Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update

Over the past two years, Madeline Beal has heard frustration and even bewilderment during public meetings about ethylene oxide, a cancer-causing gas that is used to sterilize half of the medical devices in the U.S.

Beal, senior risk communication adviser for the Environmental Protection Agency, has fielded questions about why the agency took so long to alert people who live near facilities that emit the chemical about unusually high amounts of the carcinogenic gas in their neighborhoods. Residents asked why the EPA couldn’t close those facilities, and they wanted to know how many people had developed cancer from their exposure.

“If you’re upset by the information you’re hearing tonight, if you’re angry, if it scares you to think about risk to your family, those are totally reasonable responses,” Beal told an audience in Laredo, Texas, in September 2022. “We think the risk levels near this facility are too high.”

There are about 90 sterilizing plants in the U.S. that use ethylene oxide, and for decades companies used the chemical to sterilize medical products without drawing much attention. Many medical device-makers send their products to the plants to be sterilized before they are shipped, typically to medical distribution companies.

But people living around these facilities have been jolted in recent years by a succession of warnings about cancer risk from the federal government and media reports, an awareness that has also spawned protests and lawsuits alleging medical harm.

The EPA is expected to meet a March 1 court-ordered deadline to finalize tighter safety rules around how the toxic gas is used. The proposed changes come in the wake of a 2016 agency report that found that long-term exposure to ethylene oxide is more dangerous than was previously thought.

But the anticipated final rules — the agency’s first regulatory update on ethylene oxide emissions in more than a decade — are expected to face pushback. Medical device-makers worry stricter regulation will increase costs and may put patients at higher risk of infection from devices, ranging from surgical kits to catheters, due to deficient sterilization. The new rules are also not likely to satisfy the concerns of environmentalists or members of the public, who already have expressed frustration about how long it took the federal government to sound the alarm.

“We have been breathing this air for 40 years,” said Connie Waller, 70, who lives with her husband, David, 75, within two miles of such a sterilizing plant in Covington, Georgia, east of Atlanta. “The only way to stop these chemicals is to hit them in their pocketbook, to get their attention.”

The EPA says data shows that long-term exposure to ethylene oxide can increase the risk of breast cancer and cancers of the white blood cells, such as non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. It can irritate the eyes, nose, throat, and lungs, and has been linked to damage to the brain and nervous and reproductive systems. Children are potentially more vulnerable, as are workers routinely exposed to the chemical, EPA officials say. The agency calculates the risk based on how much of the gas is in the air or near the sterilizing facility, the distance a person is from the plant, and how long the person is exposed.

Waller said she was diagnosed with breast cancer in 2004 and that her husband was found to have non-Hodgkin lymphoma eight years later.

A 2022 study of communities living near a sterilization facility in Laredo found the rates of acute lymphocytic leukemia and breast cancer were statistically significant, greater than expected compared with statewide rates.

Beal, the EPA risk adviser, who regularly meets with community members, acknowledges the public’s concerns. “We don’t think it’s OK for you to be at increased risk from something that you have no control over, that’s near your house,” she said. “We are working as fast as we can to get that risk reduced with the powers that we have available to us.”

In the meantime, local and state governments and industry groups have scrambled to defuse public outcry.

Hundreds of personal injury cases have been filed in communities near sterilizing plants. In 2020, New Mexico’s then-attorney general filed a lawsuit against a plant in Santa Teresa, and that case is ongoing. In a case that settled last year in suburban Atlanta, a company agreed to pay $35 million to 79 people who alleged ethylene oxide used at the plant caused cancer and other injuries.

In Cook County, Illinois, a jury in 2022 awarded $363 million to a woman who alleged exposure to ethylene oxide gas led to her breast cancer diagnosis. But, in another Illinois case, a jury ruled that the sterilizing company was not liable for a woman’s blood cancer claim.

Greg Crist, chief advocacy officer for the Advanced Medical Technology Association, a medical device trade group that says ethylene oxide is an effective and reliable sterilant, attributes the spate of lawsuits to the litigious nature of trial attorneys.

“If they smell blood in the water, they’ll go after it,” Crist said.

Most states have at least one sterilizing plant. According to the EPA, a handful, like California and North Carolina, have gone further than the agency and the federal Clean Air Act to regulate ethylene oxide emissions. After a media and political firestorm raised awareness about the metro Atlanta facilities, Georgia started requiring sterilizing plants that use the gas to report all leaks.

The proposed rules the EPA is set to finalize would set lower emissions limits for chemical plants and commercial sterilizers and increase some safety requirements for workers within these facilities. The agency is expected to set an 18-month deadline for commercial sterilizers to come into compliance with the emissions rules.

That would help at facilities that “cut corners,” with lax pollution controls that allow emissions of the gas into nearby communities, said Richard Peltier, a professor of environmental health sciences at the University of Massachusetts-Amherst. Stronger regulation also prevents the plants from remaining under the radar. “One of the dirty secrets is that a lot of it is self-regulated or self-policed,” Peltier added.

But the proposed rules did not include protections for workers at off-site warehouses that store sterilized products, which can continue to emit ethylene oxide. They also did not require air testing around the facilities, prompting debate about how effective they would be in protecting the health of nearby residents.

Industry officials also don’t expect an alternative that is as broadly effective as ethylene oxide to be developed anytime soon, though they support researching other methods. Current alternatives include steam, radiation, and hydrogen peroxide vapor.

Increasing the use of alternatives can reduce industry dependence on “the crutch of ethylene oxide,” said Darya Minovi, senior analyst with the Union of Concerned Scientists, an advocacy group.

But meeting the new guidelines will be disruptive to the industry, Crist said. He estimates companies will spend upward of $500 million to comply with the new EPA rules and could struggle to meet the agency’s 18-month timetable. Sterilization companies will also have difficulty adjusting to new rules on how workers handle the gas without a dip in efficiency, Crist said.

The Food and Drug Administration, which regulates drugs and medical devices, is also watching the regulatory moves closely and worries the updated emissions rule could “present some unique challenges” if implemented as proposed, said Audra Harrison, an FDA spokesperson. “The FDA is concerned about the rule’s effects on the availability of medical devices,” she added.

Other groups, like the American Chemistry Council and the Texas Commission on Environmental Quality, the state’s environmental agency, assert that ethylene oxide use isn’t as dangerous as the EPA says. The EPA’s toxicity assessment has “severe flaws” and is “overly conservative,” the council said in an emailed statement. Texas, which has several sterilizing plants, has said ethylene oxide isn’t as high a cancer risk as the agency claims, an assessment that the EPA has rejected.

Tracey Woodruff, a researcher at the University of California-San Francisco who previously worked at the EPA, said it can be hard for the agency to keep up with regulating chemicals like ethylene oxide because of constrained resources, the technical complications of rulemaking, and industry lobbying.

But she’s hopeful the EPA can strike a balance between its desire to reduce exposure and the desire of the FDA not to disrupt medical device sterilization. And scrutiny can also help the device sterilization industry think outside the box.

“We continue to discover these chemicals that we’ve already been exposed to were toxic, and we have high exposures,” she said. “Regulation is an innovation forcer.”

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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Without Medicare Part B’s Shield, Patient’s Family Owes $81,000 for a Single Air-Ambulance Flight

Debra Prichard was a retired factory worker who was careful with her money, including what she spent on medical care, said her daughter, Alicia Wieberg. “She was the kind of person who didn’t go to the doctor for anything.”

That ended last year, when the rural Tennessee resident suffered a devastating stroke and several aneurysms. She twice was rushed from her local hospital to Vanderbilt University Medical Center in Nashville, 79 miles away, where she was treated by brain specialists. She died Oct. 31 at age 70.

One of Prichard’s trips to the Nashville hospital was via helicopter ambulance. Wieberg said she had heard such flights could be pricey, but she didn’t realize how extraordinary the charge would be — or how her mother’s skimping on Medicare coverage could leave the family on the hook.

Then the bill came.

The Patient: Debra Prichard, who had Medicare Part A insurance before she died.

Medical Service: An air-ambulance flight to Vanderbilt University Medical Center.

Service Provider: Med-Trans Corp., a medical transportation service that is part of Global Medical Response, an industry giant backed by private equity investors. The larger company operates in all 50 states and says it has a total of 498 helicopters and airplanes.

Total Bill: $81,739.40, none of which was covered by insurance.

What Gives: Sky-high bills from air-ambulance providers have sparked complaints and federal action in recent years.

For patients with private insurance coverage, the No Surprises Act, which went into effect in 2022, bars air-ambulance companies from billing people more than they would pay if the service were considered “in-network” with their health insurers. For patients with public coverage, such as Medicare or Medicaid, the government sets payment rates at much lower levels than the companies charge.

But Prichard had opted out of the portion of Medicare that covers ambulance services.

That meant when the bill arrived less than two weeks after her death, her estate was expected to pay the full air-ambulance fee of nearly $82,000. The main assets are 12 acres of land and her home in Decherd, Tennessee, where she lived for 48 years and raised two children. The bill for a single helicopter ride could eat up roughly a third of the estate’s value, said Wieberg, who is executor.

The family’s predicament stems from the complicated nature of Medicare coverage.

Prichard was enrolled only in Medicare Part A, which is free to most Americans 65 or older. That section of the federal insurance program covers inpatient care, and it paid most of her hospital bills, her daughter said.

But Prichard declined other Medicare coverage, including Part B, which handles such things as doctor visits, outpatient treatment, and ambulance rides. Her daughter suspects she skipped that coverage to avoid the premiums most recipients pay, which currently are about $175 a month.

Loren Adler, a health economist for the Brookings Institution who studies ambulance bills, estimated the maximum charge that Medicare would have allowed for Prichard’s flight would have been less than $10,000 if she’d signed up for Part B. The patient’s share of that would have been less than $2,000. Her estate might have owed nothing if she’d also purchased supplemental “Medigap” coverage, as many Medicare members do to cover things like coinsurance, he said.

Nicole Michel, a spokesperson for Global Medical Response, the ambulance provider, agreed with Adler’s estimate that Medicare would have limited the charge for the flight to less than $10,000. But she said the federal program’s payment rates don’t cover the cost of providing air-ambulance services.

“Our patient advocacy team is actively engaged with Ms. Wieberg’s attorney to determine if there was any other applicable medical coverage on the date of service that we could bill to,” Michel wrote in an email to KFF Health News. “If not, we are fully committed to working with Ms. Wieberg, as we do with all our patients, to find an equitable solution.”

The Resolution: In mid-February, Wieberg said the company had not offered to reduce the bill.

Wieberg said she and the attorney handling her mother’s estate both contacted the company, seeking a reduction in the bill. She said she also contacted Medicare officials, filled out a form on the No Surprises Act website, and filed a complaint with Tennessee regulators who oversee ambulance services. She said she was notified Feb. 12 that the company filed a legal claim against the estate for the entire amount.

Wieberg said other health care providers, including ground ambulance services and the Vanderbilt hospital, wound up waiving several thousand dollars in unpaid fees for services they provided to Prichard that are normally covered by Medicare Part B.

But as it stands, Prichard’s estate owes about $81,740 to the air-ambulance company.

More from Bill of the Month

The Takeaway: People who are eligible for Medicare are encouraged to sign up for Part B, unless they have private health insurance through an employer or spouse.

“If someone with Medicare finds that they are having difficulty paying the Medicare Part B premiums, there are resources available to help compare Medicare coverage choices and learn about options to help pay for Medicare costs,” Meena Seshamani, director of the federal Center for Medicare, said in an email to KFF Health News.

She noted that every state offers free counseling to help people navigate Medicare.

In Tennessee, that counseling is offered by the State Health Insurance Assistance Program. Its director, Lori Galbreath, told KFF Health News she wishes more seniors would discuss their health coverage options with trained counselors like hers.

“Every Medicare recipient’s experience is different,” she said. “We can look at their different situations and give them an unbiased view of what their next best steps could be.”

Counselors advise that many people with modest incomes enroll in a Medicare Savings Program, which can cover their Part B premiums. In 2023, Tennessee residents could qualify for such assistance if they made less than $1,660 monthly as a single person or $2,239 as a married couple. Many people also could obtain help with other out-of-pocket expenses, such as copays for medical services.

Wieberg, who lives in Missouri, has been preparing the family home for sale.

She said the struggle over her mother’s air-ambulance bill makes her wonder why Medicare is split into pieces, with free coverage for inpatient care under Part A, but premiums for coverage of other crucial services under Part B.

“Anybody past the age of 70 is likely going to need both,” she said. “And so why make it a decision of what you can afford or not afford, or what you think you’re going to use or not use?”

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about 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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California Gov. Newsom Wants Voters to Approve Billions More to Help the Homeless. Will It Help?

SACRAMENTO, Calif. — California voters will decide March 5 whether to pump billions more dollars into combating the nation’s worst homelessness crisis, an investment Democratic Gov. Gavin Newsom argues will finally provide the housing and treatment so badly needed by tens of thousands of homeless people.

Newsom is spearheading Proposition 1, a $6.4 billion bond he says would fund 11,150 new beds and housing units for people living on the streets with untreated mental illness or addiction, and ongoing capacity for 26,700 additional outpatient appointments. It would also alter how $3 billion to $4 billion in existing annual tax funding for mental health services is spent, funneling a hefty portion of it into housing.

Many authorities on mental health and homelessness agree California desperately needs thousands more housing units and treatment beds to successfully attack the growing public health crisis. Health and law enforcement groups have lined up behind the initiative, as have the mayors of the state’s major cities.

Homelessness statistics in California have risen a staggering 20% since Newsom took office in 2019, to more than 180,000 people — 68% of them on the streets and not in shelters. The numbers are growing despite Newsom’s unprecedented investment of more than $20 billion in homelessness programs, plus billions more for health and social services.

Yet many of the front-line workers implementing Newsom’s initiatives fear that Proposition 1 would simply pour more money into a broken homelessness response system that is largely failing to house those in need.

Rather than focus on getting homeless people into mental health and addiction programs — and ultimately into housing — many caseworkers say they waste precious time and taxpayer dollars searching for their homeless clients after encampments have been cleared by state and local officials, a policy Newsom has encouraged, not only for the safety of homeless people but for those in surrounding neighborhoods.

Once they locate their clients, advocates must help them — often repeatedly — obtain food, clothing, and medication refills, and replace official government documents like birth certificates and IDs. “You can’t get housing without that stuff,” said Afton Francik, an outreach worker with the Sacramento-based nonprofit Hope Cooperative, which is implementing several of Newsom’s homelessness and mental health initiatives.

Perhaps the biggest challenge they face, outreach workers and case managers say, is rebuilding the trust that took time to establish — and which they say is essential to getting people into treatment and housing.

“It makes it so much harder to even find people or help them get into housing because you have to go back and repeat that work you already did,” Francik said.

Newsom says California has placed at least 71,000 people indoors — either in permanent or temporary housing — since he took office in 2019. State money flows to cities and counties, which have opened at least 15,000 housing units and 2,485 residential treatment beds, plus additional outpatient capacity, during his tenure.

Newsom has also revamped health programs to get people off the streets, including a massive $12 billion transformation of the state Medicaid health insurance program that provides some patients with housing and one-on-one case management services.

As he promotes Proposition 1, Newsom is calling for stricter enforcement, saying he feels a deep responsibility to keep California’s streets clean and safe, and to respond to growing neighborhood concerns about trash, mental illness, crime, and drugs. He has acknowledged that sweeps can traumatize homeless people but argues that local officials who receive state money to clear encampments are supposed to find shelter or treatment for those displaced.

Sacramento County Sheriff Jim Cooper, who supports Proposition 1, said sweeps are sometimes necessary for public health and safety.

“This is a huge drain on public resources and emergency services,” Cooper said. “Drugs are everywhere. There is so much mental illness. We’ve got to get these folks the help and treatment they need.”

But critics of the sweeps argue that it’s inhumane to forcibly move people without providing shelter or housing. “We’re seeing a ton of enforcement, but there’s literally nowhere to put people,” said Crystal Sanchez, president of the Sacramento Homeless Union.

Newsom acknowledged the state doesn’t have enough housing for everyone who needs it, and that Proposition 1 is part of the solution. The measure would expand his existing housing and treatment programs, which do not trigger the land use and environmental reviews that often delay or kill new projects.

“We are in a unique position to take what we have been promoting — these promises — and make them real,” Newsom said in January.

Like all of Newsom’s homeless housing initiatives, Proposition 1 would rely on outreach teams and caseworkers to help homeless people obtain services and housing.

But in boots-on-the-ground interviews from rural Northern California to San Diego, such workers said it would be difficult to get more people into housing if they must continue picking up the pieces after encampment clearings — a policy the U.S. Supreme Court will scrutinize in April.

The question the court will consider is whether to allow criminal or civil penalties against homeless people living outdoors if no shelter or housing is available. Newsom said in an amicus brief that cities and counties should be allowed to clear encampments, signaling he has no plans to retreat from the policy.

“When encampments are being cleared by law enforcement, it totally upends people’s lives and violates that trust in a way that they’re going to be more resistant to help,” said Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, whose California chapter supports the ballot initiative. “If someone has a mental illness and is unhoused, trust is the most important thing in trying to engage them in treatment and actually getting them into housing.”

Take Samuel Buckles, a longtime Sacramento resident who said he struggles with mental health and is addicted to fentanyl. Buckles, 53, lost his home in a fire and then his job early in the covid-19 pandemic. Since then, he has worked odd jobs as a handyman and purchased a recreational vehicle that he parked around Sacramento and called home.

When law enforcement officials cleared his camp in early February, they confiscated his RV because he had allowed the registration to lapse. He lost his birth certificate and Social Security card, all his medications for diabetes and high blood pressure, his extra clothing, and a fridge packed with groceries he’d recently purchased with his food stamp benefits.

“That was my home and everything I had in the world,” Buckles said on a cold February morning from his new form of shelter: a tent donated by outreach workers.

It was the first time in years he said he had truly felt homeless.

In mid-February, law enforcement cleared the encampment he had relocated to, forcing him to move again. Feeling despondent, he said he had given up on the promise of housing. “Please make this pain stop. I don’t know how much more I can take,” he said.

Buckles was able to grab a few possessions from his RV after it was confiscated, but replacing the documents he needs for housing may take months and repeat visits by outreach workers, said Greg Stupplebeen, an outreach manager with Hope Cooperative.

Even if Buckles had his paperwork in order, “there’s nowhere to put anybody right now,” Stupplebeen told him.

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

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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KFF Health News' 'What the Health?': Alabama Court Rules Embryos Are Children. What Now?

The Host

Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The Alabama Supreme Court’s groundbreaking ruling last week that frozen embryos have legal rights as people has touched off a national debate about the potential fallout of the “personhood” movement. Already the University of Alabama-Birmingham has paused its in vitro fertilization program while it determines the ongoing legality of a process that has become increasingly common for those wishing to start a family. 

Meanwhile, former President Donald Trump is reportedly leaning toward endorsing a national, 16-week abortion ban. At the same time, former aides are planning a long agenda of reproductive health restrictions should Trump win a second term.

This week’s panelists are Julie Rovner of KFF Health News, Lauren Weber of The Washington Post, Rachana Pradhan of KFF Health News, and Victoria Knight of Axios.

Panelists

Victoria Knight Axios @victoriaregisk Read Victoria's stories. Rachana Pradhan KFF Health News @rachanadpradhan Read Rachana's stories. Lauren Weber The Washington Post @LaurenWeberHP Read Lauren's stories.

Among the takeaways from this week’s episode:

  • The Alabama Supreme Court’s decision on embryonic personhood could have wide-ranging implications beyond reproductive health care, with potential implications for tax deductions, child support payments, criminal law, and much more.
  • Donald Trump is considering a national abortion ban at 16 weeks of gestation, according to recent reports. It is unclear whether such a ban would go far enough to please his conservative supporters, but it would be far enough to give Democrats ammunition to campaign on it. And some are looking into using a 19th-century anti-smut law, the Comstock Act, to implement a national ban under a new Trump presidency — no action from Congress necessary.
  • New reporting from KFF Health News draws on many interviews with clinicians at Catholic hospitals about how the Roman Catholic Church’s directives dictate the care they may offer patients, especially in reproductive health. It also draws attention to the vast number of religiously affiliated hospitals and the fact that, for many women, a Catholic hospital may be their only option.
  • Questions about President Joe Biden’s cognitive health are drawing attention to ageism in politics — as well as in American life, with fewer people taking precautions against the covid-19 virus even as it remains a serious threat to vulnerable people, especially the elderly. The mental fitness of the nation’s leaders is a valid, relevant question for many voters, though the questions are also fueled by frustration with a political system in which many offices are held by older people who have been around a long time.

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

Julie Rovner: Stat’s “New CMS Rules Will Throttle Access Researchers Need to Medicare, Medicaid Data,” by Rachel M. Werner.

Lauren Weber: The Washington Post’s “They Take Kratom to Ease Pain or Anxiety. Sometimes, Death Follows,” by David Ovalle.

Rachana Pradhan: Politico’s “Red States Hopeful for a 2nd Trump Term Prepare to Curtail Medicaid,” by Megan Messerly.

Victoria Knight: ProPublica’s “The Year After a Denied Abortion,” by Stacy Kranitz and Kavitha Surana.

Also mentioned on this week’s podcast:

Credits

Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on SpotifyApple PodcastsPocket 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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Lawsuits Claim South Carolina Kids Underwent Unnecessary Genital Exams During Abuse Investigations

Warning: Some readers may find graphic details in this article to be offensive or disturbing.

CAMDEN, S.C. — Three ongoing federal lawsuits filed in South Carolina accuse the state of forcing boys and girls to undergo traumatic genital exams during child abuse investigations, even when no allegations of sexual abuse have been raised.

One 14-year-old plaintiff — who goes by “Jane Doe” to protect her privacy — was placed into foster care in 2021 after she disclosed to a social services caseworker that her mother had spanked her with a belt and a tree branch.

“I never, ever mentioned sexual abuse,” said Jane, who was 12 when the South Carolina Department of Social Services launched its investigation and scheduled her to undergo a forensic medical exam at a hospital in Columbia. “I felt like I was kind of getting legally abused by someone that had the permission to do it,” she told KFF Health News during an interview at her attorney’s office.

During the exam, Jane was instructed to undress and open her legs in front of medical providers she’d never met before who took photos of her genital area, touched her breasts, and placed “fingers and/or instruments” in her vagina, according to her lawsuit.

“I felt like I had no right to say no,” she told KFF Health News. “Something inside me told me that wasn’t what they were supposed to do.”

Connelly-Anne Ragley, a spokesperson for the department, would not discuss the ongoing lawsuits. Court filings show the agency denies the allegations and argues that its employees are protected by “qualified immunity,” a type of court-created rule that often shields law enforcement officers and government officials from being sued. The department also asserts that forensic exams are “standard procedure” during abuse and neglect cases.

Investigating child abuse is notoriously complex. The investigations usually involve forensic interviews, which are typically recorded and involve a professional asking questions of a child to elicit information. And they sometimes include forensic full-body medical examinations that include a visual check of the child’s private parts and are designed to be noninvasive, meaning medical tools that can break the skin or enter the body are not used.

Together, the interview and the exam are considered effective tools for gathering information and evidence from underage victims, who may be reluctant to describe or disclose how they’ve been hurt. Often, these interviews and exams are conducted at children’s advocacy centers by social workers, doctors, and nurses who are specially trained to treat young patients with sensitivity and care — and learn to read between the lines.

Federal guidelines advise that the mere suspicion of child sexual abuse should be sufficient to trigger a forensic medical exam. Even so, there’s a growing consensus in medicine that genital and pelvic exams can be embarrassing, uncomfortable, and even traumatic.

The South Carolina lawsuits — which involve children who live in different parts of the state and who were assigned to different social services caseworkers — aren’t the first to raise red flags about the potentially harmful effects of forensic medical exams on children. Since the 1990s, federal courts from New York to California have ruled that government agencies violate children’s and parents’ civil rights when the exams are conducted without a court order or parental consent.

Claims that the exams are comparable to normal pediatric checkups are “garbage,” said Donnie Cox, a civil rights attorney in Carlsbad, California.

“At the time they’re happening, they’re scary as hell and it really does traumatize children on top of the trauma of being removed from their homes,” said Cox, who has represented plaintiffs in similar lawsuits. “They’re using these kids, basically, as pieces of evidence, and you can’t do that.”

‘A Fishing Expedition’

In one South Carolina lawsuit, a 16-year-old girl claims she was subjected to painful vaginal exams against her will, even after she denied being sexually abused. She felt as if she was “being raped” during the forensic medical exam, her complaint asserts.

In another lawsuit, a couple living in the north-central part of the state allege their sons were subjected to genital and rectal exams, without the parents’ knowledge or consent, more than a month after the children had been removed from their home in 2021. Their oldest son bruised his arms on playground equipment, they contend, instigating a child abuse investigation that resulted in all three boys temporarily moving in with their grandparents. Their youngest son was 6 months old at the time.

No one alleged during the investigation that the boys had been sexually abused, the lawsuit states, and yet the boys’ “penises were held and touched by strangers” during the forensic exam and “fingers and/or instruments were placed in their anus,” the lawsuit states.

The parents, whose names KFF Health News chose to withhold to protect the identity of their children, said their middle child suffers from night terrors because of the forensic examination. The oldest doesn’t talk about what happened in the exam room, his mother said.

“Because we didn’t know” what was going to happen, she said, “nobody could prepare him.”

Attorneys Deborah and Robert Butcher of the Foster Care Abuse Law Firm, who represent plaintiffs in all three South Carolina cases, have likened these forensic medical exams to “a fishing expedition.” One lawsuit they filed against the Department of Social Services argues the agency is financially motivated to find evidence of any form of child abuse so that it qualifies for more money from the federal government.

“They’re going to use every means possible to build a case,” Robert Butcher said. He estimated “easily thousands” of children in South Carolina have been forced to get unnecessary exams during child abuse investigations in recent years — an approximation he made based on child protective services intake data.

Ragley, the Department of Social Services spokesperson, said the agency is required by state law to follow the South Carolina Child Abuse Response Protocol to determine when children should be referred for a forensic medical evaluation, which includes “a complete and thorough medical history from the child (if verbal) and caregivers and a head to toe physical examination, including the anogenital area.”

In response to a Freedom of Information Act request filed by KFF Health News, the department said it couldn’t estimate how many forensic medical exams are conducted on children of any age in South Carolina each year.

“That is not a question SCDSS can answer,” Kaitlin Stout, the agency’s manager of policy and practice standards with the Office of Strategic Planning and Innovation, replied via email. “We do not track or tally how many forensic exams are ‘ordered/conducted’ in open DSS cases and would have no way to know how many are conducted on children who are not involved with the agency.”

But children’s advocacy centers, where many of these exams are conducted, do keep track, and national data shows that about 1 in 4 child abuse victims who are served by a children’s advocacy center get a forensic medical exam, said Teresa Huizar, chief executive officer of the National Children’s Alliance, which represents nearly 1,000 children’s advocacy centers in the U.S.

These numbers don’t capture all forensic medical exams, though, which may also be conducted in emergency departments and private clinics, Huizar said.

“I would say that they tend to be under-utilized,” she said. “Often, children who would very much benefit from an exam don’t get them because there simply isn’t enough money in the public pool.”

The cost of these exams varies by location. But in Georgia, for example, a pediatric anogenital exam with a colposcope, a medical tool used for magnification, is about $280, exclusive of lab fees, according to the Georgia Crime Victims Compensation Program.

The Right to Refuse

Child welfare experts agree that forensic medical evaluations can be worthwhile outside the strict scope of child sexual abuse investigations.

South Carolina’s Child Abuse Response Protocol indicates these exams should be conducted during investigations if children have witnessed violence or been exposed to an environment where drugs are used. An overt allegation or disclosure of child sexual abuse isn’t considered a prerequisite for a forensic medical exam, said Thomas Knapp, executive director of the South Carolina Network of Children’s Advocacy Centers.

“Children are often poly-victimized, so the head-to-toe exam is intended to ensure general well-being and pick up on evidence of any form of abuse,” Knapp explained. “There are also some children where there may be no disclosure, but we have digital images of their abuse. So, disclosure is not the only precipitating reason to request an exam.”

Like Huizar, he agreed that forensic medical exams are under-utilized. In South Carolina, specifically, more than 4,500 children passed through a children’s advocacy center with a report of sexual abuse in 2023. Only about half as many had received a forensic medical exam through mid-October, Knapp said.

State rules allow the Department of Social Services to request a forensic medical evaluation without consent from a child’s parent or legal guardian. But the rules don’t address the issue of obtaining the child’s permission before proceeding with an exam. Knapp explained that children’s advocacy centers allow patients to refuse. Federal Justice Department recommendations published in 2016 explicitly advise that children should be allowed to refuse participation in all or part of the process.

“If a patient refuses, we don’t do it,” said Anne-Marie Amies Oelschlager, a pediatric and adolescent gynecologist in Seattle. Genital exams for girls should be conducted only externally, in most cases, she said, even when sexual abuse is suspected. Internal exams and Pap smears to screen for cervical cancer aren’t recommended until age 21, according to the American College of Obstetricians and Gynecologists.

“You really want to teach kids to say no,” Oelschlager said. “This is an area that’s private and if they say no, I’ve got to respect that.”

One South Carolina lawsuit contends a 16-year-old girl was visibly “terrified and emotionally upset concerning the forensic medical exam” and that she told the medical examiner to stop. The medical examiner allegedly ignored the request.

Antoinette Laskey, a Utah pediatrician and member of the American Academy of Pediatrics’ Council on Child Abuse and Neglect, had no knowledge of the South Carolina cases but explained that a child’s wishes must be respected in the exam room, where the “inherent power differential” between a doctor and patient should be recognized.

“I would never force the issue,” she said.

In 2022, Laskey co-authored a policy statement for the American Academy of Pediatrics acknowledging that children are “especially vulnerable” to being exploited in health care settings because of their age, development level, any disability, race, ethnicity, or English language proficiency. The paper cited flagrant examples of abuse inflicted by doctors like Larry Nassar, who pleaded guilty in 2017 to sexually abusing child gymnasts under the guise of legitimate medical care.

The policy statement explained that pediatricians are responsible for assessing children’s health, including their genital health, from birth through puberty. To that end, the academy advises doctors to use sensitivity and care during anogenital exams. Children should be afforded privacy when disrobing, providers should wear gloves, and doctors should obtain permission from the child by discussing the need for the examination and what it will entail.

These exams “should never be traumatic,” said Megan Lechner, chief operating officer of the International Association of Forensic Nurses, a group that trains nurses to conduct sexual assault exams on adults and children. More than anything else, they are designed “to tell the child they’re OK,” she said. “If they’re traumatic, you’re doing it wrong.”

‘A Needle in a Haystack’

And yet courts have recognized the potentially traumatic impact of these exams before. In 2019, an Alabama judge rejected a motion that would have required child victims who were raped and abused by adults to undergo court-ordered vaginal examinations. One of the prosecutors successfully argued that the exams would “victimize the children all over again,” the Montgomery Advertiser reported.

Like many victims, the children in that case had delayed reporting the abuse. Shame and fear often prevent child victims from reporting sexual abuse right away. Some wait years before disclosing they were abused — if they ever disclose the abuse at all.

Children’s advocacy centers across the U.S. investigated nearly 250,000 cases involving child sexual abuse allegations in 2022, the National Children’s Alliance reported, but historical data shows that physical evidence is present in fewer than 5% of all reported cases.

Finding proof “is a needle in the haystack,” Laskey said.

Attorney Robert Butcher said the federal lawsuits in South Carolina may eventually be consolidated for the sake of efficiency. He doubted they would be resolved this year, but said cases already decided in favor of children and their parents in other parts of the country bolster his clients’ arguments.

In 1994, for example, a federal judge in New York found that a kindergartner who had been separated from her parents during a child abuse investigation “almost certainly did, in fact, experience psychological injury” during a forensic medical exam, when she was “subjected to intrusive bodily examinations by two strangers, in a strange location, in the absence of a parent or other reassuring figure.”

More recently, a panel of federal appeals court judges in California ruled in 2018 that the County of San Diego violated the constitutional rights of a family by failing to inform the parents that their children would undergo “significantly intrusive” and “potentially painful” forensic medical exams.

“This is as traumatic for the parents as it is for the children,” said Cox, the California attorney who represented the family in that case.

Jane Doe, who filed the first of the three South Carolina lawsuits, doesn’t know what the outcome of her case will be, and she doesn’t talk about it at middle school.

“I have a couple of close friends,” she said. “I don’t tell anybody about what happened. I just want this to be an example so that never happens to another person.”

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 Care Workers Push for Their Own Confidential Mental Health Treatment

States are redefining when medical professionals can get mental health treatment without risking notifying the boards that regulate their licenses.

Too often, health care workers wait to seek counseling or addiction treatment, causing their work and patient care to suffer, said Jean Branscum, CEO of the Montana Medical Association, an industry group representing doctors.

“They’ve invested so much time in their career,” Branscum said. “To have anything jeopardize that is a big worry on their mind.”

Montana, like other states, has a recovery program for health professionals who have a substance use disorder or mental illness. However, medical associations say such programs often come with invasive monitoring, even for voluntary care. And gray areas about when a mental illness should become public breeds fear that seeking care jeopardizes a medical career.

Montana is among the states looking to boost confidential care for health professionals as long as they’re not deemed a danger to themselves or patients. In recent years, at least a dozen states have considered or created confidential wellness programs to offer clinicians help early on for career burnout or mental health issues. States have also reworked medical licensing questions to avoid scrutiny for providers who need mental health treatment. The changes are modeled after Virginia legislation from 2020.

During a legislative committee meeting last month, advocates for Montana medical professionals asked state lawmakers to follow Virginia’s lead. They say the goal is twofold: to get clinicians treatment before patients are at risk and to curtail the workforce burnout that’s partly fueled by untreated stress.

Montana’s existing medical monitoring program, the Montana Recovery Program, is run by the global company Maximus. Montana’s professional advocates had backed another nonprofit to run Montana’s program, which didn’t win the state contract.

The Montana Recovery Program declined a request for an interview, instead referring KFF Health News to the Montana Department of Labor & Industry, which oversees the state’s medical licensing boards. Department staffers didn’t comment by deadline.

In a Medscape survey released this year, 20% of physicians said they felt depressed, with job burnout as a leading factor. The majority said confiding in other doctors wasn’t practical. Some said they might not tell anyone about their depression out of fear people would doubt their abilities, or that their employer or medical board could find out.

Health professionals are leaving their jobs. They’re retiring early, reducing work hours, or switching careers. That further dwindles patients’ care options when there already aren’t enough providers to go around. The federal government estimates 74 million people live in an area without enough primary care services due to a workforce shortage.

Aiming to ensure patient safety, state medical boards can suspend or revoke clinicians’ rights to practice medicine if substance use or psychological disorders impair their work. Those cases are rare. One study found roughly 4,400 actions against the licenses of U.S. physicians for either substance use or psychological impairment from 2004 to 2020.

Nonetheless, workforce advocates say disclosure requirements cause some health professionals to dodge questions about mental health histories on licensing and insurance forms or forgo care altogether. They’re worried divulging any weakness will signal they shouldn’t practice medicine.

The mental health questions health workers are asked vary by state and profession. For example, nurses in Montana renewing their license are asked if they have any psychological condition or substance use that limited their ability to practice “with reasonable skill and safety” in the previous six months. Along with being asked about substance use on the job, doctors are required to say whether they’ve experienced a mental condition that “might adversely affect any aspect of your ability to perform.”

“When I see that question on my renewal, do I have to report that I was depressed because I was going through a really tough divorce?” Branscum cited as an example of workers’ uncertainty. “You know, my life is turned upside down now. Am I obligated to report that?”

A “yes” wouldn’t immediately result in licensing problems. Those who do report mental health troubles would be flagged by state workers as a potential concern. They could end up before the board’s same screening panel that recommends whether to revoke a license, or be referred to long-term monitoring with regular screening.

Additionally, health professionals are required to report when other clinicians show unprofessionalism or have potential issues that affect performance. Branscum said medical professionals worry that what they say in a counseling session could be flagged for licensing boards, or that a co-worker may make a report if they seem depressed at work.

Bob Sise, a Montana addiction psychiatrist and co-founder of the nonprofit 406 Recovery, told state lawmakers that job stressors are playing into workers’ mental health challenges, such as long shifts and heavy patient loads. And with the rising cost of health care, physicians feel they’re sacrificing their commitment to healing as they routinely substitute optimal treatment for lesser care that patients can afford.

Sise said his practice now has roughly 20 health professionals as patients.

“They were able to access care before it was too late,” Sise said. “But they’re the exception.”

In Virginia, doctors, nurses, physician assistants, pharmacists, and students can join the state’s SafeHaven program. Melina Davis, CEO of the Medical Society of Virginia, said the service offers counseling and peer coaching with staffers available to answer a call 24/7.

“If you only have a moment at 2 a.m., or that’s when you had the chance to first process the death of a patient, then you can talk to somebody,” Davis said.

Those in the program are assured that those conversations are privileged and can’t be used in lawsuits. This year, the state is considering adding medical diagnoses under the program’s confidential protections.

States that have followed suit have slight variations, but most create a “safe haven” with two types of wellness and reporting systems. Those who seek out care before they’re impaired at work have broad privacy protections. The other defines a disciplinary track and monitoring system for those who pose a risk to themselves or others. Indiana and South Dakota followed Virginia’s lead in 2021.

States are also narrowing the time frame that licensing boards can ask about mental illness history. The American Medical Association has encouraged states to require health care workers to disclose current physical or mental health conditions, not past diagnoses.

Last year, Georgia updated its license renewal form to ask doctors if any current condition “for which you are not being appropriately treated” affects their ability to practice medicine. That update replaces a request for seven years of mental health history.

Even outside the “safe haven” framework, some states are grappling with how to grant doctors privacy while guaranteeing patient safety.

The Medical Board of California is creating a program to treat and monitor doctors with alcohol and drug illnesses. But patients’ advocates have argued too much privacy, even for voluntary treatment, could risk consumers’ well-being. They told the state medical board that patients have a right to know if their doctor has an addiction.

Davis said states should debate how to balance physicians’ privacy and patients’ safety.

“We in medical professions are supposed to be saving lives,” she said. “Where’s the line where that starts to fall off, where their personal situation could affect that? And how does the system know?”

According to the Montana Recovery Program website, it’s not a program of discipline but instead one “of support, monitoring, and accountability.” Participants may self-refer to the program or be referred by their licensing board.

Branscum, with the Montana Medical Association, said the state’s monitoring program is needed for cases in which an illness impairs a clinician’s work. But she wants that form of treatment to become the exception.

Vicky Byrd, CEO of the Montana Nurses Association, said nurses don’t tend to join the program until they’re forced to in order to keep their license. That leaves many nurses struggling in silence until untreated illness shows up in their work, she said.

“Let’s get them taken care of before it has to go on their license,” Byrd said.

Because after that point, she said, it’s hard to recover.

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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‘Fourth Wave’ of Opioid Epidemic Crashes Ashore, Propelled by Fentanyl and Meth

The United States is knee-deep in what some experts call the opioid epidemic’s “fourth wave,” which is not only placing drug users at greater risk but is also complicating efforts to address the nation’s drug problem.

These waves, according to a report out today from Millennium Health, began with the crisis in prescription opioid use, followed by a significant jump in heroin use, then an increase in the use of synthetic opioids like fentanyl.

The latest wave involves using multiple substances at the same time, combining fentanyl mainly with either methamphetamine or cocaine, the report found. “And I’ve yet to see a peak,” said one of the co-authors, Eric Dawson, vice president of clinical affairs at Millennium Health, a specialty laboratory that provides drug testing services to monitor use of prescription medications and illicit drugs.

The report, which takes a deep dive into the nation’s drug trends and breaks usage patterns down by region, is based on 4.1 million urine samples collected from January 2013 to December 2023 from people receiving some kind of drug addiction care.

Its findings offer staggering statistics and insights. Its major finding: how common polysubstance use has become. According to the report, an overwhelming majority of fentanyl-positive urine samples — nearly 93% — contained additional substances. “And that is huge,” said Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health.

The most concerning, she and other addiction experts said, is the dramatic increase in the combination of meth and fentanyl use. Methamphetamine, a highly addictive drug often in powder form that poses several serious cardiovascular and psychiatric risks, was found in 60% of fentanyl-positive tests last year. That is an 875% increase since 2015.

“I never, ever would have thought this,” Volkow said.

Among the report’s other key findings:

  • The nationwide spike in methamphetamine use alongside fentanyl marks a change in drug use patterns.
  • Polydrug use trends complicate overdose treatments. For instance, though naloxone, an opioid-overdose reversal medication, is widely available, there isn’t an FDA-approved medication for stimulant overdose.
  • Both heroin and prescribed opioid use alongside fentanyl have dipped. Heroin detected in fentanyl-positive tests dropped by 75% since peaking in 2016. Prescription opioids were found at historic low rates in fentanyl-positive tests in 2023, down 89% since 2013.

But Jarratt Pytell, an addiction medicine specialist and assistant professor at the University of Colorado’s School of Medicine, warned these declines shouldn’t be interpreted as a silver lining.

A lower level of heroin use “just says that fentanyl is everywhere,” Pytell said, “and that we have officially been pushed by our drug supply to the most dangerous opioids that we have available right now.”

“Whenever a drug network is destabilizing and the product changes, it puts the people who use the drugs at the greatest risk,” he said. “That same bag or pill that they have been buying for the last several months now is coming from a different place, a different supplier, and is possibly a different potency.”

In the illicit drug industry, suppliers are the controllers. It may not be that people are seeking out methamphetamine and fentanyl but rather that they’re what drug suppliers have found to be the easiest and most lucrative product to sell.

“I think drug cartels are kind of realizing that it’s a lot easier to have a 500-square-foot lab than it is to have 500 acres of whatever it takes to grow cocaine,” Pytell said.

Dawson said the report’s drug use data, unlike that of some other studies, is based on sample analysis with a quick turnaround — a day or two.

Sometimes researchers face a months-long wait to receive death reports from coroners. Under those circumstances, you are often “staring at today but relying on data sources that are a year or more in the past,” said Dawson.

Self-reported surveys of drug users, another method often used to track drug use, also have long lag times and “often miss people who are active for substance use disorders,” said Jonathan Caulkins, a professor at Carnegie Mellon University’s Heinz College. Urine tests “are based on a biology standard” and are good at detecting when someone has been using two or more drugs, he said.

But using data from urine samples also comes with limitations.

For starters, the tests don’t reveal users’ intent.

“You don’t know whether or not there was one bag of powder that had both fentanyl and meth in it, or whether there were two bags of powder, one with fentanyl in it and one with meth and they took both,” Caulkins said. It can also be unclear, he said, if people intentionally combined the two drugs for an extra high or if they thought they were using only one, not knowing it contained the other.

Volkow said she is interested in learning more about the demographics of polysubstance drug users. “Is this pattern the same for men and women, and is this pattern the same for middle-age or younger people? Because again, having a better understanding of the characteristics allows you to tailor and personalize interventions.”

All the while, the nation’s crisis continues. According to the Centers for Disease Control and Prevention, more than 107,000 people died in the U.S. in 2021 from drug overdoses, most because of fentanyl.

Caulkins said he’s hesitant to view drug use patterns as waves because that would imply people are transitioning from one to the next.

“Are we looking at people whose first substance use disorder was an opioid use disorder, who have now gotten to the point where they’re polydrug users?” he said. Or, are people now starting substance use disorders with methamphetamine and fentanyl, he asked.

One point was clear, Dawson said: “We’re just losing too many lives.”

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 Powerful Constraints on Medical Care in Catholic Hospitals Across America

Nurse midwife Beverly Maldonado recalls a pregnant woman arriving at Ascension Saint Agnes Hospital in Maryland after her water broke. It was weeks before the baby would have any chance of survival, and the patient’s wishes were clear, she recalled: “Why am I staying pregnant then? What’s the point?” the patient pleaded.

But the doctors couldn’t intervene, she said. The fetus still had a heartbeat and it was a Catholic hospital, subject to the “Ethical and Religious Directives for Catholic Health Care Services” that prohibit or limit procedures like abortion that the church deems “immoral” or “intrinsically evil,” according to its interpretation of the Bible.

“I remember asking the doctors. And they were like, ‘Well, the baby still has a heartbeat. We can’t do anything,’” said Maldonado, now working as a nurse midwife in California, who asked them: “What do you mean we can’t do anything? This baby’s not going to survive.”

The woman was hospitalized for days before going into labor, Maldonado said, and the baby died.

Ascension declined to comment for this article.

The Catholic Church’s directives are often at odds with accepted medical standards, especially in areas of reproductive health, according to physicians and other medical practitioners.

The American College of Obstetricians and Gynecologists’ clinical guidelines for managing pre-labor rupture of membranes, in which a patient’s water breaks before labor begins, state that women should be offered options, including ending the pregnancy.

Maldonado felt her patient made her wishes clear.

“Under the ideal medical practice, that patient should be helped to obtain an appropriate method of terminating the pregnancy,” said Christian Pettker, a professor of obstetrics, gynecology, and reproductive sciences at the Yale School of Medicine, who helped author the guidelines.

He said, “It would be perfectly medically appropriate to do a termination of pregnancy before the cessation of cardiac activity, to avoid the health risks to the pregnant person.”

“Patients are being turned away from necessary care,” said Jennifer Chin, an OB-GYN at UW Medicine in Seattle, because of the “emphasis on these ethical and religious directives.”

They can be a powerful constraint on the care that patients receive at Catholic hospitals, whether emergency treatment when a woman’s health is at risk, or access to birth control and abortions.

More and more women are running into barriers to obtaining care as Catholic health systems have aggressively acquired secular hospitals in much of the country. Four of the 10 largest U.S. hospital chains by number of beds are Catholic, according to federal data from the Agency for Healthcare Research and Quality. There are just over 600 Catholic general hospitals nationally and roughly 100 more managed by Catholic chains that place some religious limits on care, a KFF Health News investigation reveals.

Maldonado’s experience in Maryland came just months before the Supreme Court’s ruling in 2022 to overturn Roe v. Wade, a decision that compounded the impact of Catholic health care restrictions. In its wake, roughly a third of states have banned or severely limited access to abortion, creating a one-two punch for women seeking to prevent pregnancy or to end one. Ironically, some states where Catholic hospitals dominate — such as Washington, Oregon, and Colorado — are now considered medical havens for women in nearby states that have banned abortion.

KFF Health News analyzed state-level birth data to discover that more than half a million babies are born each year in the U.S. in Catholic-run hospitals, including those owned by CommonSpirit Health, Ascension, Trinity Health, and Providence St. Joseph Health. That’s 16% of all hospital births each year, with rates in 10 states exceeding 30%. In Washington, half of all babies are born at such hospitals, the highest share in the country.

“We had many instances where people would have to get in their car to drive to us while they were bleeding, or patients who had had their water bags broken for up to five days or even up to a week,” said Chin, who has treated patients turned away by Catholic hospitals.

Physicians who turned away patients like that “were going against evidence-based care and going against what they had been taught in medical school and residency,” she said, “but felt that they had to provide a certain type of care — or lack of care — just because of the strength of the ethical and religious directives.”

Following religious mandates can be dangerous, Chin and other clinicians said.

When a patient has chosen to end a pregnancy after the amniotic sac — or water — has broken, Pettker said, “any delay that might be added to a procedure that is inevitably going to happen places that person at risk of serious, life-threatening complications,” including sepsis and organ infection.

Reporters analyzed American Hospital Association data as of August and used Catholic Health Association directories, news reports, government documents, and hospital websites and other materials to determine which hospitals are Catholic or part of Catholic systems, and gathered birth data from state health departments and hospital associations. They interviewed patients, medical providers, academic experts, advocacy organizations, and attorneys, and reviewed hundreds of pages of court and government records and guidance from Catholic health institutions and authorities to understand how the directives affect patient care.

Nationally, nearly 800,000 people have only Catholic or Catholic-affiliated birth hospitals within an hour’s drive, according to KFF Health News’ analysis. For example, that’s true of 1 in 10 North Dakotans. In South Dakota, it’s 1 in 20. When care is more than an hour away, academic researchers often define the area as a hospital desert. Pregnant women who must drive farther to a delivery facility are at higher risk of harm to themselves or their fetus, research shows.

Many Americans don’t have a choice — non-Catholic hospitals are too far to reach in an emergency or aren’t in their insurance networks. Ambulances may take patients to a Catholic facility without giving them a say. Women often don’t know that hospitals are affiliated with the Catholic Church or that they restrict reproductive care, academic research suggests.

And, in most of the country, state laws shield at least some hospitals from lawsuits for not performing procedures they object to on religious grounds, leaving little recourse for patients who were harmed because care was withheld. Thirty-five states prevent patients from suing hospitals for not providing abortions, including 25 states where abortion remains broadly legal. About half of those laws don’t include exceptions for emergencies, ectopic pregnancies, or miscarriages. Sixteen states prohibit lawsuits against hospitals for refusing to perform sterilization procedures.

“It’s hard for the ordinary citizen to understand, ‘Well, what difference does it make if my hospital is bought by this other big health system, as long as it stays open? That’s all I care about,’” said Erin Fuse Brown, who is the director of the Center for Law, Health & Society at Georgia State University and an expert in health care consolidation. Catholic directives also ban medical aid in dying for terminally ill patients.

People “may not realize that they’re losing access to important services, like reproductive health [and] end-of-life care,” she said.

‘Our Faith-Based Health Care Ministry’

After the Supreme Court ended the constitutional right to abortion in June 2022, Michigan resident Kalaina Sullivan wanted surgery to permanently prevent pregnancy.

Michigan voters in November that year enshrined the right to abortion under the state constitution, but the state’s concentration of Catholic hospitals means people like Sullivan sometimes still struggle to obtain reproductive health care.

Because her doctor worked for the Catholic chain Trinity Health, the nation’s fourth-largest hospital system, she had the surgery with a different doctor at North Ottawa Community Health System, an independent hospital near the shores of Lake Michigan.

Less than two months later, that, too, became a Catholic hospital, newly acquired by Trinity.

To mark the transition, Cory Mitchell, who at the time was the mission leader of Trinity Health Muskegon, stood before his new colleagues and offered a blessing.

“The work of your hands is what makes our faith-based health care ministry possible,” he said, according to a video of the ceremony Trinity Health provided to KFF Health News. “May these hands continue to bring compassion, compassion and healing, to all those they touch.”

Trinity Health declined to answer detailed questions about its merger with North Ottawa Community Health System and the ethical and religious directives. “Our commitment to high-quality, compassionate care means informing our patients of all appropriate care options, and trusting and supporting our physicians to make difficult and medically necessary decisions in the best interest of their patients’ health and safety,” spokesperson Jennifer Amundson said in an emailed statement. “High-quality, safe care is critical for the women in our communities and in cases where a non-critical service is not available at our facility, the physician will transfer care as appropriate.”

Leaders in Catholic-based health systems have hammered home the importance of the church’s directives, which are issued by the U.S. Conference of Catholic Bishops, all men, and were first drafted in 1948. The essential view on abortion is as it was in 1948. The last revision, in 2018, added several directives addressing Catholic health institution acquisitions or mergers with non-Catholic ones, including that “whatever comes under control of the Catholic institution — whether by acquisition, governance, or management — must be operated in full accord with the moral teaching of the Catholic Church.”

“While many of the faithful in the local church may not be aware of these requirements for Catholic health care, the local bishop certainly is,” wrote Sister Doris Gottemoeller, a former board member of the Bon Secours Mercy Health system, in a 2023 Catholic Health Association journal article. “In fact, the bishop should be briefed on a regular basis about the hospital’s activities and strategies.”

Now, for care at a non-Catholic hospital, Sullivan would need to travel nearly 30 miles.

“I don’t see why there’s any reason for me to have to follow the rules of their religion and have that be a part of what’s going on with my body,” she said.

Risks Come With Religion

Nathaniel Hibner, senior director of ethics at the Catholic Health Association, said the ethical and religious directives allow clinicians to provide medically necessary treatments in emergencies. In a pregnancy crisis when a person’s life is at risk, “I do not believe that the ERDs should restrict the physician in acting in the way that they see medically indicated.”

“Catholic health care is committed to the health of all women and mothers who enter into our facilities,” Hibner said.

The directives permit care to cure “a proportionately serious pathological condition of a pregnant woman” even if it would “result in the death of the unborn child.” Hibner demurred when asked who defines what that means and when such care is provided, saying, “for the most part, the physician and the patients are the ones that are having a conversation and dialogue with what is supposed to be medically appropriate.”

It is common for practitioners at any hospital to consult an ethics board about difficult cases — such as whether a teenager with cancer can decline treatment. At Catholic hospitals, providers must ask a board for permission to perform procedures restricted by the religious directives, clinicians and researchers say. For example, could an abortion be performed if a pregnancy threatened the mother’s life?

How and when an ethics consultation occurs depends on the hospital, Hibner said. “That ethics consultation can be initiated by anyone involved in the direct care of that situation — the patient, the surrogate of that patient, the physician, the nurse, the social worker all have the ability to request a consultation,” he said. When asked whether a consultation with an ethics board can occur without a request, he said “sometimes it could.”

How strictly directives are followed can depend on the hospital and the views of the local bishop.

“If the hospital has made a difficult decision about a critical pregnancy or an end-of-life care situation, the bishop should be the first to know about it,” Gottemoeller wrote.

In an interview, Gottemoeller said that even when pregnancy termination decisions are made on sound ethical grounds, not informing the bishop puts him in a bad position and hurts the church. “If there’s a possibility of it being misunderstood, or misinterpreted, or criticized,” Gottemoeller said, the bishop should understand what happened and why “before the newspapers call him and ask him for an opinion.”

“And if he has to say, ‘Well, I think you made a mistake,’ well, all right,” she said. “But don’t let him be blindsided. I mean, we’re one church and the bishop has pastoral concern over everything in his diocese.”

Katherine Parker Bryden, a nurse midwife in Iowa who works for MercyOne, said she regularly tells pregnant patients that the hospital cannot perform tubal sterilization surgery, to prevent future pregnancies, or refer patients to other hospitals that do. MercyOne is one of the largest health systems in Iowa. Nearly half of general hospitals in the state are Catholic or Catholic-affiliated — the highest share among all states.

The National Catholic Bioethics Center, an ethics authority for Catholic health institutions, has said that referrals for care that go against church teaching would be “immoral.”

“As providers, you’re put in this kind of moral dilemma,” Parker Bryden said. “Am I serving my patients or am I serving the archbishop and the pope?”

In response to questions, MercyOne spokesperson Eve Lederhouse said in an email that its providers “offer care and services that are consistent with the guidelines of a Catholic health system.”

Maria Rodriguez, an OB-GYN professor at Oregon Health & Science University, said that as a resident in the early 2000s at a Catholic hospital she was able to secure permission — what she calls a “pope note” — to sterilize some patients with conditions such as gestational diabetes.

Annie Iriye, a retired OB-GYN in Washington state, said that more than a decade ago she sought permission to administer medication to hasten labor for a patient experiencing a second-trimester miscarriage at a Catholic hospital. She said she was told no because the fetus had a heartbeat. The patient took 10 hours to deliver — time that would have been cut by half, Iriye said, had she been able to follow her own medical training and expertise. During that time, she said, the patient developed an infection.

Iriye and Chin were part of an effort by reproductive rights groups and medical organizations that pushed for a state law to protect physicians if they act against Catholic hospital restrictions. The bill, which Washington enacted in 2021, was opposed by the Washington State Hospital Association, whose membership includes multiple large Catholic health systems.

State lawmakers in Oregon in 2021 enacted legislation that beefed up powers to reject health care mergers if they would reduce access to the types of care constrained by Catholic directives. The hospital lobby has sued to block the statute. Washington state lawmakers introduced similar legislation last year, which the hospital association opposes.

Hibner said Catholic hospitals are committed to instituting systemic changes that improve maternal and child health, including access to primary, prenatal, and postpartum care. “Those are the things that I think rural communities really need support and advocacy for,” he said.

Maldonado, the nurse midwife, still thinks of her patient who was forced to stay pregnant with a baby who could not survive. “To feel like she was going to have to fight to have an abortion of a baby that she wanted?” Maldonado said. “It was just horrible.”

KFF Health News data editor Holly K. Hacker contributed to this report.

Click to open the methodology Methodology

By Hannah Recht

KFF Health News identified areas of the country where patients have only Catholic hospital options nearby. The “Ethical and Religious Directives for Catholic Health Care Services” — which are issued by the U.S. Conference of Catholic Bishops, all men — dictate how patients receive reproductive care at Catholic health facilities. In our analysis, we focused on hospitals where babies are born.

We constructed a national database of hospital locations, identified which ones are Catholic or Catholic-affiliated, found how many babies are born at each, and calculated how many people live near those hospitals.

Hospital Universe

We identified hospitals in the 50 states and the District of Columbia using the American Hospital Association database from August 2023. We removed hospitals that had closed or were listed more than once, added hospitals that were not included, and corrected inaccurate or out-of-date information about ownership, primary service type, and location. We excluded federal hospitals, such as military and Indian Health Service facilities, because they are not open to everyone.

Catholic Affiliation

To identify Catholic hospitals, we used the Catholic Health Association’s member directory. We also counted as Catholic a handful of hospitals that are not part of this voluntary membership group but explicitly follow the Ethical and Religious Directives, according to their mission statements, websites, or promotional materials.

We also tracked Catholic-affiliated hospitals: those that are owned or managed by a Catholic health system, such as CommonSpirit Health or Trinity Health, and are influenced by the religious directives but do not necessarily adhere to them in full. To identify Catholic-affiliated hospitals, we consulted health system and hospital websites, government documents, and news reports.

We combined both Catholic and Catholic-affiliated hospitals for analysis, in line with previous research about the influence of Catholic directives on health care.

Births

To determine the share of births that occur at Catholic or Catholic-affiliated hospitals, we gathered the latest annual number of births by hospital from state health departments. Where recent data was not publicly available, we submitted records requests for the most recent complete year available.

The resulting data covered births in 2022 for nine states and D.C., births in 2021 for 23 states, births in 2020 for nine states, and births in 2019 for one state. We used data from the 2021 American Hospital Association survey, the latest available at the time of analysis, for the eight remaining states that did not provide birth data in response to our requests. A small number of hospitals have recently opened or closed labor and delivery units. The vast majority of the rest record about the same number of births each year. This means that the results would not be substantially different if data from 2023 were available.

We used this data to calculate the number of babies born in Catholic and Catholic-affiliated hospitals, as well as non-Catholic hospitals by state and nationally.

We used hospitals’ Catholic status as of August 2023 in this analysis. In 10 cases where the hospital had already closed, we used Catholic status at the time of the closure.

Because our analysis focuses on hospital care, we excluded births that occurred in non-hospital settings, such as homes and stand-alone birth centers, as well as federal hospitals.

Several states suppressed data from hospitals with fewer than 10 births due to privacy restrictions. Because those numbers were so low, this suppression had a negligible effect on state-level totals.

Drive-Time Analysis

We obtained hospitals’ geographic coordinates based on addresses in the AHA dataset using HERE’s geocoder. For addresses that could not be automatically geocoded with a high degree of certainty, we verified coordinates manually using hospital websites and Google Maps.

We calculated the areas within 30, 60, and 90 minutes of travel time from each birth hospital that was open in August 2023 using tools from HERE. We included only hospitals that had 10 or more births as a proxy for hospitals that have labor and delivery units, or where births regularly occur.

The analysis focused on the areas with hospitals within an hour’s drive. Researchers often define hospital deserts as places where one would have to drive an hour or more for hospital care. (For example: [1] “Disparities in Access to Trauma Care in the United States: A Population-Based Analysis,” [2] “Injury-Based Geographic Access to Trauma Centers,” [3] “Trends in the Geospatial Distribution of Inpatient Adult Surgical Services Across the United States,” [4] “Access to Trauma Centers in the United States.”)

We combined the drive-time areas to see which areas of the United States have only Catholic or Catholic-affiliated birth hospitals nearby, both Catholic and non-Catholic, non-Catholic only, or none. We then joined these areas to the 2021 census block group shapefile from IPUMS NHGIS and removed water bodies using the U.S. Geological Survey’s National Hydrography Dataset to calculate the percentage of each census block group that falls within each hospital access category. We calculated the number of people in each area using the 2021 “American Community Survey” block group population totals. For example, if half of a block group’s land area had access to only Catholic or Catholic-affiliated hospitals, then half of the population was counted in that category.

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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