Almost all people have health insurance in Vermont, a state famed for its maple syrup and Ben & Jerry’s ice cream, yet residents pay the nation’s highest insurance premiums for individual coverage and endure months-long waits for care — and most hospitals here are losing money, according to state reports and interviews with residents and industry officials.

For more than 15 years, federal and state policymakers have focused on increasing the number of people insured, which they expected would shore up hospital finances and make care more available and affordable.

“Vermont’s struggles are a wake-up call that insurance is only one piece of the puzzle to ensuring access to care,” said Keith Mueller, a rural health expert at the University of Iowa.

Regulators and consultants say the state’s small, aging population of about 650,000 makes spreading insurance risk difficult. That demographic challenge is compounded by geography, as many Vermonters live in rural areas, where it’s difficult to attract more health workers to address shortages.

Unlike most states, Vermont regulates hospital and insurance prices through an independent agency, the Green Mountain Care Board. Until recently, the board typically approved whatever price changes companies wanted, said Julie Wasserman, a health consultant in Vermont.

In September, Bruce Hamory, a consultant hired by the board, recommended changes including potentially converting four rural hospitals into outpatient facilities and consolidating specialty services at others.

He cautioned that any fix would require sacrifices from everyone, including patients. “There is no simple single policy solution.”

Lynne Drevik, who runs an inn and spa in northern Vermont, said her doctor told her in April that she needed knee replacement surgeries — but the earliest appointment would be in January for one knee and next April for the other.

Drevik said it hurts to climb the stairs in her 19th century farmhouse. “My life is on hold here, and it’s hard to make any plans.”

Andy Kehler often worries about the cost of providing health insurance to the 85 workers at Jasper Hill Farm, the cheesemaking business he co-owns in northern Vermont. The company pays half the cost of workers’ health insurance premiums because that’s all it can afford, he said.

“It’s an issue every year for us, and it looks like there is no end in sight,” he said.

Recent data shows the University of Vermont Health Network controls about two-thirds of the state’s hospital market, and its main facility, the University of Vermont Medical Center in Burlington, has some of the highest prices nationwide.

Hospital officials contend their prices are average for the industry.

But for 2025, the Green Mountain Care Board required the Burlington hospital to cut the prices it bills private insurers by 1 percent.

The nonprofit system says it is navigating its own challenges, including a lack of housing to recruit workers and a shortage of mental health providers, nursing homes and long-term care services, which often creates delays in discharging patients, adding to costs.

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William Lopez remembers clearly the day in June 2017 when he says he was asked to call the spouse of a college friend who had just died and ask for her eyes.

The spouse hadn’t responded to calls from other employees at the Rocky Mountain Lions Eye Bank, he said. As Lopez recalled, his supervisor thought a friend’s personal number would have more success.

Lopez refused. “I went for a walk,” he said.

Even without Lopez’s help, the eye bank that procures corneas from deceased donors in Wyoming and Colorado eventually collected his friend’s corneas, Lopez said. Lopez, who had entered the field to help people, became increasingly disillusioned during his three years working with the eye bank, despite rising from a technician to the distribution manager, and ultimately quit.

Checking the “donor” box on a driver’s license application, people may picture their heart, kidneys, or other organs saving another person’s life should the worst happen.

They are less likely to consider that tissues — corneas, tendons, bone marrow, skin, bone — are also covered by that checked box. In fact, donated tissues are collected much more frequently than organs, and corneas are the most commonly transplanted body part in the U.S., with nearly 51,000 transplants last year, according to the Eye Bank Association of America.

Organ and tissue donations are guided by different rules, with less transparency and what critics identify as more self-policing in the tissue donation industry. In Wyoming and Colorado, where the Rocky Mountain Lions Eye Bank estimates it collects eye tissue from about 2,500 deceased donors a year, that has contributed to a tense work environment resulting in damaged or wasted tissues due to accidents, four former eye bank employees say.

“I think there’s an urgent need for stricter oversight of the donation process in general, particularly for eye and tissue banks,” said Janell Lewis, who worked at the Rocky Mountain Lions Eye Bank for 12 years, managing public relations and overseeing fundraising before she quit in February 2023.

John Lohmeier, executive director of the Rocky Mountain Lions Eye Bank, declined to be interviewed for this article. In a prepared statement, he said he couldn’t comment on personnel matters or specific incidents raised by the former employees.

But generally, he wrote, “there are internal procedures that have been in place and continue to be followed to investigate and/or report any incident that would impact health and safety concerns.”

Lewis, Lopez, and two other former eye bank employees recalled one or more of the following problems during their time at Rocky Mountain Lions Eye Bank:

• Removal of eye tissue from the wrong body
• Damage or destruction of corneas due to improper removal
• Removal of corneas from a donor with a high-risk family history that could endanger a transplant recipient
• Lack of transparency about whether errors were being reported to federal agencies
• Pressuring and bullying of technicians
• High turnover and brief training of low-paid and inexperienced technicians

The Windshield of the Eye

The cornea is considered the windshield of the eye. It is a clear dome that protects the eye from contaminants, maintains fluid balance, and filters light. Recipients of cornea donations typically need transplants because of trauma, infection, or other conditions that cause blindness or blurred or cloudy vision.

The Rocky Mountain Lions Eye Bank is one of about 60 eye banks operating in the U.S., which leads the world in corneal transplants. New technicians often arrive at the eye bank untrained, sometimes with only a high school diploma, to perform the grim job of removing corneas from recently deceased corpses for about the same wages many fast-food workers earn.

But what eye bank technicians may lack in education and training, they generally make up for with a strong belief in the mission, according to the former employees. They said they joined the Rocky Mountain Lions Eye Bank because they wanted to help restore people’s sight.

The nonprofit employs about 70 people across Colorado and Wyoming, according to a tax filing submitted in 2023. Those records also show a net income of less than $1 million and more than $16 million in assets. Lohmeier was paid about $142,000.

Organs vs. Tissue

Organ donations fall under the purview of the Health Resources and Services Administration, and public data details performance and financial transaction records of organ procurement groups. Tissue donation is regulated by the Food and Drug Administration, as well as national industry groups, and tissue bank transactions, performance, and outcomes are not available to the public.

There’s no reason tissues and organs should be treated differently, said Robert Dickson, medical director for the Washtenaw County Tuberculosis Clinic in Michigan. A patient in his county died from a bone graft contaminated with tuberculosis just a couple of years after a contaminated bone graft killed eight other patients.

He compared the tissue regulatory environment to the Wild West and called it a major public health concern.

“It’s fundamentally no different from an organ transplant. You’re taking tissue from one deceased patient and putting it into a living recipient. But it is not regulated and not tested as rigorously,” he said.

Marc Pearce, president and CEO of the American Association of Tissue Banks, said such cases are very rare.

“We don’t believe that we’ve proven ourselves to be not capable of regulating ourselves,” he said.

FDA officials disagree that the tissue industry is largely self-regulated, pointing to federal rules that require certain organizations to register with the agency and provide a list of human cells or tissues they recover, store, or distribute.

The rules set donor eligibility requirements, and the agency inspects tissue establishments, including eye banks, said spokesperson Carly Pflaum.

“The FDA has implemented a tiered risk-based approach for the regulation of human cell, tissue and cellular and tissue-based products,” Pflaum wrote.

KFF Health News and WyoFile months ago requested reports of adverse events associated with the Rocky Mountain Lions Eye Bank, but the FDA has yet to provide them. FDA dashboards show the eye bank has not issued a recall since 2017, and inspections since at least 2009 have not resulted in any official action.

The tissue industry is largely self-monitored and the performance of eye banks is tracked internally, whereas the federal government publishes annual performance reports for organ procurement groups. Health care providers are not required to report to the FDA adverse events resulting from tissue transplants.

Organ transplant providers are required to report safety events in recipients within 72 hours to the Organ Procurement and Transplantation Network, which operates under contract with the U.S. Department of Health and Human Services. That includes an organ going unused because it was delivered to the wrong location. They have 24 hours if, for example, the recipient gets an infection or disease that may have been from the new organ.

Other countries have public registries detailing the outcomes of corneal transplants, including Australia, the United Kingdom, and Sweden. A similar registry in the U.S. could help monitor outcomes for patients and identify adverse events from transplant procedures, eye doctors and researchers wrote in the journal Ophthalmology Science.

Tissue bank industry groups are responsible for much of the oversight of their dues-paying members. Transplanting surgeons may report adverse reactions to the tissue bank, which generally then conducts a review and submits a report to the FDA and the Eye Bank Association of America or the American Association of Tissue Banks.

Nearly all eye banks in the U.S. are members of the Eye Bank Association of America, which inspects member banks at least every three years as part of its accreditation process, but such inspection reports aren’t publicly available. Safety is paramount, association president Kevin Corcoran said, and the association’s medical standards require eye banks to request patient outcome information from transplanting surgeons a few months after surgery.

“We want to make sure we don’t have an eye bank that is slipping in their performance or failing to recover tissue,” he said. He declined to comment on any individual eye bank’s performance or release quality or transplantation data, complaints filed, or investigations undertaken.

No investigations have resulted in corrective action, he said, in the 13 years he has been at the association. The Rocky Mountain Lions Eye Bank is an accredited member of the association.

Balancing Mission and Stress

Several of the former employees were hesitant to speak about the Rocky Mountain Lions Eye Bank because they didn’t want to sully the reputation of an industry they believe is essential for improving people’s lives and honoring the wishes of the dead.

But they described a high-pressure environment that they said led to many of their colleagues leaving and errors that reduced the number of successful retrievals.

Mackenzie Urban started recovering corneas as a technician for the eye bank in 2019 after finishing her bachelor’s degree. She saw it as a temporary job as she applied for medical school. But within a year of recovering her first cornea, she said, enough employees had left that she became the senior recovery technician and was training others.

She used limes for the training, guiding her students on how to use a scalpel to remove the peel without nicking the fruit beneath. Success meant lifting the peel off the lime without any juice spilling out.

“If you’re stressed, you’re going to shake,” Urban said.

Outside factors can compound the challenges of performing the delicate procedure. Maybe the coroner had drawn fluid from beneath the cornea, making collection much trickier, she said. After a person has been dead for about 24 hours, the eyes tend to deflate to the point of uselessness, adding time pressure to collecting donations, Urban said.

Sometimes, Urban said, another technician would be working on a body simultaneously, so that the entire body was moving around while she was trying to do the delicate procedure.

Interactions with grieving families could be intense, too. Sometimes, families would hug her, thankful that something good would come of their loss. Other times, they were hostile, such as the time one relative of a potential donor told her to “Cut your own f****** eyes out, you b****,” she recalled.

Urban appreciates the work the eye bank performs and doesn’t regret her time there. She said she respected that “they had a real commitment to serving the community and keeping prices low.” (It’s illegal to sell human body parts for transplant, but companies get reimbursed varying amounts for the expenses of harvesting, preparing, and shipping tissues.)

But the workplace culture made it untenable for her, she said. For example, Urban said, she was reprimanded and told that she needed to “buck up or get out” because she declined to harvest corneas from a person who died from an unknown cause. The body was purple from the neck down, covered in oozing blisters and with opaque flecks in the eyes, Urban said.

When Irish Eyes Are Smiling

The Rocky Mountain Lions Eye Bank has international contracts and ships corneas to Japan and the U.K., among other destinations. It became the exclusive eye tissue provider for Ireland when that country stopped collecting corneas over fears of transmitting mad cow disease. That means anyone who has received a cornea transplant in Ireland in the past two decades likely now sees thanks to a person who died in Colorado or Wyoming, according to the Irish Blood Transfusion Service.

Lohmeier, the eye bank CEO, said local needs are prioritized for donations, while international shipments help fulfill the eye bank’s mission and “ensure that all viable corneas are transplanted, giving the gift of restored sight.”

The U.S. is one of the few nations with a cornea surplus. FDA inspection reports confirmed that the Rocky Mountain Lions Eye Bank procures more tissue than its geographic area can use.

The demand for international orders contributed to the high-pressure environment, Lopez said.

Employee turnover and the stress of the job resulted in the collection of corneas of poor quality, Lewis said. Local hospitals inquired about why so many corneas weren’t being transplanted, she added.

The leading reason was recovery errors that damaged the tissue, Lewis said.

Lohmeier disagreed that there was a significant decline in corneas being placed. “We do not believe this description accurately reflects the state of corneal recovery and transplants,” he said.

Internal records showed that about half of recovered corneas in November 2022 had moderate to heavy stress. The Eye Bank Association of America does not have comparable national data. The closest figure it tracks is the proportion, among tissues that were prepared but not transplanted, that were unable to be transplanted because of damage during processing; in 2022, it was a quarter.

Ashi Moore, who used to lead the Rocky Mountain Lions Eye Bank’s quality assurance department, said she once filed a report to the FDA after a donor’s eye tissues were removed despite a family history indicating a high risk of Creutzfeldt-Jakob disease. The disease, which should have been disqualifying for donation purposes, is a fatal brain disorder that can be transmitted through infected tissue.

The issue was caught before the corneas could be placed in someone else’s eyes, but it should never have gotten to the point that the corneas were removed from the body, Moore said.

At least once, a technician retrieved corneas from the wrong body, according to Moore and other former employees (The FDA was unable to provide records to confirm that report by publication). Moore said she should have been told about the case of mistaken identity immediately but said she wasn’t made aware of it until after the eye bank’s leaders handled the situation themselves.

She said she couldn’t find evidence that the eye bank had reported the error to the FDA. It was one of the major reasons she decided to leave the organization, though she had derived a strong sense of purpose from working at the eye bank, she said.

When Lewis resigned, officials at the nonprofit eye bank offered her $5,000 to sign a severance agreement with a nondisparagement provision. She declined.

Lewis said she would like to see states hold tissue recovery agencies to the same standards as other organizations that handle corpses, such as hospitals, coroners, and funeral homes. And if they fail to meet those standards, they need to be held accountable to build public trust, she said.

Lewis’ and Lopez’s negative experiences with the eye bank had another consequence. Each decided they no longer wanted to be an organ or tissue donor.

“After witnessing and experiencing so many issues, I no longer feel comfortable with the potential of my family having to go through that when the time comes,” Lewis said.

WyoFile is an independent nonprofit news organization focused on Wyoming people, places, and policy.

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After their younger son was bitten by a rattlesnake and ended up in the pediatric intensive care unit, a San Diego couple received a huge bill. Listen to hear why antivenom is so expensive.

This spring, a San Diego toddler spent two days in a pediatric intensive care unit after a rattlesnake bit his hand in his family’s backyard.

The bills that followed were staggering, with the lifesaving antivenom the 2-year-old needed accounting for more than two-thirds of the total cost — $213,000.

Why is antivenom so expensive? One explanation is the markup hospitals add to balance overhead costs and make money. Another explanation is a lack of meaningful competition. There are only two rattlesnake antivenoms approved by the Food and Drug Administration.

Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center, said it can be difficult to sort out drug pricing because a hospital bill is often an instrument insurers and hospitals use to negotiate prices. Patients such as the Pfeffers often get stuck in the middle.

“When you see the word ‘charges,’ that’s a made-up number. That isn’t connected at all, usually, to what the actual drug cost,” Dusetzina said.

Read more here.

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Indiana residents and federal officials are urging state health regulators to stop two rival hospitals in Terre Haute from merging. The deal, if approved, would leave residents with a hospital monopoly.

Union Health, a nonprofit whose main hospital is licensed as a 341-bed facility, would buy the county’s only other acute care hospital, the 278-bed Terre Haute Regional Hospital, owned by for-profit chain HCA Healthcare and located 5 miles south across the city’s downtown area. Union says the merger to create one larger nonprofit health system would improve the area’s poor public health rankings.

The Indiana Department of Health received hundreds of comments on the proposed merger, according to documents KFF Health News obtained through a state public records request. Most people expressed opposition to the deal, citing concerns about longer travel times to get emergency care, higher prices, and fewer choices for Terre Haute’s 58,000 residents and those in Vigo County’s nearby rural communities.

“Monopoly should be just a board game. Not a healthcare system,” a commenter listed as H. Osborne wrote to the state health agency.

Doctors, health economists, and the Federal Trade Commission called on the Indiana Department of Health to deny Union Hospital’s merger application. Such mergers became possible after Indiana enacted a Certificate of Public Advantage law, or COPA, in 2021, shielding the deals from federal anti-monopoly laws.

Two dozen states have had COPA laws on their books at some point, despite FTC warnings that such mergers can become difficult to control and may decrease the overall quality of care. The trend has come amid a broader wave of hospital consolidation, which research shows fuels price hikes and health care spending, driving up costs for families, employers, and taxpayers who foot the bill for Medicare and Medicaid.

Union Health said its proposed deal would improve care and increase access to services while “maintaining cost efficiency” for patients.

“This is not merely a business transaction; it is a strategic effort to improve healthcare delivery in our community,” Union said in a statement.

John Collett, an executive with Garmong Construction who also serves on the board of the Terre Haute Chamber of Commerce, wrote that the deal would help the region achieve its goal of boosting population and income levels. (Garmong Construction served as construction manager for Union on multiple projects, including one worth hundreds of millions of dollars, according to an online brochure of its past projects.)

“I firmly believe this to be a step in the right direction,” Collett wrote.

But the FTC — using italics for emphasis — said the deal is “unlikely to result in improved quality and access” and “would not lead to a healthier workforce or a stronger local economy,” according to comments the agency submitted to Indiana regulators.

Zack Cooper, a health economist and associate professor at Yale University, said the merger would probably damage the local economy and squeeze residents’ wallets. Cooper’s analysis estimates the price of care would rise by at least 10% for area residents and lead to 500 lost jobs, while nurses’ pay would drop by at least 7%. His research predicts the deal also would lead to unnecessary deaths from suicide or overdose, stemming from those job losses.

“I firmly believe this merger would harm members of the public in Terre Haute and Vigo County,” Cooper wrote.

As a condition of these types of mergers, state agencies typically agree to monitor hospital quality and prices to make up for the loss of competition. Union said monitoring would hold it accountable, according to its response to the FTC’s public comments opposing the deal.

The FTC pushed back, saying the oversight mechanism “would be insufficient to contain costs” and is a “poor substitute” for competition. Even though Union would face limits on raising prices in Vigo County, the FTC said, the system might be able to hike them elsewhere, including at its hospital in neighboring Vermillion County to the north.

Indiana has some of the highest hospital prices in the nation, according to studies by Rand Corp., a research organization.

In Terre Haute, some doctors worry the deal would exacerbate existing problems. Kathleen Stienstra, a physician in private practice, voiced her concerns about Union’s management style, saying it has led to an exodus of doctors.

“A monopoly will lead to further deterioration in services,” she wrote.

Separately, the FTC referenced KFF Health News’ reporting on Tennessee’s Ballad Health, a 20-hospital monopoly in Appalachia, as a cautionary tale against such mergers.

COPAs, such as the one that Ballad operates under, “have proven unwieldy,” are “difficult to manage,” and “have failed to protect local communities from the harmful effects of anticompetitive hospital mergers,” the FTC said in its comments on the Union-Regional merger.

Since Ballad launched in 2018 and became the nation’s largest state-approved hospital monopoly, it has not lived up to some of its promises, KFF Health News reported. It has fallen short on meeting quality and charity care goals, according to annual reports from Ballad and the Tennessee Department of Health. After years of problems and complaints from patients, the state is now trying to hold Ballad more accountable for its quality of care.

Ballad declined to respond to KFF Health News inquiries regarding the FTC’s comments.

Now the Indiana Department of Health must consider the comments and decide by early December whether the proposed merger would improve health outcomes, access to services, and quality of care. Under the department’s standards, those benefits must “outweigh any potential disadvantages.”

KFF Health News correspondent Brett Kelman contributed to this report.

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Hospitals around the country are conserving critical intravenous fluid supplies to cope with a shortage that may last months. Some hospital administrators say they are changing how they think about IV fluid hydration altogether.

Hurricane Helene, which hit North Carolina in September, wrecked a Baxter International facility that produces 60% of the IV fluids used in the U.S., according to the American Hospital Association.

The company was forced to stop production and is rationing its products. In an update posted Nov. 7, Baxter said its North Cove facility had resumed producing some IV fluids. In an email to KFF Health News, the company wrote that customers will be able to order normal quantities of “certain IV solutions products” by the end of the year, but there is no timeline for when the North Cove facility will be back to prehurricane production levels.

Meanwhile, hospitals are facing seasonal strains on their already limited IV fluid resources, said Sam Elgawly, chief of resource stewardship at Inova, a health system in the Washington, D.C., area.

“We’ve been very aggressive in our conservation measures,” Elgawly said, stressing that he does not believe patient care has been compromised. He told KFF Health News that across the system IV fluid usage has dropped 55% since early October.

Elgawly called the shortage a crisis that he expects to have to continue managing for some time. “We are going to operate under the assumption that this is going to be the way it is through the end of 2024 and have adopted our demand/conservation measures accordingly,” he said.

At the end of the calendar year, many patients with insurance hurry to schedule surgical procedures before their deductibles reset in January. Elgawly is eyeing that typical surgical rush and the impending peak of respiratory virus season as he tries to stockpile IV fluid bags. Hospitals such as Inova’s are using different ways to conserve, such as giving some medications intravenously, but without a dedicated IV fluid bag, known as a push medication.

“You don’t even need a bag at all. You just give the medication without the bag,” he said. “There has been increasing literature over the last 10 to 20 years that indicates maybe you don’t need to use as much. And this accelerated our sort of innovation and testing of that idea.”

Monica Coleman is a nurse at a Department of Veterans Affairs hospital in North Chicago. She said using push medications takes more time out of a nurse’s already hectic schedule because then they need to monitor the patient.

“This could increase adverse effects within the patient, because we’re giving the medication at a faster rate,” she said.

Elgawly is also interested in retooling electronic health records to question doctor orders for more IV hydration.

“Does the patient actually need that second bag? How did they do today with eating or drinking water or juice? They did well? They don’t need the bag. So it’s little conservation mechanisms like that that, when you add them across, you know, the 2,000-patient system that Inova is, make a significant dent,” he said.

Simpler conservation measures could become common after the shortage abates, said Vince Green, chief medical officer for Pipeline Health, a small hospital system in the Los Angeles area that serves mainly people on Medicare and Medicaid.

First, Green would like to see data showing that patient outcomes aren’t affected. But for now, some of the new strategies just make sense to him. He has directed hospital staff to use up the entire IV bag before starting another.

“If they come in with IV fluids that the paramedics have started, let’s continue it. If it saves half a bag of fluids, so be it, but it adds up over time,” he said.

Patients may be asked to take more accountability for their hydration, by drinking Gatorade or water rather than the default of hydrating through an IV, he said.

“From an environmental aspect, we don’t need to have this much waste and fill up our landfills. If we could reduce stuff, I think it’d be wise,” he said.

But he’ll feel better when his hospitals receive a full order, which could be weeks away. Green said they are down to a two-week supply, with an expected increase in hospitalizations due to respiratory virus season.

“We’re purchasing every IV fluid bag that we can get,” he said.

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In March, newly installed Social Security chief Martin O’Malley criticized agency “injustices” that “shock our shared sense of equity and good conscience as Americans.”

He promised to overhaul the Social Security Administration’s often heavy-handed efforts to claw back money that millions of recipients — including people who are living in poverty, are elderly, or have disabilities — were allegedly overpaid, as described by a KFF Health News and Cox Media Group investigation last year.

“Innocent people can be badly hurt,” O’Malley said at the time.

Nearly eight months since he appeared before Congress and announced a series of policy changes, and with two months left in his term, O’Malley’s effort to fix the system has made inroads but remains a work in progress.

For instance, one change, moving away from withholding 100% of people’s monthly Social Security benefits to recover alleged overpayments, has been a major improvement, say advocates for beneficiaries.

“It is a tremendous change,” said Kate Lang of Justice in Aging, who called it “life-changing for many people.”

The number of people from whom the Social Security Administration was withholding full monthly benefits to recoup money declined sharply — from about 46,000 in January to about 7,000 in September, the agency said.

Asked to clarify whether those numbers and others provided for this article covered all programs administered by the agency, the SSA press office did not respond.

Another potentially significant change — relieving beneficiaries of having to prove that an overpayment was not their fault — has not been implemented. The agency said it is working on that.

Meanwhile, the agency seems to be looking to Congress to take the lead on a change some observers see as crucial: limiting how far back the government can reach to recover an alleged overpayment.

Barbara Hubbell of Watkins Glen, New York, called the absence of a statute of limitations “despicable.” Hubbell said her mother was held liable for $43,000 because of an SSA error going back 19 years.

“In what universe is that even legal?” Hubbell said. Paying down the overpayment balance left her mother “essentially penniless,” she added.

In response to questions for this article, Social Security spokesperson Mark Hinkle said legislation is “the best and fastest way” to set a time limit.

Establishing a statute of limitations was not among the policy changes O’Malley announced in his March congressional testimony. In an interview at the time, he said he expected an announcement on it “within the next couple few months.” It could probably be done by regulation, without an act of Congress, he said.

Speaking generally, Hinkle said the agency has “made substantial progress on overpayments,” reducing the hardship they cause, and “continues to work diligently” to update policies.

The agency is underfunded, he added, is at a near 50-year low in staffing, and could do better with more employees. The SSA did not respond to requests for an interview with O’Malley.

O’Malley announced the policy changes after KFF Health News and Cox Media Group jointly published and broadcast investigative reporting on the damage overpayments and clawbacks have done to millions of beneficiaries.

When O’Malley, a former Democratic governor of Maryland, presented his plans to three congressional committees in March, lawmakers greeted him with rare bipartisan praise. But the past several months have shown how hard it can be to turn around a federal bureaucracy that is massive, complex, deeply dysfunctional, and, as it says, understaffed.

Now O’Malley’s time may be running out.

Lang of Justice in Aging, among the advocacy groups that have been meeting with O’Malley and other Social Security officials, said she appreciates how much the commissioner has achieved in a short time. But she added that O’Malley has “not been interested in hearing about our feelings that things have fallen short.”

One long-standing policy O’Malley set out to change involves the burden of proof. When the Social Security Administration alleges someone has been overpaid and demands the money back, the burden is on the beneficiary to prove they were not at fault.

Cecilia Malone, 24, a beneficiary in Lithonia, Georgia, said she and her parents spent hundreds of hours trying to get errors corrected. “Why is the burden on us to ‘prove’ we weren’t overpaid?” Malone said.

It can be exceedingly difficult for beneficiaries to appeal a decision. The alleged overpayments, which can reach tens of thousands of dollars or more, often span years. And people struggling just to survive may have extra difficulty producing financial records from long ago.

What’s more, in letters demanding repayment, the government does not typically spell out its case against the beneficiary — making it hard to mount a defense.

Testifying before House and Senate committees in March, O’Malley promised to shift the burden of proof.

“That should be on the agency,” he said.

The agency expects to finalize “guidance” on the subject “in the coming months,” Hinkle said.

The agency points to reduced wait times and other improvements in a phone system known to leave beneficiaries on hold. “In September, we answered calls to our national 800 number in an average of 11 minutes — a tremendous improvement from 42 minutes one year ago,” Hinkle said.

Still, in response to a nonrepresentative survey by KFF Health News and Cox Media Group focused on overpayments, about half of respondents who said they contacted the agency by phone since April rated that experience as “poor,” and few rated it “good” or “excellent.”

The survey was sent to about 600 people who had contacted KFF Health News to share their overpayment stories since September 2023. Almost 200 people answered the survey in September and October of this year.

Most of those who said they contacted the agency by mail since April rated their experience as “poor.”

Jennifer Campbell, 60, a beneficiary in Nelsonville, Ohio, said in late October that she was still waiting for someone at the agency to follow up as described during a phone call in May.

“VERY POOR customer service!!!!!” Campbell wrote.

“Nearly impossible to get a hold of someone,” wrote Kathryn Duff of Colorado Springs, Colorado, who has been helping a disabled family member.

Letters from SSA have left Duff mystified. One was postmarked July 9, 2024, but dated more than two years earlier. Another, dated Aug. 18, 2024, said her family member was overpaid $31,635.80 in benefits from the Supplemental Security Income program, which provides money to people with little or no income or other resources who are disabled, blind, or at least 65. But Duff said her relative never received SSI benefits.

What’s more, for the dates in question, payments listed in the letter to back up the agency’s math didn’t come close to $31,635.80; they totaled about a quarter of that amount.

Regarding the 100% clawbacks, O’Malley in March said it’s “unconscionable that someone would find themselves facing homelessness or unable to pay bills, because Social Security withheld their entire payment for recovery of an overpayment.”

He said that, starting March 25, if a beneficiary doesn’t respond to a new overpayment notice, the agency would default to withholding 10%. The agency warned of “a short transition period.”

That change wasn’t automated until June 25, Hinkle said.

The number of people newly placed in full withholding plummeted from 6,771 in February to 51 in September, according to data the agency provided.

SSA said it would notify recipients they could request reduced withholding if it was already clawing back more than 10% of their monthly checks.

Nonetheless, dozens of beneficiaries or their family members told KFF Health News and Cox Media Group they hadn’t heard they could request reduced withholding. Among those who did ask, roughly half said their requests were approved.

According to the SSA, there has been almost a 20% decline in the number of people facing clawbacks of more than 10% but less than 100% of their monthly checks — from 141,316 as of March 8 to 114,950 as of Oct. 25, agency spokesperson Nicole Tiggemann said.

Meanwhile, the number of people from whom the agency was withholding exactly 10% soared more than fortyfold — from just over 5,000 to well over 200,000. And the number of beneficiaries having any benefits withheld to recover an overpayment increased from almost 600,000 to almost 785,000, according to data Tiggemann provided.

Lorraine Anne Davis, 72, of Houston, said she hasn’t received her monthly Social Security payment since June due to an alleged overpayment. Her Medicare premium was being deducted from her monthly benefit, so she’s been left to pay that out-of-pocket.

Davis said she’s going to need a kidney transplant and had been trying to save money for when she’d be unable to work.

A letter from the SSA dated April 8, 2024, two weeks after the new 10% withholding policy was slated to take effect, said it had overpaid her $13,538 and demanded she pay it back within 30 days.

Apparently, the SSA hadn’t accounted for a pension Davis receives from overseas; Davis said she disclosed it when she filed for benefits.

In a letter to her dated June 29, the agency said that, under its new policy, it would change the withholding to only 10% if she asked.

Davis said she asked by phone repeatedly, and to no avail.

“Nobody seems to know what’s going on” and “no one seems to be able to help you,” Davis said. “You’re just held captive.”

In October, the agency said she’d receive a payment — in March 2025.

Marley Presiado, a research assistant on the Public Opinion and Survey Research team at KFF, contributed to this report.

Do you have an experience with Social Security overpayments you’d like to share? Click here to contact our reporting team.

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President-elect Donald Trump’s incoming administration could try to remove fluoride from drinking water, according to Robert F. Kennedy Jr.

Kennedy, who was tapped last week by Trump to lead the Department of Health and Human Services, called fluoride an “industrial waste” and linked it to cancer and other diseases and disorders while campaigning for Trump.

“On January 20, the Trump White House will advise all U.S. water systems to remove fluoride from public water. Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease,” Kennedy wrote Nov. 2 on X. Kennedy linked to a video from an attorney who recently successfully sued the Environmental Protection Agency to take additional measures to regulate fluoride in drinking water.

Kennedy, who has long advocated ending water fluoridation, persisted with his pledge following Trump’s election win. When asked before the election whether his administration would remove fluoride from drinking water, Trump said, “Well, I haven’t talked to him about it yet, but it sounds OK to me. You know it’s possible.”

Kennedy is an influential vaccine skeptic whose campaign of conspiracy theories earned PolitiFact’s 2023 “Lie of the Year.”

Longtime research has found that adding fluoride to U.S. drinking water is a safe way to boost children’s oral health. Since 2015, the recommended level in the U.S. has been 0.7 milligrams per liter. Public health organizations, including the American Dental Association, the American Academy of Pediatrics, and the Centers for Disease Control and Prevention, support the practice.

Recent studies, however, have shown possible links between fluoride and bone problems and children’s IQs, particularly when fluoride is above the U.S. recommended levels.

“There is evidence that fluoride exposure has been associated with the diseases [and] disorders that RFK listed, but with caveats,” said Ashley Malin, who is an assistant professor in the University of Florida’s Epidemiology Department and has studied fluoride’s effects in pregnant women.

Malin referred to studies showing that higher fluoride exposure, particularly during pregnancy, is associated with reduced child IQ, and that prenatal exposure also is linked to decreased intellectual functioning and executive function. For high exposure in pregnancy, the studies showed symptoms associated with other neurobehavioral issues, such as attention-deficit/hyperactivity disorder.

However, many of these studies took place in countries other than the U.S. and looked at fluoride in drinking water at sometimes twice the United States’ recommended level. Also, some of the other ailments that Kennedy listed, such as an association with bone cancer, have less robust evidence and need more study.

“Aside from fluoride’s impacts on neurodevelopment, I think that there is more that we don’t know about health effects of low-level fluoride exposure than what we do know, particularly for adult health outcomes,” Malin said.

David Bellinger, a Harvard Medical School neurology professor and professor in Harvard School of Public Health’s Environmental Health Department, said the risk-benefit calculation of added fluoride differs depending on whether typical fluoride exposure levels cause health problems, or if problems occur only when recommended levels are exceeded.

“In toxicology, ‘the dose makes the poison’ is a long-standing principle,” he said. “So a general statement that fluoride is associated with diseases X, Y, and Z is not very helpful unless the dose that might be responsible is specified.”

PolitiFact contacted Kennedy through his Children’s Health Defense organization but received no reply. The organization sued PolitiFact and Meta related to a 2020 fact check. That lawsuit was dismissed by a federal court. The dismissal was upheld on appeal, and the case is pending a possible appeal to the U.S. Supreme Court.

What Is Fluoride and What Are Its Benefits?

Fluoride is a mineral naturally occurring in soil, water, and some foods that helps prevent tooth decay and cavities. It strengthens tooth enamel that acid from bacteria, plaque, and sugar can wear away.

Water fluoridation has been happening in the U.S. since 1945.

The federal Public Health Service first recommended fluoridation of tap water in 1962, but the decision still lies with states and municipalities. Around 72% of the U.S. population, or about 209 million people, had access to fluoridated water in 2022, the CDC reported. Fluoride also has been added to oral care products such as toothpaste and mouth rinse.

In 2015, U.S. health officials lowered the recommended amount of fluoride in drinking water to 0.7 milligrams per liter, saying a higher level was less necessary given other sources of fluoride, and that the lowered amount would still help protect teeth without staining them.

Pediatric dentists note that applying fluoride with toothpaste and rinses is beneficial, but small amounts circulating in the body via water consumption helps younger children who still have their baby teeth, because it can benefit the developing permanent teeth.

The American Dental Association says studies have shown that fluoride in community water systems prevents at least 25% of tooth decay in children and adults and that “for more than 75 years, the best scientific evidence has consistently shown that fluoridation is safe and effective.”

The association says on its website: “It’s similar to fortifying other foods and beverages — for example, fortifying salt with iodine, milk with vitamin D, orange juice with calcium, and bread with folic acid.”

According to the CDC, health experts and scientists from the U.S. and other countries have so far “not found convincing scientific evidence linking community water fluoridation with any potential adverse health effect or systemic disorder such as an increased risk for cancer, Down syndrome, heart disease, osteoporosis and bone fracture, immune disorders, low intelligence, renal disorders, Alzheimer’s disease, or allergic reactions.”

The agency says risks of water fluoridation are limited to dental fluorosis, which can alter dental enamel and cause white flecks, spots, lines, or brown stains on the teeth when too much fluoride is consumed.

Do Studies Show Fluoride Posing Any Other Risks?

Some studies have said that excess fluoride exposure, often at higher levels than the recommended U.S. limit, can harm infants’ and young children’s developing brains and that higher levels of fluoride exposure during pregnancy were associated with declines in children’s IQs.

A study published in May that Malin led with University of Southern California and Indiana University researchers suggested that fluoride exposure during pregnancy was linked to an increased risk of childhood neurobehavioral problems and said more studies were “urgently needed to understand and mitigate the impacts in the entire U.S. population.”

Experts noted prenatal fluoride exposure is most strongly linked to children’s IQ loss, and said timing of fluoride consumption might need to be considered when making recommendations.

A federal review of dozens of studies published in August by the Department of Health and Human Services’ National Toxicology Program concluded that higher levels of fluoride exposure were linked to lower IQs in children. But the report was based primarily on studies in countries such as Canada, China, India, Iran, Mexico, and Pakistan and involved fluoride levels at or above 1.5 milligrams per liter, twice the recommended U.S. limit. The authors said more research is needed to understand whether lower exposure has any adverse effects.

In the report, researchers said they found no evidence that fluoride exposure adversely affected adult cognition.

Bellinger, of Harvard, pointed to the review as an example of how the amount of fluoride matters. He noted how researchers concluded that a very small percentage of people in the U.S. are exposed to levels that correlate with IQ loss.

“Second, the fact that there are now multiple pathways of exposure to fluoride besides fluoridated water (toothpaste and other dental products, etc.) makes it really difficult to attribute a particular adverse effect to the fluoride added to the water,” he wrote via email. “It is the cumulative exposure from all sources that contribute to any adverse health effects.”

In September, a federal judge ordered the Environmental Protection Agency to further regulate fluoride in drinking water because of the potential risk that higher levels could affect children’s intellectual development.

U.S. District Judge Edward Chen wrote that the court’s finding didn’t “conclude with certainty that fluoridated water is injurious to public health,” saying it’s unclear whether the amount of fluoride typically added to water is causing children’s IQs to drop. But he wrote that there was enough risk to warrant investigation and that the EPA must act to further regulate it. The ruling did not specify what actions the agency should take, and the EPA is reviewing the decision.

After the ruling, the American Association of Pediatrics issued a statement that fluoride in drinking water is safe for children and said the policy is based on a robust foundation of evidence.

Besides dental fluorosis, experts say that fluoride exposure over many years above the U.S. recommended amount can cause skeletal fluorosis, a rare condition that causes weaker bones, stiffness, and joint pain. Although the Public Health Service recommends a fluoride concentration of 0.7 milligrams per liter for community water systems, the EPA, under the Safe Drinking Water Act, sets enforceable standards for drinking-water quality. Currently, to prevent skeletal fluorosis, the EPA requires that water systems not exceed 4 milligrams of fluoride per liter of water.

Malin said she and her research team are investigating a potential link between fluoride and bone fractures. She said that although several studies have found high fluoride exposure associated with increased risk of bone fractures, and some have linked fluoride with thyroid disease, rigorous, U.S.-based studies haven’t been done.

The CDC concluded that recent research found no link between cancer risk and high levels of fluoride in drinking water.

The American Cancer Society reviewed a possible link between water fluoridation and cancer risk. An organization spokesperson pointed PolitiFact to its review and said it has no data showing a definitive answer.

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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En abril, cuando apenas llevaba 12 semanas de embarazo, Kathleen Clark estaba en la recepción de su ginecólogo-obstetra cuando le pidieron que pagara $960, el total que la consulta calculaba que tendría que pagar después del parto.

Clark, de 39 años, se sorprendió de que le pidieran pagar esa cantidad en su segunda visita prenatal. Normalmente, las pacientes reciben la factura después que el seguro haya pagado su parte, y en el caso de las embarazadas eso suele ocurrir cuando termina el embarazo. Pasarían meses antes de que la consulta presentara el reclamo a su seguro médico.

Clark dijo que se sintió atrapada. La consulta de obstetricia de Cleveland, Tennessee, estaba asociada a un centro de maternidad donde ella quería dar a luz. Además, ella y su marido llevaban mucho tiempo deseando tener un hijo. Y Clark se sentía especialmente sensible porque unas semanas antes había muerto su madre.

“Estás ahí, en la ventanilla, rodeada de gente, y tratas de ser lo más amable posible”, recordó Clark, entre lágrimas. “Así que lo pagué”.

En las comunidades sobre bebés en internet y en otros foros de las redes sociales, las embarazadas afirman que sus proveedores les piden que paguen antes de lo previsto. La práctica es legal, pero los defensores de los pacientes la califican de poco ética. Los médicos alegan que pedir el pago por adelantado les garantiza una compensación por sus servicios.

Es difícil saber con qué frecuencia ocurre porque se considera una transacción privada entre el proveedor y el paciente. Por lo tanto, los pagos no se registran en los datos de reclamos de seguros y, por ende, los expertos no los analizan.

Pacientes, expertos en facturación médica y activistas afirman que esta práctica de facturación provoca una ansiedad inesperada en un momento de estrés y presión financiera ya de por sí elevados. En ocasiones, las estimaciones pueden ser superiores a lo que el paciente deba en última instancia y obligan a las personas a luchar por un reembolso si la cantidad abonada era superior a la factura final.

Los pagos por adelantado también ponen trabas a las mujeres que quieran cambiar de proveedor si no están satisfechas con la atención. En algunos casos, pueden hacer que las mujeres renuncien por completo a la atención prenatal, sobre todo en lugares donde existen pocas opciones de atención materna.

Es como “secuestrar el tratamiento”, afirmó Caitlin Donovan, directora de la Patient Advocate Foundation.

Expertos en facturación médica y salud de la mujer creen que las consultas de ginecología y obstetricia adoptaron esta práctica para gestionar el elevado costo de la atención materna y la forma en que se factura en Estados Unidos.

Cuando un embarazo llega a término, los ginecólogos y obstetras suelen presentar un único reclamo al seguro por los cuidados prenatales rutinarios, el trabajo de parto, el parto y, a menudo, la atención posparto. Esta práctica de agrupar toda la atención materna en un único código de facturación comenzó hace tres décadas, según Lisa Satterfield, directora de salud y política de pagos del American College of Obstetricians and Gynecologists. Sin embargo, la facturación agrupada ha quedado obsoleta.

Antes, las pacientes embarazadas estaban sujetas a copagos por cada visita prenatal, lo que podía llevarlas a saltarse citas cruciales para ahorrar dinero. Pero ahora la Ley de Cuidado de Salud a Bajo Precio (ACA) exige que todas las aseguradoras comerciales cubran íntegramente determinados servicios prenatales. Además, cada vez es más frecuente que las embarazadas cambien de proveedor o que diferentes proveedores se encarguen de la atención prenatal y el parto, sobre todo en las zonas rurales, donde son frecuentes los traslados de pacientes.

Algunos proveedores afirman que los pagos por adelantado les permiten repartir los pagos únicos a lo largo del embarazo para asegurarse de que se los compensa por la atención que prestan, aunque finalmente no atiendan el parto.

“Desgraciadamente hay personas que no cobran por su trabajo”, afirmó Pamela Boatner, partera en un hospital de Georgia.

Aunque cree que las mujeres deben recibir atención durante el embarazo independientemente de su capacidad de pago, también entiende que algunos proveedores quieran asegurarse de que no se ignora su factura después de que nazca el bebé. Los nuevos padres pueden verse desbordados por las facturas del hospital y los costos de cuidar a un nuevo hijo, y pueden no tener ingresos suficientes si uno de los progenitores no trabaja, explicó Boatner.

En Estados Unidos, tener un bebé puede resultar caro. Las personas que están cubiertas por un seguro médico a través de grandes empresas pagan un promedio de unos $3.000 de su bolsillo por los cuidados durante el embarazo, el parto y el posparto, según el Peterson-KFF Health System Tracker. Además, muchos optan por planes médicos con deducibles elevados, lo que les obliga a asumir una mayor parte de los costos. De los 100 millones de estadounidenses con deudas médicas, el 12% atribuye al menos parte de ellas a los cuidados de maternidad, según una encuesta de KFF de 2022.

Las familias necesitan tiempo para ahorrar y poder así hacer frente a los elevados costos del embarazo, el parto y el cuidado de los hijos, en especial si no tienen licencia por maternidad remunerada, dijo Joy Burkhard, CEO del Policy Center for Maternal Mental Health, un think tank con sede en Los Angeles. Pedirles que paguen por adelantado “es un golpe bajo”, agregó. “¿Y si no tienes dinero? ¿Lo cargas a tarjetas de crédito y esperas que funcione?”.

Calcular los costos finales del parto depende de múltiples factores, como el momento del embarazo, las prestaciones del plan y las complicaciones de salud, afirmó Erin Duffy, investigadora de políticas de salud del Centro Schaeffer de Política y Economía de la Salud de la Universidad del Sur de California. La factura final para la paciente no está clara hasta que el plan de salud decide qué parte cubrirá, explicó.

Pero a veces se elimina la opción de esperar a la aseguradora.

Durante el primer embarazo de Jamie Daw, en 2020, su ginecólogo-obstetra aceptó su negativa a pagar por adelantado porque Daw quería ver la factura final. Pero en 2023, durante su segundo embarazo, en una consulta privada de obstetricia de Nueva York le dijeron que, como tenía un plan con deducible alto, era obligatorio pagar $2.000, en pagos mensuales.

Daw, investigadora de políticas de salud en la Universidad de Columbia, dio a luz en septiembre de 2023 y recibió un cheque de reembolso ese noviembre por $640 para cubrir la diferencia entre la estimación y la factura final.

“Yo me dedico a estudiar los seguros de salud”, dijo. “Pero una no se imagina lo enormemente complicado que es cuando lo vives en persona”.

Aunque ACA obliga a las aseguradoras a cubrir algunos servicios prenatales, no prohíbe a los proveedores enviar la factura final a los pacientes antes de tiempo. Sería un reto político y práctico para los gobiernos estatales y federal intentar regular el momento de la solicitud de pago, señaló Sabrina Corlette, codirectora del Centro de Reformas de Seguros de Salud de la Universidad de Georgetown. Los grupos de presión médicos son poderosos y los contratos entre aseguradoras y proveedores médicos están protegidos por derechos de propiedad intelectual.

Debido a la zona gris legal, Lacy Marshall, corredora de seguros de Rapha Health and Life en Texas, aconseja a sus clientes que pregunten a la aseguradora si pueden negarse a pagar por adelantado su deducible. Algunos planes prohíben a los proveedores de su red exigir el pago por adelantado.

Si la aseguradora les dice que pueden negarse a pagar por adelantado, Marshall les recomienda a los clientes establecer una relación con una consulta antes de negarse a pagar, de modo que el proveedor no pueda rechazar el tratamiento.

Clark dijo que alcanzó el deducible de su seguro después de pagar las pruebas genéticas, las ecografías adicionales y otros servicios con su cuenta de salud de gastos flexibles. Entonces llamó a la consulta de su ginecólogo y pidió que le devolvieran el dinero.

“Perdí el miedo”, dijo Clark, que antes había trabajado en una aseguradora de salud y en un consultorio médico. Recibió un primer cheque por la mitad de los $960 que había pagado inicialmente.

En agosto, Clark fue trasladada al hospital después que su presión arterial se disparara. Un especialista en embarazos de alto riesgo, y no su ginecólogo-obstetra original, atendió el parto prematuro de su hijo Peter mediante cesárea de urgencia a las 30 semanas de embarazo.

Hasta que no resolvió la mayoría de las facturas del parto no recibió el resto del reembolso de la otra consulta de ginecología y obstetricia.

El último cheque llegó en octubre, pocos días después de que Clark saliera del hospital con Peter para llevarlo a su hogar y tras múltiples llamadas a la consulta. Dijo que todo eso sumó estrés a un período ya de por sí estresante.

“¿Por qué tengo que pagar el precio como paciente?”, se preguntó. “Sólo intento tener un bebé”.

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In April, just 12 weeks into her pregnancy, Kathleen Clark was standing at the receptionist window of her OB-GYN’s office when she was asked to pay $960, the total the office estimated she would owe after she delivered.

Clark, 39, was shocked that she was asked to pay that amount during this second prenatal visit. Normally, patients receive the bill after insurance has paid its part, and for pregnant women that’s usually only when the pregnancy ends. It would be months before the office filed the claim with her health insurer.

Clark said she felt stuck. The Cleveland, Tennessee, obstetrics practice was affiliated with a birthing center where she wanted to deliver. Plus, she and her husband had been wanting to have a baby for a long time. And Clark was emotional, because just weeks earlier her mother had died.

“You’re standing there at the window, and there’s people all around, and you’re trying to be really nice,” recalled Clark, through tears. “So, I paid it.”

On online baby message boards and other social media forums, pregnant women say they are being asked by their providers to pay out-of-pocket fees earlier than expected. The practice is legal, but patient advocacy groups call it unethical. Medical providers argue that asking for payment up front ensures they get compensated for their services.

How frequently this happens is hard to track because it is considered a private transaction between the provider and the patient. Therefore, the payments are not recorded in insurance claims data and are not studied by researchers.

Patients, medical billing experts, and patient advocates say the billing practice causes unexpected anxiety at a time of already heightened stress and financial pressure. Estimates can sometimes be higher than what a patient might ultimately owe and force people to fight for refunds if they miscarry or the amount paid was higher than the final bill.

Up-front payments also create hurdles for women who may want to switch providers if they are unhappy with their care. In some cases, they may cause women to forgo prenatal care altogether, especially in places where few other maternity care options exist.

It’s “holding their treatment hostage,” said Caitlin Donovan, a senior director at the Patient Advocate Foundation.

Medical billing and women’s health experts believe OB-GYN offices adopted the practice to manage the high cost of maternity care and the way it is billed for in the U.S.

When a pregnancy ends, OB-GYNs typically file a single insurance claim for routine prenatal care, labor, delivery, and, often, postpartum care. That practice of bundling all maternity care into one billing code began three decades ago, said Lisa Satterfield, senior director of health and payment policy at the American College of Obstetricians and Gynecologists. But such bundled billing has become outdated, she said.

Previously, pregnant patients had been subject to copayments for each prenatal visit, which might lead them to skip crucial appointments to save money. But the Affordable Care Act now requires all commercial insurers to fully cover certain prenatal services. Plus, it’s become more common for pregnant women to switch providers, or have different providers handle prenatal care, labor, and delivery — especially in rural areas where patient transfers are common.

Some providers say prepayments allow them to spread out one-time payments over the course of the pregnancy to ensure that they are compensated for the care they do provide, even if they don’t ultimately deliver the baby.

“You have people who, unfortunately, are not getting paid for the work that they do,” said Pamela Boatner, who works as a midwife in a Georgia hospital.

While she believes women should receive pregnancy care regardless of their ability to pay, she also understands that some providers want to make sure their bill isn’t ignored after the baby is delivered. New parents might be overloaded with hospital bills and the costs of caring for a new child, and they may lack income if a parent isn’t working, Boatner said.

In the U.S., having a baby can be expensive. People who obtain health insurance through large employers pay an average of nearly $3,000 out-of-pocket for pregnancy, childbirth, and postpartum care, according to the Peterson-KFF Health System Tracker. In addition, many people are opting for high-deductible health insurance plans, leaving them to shoulder a larger share of the costs. Of the 100 million U.S. people with health care debt, 12% attribute at least some of it to maternity care, according to a 2022 KFF poll.

Families need time to save money for the high costs of pregnancy, childbirth, and child care, especially if they lack paid maternity leave, said Joy Burkhard, CEO of the Policy Center for Maternal Mental Health, a Los Angeles-based policy think tank. Asking them to prepay “is another gut punch,” she said. “What if you don’t have the money? Do you put it on credit cards and hope your credit card goes through?”

Calculating the final costs of childbirth depends on multiple factors, such as the timing of the pregnancy, plan benefits, and health complications, said Erin Duffy, a health policy researcher at the University of Southern California’s Schaeffer Center for Health Policy and Economics. The final bill for the patient is unclear until a health plan decides how much of the claim it will cover, she said.

But sometimes the option to wait for the insurer is taken away.

During Jamie Daw’s first pregnancy in 2020, her OB-GYN accepted her refusal to pay in advance because Daw wanted to see the final bill. But in 2023, during her second pregnancy, a private midwifery practice in New York told her that since she had a high-deductible plan, it was mandatory to pay $2,000 spread out with monthly payments.

Daw, a health policy researcher at Columbia University, delivered in September 2023 and got a refund check that November for $640 to cover the difference between the estimate and the final bill.

“I study health insurance,” she said. “But, as most of us know, it’s so complicated when you’re really living it.”

While the Affordable Care Act requires insurers to cover some prenatal services, it doesn’t prohibit providers from sending their final bill to patients early. It would be a challenge politically and practically for state and federal governments to attempt to regulate the timing of the payment request, said Sabrina Corlette, a co-director of the Center on Health Insurance Reforms at Georgetown University. Medical lobbying groups are powerful and contracts between insurers and medical providers are proprietary.

Because of the legal gray area, Lacy Marshall, an insurance broker at Rapha Health and Life in Texas, advises clients to ask their insurer if they can refuse to prepay their deductible. Some insurance plans prohibit providers in their network from requiring payment up front.

If the insurer says they can refuse to pay up front, Marshall said, she tells clients to get established with a practice before declining to pay, so that the provider can’t refuse treatment.

Clark said she met her insurance deductible after paying for genetic testing, extra ultrasounds, and other services out of her health care flexible spending account. Then she called her OB-GYN’s office and asked for a refund.

“I got my spine back,” said Clark, who had previously worked at a health insurer and a medical office. She got an initial check for about half the $960 she originally paid.

In August, Clark was sent to the hospital after her blood pressure spiked. A high-risk pregnancy specialist — not her original OB-GYN practice — delivered her son, Peter, prematurely via emergency cesarean section at 30 weeks.

It was only after she resolved most of the bills from the delivery that she received the rest of her refund from the other OB-GYN practice.

This final check came in October, just days after Clark brought Peter home from the hospital, and after multiple calls to the office. She said it all added stress to an already stressful period.

“Why am I having to pay the price as a patient?” she said. “I’m just trying to have a baby.”

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The United States has made almost no progress in closing racial health disparities despite promises, research shows. The government, some critics argue, is often the underlying culprit.

KFF Health News undertook a yearlong examination of how government decisions undermine Black health — reviewing court and inspection records and government reports, and interviewing dozens of academic researchers, doctors, politicians, community leaders, grieving moms, and patients. 

During the past two decades there have been 1.63 million excess deaths among Black Americans relative to white Americans. That represents a loss of more than 80 million years of life, according to a 2023 JAMA study.

The video features senior correspondents Fred Clasen-Kelly and Renuka Rayasam, along with Morris Brown, a family care physician in Kingstree, South Carolina.

Learn more about the “Systemic Sickness” series here.

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Many scientists at the federal health agencies await the second Donald Trump administration with dread as well as uncertainty over how the president-elect will reconcile starkly different philosophies among the leaders of his team.

Trump has promised he would allow Robert F. Kennedy Jr. to “go wild” on medicines, food, and health. With that, a radical antiestablishment medical movement with roots in past centuries could threaten the achievements of a science-based public health order painstakingly built since World War II, some of these scientists fear.

If Kennedy makes good on his vision for transforming public health, childhood vaccine mandates could wither. New vaccines might never win approval, even as the FDA allows dangerous or inefficient therapies onto the market. Agency websites could trumpet unproven or debunked health ideas. And if Trump’s plan to weaken civil service rights goes through, anyone who questions these decisions could be summarily fired.

“Never has anybody like RFK Jr. gotten anywhere close to the position he may be in to actually shape policy,” said Lewis Grossman, a law professor at American University and the author of “Choose Your Medicine,” a history of U.S. public health.

Kennedy and an adviser Calley Means, a health care entrepreneur, say dramatic changes are needed because of the high levels of chronic disease in the United States. Government agencies have corruptly tolerated or promoted unhealthy diets and dangerous drugs and vaccines, they say.

Means and Kennedy did not respond to requests for comment. Four conservative members of the first Trump health bureaucracy spoke on condition of anonymity. They eagerly welcomed the former president’s return but voiced few opinions about specific policies. Days after last week’s election, RFK Jr. announced that the Trump administration would immediately fire and replace 600 National Institutes of Health officials. He set up a website seeking crowdsourced nominees for federal appointments, with a host of vaccination foes and chiropractors among the early favorites.

At meetings last week at Mar-a-Lago involving Elon Musk, Tucker Carlson, Donald Trump Jr., Kennedy, and Means, according to Politico, some candidates for leading health posts included Jay Bhattacharya, a Stanford University scientist who opposed covid lockdowns; Florida Surgeon General Joseph Ladapo, who opposes mRNA covid vaccines and rejected well-established disease control practices during a measles outbreak; Johns Hopkins University surgeon Marty Makary; and Means’ sister, Stanford-trained surgeon and health guru Casey Means.

All are mavericks of a sort, though their ideas are not uniform. Yet the notion that they could elbow aside a century of science-based health policy is profoundly troubling to many health professionals. They see Kennedy’s presence at the heart of the Trump transition as a triumph of the “medical freedom” movement, which arose in opposition to the Progressive Era idea that experts should guide health care policy and practices.

It could represent a turning away from the expectation that mainstream doctors be respected for their specialized knowledge, said Howard Markel, an emeritus professor of pediatrics and history at the University of Michigan, who began his clinical career treating AIDS patients and ended it after suffering a yearlong bout of long covid.

“We’ve gone back to the idea of ‘every man his own doctor,’” he said, referring to a phrase that gained currency in the 19th century. It was a bad idea then and it’s even worse now, he said.

“What does that do to the morale of scientists?” Markel asked. The public health agencies, largely a post-WWII legacy, are “remarkable institutions, but you can screw up these systems, not just by defunding them but by deflating the true patriots who work in them.”

FDA Commissioner Robert Califf told a conference on Nov. 12 that he worried about mass firings at the FDA. “I’m biased, but I feel like the FDA is sort of at peak performance right now,” he said. At a conference the next day, CDC Director Mandy Cohen reminded listeners of the horrors of vaccine-preventable diseases like measles and polio. “I don’t want to have to see us go backward in order to remind ourselves that vaccines work,” she said.

Exodus From the Agencies?

With uncertainty over the direction of their agencies, many older scientists at the NIH, FDA, and Centers for Disease Control and Prevention are considering retirement, said a senior NIH scientist who spoke on the condition of anonymity for fear of losing his job.

“Everybody I talk to sort of takes a deep breath and says, ‘It doesn’t look good,’” the official said.

“I hear of many people getting CVs ready,” said Arthur Caplan, a professor of bioethics at New York University. They include two of his former students who now work at the FDA, Caplan said.

Others, such as Georges Benjamin, executive director of the American Public Health Association, have voiced wait-and-see attitudes. “We worked with the Trump administration last time. There were times things worked reasonably well,” he said, “and times when things were chaotic, particularly during covid.” Any wholesale deregulation efforts in public health would be politically risky for Trump, he said, because when administrations “screw things up, people get sick and die.”

At the FDA, at least, “it’s very hard to make seismic changes,” former FDA chief counsel Dan Troy said.

But the administration could score easy libertarian-tinged wins by, for example, telling its new FDA chief to reverse the agency’s refusal to approve the psychedelic drug MDMA from the company Lykos. Access to psychedelics to treat post-traumatic stress disorder has grabbed the interest of many veterans. Vitamins and supplements, already only lightly regulated, will probably get even more of a free pass from the next Trump FDA.

‘Medical Freedom’ or ‘Nanny State‘

Trump’s health influencers are not monolithic. Analysts see potential clashes among Kennedy, Musk, and more traditional GOP voices. Casey Means, a “holistic” MD at the center of Kennedy’s “Make America Healthy Again” team, calls for the government to cut ties with industry and remove sugar, processed food, and toxic substances from American diets. Republicans lampooned such policies as exemplifying a “nanny state” when Mike Bloomberg promoted them as mayor of New York City.

Both the libertarian and “medical freedom” wings oppose aspects of regulation, but Silicon Valley biotech supporters of Trump, like Samuel Hammond of the Foundation for American Innovation, have pressed the agency to speed drug and device approvals, while Kennedy’s team says the FDA and other agencies have been “captured” by industry, resulting in dangerous and unnecessary drugs, vaccines, and devices on the market.

Kennedy and Casey Means want to end industry user fees that pay for drug and device rules and support nearly half the FDA’s $7.2 billion budget. It’s unclear whether Congress would make up the shortfall at a time when Trump and Musk have vowed to slash government programs. User fees are set by laws Congress passes every five years, most recently in 2022.

The industry supports the user-fee system, which bolsters FDA staffing and speeds product approvals. Writing new rules “requires an enormous amount of time, effort, energy, and collaboration” by FDA staff, Troy said. Policy changes made through informal “guidance” alone are not binding, he added.

Kennedy and the Means siblings have suggested overhauling agricultural policies so that they incentivize the cultivation of organic vegetables instead of industrial corn and soy, but “I don’t think they’ll be very influential in that area,” Caplan said. “Big Ag is a powerful entrenched industry, and they aren’t interested in changing.”

“There’s a fine line between the libertarian impulse of the ‘medical freedom’ types and advocating a reformation of American bodies, which is definitely ‘nanny state’ territory,” said historian Robert Johnston of the University of Illinois-Chicago.

Specific federal agencies are likely to face major changes. Republicans want to trim the NIH’s 27 research institutes and centers to 15, slashing Anthony Fauci’s legacy by splitting the National Institute of Allergy and Infectious Diseases, which he led for 38 years, into two or three pieces.

Numerous past attempts to slim down the NIH have failed in the face of campaigns by patients, researchers, and doctors. GOP lawmakers have advocated substantial cuts to the CDC budget in recent years, including an end to funding gun violence, climate change, and health equity research. If carried out, Project 2025, a policy blueprint from the conservative Heritage Foundation, would divide the agency into data-collecting and health-promoting arms. The CDC has limited clout in Washington, although former CDC directors and public health officials are defending its value.

“It would be surprising if CDC wasn’t on the radar” for potential change, said Anne Schuchat, a former principal deputy director of the agency, who retired in 2021.

The CDC’s workforce is “very employable” and might start to look for other work if “their area of focus is going to be either cut or changed,” she said.

Kennedy’s attacks on HHS and its agencies as corrupted tools of the drug industry, and his demands that the FDA allow access to scientifically controversial drugs, are closely reminiscent of the 1970s campaign by conservative champions of Laetrile, a dangerous and ineffective apricot-pit derivative touted as a cancer treatment. Just as Kennedy championed off-patent drugs like ivermectin and hydroxychloroquine to treat covid, Laetrile’s defenders claimed that the FDA and a profit-seeking industry were conspiring to suppress a cheaper alternative.

The public and industry have often been skeptical of health regulatory agencies over the decades, Grossman said. The agencies succeed best when they are called in to fix things — particularly after bad medicine kills or damages children, he said.

The 1902 Biologics Control Act, which created the NIH’s forerunner, was enacted in response to smallpox vaccine contamination that killed at least nine children in Camden, New Jersey. Child poisonings linked to the antifreeze solvent for a sulfa drug prompted the modern FDA’s creation in 1938. The agency, in 1962, acquired the power to demand evidence of safety and efficacy before the marketing of drugs after the thalidomide disaster, in which children of pregnant women taking the anti-nausea drug were born with terribly malformed limbs.

If vaccination rates plummet and measles and whooping cough outbreaks proliferate, babies could die or suffer brain damage. “It won’t be harmless for the administration to broadly attack public health,” said Alfredo Morabia, a professor of epidemiology at Columbia University and the editor-in-chief of the American Journal of Public Health. “It would be like taking away your house insurance.”

Sam Whitehead, Stephanie Armour, and David Hilzenrath contributed to this report.

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Científicos de las agencias federales de salud esperan la segunda administración de Donald Trump con incertidumbre y temor, preguntándose cómo el presidente electo conciliará filosofías radicalmente diferentes entre los líderes de su equipo.

Trump anunció hace pocos días que nominará a Robert F. Kennedy Jr. (RFK) como secretario del Departamento de Salud y Servicios Humanos (HHS), después de decir durante la campaña presidencial que dejaría que el activista antivacunas implementase “sus locuras” en materia de medicamentos, alimentos y salud.

Si el Senado confirma a Kennedy, sus críticos dicen que un movimiento médico radical antisistema, con raíces en siglos pasados, tomaría el poder, amenazando los logros de un orden de salud pública basado en la ciencia y construido con esfuerzo desde la Segunda Guerra Mundial.

Trump dijo en un post en la red social X que “los estadounidenses han sido aplastados por el complejo industrial alimentario y las compañías farmacéuticas que se han dedicado al engaño, la información falsa y la desinformación cuando se trata de salud pública”, haciéndose eco de las quejas de Kennedy sobre el establishment médico.

RFK, ex candidato presidencial demócrata, “acabará con la epidemia de enfermedades crónicas” y “¡Hará que Estados Unidos vuelva a ser grande y saludable!”, escribió Trump.

Las acciones de los fabricantes de vacunas cayeron en medio de las noticias previas al anuncio de Trump sobre RFK.

Si Kennedy hace realidad su visión de transformar la salud pública, los mandatos de vacunación infantil podrían debilitarse. Las nuevas vacunas podrían no ser aprobadas nunca, incluso si la Administración de Alimentos y Medicamentos (FDA) permite la comercialización de terapias peligrosas o ineficaces.

Los sitios web de la agencia podrían diseminar ideas sobre la salud no probadas o desacreditadas. Y si el plan de Trump de socavar los derechos de los funcionarios sigue adelante, cualquiera que cuestione estas decisiones podría ser despedido de inmediato.

“Nunca nadie como RFK Jr. se había acercado a la posición en la que podría estar para dar forma real a estas políticas”, dijo Lewis Grossman, profesor de Leyes en la American University y autor de “Choose Your Medicine”, una historia de la salud pública estadounidense.

Kennedy y su asesor Calley Means, un empresario del sector de la salud, afirman que se necesitan cambios drásticos debido a los altos niveles de enfermedades crónicas en Estados Unidos. Según ellos, las agencias gubernamentales han tolerado o promovido, de forma corrupta, dietas poco saludables, y medicamentos y vacunas peligrosos.

Means y Kennedy no respondieron a las solicitudes de comentarios. Cuatro miembros conservadores que formaron parte de la primera burocracia de la salud de Trump hablaron bajo condición de anonimato.

Recibieron con entusiasmo el regreso del ex presidente, pero expresaron pocas opiniones sobre políticas específicas. Días después de las elecciones, RFK Jr. anunció que la administración Trump despediría y reemplazaría inmediatamente a 600 funcionarios de los Institutos Nacionales de Salud (NIH). Creó un sitio web en el que buscaba candidatos por crowdsourcing para nombramientos federales, con una gran cantidad de enemigos de las vacunas y quiroprácticos entre los primeros favoritos.

En reuniones celebradas recientemente en Mar-a-Lago, la residencia de Trump en Florida, en las que participaron Elon Musk, Tucker Carlson, Donald Trump Jr, Kennedy y Means, según Politico, entre los candidatos a los principales puestos en el área de salud estaba Jay Bhattacharya, un científico de la Universidad de Stanford que se opuso a los cierres durante covid. También el cirujano general de Florida, Joseph Ladapo, que se opone a las vacunas de ARNm contra covid-19 y rechazó prácticas de control de enfermedades bien establecidas durante un brote de sarampión; el cirujano de la Universidad Johns Hopkins Marty Makary; y la hermana de Means, la cirujana formada en Stanford y gurú de la salud Casey Means.

Todos ellos pueden ser calificados de inconformistas, aunque sus ideas no son uniformes. Sin embargo, la posibilidad de que puedan dejar de lado un siglo de políticas de salud basadas en la ciencia es profundamente preocupante para muchos profesionales. Ven la presencia de Kennedy en el corazón de la transición de Trump como un triunfo del movimiento de “libertad médica”, que surgió en oposición a la idea de la Era Progresista de que los expertos son los que deben guiar la política y las prácticas de atención de salud.

Podría representar un alejamiento de la expectativa de que los médicos convencionales sean respetados por sus conocimientos especializados, dijo Howard Markel, profesor emérito de pediatría e historia en la Universidad de Michigan, que comenzó su carrera clínica tratando a pacientes con sida y la terminó tras sufrir un año de covid de larga duración.

“Hemos vuelto a la idea de ‘cada uno es su médico’”, comentó, refiriéndose a una frase que se impuso en el siglo XIX. Era una mala idea entonces y es aún peor ahora, agregó.

“¿Cómo afectará eso a la moral de los científicos?”, se preguntó Markel. Las agencias de salud pública, en gran medida un legado posterior a la Segunda Guerra Mundial, son “instituciones notables, pero se pueden echar a perder estos sistemas, no sólo quitándoles financiación, sino desmoralizando a los verdaderos patriotas que trabajan en ellas”.

El Comisionado de la FDA, Robert Califf, declaró en una conferencia el 12 de noviembre que le preocupaban los despidos masivos en la agencia. “No soy imparcial, pero creo que la FDA está en una especie de pico de rendimiento en este momento”, expresó.

Al día siguiente, en una conferencia, la directora de los Centros para el Control y Prevención de Enfermedades (CDC), Mandy Cohen, recordó los horrores de las enfermedades prevenibles mediante vacunación, como el sarampión y la poliomielitis. “No quiero que tengamos que dar marcha atrás para recordarnos que las vacunas funcionan”, afirmó.

Las acciones de algunos de los principales fabricantes de vacunas cayeron después que los medios de comunicación, encabezados por Politico, informaran de que se esperaba la elección de RFK.

Moderna, creadora de una de las vacunas más populares contra covid-19, cerró con una baja del 5,6%. Pfizer, otro fabricante de vacunas contra covid, cayó un 2,6%. GSK, que produce la vacuna contra el virus respiratorio sincitial, la hepatitis A y B, el rotavirus y la gripe, cayó algo más del 2%. La farmacéutica francesa Sanofi, cuyo sitio web presume de que sus productos vacunan a más de 500 millones de personas al año, cayó casi un 3,5%.

¿Éxodo de las agencias?

Ante la incertidumbre sobre la dirección de sus agencias, muchos científicos de edad avanzada de los NIH, la FDA y los CDC consideran la posibilidad de jubilarse, contó un científico de alto nivel de los NIH que habló bajo condición de anonimato por temor a perder su trabajo.

“Todo el mundo con quien hablo respira hondo y dice: ‘Esto no pinta bien’”, explicó el funcionario.

“Sé de muchas personas que están preparando sus currículums”, dijo Arthur Caplan, profesor de bioética en la Universidad de Nueva York. Entre ellos se encuentran dos de sus antiguos alumnos que ahora trabajan en la FDA, dijo Caplan.

Otros, como Georges Benjamin, director ejecutivo de la American Public Health Association, han han dicho que esperarán y verán qué pasa. “Trabajamos con la administración Trump la última vez. Hubo momentos en que las cosas funcionaron razonablemente bien”, explicó, “y momentos en que las cosas fueron caóticas, particularmente durante covid”.

Cualquier esfuerzo de desregulación al por mayor en la salud pública sería políticamente arriesgado para Trump, señaló Benjamin, porque cuando las administraciones “arruinan las cosas, la gente se enferma y muere”.

En la FDA, al menos, “es muy difícil hacer cambios sísmicos”, dijo Dan Troy, ex consejero jefe de la FDA.

Pero la administración podría conseguir fáciles victorias de tinte libertario, por ejemplo, diciendo a su nuevo jefe de la FDA que revierta la negativa de la agencia a aprobar el fármaco psicodélico MDMA de la empresa Lykos. El acceso a los psicodélicos para tratar el trastorno de estrés postraumático ha despertado el interés de muchos veteranos.

Las vitaminas y los suplementos, que ya sólo están ligeramente regulados, probablemente recibirán aún más carta blanca de la próxima FDA de Trump.

Libertad médica o Estado niñera

Pero los “influencers” de la salud en la futura administración Trump no son monolíticos. Los analistas ven posibles enfrentamientos entre Kennedy, Musk y las voces más tradicionales del Partido Republicano.

Casey Means, un médico holístico en el centro del equipo “Make America Healthy Again” de Kennedy, pide que el gobierno corte los lazos con la industria y elimine el azúcar, los alimentos procesados y las sustancias tóxicas de las dietas estadounidenses. Los republicanos tacharon estas políticas de “Estado niñera” cuando Mike Bloomberg las promovió como alcalde de Nueva York.

Tanto el ala libertaria como el de la “libertad médica” se oponen a aspectos de la regulación. Pero los partidarios de la biotecnología de Silicon Valley que están con Trump, como Samuel Hammond de la Foundation for American Innovation, han presionado a la agencia para que acelere la aprobación de medicamentos y dispositivos. Mientras tanto, el equipo de Kennedy dice que la FDA y otras agencias han sido “capturadas” por la industria, lo que resulta en medicamentos, vacunas y dispositivos peligrosos e innecesarios en el mercado.

Es probable que algunos organismos federales sufran cambios importantes. Los republicanos quieren reducir los 27 institutos y centros de investigación de los NIH a 15, y recortar el legado de Anthony Fauci dividiendo el Instituto Nacional de Alergias y Enfermedades Infecciosas, que dirigió durante 38 años, en dos o tres partes.

Numerosos intentos anteriores de reducir los NIH han fracasado frente a las campañas de pacientes, investigadores y médicos.

Legisladores republicanos han defendido recortes sustanciales del presupuesto de los CDC en los últimos años, incluido el fin de la financiación de la investigación sobre la violencia con armas de fuego, el cambio climático y la equidad en salud. De llevarse a cabo el Proyecto 2025, un proyecto político de la conservadora Heritage Foundation, dividiría la agencia en dos ramas: la de recopilación de datos y la de promoción de la salud. Los CDC tiene una influencia limitada en Washington, aunque ex directores y funcionarios de salud pública defienden su valor.

“Me sorprendería que los CDC no estuvieran en el radar” de posibles cambios, dijo Anne Schuchat, ex subdirectora principal de la agencia, que se jubiló en 2021.

El personal de los CDC es “muy empleable” y podría empezar a buscar otro trabajo si “su área de interés va a ser recortada o modificada”, opinó Schuchat.

Los ataques de Kennedy contra el HHS y sus agencias como herramientas corruptas de la industria farmacéutica, y sus demandas de que la FDA permita el acceso a medicamentos científicamente controversiales, recuerdan mucho a la campaña de los años 70 por parte de los conservadores que defendían el Laetrile, un peligroso e ineficaz derivado de la semilla de albaricoque promocionado como tratamiento contra el cáncer.

Al igual que Kennedy defendió fármacos sin patente como la ivermectina y la hidroxicloroquina para tratar covid, los defensores del Laetrile afirmaron que la FDA y una industria con fines de lucro estaban conspirando para suprimir una alternativa más barata.

A lo largo de las décadas, el público y la industria se han mostrado escépticos ante las agencias reguladoras de la salud, afirmó Grossman. Los organismos tienen más éxito cuando se les pide que solucionen problemas, sobre todo cuando un medicamento defectuoso mata o lastima a un niño.

La Ley de Control Biológico de 1902, que creó el precursor de los NIH, se promulgó en respuesta a vacunas contra la viruela contaminadas que mataron al menos a nueve niños en Camden, Nueva Jersey. Las intoxicaciones infantiles relacionadas con el disolvente anticongelante de un medicamento con sulfamidas impulsaron la creación de la FDA moderna en 1938.

En 1962, la agencia adquirió la facultad de exigir pruebas de seguridad y eficacia antes de la comercialización de medicamentos tras el desastre de la talidomida, cuando los hijos de mujeres embarazadas que tomaban el medicamento contra las náuseas nacieron con extremidades terriblemente malformadas.

Si las tasas de vacunación caen en picada y proliferan los brotes de sarampión y tos ferina, los bebés podrían morir o sufrir daños cerebrales. “Sufriremos las consecuencias si la administración ataca abiertamente la salud pública”, afirmó Alfredo Morabia, catedrático de Epidemiología de la Universidad de Columbia y director del American Journal of Public Health. “Sería como quitarte el seguro de tu casa”.

Sam Whitehead, Stephanie Armour, David Hilzenrath y Darius Tahir colaboraron con este artículo.

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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Health researchers are noticing a growing problem in American pregnancies: more cases of blood pressure so high it can be deadly for the parent and baby.

U.S. rates of newly developed and chronic maternal high blood pressure skyrocketed from 2007 through 2019, and researchers say they haven’t slowed down. Hospitals are working to adjust their standards of care to match best practices.

Sara McGinnis died as a result of her pregnancy in 2018. Her Kalispell, Montana, medical team didn’t recognize her symptoms of rising high blood pressure: a severe headache, swollen body and fatigue beyond anything she’d experienced in her first pregnancy. She suffered a massive stroke and seizure late in pregnancy and never got to meet her son, who survived an emergency delivery.

McGinnis had eclampsia, a condition typically characterized by seizures late in pregnancy. The severe and sometimes deadly pregnancy complication generally develops from persistent high blood pressure. Rising blood pressure makes the heart work in overdrive, which damages organs along the way.

One reason for the big increase in cases is that more doctors are looking out for the condition. But that’s not enough to explain the increase in the nation’s overall maternal death rate.

Lifestyle and genetic factors play a role, but physician and health researcher Natalie Cameron, with Northwestern University’s Feinberg School of Medicine, said people who don’t have risk factors going into pregnancy are also getting sick more often. More research is needed to understand why.

“Pregnancy is a natural stress test. It’s unmasking this risk that was there all the time,” Cameron said. “And there’s a lot we don’t know.”

The federal government has worked for years to expand training in screening and treatment for severe high blood pressure in pregnancy. The nation’s best-practice guidelines go back to 2015.

Last year, the federal government boosted funding for training to expand implementation of best practices.

“So much of the disparity in this space is about women’s voices not being heard,” said Carole Johnson, head of the federal agency charged with improving access to health care.

But it takes time for hospitals to incorporate those kinds of changes, researchers said.

Take Montana, for example, which last year became one of 35 states to implement the federal patient safety guidelines. That year, more than two-thirds of hospitals in the state provided patients with timely care. Just over half of hospitals did so before the training.

Some hospitals had treatment plans for high blood pressure in pregnancy but found their doctors’ use was “hit or miss.” One health system found that even the way nurses checked pregnant patients’ blood pressure varied.

Wanda Nicholson, who chairs the independent U.S. Preventive Services Task Force, said blood pressure in pregnancy “can change in a matter of days, or in a 24-hour period.”

That’s why, she said, consistent monitoring for high blood pressure is key to keeping people safe.

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A new federal watchdog audit is ratcheting up pressure on government officials to crack down on billions of dollars in overcharges linked to Medicare Advantage home visits.

But so far, the Centers for Medicare & Medicaid Services has rejected a recommendation from the Health and Human Services Inspector General to limit payments stemming from house visits that don’t result in any medical treatment — a potential red flag that may signal overcharges.

In late October, the HHS watchdog found that the health plans pocketed $7.5 billion in 2023 from diagnosing health conditions that prompted no medical services — about $4.2 billion of it through health assessments done in patients’ homes. And court records show that for a decade or more, CMS officials have failed to act on their concerns that the home visits waste tax dollars and should be limited.

UnitedHealthcare, the largest Medicare Advantage contractor, accounted for about two-thirds of the payments tied to home visits and chart reviews, in which health plans mine patient medical files to add new diagnoses that can bring in additional revenue, according to the audit.

Assistant Inspector General Erin Bliss said the health plans are making billions without offering any treatment for medical conditions they flag during the visits, such as diabetes and major depression.

“Frankly, it needs to stop,” Bliss said.

CMS, which runs the Medicare program, disagrees.

In a statement to KFF Health News by spokesperson Alexx Pons, the agency said it “appreciates the OIG’s review in this area” and will continue to study the issue.

However, CMS disagreed with the OIG’s call to restrict use of home health assessments in computing how much to pay health plans. People on Medicare “should have access to care that is appropriately provided in the home setting,” CMS wrote in a written response included in the audit report.

“One would think that CMS would kick its regulatory oversight up a notch or two,” said Richard Lieberman, a Colorado health data analytics expert.

“In contrast, CMS appears to be unconcerned and is telling OIG to stay out of their lane,” he said.

UnitedHealthcare spokesperson Heather Soule said in a statement that the OIG had drawn “inaccurate conclusions” in the audit.

The home visits are “among the most comprehensive and thorough assessments of a patient’s health and physical environment available in the healthcare system, helping to identify and drive needed follow-on care for the vast majority of the patients with whom we engage,” according to the company.

No Care Provided

Government spending on Medicare Advantage, which is dominated by UnitedHealthcare and a handful of other health insurance companies, is expected to hit $462 billion this year.

The industry, whose more than 33 million members make up over half of people eligible for Medicare, argues that most enrollees are satisfied with the care they receive and typically pay less out-of-pocket than those on original Medicare.

Whether Medicare Advantage is a good deal for taxpayers is another matter, largely because many health plans exaggerate how sick patients are to boost their payments, multiple federal audits and other investigations have shown. Medicare pays the health plans higher rates for sicker patients.

For fiscal year 2023, CMS identified $12.7 billion in overpayments linked to diagnoses not supported by patients’ medical records.

The OIG audit tied $7.5 billion in payments to health conditions that prompted no treatment, including serious diseases such as diabetes, congestive heart failure, and major depression. That suggests that the medical condition either didn’t exist or that the health plan failed to treat it adequately, auditors said.

“These are serious conditions. You would think you would see additional care during that year,” said Jacqualine Reid, who led the OIG audit team. “We are asking CMS to step up its oversight.”

Homegrown

The in-home visits have sparked controversy for more than a decade. A June 2014 media investigation found that a sharp rise in home visits had inflated Medicare’s costs by billions of dollars. The visits, which typically last less than an hour, are often conducted by nurse practitioners, who do not treat the patient, but go over a checklist of possible health conditions.

Sabrina Skeldon, a Texas lawyer who advises physicians on billing issues, said problems arise when health plans fail to order necessary medical tests to confirm a diagnosis made during a home visit — and treat it.

Skeldon noted that The Cigna Group in 2023 paid $172 million to settle a whistleblower lawsuit that alleged its Medicare Advantage plan illegally collected payments for medical diagnoses that were based solely on in-home assessments.

The OIG audit comes as the Justice Department presses a civil fraud case that accuses UnitedHealth Group of cheating Medicare out of more than $2 billion by mining patient records to churn up diagnoses that boosted revenue, while ignoring evidence of overpayments. The company denies the allegations.

Court filings from the case show CMS officials were concerned years ago that home visits and chart reviews could needlessly drive up costs.

In April 2014, CMS backed off a proposal to restrict their use amid complaints from the industry that it would lose billions of dollars as a result. Similarly, CMS officials scrapped a proposal to tighten scrutiny on the chart reviews after what one official called an “uproar” from the industry.

CMS officials also had concerns that unchecked home visits might affect efforts to recover overpayments through billing reviews known as “RADV” audits.

Former CMS official Thomas Hutchinson, who ran the agency’s Medicare Plan Payment Group from September 2006 through June 2010, testified in a deposition that officials had “heard about various folks that figured out how they could RADV-proof things by doing in-home visits.”

In a confidential April 2015 slide presentation, CMS officials observed that health plans were “now conducting health risk assessments in beneficiaries’ homes. One purpose of the assessments is to identify conditions and create medical records documentation that substantiates diagnoses.”

And an October 2015 CMS memo circulated among senior agency staff cites “limitations around home visits” among the possible ways to “strengthen” the RADV audits.

In its statement to KFF Health News, CMS said it was “committed” to ensuring that diagnoses health plans submitted for payment were accurate. But the agency declined to answer written questions about the impact of home visits on its audit program, which has yet to complete reviews of payments dating back as far as 2011.

UnitedHealthcare had the lowest rates of unconfirmed diagnoses among five large Medicare Advantage organizations audited in 2011, according to court records.

Overall, the company ended up with underpayments of more than $261 million for 15 of its plans audited for 2011-2013, court records show. The audit findings for other Medicare Advantage firms are blacked out in court filings.

CMS audits payments to just 30 out of more than 700 contracts a year. That’s not enough to protect tax dollars, said Matthew Fiedler, a health policy researcher at The Brookings Institution.

“They should be auditing 10 times as many contracts,” he said. “Where we are now you are not likely to get caught.”

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HURON, S.D. — Kelly Engebretson was excited to get fitted for a prosthetic after having part of his leg amputated. But he wasn’t sure how he’d get to the appointment.

Nah Thu Thu Win’s twin sons needed vaccinations before starting kindergarten. But she speaks little English, and the boys lacked health insurance.

William Arce and Wanda Serrano were recovering from recent surgeries. But the couple needed help sorting out their insurance and understanding their bills.

Engebretson, Win, Arce, and Serrano were fortunate to have someone to help.

They’re all paired with community health workers in Huron, a city of 14,000 people known for being home to the state fair and what’s billed as the world’s largest pheasant sculpture.

Three workers, employed by the Huron Regional Medical Center, help patients navigate the health system and address barriers, like poverty or unstable housing, that could keep them from getting care. Community health workers can also provide basic education on managing chronic health problems, such as diabetes or high cholesterol.

Community health worker programs are spreading across the U.S., including in rural areas and small cities as health providers and state and federal governments increasingly invest in them. These initiatives gained attention during the coronavirus pandemic and have been found to improve people’s health and access to preventive care while reducing expensive hospital visits.

Community health worker programs can address common barriers in rural areas, where people face higher rates of poverty and certain health problems, said Gabriela Boscán Fauquier, who oversees community health worker initiatives at the National Rural Health Association.

The workers are “an extension of the health care system” and serve as a link “between the formality of this health care system and the community,” she said.

The programs are often based at hospital systems or community health centers. The workers have a median pay of $23 an hour, according to the federal Bureau of Labor Statistics. Patients are typically referred to programs by clinicians who notice personal struggles or frequent visits to hospital emergency departments.

South Dakota is among the states that have recently funded community health worker programs, developed training requirements for the workers, and approved Medicaid reimbursement for their services. The state’s certification program requires 200 hours of coursework and 40 hours of job shadowing.

Huron Regional Medical Center launched its initiative in fall 2022, after receiving a $228,000 federal grant. The program is now funded by the nonprofit hospital and Medicaid reimbursements.

Huron, a small city surrounded by rural areas, is mostly populated by white people. But thousands of Karen people — an ethnic minority from the Southeast Asian country of Myanmar — began arriving in 2006. Many are refugees. The city also has a significant Hispanic population from the Caribbean, Mexico, and Central and South America.

Mickie Scheibe, one of Huron’s community health workers, recently stopped by the house of client Kelly Engebretson. The 61-year-old hadn’t been able to work since he had part of his leg amputated, due to diabetes complications.

Scheibe helps with “the hoops you’ve got to jump through,” such as applying for Medicaid, Engebretson said.

He told Scheibe that he didn’t know how he was going to get to his prosthetic fitting in Sioux Falls — a two-hour drive from home. Scheibe, 54, said she would help find him a safe ride.

She also invited Engebretson to a diabetes education program.

“Put me down as a definitely absolutely,” he replied, adding that he’d invite his mother to tag along.

The same day, Scheibe’s co-worker Sau-Mei Ramos visited the apartment where William Arce and Wanda Serrano live. Arce was recovering from heart surgery, while Serrano was healing from knee and shoulder operations.

The couple, both 61, moved three years ago from Puerto Rico to be near their children in Huron. Ramos, who’s also from Puerto Rico, coordinated their appointments, answered their billing questions, and helped Arce find a walker and supplemental insurance.

Ramos, 29, handed Arce a pamphlet about heart health and asked him to read the section on angina, the pain that results when not enough blood flows to the heart.

“Qué entiende?” she said, asking Arce what he understood about his condition. Arce, speaking in Spanish, responded that he knew what angina was and what symptoms to watch for.

Later that day, Paw Wah Sa, the third community health worker in town, met with client Nah Thu Thu Win, who moved to Huron in February from Myanmar with her husband and twin 6-year-olds. The Win family, like Sa, are part of the local Karen community, whose people have been persecuted under the military rulers of Myanmar, the country formerly known as Burma.

Win, 29, had assumed the kids would qualify for Medicaid. But unlike most other states, South Dakota does not immediately offer coverage to children who legally immigrated into the U.S. The boys’ father hopes to eventually add them to his work-sponsored insurance.

Sa didn’t want the kids to have to wait for health care. The 24-year-old previously took the twins to a free mobile dental clinic in Huron. It turned out they needed more advanced dental work, which they could get free only in Sioux Falls. Sa helped make the arrangements.

Many Karen residents and people from rural parts of Latin America had little access to health care before moving to the U.S., Sa and Ramos said. They said a major part of their job is explaining what kind of care is available, and when it’s important to seek help.

The three community health workers sometimes take clients grocery shopping, to teach them how to understand labels and identify healthful food.

Boscán Fauquier, with the National Rural Health Association, said that because community health workers are familiar with the cultures they serve, they can suggest affordable food that clients are familiar with.

Rural America’s overall population is shrinking, but the 2020 census showed it has become more diverse as people representing ethnic minorities are drawn to jobs in industries such as farming, meatpacking, and mining. Others are attracted by rural areas’ lower crime rates and cheaper housing.

Boscán Fauquier said many rural community health worker programs serve people from minority groups, who are more likely than white people to face barriers to health care.

She pointed to programs serving Native American reservations, the Black Belt region of the South, and Spanish-speaking communities, where the workers are called promotoras. But community health workers also serve rural white communities, such as those in Appalachia impacted by the opioid crisis.

Medicare, the federal health program for adults 65 or older, has been reimbursing community health worker services since January. Boscán Fauquier said advocates hope more state Medicaid programs and private insurers will allow reimbursement too.

Engebretson said he’s happy to see community health workers across South Dakota, not just in big cities.

The more they “can branch out to the people, the better it would be,” he said.

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Dentro de los más de 600 hospitales católicos en todo el país, no se puede encontrar ni una sola monja ocupando una oficina ejecutiva, según la Catholic Health Association.

Las monjas fundaron y dirigieron esos hospitales con la misión de atender a personas enfermas y pobres, aunque algunas también eran líderes empresariales astutas. La hermana Irene Kraus, ex directora ejecutiva del Sistema Nacional de Salud de las Hijas de la Caridad, fue famosa por acuñar la frase “sin margen, no hay misión”. Esto significa que los hospitales deben tener éxito —generando suficientes ingresos para superar los gastos— para cumplir con su misión original.

La Iglesia Católica aún regula la atención que se brinda a millones de personas en estos hospitales cada año, usando directrices religiosas para prohibir abortos y limitar anticonceptivos, fertilización in vitro y asistencia médica para morir.

Pero con el tiempo, ese enfoque en los márgenes llevó a los hospitales a transformarse en gigantes que operan subsidiarias con fines de lucro y pagan millones a sus ejecutivos, según informes fiscales de los propios hospitales. Estas instituciones, algunas de las cuales son empresas lucrativas, ahora se parecen más a otras megacorporaciones que a las organizaciones benéficas que supieron ser.

La ausencia de monjas en los cargos principales plantea la pregunta, dijo M. Therese Lysaught, teóloga moral católica y profesora de la Universidad Loyola en Chicago: “¿Qué significa ser un hospital católico cuando la empresa se ha comercializado tan profundamente?”.

El área de St. Louis sirve como la capital de facto de los sistemas de hospitales católicos. Es hogar de tres de los más grandes, junto con el brazo de cabildeo de hospitales católicos. El catolicismo está profundamente arraigado en la cultura de la región. Durante la única visita del Papa Juan Pablo II a Estados Unidos en 1999, celebró una misa en el centro de la ciudad en un estadio lleno con más de 100,000 personas.

Durante un cuarto de siglo, la hermana Mary Jean Ryan dirigió SSM Health, uno de esos sistemas gigantes con sede en St. Louis. Ahora retirada, a sus 86 años, dijo que fue una de las últimas monjas en el país en liderar un sistema de hospitales católicos.

Ryan creció en una familia católica en Wisconsin y se unió a un convento mientras estudiaba enfermería en los años 60, sorprendiendo a su familia. Admiraba a las monjas con las que trabajaba y sentía que estaban viviendo un propósito superior.

“Eran muy impresionantes”, dijo. “No es que necesariamente me gustaran todas”.

De hecho, las monjas que dirigían hospitales desafiaban la imagen simplificada que a menudo se les atribuye, escribió John Fialka en su libro “Sisters: Catholic Nuns and the Making of America”.

“Sus contribuciones a la cultura estadounidense no son pequeñas”, escribió. “Mujeres ambiciosas que tenían las habilidades y la resistencia para construir y dirigir grandes instituciones encontraron en el convento la primera y, durante mucho tiempo, la única vía para desarrollar sus talentos”.

Esto fue muy cierto para Ryan, quien ascendió de enfermera a directora ejecutiva de SSM Health, que hoy tiene hospitales en Illinois, Missouri, Oklahoma y Wisconsin.

El sistema se fundó hace más de un siglo cuando cinco monjas alemanas llegaron a St. Louis con $5. La viruela azotaba la ciudad y las Hermanas de Santa María caminaban por las calles ofreciendo atención gratuita a los enfermos.

Sus esfuerzos iniciales crecieron hasta convertirse en uno de los sistemas de salud católicos más grandes del país, con ingresos anuales que superan los $10 mil millones, según una auditoría de 2023. SSM Health atiende a pacientes en 23 hospitales y es co-propietaria de una gerenciadora de beneficios farmacéuticos con fines de lucro, Navitus, que coordina recetas para 14 millones de personas.

Pero Ryan, como muchas monjas en roles de liderazgo en décadas recientes, se enfrentó a una crisis existencial. A medida que menos mujeres se convertían en monjas, tuvo que asegurar el futuro del sistema sin ellas.

Cuando Ron Levy, quien es judío, comenzó como administrador en SSM, se negó a dirigir una oración en una reunión, recordó Ryan en su libro “On Becoming Exceptional”.

“Ron, no te estoy pidiendo que seas católico”, recordó diciéndole. “Y sé que solo llevas dos semanas aquí. Así que, si te gustaría que fueran tres, te sugiero que estés preparado para orar la próxima vez que te lo pidan”.

Levy trabajó en SSM por más de 30 años, rezando desde entonces, escribió Ryan.

En los hospitales católicos, las reuniones aún suelen comenzar con una oración. Los crucifijos adornan los edificios y las habitaciones de los pacientes. Las declaraciones sobre su misión en las paredes de las instalaciones de SSM recuerdan a los pacientes: “Revelamos la presencia sanadora de Dios”.

Por encima de todo, la fe católica llama a sus hospitales a tratar a todos, independientemente de su raza, religión o capacidad de pago, dijo Diarmuid Rooney, vicepresidente de la Catholic Health Association. Ninguna monja dirige los hospitales  miembros del grupo de cabildeo, según el grupo. Pero la misión que motivó a las monjas es “lo que nos motiva ahora”, dijo Rooney. “No son solo palabras en una pared”.

La Catholic Health Association insta a sus hospitales a autoevaluarse cada tres años sobre si están cumpliendo con las enseñanzas católicas. Creó una herramienta que evalúa siete criterios, incluyendo cómo un hospital actúa como extensión de la iglesia y atiende a pacientes pobres y marginados.

“No nos basamos en rumores sobre si la identidad católica está viva y bien en nuestras instalaciones y hospitales”, dijo Rooney. “Realmente podemos ver en una escala dónde se encuentran”.

La asociación no comparte los resultados con el público.

En SSM Health, “nuestra identidad católica está profunda y estructuralmente arraigada” incluso sin una monja a la cabeza, dijo el vocero Patrick Kampert. El sistema reporta a dos juntas. Una funciona como una típica junta directiva empresarial, mientras que la otra asegura que el sistema cumpla con las reglas de la Iglesia Católica. La iglesia requiere que la mayoría de esa junta de nueve miembros sea católica. Tres monjas sirven actualmente en ella; una es la presidenta.

Kampert explicó que, por separado, SSM también debe presentar un informe anual al Vaticano detallando la forma en que “profundizamos nuestra identidad católica y avanzamos el ministerio de sanación de Jesús”. SSM declinó proporcionar copias de esos informes.

Desde una perspectiva empresarial, sin embargo, es difícil distinguir un sistema de hospitales católicos como SSM de uno secular, dijo Ruth Hollenbeck, ex ejecutiva de Anthem que se retiró en 2018 tras negociar contratos de hospitales en Missouri. En los contratos, dijo, la diferencia se reducía a un solo párrafo que decía que los hospitales católicos no harían nada contrario a las directrices de la iglesia.

Para retener el estatus de exención de impuestos bajo las reglas del IRS, todos los hospitales sin fines de lucro deben proporcionar un “beneficio” a sus comunidades, como atención gratuita o a precio reducido para pacientes con bajos ingresos. Pero el IRS ofrece una definición amplia de lo que constituye un beneficio comunitario, lo que permite a los hospitales justificar su exención de impuestos.

En promedio, los hospitales sin fines de lucro del país reportaron que el 15,5% de sus gastos anuales en 2020 se destinaron a beneficios comunitarios, según la Asociación Americana de Hospitales.

SSM Health, incluyendo todas sus subsidiarias, destinó proporcionalmente mucho menos que el promedio de la asociación para hospitales individuales, asignando aproximadamente la misma proporción de sus gastos anuales a esfuerzos comunitarios durante tres años: 5.1% en 2020, 4.5% en 2021 y 4.9% en 2022, según un análisis de KFF Health News de sus declaraciones de impuestos e informes financieros auditados más recientes.

Un análisis separado del grupo de expertos Lown Institute colocó a cinco sistemas católicos —incluido Ascension en la región de St. Louis— en su lista de los 10 sistemas de salud con los mayores déficits de “cuota justa”, lo que significa que reciben más exenciones fiscales de lo que gastan en la comunidad.

Y Lown dijo que tres sistemas de salud católicos de la zona de St. Louis —Ascension, SSM Health y Mercy— tuvieron déficits de cuota justa de $614 millones, $235 millones y $92 millones, respectivamente, en el año fiscal 2021.

Ascension, Mercy y SSM cuestionaron la metodología de Lown, argumentando que no toma en cuenta la diferencia entre los pagos que reciben por los pacientes de Medicaid y el costo de atenderlos. Las declaraciones de impuestos del IRS sí lo hacen.

Sin embargo, Kampert dijo que muchos de los beneficios que SSM brinda no están reflejados en sus declaraciones de impuestos del IRS. Los formularios reflejan “cálculos muy simplistas” y no representan con precisión el verdadero impacto del sistema de salud en la comunidad, observó.

Hoy en día, SSM Health es dirigido por la veterana ejecutiva Laura Kaiser. Su compensación en 2022 fue de $8.4 millones, incluyendo pagos diferidos, según su declaración de impuestos del IRS. Kampert defendió la cantidad como necesaria “para retener y atraer al candidato más calificado”.

En contraste, SSM nunca le pagó un salario a Ryan, otorgando en su lugar una contribución anual a su convento de menos de $2 millones al año, según algunas declaraciones fiscales de su largo mandato. “No ingresé al convento para ganar dinero”, aclaró Ryan.

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Becky Carroll was missing a few teeth, and others were stained or crooked. Ashamed, she smiled with lips pressed closed. Her dentist offered to fix most of her teeth with root canals and crowns, Carroll said, but she was wary of traveling a long road of dental work.

Then Carroll saw a TV commercial for another path: ClearChoice Dental Implant Centers. The company advertises that it can give patients “a new smile in as little as one day” by surgically replacing teeth instead of fixing them.

So Carroll saved and borrowed for the surgery, she said. In an interview and a lawsuit, Carroll said that at a ClearChoice clinic in New Jersey in 2021, she agreed to pay $31,000 to replace all her natural upper teeth with pearly-white prosthetic ones. What came next, Carroll said, was “like a horror movie.”

Carroll alleged that her anesthesia wore off during implant surgery, so she became conscious as her teeth were removed and titanium screws were twisted into her jawbone. Afterward, Carroll’s prosthetic teeth were so misaligned that she was largely unable to chew for more than two years until she could afford corrective surgery at another clinic, according to a sworn deposition from her lawsuit.

ClearChoice has denied Carroll’s claims of malpractice and negligence in court filings and did not respond to requests for comment on the ongoing case.

“I thought implants would be easier, and all at once, so you didn’t have to keep going back to the dentist,” Carroll, 52, said in an interview. “But I should have asked more questions … like, Can they save these teeth?”

Dental implants have been used for more than half a century to surgically replace missing or damaged teeth with artificial duplicates, often with picture-perfect results. While implant dentistry was once the domain of a small group of highly trained dentists and specialists, tens of thousands of dental providers now offer the surgery and place millions of implants each year in the U.S.

Amid this booming industry, some implant experts worry that many dentists are losing sight of dentistry’s fundamental goal of preserving natural teeth and have become too willing to remove teeth to make room for expensive implants, according to a months-long investigation by KFF Health News and CBS News. In interviews, 10 experts said they had each given second opinions to multiple patients who had been recommended for mouths full of implants that the experts ultimately determined were not necessary. Separately, lawsuits filed across the country have alleged that implant patients like Carroll have experienced painful complications that have required corrective surgery, while other lawsuits alleged dentists at some implant clinics have persuaded, pressured, or forced patients to remove teeth unnecessarily.

The experts warn that implants, for a single tooth or an entire mouth, expose patients to costs and surgery complications, plus a new risk of future dental problems with fewer treatment options because their natural teeth are forever gone.

“There are many cases where teeth, they’re perfectly fine, and they’re being removed unnecessarily,” said William Giannobile, dean of the Harvard School of Dental Medicine. “I really hate to say it, but many of them are doing it because these procedures, from a monetary standpoint, they’re much more beneficial to the practitioner.”

Giannobile and nine other experts say they are combating a false public perception that implants are more durable and longer-lasting than natural teeth, which some believe stems in part from advertising on TV and social media. Implants require upkeep, and although they can’t get cavities, studies have shown that patients can be susceptible to infections in the gums and bone around their implants.

“Just because somebody can afford implants doesn’t necessarily mean that they’re a good candidate,” said George Mandelaris, a Chicago-area periodontist and member of the American Academy of Periodontology Board of Trustees. “When an implant has infection, or when an implant has bone loss, an implant dies a much quicker death than do teeth.”

In its simplest form, implant surgery involves extracting a single tooth and replacing it with a metal post that is screwed into the jaw and then affixed with a prosthetic tooth commonly made of porcelain, also known as a crown. Patients can also use “full-arch” or “All-on-4” implants to replace all their upper or lower teeth — or all their teeth.

For this story, KFF Health News and CBS News sought interviews with large dental chains whose clinics offer implant surgery — ClearChoice, Aspen Dental, Affordable Care, and Dental Care Alliance — each of which declined to be interviewed or did not respond to multiple requests for comment. The Association of Dental Support Organizations, which represents these companies and others like them, also declined an interview request.

ClearChoice, which specializes in full-arch implants, did not answer more than two dozen questions submitted in writing. In an emailed statement, the company said full-arch implants “have become a well-accepted standard of care for patients with severe tooth loss and teeth with poor prognosis.”

“The use of full-arch restorations reflects the evolution of modern dentistry, offering patients a solution that restores their ability to eat, speak, and live comfortably — far beyond what traditional dentures can provide,” the company said.

Carroll said she regrets not letting her dentist try to fix her teeth and rushing to ClearChoice for implants.

“Because it was a nightmare,” she said.

‘They Are Not Teeth’

Dental implant surgery can be a godsend for patients with unsalvageable teeth. Several experts said implants can be so transformative that their invention should have contended for a Nobel Prize. And yet, these experts still worry that implants are overused, because it is generally better for patients to have their natural teeth.

Paul Rosen, a Pennsylvania periodontist who said he has worked with implants for more than three decades, said many patients believe a “fallacy” that implants are “bulletproof.”

“You can’t just have an implant placed and go off riding into the sunset,” Rosen said. “In many instances, they need more care than teeth because they are not teeth.”

Generally, a single implant costs a few thousand dollars while full-arch implants cost tens of thousands. Neither procedure is well covered by dental insurance, so many clinics partner with credit companies that offer loans for implant surgeries. At ClearChoice, for example, loans can be as large as $65,000 paid off over 10 years, according to the company’s website.

Despite the price, implants are more popular than ever. Sales increased by more than 6% on average each year since 2010, culminating in more than 3.7 million implants sold in the U.S. in 2022, according to a 2023 report produced by iData Research, a health care market research firm.

Some worry implant dentistry has gone too far. In 10 interviews, dentists and dental specialists with expertise in implants said they had witnessed the overuse of implants firsthand. Each expert said they’d examined multiple patients in recent years who were recommended for full-arch implants by other dentists despite their teeth being treatable with conventional dentistry.

Giannobile, the Harvard dean, said he had given second opinions to “dozens” of patients who were recommended for implants they did not need.

“I see many of these patients now that are coming in and saying, ‘I’ve been seen, and they are telling me to get my entire dentition — all of my teeth — extracted.’ And then I’ll take a look at them and say that we can preserve most of your teeth,” Giannobile said.

Tim Kosinski, who is a representative of the Academy of General Dentistry and said he has placed more than 19,000 implants, said he examines as many as five patients a month who have been recommended for full-arch implants that he deems unnecessary.

“There is a push in the profession to remove teeth that could be saved,” Kosinski said. “But the public isn’t aware.”

Luiz Gonzaga, a periodontist and prosthodontist at the University of Florida, said he, too, had turned away patients who wanted most or all their teeth extracted. Gonzaga said some had received implant recommendations that he considered “an atrocity.”

“You don’t go to the hospital and tell them ‘I broke my finger a couple of times. This is bothering me. Can you please cut my finger off?’ No one will do that,” Gonzaga said. “Why would I extract your tooth because you need a root canal?”

Jaime Lozada, director of an elite dental implant residency program at Loma Linda University, said he’d not only witnessed an increase in dentists extracting “perfectly healthy teeth” but also treated a rash of patients with mouths full of ill-fitting implants that had to be surgically replaced.

Lozada said in August that he’d treated seven such patients in just three months.

“When individuals just make a decision of extracting teeth to make it simple and make money quick, so to speak, that’s where I have a problem,” Lozada said. “And it happens quite often.”

When full-arch implants fail, patients sometimes don’t have enough jawbone left to anchor another set. These patients have little choice but to get implants that reach into cheekbones, said Sohail Saghezchi, an oral and maxillofacial surgeon at the University of California-San Francisco.

“It’s kind of like a last resort,” Saghezchi said. “If those fail, you don’t have anywhere else to go.”

‘It Was Horrendous Dentistry’

Most of the experts interviewed for this article said their rising alarm corresponded with big changes in the availability of dental implants. Implants are now offered by more than 70,000 dental providers nationwide, two-thirds of whom are general dentists, according to the iData Research report.

Dentists are not required to learn how to place implants in dental school, nor are they required to complete implant training before performing the surgery in nearly all states. This year, Oregon started requiring dentists to complete 56 hours of hands-on training before placing any implants. Stephen Prisby, executive director of the Oregon Board of Dentistry, said the requirement — the first and only of its kind in the U.S. — was a response to dozens of investigations in the state into botched surgeries and other implant failures, split evenly between general dentists and specialists.

“I was frankly stunned at how bad some of these dentists were practicing,” Prisby said. “It was horrendous dentistry.”

Many dental clinics that offer implants have consolidated into chains owned by private equity firms that have bought out much of implant dentistry. In health care, private equity investment is sometimes criticized for overtreatment and prioritizing short-term profit over patients.

Private equity firms have spent about $5 billion in recent years to buy large dental chains that offer implants at hundreds of clinics owned by individual dentists and dental specialists. ClearChoice was bought for an estimated $1.1 billion in 2020 by Aspen Dental, which is owned by three private equity firms, according to PitchBook, a research firm focused on the private equity industry. Private equity firms also bought Affordable Care, whose largest clinic brand is Affordable Dentures & Implants, for an estimated $2.7 billion in 2021, according to PitchBook. And the private equity wing of the Abu Dhabi government bought Dental Care Alliance, which offers implants at many of its affiliated clinics, for an estimated $1 billion in 2022, according to PitchBook.

ClearChoice and Aspen Dental each said in email statements that the companies’ private equity owners “do not have influence or control over treatment recommendations.” Both companies said dentists or dental specialists make all clinical decisions.

Private equity deals involving dental practices increased ninefold from 2011 to 2021, according to an American Dental Association study published in August. The study also said investors showed an interest in oral surgery, possibly because of the “high prices” of implants.

“Some argue this is a negative thing,” said Marko Vujicic, vice president of the association’s Health Policy Institute, who co-authored the study. “On the other hand, some would argue that involvement of private equity and outside capital brings economies of scale, it brings efficiency.”

Edwin Zinman, a San Francisco dental malpractice attorney and former periodontist who has filed hundreds of dental lawsuits over four decades, said he believed many of the worst fears about private equity owners had already come true in implant dentistry.

“They’ve sold a lot of [implants], and some of it unnecessarily, and too often done negligently, without having the dentists who are doing it have the necessary training and experience,” Zinman said. “It’s for five simple letters: M-O-N-E-Y.”

Hundreds of Implant Clinics With No Specialists

For this article, journalists from KFF Health News and CBS News analyzed the webpages for more than 1,000 clinics in the nation’s largest private equity-owned dental chains, all of which offer some implants. The analysis found that more than 70% of those clinics listed only general dentists on their websites and did not appear to employ the specialists — oral surgeons, periodontists, or prosthodontists — who traditionally have more training with implants.

Affordable Dentures & Implants listed specialists at fewer than 5% of its more than 400 clinics, according to the analysis. The rest were staffed by general dentists, most of whom did not list credentialing from implant training organizations, according to the analysis.

ClearChoice, on the other hand, employs at least one oral surgeon or prosthodontist at each of its more than 100 centers, according to the analysis. But its new parent company, Aspen Dental, which offers implants in many of its more than 1,100 clinics, does not list any specialists at many of those locations.

Not everyone is worried about private equity in implant dentistry. In interviews arranged by the American Academy of Implant Dentistry, which trains dentists to use implants, two other implant experts did not express concerns about private equity firms.

Brian Jackson, a former academy president and implant specialist in New York, said he believed dentists are too ethical and patients are too smart to be pressured by private equity owners “who will never see a patient.”

Jumoke Adedoyin, a chief clinical officer for Affordable Care, who has placed implants at an Affordable Dentures & Implants clinic in the Atlanta suburbs for 15 years, said she had never felt pressure from above to sell implants.

“I’ve actually felt more pressure sometimes from patients who have gone around and been told they need to take their teeth out,” she said. “They come in and, honestly, taking a look at them, maybe they don’t need to take all their teeth out.”

Still, lawsuits filed across the country have alleged that dentists at implant clinics have extracted patients’ teeth unnecessarily.

For example, in Texas, a patient alleged in a 2020 lawsuit that an Affordable Care dentist removed “every single tooth from her mouth when such was not necessary,” then stuffed her mouth with gauze and left her waiting in the lobby as he and his staff left for lunch. In Maryland, a patient alleged in a 2021 lawsuit that ClearChoice “convinced” her to extract “eight healthy upper teeth,” by “greatly downplay[ing] the risks.” In Florida, a patient alleged in a 2023 lawsuit that ClearChoice provided her with no other treatment options before extracting all her teeth, “which was totally unnecessary.”

ClearChoice and Affordable Care denied wrongdoing in their respective lawsuits, then privately settled out of court with each patient. ClearChoice and Affordable Care did not respond to requests for comment submitted to the companies or attorneys. Lawyers for all three plaintiffs declined to comment on these lawsuits or did not respond to requests for comment.

Fred Goldberg, a Maryland dental malpractice attorney who said he has represented at least six clients who sued ClearChoice, said each of his clients agreed to get implants after meeting with a salesperson — not a dentist.

“Every client I’ve had who has gone to ClearChoice has started off meeting a salesperson and actually signing up to get their financing through ClearChoice before they ever meet with a dentist,” Goldberg said. “You meet with a salesperson who sells you on what they like to present as the best choice, which is almost always that they’re going to take out all your natural teeth.”

Becky Carroll, the ClearChoice patient from New Jersey, told a similar story.

Carroll said in her lawsuit that she met first with a ClearChoice salesperson referred to as a “patient education consultant.” In an interview, Carroll said the salesperson encouraged her to borrow money from family members for the surgery and it was not until after she agreed to a loan and passed a credit check that a ClearChoice dentist peered into her mouth.

“It seems way backwards,” Carroll said. “They just want to know you’re approved before you get to talk to a dentist.”

CBS News producer Nicole Keller contributed to this report.

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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The Host Emmarie Huetteman KFF Health News Emmarie Huetteman, senior editor, oversees a team of Washington reporters, as well as “Bill of the Month” and KFF Health News’ “What the Health?” She previously spent more than a decade reporting on the federal government, most recently covering surprise medical bills, drug pricing reform, and other health policy debates in Washington and on the campaign trail. 

With the 2024 election campaign in its final days, House Speaker Mike Johnson this week floated “massive” health care reform if former President Donald Trump wins — changes that are also dependent, of course, on whether Republicans control Congress next year.

Meanwhile, new reporting uncovers more maternal deaths under state abortion bans, plus at least one case in which a woman was jailed after a miscarriage. Plus, other investigations are shining a light on a reality of American health care, regardless of who wins on Tuesday: the consequences of health industry profiteering.

This week’s panelists are Emmarie Huetteman of KFF Health News, Lauren Weber of The Washington Post, Shefali Luthra of The 19th, and Jessie Hellmann of CQ Roll Call.

Panelists Jessie Hellmann CQ Roll Call @jessiehellmann Read Jessie's stories. Shefali Luthra The 19th @shefalil Read Shefali's stories. Lauren Weber The Washington Post @LaurenWeberHP Read Lauren's stories.

Among the takeaways from this week’s episode:

• Trump has called for reopening the fight over the Affordable Care Act, and given enough votes in Congress, Johnson suggested this week that he’s ready to back the former president’s play. To be sure, the expiration next year of enhanced ACA premium subsidies will put the health law back on the agenda — though given the law’s popularity, changes may be a hard sell even to some Republicans.
• Trump also unveiled his own proposal to address the long-term care crisis: a tax credit for family caregivers. His plan follows Vice President Kamala Harris’ proposal weeks ago to create a new Medicare benefit that pays for home health care.
• New reporting is out this week on women suffering miscarriages being denied reproductive health care — or even being charged with manslaughter and incarcerated. While many abortion opponents say they have no intention of harming or punishing women, the consequences of overturning Roe v. Wade are coming into clearer focus.

Also this week, KFF Health News’ Julie Rovner interviews Irving Washington, a senior vice president at KFF and the executive director of its Health Misinformation and Trust Initiative.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Emmarie Huetteman: KFF Health News’ “‘Dreamers’ Can Enroll in ACA Plans This Year — But a Court Challenge Could Get in the Way,” by Julie Appleby.

Lauren Weber: The New York Times’ “What Drugmakers Did Not Tell Volunteers in Alzheimer’s Trials,” by Walt Bogdanich and Carson Kessler.

Shefali Luthra: NBC News’ “They’re Middle Class and Insured. Childbirth Still Left Them With Crippling Debt,” by Aria Bendix.

Jessie Hellmann: ProPublica’s “‘Not Medically Necessary’: Inside the Company Helping America’s Biggest Health Insurers Deny Coverage for Care,” by T. Christian Miller, ProPublica; Patrick Rucker, The Capitol Forum; and David Armstrong, ProPublica.

Also mentioned on this week’s podcast:

• KFF Health News’ “Ghosts, Ghouls, and Ghastly Drug Prices in Winning Halloween Haikus.”
• ProPublica’s “A Woman Died After Being Told It Would Be a ‘Crime’ To Intervene in Her Miscarriage at a Texas Hospital,” by Cassandra Jaramillo and Kavitha Surana.
• The Washington Post’s “She Said She Had a Miscarriage — Then Got Arrested Under an Abortion Law,” by Caroline Kitchener.
• The 19th’s “Anti-Abortion Centers Are Stepping Into Electoral Politics,” by Shefali Luthra.
• The New York Times’ “How Taxpayers Are Helping Health Insurers Make Even Bigger Profits,” by Chris Hamby.
• KFF’s Health Misinformation and Trust Initiative, a program aimed at tracking health misinformation in the U.S., analyzing its impact on the American people, and mobilizing media to address the problem.

Credits Francis Ying Audio producer Stephanie Stapleton Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

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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The city of Beverly Hills has agreed to train its employees on abortion clinic protections after local officials interfered with the opening of an abortion clinic in “blatant” violation of state law, according to a proposed settlement to be unveiled Thursday by California Attorney General Rob Bonta.

Bonta’s office said the city’s then-mayor, city attorney, and city manager pressured DuPont Clinic’s landlord last spring to cancel the lease and that city officials also delayed permits to the clinic. They went so far as to warn the building owner that it could be liable for bomb threats and shootings at the medical office building in the wealthy city’s business district.

The Washington, D.C.-based reproductive health provider is one of a handful of clinics nationwide that advertise abortions past 28 weeks of gestation. It had secured a lease and begun preparations to open a second U.S. location in Beverly Hills.

Concerned about potential anti-abortion protests and negative media coverage, city officials “engaged in a pressure campaign under the guise of public safety,” according to Bonta’s complaint. The actions “blatantly violated” state law, Bonta said in the complaint. It’s the state’s first action under the voter-passed initiative known as Proposition 1, which enshrined abortion rights in the state constitution.

“It’s a stark reminder that there are efforts right here in California to undermine reproductive freedom,” Bonta said in an interview with KFF Health News ahead of the announcement. “These are city officials who took an oath to uphold the state constitution and state law, and they did the opposite.”

In signing the agreement, the city did not admit fault or liability. In a statement, Mayor Lester Friedman said the city disagreed with the allegations in the attorney general’s complaint.

“Beverly Hills is already home to medical facilities that offer complete reproductive health services,” Friedman said in a statement. “The city reaffirms and pledges that it did not and will not discriminate against any reproductive healthcare provider and strongly supports a woman’s right to choose.”

As part of the agreement which has been approved by the Beverly Hills City Council and must be approved by the Los Angeles County Superior Court, city officials will be required to train employees about state and federal protections for abortion clinics, create a protocol for handling complaints of potential violations, and appoint a “reproductive justice compliance officer” to manage the training program and materials.

California prohibits abortions past the point of fetal viability, around 24 weeks, except in cases in which the life or health of the woman is at risk. Proposition 1 strengthened reproductive freedom protections in the state constitution.

Approved by an overwhelming majority of statewide voters in 2022, the law says that the state, and by extension local governments, “shall not deny or interfere with an individual’s reproductive freedom in their most intimate decisions, which includes their fundamental right to choose to have an abortion and their fundamental right to choose or refuse contraceptives.”

Bonta said the measure, which at the time was widely regarded as a largely symbolic measure in deeply progressive California, provided a strong legal basis for the state’s case against the city of Beverly Hills and led directly to the settlement agreement.

“There are protections, both constitutional and statutory, that protect reproductive freedom in California,” Bonta said. “Cities need to honor and follow those rights and protections and when they’re not, we will get involved.”

DuPont Clinic had announced plans in October 2022 to expand to the Los Angeles area, according to Bonta’s office. The following month, flyers opposing the clinic’s opening appeared in and around the building.

Beverly Hills police officials later drafted a plan to send a letter to other tenants of the building warning them of the potential security risks, something Bonta said they’d never done with previous properties targeted by protesters.

The city attorney instructed city officials to not issue permits to DuPont until he’d spoken with the clinic about “whether the proposed use is allowed or not.” He later suggested DuPont provide a letter “confirming its intention to comply with California law” as it relates to abortions later in pregnancy.

“They acted differently and inserted themselves in delayed permits and launching a pressure campaign based on the fact that reproductive freedom is at stake,” Bonta said. “They targeted DuPont because of the fact that it provided fully legal reproductive health care.”

During a City Council meeting in April 2023, City Manager Nancy Hunt-Coffey sent an email to council members alerting them of the controversy over the new clinic, just before several activists spoke in opposition. The clinic could, she warned, “be the focus of protests, rallies and unfortunately other more violent actions on occasion.”

“How did this get through?” council member Sharona Nazarian immediately wrote back.

Hunt-Coffey replied: “Well, it’s a private business renting space in a private building.  We don’t have anything in our code that prevents it…”

What followed was a series of attempts by then-mayor Julian Gold, Hunt-Coffey, and the Beverly Hills police chief to stymie the clinic’s opening, Bonta said. Gold and the police chief met with building owner Douglas Emmett Inc., warning that the clinic could become a “lightning rod” for the city and that the landlord would be “responsible” and “liable” if anything were to happen. Gold also raised the possibility of bomb threats and active shooters, and the safety of other tenants in the building.

The clinic never opened.

Bonta said his office is prepared to go after local governments that shirk their responsibility to uphold state laws that protect abortion rights. He also suggested he would support amending state law to levy financial penalties on those who violate it.

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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Exactech, a Florida device manufacturer that faces more than 2,000 state and federal lawsuits from patients who allege the company sold defective hip and knee implants, filed for bankruptcy protection Tuesday.

The Gainesville-based company said in a statement it was restructuring and would be sold to an investor group of private equity and “alternative asset” firms, which would provide about $85 million in financing to fund the company’s operations.

Darin Johnson, Exactech’s president and chief executive officer, said in the statement that the device company faces “unsustainable liabilities associated with knee and hip litigation related to the packaging recalls we voluntarily initiated between 2021 and 2022.” The company said it would continue to operate during the bankruptcy proceedings.

“We take our commitment to patient well-being very seriously and have provided substantial out-of-pocket patient reimbursements and surgeon support for related expenses,” Johnson said.

The bankruptcy proceedings in federal court in Delaware will pause the lawsuits from patients seeking damages.

The surprise action dismayed lawyers representing injured patients.

“Exactech’s bankruptcy filing is a slap in the face to all the joint-implant patients and doctors who trusted the company. A medical device company that sells products for implantation in the human body has a special responsibility for public health,” said Joe Saunders, a Florida attorney who has sued the company on behalf of injured patients.

Saunders said the bankruptcy “serves to cover up public disclosure of the company putting profits ahead of safety.”

Injured patients were expecting one of the first jury trials against the company to begin in December in the circuit court in Alachua County, Florida. But the bankruptcy filing “stops the public trial and conceals the truth about the company’s conduct,” Saunders said.

Exactech, which grew over three decades from a small device manufacturer into a global entity, was the subject of a KFF Health News investigation published in October 2023.

The investigation found that, in hundreds of instances, the company took years to report adverse events to a federal database that tracks device failures.

Many of the lawsuits allege that the company’s knee and hip implants had an “unacceptable failure and complication rate.” Exactech has denied the allegations, and the company had no comment on the lawsuits.

Exactech began a series of recalls of artificial knees, hips, and ankles, starting in August 2021. Exactech initially blamed a packaging defect dating back as far as 2004 for possibly causing the plastic component to wear out prematurely in about 140,000 implants.

The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years, far sooner than the 15 to 20 years these products typically last.

“I’m so angry. How did they [Exactech] think they are not responsible for this?” said Sue Sacher, 76, a New Jersey resident. She said she had her right knee replaced with an Exactech implant in 2006 and the left one done three years later, both at the Hospital for Special Surgery in New York.

Since then, she’s had both implants replaced.

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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