said his own hip implant did not fracture but had to be replaced in 2012 because of other complications.
If he had been told about a fracture risk, Connors said, he might have chosen another implant.
"If I was going through it now, I'd know a lot more to ask than I did back in the first time," Connors said.
Perry Parks, 79, who played football for the Los Angeles Rams in the '60s, said Connors' endorsement persuaded him to get a Profemur hip in 2007. His implant snapped six years later during a bike ride, according to his lawsuit. Wright Medical denied liability and settled out of court.
In an interview, Parks said he was lucky to be biking at the beach at the time of the break, where he tumbled into sand, instead of in traffic.
"The thing that incenses me more is that they knew this," Parks said. "There was some intentionality here to put … profits over the health of people."
New Metal, New Complications
In 2009, Wright Medical introduced a new version of the Profemur modular neck that once again was cleared for sale by the FDA. Agency documents show that the neck material was switched from titanium to a cobalt-chromium alloy, a stronger metal.
"That was a big mistake," Fokter said.
While the cobalt-chromium necks were less susceptible to fracture, they created a new problem at the same junction between the neck and stem, said Fokter and the two Yale experts. Once implanted, the cobalt-chromium neck could rub against the stem's titanium socket, leading to a form of bimetallic corrosion that can cause pain and swelling and leak small amounts of metal ions into a patient's bloodstream, potentially causing a long list of complications, the three experts said.
Robert Rembisz, 75, a retiree in Vero Beach, Florida, alleged in an ongoing lawsuit that Profemur corrosion in his right leg caused elevated metal levels in his blood and "neurologic symptoms" including nerve damage, tinnitus, and balance and coordination problems. Wright Medical has not yet responded to the allegations in Rembisz's lawsuit.
Rembisz added in an interview that he believes the implant hindered his memory and cognition, leading him to question whether he was suffering early signs of dementia. He provided to KFF Health News and CBS News lab reports showing the metals in his blood rising over years, with cobalt levels peaking at nearly 12 times the normal range. Rembisz said most of the symptoms faded after his implant was removed in 2021.
"The problems I developed weren't even close to my hip," Rembisz said. "This problem could be occurring in [other people's] bodies as well. And they don't even know it."
Six years after Profemur switched metals, MicroPort recalled one size of the cobalt-chromium neck affecting about 10,500 implants, citing an "unexpected rate of postoperative fractures," according to FDA records. But it is unknown how many could not be returned because they'd already been implanted.
Kristin Biorn had one.
Biorn, 74, of Pasadena, California, alleged in a lawsuit that this particular size of Profemur neck was implanted in her left leg in 2013 and broke within two years — four months before the recall. Wright Medical and MicroPort denied liability in her lawsuit, then settled out of court.
In an interview, Biorn said the break occurred as she was working at her burgeoning home-staging business. While putting final touches on a client's home with her teenage son, she fell to the floor, unable to stand or crawl, she said.
"Honestly, it gives me nightmares about what could have happened had my son not been there," Biorn said. "My phone was downstairs and there was no way I could have gotten down the stairs alone. No one was scheduled to come in for four days."
Biorn said in her interview that it took three surgeries to fix her hip after the Profemur fracture and she was ultimately forced to close her business and retire.
She now walks with a cane.
Although MicroPort recalled one cobalt-chromium size in 2015, the company did not recall 11 other sizes made of the same metal with the same design, and some lawsuits have faulted the company for leaving "interchangeable" products on the market. MicroPort also did not at that time recall any of the titanium necks, which as of 2015 were identified in more than 500 fracture reports in FDA's database. MicroPort recalled 10 titanium sizes in 2020.
Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records.
The recall was temporary so MicroPort could update the documents included in the packaging of Profemur implants. The revised documents added a "general precaution" that doctors should consider a patient's activity level and weight before implanting them with a Profemur, and said that patients should not have "unrealistic" expectations that include "substantial walking, running, lifting, or muscle strain."
Afterward, the recall was lifted, and the FDA once again allowed the implants to be put up for sale.
KFF Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.
SACRAMENTO, Calif. — Nearly two years into Gov. Gavin Newsom's $12 billion experiment to transform California's Medicaid program into a social services provider for the state's most vulnerable residents, the institutions tasked with providing the new services aren't effectively doing so, according to a survey released Tuesday.
As part of the ambitious five-year initiative, called CalAIM, the state is supposed to offer the sickest and costliest patients a personal care manager and new services ranging from home-delivered healthy meals to help paying rental security deposits.
But a quarter of the health care insurers, nonprofit organizations, and others responsible for implementing the program don't know enough about it to serve those in need, and many are not equipped to refer and enroll vulnerable patients, according to research by the California Health Care Foundation. (KFF Health News publishes California Healthline, an editorially independent service of the California Health Care Foundation.)
The survey found that only about half of primary care providers and hospital discharge planners are very or somewhat familiar with the initiative, even though they are essential to identifying patients and referring them for services.
"These workers are on the front lines and if they don't know about it, that's a pretty easy win to educate them so they can help more people," said Melora Simon, an associate director at the foundation, which conducted the survey between July 21 and Sept. 12. The initiative debuted in January 2022.
"These workers are most likely to see people in the hospital, in crisis," she added, and "have the opportunity to do something about it."
The roughly two dozen managed care insurance companies serving patients in Medi-Cal, California's Medicaid program for low-income people, are responsible for identifying and enrolling patients into the program, and providing the new services. To make this happen, they contract with local government agencies, community nonprofit groups, social service organizations, hospitals, community clinics, and more. Those organizations can also make referrals and link patients to new services. The foundation surveyed 1,196 of these so-called implementers.
Most of the respondents said state payment rates do not cover the cost of providing expensive social services, and half say the workforce they need to deliver them is "tapped out and overwhelmed."
About 44% also cited inconsistencies and different rules imposed by managed care plans, making participation very or somewhat challenging. For example, some insurers provide on-the-spot Uber rides for doctor appointments while others offer only a bus pass. Plus, not all plans offer the same services.
The survey did pinpoint some early successes. For instance, about half of respondents said the initiative has enabled them to serve more people, and that their ability to manage the comprehensive needs of patients has gotten better.
Tony Cava, a spokesperson for the state Department of Health Care Services, which administers Medi-Cal, acknowledged that the survey findings "resonate" and said the state is working to streamline and standardize patient referrals and authorizations.
"Implementers are on board with the core goals, and we are seeing improvements. But there is room to increase familiarity with CalAIM and broaden and deepen networks," Cava said.
He said CalAIM represents a major shift in how Medi-Cal delivers care, and that the "kind of seismic system change that we are undergoing takes time."
"Rather than reactive, we are moving toward a system that is proactive and considers all factors affecting health — the social drivers of health — and not simply what may happen inside of a medical facility," he added.
The department provides financial and technical assistance to implementers, though only about one-third of survey respondents have found the training, technical guidance, and other resources adequate.
Van Do-Reynoso, chief healthy equity officer for CenCal Health, the Medi-Cal health insurer serving Santa Barbara and San Luis Obispo counties, acknowledged that it has been difficult to provide a full complement of CalAIM services. She cited a variety of obstacles such as inadequate reimbursement, lack of housing, and working with social services agencies unfamiliar with the health care system.
Nearly 3,000 CenCal enrollees are receiving CalAIM services, she said, many of them housing- and homelessness-related.
"We are working hard to better engage with hospital CEOs, community providers, and medical providers," Do-Reynoso said. "People are getting housed. They're practicing sobriety. It has only whetted our appetite to continue doing this work."
When Newsom launched CalAIM, the Democratic governor promised it would transform Medi-Cal. The goal, his administration said, is to improve health and prevent people from winding up in costly institutions like the emergency room and jail, and to help move homeless people into housing.
It's unclear how many of the 15.2 million Californians enrolled in Medi-Cal are eligible for new services and benefits, but several large populations qualify, including homeless Californians, people leaving jail or prison, foster children, people with severe mental illness or addiction, and older nursing home residents who want to transition home.
So far, about 141,000 Medi-Cal patients have a personal care manager through CalAIM, according to Cava, though hundreds of thousands more likely qualify. About 76,000 patients are receiving other social services, which are optional for plans to offer, he said.
In some cases, qualified Medi-Cal enrollees are turning down new services because they are being offered at the wrong time or by the wrong person, Simon said. For instance, a homeless person might not accept services from a police or code enforcement officer.
Insurers say they want to do more but need more help from the state.
"I am very hopeful that a year from now, we are going to be able to demonstrate even greater strides," Do-Reynoso said. "What we hear often is what is reflected in the survey. We need higher rates, more communication, a more streamlined approval process."
It's a good day when Frank Lee, a retired chef, can slip out to the hardware store, fairly confident that his wife, Robin, is in the hands of reliable help. He spends nearly every hour of every day anxiously overseeing her care at their home on the Isle of Palms, a barrier island near Charleston, South Carolina.
Robin Lee, 67, has had dementia for about a decade, but the couple was able to take overseas trips and enjoy their marriage of some 40 years until three years ago, when she grew more agitated, prone to sudden outbursts, and could no longer explain what she needed or wanted. He struggled to care for her largely on his own.
"As Mom's condition got more difficult to navigate, he was just handling it," said Jesse Lee, the youngest of the couple's three adult children. "It was getting harder and harder. Something had to change, or they would both perish."
Frank Lee's search for trustworthy home health aides — an experience that millions of American families face — has often been exhausting and infuriating, but he has persisted. He didn't entirely trust the care his wife would get in an assisted living facility. Last August, when a respite program paid for her brief stay in one so Frank, 69, could take a trip to the mountains, she fell and fractured her sacrum, the bone that connects the spine to the pelvis.
There is precious little assistance from the government for families who need a home health aide, unless they are poor. The people working in these jobs are often woefully underpaid and unprepared to help a frail, older person with dementia bathe and use the bathroom, or to defuse an angry outburst.
Usually, it is family that steps into the breach — grown children who cobble together a fragile chain of visitors to help an ailing father; a middle-aged daughter who returns to her childhood bedroom; a son-in-law working from home who keeps a watchful eye on a confused parent; a wife who can barely manage herself looking after a faltering husband.
Frank Lee finally found two aides on his own, with no help from an agency. Using the proceeds from the sale of his stake in a group of restaurants, including the popular Charleston bistro Slightly North of Broad, he pays them the going rate of about $30 an hour. Between his wife's care and medical expenses, he estimates he's spending between $80,000 and $100,000 a year.
"Who the hell can afford this?" he asked. "There's no relief for families unless they have great wealth or see their wealth sucked away." He worries that he will run out of money and be forced to sell their home of more than three decades. "Funds aren't unlimited," he said.
Credited with emphasizing local ingredients and mentoring young chefs in Charleston, Lee retired in 2016, a few years after his wife's diagnosis.
In an interview at the time, he said, "My wife has given up her life to help me in my career, and now I need to pay attention to her."
In 2020, he contacted a half-dozen home care agencies. Some couldn't fill the position. Others sent aides who were quickly overwhelmed by his wife's behavior. Doctors told the family they believed she has frontotemporal dementia, which appeared to affect her language and how she behaved.
One woman seemed promising, only to quit after a week or two. "We never saw her again," Lee said. He tried a friend of the family for a time, but she left when her grandmother developed liver cancer.
"It was the whole year of going through different caregivers," said son Jesse.
Finally, Frank found two women to help. One of them, Ronnie Smalls, has more than a dozen years of experience and is trained in dementia care. She has developed a rapport with Robin, who seems reassured by a quick touch. "We have a really good bond," Smalls said. "I know her language, her expression."
One day at the Lees' cozy one-story house, decorated with furniture made by Robin, and with a yard overflowing with greenery, Smalls fed her lunch at the kitchen table with her husband and daughter. Robin seemed to enjoy the company, murmuring in response to the conversation.
At other times, she seemed oblivious to the people around her. She can no longer walk on her own. Two people are often needed to help her get up from a chair or go to the bathroom, transitions she often finds upsetting. A day without an aide — out because of illness or a family emergency — frays the tenuous links that hold the couple's life together.
Lee said his wife barely resembles the woman he married, the one who loved hiking, skiing, and gardening, and who started a neighborhood preschool while raising their three children. A voracious reader, she is now largely silent, staring into space.
The prognosis is bleak, with doctors offering little to hang onto. "What's the end game look like?" Lee asks, wondering if it would be better if his wife had the right to die rather than slowly disappear before his eyes. "As she disintegrates, I disintegrate," he said. She recently qualified for hospice care, which will involve weekly visits from a nurse and a certified nursing assistant paid under Medicare.
Charleston is flush with retirees attracted by its low taxes and a warm climate, and it boasts of ways to care for them with large for-profit home health chains and a scattering of small agencies. But many families in Charleston and across the nation can't find the help they need. And when they do, it's often spotty and far more expensive than they can afford.
Most Americans want to remain in their own homes, living independently, for as long as possible. They want to avoid nursing homes, which they see as providing poor care, polls have found. And the ranks of older people who need such help will grow. By 2030, 1 in 5 Americans will be at least 65 as millions in the baby boomer generation retire.
In dozens of interviews, families described a desperate and sometimes fruitless search for aides to help loved ones with simple tasks on a predictable schedule at an hourly rate they can afford.
Roughly 8 million people 65 and older had dementia or needed help with two or more activities of basic daily life, like getting out of bed, according to an analysis of a federally funded survey of older Americans by KFF Health News and The New York Times. Only a million received paid help outside of a nursing home, and nearly 3 million had no help at all.
Most families can't afford what agencies charge — about $27 an hour, according to Genworth, a long-term care insurance company. So, many take their chances on untrained caregivers found through word-of-mouth, Craigslist, or other resources.
A Scarcity of Workers
One of the main obstacles to finding paid help is the chronic shortage of workers. Some 3.7 million people had jobs as aides in home health or personal care in 2022, with half of them earning less than $30,000 year, or $14.51 an hour, according to the Bureau of Labor Statistics. The number of people needed is expected to increase by more than 20% over the next decade. But the working conditions are hard, the pay is usually bad, and the hours are inconsistent.
About 3 million people are working in private homes, according to a 2023 analysis by PHI, a nonprofit that studies and acts as an advocate for the workforce, although official estimates may not count many workers paid off the books or hired outside of an agency by a family. Eighty-five percent of home care workers are women, two-thirds are people of color, and roughly a third are immigrants. The pay is often so low that more than half qualify for public assistance like food stamps or Medicaid.
Dawn Geisler, 53, has made only $10 an hour working as a home health aide in the Charleston area for the past four years, without ever getting a raise. She declined to name the agency that employs her because she doesn't want to lose her job.
Geisler discovered she liked the work after caring for her mother. Unlike an office job, "every day is just a little bit different," she said. She now juggles two clients. She might accompany one to the doctor and keep the other one company. "I'm taking care of them like they were my own family," she said.
The agency provides no guarantee of work and doesn't always tell her what to expect when she walks through the door, except to say someone has Alzheimer's or is in a wheelchair. Her supervisors often fail to let her know if her client goes to the hospital, so families know to call her cellphone. She has waited weeks for a new assignment without getting paid a penny. She herself has no health insurance and sometimes relies on food banks to put meals on the table.
"I'm not making enough to pay all the bills I have," said Geisler, who joined an advocacy group called the Fight for $15, which is pushing to raise the minimum wage in South Carolina and across the country. When her car broke down, she couldn't afford to get it fixed. Instead, she walked to work or borrowed her fiancé's bicycle.
Most home health agencies nationwide are for-profit and are often criticized for ignoring the needs of workers in favor of the bottom line.
"The business models are based on cheap labor," said Robyn Stone, senior vice president of research for LeadingAge, which represents nonprofit agencies. The industry has historically tolerated high turnover but now can't attract enough workers in a strong, competitive job market. "I think there has been a rude awakening for a lot of these companies," she said.
Many agencies have also refused to pay overtime or travel costs between jobs, and many have been accused of wage theft in lawsuits filed by home care workers or have been sanctioned by state and federal agencies.
Medicaid, the federal-state program that provides health care for the poor, is supposed to provide home aides but faces shortages of workers at the rates it pays workers. At least 20 states pay less than $20 an hour for a personal care aide, according to a recent state survey by KFF. Aides are often paid less under Medicaid than if they care for someone paying privately.
With low pay and few benefits, many people would rather work the checkout line in a supermarket or at a fast-food chain than take on the emotionally demanding job of caring for an older person, said Ashlee Pittmann, the chief executive of Interim HealthCare of Charleston, a home health agency. She said that she recently raised wages by $2 an hour and had had more success keeping employees, but that she still worried that "we may not be able to compete with some larger companies."
The Biden administration failed to obtain an additional $400 billion from Congress for home- and community-based services to shift emphasis away from institutional care. President Joe Biden signed an executive order this year to encourage some reforms, and federal officials have proposed requiring home health agencies to spend 80 cents of every government dollar on paying workers under Medicaid. But so far, little has changed.
Falling Through the ‘Doughnut Hole‘
Long-term care coverage for most Americans is a yawning gap in government programs. And the chasm is widening as more Americans age into their 70s, 80s, and 90s.
The government's main program for people 65 and older is Medicare, but it pays for a home aide only when a medical condition, like recovery from a stroke, has made a person eligible for a nurse or therapist to come to the home. And the aide is usually short-term. Medicare doesn't cover long-term care.
Medicaid, which does pay for long-term care at home, is limited to serving the poor or those who can demonstrate they have hardly any assets. But, again, the worker shortage is so pervasive that waiting lists for aides are years long, leaving many people without any option except a nursing home.
So millions of Americans keep trying to hang in and stay home as long as they can. They're not poor enough to qualify for Medicaid, but they can't afford to hire someone privately.
Many fall through what April Abel, a former home health nurse from Roper St. Francis Healthcare in Charleston, described as "the doughnut hole."
"I feel so bad for them because they don't have the support system they need," she said.
She tried fruitlessly for months to find help for Joanne Ganaway, 79 and in poor health, from charities or state programs while she visited her at home. Ganaway had trouble seeing because of a tear in her retina and was often confused about her medications, but the small pension she had earned after working nearly 20 years as a state employee made her ineligible for Medicaid-sponsored home care.
So Ganaway, who rarely leaves her house, relies on friends or family to get to the doctor or the store. She spends most of her day in a chair in the living room. "It has been difficult for me, to be honest," she said.
Turning to Respite Services
With no hope of steady help, there is little left to offer overstretched wives, husbands, sons, and daughters other than a brief respite. The Biden administration has embraced the idea of respite services under Medicare, including a pilot program for the families of dementia patients that will begin in 2024.
One nonprofit, Respite Care Charleston, provides weekday drop-off sessions for people with dementia for almost four hours a day.
Lee's wife went for a couple of years, and he still makes use of the center's support groups, where caregivers talk about the strain of watching over a loved one's decline.
On any given morning, nearly a dozen people with dementia gather around a table. Two staff members and a few volunteers work with the group as they play word games, banter, bat balls around, or send a small plastic jumping frog across the table.
Their visits cost $50 a session, including lunch, and the organization's brief hours keep it under the minimum state requirements for licensing.
"We're not going to turn someone away," Sara Perry, the group's executive director, said. "We have some folks who pay nothing."
The service is a godsend, families say. Parkinson's disease and a stroke have left Dottie Fulmer's boyfriend, Martyn Howse, mentally and physically incapacitated, but he enjoys the sessions.
"Respite Care Charleston has been a real key to his keeping going," she said, "to both of us, quite frankly, continuing to survive."
A recent Federal Trade Commission civil lawsuit accusing one of the nation's largest anesthesiology groups of monopolistic practices that sharply drove up prices is a warning to private equity investors that could temper their big push to snap up physician groups.
Over the past three years, FTC andDepartment of Justice officials have signaled they would apply more scrutiny to private equity acquisitions in healthcare, including roll-up deals in which larger provider groups buy smaller groups in a local market.
Nothing happened until September, when the FTC sued U.S. Anesthesia Partners and the private equity firm Welsh, Carson, Anderson & Stowe in federal court in Houston, alleging they had rolled up nearly all large anesthesiology practices in Texas. In the first FTC legal challenge against a private equity purchase of medical practices, the federal agency targeted one of the most aggressive private equity firms involved in building large, market-dominating medical groups.
In an interview, FTC Chair Lina Khan confirmed that her agency wants to send a message with this suit. Welsh Carson and USAP "bought up the largest anesthesiology practices, then jacked up prices and entered into price-setting and market-allocation schemes," said Khan, who was appointed by President Joe Biden in 2021 to head the antitrust enforcement agency, with a mandate to combat healthcare consolidation. "This action puts the market on notice that we will scrutinize roll-up schemes."
The large and growing volume of private equity acquisitions of physician groups in recent years has raised mounting concerns about the impact on health costs, quality of care, and providers' clinical autonomy. A JAMA Internal Medicine study published last year found that prices charged by anesthesiology groups increased 26% after they were acquired by private equity firms.
"Now we're seeing that scrutiny with this suit," said Ambar La Forgia, an assistant professor of business management at the University of California-Berkeley, who co-authored the JAMA article. "This suit will cause companies to be more careful not to create too much local market power."
The FTC's lawsuit alleges that USAP and Welsh Carson engaged in an anti-competitive scheme to gain market power and drive up prices for hospital anesthesiology services. The FTC also accuses USAP and Welsh Carson — which established the medical group in 2012 and has expanded it to eight states — of cutting deals with competing anesthesiology groups to raise prices and stay out of one another's markets.
USAP now controls 60% of Texas' hospital anesthesia market, and its prices are double the median rates of other anesthesia providers in the state, according to the lawsuit. Learning that USAP would boost rates following one acquisition, a USAP executive wrote, "Awesome! Cha-ching," the civil complaint said.
In a written statement, Welsh Carson, which also holds sizable ownership shares in radiology, orthopedic, and primary care groups, called the FTC lawsuit "without merit in fact or law." It said USAP's commercial rates "have not exceeded the rate of medical cost inflation for close to 10 years."
The New York firm also said its investment in USAP "has allowed independent anesthesiologists to deliver superior clinical outcomes to underserved populations" and that the FTC's action will harm clinicians and patients. Welsh Carson declined a request for interviews with its executives.
"This is a pretty common roll-up strategy, and some of the big private equity companies must be wondering if more FTC complaints are coming," said Loren Adler, associate director of the Brookings Schaeffer Initiative on Health Policy. "If the FTC is successful in court, it will have a chilling effect."
Since the FTC filed the USAP lawsuit, Khan said, the agency has received information from people in other health fields about roll-ups it should scrutinize. "We have limited resources, but it's an area we are interested in," she said. "We want to focus on where we see the most significant harm."
In physician acquisition deals, PE firms typically use mostly borrowed money to acquire a controlling interest in a large medical group, pay the physician owners a substantial upfront sum in exchange for sharply cutting their future compensation, and install a management team. Then they seek to acquire smaller groups in the same geographic market and bolt them onto the original medical group for more bargaining clout and operating efficiencies.
The PE firm's goal is to garner at least 20% dividends a year and then sell the group to another investor for at least three times the purchase price in three to seven years. Critics say this short-term investment model spurs the investors and medical groups to boost prices and cut staffing to generate large profits as fast as possible.
"Private equity is trying to extract value quickly and sell the company for a profit, so there's a lot more incentive to increase prices quickly and extract higher revenue," La Forgia said.
In the two years after a sale, PE-owned practices in dermatology, gastroenterology, and ophthalmology charged insurers 20% more per claim on average than did practices not owned by private equity, according to a JAMA study published last year.
There are similar concerns about hospital systems acquiring physician practices, which also have raised prices. "The evidence shows that both private equity and hospital acquisitions of physician practices are bad for consumers, and scrutiny should be applied to all acquirers," Adler said.
Critics warn that private equity roll-ups of medical groups can jeopardize quality of care, too. Chris Strouse, a Denver anesthesiologist who served on USAP's national board of directors but left the company's Colorado group out of disapproval in 2020, cited patient safety issues arising from short staffing and mismanagement. He said USAP would schedule shifts so that three or four providers would hand off to each other a single surgical procedure, which he said is risky. In addition, USAP frequently asked anesthesiologists to work the day after working a 24-hour on-call shift, he said. "The literature shows that's outside the safety range," he said. As a result, many providers have left USAP, he added.
The FTC has long been lax in monitoring roll-ups of physician groups, in part because federal law does not require public reporting of these deals unless they exceed $111.4 million in value, a threshold adjusted over time. Lowering the threshold would require congressional action. As a result, regulators may be unaware of many deals that lead to gradual market concentration, which allows providers to demand higher prices from insurers and employer health plans.
Recognizing that problem, the FTC proposed in June to beef up its reporting requirements for companies planning mergers, in hopes of spotting previous acquisitions of smaller groups that could lead to excessive market power and higher prices. In addition, in a draft of their merger review guidelines, issued in July, the FTC and the Department of Justice said they would consider the cumulative effect of a series of smaller acquisitions.
"The ways PE firms are making serial acquisitions, each individual acquisition is under the radar, but in aggregate they roll up the whole market," Khan said. "Between the merger reporting form and the new merger guidelines, we want to be able to better catch unlawful roll-up schemes. … This would enable us to stop roll-ups earlier."
But Brian Concklin, a lawyer with the law firm Clifford Chance, whose clients include private equity firms, said the FTC's proposed reporting requirements would hamper many legitimate mergers. "The notion that they need all that information to catch deals that lessen competition seems overblown and false, given that the vast majority of these deals do not lessen competition," he said. "It will be a substantial burden on most if not all clients to comply."
Researchers and employer groups, however, were encouraged by the FTC's action, though they fear it's too little, too late, because consolidation already has reduced competition sharply. Some even say the market has failed and price regulation is needed.
"Providers have been able to extort higher prices on services with no improvement in quality or value or access," said Mike Thompson, CEO of the National Alliance of Healthcare Purchaser Coalitions. "The FTC stepping up its game is a good thing. But this horse is out of the barn. If we don't have better enforcement, we won't have a marketplace."