McALESTER, Okla. — It took little more than an hour for Deborah Hackler to dispense with the tall stack of debt collection lawsuits that McAlester Regional Medical Center recently brought to small-claims court in this Oklahoma farm community.
Hackler, a lawyer who sues patients on behalf of the hospital, buzzed through 51 cases, all but a handful uncontested, as is often the case. She bantered with the judge as she secured nearly $40,000 in judgments, plus 10% in fees for herself, according to court records.
It's a payday the hospital and Hackler have shared frequently over the past three decades, records show. The records indicate McAlester Regional Medical Center and an affiliated clinic have filed close to 5,000 debt collection cases since the early 1990s, most often represented by the father-daughter law firm of Hackler & Hackler.
Some of McAlester's 18,000 residents have been taken to court multiple times. A deputy at the county jail and her adult son were each sued recently, court records show. New mothers said they compare stories of their legal run-ins with the medical center.
"There's a lot that's not right," Sherry McKee, a dorm monitor at a tribal boarding school outside McAlester, said on the courthouse steps after the hearing. The hospital has sued her three times, most recently over a $3,375 bill for what she said turned out to be vertigo.
In recent years, major health systems in Virginia, North Carolina, and elsewhere have stopped suing patients following news reports about lawsuits. And several states, such as Maryland and New York, have restricted the legal actions hospitals can take against patients.
But with some 100 million people in the U.S. burdened by health care debt, medical collection cases still clog courtrooms across the country, researchers have found. In places like McAlester, a hospital's debt collection machine can hum away quietly for years, helped along by powerful people in town. An effort to limit hospital lawsuits failed in the Oklahoma Legislature in 2021.
In McAlester, the lawsuits have provided business for some, such as the Adjustment Bureau, a local collection agency run out of a squat concrete building down the street from the courthouse, and for Hackler, a former president of the McAlester Area Chamber of Commerce. But for many patients and their families, the lawsuits can take a devastating toll, sapping wages, emptying retirement accounts, and upending lives.
McKee said she wasn't sure how long it would take to pay off the recent judgment. Her $3,375 debt exceeds her monthly salary, she said.
"This affects a large number of people in a small community," said Janet Roloff, an attorney who has spent years assisting low-income clients with legal issues such as evictions in and around McAlester. "The impact is great."
Settled more than a century ago by fortune seekers who secured land from the Choctaw Nation to mine coal in the nearby hills, McAlester was once a boom town. Vestiges of that era remain, including a mammoth, 140-foot-tall Masonic temple that looms over the city.
Recent times have been tougher for McAlester, now home by one count to 12 marijuana dispensaries and the state's death row. The downtown is pockmarked by empty storefronts, including the OKLA theater, which has been dark for decades. Nearly 1 in 5 residents in McAlester and the surrounding county live below the federal poverty line.
The hospital, operated by a public trust under the city's authority, faces its own struggles. Paint is peeling off the front portico, and weeds poke up through the parking lots. The hospital has operated in the red for years, according to independent audit reports available on the state auditor's website.
"I'm trying to find ways to get the entire community better care and more care," said Shawn Howard, the hospital's chief executive. Howard grew up in McAlester and proudly noted he started his career as a receptionist in the hospital's physical therapy department. "This is my hometown," he said. "I am not trying to keep people out of getting care."
The hospital operates a clinic for low-income patients, whose webpage notes it has "limited appointments" at no cost for patients who are approved for aid. But data from the audits shows the hospital offers very little financial assistance, despite its purported mission to serve the community.
In the 2022 fiscal year, it provided just $114,000 in charity care, out of a total operating budget of more than $100 million, hospital records show. Charity care totaling $2 million or $3 million out of a $100 million budget would be more in line with other U.S. hospitals.
While audits show few McAlester patients get financial aid, many get taken to court.
Renee Montgomery, the city treasurer in an adjoining town and mother of a local police officer, said she dipped into savings she'd reserved for her children and grandchildren after the hospital sued her last year for more than $5,500. She'd gone to the emergency room for chest pain.
Dusty Powell, a truck driver, said he lost his pickup and motorcycle when his wages were garnished after the hospital sued him for almost $9,000. He'd gone to the emergency department for what turned out to be gastritis and didn't have insurance, he said.
"Everyone in this town probably has a story about McAlester Regional," said another former patient who spoke on the condition she not be named, fearful to publicly criticize the hospital in such a small city. "It's not even a secret."
The woman, who works at an Army munitions plant outside town, was sued twice over bills she incurred giving birth. Her sister-in-law has been sued as well.
"It's a good-old-boy system," said the woman, who lowered her voice when the mayor walked into the coffee shop where she was meeting with KFF Health News. Now, she said, she avoids the hospital if her children need care.
Nationwide, most people sued in debt collection cases never challenge them, a response experts say reflects widespread misunderstanding of the legal process and anxiety about coming to court.
At the center of the McAlester hospital's collection efforts for decades has been Hackler & Hackler.
Donald Hackler was city attorney in McAlester for 13 years in the '70s and '80s and a longtime member of the local Lions Club and the Scottish Rite Freemasons.
Daughter Deborah Hackler, who joined the family firm 30 years ago, has been a deacon at the First Presbyterian Church of McAlester and served on the board of the local Girl Scouts chapter, according to the McAlester News-Capital newspaper, which named her "Woman of the Year" in 2007. Since 2001, she also has been a municipal judge in McAlester, hearing traffic cases, including some involving people she has sued on behalf of the hospital, municipal and county court records show.
For years, the Hacklers' debt collection cases were often heard by Judge James Bland, who has retired from the bench and now sits on the hospital board. Bland didn't respond to an inquiry for interview.
Hackler declined to speak with KFF Health News after her recent court appearance. "I'm not going to visit with you about a current client," she said before leaving the courthouse.
Howard, the hospital CEO, said he couldn't discuss the lawsuits either. He said he didn't know the hospital took its patients to court. "I had to call and ask if we sue people," he said.
Howard also said he didn't know Deborah Hackler. "I never heard her name before," he said.
Despite repeated public records requests from KFF Health News since September, the hospital did not provide detailed information about its financial arrangement with Hackler.
McAlester Mayor John Browne, who appoints the hospital's board of trustees, said he, too, didn't know about the lawsuits. "I hadn't heard anything about them suing," he said.
At the century-old courthouse in downtown McAlester, it's not hard to find the lawsuits, though. Every month or two, another batch fills the docket in the small-claims court, now presided over by Judge Brian McLaughlin.
After court recently, McLaughlin, who is not from McAlester, shook his head at the stream of cases and patients who almost never show up to defend themselves, leaving him to issue judgment after judgment in the hospital's favor.
"All I can do is follow the law," said McLaughlin. "It doesn't mean I like it."
About This Project
"Diagnosis: Debt" is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.
The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country.
Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health status for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.
The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how customers' balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability.
KFF Health News journalists worked with KFF public opinion researchers to design and analyze the "KFF Health Care Debt Survey." The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current health care debt and 382 adults who had health care debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.
Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.
Charity Watkins sensed something was deeply wrong when she experienced exhaustion after her daughter was born.
At times, Watkins, then 30, had to stop on the stairway to catch her breath. Her obstetrician said postpartum depression likely caused the weakness and fatigue. When Watkins, who is Black, complained of a cough, her doctor blamed the flu.
About eight weeks after delivery, Watkins thought she was having a heart attack, and her husband took her to the emergency room. After a 5½-hour wait in a North Carolina hospital, she returned home to nurse her baby without seeing a doctor.
When a physician finally examined Watkins three days later, he immediately noticed her legs and stomach were swollen, a sign that her body was retaining fluid. After a chest X-ray, the doctor diagnosed her with heart failure, a serious condition in which the heart becomes too weak to adequately pump oxygen-rich blood to organs throughout the body. Watkins spent two weeks in intensive care.
She said a cardiologist later told her, "We almost lost you."
In a study published Jan. 8 in JAMA Internal Medicine, researchers found that nearly 1 in 4 hospital patients who died or were transferred to intensive care had experienced a diagnostic error. Nearly 18% of misdiagnosed patients were harmed or died.
In all, an estimated 795,000 patients a year die or are permanently disabled because of misdiagnosis, according to a study published in July in the BMJ Quality & Safety periodical.
Some patients are at higher risk than others.
Women and racial and ethnic minorities are 20% to 30% more likely than white men to experience a misdiagnosis, said David Newman-Toker, a professor of neurology at Johns Hopkins School of Medicine and the lead author of the BMJ study. "That's significant and inexcusable," he said.
Researchers call misdiagnosis an urgent public health problem. The study found that rates of misdiagnosis range from 1.5% of heart attacks to 17.5% of strokes and 22.5% of lung cancers.
Heart failure "should have been No. 1 on the list of possible causes" for Watkins' symptoms, said Ronald Wyatt, chief science and chief medical officer at the Society to Improve Diagnosis in Medicine, a nonprofit research and advocacy group.
Maternal mortality for Black mothers has increased dramatically in recent years. The United States has the highest maternal mortality rate among developed countries. According to the Centers for Disease Control and Prevention, non-Hispanic Black mothers are 2.6 times as likely to die as non-Hispanic white moms. More than half of these deaths take place within a year after delivery.
Research shows that Black women with childbirth-related heart failure are typically diagnosed later than white women, said Jennifer Lewey, co-director of the pregnancy and heart disease program at Penn Medicine. That can allow patients to further deteriorate, making Black women less likely to fully recover and more likely to suffer from weakened hearts for the rest of their lives.
Watkins said the diagnosis changed her life. Doctors advised her "not to have another baby, or I might need a heart transplant," she said. Being deprived of the chance to have another child, she said, "was devastating."
Racial and gender disparities are widespread.
Women and minority patients suffering from heart attacks are more likely than others to be discharged without diagnosis or treatment.
Minorities are less likely than whites to be diagnosed early with dementia, depriving them of the opportunities to receive treatments that work best in the early stages of the disease.
Misdiagnosis isn't new. Doctors have used autopsy studies to estimate the percentage of patients who died with undiagnosed diseases for more than a century. Although those studies show some improvement over time, life-threatening mistakes remain all too common, despite an array of sophisticated diagnostic tools, said Hardeep Singh, a professor at Baylor College of Medicine who studies ways to improve diagnosis.
"The vast majority of diagnoses can be made by getting to know the patient's story really well, asking follow-up questions, examining the patient, and ordering basic tests," said Singh, who is also a researcher at Houston's Michael E. DeBakey VA Medical Center. When talking to people who've been misdiagnosed, "one of the things we hear over and over is, ‘The doctor didn't listen to me.'"
Racial disparities in misdiagnosis are sometimes explained by noting that minority patients are less likely to be insured than white patients and often lack access to high-quality hospitals. But the picture is more complicated, said Monika Goyal, an emergency physician at Children's National Hospital in Washington, D.C., who has documented racial bias in children's health care.
In a 2020 study, Goyal and her colleagues found that Black kids with appendicitis were less likely than their white peers to be correctly diagnosed, even when both groups of patients visited the same hospital.
Although few doctors deliberately discriminate against women or minorities, Goyal said, many are biased without realizing it.
"Racial bias is baked into our culture," Goyal said. "It's important for all of us to start recognizing that."
Demanding schedules, which prevent doctors from spending as much time with patients as they'd like, can contribute to diagnostic errors, said Karen Lutfey Spencer, a professor of health and behavioral sciences at the University of Colorado-Denver. "Doctors are more likely to make biased decisions when they are busy and overworked," Spencer said. "There are some really smart, well-intentioned providers who are getting chewed up in a system that's very unforgiving."
Doctors make better treatment decisions when they're more confident of a diagnosis, Spencer said.
In an experiment, researchers asked doctors to view videos of actors pretending to be patients with heart disease or depression, make a diagnosis, and recommend follow-up actions. Doctors felt far more certain diagnosing white men than Black patients or younger women.
"If they were less certain, they were less likely to take action, such as ordering tests," Spencer said. "If they were less certain, they might just wait to prescribe treatment."
That may help explain why patients with darker complexions are less likely to receive a timely diagnosis with conditions that affect the skin, from cancer to Lyme disease, which causes a red or pink rash in the earliest stage of infection. Black patients with Lyme disease are more likely to be diagnosed with more advanced disease, which can cause arthritis and damage the heart. Black people with melanoma are about three times as likely as whites to die within five years.
The covid-19 pandemic helped raise awareness that pulse oximeters — the fingertip devices used to measure a patient's pulse and oxygen levels — are less accurate for people with dark skin. The devices work by shining light through the skin; their failures have delayed critical care for many Black patients.
Seven years after her misdiagnosis, Watkins is an assistant professor of social work at North Carolina Central University in Durham, where she studies the psychosocial effects experienced by Black mothers who survive severe childbirth complications.
"Sharing my story is part of my healing," said Watkins, who speaks to medical groups to help doctors improve their care. "It has helped me reclaim power in my life, just to be able to help others."
The number of older adults with disabilities — difficulty with walking, seeing, hearing, memory, cognition, or performing daily tasks such as bathing or using the bathroom — will soar in the decades ahead, as baby boomers enter their 70s, 80s, and 90s.
But the healthcare system isn't ready to address their needs.
That became painfully obvious during the COVID-19 pandemic, when older adults with disabilities had trouble getting treatments and hundreds of thousands died. Now, the Department of Health and Human Services and the National Institutes of Health are targeting some failures that led to those problems.
One initiative strengthens access to medical treatments, equipment, and web-based programs for people with disabilities. The other recognizes that people with disabilities, including older adults, are a separate population with special health concerns that need more research and attention.
Lisa Iezzoni, 69, a professor at Harvard Medical School who has lived with multiple sclerosis since her early 20s and is widely considered the godmother of research on disability, called the developments "an important attempt to make healthcare more equitable for people with disabilities."
"For too long, medical providers have failed to address change in society, changes in technology, and changes in the kind of assistance that people need," she said.
Among Iezzoni's notable findings published in recent years:
Most doctors are biased. In survey results published in 2021, 82% of physicians admitted they believed people with significant disabilities have a worse quality of life than those without impairments. Only 57% said they welcomed disabled patients.
"It's shocking that so many physicians say they don't want to care for these patients," said Eric Campbell, a co-author of the study and professor of medicine at the University of Colorado.
While the findings apply to disabled people of all ages, a larger proportion of older adults live with disabilities than younger age groups. About one-third of people 65 and older — nearly 19 million seniors — have a disability, according to the Institute on Disability at the University of New Hampshire.
Doctors don't understand their responsibilities. In 2022, Iezzoni, Campbell, and colleagues reported that 36% of physicians had little to no knowledge of their responsibilities under the 1990 Americans With Disabilities Act, indicating a concerning lack of training. The ADA requires medical practices to provide equal access to people with disabilities and accommodate disability-related needs.
Among the practical consequences: Few clinics have height-adjustable tables or mechanical lifts that enable people who are frail or use wheelchairs to receive thorough medical examinations. Only a small number have scales to weigh patients in wheelchairs. And most diagnostic imaging equipment can't be used by people with serious mobility limitations.
Iezzoni has experienced these issues directly. She relies on a wheelchair and can't transfer to a fixed-height exam table. She told me she hasn't been weighed in years.
Among the medical consequences: People with disabilities receive less preventive care and suffer from poorer health than other people, as well as more coexisting medical conditions. Physicians too often rely on incomplete information in making recommendations. There are more barriers to treatment and patients are less satisfied with the care they do get.
Egregiously, during the pandemic, when crisis standards of care were developed, people with disabilities and older adults were deemed low priorities. These standards were meant to ration care, when necessary, given shortages of respirators and other potentially lifesaving interventions.
There's no starker example of the deleterious confluence of bias against seniors and people with disabilities. Unfortunately, older adults with disabilities routinely encounter these twinned types of discrimination when seeking medical care.
Such discrimination would be explicitly banned under a rule proposed by HHS in September. For the first time in 50 years, it would update Section 504 of the Rehabilitation Act of 1973, a landmark statute that helped establish civil rights for people with disabilities.
The new rule sets specific, enforceable standards for accessible equipment, including exam tables, scales, and diagnostic equipment. And it requires that electronic medical records, medical apps, and websites be made usable for people with various impairments and prohibits treatment policies based on stereotypes about people with disabilities, such as COVID-era crisis standards of care.
"This will make a really big difference to disabled people of all ages, especially older adults," said Alison Barkoff, who heads the HHS Administration for Community Living. She expects the rule to be finalized this year, with provisions related to medical equipment going into effect in 2026. Medical providers will bear extra costs associated with compliance.
Also in September, NIH designated people with disabilities as a population with health disparities that deserves further attention. This makes a new funding stream available and "should spur data collection that allows us to look with greater precision at the barriers and structural issues that have held people with disabilities back," said Bonnielin Swenor, director of the Johns Hopkins University Disability Health Research Center.
One important barrier for older adults: Unlike younger adults with disabilities, many seniors with impairments don't identify themselves as disabled.
"Before my mom died in October 2019, she became blind from macular degeneration and deaf from hereditary hearing loss. But she would never say she was disabled," Iezzoni said.
Similarly, older adults who can't walk after a stroke or because of severe osteoarthritis generally think of themselves as having a medical condition, not a disability.
Meanwhile, seniors haven't been well integrated into the disability rights movement, which has been led by young and middle-aged adults. They typically don't join disability-oriented communities that offer support from people with similar experiences. And they don't ask for accommodations they might be entitled to under the ADA or the 1973 Rehabilitation Act.
Many seniors don't even realize they have rights under these laws, Swenor said. "We need to think more inclusively about people with disabilities and ensure that older adults are fully included at this really important moment of change."
On the presidential campaign trail, former President Donald Trump is, once again, promising to repeal and replace the Affordable Care Act — a nebulous goal that became one of his administration's splashiest policy failures.
"We're going to fight for much better healthcare than Obamacare. Obamacare is a catastrophe," Trump said at a campaign stop in Iowa on Jan. 6.
The perplexing revival of one of Trump's most politically damaging crusades comes at a time when the Obama-era health law is even more popular and widelyused than it was in 2017, when Trump and congressional Republicans proved unable to pass their own plan to replace it. That failed effort was a big part of why Republicans lost control of the House of Representatives in the 2018 midterms.
Despite repeated promises, Trump never presented his own Obamacare replacement. And much of what Trump's administration actually accomplished in healthcare has been reversed by the Biden administration.
Still, Trump secured some significant policy changes that remain in place today, including efforts to bring more transparency to prices charged by hospitals and paid by health insurers.
Trying to predict Trump's priorities in a second term is even more difficult given that he frequently changes his positions on issues, sometimes multiple times.
The Trump campaign did not respond to a request for comment.
Perhaps Trump's biggest achievement is something he rarely talks about on the campaign trail. His administration's "Operation Warp Speed" managed to create, test, and bring to market a covid-19 vaccine in less than a year, far faster than even the most optimistic predictions.
Many of Trump's supporters, though, don't support — and some even vehemently oppose — covid vaccines.
Here is a recap of Trump's healthcare record:
Public Health
Trump's pandemic response dominates his overall record on healthcare.
More than 400,000 Americans died from covid over Trump's last year in office. His travel bans and other efforts to prevent the global spread of the virus were ineffective, his administration was slower than other countries' governments to develop a diagnostic test, and he publicly clashed with his own government's health officials over the response.
Ahead of the 2020 election, Trump resumed large rallies and other public campaign events that many public health experts regarded as reckless in the face of a highly contagious, deadly virus. He personally flouted public health guidance after contracting covid himself and ending up hospitalized.
At the same time, despite what many saw as a politicizationof public health by the White House, Trump signed a massive covid relief bill (after first threatening to veto it). He also presided over some of the largest boosts for the National Institutes of Health's budget since the turn of the century. And the mRNA-based vaccines Operation Warp Speed helped develop were an astounding scientific breakthrough credited with helping save millions of lives while laying the groundwork for future shots to fight other diseases including cancer.
Abortion
Trump's biggest contribution to abortion policy was indirect: He appointed three Supreme Court justices, who were instrumental in overturning the constitutional right to an abortion.
During his 2024 campaign, Trump has been all over the place on the red-hot issue. Since the Supreme Court overturned Roe v. Wade in 2022, Trump has bemoaned the issue as politically bad for Republicans; criticized one of his rivals, Florida Gov. Ron DeSantis, for signing a six-week abortion ban; and vowed to broker a compromise with "both sides" on abortion, promising that "for the first time in 52 years, you'll have an issue that we can put behind us."
He has so far avoided spelling out how he'd do that, or whether he'd support a national abortion ban after any number of weeks.
More recently, however, Trump appears to have mended fences over his criticism of Florida's six-week ban and more with key abortion opponents, whose support helped him get elected in 2016 — and whom he repaid with a long list of policy changes during his presidency.
Among the anti-abortion actions taken by the Trump administration were a reinstatement of the "Mexico City Policy" that bars giving federal funds to international organizations that support abortion rights; a regulation to bar Planned Parenthood and other organizations that provide abortions from the federal family planning program, Title X; regulatory changes designed to make it easier for healthcare providers and employers to decline to participate in activities that violate their religious and moral beliefs; and other changes that made it harder for NIH scientists to conduct research using fetal tissue from elective abortions.
All of those policies have since been overturned by the Biden administration.
Health Insurance
Unlike Trump's policies on reproductive health, many of his administration's moves related to health insurance still stand.
For example, in 2020, Trump signed into law the No Surprises Act, a bipartisan measure aimed at protecting patients from unexpected medical bills stemming from payment disputes between healthcare providers and insurers. The bill was included in the $900 billion covid relief package he opposed before signing, though Trump had expressed support for ending surprise medical bills.
His administration also pushed — over the vehement objections of health industry officials — price transparency regulations that require hospitals to post prices and insurers to provide estimated costs for procedures. Those requirements also remain in place, although hospitals in particular have been slow to comply.
Medicaid
While first-time candidate Trump vowed not to cut popular entitlement programs like Medicare, Medicaid, and Social Security, his administration did not stick to that promise. The Affordable Care Act repeal legislation Trump supported in 2017 would have imposed major cuts to Medicaid, and his Department of Health and Human Services later encouraged states to require Medicaid recipients to prove they work in order to receive health insurance.
Drug Prices
One of the issues the Trump administration was most active on was reducing the price of prescription drugs for consumers — a top priority for both Democratic and Republican voters. But many of those proposals were blocked by the courts.
One Trump-era plan that never took effect would have pegged the price of some expensive drugs covered by Medicare to prices in other countries. Another would have required drug companies to include prices in their television advertisements.
A regulation allowing states to import cheaper drugs from Canada did take effect, in November 2020. However, it took until January 2024 for the FDA, under Trump's successor, to approve the first importation plan, from Florida. Canada has said it won't allow exports that risk causing drug shortages in that country, leaving unclear whether the policy is workable.
Trump also signed into law measures allowing pharmacists to disclose to patients when the cash price of a drug is lower than the cost using their insurance. Previously pharmacists could be barred from doing so under their contracts with insurers and pharmacy benefit managers.
Veterans' Health
Trump is credited by some advocates for overhauling Department of Veterans Affairs healthcare. However, while he did sign a major bill allowing veterans to obtain care outside VA facilities, White House officials also tried to scuttle passage of the spending needed to pay for the initiative.
Medical Freedom
Trump scored a big win for the libertarian wing of the Republican Party when he signed into law the "Right to Try Act," intended to make it easier for patients with terminal diseases to access drugs or treatments not yet approved by the FDA.
But it is not clear how many patients have managed to obtain treatment using the law because it is aimed at the FDA, which has traditionally granted requests for "compassionate use" of not-yet-approved drugs anyway. The stumbling block, which the law does not address, is getting drug companies to release doses of medicines that are still being tested and may be in short supply.
Trump said in a Jan. 10 Fox News town hall that the law had "saved thousands and thousands" of lives. There's no evidence for the claim.
KEOKUK, Iowa — Folks in this Mississippi River town hope a new federal program can revive the optimism engraved long ago in a plaque on the side of their hospital.
"Dedicated to the Future of Health Care in the Tri-State Area," the sign declares. "May 11, 1981."
More recent placards posted at the facility's entryways are ominous, however. "Closed," they say. "No Trespassing."
The Keokuk hospital, which served rural areas of Iowa, Illinois, and Missouri, closed in October 2022. But new owners plan to reopen the hospital with the help of a new federal payment system. The Rural Emergency Hospital program guarantees hospitals extra cash if they provide emergency and outpatient services but end inpatient care.
"We've been without a hospital for over a year — and I don't think anybody in Keokuk or the surrounding areas will be picky in any way, shape, or form," said Kathie Mahoney, mayor of the town of about 9,800 people. She said residents would prefer to have a full-service hospital with inpatient beds, even though those types of beds had been used sparingly in recent years.
The revival of the Keokuk hospital would mark a small victory in the nationwide struggle to save rural hospitals, which continue to close due to staffing shortages, low reimbursement rates, and declining patient numbers. The new federal program, which went into effect in January 2023, is meant to stem the closures. But there have been growing pains, said George Pink, deputy director of the North Carolina Rural Health Research Program, which tracks hospital closures and conversions.
Just 18 of the more than 1,700 eligible rural hospitals nationwide have applied for and won the new designation. Many hospitals are reluctant to give up inpatient services entirely, and some are concerned about how other payment streams could be affected, rural health leaders say. The new designation's unclear definition of "rural" has also caused confusion.
"We are still in an era of rural hospital closures," Pink said. Nine hospitals closed in 2023, and that number could rise in 2024, he said. An influx of federal relief funds during the pandemic kept struggling hospitals afloat, but now that money is largely gone.
The Rural Emergency Hospital program is the first new federal payment model for hospitals since 1997. Dora Hughes, acting chief medical officer of the Centers for Medicare & Medicaid Services, said the new model's criteria are outlined by statute and "hospitals should consider specific circumstances before making the decision to apply."
The federal agency is providing outreach to rural communities and welcomes feedback, Hughes wrote in an email to KFF Health News.
Now, rural health leaders and federal lawmakers are working quickly to tweak the new program to attract more applicants, said Carrie Cochran-McClain, chief policy officer of the National Rural Health Association.
Currently, facilities that convert to rural emergency hospitals receive a 5% increase in Medicare payments, plus an average annual payment of about $3.2 million, in exchange for giving up their expensive inpatient beds and focusing solely on emergency and outpatient care. Rural hospitals with no more than 50 beds, like Keokuk's, that closed after the law was signed on Dec. 27, 2020, are eligible to apply for the program and reopen with emergency and outpatient services.
More than 100 rural hospitals nationwide have inquired about converting, said Janice Walters, interim executive director for the Rural Health Redesign Center, which has a federal grant to provide technical assistance to hospitals that want to apply.
But only about a quarter of those inquiries are likely to become a rural emergency hospital, and persuading more troubled hospitals to make the leap would require regulators to make changes, Walters said.
Her advice? "Give them 10 beds to just take care of their community."
In a journal article published last year, general surgeon Sara Schaefer worried about the unintended consequences of getting rid of rural inpatient beds. Schaefer, who spent six months of medical school at a small rural Idaho hospital, said she saw firsthand how difficult it was for the hospital to transfer patients to bigger facilities, which were often too full to take them.
"There has to be a better way," said Schaefer, who is also a research fellow at the Center for Healthcare Outcomes & Policy at the University of Michigan.
The rural health association's Cochran-McClain said lawmakers are considering changes that could allow the hospitals to:
Keep overnight beds for patients who need moderate levels of care, such as those with pneumonia or in need of physical therapy after surgery.
Allow participation in a federal drug discount program called 340B, which provides hospitals with extra revenue.
Keep inpatient psychiatric or rehabilitation units open.
Clarify eligibility, including which facilities qualify under the definition of "rural" and whether the hospitals that closed before the 2020 date in the law can apply.
Updates to the law could affect communities nationwide. In Fort Scott, Kansas, where the hospital closed in late 2018, Mayor Matthew Wells said the community wants the eligibility date pushed back. U.S. Sen. Jerry Moran (R-Kan.) introduced a bill in December that, if passed, would push eligibility back to 2015.
"This is a matter of life and death to my community," Wells said. "I see a clear path, but the federal regulations in particular make that path nearly impossible."
In Holly Springs, Mississippi, hospital chief executive Kenneth Williams said he doesn't understand the federal definition of "rural." His hospital, Alliance Healthcare Hospital, was one of the first to win the new Rural Emergency Hospital designation in early 2023. He laid off staff and shut down his inpatient beds. Then, CMS officials called to tell him they had made a mistake.
"And I said, 'Wait a minute,'" Williams said. The hospital, which is about an hour south of Memphis, Tennessee, doesn't meet the current criteria of rural, they told him. Williams, an internal medicine doctor, bought the hospital in 1999 and has been trying to keep it running since.
Federal regulators are now asking Williams to convert the facility into another type of Medicare payment model, such as the sole community hospital with inpatient beds that it was before. Williams said that would be difficult: "What kind of transition can I make, especially with reduced services?"
In Keokuk, the hospital fits the current requirements. Insight Health Group, the Michigan company that bought the shuttered facility last March, plans to apply for the new federal designation as soon as it obtains state permits under new Iowa regulations tailored to rural emergency hospitals. It would be the first such hospital in the state.
Like many other rural hospitals struggling to survive, Keokuk's shuttered several key departments years ago, including its birthing and inpatient psychiatric units. In 2021, the last full year it was open, the hospital averaged fewer than three inpatients per night, according to data posted by the Iowa Hospital Association.
More than half of the three-story building would remain mothballed if the facility reopened under the new designation, but the emergency department could serve patients again as soon as late summer, said Atif Bawahab, Insight"s chief strategy officer.
Bruce Mackie has worked 32 years at the hospital, including 10 years as director of plant operations. The new owners kept him on to watch over the building. Beds, high-tech scanners, and lab equipment remain, but most of the clocks have stopped. "It's spooky," he said.
Even if the services are more limited than before, Mackie said, "everybody wants the hospital to reopen. This city needs an ER."
Former HHS Secretary Alex Azar is chairman of LifeScience Logistics, a company Florida is paying $39 million to manage its Canadian drug importation program.
This article was published on Monday, January 15, 2024 in KFF Health News.
The Food and Drug Administration's unprecedented approval of Florida's plan to import drugs from Canada was made possible only after Alex Azar, as the Trump administration's Health and Human Services secretary, certified that bringing medicines over the border could be done safely.
Azar made the historic declaration in September 2020, just two months before his boss, former President Donald Trump, lost reelection.
Now, Azar's involved in the business of making importation happen. He is chairman of the board of LifeScience Logistics, a Dallas-based company that Florida is paying as much as $39 million to help manage its Canadian drug importation program, not including the cost of drugs.
LifeScience officials confirmed Azar's position but didn't respond to questions about how much he is paid or whether he's involved in the Florida work. Azar didn't return messages left with his employers or sent to a personal email address.
The revolving door between government and private sector jobs is well documented. It's common for top U.S. officials in both parties to leave government service for what are often far better-paid jobs or board seats at companies in the industries they formerly regulated.
About 57% of presidential Cabinet-level officials later served on corporate boards of directors, according to a 2019 study by researchers at Boston and Harvard universities in The Journal of Politics, which examined 84 Cabinet members who served from 1992 to 2014.
"In general, we favor Cabinet secretaries not going into industries which they once regulated, because the possibility of conflicts of interest are unavoidable," said Robert Weissman, president of Public Citizen, a government watchdog group.
He called Azar's case atypical because his approval of drug importation was opposed by the pharmaceutical industry, in which Azar was formerly employed. Drugmakers argue the policy puts patients at risk of consuming counterfeit medicines. Azar joined the LifeScience board in January 2022, one year after the end of Trump's term and about a year after Florida contracted with LifeScience in late 2020.
Katie Hernandez, a spokesperson for LifeScience Logistics, said in a statement that the company, which manages nearly 6 million square feet of warehouse storage across 11 states, signed its deal with Florida before Azar joined the board.
Ivana Katic, assistant professor of organizational behavior at the Yale School of Management, said that Azar's position at LifeScience "can appear as a conflict of interest" because his policy decision as HHS secretary later benefited him professionally.
Azar was a deputy secretary at HHS during the George W. Bush administration before joining pharmaceutical giant Eli Lilly and Co. as a top executive in 2007, remaining there until months before joining the Trump administration.
Weissman, who supports drug importation, said he doubts Azar had any personal benefit in mind before his decision. Florida Gov. Ron DeSantis had pushed Trump to authorize importation from Canada, and the former president had said he supported importation before Azar certified it was safe.
Canadian drug importation has been the subject of decades of debate. While the U.S. does not regulate most drug costs, Canada does, generally resulting in lower prices than across the border.
In 2018, Azar called importation a "gimmick" because Canada's pharmaceutical market isn't large enough to meet U.S. demand. Indeed, the Canadian government has repeatedly warned the U.S. against importation, promising to block any plan that poses a risk of causing shortages in Canada.
The country has implemented regulations "to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada," Health Canada, which regulates drug safety, said in a Jan. 8 statement after the FDA's approval of Florida's plan. "This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other US state's future importation programs."
Under its contract with Florida, LifeScience Logistics must buy drugs from Canadian suppliers, contract with a lab to verify their authenticity, store the medicines, and ship them to state agencies for distribution. LifeScience built a 100,000-square-foot facility in Lakeland, Florida, to warehouse drugs imported from Canada.
President Joe Biden supported drug importation during his 2020 campaign, but after the election his administration moved slowly to advance the process. Colorado has an importation application pending with the FDA, while several other states have passed laws allowing for importation. DeSantis has accused the Biden administration of slow-walking a decision, and his administration filed a lawsuit over the FDA's delay.
Florida's importation plan will save the state up to $180 million in the first year of the program, the state said. The importation program wouldn't aid consumers directly. It's instead aimed at helping state agencies, including its prisons, health department, and Medicaid program, obtain lower-cost drugs for HIV and AIDS, diabetes, and other conditions.
Florida's plan still faces many hurdles. On top of Canada's reluctance to participate in U.S. importation programs, some drug manufacturers have deals with Canadian wholesalers preventing them from exporting medicines, and the FDA decision is likely to face a legal challenge by drugmakers.
The drug industry's major lobbying group, the Pharmaceutical Research and Manufacturers of America, or PhRMA, previously sued to stop Azar's importation decision. It's expected to file suit to block Florida's program as well.
A PhRMA spokesperson declined to comment on Azar's role.
Kevin Stansbury, the CEO of Lincoln Community Hospital in the 800-person town of Hugo, Colorado, is facing a classic Catch-22: He could boost his rural hospital's revenues by offering hip replacements and shoulder surgeries, but the 64-year-old hospital needs more money to be able to expand its operating room to do those procedures.
"I've got a surgeon that's willing to do it. My facility isn't big enough," Stansbury said. "And urgent services like obstetrics I can't do in my hospital, because my facility won't meet code."
Besides securing additional revenue for the hospital, such an expansion could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.
Rural hospitals throughout the nation are facing a similar conundrum. An increase in costs amid lower payments from insurance plans makes it harder for small hospitals to fund large capital improvement projects. And high inflation and rising interest rates coming out of the pandemic are making it tougher for aging facilities to qualify for loans or other types of financing to upgrade their facilities to meet the ever-changing standards of medical care.
"Most of us are operating at very low margins, if any margin at all," Stansbury said. "So, we're struggling to find the money."
Aging hospital infrastructure, particularly in rural areas, is a growing concern. Data on the age of hospitals is hard to come by, because hospitals expand, upgrade, and refurbish different parts of their facilities over time. A 2017 analysis by the American Society for Health Care Engineering, a part of the American Hospital Association, found that the average age of hospitals in the U.S. increased from 8.6 years in 1994 to 11.5 years in 2015. That number has likely grown, industry insiders say, as many hospitals delayed capital improvement projects, particularly during the pandemic.
Research published in 2021 by the capital planning firm Facility Health Inc., now called Brightly, found that U.S. health care facilities had deferred about 41% of their maintenance and would need $243 billion to complete the backlog.
Rural hospitals don't have the resources of larger hospitals, particularly those in hospital chains, to fund billion-dollar expansions.
Most of today's rural hospitals were opened with funding from the Hill-Burton Act, passed by Congress in 1946. That program was rolled into the Public Health Service Act in the 1970s and, by 1997, had funded the construction of nearly 7,000 hospitals and clinics. Now, many of those buildings, particularly those in rural areas, are in dire need of improvements.
Stansbury, who is also board chair of the Colorado Hospital Association, said at least a half-dozen rural hospitals in the state need significant capital investment.
Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform, a think tank in Pittsburgh, said the major problem for small rural hospitals is that private insurance is no longer covering the full cost of providing care. Medicare Advantage, a program under which Medicare pays private plans to provide coverage for seniors and people with disabilities, is a major contributor to the problem, he said.
"You're basically taking patients away from what may be the best payer that the small hospital has, and pushing those patients onto a private insurance plan, which doesn't pay the same way that traditional Medicare pays and ends up also using a variety of techniques to deny claims," Miller said.
Rural hospitals also must staff their emergency rooms with physicians round-the-clock, but the hospitals get paid only if someone comes in.
Meanwhile, labor costs coming out of the pandemic have increased, and inflation has driven up the cost of supplies. Those financial headwinds will likely push more rural hospitals out of business. Hospital closures dropped during the pandemic, from a record 18 closures in 2020 to a combined eight closures in 2021 and 2022, according to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina-Chapel Hill, as emergency relief funds kept them open. But that life support has ended, and at least nine more closed in 2023. Miller said closures are reverting to pre-pandemic rates.
That raises concerns that some hospitals might invest in new facilities and end up shutting down anyway. Miller said only a small portion of rural hospitals might be able to make a meaningful difference to their bottom lines by adding new services.
Lawmakers have tried to help. California, for example, has loan programs charging low to no interest that rural hospitals can participate in, and hospital representatives are urging Colorado legislators to approve similar support.
At the federal level, Rep. Yadira Caraveo, a Colorado Democrat, has introduced the bipartisan Rural Health Care Facilities Revitalization Act, which would help rural hospitals get more funding for capital projects through the U.S. Department of Agriculture. The USDA has been one of the largest funders of rural development through its Community Facilities Programs, providing over $3 billion in loans a year. In 2019, half of the more than $10 billion in outstanding loans through the program helped health care facilities.
"Otherwise, facilities would have to go to private lenders," said Carrie Cochran-McClain, chief policy officer for the National Rural Health Association.
Rural hospitals might not be very attractive to private lenders because of their financial constraints, and thus may have to pay higher interest rates or meet additional requirements to get those loans, she said.
Caraveo's bill would also allow hospitals that already have loans to refinance at lower interest rates, and would cover more categories of medical equipment, such as devices and technology used for telehealth.
"We need to keep these places open, even not just for emergencies, but to deliver babies, to have your cardiology appointment," said Caraveo, who is also a pediatrician. "You shouldn't have to drive two, three hours to get it."
"They're trying to do this while they're doing their regular jobs running a hospital," Juliar said. "A lot of times when there are funding opportunities, for example, the timing may be just too tight for them to put together a project."
Some funding is contingent on the hospital raising matching funds, which may be difficult in distressed rural communities. And most projects require hospitals to cobble together funding from multiple sources, adding complexity. And since these projects often take a long time to put together, rural hospital CEOs or board members sometimes leave before they come to fruition.
"You get going at something and then key people disappear, and then you feel like you're starting all over again," she said.
Expansion of Lincoln Community Hospital could keep locals from having to drive the 100 miles to Denver for orthopedic surgeries or to deliver babies.(Lincoln Health)
The hospital in Hugo opened in 1959 after soldiers coming back from World War II decided that Lincoln County on the eastern Colorado plains needed a hospital. They donated money, materials, land, and labor to build it. The hospital has added four family practice clinics, an attached skilled nursing facility, and an off-site assisted living center. It brings in specialists from Denver and Colorado Springs.
Stansbury would like to build a new hospital roughly double the size of the current 45,000-square-foot facility. With inflation easing and interest rates likely to go down this year, Stansbury hopes to get financing lined up in 2024 and to break ground in 2025.
"The problem is, every day I wake up, it gets more expensive," Stansbury said.
When hospital officials first contemplated building a new hospital three years ago, they estimated a total project cost of about $65 million. But inflation skyrocketed and now interest rates have gone up, pushing the total cost to $75 million.
"If we have to wait another couple of years, we may be pushing up closer to $80 million," Stansbury said. "But we've got to do it. I can't wait five years and think the costs of construction are going to go down."
SACRAMENTO, Calif. — Gov. Gavin Newsom is revisiting California's phase-in of a nation-leading $25 minimum wage for health workers in the face of a projected $38 billion deficit, less than three months after he approved the measure. But renegotiating wages could threaten a delicate compromise between unions and the health industry.
Newsom, whose administration initially opposed the wage deal as too costly, signed the bill, SB 525, into law without knowing the final price tag. His Democratic administration now projects the first-year cost to be $4 billion, though that number has been questioned by labor leaders.
Citing data from the U.S. Bureau of Labor Statistics, finance officials said the law would boost wages for at least 500,000 workers who directly provide health care, not including related employees like janitors, groundskeepers, and security staff who also are covered under the law. According to the Department of Finance, it would also increase wages for state employees and boost the cost of health services by increasing Medi-Cal managed care payments. About half that cost is expected to be paid by California taxpayers and the rest covered by federal payments to Medi-Cal providers.
The governor's latest budget asks the state legislature to add an annual trigger making the minimum wage increases contingent on state revenues and to clarify which state employees are included, citing "the significant fiscal impact" of the law. Newsom acknowledged that negotiations are ongoing, a month after his office said talks would begin.
"We continue to work to land that," he said, adding he hoped for legislation in a matter of weeks.
The governor insisted he had reservations all along and pledged to work with fellow Democrats, who control the legislature, to make the law more affordable. But the bill he signed did not include built-in triggers, such as those used by his predecessor, Democratic Gov. Jerry Brown, that could have delayed the increase in the face of a budgetary downturn. Newsom did, however, reject a number of spending bills last year.
"We had a commitment on the trigger," even though it wasn't in the bill, Newsom said in response to reporters' questioning on Jan. 10. "We're confident all parties that committed to that agreement are going to meet it and do so very shortly."
David Huerta, president of Service Employees International Union California and SEIU United Service Workers West, said in a statement Jan. 10 that the union looks forward to working with the administration and the legislature "to ensure that these critically needed workforce investments are implemented while maximizing federal funds and holding the healthcare industry accountable for investing their resources in their workers and in patient care."
Yet last month, SEIU-United Healthcare Workers West President Dave Regan asserted the state must "hold fast to its commitment." SEIU-UHW is a local affiliate of SEIU California.
Assembly Speaker Robert Rivas, who helped negotiate the earlier deal, wouldn't comment on reopening the negotiations, and State Sen. María Elena Durazo, the Los Angeles Democrat who introduced the bill, also declined comment.
The law currently phases in the wage boosts, with large health facilities and dialysis clinics reaching the $25 hourly minimum in 2026; community clinics in 2027; and other health facilities in 2028. The $25 minimum would not take effect until 2033 for hospitals with a high percentage of patients covered by Medicare or Medicaid, rural independent hospitals, and small county facilities.
The phase-ins are set to start in June, giving state officials time to roll them back before the new fiscal year.
"I just don't understand how the governor signed the bill to begin with. I don't know why anyone thought it was going to be relatively cheap for the government," said Michael Genest, now a private consultant after serving as former Republican Gov. Arnold Schwarzenegger's finance director. "Does he think the unions care so much about him that they will go back to the table on something they've already won? That would be incredibly naive."
Proponents of the law say it covers about 3,000 employees in the state departments of Corrections and Rehabilitation, Veterans Affairs, and Developmental Services because they operate facilities licensed as hospitals, clinics, or nursing homes.
But undoing one portion of the law threatens to unravel the entire intricate compromise between labor and the health industry.
For instance, as part of the deal United Healthcare Workers West agreed in a separate memorandum of understanding to halt for four years its repeated attempts to impose regulations on dialysis clinics.
The union also previously advocated for health worker minimum wage increases in several California cities. The compromise banned such local boosts for 10 years, a big relief to the California Hospital Association.
Regan, of SEIU-UHW, said the administration's cost estimate "has been severely overstated."
Nearly half of health workers who would see wage increases, or a family member, currently rely on safety-net programs such as Medi-Cal, CalFresh, and CalWORKs, said Laurel Lucia, director of the Health Care Program at the University of California-Berkeley Labor Center. So increasing their income would reduce their reliance on those tax-funded programs.
"We're estimating that the health care minimum wage impact on the state budget could be up to $300 million in the first year, but it's possible that it could be substantially less than that" depending on how and when the state adjusts Medi-Cal payments to hospitals and clinics, Lucia said.
Genest put the cost to the state's general fund at about $1.2 billion in an August calculation for the health industry when it opposed the bill before the last-minute compromise.
Finance Department spokesperson H.D. Palmer acknowledged the administration's calculation did not include offsets such as a reduction in the number of lower-income workers relying on Medi-Cal.
Lucia estimated the $25 minimum wage law would raise wages for about 450,000 health workers, both those providing direct care and those in related occupations — at least 50,000 fewer than the administration's estimate.
As I checked in at a Manhattan radiology clinic for my annual mammogram in November, the front desk staffer reviewing my paperwork asked an unexpected question: Would I like to spend $40 for an artificial intelligence analysis of my mammogram? It's not covered by insurance, she added.
I had no idea how to evaluate that offer. Feeling upsold, I said no. But it got me thinking: Is this something I should add to my regular screening routine? Is my regular mammogram not accurate enough? If this AI analysis is so great, why doesn't insurance cover it?
I'm not the only person posing such questions. The mother of a colleague had a similar experience when she went for a mammogram recently at a suburban Baltimore clinic. She was given a pink pamphlet that said: "You Deserve More. More Accuracy. More Confidence. More power with artificial intelligence behind your mammogram." The price tag was the same: $40. She also declined.
In recent years, AI software that helps radiologists detect problems or diagnose cancer using mammography has been moving into clinical use. The software can store and evaluate large datasets of images and identify patterns and abnormalities that human radiologists might miss. It typically highlights potential problem areas in an image and assesses any likely malignancies. This extra review has enormous potential to improve the detection of suspicious breast masses and lead to earlier diagnoses of breast cancer.
While studies showing better detection rates are extremely encouraging, some radiologists say, more research and evaluation are needed before drawing conclusions about the value of the routine use of these tools in regular clinical practice.
"I see the promise and I hope it will help us," said Etta Pisano, a radiologist who is chief research officer at the American College of Radiology, a professional group for radiologists. However, "it really is ambiguous at this point whether it will benefit an individual woman," she said. "We do need more information."
The radiology clinics that my colleague's mother and I visited are both part of RadNet, a company with a network of more than 350 imaging centers around the country. RadNet introduced its AI product for mammography in New York and New Jersey last February and has since rolled it out in several other states, according to Gregory Sorensen, the company's chief science officer.
Sorensen pointed to research the company conducted with 18 radiologists, some of whom were specialists in breast mammography and some of whom were generalists who spent less than 75% of their time reading mammograms. The doctors were asked to find the cancers in 240 images, with and without AI. Every doctor's performance improved using AI, Sorensen said.
Among all radiologists, "not every doctor is equally good," Sorensen said. With RadNet's AI tool, "it's as if all patients get the benefit of our very top performer."
But is the tech analysis worth the extra cost to patients? There's no easy answer.
"Some people are always going to be more anxious about their mammograms, and using AI may give them more reassurance," said Laura Heacock, a breast imaging specialist at NYU Langone Health's Perlmutter Cancer Center in New York. The health system has developed AI models and is testing the technology with mammograms but doesn't yet offer it to patients, she said.
Still, Heacock said, women shouldn't worry that they need to get an additional AI analysis if it's offered.
"At the end of the day, you still have an expert breast imager interpreting your mammogram, and that is the standard of care," she said.
About 1 in 8 women will be diagnosed with breast cancer during their lifetime, and regular screening mammograms are recommended to help identify cancerous tumors early. But mammograms are hardly foolproof: They miss about 20% of breast cancers, according to the National Cancer Institute.
The FDA has authorized roughly two dozen AI products to help detect and diagnose cancer from mammograms. However, there are currently no billing codes radiologists can use to charge health plans for the use of AI to interpret mammograms. Typically, the federal Centers for Medicare & Medicaid Services would introduce new billing codes and private health plans would follow their lead for payment. But that hasn't happened in this field yet and it's unclear when or if it will.
CMS didn't respond to requests for comment.
Thirty-five percent of women who visit a RadNet facility for mammograms pay for the additional AI review, Sorensen said.
Radiology practices don't handle payment for AI mammography all in the same way.
The practices affiliated with Boston-based Massachusetts General Hospital don't charge patients for the AI analysis, said Constance Lehman, a professor of radiology at Harvard Medical School who is co-director of the Breast Imaging Research Center at Mass General.
Asking patients to pay "isn't a model that will support equity," Lehman said, since only patients who can afford the extra charge will get the enhanced analysis. She said she believes many radiologists would never agree to post a sign listing a charge for AI analysis because it would be off-putting to low-income patients.
Sorensen said RadNet's goal is to stop charging patients once health plans realize the value of the screening and start paying for it.
Some large trials are underway in the United States, though much of the published research on AI and mammography to date has been done in Europe. There, the standard practice is for two radiologists to read a mammogram, whereas in the States only one radiologist typically evaluates a screening test.
Interim results from the highly regarded MASAI randomized controlled trial of 80,000 women in Sweden found that cancer detection rates were 20% higher in women whose mammograms were read by a radiologist using AI compared with women whose mammograms were read by two radiologists without any AI intervention, which is the standard of care there.
"The MASAI trial was great, but will that generalize to the U.S.? We can't say," Lehman said.
In addition, there is a need for "more diverse training and testing sets for AI algorithm development and refinement" across different races and ethnicities, said Christoph Lee, director of the Northwest Screening and Cancer Outcomes Research Enterprise at the University of Washington School of Medicine.
The long shadow of an earlier and largely unsuccessful type of computer-assisted mammography hangs over the adoption of newer AI tools. In the late 1980s and early 1990s, "computer-assisted detection" software promised to improve breast cancer detection. Then the studies started coming in, and the results were often far from encouraging. Using CAD at best provided no benefit, and at worst reduced the accuracy of radiologists' interpretations, resulting in higher rates of recalls and biopsies.
"CAD was not that sophisticated," said Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. Artificial intelligence tools today are a whole different ballgame, he said. "You can train the algorithm to pick up things, or it learns on its own."
Smith said he found it "troubling" that radiologists would charge for the AI analysis.
"There are too many women who can't afford any out-of-pocket cost" for a mammogram, Smith said. "If we're not going to increase the number of radiologists we use for mammograms, then these new AI tools are going to be very useful, and I don't think we can defend charging women extra for them."
After Iowa lawmakers passed a ban on gender-affirming care for minors in March, managers of an LGBTQ+ health clinic located just across the state line in Moline, Illinois, decided to start offering that care.
The added services would provide care to patients who live in largely rural eastern Iowa, including some of the hundreds previously treated at a University of Iowa clinic, saving them half-day drives to clinics in larger cities like Chicago and Minneapolis.
By June, The Project of the Quad Cities, as the Illinois clinic is called, had hired a provider who specializes in transgender health care. So, Andy Rowe, The Project's health care operations director, called the clinic's insurance broker to see about getting the new provider added to the nonprofit's malpractice policy.
"I didn't anticipate that it was going to be a big deal," Rowe said. Then the insurance carriers' quotes came. The first one specifically excluded gender-affirming care for minors. The next response was the same. And the one after that. By early November, more than a dozen malpractice insurers had declined to offer the clinic a policy.
Rowe didn't know it at the time, but he wasn't alone in his frustrating quest.
Nearly half the states have banned medication or surgical treatment for transgender youth. Independent clinics and medical practices located in states where such care is either allowed or protected have moved to fill that void for patients commuting or relocating across state lines. But as the risk of litigation rises for clinics, obtaining malpractice insurance on the commercial marketplace has become a quiet barrier to offering care, even in states with legal protections for health care for trans people. In extreme cases, lawmakers have deployed malpractice insurance regulations against gender-affirming care in states where courts have slowed or blocked anti-trans legislation.
Five months after starting his search for malpractice insurance, Rowe said, he received a quote for a policy that would allow The Project to treat trans youth. That's when he realized finding a policy was only the first hurdle. He expected the coverage to cost $8,000 to $10,000 a year, but he was quoted $50,000.
Rowe said he hadn't experienced anything like it in his 20 years working in health care administration.
Insurance industry advocates argue that higher premiums are justified because the rise in legislation surrounding gender-affirming care for minors means clinics are at increased risk of being sued.
"If state laws increase the risk of civil liability for health professionals, premiums will be adjusted accordingly and appropriately to reflect the level of financial risk incurred by the insured," Mike Stinson, vice president of public policy and legal affairs at the Medical Professional Liability Association, an insurance trade association, said in an emailed statement. If state laws make an activity illegal, then insurance will not cover it at all, he said.
Only a few states have passed laws preventing malpractice insurers from treating gender-affirming care differently than other care. Massachusetts was the first, when lawmakers there passed legislation that says insurers could not increase rates for health care providers for offering services that are illegal in other states.
Since then, five other states have passed laws requiring malpractice insurers to treat gender-affirming health care as they do any other legally protected health activity: Colorado, Vermont, New York, Oregon, and California (similar legislation is pending in Hawaii).
"This was a preventative measure, and it was met with full acceptance by both the insured and the insurers," said Vermont state Sen. Virginia "Ginny" Lyons, a Democrat who co-sponsored the state's law. She said lawmakers consulted with both physicians and malpractice insurance companies to make sure the language was accurate. Insurers just wanted to be able to clearly assess the risk, she said.
Lyons said she hadn't heard of any providers in Vermont who had trouble with their malpractice insurance before the law was enacted, but she was concerned politics might get in the way of doctors' ability to offer care. In March 2022, The Texas Tribune reported that one Texas doctor had stopped offering care because his malpractice provider had stopped covering hormone therapy for minors.
Lawmakers in some states have gone further and revised malpractice provisions to restrict access to gender-affirming care, often while bans on offering that care to trans youth are stalled in court. In 2021, Arkansas became the first state to ban gender-affirming care for trans children. When that ban was held up in court last year, the governor signed a new law allowing anyone who received gender-affirming care as a minor to file a malpractice lawsuit up to 15 years after they turn 18.
Similar laws followed in Tennessee, Florida, and Missouri, all extending the statute of limitations on filing a malpractice claim anywhere from 15 to 30 years. (Another was introduced but not passed in Texas that would have stretched the statute of limitations to the length of the patient's life.) Typically, malpractice suits must be filed within one to three years of injury.
The civil liability that those laws created has forced at least one clinic to stop offering some treatments. The Washington University Transgender Center in Missouri said the law subjected the clinic to "unacceptable level of liability."
Alejandra Caraballo, a civil rights attorney and clinical instructor at the Harvard Law School Cyberlaw Clinic, said there has been "a concerted effort on the part of anti-trans activists to utilize malpractice insurance as a means of eliminating care."
She likens the strategy to laws that have long targeted abortion providers by increasing "legal liability to chill a certain type of conduct."
Anti-trans activists have drawn attention to a small number of "detransitioners," who have filed lawsuits against the doctors who provided them with gender-affirming care, she said. She believes those lawsuits, filed in such states as California, Nebraska, and North Carolina, will be used to lobby for longer statutes of limitations and to create the perception that liability for providers is increasing.
For independent clinics, like The Project in the Quad Cities, and small medical practices that purchase their malpractice insurance on the commercial marketplace, those tactics are restricting their ability to offer care. Many providers of gender-affirming care are protected from rising premiums such as health centers that receive federal funding, which are covered under the Federal Tort Claims Act, or academic medical centers and Planned Parenthood clinics, which are self-insured. But a small number of independent clinics have been priced out.
In Albuquerque, New Mexico, a state that, like Illinois, has protected access to gender-affirming care, family medicine physician Anjali Taneja said the clinic where she works is running into the same trouble getting coverage.
Casa de Salud, where Taneja is the executive director, has provided gender-affirming care to adults for years, but when the clinic decided to start offering that care to younger patients, insurers wouldn't issue a malpractice policy. The clinic was quoted "double what we paid a few years ago," just to cover the gender-affirming care it offers to adults, Taneja said.
The red tape both Casa de Salud and The Project are encountering has prevented treatment for patients. When Iowa's ban on gender-affirming care took effect Sept. 1, officials at The Project had hoped to offer services to the transgender youth who previously sought care an hour west at the University of Iowa's LGBTQ Clinic. Instead, Rowe said, patients are making the difficult decision between going without treatment or commuting four hours to Chicago or Minneapolis.
After months of fundraising, The Project has almost enough money to pay for the $50,000 malpractice policy. But, Rowe said, "it's a tough swallow."