Health and Fitness Tips

Appeals Court Revives Lawsuits Tying Tylenol Use in Pregnancy to Autism and A.D.H.D.

A federal appeals court overruled a district court judge who dismissed the lawsuits, citing unreliable scientific evidence.

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As GOP Cries Fraud, Newsom Backs Medicaid Spending on Housing and Food

SACRAMENTO, Calif. — Sen. John Kennedy of Louisiana is taking aim at California’s Medicaid program for providing housing assistance, food, and other social services to high-need, low-income patients who tend to rack up big healthcare costs and, he argued, strain taxpayer funds.

The Republican blasted California during back-to-back political attacks in May, saying the heavily Democratic state is committing “outrageous fraud” and “stealing” by spending state and federal Medicaid money meant for basic medical treatment on unconventional services such as housing and nutrition assistance, gym memberships, and even tribal prayers and, he claimed, exorcisms.

“The California Medicaid program will pay for herbal medicines, meal deliveries. They’ll pay for housing,” Kennedy said. “I don’t know what housing has to do with healthcare.”

“California, they’re just setting all kind of records,” he added. “They’re wild people.”

Despite criticism from congressional Republicans and growing scrutiny from the Trump administration, Gov. Gavin Newsom, a Democrat considering a presidential run, said he’s proud of California’s spending on social services in Medi-Cal, the state’s Medicaid program. It’s a multibillion-dollar experiment to help medically frail patients meet their housing, food, and other social needs that Newsom says is not only legal but also a more cost-effective and evidence-backed approach to providing healthcare for Californians with complex health conditions. He counters that investing in services outside clinical settings can help people avoid emergency rooms and hospital admissions, improve their long-term health, and ultimately save taxpayers money.

“It’s about whole-person care,” Newsom said, adding that he hopes President Donald Trump’s administration sees California’s leadership and agrees with the “reforms we’re advancing as national best practices.”

Now one of the governor’s marquee health initiatives is at the center of an intensifying partisan battle with Republicans in Washington, D.C., who have moved to rein in billions in healthcare spending on low-income and disabled people across red and blue states. It’s a philosophical divide: Conservatives say social services are a financial strain on Medicaid and shouldn’t be considered healthcare, while liberals argue that investing in prevention ultimately saves money. While experiments proliferated across the country under President Joe Biden, the Trump administration has rescinded federal policy encouraging state Medicaid programs to address health-related social needs.

The Medicaid fight is putting patients in limbo.

Lucy Rodriguez teaches Mexican folk dancing in the town of Hollister, in California’s Central Coast region. She said her life turned around this year once an intensive case manager with Titanium Healthcare, which contracts with health insurers to provide services, began helping her manage her chronic diseases and stay on top of her medical appointments and prescriptions, even picking up free food boxes for her. The 73-year-old is on Medicare and Medi-Cal, which offers more extensive benefits. The low-income health program has helped pay her utility bills, and she was recently approved for home-delivered meals.

“This has been a godsend,” said Rodriguez, who has diabetes, high blood pressure, and kidney disease. “I was getting so stressed out and depressed. It’s really hard when you’re on a fixed income. Groceries are so expensive, and with summer, electricity gets even more expensive. But this is really improving my life.”

She worries the Trump administration will cut benefits to low-income older people.

A woman with short gray hair smiles towards the camera. — Lucy Rodriguez, an enrollee in California’s Medicaid program, known as Medi-Cal, has benefited from social services the program covers, including a care manager who helps her manage her diabetes and kidney disease. (Angela Hart/KFF Health News)

Last year, the Centers for Medicare & Medicaid Services warned states that federal funding for social services would be determined on a case-by-case basis. CMS spokesperson Christopher Krepich said the agency is not ending current agreements, known as waivers, that grant states temporary permission to provide social services, which are paid for with state and federal dollars. But future applications, for new services or to extend existing initiatives, could be at risk if they veer too far from traditional healthcare.

“Moving forward, CMS will work with states on innovative waivers that address core healthcare needs, as consistent with evidence-based approaches tied to clinical diagnoses and services, to the goal of ultimately improving health outcomes in the Medicaid population,” Krepich said in a statement.

In a further escalation, the Justice Department put out a recent memo allowing states to institutionalize people with disabilities and severe mental illness instead of providing community-based care. Republicans have also targeted states, mostly blue ones, for what they say is a failure to go after waste, fraud, and abuse in Medicaid. In May, CMS Administrator Mehmet Oz stood alongside JD Vance as the vice president announced the deferral of $1.3 billion in Medicaid money to California over suspicions of fraud.

California Attorney General Rob Bonta said Republicans are simply trying to score political points while ignoring the healthcare needs of poor people. “The federal government wants to politicize fraud,” Bonta said, “and use it, unfortunately, as a bludgeon and a cajole to beat up on blue states.”

Social Healthcare

Health policy researchers say roughly 80% of health outcomes are linked to socioeconomic, environmental, and behavioral factors, such as housing instability, homelessness, food insecurity, and exposure to violence, whereas 20% is associated with medical care delivered in hospitals and clinics. That evidence fueled the Biden administration’s efforts to tackle social services.

At least 24 states use their own money while drawing federal Medicaid funds for social healthcare experiments. Colorado, Massachusetts, New York, North Carolina, Oregon, and Pennsylvania are among those that provide housing and nutrition assistance.

As the Trump administration pulls back on social services, states are rethinking how to fund benefits that have improved preventive care for low-income people. Some have launched new benefits under what’s known as a state plan amendment, a mechanism states use to modify their Medicaid programs that doesn’t need federal waiver approval. Michigan and Minnesota, for example, use this to add recuperative care for homeless patients after hospitalization. These short-term care facilities offer people the opportunity to recover, bridging the gap between hospital discharge and independent living.

This approach “has the advantage of establishing a permanent, statewide benefit that does not require ongoing federal renewals, offering greater stability and predictability,” said Lynn Sutfin, a spokesperson for the Michigan Department of Health and Human Services.

Other states, meanwhile, rely on federal waivers, which require renewal every five years, to provide social services. Arizona officials said the state intends to submit a request by the end of September to continue its program to provide housing and other services to homeless patients, or those at risk of homelessness, with a serious mental illness and a chronic health condition or recent incarceration.

“When members have access to stable housing and supportive services, they are more likely to engage in ongoing care and less likely to experience avoidable emergency department visits and inpatient admissions,” said Roberta Harrison, interim director of the Arizona Health Care Cost Containment System.

California, which has been the most aggressive state in adopting social services, has taken a two-pronged approach to keep its vast offerings funded past this year. The state is using its authority to make most of its existing social services and benefits permanent in Medi-Cal managed-care coverage. That regulatory maneuver bypasses federal waiver approval — a move that could attract further Republican scrutiny.

But not everything the state offers can be funded without permission from the federal government. As some services are made permanent, the Newsom administration is seeking new waivers to continue other social services, while also adding more.

It’s an ambitious approach that would expand California’s social healthcare experiment. Newsom said he’s worried that the federal government will decline the latest waiver request. “How could you not be with this administration?” he said. “I’m always concerned.”

A senior woman checks her blood pressure at her kitchen counter. — Rodriguez tests her blood sugar to help manage her diabetes. Conservatives say that spending healthcare funds on nontraditional services such as housing and nutrition assistance is inappropriate, but liberals say it saves money in the long run. (Angela Hart/KFF Health News)

A senior woman shows the place on her arm where her blood pressure cuff goes. — Through Medi-Cal, Rodriguez has received help managing medical appointments after arm surgery. State officials say social healthcare provides a more cost-effective approach for people with complex health conditions. (Angela Hart/KFF Health News)

New Front in Healthcare

California offers most of its health-related social services under Biden-era waivers within Medi-Cal, which has a proposed budget of $217 billion. Although there are more than 14 million residents on Medi-Cal, the state has been selective about who gets help from 15 types of social services in its program, called California Advancing and Innovating Medi-Cal, or CalAIM. Patients with complex needs can also receive help navigating their health and social needs from specialized social workers under a benefit known as enhanced care management.

Since 2022, California has been offering social services, spending nearly $12 billion in joint state and federal money, with the hope of reducing long-term Medi-Cal spending by keeping enrollees out of costly institutions including emergency rooms, jails, nursing homes, and mental health crisis centers.

CalAIM had provided social services to more than 528,000 patients as of September 2025, the most recent state data available. And nearly 453,000 low-income Californians have received intensive case management. Some patients receive both services.

Among the services California is making permanent: Homeless patients can get help finding an apartment, with Medi-Cal paying rental security deposits and six months of rent. Patients with chronic conditions such as diabetes and heart disease are eligible for home-delivered meals. Asthmatic patients can get mold removed from their homes to control flare-ups. Low-income seniors with disabilities can get a wheelchair ramp installed free of charge. And inmates leaving jail or prison can be connected immediately with primary care, mental health, and substance use treatment.

The social services — especially housing, food assistance, and home modifications — are already demonstrating success in stabilizing the health of the most complex patients, while achieving savings for Medi-Cal through reductions in emergency room visits and hospitalizations and less reliance on institutional care such as nursing homes, according to the state Department of Health Care Services.

In the Central Valley, for instance, Health Plan of San Joaquin CEO Lizeth Granados said CalAIM has helped place homeless patients who were routinely hospitalized into housing. And patients with uncontrolled diabetes saw their blood sugar drop after receiving nutrition counseling and home-delivered meals.

Overall, Granados said, the health plan has seen major improvements in chronic disease management and reductions in hospital stays, dropping to 44 inpatient hospitalizations per 1,000 members since it launched in 2022, down from 61 per 1,000 before CalAIM.

In Orange County, officials with CalOptima Health credited CalAIM housing services for contributing to a nearly 27% drop in unsheltered homelessness. “We’ve been able to expand our street medicine programs, too,” said Yunkyung Kim, the insurer’s chief operating officer.

Around the state, Medi-Cal health insurers said they’re optimistic that CalAIM will continue to save money and improve patient health. Yet, the fate of some services will be decided by the Trump administration.

California has asked CMS to continue enrolling jail and prison inmates in Medi-Cal 90 days before their release to maintain consistent treatment for substance use, mental disorders, or physical conditions, a CalAIM service still in its early stages.

The state has also proposed a new job assistance benefit that counties could opt into to help patients find and retain work in response to upcoming federal work requirements imposed by congressional Republicans’ One Big Beautiful Bill Act, signed by Trump last summer.

And the state wants to continue its array of traditional healers and natural helpers for Californians with tribal affiliations, including music therapy, dancing, drumming, and referrals to sweat lodges for mental health treatment and substance use recovery. While it covers spiritual services, such as ceremonies, rituals, and herbal remedies, state officials said Medi-Cal does not cover exorcisms.

Already, the Trump administration’s positioning has forced the state to eliminate room-and-board benefits, which is threatening local efforts to provide recovery beds.

The state is cutting short-term post-hospitalization housing, which was meant to prevent hospitals from dumping homeless patients or those at risk of homelessness onto the streets. The CalAIM service providing up to six months of temporary housing and ongoing care is ending at the close of this year. And the state is cutting recuperative care benefits, no longer paying for beds for patients to recover from illness or injury, instead offering only wraparound services.

In San Francisco, these beds have been crucial in reducing overdose deaths, helping transition homeless people off the streets and into housing, and reducing hospital bed usage, said Neal Sheran, a medical director with the city’s Department of Public Health. The city’s health plan operates a sobering center, and recuperative care facilities where patients can recover from hospitalizations.

“We’re concerned,” Sheran said. “Funding for the overnight piece of these programs is really crucial to their success.”

Cuts on the Horizon

Even without federal threats, state budget pressures have strained CalAIM financing. Newsom has proposed reducing funding for social services by $68.3 million this fiscal year. The cut will deepen next year and remain at $150.2 million per year beginning in 2028.

Providers worry that Medi-Cal patients will lose access. And services, such as home-delivered meals and housing assistance, will be further restricted.

“It’s moving us back to the old days where our healthcare system is more expensive and reactive, instead of investing in prevention,” said Anwar Zoueihid, a vice president and the chief strategy officer at the Los Angeles-based Partners in Care Foundation, a CalAIM provider. “It’s contradictory to Make America Healthy Again.”

To save money, the state is tightening eligibility to limit services and reduce inappropriate use. For instance, Medi-Cal patients with food insecurity would no longer be eligible for home-delivered healthy meals without a qualifying condition like diabetes. And a homeless patient would get capped at six months for help finding an apartment.

Some of the biggest providers of CalAIM say services should be continuously evaluated and curtailed if health plans were too permissive. In some cases, food and housing services were given to low-income patients who didn’t necessarily qualify as the highest-need.

“It’s important everybody takes a look with a very sober view at whether we’re truly benefiting people so we’re spending money in the right places,” said Charlie Robinson, the chief health equity officer at L.A. Care, one of the state’s largest Medi-Cal health insurers.

Dorothy Seleski, the Medi-Cal president for Health Net, said the health insurer isn’t deterred by state and federal cuts.

“Regardless of what happens at the federal level, we are committed,” she said. “This is a significant transformation of the healthcare system, and we are already seeing major reductions in avoidable emergency room trips, avoidable hospital admissions, and we’ve closed gaps in preventive care.”

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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What Is an Aortic Dissection?

The condition that killed Senator Lindsey Graham is deadly, sudden and difficult to treat — “like a knife to the back,” one expert said.

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Céline Gounder, KFF Health News’ editor-at-large for public health, discussed the health risks of consuming raw milk and an outbreak of infant botulism linked to recalled formula on CBS News’ CBS Mornings and CBS News 24/7’s The Daily Report on July 7. Gounder also discussed allegations about Health and Human Services Secretary Robert F. Kennedy Jr.’s oversight of the Centers for Disease Control and Prevention on CBS Mornings on July 6.

KFF Health News Georgia correspondent Briah Lumpkins discussed extreme heat in Georgia on WUGA’s The Georgia Health Report on July 3.

Click here to hear Lumpkins on The Georgia Health Report.

KFF Health News senior correspondent Aneri Pattani discussed strategically directing opioid settlement money to support long-term impact during the National League of Cities’ June 25 webinar “Sustaining the Work: Strategically Leveraging Opioid Settlement Funds.”

Click here to watch Pattani on the webinar (starting ~27:00).
Read KFF Health News’ ongoing series “Payback: Tracking the Opioid Settlement Cash.”

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U.S. Citizen Tests Positive for Ebola in Democratic Republic of Congo

The American works for a humanitarian organization in Congo, the Centers for Disease Control and Prevention said.

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Joseph Fraumeni, 93, Dies; Helped Discover Genetic Link to Cancer

Considered the founder of molecular epidemiology, he worked with Frederick P. Li to identify a hereditary disorder that increased the risk of developing cancer at a young age.

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They Harvest the Nation’s Food, but a New Rule May Strip Them of Health Insurance

Seasonal work. Inconsistent hours. Frequent moves. Cash payments and informal jobs. For farmworkers who rely on Medicaid, these common employment patterns could put their health coverage at risk.

It’s a heightened concern for the estimated million-plus farmworkers who are U.S. citizens or legal permanent residents, as new work requirements kick in for the federal-state healthcare program that serves low-income and disabled Americans.

Starting next year in most states, many adults enrolled in Medicaid will have to prove they work, are enrolled in college or vocational courses, volunteer, or do unpaid work for at least 80 hours a month.

Advocates say this could pose a significant challenge to Medicaid-eligible farmworkers, who frequently work more than 80 hours a month during harvest season but less in other months. What’s more, outside the harvest season, many workers take on informal jobs in construction, landscaping, or home repair for which they don’t receive formal paychecks that would prove their continuing Medicaid eligibility. Still, they can establish eligibility if they prove their average monthly income over six months is equivalent to at least 80 hours of work at the federal minimum wage.

“Having a work requirement — having to create more paperwork and more proof — is certainly extremely challenging for farmworkers and others who are low-income and who may especially have seasonal jobs, not year-round, and do have periods” when there is no work available, said Alexis Guild, vice president of strategy and programs at Farmworker Justice.

New Requirements, Additional Hurdles

Agriculture is a trillion-dollar industry, and Americans depend on an estimated 2.9 million farmworkers to put food on their tables. Nearly 60% of those workers are U.S. citizens or green-card holders, according to the U.S. Department of Agriculture. The remaining 40% lack legal status or are otherwise ineligible for Medicaid.

Even among farmworkers with citizenship or legal status, the uninsured rate is three times that of the general population, and most farmworkers with insurance are Medicaid beneficiaries, although participation rates vary by state. According to a new analysis, 71%-79% of eligible farmworker households report participation in Medicaid.

The new Medicaid work requirements were a key provision of the One Big Beautiful Bill Act signed last July by President Donald Trump. Under the federal law, 43 states and the District of Columbia must implement the requirements by Jan. 1. A few states have moved to implement the work rule early.

The 80-hour rule applies in states that expanded Medicaid, a process that began in 2014 and was tied to the Affordable Care Act. Following the initial expansions, agricultural workers with legal documentation became 24% more likely to have health insurance, according to a 2021 article in the American Journal of Agricultural Economics.

Immigration Anxieties

The work requirements are the latest in a long list of obstacles placed between workers and the healthcare they’re legally entitled to, Guild said. “Medicaid certainly helps because it alleviates the cost issue,” she said. “But there are still other barriers, such as transportation, taking sick leave, and finding time to visit a health center. All these factors can prevent them from actually receiving medical care.”

For farmworkers with green cards and naturalized U.S. citizens, there is another source of stress: the fear that signing up for Medicaid could put personal information in the hands of immigration authorities.

That’s what worries Luis, a 45-year-old green-card holder and Medicaid recipient who dreams of becoming a U.S. citizen. Luis — who asked to be identified by only his middle name — lives with his wife and daughter in North Carolina, where he has worked in agriculture for nearly a decade.

Speaking in Spanish, he said that when he learned about the work requirements, he knew it would be challenging for him to prove that he works 80 hours a month. “I only work on farms for six or seven months; the rest of the year I work in whatever I can find,” he said.

Republicans in Congress argue that work requirements will reduce federal healthcare spending, encourage nondisabled adults to enter the workforce, and preserve safety net resources for the most vulnerable populations.

Among Hispanic adults enrolled in Medicaid, 67% are already working, according to a 2025 KFF report.

The Centers for Medicare & Medicaid Services did not respond to requests for comment for this article. But in June, when CMS announced its “nationwide framework” to implement the Medicaid work requirements, Administrator Mehmet Oz said it would help beneficiaries “build skills and independence through work, education, job training, or community service, creating new opportunities for themselves and their families.” Federal officials say the new requirements “could reduce poverty by as much as 2.9 million people.”

Chronic Illness

Agricultural work is one of the nation’s most dangerous occupations, and it is associated with long-term health impacts and high rates of chronic illness, including respiratory conditions. A 2021-22 California survey found that 37% of male farmworkers and 47% of female farmworkers in the state had at least one chronic health condition. The new work requirements present one more barrier for those seeking care, advocates said.

“People skip checkups and screenings, and conditions that could be caught early and treated cost-effectively” aren’t, said Adriana Cadena, executive director of Protecting Immigrant Families.

Emergency rooms often become the “natural” place to go for healthcare, Cadena added. “This drives up waiting times and costs for all of us. … And when people are sick enough that they miss work, it starts a vicious cycle of lost productivity and family economic instability that again threatens all of us.”

A Loss for Families and Children

The new federal rules also require beneficiaries to verify their eligibility at least twice a year, twice as often as previously, creating another potential obstacle.

“Letters can easily be missed, and forms may go unfilled. If people get caught up in the paperwork, they could lose coverage,” said Akeiisa Coleman, an assistant vice president at The Commonwealth Fund, a nonprofit that promotes an equitable healthcare system.

For farmworkers who travel from state to state, the process can be especially difficult.

“You have to find the time to transfer your coverage and probably find a person or organization that can help you — and that can be really hard when you’re constantly moving,” Cadena said.

The situation highlights the difficulties of navigating a complex system for individuals and families already struggling to make ends meet.

“The result,” Cadena said, “could be the loss of coverage not only for workers, but also for their families and children.”

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My Search for a Psychiatric Bed in an Overburdened Health System

If you or someone you know may be experiencing a mental health crisis, contact the 988 Suicide & Crisis Lifeline by dialing or texting “988.”

Eight days before my 33rd birthday in April, a social worker at a crisis clinic near Denver determined I was an imminent danger to myself. She placed me on an involuntary 72-hour mental health hold.

What came next wasn’t treatment, but a search for a bed. Clinic staffers called area hospitals with inpatient psychiatric units, asking if they had available beds. They didn’t. So, I was told I had to spend the night at the clinic, which is open 24/7. I settled into a recliner, trying to make myself comfortable as my mind drifted in a blank, disassociated haze. Sleep came in brief bursts.

Since the 1950s, the United States has seen a dramatic decline in the number of psychiatric beds nationwide due in part to deinstitutionalization and the rise of antipsychotics. But that has created a critical shortage for those needing help. From 2011 to 2023, the number of hospitals with inpatient psychiatric units dropped significantly, according to a 2025 study. Another study from that year found that this country has 28.4 inpatient psychiatric beds per 100,000 people — not even half the 60-bed ratio researchers frequently refer to as the optimal level.

The shortage has created what the American Psychiatric Association calls a crisis: emergency rooms overwhelmed with people suffering from severe mental health illnesses, inpatient stays prematurely shortened to speed up bed turnover, and acutely ill individuals left without critical care.

A pen-and-ink illustration shows a scene in three panels. 1 (left): A woman looks up, concerned. She then looks down at her hands, which are shaking over an intake form on a clipboard. 2 (center): An intake nurse talks to the woman, who is sitting in a chair with one leg folded over the other. 3 (right): She tries to answer a question on the form, which is obscured but hints at "why do you feel like you want to..." She scribbles out an answer and tries again. Below, she's seen nervously twirling her hair around her fingers. In the margins of the page, a thunderstorm fills the borders. — (Oona Zenda/KFF Health News)

“Where are these people going?” said Zoe Lindenfeld, an assistant health policy professor at Rutgers University, who co-authored those 2025 studies. “For people who don’t receive this care, they don’t just go away. How is it affecting them? Society? Their families?”

Meanwhile, the White House shut down the part of the national suicide hotline catering to LGBTQ+ youth, President Donald Trump’s 2027 budget proposal calls for cuts to agencies engaged in mental health work, and Health and Human Services Secretary Robert F. Kennedy Jr. recently announced a plan to reduce the “overuse of psychiatric medications.”

A Fractured System

I was already intimately familiar with the country’s fractured mental healthcare system before I was involuntarily committed. What I had yet to experience myself, I saw through my wife: waitlists, outpatient programs stretched beyond capacity, and inpatient psychiatric care so scarce that access often depends on surviving a crisis severe enough to justify it.

She died by suicide after we had separated.

As the years passed, grief and anxiety pushed me from observer to patient.

At the crisis clinic, I woke up the following morning disoriented and groggy. In the bathroom — its door deliberately unable to latch, swinging both ways so staffers could enter in case of an emergency — I stood at the sink and watched the faucet run, trying to piece together how I had ended up here.

A hand-drawn pen and ink illustration. Three panels are set up in a triptych style. 1 (left): We see a scene, through a bathroom mirror, from a memorial of the main character's wife. The wife's picture is obscured by a large flower. There's a condolence card and medical bill on the table in front of the picture frame. 2 (center): The main character's face is reflected in a bathroom mirror as she washes her hands in rushing water. 3 (right): Medical bills, legislation, and a hand holding a pill bottle are all visible in a collage. Around the three panels, water gushes down from above and floods the bottom half of the page. — (Oona Zenda/KFF Health News)

America’s history of treating mental illness is long and complicated.

The 19th and 20th centuries saw the removal of people with severe mental disorders from jails and poorhouses — squalid facilities designed to house the poor — to state asylums that promised “moral treatment” (though they ultimately became overcrowded hospitals for the impoverished). From the 1860s to the 1930s, the number of psychiatric hospitals increased dramatically, according to the American Psychiatric Association, and by 1955, the number of psychiatric beds in the U.S. peaked at more than half a million.

However, owing to the development of antipsychotics, the belief that psychiatric institutions were inhumane, and President John F. Kennedy’s 1963 Community Mental Health Act to free thousands of Americans from a life in institutions, many state hospitals shut down. An estimated 61,000 inpatient psychiatric beds for adults and kids are left in a country where more than 14 million experience severe mental illness each year.

Two years after JFK’s legislation passed, a new policy prohibited federal Medicaid funds from covering inpatient psychiatric care in facilities with more than 16 beds. The goal was to encourage states to move patients out of large, often substandard psychiatric institutions into community-based care settings.

The consequences of these changes, however, have been far-ranging. People with severe mental illnesses are often forced to board in emergency departments as they wait for a bed to open. The length of stay in state psychiatric hospitals is shrinking while readmission rates rise, according to research by the Treatment Advocacy Center, a national organization focused on eliminating barriers to the treatment of severe mental illness. And some people with mental illness languish for months, or even years, in jail.

From 1986 to 2014, as the behavioral health crisis intensified, mental health expenditures in the U.S. rose from $32 billion to $186 billion — though the proportion of that spending allocated to inpatient care fell from 42% to 27%.

This period also recorded major policy shifts affecting inpatient hospitalization rates, notably the 1999 U.S. Supreme Court decision in Olmstead v. L.C. The ruling shifted care away from psychiatric facilities by mandating states provide home and community-based services to people with developmental and mental disabilities.

“The road to hell is paved with good intentions,” said Leslie Carpenter, legislative advocacy manager at the Treatment Advocacy Center. “A lot of these bills, including the Community Mental Health Act, were really well intended and ended up with adverse consequences.”

For me, that next day at the clinic passed both painfully slowly and in a blur. A staff member I hadn’t met before told me they were still reaching out to hospitals across the region. The search for a bed continued.

A hand-drawn pen and ink illustration. Three panels are set up in a triptych style. In each, the main character is trying to figure out a comfortable way to sleep in the medical recliner. Dali-esque melting clocks float around her. Paper legislation frames the bottom of the page. — (Oona Zenda/KFF Health News)

‘No One Wants To Pay for Any of This Care’

Last year, members of Congress introduced two bills to change the 16-bed Medicaid funding cap at inpatient psychiatric facilities, the Repealing the Institution for Mental Diseases Exclusion Act and the Michelle Alyssa Go Act, which would increase the cap to 36 beds. Both have stalled in the House.

According to the Congressional Budget Office, a federal agency that analyzes budgetary and economic issues, eliminating the 16-bed limit would increase Medicaid expenditures by $33.5 billion from 2024 to 2033.

“No one wants to pay for any of this care that people need,” said Colorado state Sen. Judy Amabile, a Democrat who has witnessed limitations to Colorado’s mental healthcare system firsthand because her son has schizoaffective disorder.

In lieu of federal action, states are stepping up to bridge the gaps.

Colorado, 15 other states, and Washington, D.C., now operate under waivers allowing Medicaid to fund inpatient facilities with more than 16 beds for mental health treatment, according to KFF data. Seven additional states have waivers pending. One 2025 study found that these waivers may be tied to fewer hospitalizations, emergency department visits, and incarcerations among adults with serious mental illness.

Yet even local efforts to improve mental healthcare face resistance. In California, Colorado, Iowa, Missouri, Nebraska, and New York, locals have pushed back against proposed psychiatric facilities for minors, claiming such facilities will worsen safety and lower property values. Behavioral health advocates have disputed these claims and argued they are rooted in stigma.

That psychiatric facility in Colorado was ultimately greenlit. The state has nearly 20 inpatient beds per 100,000 people, ranking 24th nationwide, according to 2022 data across all 50 states plus Washington, D.C., collected by the Treatment Advocacy Center. Wyoming ranked first with 47.3 beds per 100,000 residents, although, as the least populous state, it has only 275 total inpatient beds compared with California’s 5,703. Minnesota ranked last, with only 4.3 inpatient beds per 100,000 residents.

While increasing the number of inpatient psychiatric beds is vital, mental health advocates are also calling for more community-based supports, such as peer support specialists and clubhouses, where people with serious mental illnesses can learn life skills and find community.

A hand-drawn pen and ink illustration. Three panels are set up in a triptych style. 1 (left): The main character is lying in bed, discussing her mental health with a doctor who sits at her bedside. 2 (center): The main character is sleeping peacefully in a hospital bed. 3 (right), top panel: A warm handshake radiates good vibrations. Bottom panel: An empty hospital bed with a hand-written note that says "thank you" on its pillow. In the margins/borders of the page, a moon and sun radiate in the background, while new flowers bloom after the drenching storm of the previous images. — (Oona Zenda/KFF Health News)

When it came time for me to use our mental health safety net, I was among the fortunate ones: At noon the day after my hold began, a bed opened at a hospital in Denver — a rare stroke of luck in a system in which many people wait days or weeks for the care they need. An ambulance transferred me to the hospital at 3 p.m., marking 21 hours into my 72-hour hold.

Two days later, on my last day at the psychiatric hospital, I stood outside the nurse’s station awaiting discharge papers.

A man I had not seen before looked at me and asked, “Are you leaving?”

“Yes,” I said. “Are you being admitted?”

“Yeah,” he responded. “This is my third time being hospitalized in a year.”

I shook his hand. “Good luck,” I said, and I walked out the door.

This <a target="_blank" href="https://kffhealthnews.org/health-industry/psychiatric-bed-shortage-overburdened-health-system/">article</a> first appeared on <a target="_blank" href="https://kffhealthnews.org">KFF Health News</a> and is republished here under a <a target="_blank" href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="https://kffhealthnews.org/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150" style="width:1em;height:1em;margin-left:10px;">

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This Kind of Obsessive Attraction Isn’t Love. But It Has a Name.

Limerence is more than a crush, psychologists say, and it can persist for months or years.

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Patients Face a Thicket of Red Tape Trying To Maintain Consistent Health Coverage

By the time Derion Blackman collapsed in front of a Dollar General in Kissimmee, Florida, in March, he had been waiting two months to regain access to some of the vital medications he’d been taking since undergoing a heart transplant two years ago.

“He was on a nasty, dirty ground in front of a store,” recalled Sonja Smith, who is enraged about the circumstances that led to her husband’s heart failure. “He didn’t deserve to die like that.”

Problems started last year when the couple learned the monthly premium payment for their Federal Employees Health Benefits plan would more than double to $307 and their deductible would also go up. They decided to switch Blackman’s primary coverage to CHAMPVA, a health benefits program for dependents of disabled veterans, which had no premium and a $3,000 deductible.

Smith thought she and Blackman had carefully prepared so that the transition between health plans would be seamless. It was anything but.

After the new health plan became active in January, Smith said, Blackman faced one hurdle after another getting approval for the antirejection medications needed to prevent his body from attacking his transplanted heart. Patients who rely on these drugs can develop severe and life-threatening heart issues if they miss even a few days. She said Blackman had enough medication to last only about a month into the new plan year. He told her just before his death that he had run out.

“I screamed at CHAMPVA. I screamed at the Trump administration. I screamed at the overall healthcare system in this godforsaken country,” she said. “Everybody played a part in what happened to my husband.”

A selfie of a husband and wife smiling together. — Derion Blackman pictured with his wife, Sonja Smith. Blackman died from heart failure after waiting two months for his new insurer to approve the expensive medications he had needed to take daily since undergoing a heart transplant two years ago. (Sonja Smith)

The Department of Veterans Affairs declined to comment on the record about Blackman’s case.

While the couple’s situation was extreme, their challenge of trying to continue a treatment is faced by many who shop for cheaper options as health insurance costs have soared across the country. The United States already has a fragmented health system, in which insurers, clinicians, and drugmakers are largely left on their own to hash out the cost of each medication or service. That lack of standardization leads to layers of bureaucracy for patients; moving to a new plan can ensnare patients in a thicket of red tape, keeping them from care.

Making matters more challenging, Congress didn’t renew covid pandemic-era subsidies that helped lower premiums for Affordable Care Act marketplace plans before this year. The Trump administration is also adding hurdles for people to access Medicaid, a state-federal health insurance program for Americans with low incomes or disabilities, so more people may lose their current coverage.

“We’ve basically set up a series of cracks in our healthcare system that we ask people to jump over,” said Adrianna McIntyre, an assistant professor of health policy at the Harvard T.H. Chan School of Public Health. “But if you don’t jump over those cracks, you can lose coverage, or lose access to your doctor, or lose access to your medications.”

‘This Is a Lot’

Insurers calibrate plan prices by negotiating rates with individual clinicians, hospital systems, and drugmakers, leading to varying levels of coverage. Plans with lower monthly costs often have narrower networks of doctors and hospitals, and less generous drug coverage.

As a result, when patients choose an insurer — or even a new plan with the same insurer — they may lose access to medications or doctors that they have had for years, said Sabrina Corlette, a research professor in health policy at Georgetown University. There are so many ways “patients could get tripped up,” she said. “When you switch to a new insurance company, they’re going to apply their rules.”

In a pledge announced by the Trump administration last year, many insurers voluntarily agreed to reduce some red tape by honoring existing prior authorizations for 90 days when a patient switches health plans. As required by law, they also offer resources such as plain-language plan descriptions and searchable online clinician directories to help patients coordinate care, according to AHIP, the main health insurance industry trade group.

“The goal is to ensure every member understands their benefits and can access the care they need without interruption,” said Conner Coles, an AHIP spokesperson.

But patients say understanding their benefits can still be a challenge.

Monique Acosta, 54, had to navigate two health insurance changes after she was laid off from her job at a disability nonprofit in October. The heart transplant recipient and cancer survivor said she paid nearly $900 a month to continue her employer coverage under COBRA, the Consolidated Omnibus Budget Reconciliation Act. Then, in January, the Woodbridge, Virginia, resident switched to Medicaid.

During the transitions, Acosta said, she lost coverage for a postchemotherapy drug. So, she changed her care team to qualify for lower-cost medications through a local hospital’s charity program. Then one of her new doctors reduced the frequency of an injection she had gotten for years. During that time, she said, her red and white blood cell counts plummeted and she struggled to recover from a heart catheterization procedure.

Eventually, her new physician upped the frequency of her injections back to twice a month. “He needed to document it so he could see it himself,” Acosta said. “I was very, very fatigued, very weak, and it’s unnecessarily so.”

Acosta said she is putting off a mammogram until she can better understand her Medicaid plan or find a job with better benefits. “This is overwhelming,” she said. “This is a lot.”

Burden on the Patient

Federal regulations, 43 states, and Washington, D.C., have continuity of care protections that require health plans to continue covering doctors and drugs when there is a network change, like when a clinician or hospital that a patient goes to is terminated from the insurer’s network of providers.

But Corlette said that not all the protections address the trip wires people face when they switch insurers on their own, such as during open enrollment or after a major life change.

Still, people can be proactive in a few ways about maintaining care when they change plans, said Shelli Quenga, an insurance agent in South Carolina.

She advises patients to keep written records of their medical and drug history for new providers. Quenga tells her customers to get their new insurance information to their doctors as soon as they switch, not to wait until an appointment. In addition, she said patients can request a case manager with their insurer so they don’t have to repeat their concerns to different staffers.

Even when a patient does homework, doctors can drop out of a network and insurers can change the contours of their plans, McIntyre said.

“Nobody has an incentive to make it make sense,” she said. “This puts a lot of burden on the patient.”

They Switched to a Lower-Cost Plan. Then the Bureaucracy Battle Began.

Sonja Smith, 50
Kissimmee, Florida

Sonja Smith and her husband, Derion Blackman, switched insurers last year when the premium payments for their previous plan were set to more than double. The couple planned to make the transition seamless. But after the new health plan became active in January, Smith said, Blackman faced one hurdle after another getting approval for the antirejection medications needed to prevent his body from attacking his transplanted heart. In mid-March, Blackman collapsed and died.

“I screamed at the overall healthcare system in this godforsaken country,” Smith said. “Everybody played a part in what happened to my husband.” — Renuka Rayasam

The cost-sharing program Blackman was part of, which has about 1 million enrollees, doesn’t work like traditional insurance. It has no networks or third-party appeals process, according to Caira Benson, a staffer at Code of Support Foundation, an organization that supports veterans. Instead, the program covers part of a patient’s cost of care.

Blackman qualified for the program because Smith was declared permanently disabled due to physical and mental injuries she sustained following an assault on an Air Force base during her service. CHAMPVA was Blackman’s secondary insurance previously.

One of his medications was about $800 a month, more than half his disability check. Knowing that these heart medications were crucial, Smith said, the couple in November called CHAMPVA, which she said confirmed it would cover the drugs. But they still got caught in red tape.

CHAMPVA had Blackman’s previous insurance listed as his primary, even though he had canceled that plan. That took six weeks to resolve. Some but not all of his medications came, because the health plan said his provider needed to clarify his prescriptions.

“Now I’m left here trying to piece together all the things that happened,” Smith said.

And she is full of regrets, too.

“I would have kissed him one more time before he walked out the door,” she said through sobs. “I feel so cheated.”

KFF Health News South Carolina correspondent Lauren Sausser contributed to this report.

Are you struggling to afford your health insurance? Have you decided to forgo coverage? Click here to contact KFF Health News and share your story.

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The Unknown Universe Inside Your Gut

The human microbiome is essential to our health, but scientists have only begun to understand why. Two researchers set out to map this largely uncharted terrain.

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Nation’s 250th Celebration Fireworks Sent D.C. Air Pollution Spiking

Trump promised a record display of some 850,000 pyrotechnics for the country’s 250th birthday. The Park Service warned it could get dirty.

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Trump Administration Guts Efforts to Prevent Gun Violence, Suppressing Reports

As the administration works to expand gun rights, hospitals and community groups have lost funding, and reports on preventing firearm injuries have vanished from government websites.

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Thousands of Medicare Beneficiaries Thought Their Drug Plan Was Free. Then They Lost It.

Jude Pare and his partner, Diane Tix, live in rural Minnesota until temperatures dip below freezing, when they take refuge in Arizona for the winter. While away, their mail is forwarded. But Pare, 77, said he didn’t receive any warning from his Medicare prescription drug plan that his $0 monthly premium was about to increase.

So he didn’t know he had a bill to pay. After he and Tix returned home to Minnesota in April, they got a letter from Wellcare, the insurer that provided his drug plan, saying his coverage had been terminated after three months of unpaid premiums totaling $28.80. Under Medicare’s rules, he can’t enroll in a plan again until the fall, for coverage beginning in 2027.

Pare takes Xarelto, a blood thinner that reduces his risk of strokes, blood clots, and pulmonary embolism. “He could bleed to death without it,” Tix said. A 90-day supply of the drug costs about $1,800 using a coupon from GoodRx, a discount drug website, she said.

Pare is among tens of thousands of Medicare beneficiaries who were on Wellcare’s Value Script drug plan who will likely go without prescription drug coverage for the rest of the year because they didn’t pay premiums for three months.

Next year, thousands more people in 32 states and Washington, D.C., who are enrolled in zero-premium drug plans from Wellcare and other insurance companies may find themselves in the same situation if their premiums go up and they don’t realize it, according to a KFF Health News analysis of drug plan data. Premiums and other changes for 2027 will be unveiled in September.

Going without medication can be life-threatening, especially for Medicare beneficiaries. Nearly 90% take one or more prescription drugs, according to the Centers for Disease Control and Prevention. Almost half live with four or more chronic health conditions that can cause functional or cognitive impairments.

By the time Jude Pare and his partner, Diane Tix, found out he owed $28.80 for three months of drug plan premiums, his coverage had been canceled. He is among tens of thousands of Medicare beneficiaries who will likely go without prescription drug coverage for the rest of the year after their drug plans were canceled. (Diane Tix)

Congress added prescription drug coverage to Medicare in 2003. But the coverage is administered by commercial insurance companies, which compete fiercely with one another for the business of about 56 million Medicare beneficiaries enrolled in drug plans.

Zero-dollar or very low monthly premiums have helped make Wellcare’s Value Script the bestselling stand-alone prescription drug plan in Medicare, with nearly 6 million customers across the U.S., according to government data. But in 26 states and Washington, D.C., some Value Script members who didn’t have to pay a premium last year were caught off guard by increases in 2026.

After a two-month grace period — which Wellcare extended to three — Medicare drug plans can drop customers who don’t pay their premiums, no matter how small the amount. Some members who lost their coverage in Nevada, for example, owed as little as $8.10 for three months, according to a KFF Health News analysis of Medicare drug plan data.

Wellcare terminated coverage for about 140,000 Value Script beneficiaries in April, according to a person with knowledge of the matter who was not authorized to speak publicly about it and feared reprisals at work for doing so. About 40,000 of the people who were dropped may be able to enroll in new coverage immediately because they have low incomes and receive financial assistance through a program Medicare calls “Extra Help.”

Multiple state officials said they had heard the same disenrollment figures, including Nevada’s insurance commissioner, Ned Gaines, who chairs the National Association of Insurance Commissioners’ senior issues task force; Rebecca Gouty, director of the State Health Insurance Assistance Program in West Virginia; and Tim Smolen, director of Washington state’s Statewide Health Insurance Benefits Advisors. The West Virginia and Washington initiatives are part of the federally funded State Health Insurance Assistance Program, or SHIP, which provides free, unbiased help navigating Medicare.

Surprise Bills

The Centers for Medicare & Medicaid Services, which oversees Medicare drug plans, declined to provide the number of Value Script members who lost coverage due to unpaid premiums. “The agency does not publicly provide plan-specific disenrollment figures or state-level breakdowns related to the non-payment of premiums,” Christopher Krepich, a spokesperson, said in a written statement to KFF Health News.

Centene Corp., Wellcare’s parent company, also declined to provide disenrollment numbers.

“We recognize how disruptive a loss of coverage can be and are committed to helping members understand their options,” said Sarah Baiocchi, senior vice president for specialty and prescription drug plans at Centene. She acknowledged that “some members in our Value Script plan experienced a premium for the first time, or for the first time in several years.”

Baiocchi said all Value Script members received a CMS-required annual notice of changes in September, before the premium increases took effect.

A version of the booklet sent to members in two states and Washington, D.C., is 21 pages long. The new premium is mentioned on pages 3 and 8, along with changes to out-of-pocket costs and how to find updates on covered drugs and network pharmacies.

The company also informed members about 2026 premium changes through phone calls, text messages, regular mail, or email, Baiocchi said.

People who are dropped are not able to reenroll or join another drug plan until the start of the open enrollment period this fall for coverage beginning Jan. 1, unless they qualify for an exception, Krepich said. And because they will have gone without coverage for at least 63 days, they could be hit with a permanent late-enrollment penalty that increases every year for the rest of their lives.

“Medicare should be doing something about this so that we can go ahead and get coverage now,” said Wayne Bennett, 74, who lives in Durham, North Carolina.

In May, he found out that Wellcare had canceled his Value Script plan because he hadn’t paid his $3.60 monthly premiums. He takes nine prescription drugs to treat his blood pressure, glaucoma, chronic obstructive pulmonary disease, and other health problems. He filled most of his prescriptions — including several at no cost — before he lost coverage. He doesn’t know what he’ll have to pay when his supply runs out.

Gouty, the West Virginia program head, said many Medicare beneficiaries arrange for their monthly drug plan premium to be automatically deducted from their Social Security benefits, and that many likely thought that choice remained in place until they changed it.

“They didn’t realize that when the plan was a zero premium in 2025, that stopped the Social Security premium deduction and they would have had to reelect it for 2026,” Gouty said.

In other words, even if they mistakenly thought the premium was still zero, Medicare beneficiaries would have needed to somehow allow Social Security to make deductions — something the agency doesn’t do — or set up a payment plan through their bank or credit card in case payment was necessary.

“That sounds goofy,” Tix said.

Centene’s Baiocchi blamed the Social Security Administration for the problem: “We believe this was a key driver of non-payment disenrollments and subsequent complaints.”

Spokespeople for the agency referred questions about the matter to CMS.

Krepich said legal requirements for drug plan enrollment and disenrollment limit what CMS can do to help beneficiaries who lose coverage for not paying their premiums.

‘Pretty Upset’

Now that Pare has no prescription drug coverage, his doctor replaced his blood thinner medication with a much less expensive drug that should be just as effective. Pare paid $111 for four other medications that used to be free under his Value Script plan. He hasn’t had to refill four more prescriptions yet and doesn’t know what they will cost, Tix said.

If Wellcare members knew about the premium increases, they could have set up direct billing or an automatic payment plan early this year before the payment grace period ended April 1. But they would have been able to fill prescriptions during the grace period, so if they didn’t see Wellcare’s notices, they likely assumed there was no problem with their coverage.

Bennett, the North Carolina man, said Wellcare used to send him text messages with health tips and reminders when it was time to pick up a prescription. He didn’t know his premium had increased from $0 to $3.60 until it was too late.

An older man with white hair stands with his arms crossed. — Wayne Bennett lost his Medicare drug coverage because he didn’t pay the premium, which was free last year but — without his knowing — went up this year. “Medicare should be doing something about this so that we can go ahead and get coverage now,” he says. (Wayne Bennett)

“I was pretty upset,” he said, when he called the company. “The premium wasn’t that much, and I was ready to pay it right off the bat. I had my credit card out ready to make the payment.”

The customer service representative wouldn’t let him pay because his coverage had been canceled, Bennett said.

Hoping to restore it, Bennett called Senior PharmAssist, a Durham nonprofit that advises Medicare beneficiaries and is one of more than 2,200 SHIP sites across the country. He was told he must wait until January to restart his drug coverage, said the group’s executive director, Gina Upchurch.

He doesn’t qualify for the “Extra Help” low-income subsidy or meet other CMS criteria for a special enrollment period, which would allow him to change drug plans during the year. CMS typically allows midyear switches for beneficiaries who, for example, move out of their plan’s service area, experience a natural disaster, or get help paying for drugs from a state program.

Senior PharmAssist was able to help one of its participants join another drug plan after she lost Value Script coverage because she is in North Carolina’s pharmacy assistance program for people with HIV/AIDS and has limited income, Upchurch said.

A further exception allows any Medicare beneficiary to enroll at any time in a drug plan that has earned five stars, the top grade in Medicare’s performance ratings. However, there are no five-star Medicare drug plans available to the general public. Only two insurers offer five-star plans, and only for retirees from certain employers. Their combined enrollment is about 8,700 as of June 1, according to the insurers.

But Upchurch, with more than two decades of Medicare expertise, doesn’t blame beneficiaries for not paying attention or for assuming Wellcare’s messages were bogus. Older adults are particularly vulnerable to identity theft and other scams and are often advised to ignore junk mail and calls from telemarketers.

Since Value Script members such as Bennett continued to get their prescriptions filled during the payment grace period, “why wouldn’t they think this was a scam?” Upchurch asked. “They are constantly bombarded by people selling them something that’s illegitimate or trying to scam them.”

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For Families With Nonspeaking Autistic Children, a Fierce Debate Over Assisted Spelling

Popular communication methods for nonspeaking autistic people have ignited a fierce debate over what counts as evidence of hidden cognitive abilities.

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New Medicaid Work Rule Means More Opportunities To Lose Coverage

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Too sick to work? You may have to prove it. Next year, Medicaid recipients will have to start showing documentation such as a doctor’s note to avoid a new work requirement. KFF Health News correspondent Sam Whitehead broke down the rule and exceptions on WAMU’s Health Hub on July 1.

A man with white hair stands behind a lectern with the seal of the President of the United States on it, and speaks into a microphone. — Centers for Medicare & Medicaid Services Administrator Mehmet Oz. (Daniel Heuer/Bloomberg via Getty Images)

Study, work, or volunteer: That’s what many people will have to do to keep their Medicaid starting next year, according to new rules issued by the Trump administration. But consumer advocates worry the new requirements will catch many recipients flat-footed.

KFF Health News correspondent Sam Whitehead joined WAMU’s Health Hub on July 1 to explain who will be affected, who can get an exemption, and what enrollees can start doing now to prepare.

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Zyn’s Popularity Has Tobacco Companies Racing to Cash In

The makers of nicotine pouches are building new plants and expanding to meet demand. While influencers claim health benefits, experts warn the products can be highly addictive.

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A Bird’s Brain Holds Clues to the Sounds of Music

The neurobiologist Erich Jarvis studies the few species capable of speech. He has long hoped to genetically engineer an animal that can make new calls.

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A Bird’s Brain Holds Clues to the Sounds of Music

The neurobiologist Erich Jarvis studies the few species capable of speech. He has long hoped to genetically engineer an animal that can make new calls.

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Clusters of Severe Stomach Illness Reported Across the U.S.

Public health experts said there were more cases than usual of the disease caused by cyclospora, which is spread through contaminated food and drink.

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Blistering Heat Expected to Persist Into the Fourth of July

While relief could come to the Great Lakes and the far Northeast over the weekend, the Mid-Atlantic and Southeast will stay hot.

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A Mom Said Infant Formula Killed Her Baby. The Manufacturer Didn’t Tell the FDA.

In September 2016, a distraught mother sent infant formula maker Mead Johnson a message:

“REMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!

“It is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU’s that my son is dead from NEC.”

The mother was referring to neonatal intensive care units and necrotizing enterocolitis, an often fatal condition in which intestinal tissue can die and allow infection to spread through the body of an infant born prematurely.

In an internal memo, Mead Johnson cited its “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the formula caused the baby’s death. “No further investigation is needed. This file can be closed,” the memo said.

And with that decision, the company narrowed the chance that the mother’s anguish could draw attention to any danger the formula might pose to other infants.

The mother’s email and the company’s memo assessing it were used as evidence in the court cases Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al.

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry.

Mead Johnson’s handling of the mother’s email showed how that can play out.

Under federal rules, if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate.

But it doesn’t always have to inform the government agency that oversees the safety of infant formula.

A company must complete an investigation and notify the Food and Drug Administration within 15 days only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”

If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

‘Never Reported’

Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications that manufacturers of infant formula sent the agency per the regulatory requirement since Jan. 1, 2020. The agency’s Human Foods Program “did not receive any,” Kimberly Jones, a government information specialist at the FDA, responded in March.

KFF Health News then asked the FDA to go back decades further — to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on May 5.

The FDA’s search results were consistent with court testimony.

John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had never reported a single death under any regulation for preterm infant formula.

Wallingford clarified that he was not referring to adverse events in clinical trials, which are studies used for research and development and are subject to different procedures. Abbott informed the FDA about adverse events that occurred during a clinical trial, Wallingford testified.

John Wallingford, an expert witness for Abbott Laboratories, testified in 2024 that, outside of clinical trials, the company had never reported to the FDA that there was a reasonable possibility a death was caused by an Abbott preterm formula, according to a transcript posted by the Missouri Court of Appeals Eastern District in an appeal of the *Whitfield v. St. Louis Children’s Hospital* case.

Christina Valentine testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven years as Mead Johnson’s medical director for North America. In the deposition, used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s death from NEC might have been related to a Mead Johnson product.

As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson trial.

In the deposition, Valentine said she wasn’t sure whether anyone else at the company sent a death report to the FDA.

In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the picture.

“Where there is a physician report that includes an opinion that one of our products caused NEC in a preterm infant, we have treated that as a ‘reasonable possibility of a causal relationship,’ and we submitted an adverse event report to the FDA,” she wrote.

“These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” she wrote.

O’Neill left unclear whether events Mead Johnson reported to the FDA were raised in lawsuits and, if so, whether the company reported them to the FDA before they surfaced in litigation.

Asked repeatedly when Mead Johnson filed the reports, O’Neill didn’t say.

It’s unclear why the FDA found no record of them.

Nor would O’Neill say whether the company submitted one related to the distraught mother’s September 2016 complaint.

That mother’s name wasn’t publicly disclosed in the court record containing her complaint.

“[P]rior to the current litigation, we received very few reports relating to our products and NEC and even fewer for which our investigation uncovered any evidence supporting a reasonable possibility of a causal relationship,” O’Neill wrote.

Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson, Whitfield, and Gill v. Abbott Laboratories cases. Company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm, records show.

‘Reprehensible’ Conduct

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost one per day, according to a KFF Health News analysis of a government data set for those years. The database doesn’t attempt to explain what caused those babies to develop NEC, and it doesn’t count babies who survived NEC.

A wave of lawsuits has alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to cases of NEC. As of late January, 1,760 NEC lawsuits were pending against Abbott, company spokesperson Scott Stoffel said, clarifying a disclosure in a regulatory filing.

This article is based largely on transcripts, deposition videos, and exhibits from three court cases that went to trial in 2024. The lawsuits were filed by parents of babies who suffered or died from NEC.

Abbott and Mead Johnson have denied fault. They, along with various medical authorities including federal regulatory agencies and the American Academy of Pediatrics, have said that, when nutritional needs can’t be met with human milk, formula is vital.

One of the cases, Watson v. Mead Johnson, led to a $60 million judgment against Mead Johnson. Another, Gill v. Abbott, led to a $495 million judgment against Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., led to a jury verdict in favor of Abbott and Mead Johnson, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and ruled the plaintiff was entitled to a new trial.

The judge’s ruling in the Whitfield case is on appeal.

On May 5, a Missouri appeals court upheld the $495 million judgment against Abbott, saying “we find Abbott’s conduct significantly reprehensible.”

“Throughout the trial, the jury heard evidence that Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk,” the court wrote.

On June 12, an Illinois appeals court reversed the $60 million judgment against Mead Johnson and sent the case back for a new trial. The trial court risked prejudicing the jury by improperly admitting evidence about Mead Johnson’s finances, including its revenues, profits, and executive compensation, the appeals court said.

In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson’s part hinged on a failure to warn, and the company’s duty was not to warn the mother in that case of any danger, as she had claimed, but rather to warn doctors, the appeals court ruled.

In April, after another trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict and the Missouri appeals court’s decision.

In at least four cases, judges have granted summary judgment in favor of Abbott — ruling for the company before the lawsuits reached trial.

‘Branding NICU Babies’

Abbott makes Similac products, and Mead Johnson makes the Enfamil line.

The two companies have vied to place their products in neonatal intensive care units, which serve as entry points to hospital contracts and the retail market, KFF Health News reported in a March article based largely on records from court cases.

For instance, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”

A Mead Johnson slide for a 2020 national sales meeting outlined a plan for “Branding NICU Babies.” The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the *Whitfield v. St. Louis Children’s Hospital* lawsuit.

The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.

“Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints,” Stoffel said in November. “FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting as part of its active regulation of infant nutrition.”

Mead Johnson’s O’Neill echoed that.

“Our adverse event reporting complies with all applicable regulatory requirements,” O’Neill said in a November statement to KFF Health News. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”

The reports the company filed with the FDA were submitted through the agency’s regional office in Detroit, she said.

It’s unclear whether the FDA looked in Detroit.

FDA rules require manufacturers to send written confirmations to a central office in the Washington area that oversees infant formula and other foods.

Asked if the company sent them to that office, O’Neill did not answer.

KFF Health News requested an interview with Mead Johnson to clarify its statements about how it handled adverse event reports. The company did not grant one.

Plaintiffs have used internal documents from the companies to allege that, in house, people have long recognized a correlation between NEC and the use of preterm formulas made from cow’s milk.

For example, in a 2010 research proposal shown in a deposition used in the Gill case, Abbott scientists wrote that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”

An Abbott document from 2010 said necrotizing enterocolitis “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.” The document was displayed in deposition video clips KFF Health News obtained from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the *Gill v. Abbott* lawsuit.

A Mead Johnson document used in the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”

Abbott has argued that correlation does not equal causation.

“Numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it’s the absence of human milk that increases NEC risk rather than anything harmful in formula,” Abbott spokesperson Stoffel said.

The FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health weighed in with a joint statement in October 2024, saying, “There is no conclusive evidence that preterm infant formula causes NEC” and “there is strong evidence that human milk is protective against NEC.”

Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.

O’Neill cited a statement by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”

In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC related risks” of a formula for preterm infants “are the subject of medical debate.”

Managing Potential Warnings

Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.

Fabrizis Suarez, who was director of medical safety and surveillance at Abbott from 2006 to 2023, said in a January 2024 deposition used in the Gill and Whitfield cases that he knew of no instance in which Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott’s formula for preterm infants.

There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.

Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.

Fabrizis Suarez, identifying himself as director of medical safety and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition about Abbott’s handling of adverse event reports. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill and Whitfield cases as director of postmarketing medical safety and surveillance at Abbott, likewise testified that she knew of no instance in which Abbott reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a death caused by NEC.

Abbott wasn’t hiding complaints from the FDA, according to testimony from Wallingford, a paid expert witness on regulatory matters who spent 10 years at the FDA. The complaints were in company files FDA inspectors reviewed during annual inspections, he said in the Whitfield case.

Wallingford also testified that inspections are not a replacement for reporting infant deaths.

Questioning Wallingford in court, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché about the fox guarding the henhouse.

Wallingford declined to comment for this article. Valentine and Colombo did not respond to messages sent via LinkedIn. Valentine and Suarez did not respond to letters mailed to addresses that appeared to be associated with them. A letter to Colombo with signature required, sent to an address apparently associated with her, was returned unopened.

Not Publicly Reported

Adverse event reports can prompt the FDA to take action to protect the public.

For example, in 2011, the FDA warned parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening gel, to premature infants fitting a particular profile. The product, used to manage swallowing difficulties, might cause NEC, the FDA said.

The FDA first learned about possible problems with SimplyThick from physicians, according to an FDA document that an attorney for Abbott, Sierra Elizabeth, read from during the Whitfield trial.

The stakes for companies and consumers are high.

A finding under the “reasonable possibility” standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.

The FDA’s handling of adverse event reports for infant formulas — and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely — contrasts with its handling of reports about drugs and medical devices.

The FDA posts manufacturers’ adverse event reports on drugs and medical devices online in databases available to the public.

But the notifications manufacturers are required to submit about formulas and fortifiers are not publicly reported, said Emily Hilliard, a spokesperson for the Department of Health and Human Services, which includes the FDA.

In addition, the FDA’s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.

Device makers must report not just deaths but also “serious injuries” that the product “may have caused or contributed to.”

Drugmakers are required to report any “serious and unexpected” adverse event, “whether or not considered drug related.” That goes beyond fatal or life-threatening events.

The FDA also maintains a public database about dietary supplements, foods, and infant formulas, among other products, that includes voluntary reports from consumers and healthcare practitioners.

KFF Health News searched that database and found one death report that mentioned NEC and a formula made for premature or low-birth-weight babies.

The search turned up seven other reports of infant deaths that mentioned NEC and fortifiers designed for premature or low-birth-weight babies. One of those reports, obtained by KFF Health News through the Freedom of Information Act, said three preterm babies at the same hospital had NEC and died within a month of one another in 2024.

The FDA cautions that reports are not verified and do not prove causation.

A former attorney for Abbott now leads the FDA.

Before becoming the FDA’s deputy commissioner for food last year and being named acting head of the agency in May, Kyle Diamantas represented Abbott in the Gill and Whitfield lawsuits, court records show.

Diamantas “complies with all applicable ethics laws and regulations,” said Hilliard, the HHS spokesperson. “That included a specific recusal related to Abbott Laboratories, which concluded in January 2026.”

“During that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,” Hilliard said.

‘No Health Hazard’

KFF Health News asked the FDA a series of questions for this article. The agency left many unanswered.

“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard said.

KFF Health News asked Abbott and Mead Johnson for data on all infant death reports the companies received and those they forwarded to the FDA. Neither company provided that information.

Court records provide fragmentary data.

Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him 789 complaint files from 2005 through 2022 that contained the search term “NEC.”

When Wallingford went through the files, he found about 130 that mentioned death and NEC, he testified.

If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, “you would expect to see tens of thousands of complaints,” Wallingford testified.

In 2010, a registered dietitian at a Cincinnati hospital notified Abbott that three babies had died of NEC shortly after starting on an Abbott formula. The dietitian thought there might be a correlation, according to an internal Abbott summary of the complaint shown during Colombo’s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.

After reviewing the complaint, Abbott’s Colombo wrote, as shown in a deposition video, that she found “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.”

“PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,” she concluded.

Courtney Colombo, who identified herself in a March 2024 deposition as director of postmarketing medical safety and surveillance at Abbott, testified about Abbott’s response to a report that three babies had died of NEC shortly after starting on an Abbott formula. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

As for Mead Johnson, Valentine “testified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,” O’Neill, the company spokesperson, told KFF Health News.

Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and parent company Reckitt’s chief medical officer from 2022 to 2023, according to a LinkedIn profile — signed off on the decision to close the 2016 file on the distraught mother’s complaint, according to an exhibit and her deposition testimony played in the Whitfield trial.

When she signed off, Mead Johnson didn’t know which of its products the complaint involved, Valentine said in the deposition.

Asked about it during the Watson trial in February 2024, Valentine testified that, in light of the mother’s request never to contact her again, it wouldn’t have been appropriate to call her back for more information.

Valentine “testified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,” Mead Johnson’s O’Neill said.

Valentine also testified that the FDA encourages infant formula companies to send in all adverse event reports and that nothing prevented Mead Johnson from doing so.

As reflected in an email thread used in the Watson case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.

“They had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,” the colleague reported.

Valentine agreed to follow up but added: “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”

A screenshot of a CVN video of a woman with shoulder-length light hair and glasses looks into a computer camera. Underneath the video image is the text "Whitfield v. St. Louis Children's Hospital, et al." and "2024-10-07". — Christina Valentine, who was Mead Johnson Nutrition’s director of medical affairs for North America, testified that she approved the decision to close the company’s file on a 2016 complaint about a baby’s death. (CVN courtroom video from the Whitfield v. St. Louis Children's Hospital, et al., trial.)

Share your story with us: Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you’d like to share? We’d like to hear from you. Click here to contact the KFF Health News reporting team.

This <a target="_blank" href="https://kffhealthnews.org/health-industry/infant-formula-adverse-events-nec-baby-deaths-fda-reporting/">article</a> first appeared on <a target="_blank" href="https://kffhealthnews.org">KFF Health News</a> and is republished here under a <a target="_blank" href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="https://kffhealthnews.org/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150" style="width:1em;height:1em;margin-left:10px;">

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