Jodi Bobbitt, the school nurse at William Ramsay Elementary in Alexandria, Virginia, is always ready to see children with a wide range of injuries and illnesses. One day during the first week of school, the parade started before the first bell when a little girl walked in with red, irritated eyes.
A student fell from the monkey bars and another tripped while playing tag. Two kids hit each other's heads with lunchboxes and needed ice packs. A young boy had a stomachache. Bobbitt also saw her regular kiddos: one who has special needs and uses a wheelchair and another who has diabetes and gets his blood sugar checked daily before lunch.
"Every day, I'm seeing more and more [youngsters]," Bobbitt, who is a certified nurse practitioner, said with a smile. "I saw more today than yesterday, so we just have to wait and see what the year has in store."
As the only school nurse at this suburban Washington, D.C., elementary school, Bobbitt's responsibilities extend beyond treating scraped knees and sniffles for the school's 600 pupils. At her under-the-sea-themed clinic, she administers medications, teaches kids about health care, and conducts routine health screenings. As the school nurse, she also serves as a public health point person — tracking student vaccinations, linking parents to local health care resources, and communicating sometimes difficult messages to them, such as warnings about sexually transmitted diseases and signs of depression.
It's a full plate, but Bobbitt considers herself lucky. In a previous school nursing job, she split her time between two buildings within the same school district — some years three. What hasn't changed is that school nurses play a critical role in keeping students healthy and ready to learn, but it's an often-unrecognized field for which schools struggle to attract and retain employees.
School nurses' roles were further complicated by COVID-19. Since the pandemic took hold, they've been tasked with tracking cases and tracing exposures. An "extreme load of work was put on school nurses' shoulders during the pandemic," said Kate King, president of the NASN.
They got caught in the middle between anti-maskers and maskers and anti-vaccine and pro-vaccine parents, and were the point of contact whenever students had to quarantine. "School nurses are used to interacting with parents who are angry," said King, but because of the pandemic "that anger just got to levels we had never seen before."
In general, kids' attendance and learning can suffer when students don't have access to a school nurse. "You're going to see more absences," she said, citing a study from the Journal of School Nursing that found students with illnesses or injuries were sent home 18% of the time when evaluated by an unlicensed school employee while only 5% went home after being seen by a school nurse.
Teachers and administrators are shouldering some of the burden by learning how to handle injuries and illnesses themselves, but "it doesn't take the place of having a school nurse who can respond immediately," King said.
Though there is no federal law requiring schools to have nurses on staff, the Centers for Disease Control and Prevention recommends at least one full-time nurse for every 750 students enrolled — but most states are missing the mark by miles. School nurses in California have one of the heaviest workloads in the country with a student-to-school-nurse ratio of 2,410 students for every nurse, according to the Public Policy Institute of California.
According to research organization Child Trends, California, along with 34 other states and the District of Columbia, requires schools to employ school nurses. Of those, 12 set required nurse-to-student ratios. Seven states encourage schools to have nurses on staff. Eight states don't have mandates on the books.
Still, schools were scrambling over the summer to hire nurses.
Jessica Sawko, director of education for Children Now, a California-based nonprofit organization, said schools struggle not only to retain nurses but also encourage aspiring nurses to consider working in schools. Districts can't compete with the salaries and benefits hospitals offer. The national median salary for school nurses is nearly $55,000 a year, but a registered nurse could make nearly $30,000 more annually working at a hospital.
In some states, school nurses need special certification in addition to their nursing degrees.
The lack of school nurses is a byproduct of a larger issue: the nation's overall nursing shortage. Health organizations in general — even those that offer healthy salaries — are facing difficulties hiring and keeping nurses. Around 40% of nurses who participated in a 2023 survey by McKinsey & Co. said they were considering leaving their position.
As a nurse for junior high students, King said she is keenly aware that school nurses sometimes serve as students' only contact with a health care professional, especially at her campus.
World Language Middle School in Columbus, Ohio, where King works, has a diverse student body and takes in many students who are new to the country. "So that requires school nurses like myself to have a very broad range of knowledge of diseases and symptoms," she said.
Robin Wallin, director of school health services for Alexandria City Public Schools, said that another layer of this issue is that school nursing "is an aging cohort." The district has at least one school nurse in each of its 18 campuses — but this year it was a challenge to fill every spot. That's partly because many school nurses are aging out, starting to retire, she said. "We need to start to replenish our cohorts."
Bobbitt said the nursing students who shadow her almost never imagine themselves working in a school. "They want to work in the ER, they want to work in the hospital, they want to work in the NICU, or somewhere where they can have that adrenaline," Bobbitt said. "This is a little different," she said, adding that it is fast paced in its own way.
Robin Cogan is a clinical coordinator at Rutgers University's School Nurse Specialty Program in New Jersey, and she said one of the biggest learning curves for nurses who opt to work in school settings is that they are "often an independent practitioner," which involves juggling a lot of responsibilities.
Meanwhile, Bobbitt, working in her brightly colored clinic, stays focused on her daily mission: to address the students' needs as quickly as possible. "We don't want them to miss very much school or much class work," Bobbit said. "That's our goal, right?"
Don Smith remembers the moment he awoke in an intensive care unit after 13 days in a medically induced coma. His wife and daughter were at his bedside, and he thought it had been only a day since he arrived at the emergency room with foot pain.
Smith said his wife "slowly started filling me in" on the surgery, the coma, the ventilator. The throbbing in his foot had been a signal of a raging problem.
"When you hear someone say a person died of infection, that's sepsis," said Smith, 66, of Colorado Springs, Colorado, who went to the ER shortly before Christmas 2017. Ultimately, he spent almost two months in the hospital and a rehab center following multiple surgeries to clear the infected tissue and, later, to remove seven toes.
Sepsis, the body's extreme response to an infection, affects 1.7 million adults in the United States annually. It stems from fungal, viral, or bacterial infections, similar to what struck Madonna this year, although the singer never said whether she was diagnosed with sepsis. Treatment delays of even a few hours can undermine a patient's chance of survival. Yet sepsis can be difficult to diagnose because some patients don't present with common symptoms like fever, rapid heart rate, or confusion.
A Biden administration rule, finalized in August, ups the ante for hospitals, setting specific treatment metrics that must be met for all patients with suspected sepsis, which could help save some of the 350,000 adults who die of infections annually. Children, too, are affected, with some estimates that 75,000 are treated each year for sepsis and up to 20% of them die. Hospitals that fail to meet the requirements risk losing potentially millions in Medicare reimbursement for the year.
Still, because the rule applies broadly, it has triggered pushback for its lack of flexibility.
Efforts to reduce sepsis deaths are welcome, but "where it gets controversial becomes 'Is this the best way to do it?'" said Chanu Rhee, an infectious disease physician and associate professor of population medicine at Harvard Medical School.
The approach requires that blood tests be done quickly to look for markers that may indicate sepsis. Also, the measures say antibiotics must be started within three hours of identifying a possible case. The quality measures, called the Severe Sepsis/Septic Shock Early Management Bundle, also call for certain other tests and intravenous fluids to keep blood pressure from dropping dangerously low.
In the proposed rule, which was issued in May, Medicare regulators wrote that the treatments have resulted in "significant reductions in hospital length of stay, re-admission rates and mortality," since the guidelines were initiated in 2015 under a requirement that hospitals simply report whether they were following them or not.
"These are core things that everyone should do every time they see a septic patient," said Steven Simpson, a critical-care physician, a professor of medicine at the University of Kansas, and the chairman of the Sepsis Alliance, an advocacy group backed by individual, government, and health industry funding.
The final rule builds on that earlier effort. Nationwide, an average of 57% of patients received care that met the guidelines in 2021, with the most compliant averaging 80%, according to the Biden administration.
But, starting in fall 2024, hospitals must move beyond simply reporting on the measures and meet the specific treatment benchmarks, which will be added to Medicare's Hospital Value-Based Purchasing Program.
"Before, even if you were reporting 0% compliance, you didn't lose your money. Now you actually have to do it," said Simpson.
Failing to meet those measures and other patient-safety standards could be costly: Smaller hospitals could lose "hundreds of thousands" of dollars in Medicare reimbursements annually; for large institutions, "it's in the millions-of-dollars range," said Akin Demehin, senior director of quality and patient safety policy at the American Hospital Association.
The hospital association opposed the final rule, writing in a June letter to the Centers for Medicare & Medicaid Services that the recommended treatments had not kept up with evolving science and that their focus on quick antibiotic administration for all suspected cases "has the high potential to lead to excessive use." That could fuel antibiotic resistance.
Similar concerns have been cited by other professional medical associations, including the Infectious Diseases Society of America. In a 2020 paper, it called for modifying the metrics to target only patients with septic shock, the most serious form of the condition, rather than all suspected sepsis cases. The society also argued that physicians need more flexibility.
What's more, there is debate over whether broadly implementing the treatment regimen will save lives.
Rhee raised this issue early this year in JAMA. In an opinion piece he co-authored, Rhee cited four studies, including one he led, showing broad-spectrum antibiotic use increased after the sepsis bundle was introduced eight years ago, yet there was little or no change in outcomes for patients.
"Unfortunately, we do not have good evidence that implementation of the sepsis policy has led to an improvement in sepsis mortality rates," he said.
Another study offers a different view. It showed that adhering to the treatments reduced deaths by about 5.7% among patients who received them. Medicare officials cited the study and its results in their proposal for the rule.
Rhee is unconvinced that the treatment protocols alone led to the drop.
Simpson, at the Sepsis Alliance, said there is enough evidence that the effort to follow the treatment standard resulted in improvements, and he is looking forward to more.
"It is quite clear that this works better than what was present before, which was nothing," Simpson said. If the current sepsis mortality rate could be cut "by even 5%, we could save a lot of lives."
All those involved agree that awareness is crucial, not only on the part of medical teams, but among patients, too. Crystal Waguespack, 41, a nurse in Baton Rouge, Louisiana, said she knew about sepsis but didn't apply that to her own symptoms when she began experiencing severe pain in 2018, two weeks after an operation.
"I never checked to see if I had a fever," or noticed her increased heart rate, she said.
But she did speak up. Waguespack said the severe pain, which occurred on a weekend when her regular doctor was unavailable, led her to see a physician unfamiliar with her case who told her that the pain was normal and that she was simply anxious. So she went to the emergency department.
"I did not take no for an answer, and I think that saved my life," she said.
At the hospital, doctors found she had spinal fluid leaking and a surgery-site infection. She spent 14 days in the hospital battling sepsis, meningitis, and a heart infection.
Key takeaways from her experience: Always ask, "Could this be sepsis?" said advocates. And don't wait.
Smith certainly wishes he had gone directly to a hospital instead of first seeing a foot specialist.
"I went to a foot doctor because my foot hurt," said Smith. "But a foot doctor is not an infectious disease doctor. You need to get to a place where different kinds of doctors can see you. That's called a hospital."
More than 1,100 patients have sued Exactech since it began recalling artificial knees, hips, and ankles, starting in August 2021.
This article was published on Tuesday, October 10, 2023 in KFF Health News.
By Fred Schulte
Ron Irby expected the artificial knee implanted in his right leg in September 2018 would last two decades — perhaps longer.
Yet in just three years, the Optetrak implant manufactured by Exactech in Gainesville, Florida, had worn out and had to be replaced — a painful and debilitating operation.
"The surgery was a huge debt of pain paid over months," said Irby, 71, a Gainesville resident and retired medical technologist with the Department of Veterans Affairs.
Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.
Although Exactech does not offer an express warranty on its products, the company stresses the durability of its implants in advertising, even suggesting they likely will outlive their human recipients.
Exactech, which grew over three decades from a mom-and-pop device manufacturer into a global entity that sold for $737 million in 2018, declined comment, citing the "ongoing litigation," said company spokesperson Tom Johnson. In court filings, Exactech has argued that its products are not defective and have "an excellent history."
A KFF Health News review of thousands of pages of court filings in patient lawsuits, a pending whistleblower lawsuit, and other government records shows that the company is being accused of downplaying or concealing evidence of product failures from patients and federal regulators for years. In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.
In his suit, Irby alleges that Exactech "knew or should have known" that the Optetrak "had an unacceptable failure and complication rate." He said Exactech used packaging materials of "an inferior grade or quality."
"I think they were cutting corners to improve their bottom line," Irby told KFF Health News.
Exactech denied the allegations in a legal filing in Irby's suit, in which it described the Optetrak device as "safe and effective."
A Family Affair
Surgeon William "Bill" Petty chaired the orthopedics department at the University of Florida in Gainesville, when he, his wife, Betty, and Gary Miller, a biomedical engineer and fellow faculty member, formed Exactech in November 1985. The Pettys served in corporate roles until retiring in early 2020. Their first hire was their son David in 1988, who remains on Exactech's board of directors.
Exactech's fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.
So did its pedigree as a "surgeon-focused" business with a family-run vibe, small enough that surgeons considering its wares could meet the owners and tour its Florida plant.
Building on that goodwill, Exactech's sales shot past $124 million in 2007, about half generated by the Optetrak knee system.
"It's not just a road we're on, it's a trail we're blazing," the company boasted in sales literature aimed at surgeons.
Exactech's corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an "open secret" inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.
For starters, several surgeons complained that the knee implants loosened prematurely, causing patients pain and limiting their ability to move around, court records allege.
While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components — a complex operation known as revision surgery — much sooner, according to allegations in patient lawsuits.
Christopher Hutchins, a Connecticut orthopedic surgeon who relied on the Optetrak finned devices for more than 350 knee surgeries, said in a court deposition that some loosened in as little as two to three years. He called that "awfully premature" and "extraordinary."
Hutchins vented his frustrations in a brief meeting with Exactech co-founder Bill Petty at a Rhode Island hospital in either 2006 or 2007, according to his deposition. Petty told him at the meeting he "realized that it was a problem" with the device, according to Hutchins.
"I was somewhat struck that if they knew there was a problem why it wasn't being addressed and why the product wasn't being pulled from the market," Hutchins testified in the November 2021 deposition.
"There was no disclosure or transparency."
Older patients not only suffered physical pain, but also felt an "emotional burden" from facing revision surgery in which results often are "not as good as the first go around," Hutchins explained during his deposition testimony."I'm in the business to try to make people better, and when things fail, I take it to heart."
Hutchins was not the only surgeon alarmed by what he says were early failures of the Optetrak devices and the company's tepid response.
‘Popping Out'
In August 2005, Maine orthopedic surgeon Wayne Moody told company officials that Optetrak had loosened and needed to be revised in 25 out of 385 operations he had performed over the previous four years, according to meeting minutes filed in court.
One knee implant gave out in just nine months, Moody told the group, according to the minutes.
In a deposition, Robert Farley, a former Exactech sales agent who filed a whistleblower lawsuit in 2018 alleging fraud by the company, alleged that he heard two colleagues joke about Moody's tribulations at a national sales conference.
Moody "probably had 50-something revisions. … They're just popping out right and left," the sales agent said, according to Farley's suit.
Fellow whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 "would have been the ethical and moral thing to do."
At a meeting in early 2008 attended by the company's top brass, including Bill Petty, the company's marketing director at the time, Charley Rye, floated the idea of a recall, Fuentes said. Company executives shot that down as "financially detrimental," Fuentes testified in a sworn declaration filed with the court.
Asked about the meeting during a December 2021 deposition, Petty replied, "I don't recall that anyone suggested a recall."
'Silent Recall'
Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company "began to get some negative feedback" about the Optetrak "that was at times confounding and difficult to process," court records show.
The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.
The results did little to dim Exactech's prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.
Many lawsuits argue that instead of warning patients and surgeons about the loosening problem, Exactech replaced the finned tray component in its newest products, a strategy device industry critics refer to as a "silent recall." Exactech denies that and said in a court filing that design changes it made were part of a "natural evolution" of the Optetrak.
Even as Exactech rolled out newer generations of the Optetrak, the company faced lawsuits and other criticism alleging it had failed to come clean about unusually high surgical revision rates.
Late Notices
The Food and Drug Administration runs a massive, public, searchable databank called MAUDE to warn the public of dangers linked to medical devices and drugs.
Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.
But court and government records show that reports of adverse reactions tied to Exactech's implant sometimes took years to show up in the government database — if they were reported at all.
Exactech failed to advise the FDA of dozens of Optetrak early revision complaints lodged by orthopedic surgeons Moody and Hutchins, a company representative acknowledged in a court filing.
KFF Health News downloaded the FDA data and found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them.
FDA inspectors who combed through Exactech's internal files in 2017 cited the company for failing to undertake an "adequate investigation" of complaints, according to FDA records cited in court filings.
In court filings, Exactech steadfastly denied Optetrak has any defects. Instead, it blamed the loosening problem on surgeons, saying they had failed to cement the knee implants into place correctly or misaligned them.
The company said it had no obligation to report poor outcomes tied to mistakes by surgeons — even though the FDA requires companies to report injuries involving "user error." In 2022, a federal judge in the whistleblower case, in denying a motion to dismiss, found that Exactech was "hard-pressed" to claim it was not obligated to report the adverse events.
The three whistleblowers are accusing Exactech of fraud for allegedly selling defective products to Medicare and other federal health care programs. The case is pending in federal court in Alabama and Exactech has denied any wrongdoing. Exactech in mid-August filed a motion to dismiss the case.
Lawyers for more than 300 injured patients suing in Alachua County Circuit Court in Florida are pressing for full disclosure of 2,435 complaints to the company alleging deficiencies with Exactech knee products, which the company admits receiving as of the end of April.
In other pending lawsuits, patients argue the company pointedly ignored evidence of chronic safety issues to fuel profits.
Keith Nuzzo, of Litchfield, Maine, is one. He alleged that Exactech "cut corners, utilized inferior manufacturing practices … [and] only disclosed information or took corrective action if contacted by regulatory authorities."
Nuzzo had a right knee replacement done by orthopedic surgeon Moody in February 2012 and a left knee implanted a week afterward.
His right knee became painful and wobbly about four years later and a second surgeon replaced it in August 2016. The left knee gave out in November 2020, also requiring replacement, according to the suit.
Despite the revisions, Nuzzo lives with "daily knee pain and discomfort," which limits his "activities of daily living and recreation," according to the suit. The case is pending. As of mid-September, Exactech had not filed an answer.
No Guarantees
In advertising directed at surgeons, Exactech boasts about the long life of its implants.
One sales brochure states that the Optetrak "demonstrated 91-99 percent implant survival rates" over just under a decade. That is consistent with, if not superior to, industry standards, though as a rule of thumb many surgeons expect implants to last 15 to 20 years, sometimes longer.
The mounting legal claims allege many Exactech knee and hip implants have worn out well before their time.
The KFF Health News analysis of more than 300 pending cases in Alachua County found that surgeons removed about 200 implants after less than seven years. Some people in the sample, whose surgeries spanned more than two dozen states, were awaiting revision procedures. In the federal court sample, patients alleged that half of the 400 implants that were removed lasted less than six years.
Advertising materials aside, Exactech is circumspect in describing the reliability of its implants when it speaks to courts. In a 2021 filing, the company noted that the Optetrak comes with no express warranty.
How long it lasts "depends on a multitude of factors, including those pertaining to surgical technique and the particular patient," the company said.
Promoting the Products
Exactech's focus on its surgeon customers includes paying handsome consulting fees to some orthopedists who have used the company's implants in the operating room or promoted them in advertising.
Exactech paid surgeon consultants $23.2 million combined from the start of 2013 through the end of 2022, the most recent year available, according to a government database called Open Payments.
In promoting the Optetrak in sales materials, Exactech touted "excellent results" achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants "were compensated in exchange for product promotion." Robinson could not be reached for comment.
Exactech's sales brochures also boast that surgeons "around the world have documented excellent results with the Optetrak knee system."
Yet Exactech bottled up a succession of sharply negative reports from other countries, while working to discredit others, according to internal company records filed in court by the whistleblowers.
One surgery group in France concluded in 2012 that nine of 110 Optetrak procedures required revision due to loosening in under three years, for instance. Exactech disputed the findings in a published response, and in a court filing said the conclusions were "based on incorrect information and a flawed understanding of the true causes."
A hospital in Buenos Aires, Argentina, reported that 25% to 30% of Optetrak knees required revisions in under two years, according to whistleblower Fuentes.
The Australian implant registry criticized Optetrak's reliability as early as 2007 and in several later years. In response, Exactech executives said in depositions and court filings that they traced many of the poor results to a single hospital and three surgeons who failed to align the implants correctly.
The Australian registry pegged Exactech's revision rate at 19.4% at seven years and 22% at 10 years, the worst of any knee implant on the market, which led the government health system to stop purchasing it, court records allege. Exactech denied the allegations in a court filing.
James Brooks, a retired Texas orthopedic surgeon, said in a court affidavit that he believed Exactech had an obligation to tell surgeons about the poor outcomes overseas rather than touting rosy results tied to doctors on its payroll.
In the 2021 affidavit, Brooks recalled implanting the Optetrak knee in a Dallas man in 2011, only to confirm from X-rays that it was failing in 2017 and needed to be replaced two years later. Brooks said he would have steered clear of Optetrak had he known of its "much higher failure rate than comparable products."
Clicking Sounds
Laura Grandis is suing Ohio orthopedic surgeon and Exactech consultant Ian Gradisar, who received $132,720 from the company, including research payments, from 2013 through 2022, according to government records.
Gradisar's father, Ivan, also an orthopedic surgeon, served on the original Optetrak design team. In 2008, Ian Gradisar helped his father with an audit of "patient outcomes" commissioned by Exactech. The audit showed that 12 of 47 Optetrak patients operated on over the course of 15 months required revisions, giving the son "first-hand knowledge of the failing and defective Optetrak," Grandis alleges in her suit.
Ian Gradisar put an Exactech implant in Grandis' left knee in Akron, Ohio, in November 2020.
In early 2021, she had "severe" pain in her knee and needed a cane or a walker to get around, according to the suit.
Gradisar told her the knee had failed, which he said was "very rare and only happened 5% of the time," according to the suit.
Grandis had revision surgery in July 2021 with an Optetrak implant. Some seven months later, she felt pain that worsened throughout the day. She tried ice and rest, but that did not work. Her knee hurt when she put weight on it and started making a clicking sound when she moved, according to the suit.
In June 2022, Grandis received a "Dear Patient" form letter from the hospital where her surgery was performed notifying her of the Exactech recall.
Gradisar's office told her the surgeon could not see her until October 2022 "as he was inundated with phone calls from patients about the Exactech recall," according to the suit.
In response to the suit, Exactech denied the allegations, including that its knee implants had "increased failure rates." The case is pending. Gradisar and his lawyer did not respond to requests for comment.
But in a court filing, Gradisar denied any defects in the implant and said he "provided quality care and treatment" to Grandis.
In December 2022, Grandis ended up having a second revision operation that kept her hobbling around on crutches for six weeks, according to her suit.
Total Recall
Two years after the initial recall, Exactech and its owners — past and present — face a rush of lawsuits demanding accountability for alleged patient injuries.
Most of the suits in the Alachua County group name Bill, Betty, and David Petty and Miller as defendants for their roles at Exactech. Their attorney did not respond to requests for comment, but in May, the defendants jointly filed a motion to dismiss, arguing that the suits fail "to allege sufficient facts to impose liability."
Many suits in the federal court cluster also name as a defendant TPG Capital, a Texas-based private equity firm that paid $737 million to acquire Exactech in February 2018. TPG declined to comment but has filed a motion to dismiss the cases.
In one recall letter sent to surgeons, Exactech acknowledged that the data from the Australian registry confirmed that Optetrak had "statistically significant" higher rates of revisions than knee implants made by other companies — a conclusion it had previously disputed.
The letter adds that Exactech is "uncertain" if the packaging defect is the "root cause" of Optetrak's poor performance. An FDA "safety communication" issued in March said the agency is working with Exactech to assess whether other implants packaged in the defective bags pose similar risks.
Exactech lawyers say the company may not be to blame for every implant that wears out unexpectedly.
In a November 2022 hearing, Exactech attorney Michael Kanute said wear of polyethylene implant components is a "known risk no matter who makes them." He said the patient's size and activity level as well as the technique of the surgeons could also be factors.
"So every case is different," he said.
KFF Health News data editor Holly K. Hacker and reporter Megan Kalata contributed to this report.
The Hospital Consumer Assessment of Healthcare Providers and Systems doesn't ask about maternity care or discrimination and has low response rates among people of color.
This article was published on Friday, October 6, 2023 in KFF Health News.
When Selam Solomon Caldwell and her husband learned she was pregnant last year, the stakes for finding the right OB-GYN felt high. Caldwell, a Black woman, had heard stories from family and friends of maternity care providers who ignored their requests or pressured them into cesarean sections without clear medical justification.
As a relative newcomer to Los Angeles, the recruiter, now 31, knew few Black people who could recommend doctors who had treated them with respect. She combed review sites, including Google reviews and Healthgrades, but couldn't find how nearby physicians and hospitals might treat a Black woman like her.
"It's hard to tell if it's a fellow Black person who's giving the review," Caldwell said.
Consumer ratings sites rarely identify patient experiences by race or ethnicity and hospitals are under no obligation to reveal the racial and ethnic breakdowns of their patient satisfaction scores. Yet that information could be instrumental in holding maternity care providers and hospitals accountable for treating patients inequitably and could empower expectant mothers like Caldwell in finding quality obstetric care.
"You can't change what you don't see," said Kimberly Seals Allers, founder of Irth, an app allowing Black and brown women to find and leave reviews of maternity care providers. She's one of a few entrepreneurs developing new tools for collecting feedback from mothers of color.
A steady drip of new research over the past several years has spotlighted racial discrimination by maternity care providers and the role it may play in one of the country's most vexing health disparities: Black women experience the worst birthing outcomes, a gap not explained by income or education, according to a KFF analysis. In 2021, they were nearly three times as likely to die of pregnancy-related causes as white women.
Mothers of color, especially Black women, report that they do in fact experience discrimination. They are more likely than white women to say that their care providers ignored them, scolded them, or pressured them into treatments they didn't want. The extent to which discrimination is reported varies widely by survey, but one recently published report by the Centers for Disease Control and Prevention found roughly 30% of Black, Hispanic, and multiracial women reported mistreatment during maternity care, compared with 20% of women overall.
It's unclear how many hospitals track survey responses by race, and, even if they do, they rarely reveal that information. And the federal government requires generic reporting on how patients say they were treated, making it difficult to pin down and address incidents of bias in maternity care.
Funding and Regulations Lag
Currently, the results of the industry's standard patient experience survey, known as the Hospital Consumer Assessment of Healthcare Providers and Systems, are made publicly available by the federal government to help patients compare hospitals. They incentivize hospitals to improve care and are included in the rankings of many hospital ratings sites, such as U.S. News & World Report's Best Hospitals. But it doesn't ask about maternity careor discrimination and has low response rates, particularly among people of color.
These flaws can also make the survey inadequate for improving birth equity. "We know it's insufficient," said Amanda P. Williams, an OB-GYN and clinical innovation adviser to the nonprofit California Maternal Quality Care Collaborative. Hospitals, she said, could fill in the gaps by collecting feedback from maternity care surveys and breaking the results out by race and other demographic information; they could also talk to patients through forums such as town halls or focus groups.
Joy Lewis, senior vice president for health equity strategies at the American Hospital Association, said many hospitals do this work, both generally and in obstetrics.
However, Williams believes it isn't happening enough in maternity care.
She said there are some pockets where people are doing these activities but that they are not yet widespread. At a national conference of 200 hospital executives this year, Williams said, only a few raised their hands when asked if they break out their maternity outcomes data. "If your overall C-section rate is fine, you might think everything's hunky-dory," she said. "But if you see that your Black people are having 50% higher C-section rates than your white and Asian patients, there's very important work to be done."
Fearing retaliation and being seen as an "angry Black woman," Ta-She-Ra Manning, a maternal health program coordinator in Fresno, California, said she didn't provide any critical feedback when her OB-GYN dismissed her concerns about unusual symptoms during her 2021 pregnancy.
Meanwhile, new funding to measure disparities has been slow in coming. President Biden's 2023 budget proposed $7.4 million to develop a supplemental survey aimed at reducing maternal health disparities, among other steps. But Congress did not fund the item. Instead, an agency in the Department of Health and Human Services is developing it with its own funding and estimates the work will take less than five years, according to a statement from Caren Ginsberg, who directs the agency's surveys.
Still, the public likely won't see changes anytime soon. After a survey's measures are created, it can take several years for the results to be publicly reported or tied to payment, said Carol Sakala, senior director for maternal health at the National Partnership for Women & Families, an advocacy organization.
"This molasses level of movement contrasts acutely with all the things hitting the news about people not getting the right care and attention and respect," Sakala said.
Amid growing interest in health equity, traditional ratings sites are grappling with how much to share with the public. For its birthing hospital ratings, U.S. News & World Report recently started assessing whether hospitals tracked racial disparities in maternity outcomes measures, but it withholds actual results. Healthgrades is taking time to think through how to collect and display sensitive information publicly, said spokesperson Sarah Javors in a statement.
Black Innovators Fight for Better Data
Some Black women are trying to fill the void by creating new feedback mechanisms that could be more trusted by the community. Allers said she created Irth after a traumatic birth experience as a Black mother at a highly rated hospital left her feeling failed by mainstream ratings. On the app, verified users answer questions, from whether they felt respected by their doctor to if they experienced certain types of mistreatment such as dismissal of pain. Irth currently has 10,000 reviews of hospitals, OB-GYNs, and pediatricians nationally, according to Allers.
"Our data is for the community," said Allers. "They know their feedback has value to another mom or family."
Irth also offers analysis of the reviews to hospitals and leads campaigns to collect more reviews for them. But Allers said many hospitals have expressed little interest.
Karen Scott, an OB-GYN who created PREM-OB, a scientifically validated survey that measures racism in Black birthing experiences, said she has met hospital leaders who don't think their providers could mistreat patients or who worry that documenting responses could carry legal risk.
The American Hospital Association's Lewis declined to comment specifically on Irth and PREM-OB but acknowledged the Black community's long-standing mistrust of health care providers. She said hospitals want to hear more from patients in historically marginalized groups.
Early signs of progress are emerging in parts of the country.
California hospitals will likely report disparities in birth outcomes and patient satisfaction measures. Hospitals are expected to start posting data broken out by race and other demographics on their websites in 2026, though the state hasn't finalized the measures that will be required, said Andrew DiLuccia, a spokesperson for the state's health data agency. At least two states, Washington and New Jersey, have disclosed rates of C-sections among low-risk patients by race for individual hospitals.
Scott founded Birthing Cultural Rigor to increase uptake of her survey. The firm has partnered with birth equity groups to recruit respondents in select counties in Georgia, Michigan, Ohio, and Tennessee. Scott said results will be used to train local health professionals on how to reduce racism in maternity care.
Separately, Irth will collect and analyze reviews for three hospitals or health systems in California, said Allers. One of them, MemorialCare Miller Children's and Women's Hospital Long Beach, will work with Irth to better understand the impact of birth equity efforts such as implicit bias training.
"We'll get to see if what we're doing is actually working," said Sharilyn Kelly, executive director of the hospital's perinatal services.
Caldwell, the recruiter, eventually found a doctor she trusted and went on to have a smooth pregnancy and delivery. Her son is now 8 months old. But with so little information available on how she might be treated, she said, she felt anxious until she met her doctor, when "a lot of that stress and anxiety melted away."
Digital strategy & audience engagement editor Chaseedaw Giles contributed to this report.
[Editor's note: California Healthline is an editorially independent service of the California Health Care Foundation, which has contributed funding to PREM-OB and the birth equity nonprofit Narrative Nation, which developed Irth.]
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.