In a recent campaign video, former President Donald Trump blasted President Joe Biden for "a catastrophic increase" in drug shortages.
"It's a mess," Trump said in the video, adding that new drug shortages were up last year by 30%, with "295 active drug shortages" by the end of 2022.
The continued availability of lifesaving drugs is a concern in this country. Reports of shortages of medicines on which many Americans rely — from widely used cancer medications like cisplatin to over-the-counter painkillers such as Children's Tylenol — have been widespread in recent years. The shortages have caused treatment delays or forced clinicians to substitute alternatives in place of preferred therapies.
But is Biden responsible, or is Trump's claim an oversimplification?
We contacted the Trump campaign for answers, but got no reply. So, we poked around on our own. What we found didn't align with Trump's claims. By some measures, drug shortages increased more on Trump's watch than on Biden's.
Where to Place the Blame?
Trump's statistics were in the ballpark. According to a March report by the Senate Committee on Homeland Security and Governmental Affairs, cited in the video's footnotes, the number of active drug shortages in 2022 did hit 295 at the end of 2022. The count was 246 at the end of 2021, according to the American Society of Health-System Pharmacists.
But our calculations suggest the report's math was off. The report stated an increase of "approximately 30%," but it was closer to 20%. Likewise, new drug shortages grew from 114 to 160 in 2022, a 40% increase, not the "nearly 30%" cited in an earlier version of the report, which Trump apparently relied on.
The Senate panel's report is based on data from the FDA and the society. The pharmacy group works with the University of Utah Health's Drug Information Service to track drug shortages.
The society's shortage information derives from pharmacists' and patients' reports of supply issues that affect how pharmacies prepare or dispense drugs, or influence patient care, often locally. The FDA, with its national scope, declares a drug shortage when demand or projected demand exceeds supply, as projected by drug manufacturers. So, the FDA's shortage tallies are bound to be different from the society's. For instance, the FDA reported that new and active drug shortages grew from 124 in 2021 to 135 in 2022, a 9% increase.
But Biden isn't the only president whose administration has contended with rising drug shortages. And his numbers to date aren't the worst.
Active drug shortages grew from 195 in 2016 to 264 in 2019 — when Trump was president. That's a 35% increase, according to the society's figures. During Biden's first 3½ years in office, that same category of shortages increased 12%, from 276 to 309.
New drug shortages peaked at 267, in 2011, during the Obama administration, the society reported. Some experts credit an executive order that Obama signed that year directing the FDA to broaden its shortage reporting as a turning point. Since that 2011 high, the U.S. recorded the next-largest number of new drug shortages — 186 — in 2018, when Trump was president.
The point isn't that Trump managed drug shortages badly then or that Biden is handling them badly now, experts said.
"I don't think you can tie this to any administration or specific person," said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
Many factors — from natural disasters and manufacturing problems to slim profit margins on generic drugs — can contribute to shortages. Lingering drug shortages from before the pandemic, "compounded with shortages due to covid and poor quality at U.S.-based companies like Akorn pharmaceuticals, have really contributed to the very large numbers of shortages we have right now," said Erin Fox, associate chief pharmacy officer at University of Utah Health.
The Complexity of Medication Supplies
For decades, the U.S. has suffered periodic drug and medical device shortages. Disruptions at any point in the complex supply chain involving people, production, technologies, and policy decisions can ripple throughout the system, causing scarcities that may last years.
A Health Affairs article published this past January described the current system's complexity. More than 20,000 prescription drugs and more than 13,000 facilities worldwide are registered to make drugs or their active ingredients. More than three-quarters of active pharmaceutical ingredients are made outside the United States, the authors said.
Experts acknowledge that relying on overseas drug manufacturers can lead to quality control and oversight problems, because it's harder for the FDA to inspect plants overseas. For example, after an FDA inspection last December that found numerous manufacturing problems, Intas Pharmaceuticals in India voluntarily suspended production and distribution of its products that were destined for the United States. The company was allowed to distribute some drugs, including critical cancer drugs, that are in short supply, with strict third-party oversight. In the video, Trump also zeroed in on this concern. He pledged — with an emphasis on minimizing China's role in the production of medications — to return manufacturing of all essential medicines to the United States, "where they belong."
But the United States experiences manufacturing problems and weather emergencies, just as everywhere else in the world does. For example, Lake Forest, Illinois-based drugmaker Akorn filed for bankruptcy this year and stopped making more than 70 generic drugs. After a tornado hit its Rocky Mount, North Carolina, plant in July, Pfizer temporarily shuttered the facility. The company said Sept. 25 that it had restarted production at the plant.
"Bringing all manufacturing back to the United States not only isn't feasible, because we don't have the raw materials, but that also creates a reliance on a single geographical area," said Soumi Saha, senior vice president of government affairs at Premier, a large group-purchasing organization for hospitals and other health providers. "What you need is global diversification."
Marta Wosińska, a health care economist at the Brookings Schaeffer Initiative on Health Policy, agreed with Saha — domestic manufacturing isn't a panacea. "Domestic production is no guarantee of having a stable supply chain," she said. "Most shortages are caused by quality problems in both the United States and overseas."
Trump also criticized Biden for "shamefully" not following through on an executive order Trump signed that directed federal agencies to identify ways to maximize domestic production of essential medicines.
The White House didn't respond to questions about the status of Trump's order. But spokesperson Kelly Scully in a statement pointed to the five executive orders Biden issued since taking office "focused on strengthening the resilience of critical supply chains," including those for pharmaceuticals.
Our Ruling
Trump said there was a "catastrophic increase" in drug shortages under Biden's watch. Trump was correct that drug shortages have ticked upward. But Trump's statements blaming Biden for those shortages are inaccurate and lack context.
Not only have significant drug shortages increased during other presidential administrations — including Trump's — experts generally agree that there are multiple, complex, and interlocking factors that cause them, meaning no one person is at fault, not even the president.
AI tools often predict a patient's date of discharge, which coincides with the date their insurer cuts off coverage, even if the patient needs further treatment.
This article was published on Thursday, October 5, 2023 in KFF Health News.
Judith Sullivan was recovering from major surgery at a Connecticut nursing home in March when she got surprising news from her Medicare Advantage plan: It would no longer pay for her care because she was well enough to go home.
At the time, she could not walk more than a few feet, even with assistance — let alone manage the stairs to her front door, she said. She still needed help using a colostomy bag following major surgery.
"How could they make a decision like that without ever coming and seeing me?" said Sullivan, 76. "I still couldn't walk without one physical therapist behind me and another next to me. Were they all coming home with me?"
UnitedHealthcare — the nation's largest health insurance company, which provides Sullivan's Medicare Advantage plan — doesn't have a crystal ball. It does have naviHealth, a care management company it bought in 2020, and one of several businesses that use computers to help insurance companies make coverage decisions.
Its proprietary "nH Predict" tool sifts through millions of medical records to match patients with similar diagnoses and characteristics, including age, preexisting health conditions, and other factors. Based on these comparisons, an algorithm anticipates what kind of care a specific patient will need and for how long.
But patients, providers, and patient advocates in several states said they have noticed a suspicious coincidence: The tool often predicts a patient's date of discharge, which coincides with the date their insurer cuts off coverage, even if the patient needs further treatment that government-run Medicare would provide.
"When an algorithm does not fully consider a patient's needs, there's a glaring mismatch," said Rajeev Kumar, a physician and the president-elect of the Society for Post-Acute and Long-Term Care Medicine, which represents long-term care practitioners. "That's where human intervention comes in."
The federal government will try to even the playing field next year, when the Centers for Medicare & Medicaid Services begins restricting how Medicare Advantage plans use predictive technology tools to make some coverage decisions.
Medicare Advantage plans, an alternative to the government-run, original Medicare program, are operated by private insurance companies. About half the people eligible for full Medicare benefits are enrolled in the private plans, attracted by their lower costs and enhanced benefits like dental care, hearing aids, and a host of nonmedical extras like transportation and home-delivered meals.
Insurers receive a monthly payment from the federal government for each enrollee, regardless of how much care they need. According to the Department of Health and Human Services' inspector general, this arrangement raises "the potential incentive for insurers to deny access to services and payment in an attempt to increase profits." Nursing home care has been among the most frequently denied services by the private plans — something original Medicare likely would cover, investigators found.
After UHC cut off her nursing home coverage, Sullivan's medical team agreed with her that she wasn't ready to go home and provided an additional 18 days of treatment. Her bill came to $10,406.36.
Beyond her mobility problems, "she also had a surgical wound that needed daily dressing changes" when UHC stopped paying for her nursing home care, said Debra Samorajczyk, a registered nurse and the administrator at the Bishop Wicke Health and Rehabilitation Center, the facility that treated Sullivan.
Sullivan's coverage denial notice and nH Predict report did not mention wound care or her inability to climb stairs. Original Medicare would have most likely covered her continued care, said Samorajczyk.
Sullivan appealed twice but lost. Her next appeal was heard by an administrative law judge, who holds a courtroom-style hearing usually by phone or video link, in which all sides can provide testimony. UHC declined to send a representative, but the judge nonetheless sided with the company. Sullivan is considering whether to appeal to the next level, the Medicare Appeals Council, and the last step before the case can be heard in federal court.
Sullivan's experience is not unique. In February, Ken Drost's Medicare Advantage plan, provided by Security Health Plan of Wisconsin, wanted to cut his coverage at a Wisconsin nursing home after 16 days, the same number of days naviHealth predicted was necessary. But Drost, 87, who was recovering from hip surgery, needed help getting out of bed and walking. He stayed at the nursing home for an additional week, at a cost of $2,624.
After he appealed twice and lost, his hearing on his third appeal was about to begin when his insurer agreed to pay his bill, said his lawyer, Christine Huberty, supervising attorney at the Greater Wisconsin Agency on Aging Resources Elder Law & Advocacy Center in Madison.
"Advantage plans routinely cut patients' stays short in nursing homes," she said, including Humana, Aetna, Security Health Plan, and UnitedHealthcare. "In all cases, we see their treating medical providers disagree with the denials."
UnitedHealthcare and naviHealth declined requests for interviews and did not answer detailed questions about why Sullivan's nursing home coverage was cut short over the objections of her medical team.
Aaron Albright, a naviHealth spokesperson, said in a statement that the nH Predict algorithm is not used to make coverage decisions and instead is intended "to help the member and facility develop personalized post-acute care discharge planning." Length-of-stay predictions "are estimates only."
However, naviHealth's website boasts about saving plans money by restricting care. The company's "predictive technology and decision support platform" ensures that "patients can enjoy more days at home, and healthcare providers and health plans can significantly reduce costs specific to unnecessary care and readmissions."
New federal rules for Medicare Advantage plans beginning in January will rein in their use of algorithms in coverage decisions. Insurance companies using such tools will be expected to "ensure that they are making medical necessity determinations based on the circumstances of the specific individual," the requirements say, "as opposed to using an algorithm or software that doesn't account for an individual's circumstances."
The CMS-required notices nursing home residents receive now when a plan cuts short their coverage can be oddly similar while lacking details about a particular resident. Sullivan's notice from UHC contains some identical text to the one Drost received from his Wisconsin plan. Both say, for example, that the plan's medical director reviewed their cases, without providing the director's name or medical specialty. Both omit any mention of their health conditions that make managing at home difficult, if not impossible.
The tools must still follow Medicare coverage criteria and cannot deny benefits that original Medicare covers. If insurers believe the criteria are too vague, plans can base algorithms on their own criteria, as long as they disclose the medical evidence supporting the algorithms.
And before denying coverage considered not medically necessary, another change requires that a coverage denial "must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue."
Jennifer Kochiss, a social worker at Bishop Wicke who helps residents file insurance appeals, said patients and providers have no say in whether the doctor reviewing a case has experience with the client's diagnosis. The new requirement will close "a big hole," she said.
The leading MA plans oppose the changes in comments submitted to CMS. Tim Noel, UHC's CEO for Medicare and retirement, said MA plans' ability to manage beneficiaries' care is necessary "to ensure access to high-quality safe care and maintain high member satisfaction while appropriately managing costs."
Restricting "utilization management tools would markedly deviate from Congress' intent in creating Medicare managed care because they substantially limit MA plans' ability to actually manage care," he said.
In a statement, UHC spokesperson Heather Soule said the company's current practices are "consistent" with the new rules. "Medical directors or other appropriate clinical personnel, not technology tools, make all final adverse medical necessity determinations" before coverage is denied or cut short. However, these medical professionals work for UHC and usually do not examine patients. Other insurance companies follow the same practice.
David Lipschutz, associate director of the Center for Medicare Advocacy, is concerned about how CMS will enforce the rules since it doesn't mention specific penalties for violations.
CMS' deputy administrator and director of the Medicare program, Meena Seshamani, said that the agency will conduct audits to verify compliance with the new requirements, and "will consider issuing an enforcement action, such as a civil money penalty or an enrollment suspension, for the non-compliance."
Although Sullivan stayed at Bishop Wicke after UHC stopped paying, she said another resident went home when her MA plan wouldn't pay anymore. After two days at home, the woman fell, and an ambulance took her to the hospital, Sullivan said. "She was back in the nursing home again because they put her out before she was ready."
Dollar General's pilot mobile clinic program has been touted by company officials, rural health experts, and analysts as a model that could help solve rural America's primary care shortage. But its Tennessee launch has been met with local skepticism.
This article was published on Wednesday, October 4, 2023 in KFF Health News.
CLARKSVILLE, Tenn. — On a hot July morning, customers at the Dollar General along a two-lane highway northwest of Nashville didn't seem to notice signs of the chain store's foray into mobile healthcare, particularly in rural America.
A woman lifted a child from the back of an SUV and walked into the store. A dog barked from a black pickup truck before its owner returned with cases of soda. Another woman checked her hair in a convertible's rearview mirror before shopping.
Each went right by a sign exclaiming "Quick, Easy Health Visits," with an image of a mobile clinic.
Just after 10 a.m., registered nurse Kimberly French arrived to work at the DocGo mobile clinic parked in the store's lot. She checked her schedule.
"We don't have any appointments so far today, but that could change," French said. "Last night we didn't have any appointments and three or four people showed up all at one time."
Dollar General, the nation's largest retailer by number of stores, with more than 19,000, partnered with New York-based mobile medical services company DocGo to test whether they could draw more customers and tackle persistent health inequities.
Deploying mobile clinics to fill care gaps in underserved areas isn't a new idea. But pairing them with Dollar General's ubiquitous small-town presence has been heralded by investment analysts and some rural health experts as a way to ease the healthcare drought in rural America.
Dollar General's latest annual report notes that about 80% of the company's stores are in towns with populations of fewer than 20,000 — precisely where medical professionals are scarce.
Catering to those who want urgent or primary care, the mobile clinics take private insurance as well as Medicaid and Medicare. The company's website says DocGo's self-pay rates start at $69 for patients without insurance or who are out of network. DocGo officials said Tennessee patients may be charged different rates but declined to provide details.
On the ground in Tennessee, primary care doctors and patients are skeptical.
"Honestly, they don't really grasp, I don't think, what they're getting into," said Brent Staton, a family medicine doctor and the leader of the Cumberland Center for Healthcare Innovation, a statewide organization that helps small-town family care doctors coordinate care and negotiate with insurers, including Medicare.
Michelle Green manages the popular Sweet Charlotte grill about 10 miles south of Dollar General's most rural test site. Green, who was handing out hamburgers and hand-cut fries during a Saturday rush, said she hadn't heard of the mobile clinic. She said with a shrug that Dollar General and healthcare clinics "don't go together."
"I wouldn't want to go to a healthcare clinic in a parking lot; that's just me," Green said, adding that someone might go if "you're sick and you can't go anywhere else."
Bumps in the Road
The Clarksville-area pilot, which launched last fall, is in a federally designated primary care shortage area for low-income residents.
About 1,000 patients have been seen in the company's clinics, either at Dollar General sites or community pop-up events, and some became repeat visitors, according to DocGo. Payment is taken outside on a mobile device and, once inside, patients meet with an on-site staff member, like French, and connect via telehealth on an iPad screen with a physician assistant or nurse practitioner.
The clinic rotates between three Dollar General pilot sites each week. The stores are in the Clarksville area and, early this summer, the van stopped going to the most rural site, near Cumberland Furnace, because of low utilization, according to company leaders. DocGo moved that location's time slot to busy Fort Campbell Boulevard in Clarksville.
"We do try for months in a given area to see where it makes sense and where it doesn't," former DocGo CEO Anthony Capone said in a July interview. "Our goal is to align the supply we have with the demand of the local community."
Capone, though, said he thought the pilot would work in rural areas when insurers are signed on to refer their members to the mobile clinic. DocGo recently announced a deal with Blue Cross Blue Shield of Tennessee.
Capone abruptly resigned on Sept. 15 after the Albany Times Union reported he lied about having a graduate degree.
Dollar General stores have a "tremendous opportunity" to have "a major impact on health there and really bond themselves as a member of the community," said Tom Campanella, the healthcare executive-in-residence at Baldwin Wallace University, who has managed mobile clinics in rural places.
Near tiny Cumberland Furnace, south of Clarksville, William "Bubba" Murphy stopped on his way into a Dollar General, paused to wave and holler hello to friends getting out of their cars, and shared that multiple family members — his sister-in-law, nephew, and niece's boyfriend — used and liked "the little clinic on wheels."
"We don't have to go to town and fight all that traffic," he said. "They come to us. That's a wonderful thing. It helps a lot of people."
Over on busy Fort Campbell Boulevard in Clarksville, Marina Woolever, a mother of three, said she might use the clinic if she didn't have insurance. Natural health professional Nichole Clemmer glanced toward the clinic and called it a "ploy" to make more money.
Jefferies lead equity analyst Corey Tarlowe, who follows discount retailers, said the clinics will help "democratize" access to healthcare and simultaneously boost traffic to Dollar General stores.
With its rapid growth in recent years, Dollar General has faced accusations that its stores kill off local grocery stores and other businesses, reduce employment, and contribute to the creation of food deserts. More recently, the U.S. Labor Department said the chain "continues to discount safety" for employees as it has piled up more than $21 million in federal fines.
Crystal Luce, senior director of public relations for Dollar General, said the company believes each new store provides "positive economic benefits," including new jobs, low-cost products, and its literacy foundation. On the federal fines, Luce said Dollar General is "committed to providing a safe work environment for its associates and shopping experience for its customers." The company declined to provide an interview.
The DocGo pilot, she wrote, is intended to "complement" the DG Wellbeing initiative, which is a corporatewide push. Dollar General wants to increase "access to basic healthcare products and, ultimately, services over time, particularly in rural America," Luce wrote.
States away, DocGo is under fire for a no-bid contract to provide housing, busing, and other services for asylum-seekers in New York. State Attorney General Letitia James is investigating complaints levied by migrants under the company's care. In August, DocGo officials said claims aired by sources in a New York Times article that first reported the problems were "not reflective of the overall scope and quality" of the services the company has provided.
The company's pilot with Dollar General is "supported with funding from the state of Tennessee," DocGo's Capone said during the company's first-quarter earnings call. The Dollar General partnership is cited in quarterly grant reports DocGo's Rapid Reliable Testing LLC submitted to the state, according to records KFF Health News obtained through public information requests.
In the grant filing, DocGo listed Dollar General along with other organizations as "trusted messengers" in building vaccine awareness.
Dollar General declined to respond to a question about its involvement in the grant. Instead, Luce stated, "We continue to test and learn through the DocGo pilot."
'Relational Care'
The goal of the $2.4 million grant, funded by the Centers for Disease Control and Prevention and distributed by the Tennessee Department of Health, is to administer COVID-19 vaccines. In a written response provided by DocGo's marketing director, Amanda Shell Jennings, the company said, "Dollar General has no involvement with the TN Department of Health grant funding or allocations."
The grant covers storage and maintenance of COVID-19 vaccines on the DocGo mobile clinics, Jennings' statement said, adding that, as of September, DocGo has held 41 vaccine events and provided 66 vaccines to rural Tennesseans.
Lulu West, 72, was visiting a friend at the Historic Cumberland Furnace Iron Museum when she stopped to consider the mobile clinic. West said she would rather go to her primary care doctor.
"When you say mobile clinic outside a Dollar General it just kind of has a connotation that you may not be comfortable with. You know what I mean?" she said.
That kind of response doesn't surprise Carlo Pike, a doctor who for years has practiced family medicine in Clarksville. He said he's not worried about the competition because providing primary care is about developing relationships.
"If I can do this relationship right," Pike said, "maybe we can keep you from getting a [blood] sugar of 500 [mg/dL] or from Grandpa climbing up a ladder and trying to fix something he has no business with and falling off and breaking his leg."
Staton said the Cumberland Center for Healthcare Innovation, his accountable care organization, has saved Medicare and Medicare Advantage companies more than $100 million by focusing on preventive care and reducing hospitalizations and emergency visits for patients.
"We're just small rural primary care docs doing our jobs with a process that works," Staton said. In another interview, Staton called it "relational care."
DocGo surveyed its patients and found that 19% of them did not have a primary care physician or hadn't seen theirs in more than a year. In the written responses Jennings provided, DocGo said it follows up with every patient after the initial visit, offers telemedicine support between visits, and provides ongoing preventive care on a regular schedule.
But despite its outreach, DocGo struggled to get a foothold in rural Cumberland Furnace.
Lottie Stokes, the president of the community center in Cumberland Furnace, said DocGo's team had "called and asked to come down here." Stokes said she would rather use the local emergency medical technicians and firefighters, who she knows are "legit."
Her father-in-law, Bobby Stokes, who's nearly 80 years old, said he used the mobile clinic before it moved locations.
His wife couldn't breathe. They pulled into the parking lot and climbed onto the van.
"We wasn't in there five minutes," he said. "They done the blood pressure test and what they need to do and put her in the car and said, ‘Get her to the hospital, to the emergency room.'"
The DocGo staff, he said, did not ask for payment: "Nothing."
"They were more concerned with her than they were with I guess getting their money," he said, adding that his wife is doing well now. "They told me to get there, and I took them at their word. My car runs fast."
KFF Health News correspondent Brett Kelman contributed to this report.
The way Sheldon Haleck's parents see it, the 38-year-old's only crime was jaywalking. But that March night in 2015, after Honolulu police found him behaving erratically, they pepper-sprayed him, shocked him with a Taser, and restrained him. Haleck became unresponsive and was taken to a hospital. Before his parents could get from their home in Utah to Hawaii, the former Hawaii Air National Guardsman was taken off life support.
"Nobody's supposed to die from something like this," said Haleck's father, William.
An initial autopsy ruled Haleck's death a homicide and his family filed a civil lawsuit in federal court against the three officers who tried to remove him from the street. The case should have been "one of the easiest wrongful death cases" to win, said Eric Seitz, an attorney who represented Haleck's family.
But the officers' attorneys seized on a largely discredited, four-decade-old diagnostic theory called "excited delirium," which has been increasingly used over the past 15 years as a legal defense to explain how a person experiencing severe agitation can die suddenly through no fault of the police. "The entire use of that particular theory, I think, is what convinced the jury," Seitz said.
Haleck's case is just one legal battle in which the theory of excited delirium exonerated law enforcement despite mounting opposition to the term among most prominent medical groups. The theory has been cited as a defense in the 2020 deaths of George Floyd in Minneapolis; Daniel Prude in Rochester, New York; and Angelo Quinto in Antioch, California. It figures in a criminal trial against two police officers involved in the 2019 death of Elijah McClain in Aurora, Colorado, now underway. It has allowed defense attorneys to argue that individuals in police custody died not of restraint, not of a Taser shock, but of a medical condition that can lead to sudden death.
But now, the American College of Emergency Physicians will vote at an October meeting on whether to formally disavow its 2009 position paper supporting excited delirium as a diagnosis that helped undergird those court cases. The draft resolution also calls on ACEP to discourage physicians who serve as expert witnesses from promoting the theory in criminal and civil trials.
"It's junk science," said Martin Chenevert, an emergency medicine physician at UCLA Santa Monica Medical Center, who often testifies as an expert witness. The theory has been used to provide a cover for police misconduct, he said. "It had an agenda."
Passing the resolution wouldn't bring Haleck back, but his parents hope it would prevent other families from experiencing their agony. "May that excited delirium die here," said his mother, Verdell.
Democratic California Gov. Gavin Newsom is considering signing into law a bill passed Sept. 12 that would do much of the same in his state.
"If we don't fully denounce this now, it will be there for the grasping, again," said Jennifer Brody, a physician with the Boston Health Care for the Homeless Program, who co-authored a 2021 editorial calling on organized medicine to denounce excited delirium. "Historically, we know what happens: The pendulum swings the other way."
Most major medical societies, including the American Medical Association and the American Psychiatric Association, don't recognize excited delirium as a medical condition. This year, the National Association of Medical Examiners rejected excited delirium as a cause of death. No blood test or other diagnostic test can confirm the syndrome. It's not listed in the "Diagnostic and Statistical Manual of Mental Disorders," a reference book of mental health conditions, nor does it have its own diagnostic code, a system used by health professionals to identify diseases and disorders.
But the argument's pervasiveness in excessive-use-of-force cases has persisted in large part because of the American College of Emergency Physicians' 2009 white paper proposing that individuals in a mental health crisis, often under the influence of drugs or alcohol, can exhibit superhuman strength as police try to control them, and then die from the condition.
The ACEP white paper has been cited in cases across the U.S., and lawyers who file police misconduct cases said that courts and judges accept the science without sufficient scrutiny.
ACEP's position "has done a lot of harm" by justifying first responder tactics that contribute to a person's death, said Joanna Naples-Mitchell, an attorney who worked on a Physicians for Human Rights review of excited delirium. The term has also been used in cases in Australia, the United Kingdom, Canada, and other countries, according to the group.
"This is a really important opportunity for ACEP to make things right," she said of the upcoming vote.
ACEP officials declined KFF Health News requests for an interview.
Starting in the mid-1990s, the leading proponents of excited delirium produced research with funding from Taser International, a maker of stun guns used by police, which later changed its name to Axon. The research purported to show that the technique of prone restraint, in which suspects are lying face down on the ground with the police officer's weight on top of them, and Taser shocks couldn't kill someone. That research formed the basis of the white paper, providing an alternative cause of death that defense attorneys could argue in court. Many emergency physicians say the ACEP document never lived up to the group's standard for clinical guidelines.
Axon officials did not respond to a call or email seeking comment on the white paper or the upcoming ACEP vote. In 2017, Taser officials used the American College of Emergency Physicians' position on excited delirium as evidence that it is a "universally recognized condition," according to Reuters.
A recent review published in the journal Forensic Science, Medicine, and Pathology concluded no scientific evidence exists for the diagnosis, and that the authors of the 2009 white paper engaged in circular reasoning and faulty logic.
"Excited delirium is a proxy for prone-related restraint when there is a death," said Michael Freeman, an associate professor of forensic medicine at Maastricht University in the Netherlands, who co-authored the review. "You don't find that people get ‘excited delirium' if they haven't also been restrained."
Between 2009 and 2019, Florida medical examiners attributed 85 deaths to excited delirium, and at least 62% involved the use of force by law enforcement, according to a January 2020 report in Florida Today. Black and Hispanic people accounted for 56% of 166 deaths in police custody attributed to excited delirium from 2010 to 2020, according to a December 2021 Virginia Law Review article.
This year, ACEP issued a formal statement saying the group no longer recognizes the term "excited delirium" and new guidance to doctors on how to treat individuals presenting with delirium and agitation in what it now calls "hyperactive delirium syndrome." But the group stopped short of retracting the 2009 white paper. For the past 14 years, ACEP took no steps to withdraw the document or to discourage defense attorneys from using it in court.
Even now, lawyers say, they must continually debunk the theory.
"Excited delirium has continued to come up in every single restraint asphyxia case that my partner and I have handled," said Julia Sherwin, a California civil rights attorney. "Instead of acknowledging that the person died from the police tactics, they want to point to this alternate theory of deaths."
Now, plaintiffs' attorneys say, if ACEP passes the resolution it would be the most meaningful step yet toward keeping the theory out of the courtroom. The resolution calls on ACEP to "clarify its position in writing that the 2009 white paper is inaccurate and outdated," and to withdraw approval for it.
Despite the theory's lack of scientific underpinning, backers of the ACEP resolution expect heated debate before the vote scheduled for the weekend of Oct. 7-8. Emergency physicians often encounter patients with agitation and delirium, they say, and are sympathetic to other first responders who share the challenge of managing such patients. While they have tools like sedation to help them in the emergency room, law enforcement officials must often subdue potentially dangerous individuals without such help.
Most people won't die as a result of police tactics such as prone restraint or Taser use, but a small fraction do.
"It's a crappy, crappy situation, when you have someone who's out of control, who can't make decisions for himself, and is potentially a threat somewhere," said Jared Strote, an emergency medicine professor at the University of Washington. "It's not like they have a sticker on their head that says, ‘Hey, I'm at high risk. If you hold me down, then I could go into sudden cardiac arrest.'"
Nonetheless, sentiment is growing among emergency physicians that the 2009 ACEP white paper has resulted in real harm and injustices, and it's time to set it aside.
"We'll be able to close the chapter on it and move forward to recognize explicitly that this was in error," said Brooks Walsh, an emergency physician from Bridgeport, Connecticut, and a key player in bringing the resolution up for a vote. "We definitely have an ethical responsibility to address mistakes or evolutions in medical thinking."
Chris Vanderveen, KUSA-TV's director of special projects, contributed to this report.
A federal program to combat the alarming rates of rural women dying from pregnancy complications has marked a first: It's supporting an organization that serves predominantly Black counties in the Deep South.
The news came Sept. 27, three months after KFF Health News' reporting raised questions about why a federal Health Resources and Services Administration program targeting rural maternal mortality hadn't sent a grant to serve mothers in majority-Black rural communities.
Non-Hispanic Black women — regardless of income or education level — die of pregnancy-related causes at nearly three times the rate of non-Hispanic white women.
The Institute for the Advancement of Minority Health in Madison, Mississippi, was one of two winners in the latest round of an initiative administered by HRSA. Mary Hitchcock Memorial Hospital in Lebanon, New Hampshire, was the other winner, according to an agency announcement.
"Very happy to see Mississippi," said Peiyin Hung, deputy director of the University of South Carolina's Rural and Minority Health Research Center. Mississippi has the highest rate of maternal mortality in the U.S. and the highest proportion of Black births in the U.S., she said.
Hung, who is a member of the health equity advisory group for the maternal grant program, said the Mississippi nonprofit is an unusual awardee because it is not part of a larger health system.
In June, KFF Health News found that HRSA's Rural Maternity and Obstetrics Management Strategies Program, or RMOMS, had failed to fund any sites in the Southeast, where the U.S. Census Bureau shows the largest concentration of predominantly Black rural communities. The program began four years ago and had budgeted nearly $32 million to provide access and care for thousands of mothers and babies nationwide — including Hispanic women along the Rio Grande and Indigenous mothers in Minnesota.
The rural Southeast was omitted despite a White House declaration to make Black maternal health a priority, and despite statistics showing America's maternal mortality rate rising sharply in recent years.
Rep. Robin Kelly (D-Ill.) introduced the "CARE for Moms Act" in mid-September and — in response to KFF Health News' reporting ― called for accountability and reporting requirements for maternal health grants under the Department of Health and Human Services.
"Where is the money going?" she said during a September press conference. "Is it going where it's needed or is it going to bigger organizations who have the people who can write the grants?" She added that "maybe smaller areas or more rural areas" need it more.
HRSA spokesperson Martin Kramer declined to provide more information about the rural maternity grant awards and did not respond when asked about Kelly's bill. The legislation also would establish regional "centers of excellence," Kelly said, to address implicit bias and cultural competency in healthcare providers. She said the bill would also "build up the doula workforce" and establish a state-based perinatal quality collaborative to improve care nationwide.
In an interview with KFF Health News, Kelly, co-chair of the House Maternity Care Caucus and a congressional leader in expanding Medicaid for postpartum care, suggested the lack of grants to the predominantly Black rural South could be because of "implicit bias," and she said her bill would help "get to the heart of the matter and get [the money] to the people that really need it."
The roughly $2 million in new rural grants are part of nearly $90 million in maternal health funding announced in late September by HRSA, an agency within HHS.
The Mississippi-based Institute for the Advancement of Minority Health was created in 2019 to reduce health disparities through partnerships, according to federal filings. Chief executive Sandra Melvin confirmed in an email that this is the first time the institute has applied for the grant, but also noted that it has been working to reduce maternal and infant health disparities since 2019.
Work performed with the grant "will be successful," she said, because the organization plans to take a community-based approach that includes partnering with health centers, hospitals, and a university.
In past years, the grant application process skewed toward large health systems because they "have much higher capacity to form a statewide network," Hung said. That's, in part, because grant winners were required to create a network of specific healthcare clinics, hospitals, and the state Medicaid office. In recent years, the agency has "become much more flexible," Hung said.
The success of the Mississippi application is a "promising signal" for states that don't have large rural health systems focusing on maternal care, said Hung, who hopes a South Carolina applicant receives a grant in the future.
In New Hampshire — where awardee Mary Hitchcock Memorial Hospital is part of the larger Dartmouth Health system in New England ― three rural hospital labor and delivery units have closed in recent years. The closures forced pregnant women to drive up to an hour and a half to appointments or delivery services, said Greg Norman, senior director of community health at Dartmouth Hitchcock Medical Center.
Its HRSA application included the North Country Maternity Network, a collaboration of hospitals and clinics created in late 2021, Norman said. The New Hampshire group did not win the federal maternity grant the first time it applied. But this time the network was more established , he said.
The money from the New Hampshire grant — up to $1 million a year for four years — will help create standardized medical and social screening for pregnant people. It will also pay for a shared high-risk coordinator and increased use of doulas and community health workers who could do home visits, he said.
The whole project, Norman said, is "a step in the direction of more equitable care."
JOHNSON CITY, Tenn. — Five years ago, rival hospital companies in this blue-collar corner of Appalachia made a deal. If state lawmakers let them merge, leaving no competitors, the hospitals promised not to gouge prices or cut corners. They agreed to dozens of quality-of-care conditions, spelled out with benchmarks, and to provide hundreds of millions of dollars in charity care to patients in need.
Today, Ballad Health's 20 hospitals remain the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina. But Ballad has not met many of the quality benchmarks nor provided much of the charity, spurring discontent among those with no choice but to rely on Ballad for their care.
Two dozen states, from Florida to Washington, have at some point passed so-called COPA laws that allow hospital systems to merge into monopolies, disregarding warnings from the Federal Trade Commission that such mergers can become difficult to control and may decrease the overall quality of care. In the case of Ballad, the nation's largest-known COPA deal, public records suggest that is exactly what happened.
Documents released by the Tennessee Department of Health show:
Ballad has not fulfilled the annual charity care obligation it made to Tennessee, falling short by about $148 million over a four-year span. In those same years, Ballad took thousands of patients to court to collect unpaid bills.
Ballad failed to meet about 80% of benchmarks designed to monitor and improve its quality of care — including rates of infection and death — in the most recent year for which data is available. Federal health officials cited some of these same problems this year in issuing one-star ratings to three Ballad hospitals, including a flagship, Johnson City Medical Center.
"The state of Virginia and the state of Tennessee took a chance on [Ballad] to do the right thing," said Michele Johnson, executive director of the Tennessee Justice Center, a nonprofit focused on healthcare for the poor. "And they've proven that they are not worthy of that chance."
In a two-hour interview with KFF Health News, Ballad Health CEO Alan Levine defended the merger as "hugely successful" for a region rife with poverty and sickness, saying his company had planted seeds of better health that "you can't quantify today." More specifically, Levine said the enormous pressure of the coronavirus pandemic caused Ballad's slumping quality of care. He attributed charity care shortfalls to Medicaid changes beyond Ballad's control and new preventive care programs that keep patients out of the hospital so they don't need charity.
Levine said the Ballad merger had likely prevented at least three hospital closures and kept giant corporations from swooping into Appalachia to buy up the scraps.
"Our critics say, ‘No Ballad. We don't want Ballad.' Well, then what?" Levine said. "Because the hospitals were on their way to being closed."
Ballad is centered in Tennessee and Virginia's Tri-Cities region, a cluster of hardscrabble towns and wooded foothills that is home to the famous Bristol Motor Speedway and recognized by Congress as "the birthplace of Country Music." Census data shows the Tri-Cities poverty rate is about 30% higher than the national average, and residents' general health is below average for the nation and their respective states, according to the BlueCross BlueShield National Health Index.
Ballad launched in 2018 after state officials approved the nation's largest-known Certificate of Public Advantage, or COPA, agreement, which waived anti-monopoly laws so the region's only two hospital systems — Mountain States Health Alliance and Wellmont Health System — could merge. To offset the perils of a monopoly, the COPA requires Ballad to agree to increased oversight by the state and a long list of special conditions, including limiting price increases, maintaining quality, and providing charity care. Ballad also committed to investing $308 million over 10 years to improve the health of the region, some of which it has spent on a low-to-no-cost care network for the uninsured and expanded addiction treatment services.
Even with this spending, Ballad has turned a profit. The company generated net income of more than $143 million and $63 million in fiscal years 2022 and 2021, respectively, while receiving $175 million in pandemic relief funds, according to an S&P Global Ratings independent analysis, which excludes items like gains and losses separate from hospital operations.
The merger was profitable for Levine too. His total compensation has nearly doubled to about $4.3 million since the merger, including some deferred retirement payments, according to reports filed with the IRS. Prior to Ballad, Levine worked as a high-level health official in Florida and Louisiana and was an executive at two larger hospital corporations, HCA Healthcare and Health Management Associates. Federal prosecutors accused both companies of widespread healthcare fraud during some of the years when Levine was one of their leaders, claims the companies denied but later paid hundreds of millions of dollars to settle.
Nationwide, the COPA model is uncommon but gaining momentum. COPAs have been used in about 10 hospital mergers over the past three decades, including two in Texas and one in Louisiana in just the past three years, and another is being proposed in Indiana. Nineteen states have laws on the books allowing for COPAs, although not all have approved a specific merger, and five other states passed COPA laws and later repealed them, according to The Source on HealthCare Price & Competition, a website by the University of California College of the Law-San Francisco.
Rahul Rao, a deputy director of the Bureau of Competition at the Federal Trade Commission, which consistently opposes COPAs, said removing hospital competition leads to predictable results — rising prices, decreasing quality, and monopolies that are very hard to break up.
Rao said the FTC has for years studied how the Ballad merger is affecting healthcare in the region but that it is not yet ready to publish its findings.
"States should be very wary and distrustful of COPAs in general," Rao said. "It's very hard to unscramble the eggs."
Tennessee began to pave the way for Ballad in 2015 when state Sen. Rusty Crowe (R-Johnson City) co-sponsored a bill allowing for the merger, which was later mirrored in Virginia. Crowe was also working as a contractor for Mountain States Health Alliance when the bill was introduced, and since the merger he has been similarly contracted with Ballad, the lawmaker said.
Tennessee financial disclosure records confirm Crowe was paid by both hospital systems but don't say how much or for what. Crowe, who did not agree to an interview, said in an email that he was hired to "help in the development of wound care and hyperbaric medicine" and that he "complied with all the Senate ethics code requirements regarding any potential conflict of interest."
Tennessee and Virginia health officials have concluded annually that the merger remains beneficial to the public and, in reports and interviews, credited Ballad for weathering the pandemic and keeping hospitals open.
Dennis Barry, one of the state monitors hired to keep tabs on Ballad, said he believed Ballad had largely lived up to the agreement, or at least the "intent." Barry dismissed the FTC's position that hospital competition is necessarily beneficial and said no one knows how the region would have fared without the merger.
"In a sense, we'll never be able to determine whether or not this was a good idea or a bad idea," Barry said. "I view it as an experiment."
As Ballad fell short of its COPA benchmarks, state officials took steps to relax the oversight of its hospitals, particularly in Tennessee. Both Tennessee and Virginia gave Ballad more time to spend tens of millions to benefit the region, and Tennessee officials have repeatedly waived Ballad's annual charity care obligation. Tennessee in 2021 stopped publishing a "final score" for Ballad's adherence to the COPA terms and in 2022 revised COPA rules so Ballad could oppose the opening of competing hospitals or other medical facilities in the region, according to state documents. A local COPA advisory council, created to hear complaints from residents, no longer hosts public hearings.
Ballad Cites Pandemic Amid Quality Decline
Ballad has failed to meet quality-of-care benchmarks established in the COPA agreement in recent years, according to public reports from the Tennessee government and the hospital system itself. For example, a Tennessee report shows that from July 2021 through June 2022, Ballad hospitals fell short of 61 of 75 benchmarks, including some about sepsis, surgery-related infections, emergency room speed, and rates of readmission and death from heart failure.
The Centers for Medicare & Medicaid Services this year issued one-star ratings to three Ballad hospitals, all of which had ratings of at least two stars before the merger. Because CMS calculates star ratings from data collected over several years, the ratings released this year are the first to grade the Ballad hospitals entirely on post-merger data.
Levine, citing arguments similar to those of other hospital leaders, insisted the CMS five-star rating system is broken because it judges hospitals on a sliver of patients and doesn't account for poor health in the region. He said Ballad fell short of the COPA benchmarks because the coronavirus overwhelmed hospitals and sparked an unprecedented nursing turnover.
But Ballad's hospitals have since rebounded, Levine said, pointing to partial data on the company website — not yet reported by the states — that appears to show improving performance as of this summer. And Levine said internal data showed Ballad was now tracking with the top 10% of U.S. hospitals on some quality-of-care metrics.
"We went way backwards during covid, no question about it. And now we've emerged out of covid," Levine said. "We're recovering faster than other people."
Erik Bodin, a Virginia Department of Health official who oversees the agreement with Ballad, said the pandemic caused quality issues at hospitals across the state, including Ballad's, which were "not acceptable" but "to some extent understandable." Bodin said Virginia still has "concerns" and is "watching very closely" because not all of Ballad's metrics are rebounding.
The Tennessee Department of Health, which has the most robust role in regulating Ballad, declined an interview request and did not answer questions submitted in writing.
Ballad has also cut back on facilities for patients with life-threatening conditions. Citing redundancy with other hospitals, it downgraded the capabilities of trauma centers at Bristol Regional Medical Center and Holston Valley Medical Center and closed the intensive care unit at Sycamore Shoals Hospital. Ballad also shuttered the Holston Valley neonatal ICU. Residents were so angry that protesters gathered outside Holston Valley for eight months.
"I packed a sleeping bag, a backpack, and my laptop bag. I made two signs in my living room," said Dani Cook, the protest leader and grandmother of a former Holston Valley NICU patient. "And next thing you know, 50 people showed up."
One month after Holston Valley's trauma center was downgraded, Jeremiah Shane Fields, 37, died at the hospital from chest injuries sustained in a car crash. According to a CMS investigation report obtained by KFF Health News, Fields' blood pressure dropped for hours before his death, but his doctor did not come to his bedside as his condition deteriorated.
Holston Valley's chief medical officer, who is quoted in the report but not named, called the case a "fundamental failure of basic trauma care" in which Fields' doctor was "not following essential standards," according to the report. Holston Valley was cited for "deficiencies" that were likely to harm patients, which the hospital immediately corrected, the report states.
Fields' family has filed an ongoing lawsuit alleging negligent care, and Ballad Health has denied all wrongdoing in court filings. Molly Luton, a spokesperson for Ballad, said that Fields' death was "an outlier" and "not the result of a systemic issue."
Fields' mother, Penny Meade, 59, said she believed the hospital could have done more to save her son.
"It used to be wonderful," Meade said. "But then everything changed. They took it all away, after that merger."
‘Helping People' vs. ‘Coming After Them'
Ballad has fallen short of the annual charity care commitment in the COPA agreement by about $20 million to $48 million each year, according to Tennessee Department of Health documents. The agency waived this obligation each year after it wasn't met, the documents show.
Charity care comes in two forms: free or discounted care for low-income patients, or the amount left over when Medicaid patients are treated but their entire cost is not covered. Most of Ballad's charity care is from the second scenario, the documents show.
Ballad said in its annual reports it is unable to meet its charity care obligation because after the COPA was negotiated both Tennessee and Virginia increased their Medicaid reimbursement and Virginia expanded Medicaid to cover more people, leaving fewer people uninsured and in need of charity. (Tennessee has not expanded Medicaid.)
"We are doing everything we can, for instance, to manage their diabetes so that they don't end up with a spike and end up in the ER," Levine said. "That reduces your charity care."
Some are unconvinced. Chris Garmon, a former FTC economist and a leading expert on COPAs at the University of Missouri-Kansas City, said Ballad had put forth a "strange defense" for its lack of charity care in a state where so many are uninsured.
"Last time I checked, Tennessee had not expanded Medicaid," Garmon said. "This sounds like Ballad is pushing the envelope, like a toddler, trying to see when their parents will actually institute some discipline."
As it was falling short of its charity commitment, Ballad filed thousands of debt collection lawsuits against patients in its first two years of operation, according to reporting from The New York Times and Modern Healthcare.
Levine said that Ballad does not sue patients who qualify for charity care and that its lawsuits slowed significantly after it adopted a more generous charity care policy in 2020. Ballad now offers free care to those who live at or below 225% of the federal poverty level, or an income of less than $67,500 for a family of four.
But the company still takes many patients to court. For example, in Tennessee's Sullivan County, one of the most populous areas in Ballad's market, the company has filed about 500 lawsuits since enacting the new charity care policy, court records show.
Wendy McClanahan, 44, said Ballad started garnishing her paycheck this summer over a lingering debt from a 2017 surgery. McClanahan said she was unemployed and unable to afford the bill at the time and she believed it was written off until court papers arrived in the mail.
Ballad will take 25% of McClanahan's paycheck until she has paid off $2,747, court records show. McClanahan said she's working overtime at her office job to make up for the lost income.
"They're supposed to be helping people instead of coming after them," she said. "It's a lot of money to me, you know, and nothing to them."
KFF Health News correspondent Bram Sable-Smith contributed to this report.
As Medicare Advantage continues to gain popularity among seniors, three Southern California companies are pioneering new types of plans that target cultural and ethnic communities with special offerings and native-language practitioners.
Clever Care Health Plan, based in Huntington Beach, and Alignment Health, based in nearby Orange, both have plans aimed at Asian Americans, with extra benefits including coverage for Eastern medicines and treatments such as cupping and tui na massage. Alignment also has an offering targeting Latinos, while Long Beach-based SCAN Health Plan has a product aimed at the LGBTQ+ community. All of them have launched since 2020.
While many Medicare Advantage providers target various communities with their advertising, this trio of companies appear to be among the first in the nation to create plans with provider networks and benefits designed for specific cultural cohorts. Medicare Advantage is typically cheaper than traditional Medicare but generally requires patients to use in-network providers.
"This fits me better," said Clever Care member Tam Pham, 78, a Vietnamese American from Westminster, California. Speaking to KFF Health News via an interpreter, she said she appreciates the dental care and herbal supplement benefits included in her plan, and especially the access to a Vietnamese-speaking doctor.
"I can always get help when I call, without an interpreter," she said.
Proponents of these new culturally targeted plans say they can offer not only trusted providers who understand their patients' unique context and speak their language, but also special products and services designed for their needs. Asian Americans may want coverage for traditional Eastern treatments, while LGBTQ+ patients might be especially concerned with HIV prevention or management, for example.
Health policy researchers note that Medicare Advantage tends to be lucrative for insurers but can be a mixed bag for patients, who often have a limited choice of providers — and that targeted plans would not necessarily solve that problem. Some also worry that the approach could end up being a new vector for discrimination.
"It's strange to think about commodifying and profiting off people's racial and ethnic identities," said Naomi Zewde, an assistant professor at the UCLA Fielding School of Public Health. "We should do so with care and proceed carefully, so as not to be exploitive."
Still, there's plenty of evidence that patients can benefit from care that is targeted to their race, ethnicity, or sexual orientation.
A November 2020 study of almost 118,000 patient surveys, published in JAMA Network Open, underscored the need for a connection between physician and patient, finding that patients with the same racial or ethnic background as their physicians are more likely to rate the latter highly. A 2022 survey of 11,500 people around the world by the pharmaceutical company Sanofi showed a legacy of distrust in health care systems among marginalized groups, such as ethnic minorities, LGBTQ+ people, and people with disabilities.
Clever Care, founded by Korean American health care executive Myong Lee, aimed from the start to create Medicare Advantage plans for underserved Asian communities, said Peter Winston, the senior vice president and general manager of community and provider development at the company. "When we started enrollments, we realized there is no one ‘Asian,' but there is Korean, Chinese, Vietnamese, Filipino, and Japanese," Winston added.
The company has separate customer service lines by language and gives members flexibility on how and where to spend their allowances for benefits like fitness programs.
Winston said the plan began with 500 members in January 2021 and is now up to 14,000 (still very small compared with mainstream plans). Herbal supplement benefit dollars vary by plan, but more than 200 products traditionally used by Asian clients are on offer, with coverage of up to several hundred dollars per quarter.
Sachin Jain, a physician and the CEO of SCAN Group, said its LGBTQ+ plan serves 600 members.
"This is a group of people who, for much of their lives, lived in the shadows," Jain added. "There is an opportunity for us as a company to help affirm them, to provide them with a special set of benefits that address unmet needs."
SCAN has run into bias issues itself, with some of its employees posting hate speech and one longtime provider refusing to participate in the plan, Jain recounted.
Alignment Health offers a plan targeting Asian Americans in six California counties, with benefits such as traditional wellness services, a grocery allowance for Asian stores, nonemergency medical transportation, and even pet care in the event a member has a hospital procedure or emergency and needs to be away from home.
Alignment also has an offering aimed at Latinos, dubbed el Único, in parts of Arizona, Nevada, Texas, Florida, and California. The California product, an HMO co-branded with Rite Aid, is available in six counties, while in Florida and Nevada, it's a so-called special needs plan for Medicare beneficiaries who also qualify for Medicaid. All offer a Spanish-speaking provider network.
Todd Macaluso, the chief growth officer for Alignment, declined to share specific numbers but said California membership in Harmony — its plan tailored to Asian Americans — and el Único together has grown 80% year over year since 2021.
Alignment's marketing efforts, which include visiting places where prospective members may shop or socialize, are about more than just signing up customers, Macaluso said.
"Being present there means we can see what works, what's needed, and build it out. The Medicare-eligible population in Fresno looks very different from one in Ventura."
"Just having materials in the same language is important, as is identifying the caller and routing them properly," Macaluso added.
Blacks, Latinos, and Asians overall are significantly more likely than white beneficiaries to choose Medicare Advantage plans, according to recent research conducted for Better Medicare Alliance, a nonprofit funded by health insurers. (Latino people can be of any race or combination of races.) But it's not clear to what extent that will translate into the growth of targeted networks: Big insurers' Medicare Advantage marketing efforts often target specific racial or ethnic cohorts, but the plans don't usually include any special features for those groups.
Utibe Essien, an assistant professor of medicine at UCLA, noted the historical underserving of the Black community, and that the shortage of Black physicians could make it hard to build a targeted offering for that population. Similarly, many parts of the country don't have a high enough concentration of specific groups to support a dedicated network.
Still, all three companies are optimistic about expansion among groups that haven't always been treated well by the health care system. "If you treat them with respect, and bring care to them the way they expect it, they will come," Winston said.
St. Louis' largest health system, BJC HealthCare, plans to merge with Kansas City's second-largest, Saint Luke's Health System, uniting more than 28 hospitals on both sides of Missouri by the end of this year.
The merger, which would span markets 250 miles apart and include facilities in neighboring Kansas and Illinois, is just one of the latest in a quickly consolidating hospital industry. Cross-market deals accounted for more than half of all hospital mergers and acquisitions during the last decade, according to a paper from experts on antitrust law. Today, nearly 60% of health systems operate multiple hospitals in different geographic markets.
Not only are such deals more common, they can increase costs for patients. Merged hospitals in the same state but in different markets raised prices as much as 10% compared with other hospitals, researchers found after analyzing past deals. A separate study found stand-alone hospitals raised prices 17% after they were acquired by a hospital company in another market.
But for some 50 years, federal regulators have not stepped in to prevent hospitals from merging with systems in other markets, according to antitrust law experts. Without federal intervention, states that have seen such megamergers, such as Michigan and California, are often left to wrestle with the complex question of how to respond, given the likelihood of higher prices for their residents.
The Federal Trade Commission and the Justice Department are reviewing public comments on draft merger guidelines designed to crack down on mergers in multiple sectors, including healthcare. It's not yet clear if or how cross-market hospital mergers within a state could be affected. Still, the draft says consolidation should not "entrench or extend a dominant position" by extending into "new markets."
But such cross-market mergers aren't quite a textbook case of a monopoly. When hospitals have bought up local rivals, knocking out their competition, federal regulators have intervened to block these traditional mergers to protect patients from the resulting loss of competition. In recent years, they helped stop proposed mergers in New Jersey, Utah, and Rhode Island. The thinking is that without local competition, prices increase and the quality of care decreases.
It's harder to prove how cross-market mergers, like the one planned in Missouri, reduce competition if the hospitals do not operate within a single market, said Chris Garmon, an assistant professor at the University of Missouri-Kansas City, who researches hospital mergers. Regulators would have to prove the mergers don't just raise prices but also run afoul of the law by suppressing competition.
"That's why we haven't seen a cross-market merger challenge yet. It's because it's hard to tell the story of why this would be a problem," he said.
The Federal Trade Commission did not answer questions from KFF Health News on its broader strategy around such deals or the BJC-Saint Luke's merger. Whether an investigation is underway is not public information, said Mitchell Katz, an agency spokesperson.
After the FTC didn't stop cross-market hospital mergers in California and Michigan, those states landed poles apart in handling the deals. California won concessions after challenging a deal, while Michigan did not intervene.
The FTC did closely examine the 2020 deal in Michigan between Spectrum Health, based in Grand Rapids, and the Detroit area's Beaumont Health. Still, it ultimately didn't oppose the marriage that created the state's largest hospital chain, Corewell Health, with 22 hospitals in regions more than 150 miles apart.
The lack of intervention frustrated some, including Bret Jackson, CEO of the Economic Alliance for Michigan, a nonprofit that helps employers wrangle health costs. Spectrum was already the more expensive operator, said Jackson. He worries Beaumont prices will rise to match Spectrum's once the insurance contracts with the individual hospital systems expire.
"They're not going to want to take a pay cut," Jackson said of Spectrum. "We're really concerned about it."
Jackson said that he was already fed up with rising hospital prices and that so are the automotive companies and laborers he represents. Health costs consume about 10% of a typical U.S. family's income.
Ellen Bristol, a Corewell Health spokesperson, did not address KFF Health News' questions about patient costs but said that the collaboration is improving quality statewide and creating efficiencies that help the company navigate economic headwinds.
Even though regulators did not step in, FTC staffers and Michigan's Department of the Attorney General volleyed emails back and forth for months, according to communications obtained by KFF Health News through a public records request from the state.
The FTC asked the attorney general's office to connect its staffers to employers and state officials, plus provide information and data on the healthcare landscape in the state, the emails show. The FTC interviewed executives from BorgWarner, an automotive supplier, and CMS Energy, a utility company.
Jackson said he, too, was interviewed by the FTC, which he said was less interested in his thoughts on the deal than in Michigan's market dynamics.
It's hard to glean much from the FTC's assessment of the merger because many of the emails the state supplied to KFF Health News are redacted. But they do illustrate what information and which people the FTC consulted to reach a decision.
The emails also suggest state officials were made aware of the FTC's findings. On the evening of Jan. 13, 2022, an assistant AG sent a lengthy email to Michigan Attorney General Dana Nessel about the FTC's review of possible antitrust implications, according to the subject line. In the version provided to KFF Health News, though, the entire email — except for the greeting and the signature — was blacked out.
The next day, other emails show, hospital officials began discussing final language with the AG's office for a press release announcing the deal would soon close.
Michigan did not move to block the deal or investigate further. Danny Wimmer, a spokesperson for Nessel, a Democrat, said the deal fell outside the authority of her office, further frustrating Jackson, of the Economic Alliance for Michigan.
"We need to give state regulators the tools to at least assess mergers in the healthcare system," Jackson said.
Nessel's position is not the attitude taken in all states. A 2020 merger agreement in California between Huntington Hospital in Pasadena and Cedars-Sinai Health System, with its flagship hospital in Los Angeles, attracted the attention of then-state Attorney General Xavier Becerra, who imposed conditions, such as price caps to protect consumers.
Becerra, a Democrat who is now Health and Human Services secretary, had argued the cross-market merger would lead to higher prices.
Employers relied on having both Cedars-Sinai and Huntington Hospital in their networks to ensure adequate access to all employees scattered across the massive Los Angeles region — with a population larger than that of most states — which California officials said has several distinct markets serving patients. If the two were to combine, employers would have to accept price hikes to maintain access to both entities, according to an analysis the AG's office commissioned. Health systems can "threaten to create important holes in a health plan's provider network," the analysis said, by refusing to include all hospitals, giving the system greater leverage to extract higher prices from the health plan.
Ultimately, the parties settled on revised conditions, which included a 10-year ban on all-or-nothing contracting with insurers and a cap on price increases for five years.
The settlement allowed Cedars-Sinai to expand access while reflecting a shared goal of "keeping healthcare affordable," said Duke Helfand, a spokesperson for Cedars-Sinai. Still, it was considered a win for antitrust enforcers, with implications that could reverberate across the country, some health economists said.
In Missouri, the key question is whether state officials will intervene. Attorney General Andrew Bailey, a Republican, is reviewing the merger, which requires his office's approval before it can close, said Madeline Sieren, a spokesperson for the AG.
Neither BJC nor Saint Luke's answered questions from KFF Health News about potential price increases or plans to improve quality. The hospitals have estimated the merged system will generate annual revenue topping $10 billion.
The Missouri systems ought to explain how this merger will benefit patients by lowering costs and improving quality, Garmon said.
"Whether they actually do them or not depends on whether they actually have the incentive to do them," Garmon said.
For the first time since 2019, congressional gridlock is poised to at least temporarily shut down big parts of the federal government — including many health programs.
If it happens, some government functions would stop completely and some in part, while others wouldn't be immediately affected — including Medicare, Medicaid, and health plans sold under the Affordable Care Act. But a shutdown could complicate the lives of everyone who interacts with any federal health program, as well as the people who work at the agencies administering them.
Here are five things to know about the potential impact to health programs:
1. Not all federal health spending is the same.
"Mandatory" spending programs, like Medicare, have permanent funding and don't need Congress to act periodically to keep them running. But the Department of Health and Human Services is full of "discretionary" programs — including at the National Institutes of Health, Centers for Disease Control and Prevention, community health centers, and HIV/AIDS initiatives — that must be specifically funded by Congress through annual appropriations bills.
The appropriations bills (there are 12 of them, each covering various departments and agencies) are supposed to be passed by both chambers of Congress and signed by the president before the start of the federal fiscal year, Oct. 1. This almost never happens. In fact, according to the Pew Research Center, Congress has passed all the appropriations bills in time for the start of the fiscal year only four times since the modern budget process was adopted in the 1970s; the last time was in 1997.
Congress usually keeps the lights on for the government by passing short-term funding bills, known as "continuing resolutions," or CRs, until lawmakers can resolve their differences on longer-term spending.
This year, however, a handful of conservative Republicans in the House have said they won't vote for any CR, in an attempt to force deeper spending cuts than those agreed to this spring in a bipartisan bill to raise the nation's borrowing authority. House Speaker Kevin McCarthy and his allies could join with Democrats to keep the government running, but that would almost certainly cost McCarthy his speakership. Several of the rebellious conservatives are already threatening to force a vote to oust him.
2. The Biden administration decides what stays open.
The White House Office of Management and Budget is responsible for drawing up contingency plans in case of a government shutdown and publishes one for each federal department. The plan for Health and Human Services estimates that 42% of its staff would be furloughed in a shutdown and 58% retained.
The general rule is that two types of activities may continue absent annual spending authority from Congress. One is activities needed "for safety of human life or the protection of property." At HHS, that would include caring for patients at the hospital on the campus of the National Institutes of Health — though new patients generally would not be admitted — as well as the agency's laboratory animals, and CDC investigations of disease outbreaks.
Other activities that may continue are those with funding sources that aren't dependent on annual appropriations. Medicare and Social Security, for example, are entitlements funded by taxes and premiums. Drug approvals at the FDA are largely funded by user fees paid by drugmakers, so they could continue as usual.
Also unaffected are programs that have been funded in advance by Congress. For example, the Indian Health Service is already funded through the 2024 fiscal year.
3. What happens to enrollment in Medicare and Affordable Care Act plans?
It depends on how long the shutdown lasts. In the short term, mandatory spending programs would be mostly, but not completely, unaffected by a government shutdown. Benefits would continue under programs like Medicare, Medicaid, and the Affordable Care Act, and doctors and hospitals could continue to submit bills and get paid. But federal staffers not considered "essential" would be furloughed.
That means initial Medicare enrollment could be temporarily stopped. According to the Committee for a Responsible Federal Budget, an independent group that tracks federal spending, during the 1995-96 federal shutdown, "more than 10,000 Medicare applicants were temporarily turned away every day of the shutdown."
A shutdown shouldn't much affect Medicare's annual open enrollment period, which starts Oct. 15 and allows current beneficiaries to join or change private Medicare Advantage or prescription drug plans. That's because much of the funding to help seniors and other beneficiaries choose or change Medicare health plans has already been allocated.
Rebecca Kinney, who runs the HHS office that oversees the federal program that counsels Medicare beneficiaries about their myriad choices, said Sept. 22 that funding for both the 1-800-MEDICARE hotline and federally funded state counseling agencies has already been distributed for this year, so neither would be affected, at least in the short run.
The same is true for Affordable Care Act plans, which open for enrollment Nov. 1. The HHS contingency documents say the Centers for Medicare & Medicaid Services, which oversees the federal health exchange, healthcare.gov, "will continue Federal Exchange activities, such as eligibility verification," using fees paid by insurers left over from the previous year.
Still, about half of CMS staffers would be furloughed in a shutdown. That could complicate a lot of other activities there, starting with drug price negotiations set to begin Oct. 1. HHS Secretary Xavier Becerra told reporters at the White House last week that a shutdown would likely push back the timeline for negotiations.
A shutdown would also threaten HHS oversight of the Medicaid "unwinding" process, as states reevaluate the eligibility of those enrolled in the program for low-income people. State workers would be unaffected, according to the Georgetown University Center for Children and Families, so eligibility reviews would continue regardless. But because of federal furloughs, "technical assistance to help states address unwinding problems and adopt mitigation strategies could cease," wrote the center's Kelly Whitener and Edwin Park. "Efforts to determine if there are further renewal processes that are out of compliance with federal requirements could be limited or ended."
4. What if the shutdown is prolonged?
More programs could be affected. For example, the HHS shutdown contingency document says that "CMS will have sufficient funding for Medicaid to fund the first quarter" of fiscal year 2024. The government has never been shut down long enough to know what would happen after that. The 2013 shutdown, which included HHS, lasted just over two weeks. Most of the agency wasn't affected by the 2018-19 shutdown because its annual appropriations bill had already been signed into law. (The FDA is funded under the appropriations bill that covers the Agriculture Department rather than the one that funds HHS.)
5. Do federal employees get paid during a shutdown?
It depends. Employees whose programs are funded continue to work and be paid. Those considered "essential" but whose programs are not funded would continue to work, but they wouldn't get paid until after the shutdown ends. A 2019 law now requires federal workers to get back pay when funding resumes, which was not always the case. However, federal contractors, including those who work in food service or maintenance jobs, have no such guarantee.
Kaiser Permanente and union representatives pledged to continue negotiating a new contract up until the last minute as the threat of the nation's latest large-scale strike looms next month.
Unless a deal is struck, more than 75,000 health workers will walk out for three days from Oct. 4-7, disrupting care for KP patients in California, Colorado, Oregon, Virginia, Washington, and Washington, D.C. The unions represent a wide range of KP health workers, including lab technicians, phlebotomists, pharmacists, optometrists, social workers, orderlies, and support staff.
A strike, if it occurs, would affect most of Kaiser Permanente's 39 hospitals and 622 medical offices across the U.S., and would disrupt care for many of its nearly 13 million patients. If workers walk off their jobs, "it will start to impact patient care right away," said John August, director of healthcare and partner programs at Cornell University's Scheinman Institute on Conflict Resolution, who is a former head of the union coalition currently negotiating with KP.
"You are immediately subject to problems with not being able to get patients in and out of the hospital. You risk problems with infection control. You're not going to get meals," August said.
Arlene Peasnall, Kaiser Permanente's senior vice president for human resources, said the Oakland, California-based healthcare giant's goal is "to reach a mutually beneficial agreement before any work stoppage occurs." But she also said the nonprofit has plans in place to blunt the impact of a walkout.
"We will be bargaining with Kaiser up until the day we go on strike," said Caroline Lucas, executive director of the Coalition of Kaiser Permanente Unions, which represents about 40% of KP's workforce. "Our front-line healthcare workers are fed up, and we really need Kaiser executives to seize the initiative and move forward on resolving the contract."
The current contract expires Sept. 30 and, after months of talks, the two sides still disagree over pay and staffing. The coalition wants a $25-an-hour minimum wage across the company. KP executives agree there should be an organization-wide floor, but they've proposed $21.
KP prefers varying wage increases across regions, since the cost of living can vary sharply. The coalition, which is pushing for uniform wage increases across all regions, contends that management's proposal is part of a "divide-and-conquer strategy." Peasnall said the union's stance "would prevent us from addressing fair market wages where we need to pay more to attract and retain the best people."
The unions say their lowest-paid workers can barely make ends meet in the face of soaring prices for food, gasoline, and other essentials. And, they say, KP hospitals and clinics are severely understaffed, forcing workers to put in long hours and fill multiple roles. They argue that management is not moving quickly enough to fill positions and that the quality of care has suffered as patients, some with serious illnesses, often wait months for appointments, face extremely long waits in the emergency room, and experience delays in hospital admissions.
An industrywide labor shortage hangs heavily over the contract talks. The pandemic was particularly brutal for healthcare workers who often worked long hours in grueling conditions, as colleagues fell ill, died, or quit. Workers say many of the positions that became vacant during the pandemic still have not been filled.
Miriam De La Paz, a secretary in the labor and delivery department of KP's Downey Medical Center in Southern California and a union steward, said when she is alone on a shift, she is responsible for two labor and delivery stations as well as triage, where patients are prioritized based on the acuity of their cases.
"Imagine if I'm putting this baby in the system and your wife shows up in pain, crying, but I'm not there to register her," De La Paz said. "I can't break myself in two."
Unions want KP to invest more in education, training, and recruitment to fill current openings and create a pipeline of future workers. KP says it is doing so.
Peasnall said KP has already filled more than 9,700 out of 10,000 new coalition-represented jobs the two sides had agreed to create this year. And she said KP's turnover rate is one-third the industry rate, in part because of "excellent pay and benefits."
Earlier this month, California lawmakers passed legislation to gradually raise the minimum wage for healthcare workers in the state to $25 an hour. If Democratic Gov. Gavin Newsom signs the bill into law, KP will have to comply. And nearly 80% of workers represented by the coalition in the current contract talks are in California.
On Sept. 22, as bargaining continued in San Francisco, the unions announced that more than 75,000 of the 85,000 workers they represent would stage the three-day walkout if there's no deal. Federal law requires 10 days' notice of strikes at healthcare facilities. The coalition said it is "prepared to engage in another longer, stronger strike in November," if no agreement is reached by then.
A coalition spokesperson, Betsy Twitchell, said workers would welcome the Biden administration's involvement in the talks "because of the importance of these negotiations to millions of patients and 75,000 frontline healthcare workers."
The unions say KP can afford to be more generous, citing its robust financial health.
Although KP reported a net loss of almost $4.5 billion in 2022, it generated a cumulative net income of nearly $22 billion over the three preceding years — both results driven largely by investment performance. In the first half of this year, KP posted profits of over $3 billion. And it is in a strong position to manage its debt, according to a report earlier this year by Fitch Ratings.
The unions note that Kaiser Permanente's CEO, Greg Adams, received almost $16 million in compensation in 2021 and that dozens of others in KP management made more than $1 million, according to a KP filing with the IRS.
Peasnall said the compensation of KP's senior management is less than that of their peers at other healthcare companies.
A KP walkout would be the latest in a string of worker movements. Strikes have hit Hollywood, hotels, auto manufacturers, and other industries. Public approval of unions is at a nearly 60-year high, according to a Gallup Poll released in August 2022.
Health workers are increasingly engaged, too. Several hospital groups have been hit by strikes, including Cedars-Sinai Medical Center in Los Angeles and numerous facilities belonging to Sutter Health in Northern California, as well as healthcare organizations in other states.
"There is an atmosphere in the country: It's labor summer, it's strike summer, it's all that," August said. "That definitely has an influence on union leadership that says, ‘We need to be a part of that.'"