OSHA Let Employers Decide Whether to Report Health Care Worker Deaths. Many Didn’t.

As Walter Veal cared for residents at the Ludeman Developmental Center in suburban Chicago, he saw the potential future of his grandson, who has autism.

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So he took it on himself not just to bathe and feed the residents, which was part of the job, but also to cut their hair, run to the store to buy their favorite body wash and barbecue for them on holidays.

“They were his second family,” said his wife, Carlene Veal.

Even after COVID-19 struck in mid-March and cases began spreading through the government-run facility, which serves nearly 350 adults with developmental disabilities, Walter was determined to go to work, Carlene said.

Staff members were struggling to acquire masks and other personal protective equipment at the time, many asking family members for donations and wearing rain ponchos sent by professional baseball teams.

All Walter had was a pair of gloves, Carlene said.

By mid-May, rumors of some sick residents and staffers had turned into 274 confirmed positive COVID tests, according to the Illinois Department of Human Services COVID tracking site. On May 16, Walter, 53, died of the virus. Three of his colleagues had already passed, according to interviews with Ludeman workers, the deceased employees’ families and union officials.

State and federal laws say facilities like Ludeman are required to alert Occupational Safety and Health Administration officials about work-related employee deaths within eight hours. But facility officials did not deem the first staff death on April 13 work-related, so they did not report it. They made the same decision about the second and third deaths. And Walter’s.

It’s a pattern that’s emerged across the nation, according to a KHN review of hundreds of worker deaths detailed by family members, colleagues and local, state and federal records.

Workplace safety regulators have taken a lenient stance toward employers during the pandemic, giving them broad discretion to decide internally whether to report worker deaths. As a result, scores of deaths were not reported to occupational safety officials from the earliest days of the pandemic through late October.

KHN examined more than 240 deaths of health care workers profiled for the Lost on the Frontline project and found that employers did not report more than one-third of them to a state or federal OSHA office, many based on internal decisions that the deaths were not work-related — conclusions that were not independently reviewed.

Work-safety advocates say OSHA investigations into staff deaths can help officials pinpoint problems before they endanger other employees as well as patients or residents. Yet, throughout the pandemic, health care staff deaths have steadily climbed. Thorough reviews could have also prompted the Department of Labor, which oversees OSHA, to urge the White House to address chronic protective gear shortages or sharpen guidance to help keep workers safe.

Since no public agency releases the names of health care workers who die of COVID-19, a team of reporters building the Lost on the Frontline database has scoured local news stories, GoFundMe campaigns, and obituary and social media sites to identify nearly 1,400 possible cases. More than 260 fatalities have been vetted with families, employers and public records.

For this investigation, journalists examined worker deaths at more than 100 health care facilities where OSHA records showed no fatality investigation was underway.

At Ludeman, the circumstances surrounding the April 13 worker death might have shed light on the hazards facing Veal. But no state work safety officials showed up to inspect — because the Department of Human Services, which operates Ludeman and employs the staff, said it did not report any of the four deaths there to Illinois OSHA.

The department said “it could not determine the employees contracted COVID-19 at the workplace” — despite its being the site of one of the largest U.S. outbreaks. Since Veal’s death in May, dozens more workers have tested positive for COVID-19, according to DHS’ COVID tracking site.

OSHA inspectors monitor local news media and sometimes will open investigations even without an employer’s fatality report. Through Nov. 5, federal OSHA offices issued 63 citations to facilities for failing to report a death. And when inspectors do show up, they often force improvements — requiring more protective equipment for workers and better training on how to use it, files reviewed by KHN show.

Still, many deaths receive little or no scrutiny from work-safety authorities. In California, public health officials have documented about 200 health care worker deaths. Yet the state’s OSHA office received only 75 fatality reports at health care facilities through Oct. 26, Cal/OSHA records show.

Nursing homes, which are under strict Medicare requirements, reported more than 1,000 staff deaths through mid-October, but only about 350 deaths of long-term care facility workers appear to have been reported to OSHA, agency records show.

Workers whose deaths went unreported include some who took painstaking precautions to avoid getting sick and passing the virus to family members: One California lab technician stayed in a hotel during the workweek. An Arizona nursing home worker wore a mask for family movie nights. A Nevada nurse told his brother he didn’t have adequate PPE. Nevada OSHA confirmed to KHN that his death was not reported to the agency and that officials would investigate.

KHN asked health care employers why they chose not to report fatalities. Some cited the lack of proof that a worker was exposed on-site, even in workplaces that reported a COVID outbreak. Others cited privacy concerns and gave no explanation. Still others ignored requests for comment or simply said they had followed government policies.

“It is so disrespectful of the agencies and the employers to shunt these cases aside and not do everything possible to investigate the exposures,” said Peg Seminario, a retired union health and safety director who co-authored a study on OSHA oversight with scholars from Harvard’s T.H. Chan School of Public Health.

A Department of Labor spokesperson said in a statement that an employer must report a fatality within eight hours of knowing the employee died and after determining the cause of death was a work-related case of COVID-19.

The department said employers also are bound to report a COVID death if it comes within 30 days of a workplace incident — meaning exposure to COVID-19.

Yet pinpointing exposure to an invisible virus can be difficult, with high rates of pre-symptomatic and asymptomatic transmission and spread of the virus just as prevalent inside a hospital COVID unit as out.

Those challenges, plus May guidance from OSHA, gave employers latitude to decide behind closed doors whether to report a case. So it’s no surprise that cases are going unreported, said Eric Frumin, who has testified to Congress on worker safety and is health and safety director for Change to Win, a partnership of seven unions.

“Why would an employer report unless they feel for some reason they’re socially responsible?” Frumin said. “Nobody’s holding them to account.”

Downside of Discretion

OSHA’s guidance to employers offered pointers on how to decide whether a COVID death is work-related. It would be if a cluster of infections arose at one site where employees work closely together “and there is no alternative explanation.” If a worker had close contact with someone outside of work infected with the virus, it might not have been work-related, the guidance says.

Ultimately, the memo says, if an employer can’t determine that a worker “more likely than not” got sick on the job, “the employer does not need to record that.”

In mid-March, the union that represented Paul Odighizuwa, a food service worker at Oregon Health & Science University, raised concerns with university management about the virus possibly spreading through the Food and Nutrition Services Department.

Workers there — those taking meal orders, preparing food, picking up trays for patient rooms and washing dishes — were unable to keep their distance from one another, said Michael Stewart, vice president of the American Federation of State, County and Municipal Employees Local 328, which represents about 7,000 workers at OHSU. Stewart said the union warned administrators they were endangering people’s lives.

Soon the virus tore through the department, Stewart said. At least 11 workers in food service got the virus, the union said. Odighizuwa, 61, a pillar of the local Nigerian community, died on May 12.

OHSU did not report the death to the state’s OSHA and defended the decision, saying it “was determined not to be work-related,” according to a statement from Tamara Hargens-Bradley, OHSU’s interim senior director of strategic communications.

She said the determination was made “[b]ased on the information gathered by OHSU’s Occupational Health team,” but she declined to provide details, citing privacy issues.

Stewart blasted OHSU’s response. When there’s an outbreak in a department, he said, it should be presumed that’s where a worker caught the virus.

“We have to do better going forward,” Stewart said. “We have to learn from this.” Without an investigation from an outside regulator like OSHA, he doubts that will happen.

Stacy Daugherty heard that Oasis Pavilion Nursing and Rehabilitation Center in Casa Grande, Arizona, was taking strict precautions as COVID-19 surged in the facility and in Pinal County, almost halfway between Phoenix and Tucson.

Her father, a certified nursing assistant there, was also extra cautious: He believed that if he got the virus, “he wouldn’t make it,” Daugherty said.

Mark Daugherty, a father of five, confided in his youngest son when he fell ill in May that he believed he contracted the coronavirus at work, his daughter said in a message to KHN.

Early in June, the facility filed its first public report on COVID cases to Medicare authorities: Twenty-three residents and eight staff members had fallen ill. It was one of the largest outbreaks in the state. (Medicare requires nursing homes to report staff deaths each week in a process unrelated to OSHA.)

By then, Daugherty, 60, was fighting for his life, his absence felt by the residents who enjoyed his banjo, accordion and piano performances. But the country’s occupational safety watchdog wasn’t called in to figure out whether Daugherty, who died June 19, was exposed to the virus at work. His employer did not report his death to OSHA.

“We don’t know where Mark might have contracted COVID 19 from, since the virus was widespread throughout the community at that time. Therefore there was no need to report to OSHA or any other regulatory agencies,” Oasis Pavilion’s administrator, Kenneth Opara, wrote in an email to KHN.

Since then, 15 additional staffers have tested positive and the facility suspects a dozen more have had the virus, according to Medicare records.

Gaps in the Law

If Oasis Pavilion needed another reason not to report Daugherty’s death, it might have had one. OSHA requires notice of a death only within 30 days of a work-related incident. Daugherty, like many others, clung to life for weeks before he died.

That is one loophole — among others — in work-safety laws that experts say could use a second look in the time of COVID-19.

In addition, federal OSHA rules don’t apply to about 8 million public employees. Only government workers in states with their own state OSHA agency are covered. In other words, in about half the country if a government employee dies on the job — such as a nurse at a public hospital in Florida, or a paramedic at a fire department in Texas — there’s no requirement to report it and no one to look into it.

So there was little chance anyone from OSHA would investigate the deaths of two health workers early this year at Central State Hospital in Georgia — a state-run psychiatric facility in a state without its own worker-safety agency.

On March 24, a manager at the facility had warned staff they “must not wear articles of clothing, including Personal Protective Equipment” that violate the dress code, according to an email KHN obtained through a public records request.

Three days later, what had started as a low-grade illness for Mark DeLong, a licensed practical nurse at the facility, got serious. His cough was so severe late on March 27 that he called 911 — and handed the phone to his wife, Jan, because he could barely speak, she said.

She went to visit him in the hospital the next day, fully expecting a pleasant visit with her karaoke partner. “By the time I got there it was too late,” she said. DeLong, 53 “had passed.”

She learned after his death that he’d had COVID-19.

Back at the hospital, workers had been frustrated with the early directive that employees should not wear their own PPE.

Bruce Davis had asked his supervisors if he could wear his own mask but was told no because it wasn’t part of the approved uniform, according to his wife, Gwendolyn Davis. “He told me ‘They don’t care,’” she said.

Two days after DeLong’s death, the directive was walked back and employees and contractors were informed they could “continue and are authorized to wear Personal Protective Gear,” according to a March 30 email from administrators. But Davis, a Pentecostal pastor and nursing assistant supervisor, was already sick. Davis worked at the hospital for 27 years and saw little distinction between the love he preached at the altar and his service to the patients he bathed, fed and cared for, his wife said.

Sick with the virus, Davis died April 11.

At the time, 24 of Central State’s staffers had tested positive, according to the Georgia Department of Behavioral Health and Developmental Disabilities, which runs the facility. To date, nearly 100 staffers and 33 patients at Central State have gotten the virus, according to figures from the state agency.

“I don’t think they knew what was going on either,” Jan DeLong said. “Somebody needs to check into it.”

In response to questions from KHN, a spokesperson for the department provided a prepared statement: “There was never a ban on commercially available personal protective equipment, even if the situation did not call for its use according to guidelines issued by the Centers for Disease Control and Prevention and the Georgia Department of Public Health at the time.”

KHN reviewed more than a dozen other health worker deaths at state or local government workplaces in states like Texas, Florida and Missouri that went unreported to OSHA for the same reason — the facilities were run by government agencies in a state without its own worker safety agency.

Inside Ludeman

In mid-March, staff members at the Ludeman Developmental Center were desperate for PPE. The facility was running low on everything from gloves and gowns to hand sanitizer, according to interviews with current and former workers, families of deceased workers, and union officials.

Due to a national shortage at the time, surgical masks went only to staffers working with known positive cases, said Anne Irving, regional director for AFSCME Council 31, the union that represents Ludeman employees.

Residents in the Village of Park Forest, Illinois, where the facility is located, tried to help by sewing masks or pivoting their businesses to produce face shields and hand sanitizer, said Mayor Jonathan Vanderbilt. But providing enough supplies for more than 900 Ludeman employees proved difficult.

Michelle Abernathy, 52, a newly appointed unit director, bought her own gloves at Costco. In late March, a resident on Abernathy’s unit showed symptoms, said Torrence Jones, her fiancé who also works at the facility. Then Abernathy developed a fever.

When she died on April 13 — the first known Ludeman staff member lost to the pandemic — the Illinois Department of Human Services, which runs Ludeman, made no report to safety regulators. After seeing media reports, Illinois OSHA sent the agency questions about Abernathy’s daily duties and working conditions. Based on DHS’ responses and subsequent phone calls, state OSHA officials determined Abernathy’s death was “not work-related.”

Barbara Abernathy, Michelle’s mom, doesn’t buy it. “Michelle was basically a hermit,” she said, going only from work to home. She couldn’t have gotten the virus anywhere else, she said. In response to OSHA’s inquiry for evidence that the exposure was not related to her workplace, her employer wrote “N/A,” according to documents reviewed by KHN.

Two weeks after Abernathy’s passing, two more employees died: Cephus Lee, 59, and Jose Veloz III, 52. Both worked in support services, boxing food and delivering it to the 40 buildings on campus. Their deaths were not reported to Illinois OSHA.

Veloz was meticulous at home, having groceries delivered and wiping down each item before bringing it inside, said his son, Joseph Ricketts.

But work was another story. Maintaining social distance in the food prep area was difficult, and there was little information on who had been infected or exposed to the virus, according to his son.

“No matter what my dad did, he was screwed,” Ricketts said. Adding, he thought Ludeman did not do what it should have done to protect his dad on the job.

A March 27 complaint to Illinois OSHA said it took a week for staff to be notified about multiple employees who tested positive, according to documents obtained by the Documenting COVID-19 project at the Brown Institute for Media Innovation and shared with KHN. An early April complaint was more frank: “Lives are endangered,” it said.

That’s how Rose Banks felt when managers insisted she go to work, even though she was sick and awaiting a test result, she said. Her husband, also a Ludeman employee, had already tested positive a week earlier.

Banks said she was angry about coming in sick, worried she might infect co-workers and residents. After spending a full day at the facility, she said, she came home to a phone call saying her test was positive. She’s currently on medical leave.

With some Ludeman staff assigned to different homes each shift, the virus quickly traveled across campus. By mid-May, 76 staff and 198 residents had tested positive, according to DHS’ COVID tracking site.

Carlene Veal said her husband, Walter, was tested at the facility in late April. But by the time he got the results weeks later, she said, he was already dying.

Carlene can still picture the last time she saw Walter, her high school sweetheart and a man she called her “superhero” for 35 years of marriage and raising four kids together. He was lying on a gurney in their driveway with an oxygen mask on his face, she said. He pulled the mask down to say “I love you” one last time before the ambulance pulled away.

The Illinois Department of Human Services said that, since the beginning of the pandemic, it has implemented many new protocols to mitigate the outbreak at Ludeman, working as quickly as possible based on what was known about the virus at the time. It has created an emergency staffing plan, identified negative-airflow spaces to isolate sick individuals and made “extensive efforts” to procure more PPE, and it is testing all staffers and residents regularly.

“We were deeply saddened to lose four colleagues who worked at Ludeman Developmental Center and succumbed to the virus,” the agency said in a statement. “We are committed to complying with and following all health and safety guidelines for COVID-19.”

The number of new cases at Ludeman has remained low for several months now, according to DHS’ COVID tracking site.

But that does little to console the families of those who have died.

When a Ludeman supervisor called Barbara Abernathy in June to express condolences and ask if there was anything they could do, Abernathy didn’t know how to respond.

“There was nothing they could do for me now,” she said. “They hadn’t done what they needed to do before.”

Shoshana Dubnow, Anna Sirianni, Melissa Bailey and Hannah Foote contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Thousands of Doctors’ Offices Buckle Under Financial Stress of COVID

Cormay Caine misses a full day of work and drives more than 130 miles round trip to take five of her children to their pediatrician. The Sartell, Minnesota, clinic where their doctor used to work closed in August.

Caine is one of several parents who followed Dr. Heather Decker to her new location on the outskirts of Minneapolis, an hour and a half away. Many couldn’t get appointments for months with swamped nearby doctors.

“I was kind of devastated that she was leaving because I don’t like switching providers, and my kids were used to her. She’s just an awesome doctor,” said Caine, a postal worker who recently piled the kids into her car for back-to-back appointments. “I just wish she didn’t have to go that far away.”

So does Decker, who had hoped to settle in the Sartell area. She recently bought her four-bedroom “dream home” there.

The HealthPartners Central Minnesota Clinic where Decker worked is part of a wave of COVID-related closures starting to wash across America, reducing access to care in areas already short on primary care doctors.

Although no one tracks medical closures, recent research suggests they number in the thousands. A survey by the Physicians Foundation estimated that 8% of all physician practices nationally — around 16,000 — have closed under the stress of the pandemic. That survey didn’t break them down by type, but another from the Virginia-based Larry A. Green Center and the Primary Care Collaborative found in late September that 7% of primary care practices were unsure they could stay open past December without financial assistance.

And many more teeter on the economic brink, experts say.

“The last few years have been difficult for primary care practices, especially independent ones,” said Dr. Karen Joynt Maddox, co-director of the Center for Health Economics and Policy at Washington University in St. Louis. “Putting on top of that COVID, that’s in many cases the proverbial straw. These practices are not operating with huge margins. They’re just getting by.”

When offices close, experts said, the biggest losers are patients, who may skip preventive care or regular appointments that help keep chronic diseases such as diabetes under control.

“This is especially poignant in the rural areas. There aren’t any good choices. What happens is people end up getting care in the emergency room,” said Dr. Michael LeFevre, head of the family and community medicine department at the University of Missouri and a practicing physician in Columbia. “If anything, what this pandemic has done is put a big spotlight on what was already a big crack in our health care system.”

Federal data shows that 82 million Americans live in primary care “health professional shortage areas,” and the nation needed more than 15,000 more primary care practitioners even before the pandemic began.

Once the coronavirus struck, some practices buckled when patients stayed away in droves for fear of catching it, said Dr. Gary Price, president of the Physicians Foundation, a nonprofit grant-making and research organization. Its survey, based on 3,513 responses from emails to half a million doctors, found that 4 in 10 practices saw patient volumes drop by more than a quarter.

On the West Coast, a survey released in October by the California Medical Association found that one-quarter of practices in that state saw revenues drop by at least half. One respondent wrote: “We are closing next month.”

Decker’s experience at HealthPartners is typical. Before the pandemic, she saw about 18 patients a day. That quickly dropped to six or eight, “if that,” she said. “There were no well checks, which is the bread-and-butter of pediatrics.”

In an emailed statement, officials at HealthPartners, which has more than 50 primary care clinics around the Twin Cities and western Wisconsin, said closing the one in Sartell “was not an easy decision,” but the pandemic caused an immediate, significant drop in revenue. While continuing to provide dental care in Sartell, northwest of Minneapolis, the company encouraged employees to apply for open positions elsewhere in the organization. Decker got one of them. Officials also posted online information for patients on where more than 20 clinicians were moving.

The pandemic’s financial ripples rocked practices of all sizes, said LeFevre, the Missouri doctor. Before the pandemic, he said, the 10 clinics in his group saw a total of 3,500 patients a week. COVID-19 temporarily cut that number in half.

“We had fiscal reserves to weather the storm. Small practices don’t often have that. But it’s not like we went unscathed,” he said. “All staff had a one-week furlough without pay. All providers took a 10% pay cut for three months.”

Federal figures show pediatricians earn an average of $184,400 a year, and doctors of general internal medicine $201,400, making primary care doctors among the lowest-paid physicians.

As revenues dropped in medical practices, overhead costs stayed the same. And practices faced new costs such as personal protective equipment, which grew more expensive as demand exceeded supply, especially for small practices without the bulk buying power of large ones.

Doctors also lost money in other ways, said Rebecca Etz, co-director of the Green Center research group. For example, she said, pediatricians paid for vaccines upfront, “then when no one came in, they expired.”

Some doctors took out loans or applied for Provider Relief Fund money under the federal CARES Act. Dr. Joseph Provenzano, who practices in Modesto, California, said his group of more than 300 physicians received $8.7 million in relief in the early days of the pandemic.

“We were about ready to go under,” he said. “That came in the nick of time.”

While the group’s patient loads have largely bounced back, it still had to permanently close three of 11 clinics.

“We’ve got to keep practice doors open so that we don’t lose access, especially now that people need it most,” said Dr. Ada Stewart, president of the American Academy of Family Physicians.

Caine, the Minnesota mom, said her own health care has suffered because she also saw providers at the now-closed Sartell clinic. While searching for new ones, she’s had to seek treatment in urgent care offices and the emergency room.

“I’m fortunate because I’m able to make it. I’m able to improvise. But what about the families that don’t have transportation?” she said. “Older people and the more sickly people really need these services, and they’ve been stripped away.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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After Kid’s Minor Bike Accident, Major Bill Sets Legal Wheels in Motion

Adam Woodrum was out for a bike ride with his wife and kids on July 19 when his then 9-year-old son, Robert, crashed.

“He cut himself pretty bad, and I could tell right away he needed stitches,” said Woodrum.

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Because they were on bikes, he called the fire department in Carson City, Nevada.

“They were great,” said Woodrum. “They took him on a stretcher to the ER.”

Robert received stitches and anesthesia at Carson Tahoe Regional Medical Center. He’s since recovered nicely.

Then the denial letter came.

The Patient: Robert Woodrum, covered under his mother’s health insurance plan from the Nevada Public Employees’ Benefits Program

Total Bill: $18,933.44, billed by the hospital

Service Provider: Carson Tahoe Regional Medical Center, part of not-for-profit Carson Tahoe Health

Medical Service: Stitches and anesthesia during an emergency department visit

What Gives: The Aug. 4 explanation of benefits (EOB) document said the Woodrum’s claim had been rejected and their patient responsibility would be the entire sum of $18,933.44.

This case involves an all-too-frequent dance between different types of insurers about which one should pay a patient’s bill if an accident is involved. All sides do their best to avoid paying. And, no surprise to Bill of the Month followers: When insurers can’t agree, who gets a scary bill? The patient.

The legal name for the process of determining which type of insurance is primarily responsible is subrogation.

Could another policy — say, auto or home coverage or workers’ compensation — be obligated to pay if someone was at fault for the accident?

Subrogation is an area of law that allows an insurer to recoup expenses should a third party be found responsible for the injury or damage in question.

Health insurers say subrogation helps hold down premiums by reimbursing them for their medical costs.

About two weeks after the accident, Robert’s parents — both lawyers — got the EOB informing them of the insurer’s decision.

The note also directed questions to Luper Neidenthal & Logan, a law firm in Columbus, Ohio, that specializes in helping insurers recover medical costs from “third parties,” meaning people found at fault for causing injuries.

The firm’s website boasts that “we collect over 98% of recoverable dollars for the State of Nevada.”

Another letter also dated Aug. 4 soon arrived from HealthScope Benefits, a large administrative firm that processes claims for health plans.

The claim, it said, included billing codes for care “commonly used to treat injuries” related to vehicle crashes, slip-and-fall accidents or workplace hazards. Underlined for emphasis, one sentence warned that the denied claim would not be reconsidered until an enclosed accident questionnaire was filled out.

Adam Woodrum, who happens to be a personal injury attorney, runs into subrogation all the time representing his clients, many of whom have been in car accidents. But it still came as a shock, he said, to have his health insurer deny payment because there was no third party responsible for their son’s ordinary bike accident. And the denial came before the insurer got information about whether someone else was at fault.

“It’s like deny now and pay later,” he said. “You have insurance and pay for years, then they say, ‘This is denied across the board. Here’s your $18,000 bill.’”

When contacted, the Public Employees’ Benefits Program in Nevada would not comment specifically on Woodrum’s situation, but a spokesperson sent information from its health plan documents. She referred questions to HealthScope Benefits about whether the program’s policy is to deny claims first, then seek more information. The Little Rock, Arkansas-based firm did not return emails asking for comment.

The Nevada health plan’s documents say state legislation allows the program to recover “any and all payments made by the Plan” for the injury “from the other person or from any judgment, verdict or settlement obtained by the participant in relation to the injury.”

Attorney Matthew Anderson at the law firm that handles subrogation for the Nevada health plan said he could not speak on behalf of the state of Nevada, nor could he comment directly on Woodrum’s situation. However, he said his insurance industry clients use subrogation to recoup payments from other insurers “as a cost-saving measure,” because “they don’t want to pass on high premiums to members.”

Despite consumers’ unfamiliarity with the term, subrogation is common in the health insurance industry, said Leslie Wiernik, CEO of the National Association of Subrogation Professionals, the industry’s trade association.

“Let’s say a young person falls off a bike,” she said, “but the insurer was thinking, ‘Did someone run him off the road, or did he hit a pothole the city didn’t fill?’”

Statistics on how much money health insurers recover through passing the buck to other insurers are hard to find. A 2013 Deloitte consulting firm study, commissioned by the Department of Labor, estimated that subrogation helped private health plans recover between $1.7 billion and $2.5 billion in 2010 — a tiny slice of the $849 billion they spent that year.

Medical providers may have reason to hope that bills will be sent through auto or homeowner’s coverage, rather than health insurance, as they’re likely to get paid more.

That’s because auto insurers “are going to pay billed charges, which are highly inflated,” said attorney Ryan Woody, who specializes in subrogation. Health insurers, by contrast, have networks of doctors and hospitals with whom they negotiate lower payment rates.

Resolution: Because of his experience as an attorney, Woodrum felt confident it would eventually all work out. But the average patient wouldn’t understand the legal quagmire and might not know how to fight back.

“I hear the horror stories every day from people who don’t know what it is, are confused by it and don’t take appropriate action,” Woodrum said. “Then they’re a year out with no payment on their bills.” Or, fearing for their credit, they pay the bills.

After receiving the accident questionnaire, Woodrum filled it out and sent it back. There was no liable third party, he said. No driver was at fault.

His child just fell off his bicycle.

HealthScope Benefits reconsidered the claim. It was paid in September, two months after the accident. The hospital received less than half of what it originally billed, based on rates negotiated through his health plan.

The insurer paid $7,414.76 of the cost, and the Woodrums owed $1,853.45, which represented their share of the deductibles and copays.

The Takeaway: The mantra of Bill of the Month is don’t just write the check. But also don’t ignore scary bills from insurers or hospitals.

It’s not uncommon for insured patients to be questioned on whether their injury or medical condition might have been related to an accident. On some claim forms, there is even a box for the patient to check if it was an accident.

But in the Woodrums’ case, as in others, it was an automatic process. The insurer denied the claim based solely on the medical code indicating a possible accident.

If an insurer denies all payment for all medical care related to an injury, suspect that some type of subrogation is at work.

Don’t panic.

If you get an accident questionnaire, “fill it out, be honest about what happened,” said Sean Domnick, secretary of the American Association for Justice, an organization of plaintiffs lawyers. Inform your insurer and all other parties of the actual circumstances of the injury.

And do so promptly.

That’s because the clock starts ticking the day the medical care is provided and policyholders may face a statutory or contractual requirement that medical bills be submitted within a specific time frame, which can vary.

“Do not ignore it,” said Domnick. “Time and delay can be your enemy.”

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Rural Areas Send Their Sickest Patients to Cities, Straining Hospitals

Registered nurse Pascaline Muhindura has spent the past eight months treating COVID patients at Research Medical Center in Kansas City, Missouri.

But when she returns home to her small town of Spring Hill, Kansas, she’s often stunned by what she sees, like on a recent stop for carryout food.

“No one in the entire restaurant was wearing a mask,” Muhindura said. “And there’s no social distancing. I had to get out, because I almost had a panic attack. I was like, ‘What is going on with people? Why are we still doing this?'”

Many rural communities across the U.S. have resisted masks and calls for social distancing during the coronavirus pandemic, but now rural counties are experiencing record-high infection and death rates.

Critically ill rural patients are often sent to city hospitals for high-level treatment and, as their numbers grow, some urban hospitals are buckling under the added strain.

Kansas City has a mask mandate, but in many smaller communities nearby, masks aren’t required — or masking orders are routinely ignored. In the past few months, rural counties in both Kansas and Missouri have seen some of the highest rates of COVID-19 in the country.

At the same time, according to an analysis by KHN, about 3 in 4 counties in Kansas and Missouri don’t have a single intensive care unit bed, so when people from these places get critically ill, they’re sent to city hospitals.

A recent patient count at St. Luke’s Health System in Kansas City showed a quarter of COVID patients had come from outside the metro area.

Two-thirds of the patients coming from rural areas need intensive care and stay in the hospital for an average of two weeks, said Dr. Marc Larsen, who leads COVID-19 treatment at St. Luke’s.

“Not only are we seeing an uptick in those patients in our hospital from the rural community, they are sicker when we get them because [doctors in smaller communities] are able to handle the less sick patients,” said Larsen. “We get the sickest of the sick.”

Dr. Rex Archer, head of Kansas City’s health department, warns that capacity at the city’s 33 hospitals is being put at risk by the influx of rural patients.

“We’ve had this huge swing that’s occurred because they’re not wearing masks, and yes, that’s putting pressure on our hospitals, which is unfair to our residents that might be denied an ICU bed,” Archer said.

study newly released by the Centers for Disease Control and Prevention showed that Kansas counties that mandated masks in early July saw decreases in new COVID cases, while counties without mask mandates recorded increases.

Hospital leaders have continued to plead with Missouri Republican Gov. Mike Parson, and with Kansas’ conservative legislature, to implement stringent, statewide mask requirements but without success.

Parson won the Missouri gubernatorial election on Nov. 3 by nearly 17 percentage points. Two days later at a COVID briefing, he accused critics of “making the mask a political issue.” He said county leaders should decide whether to close businesses or mandate masks.

“We’re going to encourage them to take some sort of action,” Parson said Thursday. “The holidays are coming and I, as governor of the state of Missouri, am not going to mandate who goes in your front door.”

In an email, Dave Dillon, a spokesperson for the Missouri Hospital Association, agreed that rural patients might be contributing to hospital crowding in cities but argued that the strain on hospitals is a statewide problem.

The reasons for the rural COVID crisis involve far more than the refusal to mandate or wear masks, according to health care experts.

Both Kansas and Missouri have seen rural hospitals close year after year, and public health spending in both states, as in many largely rural states, is far below national averages.

Rural populations also tend to be older and to suffer from higher rates of chronic health conditions, including heart disease, obesity and diabetes. Those conditions can make them more susceptible to severe illness when they contract COVID-19.

Rural areas have been grappling with health problems for a long time, but the coronavirus has been a sort of tipping point, and those rural health issues are now spilling over into cities, explained Shannon Monnat, a rural health researcher at Syracuse University.

“It’s not just the rural health care infrastructure that becomes overwhelmed when there aren’t enough hospital beds, it’s also the surrounding neighborhoods, the suburbs, the urban hospital infrastructure starts to become overwhelmed as well,” Monnat said.

Unlike many parts of the U.S., where COVID trend lines have risen and fallen over the course of the year, Kansas, Missouri and several other Midwestern states never significantly bent their statewide curve.

Individual cities, such as Kansas City and St. Louis, have managed to slow cases, but the continual emergence of rural hot spots across Missouri has driven a slow and steady increase in overall new case numbers — and put an unrelenting strain on the states’ hospital systems.

The months of slow but continuous growth in cases created a high baseline of cases as autumn began, which then set the stage for the sudden escalation of numbers in the recent surge.

“It’s sort of the nature of epidemics that things often look like they’re relatively under control, and then very quickly ramp up to seem that they are out of hand,” said Justin Lessler, an epidemiologist at Johns Hopkins Bloomberg School of Public Health.

Now, a recent local case spike in the Kansas City metro area is adding to the statewide surge in Missouri, with an average of 190 COVID patients per day being admitted to the metro region’s hospitals. The number of people hospitalized throughout Missouri increased by more than 50% in the past two weeks.

Some Kansas City hospitals have had to divert patients for periods of time, and some are now delaying elective procedures, according to the University of Kansas Health system’s chief medical officer, Dr. Steven Stites.

But bed space isn’t the only hospital resource that’s running out. Half of the hospitals in the Kansas City area are now reporting “critical” staffing shortages. Pascaline Muhindura, the nurse who works in Kansas City, said that hospital workers are struggling with anxiety and depression.

“The hospitals are not fine, because people taking care of patients are on the brink,” Muhindura said. “We are tired.”

This story is from a reporting partnership that includes KCUR, NPR and KHN.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Need a COVID-19 Nurse? That’ll Be $8,000 a Week

DENVER — In March, Claire Tripeny was watching her dream job fall apart. She’d been working as an intensive care nurse at St. Anthony Hospital in Lakewood, Colorado, and loved it, despite the mediocre pay typical for the region. But when COVID-19 hit, that calculation changed.

She remembers her employers telling her and her colleagues to “suck it up” as they struggled to care for six patients each and patched their protective gear with tape until it fully fell apart. The $800 or so a week she took home no longer felt worth it.

“I was not sleeping and having the most anxiety in my life,” said Tripeny. “I’m like, ‘I’m gonna go where my skills are needed and I can be guaranteed that I have the protection I need.’”

In April, she packed her bags for a two-month contract in then-COVID hot spot New Jersey, as part of what she called a “mass exodus” of nurses leaving the suburban Denver hospital to become traveling nurses. Her new pay? About $5,200 a week, and with a contract that required adequate protective gear.

Months later, the offerings — and the stakes — are even higher for nurses willing to move. In Sioux Falls, South Dakota, nurses can make more than $6,200 a week. A recent posting for a job in Fargo, North Dakota, offered more than $8,000 a week. Some can get as much as $10,000.

Early in the pandemic, hospitals were competing for ventilators, COVID tests and personal protective equipment. Now, sites across the country are competing for nurses. The fall surge in COVID cases has turned hospital staffing into a sort of national bidding war, with hospitals willing to pay exorbitant wages to secure the nurses they need. That threatens to shift the supply of nurses toward more affluent areas, leaving rural and urban public hospitals short-staffed as the pandemic worsens, and some hospitals unable to care for critically ill patients.

“That is a huge threat,” said Angelina Salazar, CEO of the Western Healthcare Alliance, a consortium of 29 small hospitals in rural Colorado and Utah. “There’s no way rural hospitals can afford to pay that kind of salary.”

Surge Capacity

Hospitals have long relied on traveling nurses to fill gaps in staffing without committing to long-term hiring. Early in the pandemic, doctors and nurses traveled from unaffected areas to hot spots like California, Washington state and New York to help with regional surges. But now, with virtually every part of the country experiencing a surge — infecting medical professionals in the process — the competition for the finite number of available nurses is becoming more intense.

“We all thought, ‘Well, when it’s Colorado’s turn, we’ll draw on the same resources; we’ll call our surrounding states and they’ll send help,’” said Julie Lonborg, a spokesperson for the Colorado Hospital Association. “Now it’s a national outbreak. It’s not just one or two spots, as it was in the spring. It’s really significant across the country, which means everybody is looking for those resources.”

In North Dakota, Tessa Johnson said she’s getting multiple messages a day on LinkedIn from headhunters. Johnson, president of the North Dakota Nurses Association, said the pandemic appears to be hastening a brain drain of nurses there. She suspects more nurses may choose to leave or retire early after North Dakota Gov. Doug Burgum told health care workers to stay on the job even if they’ve tested positive for COVID-19.

All four of Utah’s major health care systems have seen nurses leave for traveling nurse positions, said Jordan Sorenson, a project manager for the Utah Hospital Association.

“Nurses quit, join traveling nursing companies and go work for a different hospital down the street, making two to three times the rate,” he said. “So, it’s really a kind of a rob-Peter-to-pay-Paul staffing situation.”

Hospitals not only pay the higher salaries offered to traveling nurses but also pay a commission to the traveling nurse agency, Sorenson said. Utah hospitals are trying to avoid hiring away nurses from other hospitals within the state. Hiring from a neighboring state like Colorado, though, could mean Colorado hospitals would poach from Utah.

“In the wake of the current spike in COVID hospitalizations, calling the labor market for registered nurses ‘cutthroat’ is an understatement,” said Adam Seth Litwin, an associate professor of industrial and labor relations at Cornell University. “Even if the health care sector can somehow find more beds, it cannot just go out and buy more front-line caregivers.”

Litwin said he’s glad to see the labor market rewarding essential workers — disproportionately women and people of color — with higher wages. Under normal circumstances, allowing markets to determine where people will work and for what pay is ideal.

“On the other hand, we are not operating under normal circumstances,” he said. “In the midst of a severe public health crisis, I worry that the individual incentives facing hospitals on the one side and individual RNs on the other conflict sharply with the needs of society as whole.”

Some hospitals are exploring ways to overcome staffing challenges without blowing the budget. That could include changing nurse-to-patient ratios, although that would likely affect patient care. In Utah, the hospital association has talked with the state nursing board about allowing nursing students in their final year of training to be certified early.

Growth Industry

Meanwhile business is booming for companies centered on health care staffing such as Wanderly and Krucial Staffing.

“When COVID first started and New York was an epicenter, we at Wanderly kind of looked at it and said, ‘OK, this is our time to shine,’” said David Deane, senior vice president of Wanderly, a website that allows health care professionals to compare offers from various agencies. “‘This is our time to help nurses get to these destinations as fast as possible. And help recruiters get those nurses.’”

Deane said the company has doubled its staff since the pandemic started. Demand is surging — with Rocky Mountain states appearing in up to 20 times as many job postings on the site as in January. And more people are meeting that demand.

In 2018, according to data from a national survey, about 31,000 traveling nurses worked nationwide. Now, Deane estimated, there are at least 50,000 travel nurses. Deane, who calls travel nurses “superheroes,” suspects a lot of them are postoperative nurses who were laid off when their hospitals stopped doing elective surgeries during the first lockdowns.

Competition for nurses, especially those with ICU experience, is stiff. After all, a hospital in South Dakota isn’t competing just with facilities in other states.

“We’ve sent nurses to Aruba, the Bahamas and Curacao because they’ve needed help with COVID,” said Deane. “You’re going down there, you’re making $5,000 a week and all your expenses are paid, right? Who’s not gonna say yes?”

Krucial Staffing specializes in sending health care workers to disaster locations, using military-style logistics. It filled hotels and rented dozens of buses to get nurses to hot spots in New York and Texas. CEO Brian Cleary said that, since the pandemic started, the company has grown its administrative staff from 12 to more than 200.

“Right now we’re at our highest volume we’ve been,” said Cleary, who added that over Halloween weekend alone about 1,000 nurses joined the roster of “reservists.”

With a base rate of $95 an hour, he said, some nurses working overtime end up coming away with $10,000 a week, though there are downsides, like the fact that the gig doesn’t come with health insurance and it’s an unstable, boom-and-bust market.

Hidden Costs

Amber Hazard, who lives in Texas, started as a traveling ICU nurse before the pandemic and said eye-catching sums like that come with a hidden fee, paid in sanity.

“How your soul is affected by this is nothing you can put a price on,” she said.

At a high-paying job caring for COVID patients during New York’s first wave, she remembers walking into the break room in a hospital in the Bronx and seeing a sign on the wall about how the usual staff nurses were on strike.

“It said, you know, ‘We’re not doing this. This is not safe,’” said Hazard. “And it wasn’t safe. But somebody had to do it.”

The highlight of her stint there was placing a wedding ring back on the finger of a recovered patient. But Hazard said she secured far more body bags than rings on patients.

Tripeny, the traveling nurse who left Colorado, is now working in Kentucky with heart surgery patients. When that contract wraps up, she said, she might dive back into COVID care.

Earlier, in New Jersey, she was scarred by the times she couldn’t give people the care they needed, not to mention the times she would take a deceased patient off a ventilator, staring down the damage the virus can do as she removed tubes filled with blackened blood from the lungs.

She has to pay for mental health therapy out-of-pocket now, unlike when she was on staff at a hospital. But as a so-called traveler, she knows each gig will be over in a matter of weeks.

At the end of each week in New Jersey, she said, “I would just look at my paycheck and be like, ‘OK. This is OK. I can do this.’”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Florida’s New Hospital Industry Head Ran Medicaid in State and Fought Expansion

With its choice of a new leader, the Florida Hospital Association has signaled that seeking legislative approval to expand Medicaid to nearly 850,000 uninsured adults won’t be among its top priorities.

In October, Mary Mayhew became the association’s CEO. Mayhew, who led the state’s Medicaid agency since 2019, has been a vocal critic of the Affordable Care Act’s Medicaid expansion adopted by 38 other states. She has argued that expansion puts states in a difficult position because the federal government is unlikely to keep its financial commitment to pay its share of the costs.

Had Medicaid been expanded in Florida, hospitals there would have gained thousands of paying patients. But the institutions have done little in recent years to persuade the Republican-led legislature and Gov. Ron DeSantis, also Republican, who oppose such a move.

Mayhew acknowledged in an interview with KHN that expanding Medicaid to cover more uninsured patients could help hospitals financially, especially at a time when facilities have seen demand for services decline as people avoid care for fear of contracting COVID-19.

With that in mind, she said, she is now open to the idea of expanding Medicaid. “We need to look at all options on the table,” she said. “Is it doable? Yes.”

Still, she was quick to point out concerns about whether Florida can afford to expand.

Under the ACA, the federal government pays 90% of the costs for newly enrolled Medicaid recipients. In the traditional Medicaid program — which covers children, people who are disabled and pregnant women — the federal government pays nearly two-thirds of Florida’s Medicaid costs.

“It will be financially challenging in our state budget as revenues have dropped,” Mayhew said, echoing comments of state officials. “That 10% cost has to come from somewhere.”

Mayhew’s hire worries advocates who have spent more than seven years lobbying lawmakers to expand Medicaid. Without strong support from the hospital industry, they fear they’re unlikely to change many votes.

“It may make it harder,” said Karen Woodall, executive director of Florida People’s Advocacy Center, a group that lobbies for policies to help low-income citizens. Marshaling hospital support is important, she said, because of the industry’s money and political clout.

In many state capitals, hospitals have led the fight for Medicaid expansion either by lobbying lawmakers or bankrolling ballot initiatives. The latest example was in Missouri, which this summer expanded Medicaid via a voter initiative. The campaign for the measure was partly funded by hospitals.

But in Florida, hospitals appear to have made a calculated decision to avoid pushing an initiative that Republican leaders have said they don’t want. Among the dozen states that have not expanded Medicaid, Florida is second only to Texas in the number of residents who could gain coverage.

Aurelio Fernandez, CEO of Memorial Healthcare System in Hollywood, Florida, who was chair of the hospital association board when it hired Mayhew, said her opposition to Medicaid expansion never came up in the process. The association hired Mayhew because of the “phenomenal job” she did guiding hospitals amid the COVID pandemic, he said.

“There is no appetite at this juncture [for the legislature] to expand the Medicaid program with Obamacare,” said Fernandez, despite his belief that expansion would help hospitals and patients.

Mayhew, sounding more like a state official than a hospital industry spokesperson, said the ultimate decision on expansion will be up to lawmakers, who must review spending priorities. When states face a financial crunch, lawmakers look to reduce spending in education and Medicaid, which are the biggest parts of the budget, she said.

“The last thing we want to see is the state budget balanced on the backs of hospitals with deep Medicaid reimbursement cuts,” Mayhew said.

Mayhew said her previous opposition to expanding Medicaid occurred when she was responsible for balancing the state budget and managing the programs in Florida and, before that, in Maine. When she ran Maine’s program, she said she opposed expanding Medicaid to allow nondisabled adults into the program while there were disabled enrollees already on waiting lists to get care.

The Florida Hospital Association, which represents more than 200 hospitals, spent years lobbying state lawmakers to expand Medicaid. But since DeSantis was elected in 2018, the group has focused on other issues because the governor and Republican lawmakers made clear they would not expand the program.

Asked what the association’s current position is on Medicaid expansion, Mayhew noted she has been in her job less than a month and “we have not had that policy decision by the board for me to answer that.”

Miriam Harmatz, executive director of the Florida Health Justice Project, an advocacy group, said Mayhew’s hire suggests that hospitals are unlikely to get behind a fledgling effort to put the expansion question to voters in 2022.

Others advocating for Medicaid expansion agree.

“It does not look like they [Florida’s hospitals] are on board with helping us expand Medicaid at the moment,” said Louisa McQueeney, program director of Florida Voices for Health, a consumer group helping with the ballot initiative.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines

When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic.

Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial.

Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products.

The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly out of a partnership between Moderna and Graham’s NIH laboratory.

Coronavirus vaccines are likely to be worth billions to the drug industry if they prove safe and effective. As many as 14 billion vaccines would be required to immunize everyone in the world against COVID-19. If, as many scientists anticipate, vaccine-produced immunity wanes, billions more doses could be sold as booster shots in years to come. And the technology and production laboratories seeded with the help of all this federal largesse could give rise to other profitable vaccines and drugs.

The vaccines made by Pfizer and Moderna, which are likely to be the first to win FDA approval, in particular rely heavily on two fundamental discoveries that emerged from federally funded research: the viral protein designed by Graham and his colleagues, and the concept of RNA modification, first developed by Drew Weissman and Katalin Karikó at the University of Pennsylvania. In fact, Moderna’s founders in 2010 named the company after this concept: “Modified” + “RNA” = Moderna, according to co-founder Robert Langer.

“This is the people’s vaccine,” said corporate critic Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “Federal scientists helped invent it and taxpayers are funding its development. … It should belong to humanity.”

Moderna, through spokesperson Ray Jordan, acknowledged its partnership with NIH throughout the COVID-19 development process and earlier. Pfizer spokesperson Jerica Pitts noted the company had not received development and manufacturing support from the U.S. government, unlike Moderna and other companies.

The idea of creating a vaccine with messenger RNA, or mRNA — the substance that converts DNA into proteins — goes back decades. Early efforts to create mRNA vaccines failed, however, because the raw RNA was destroyed before it could generate the desired response. Our innate immune systems evolved to kill RNA strands because that’s what many viruses are.

Karikó came up with the idea of modifying the elements of RNA to enable it to slip past the immune system undetected. The modifications she and Weissman developed allowed RNA to become a promising delivery system for both vaccines and drugs. To be sure, their work was enhanced by scientists at Moderna, BioNTech and other laboratories over the past decade.

Another key element in the mRNA vaccine is the lipid nanoparticle — a tiny, ingeniously designed bit of fat that encloses the RNA in a sort of invisibility cloak, ferrying it safely through the blood and into cells and then dissolving, thereby allowing the RNA to do its work of coding a protein that will serve as the vaccine’s main active ingredient. The idea of enclosing drugs or vaccines in lipid nanoparticles arose first in the 1960s and was developed by Langer and others at the Massachusetts Institute of Technology and various academic and industry laboratories.

Karikó began investigating RNA in 1978 in her native Hungary and wrote her first NIH grant proposal to use mRNA as a therapeutic in 1989. She and Weissman achieved successes starting in 2004, but the path to recognition was often discouraging.

“I keep writing and doing experiments, things are getting better and better, but I never get any money for the work,” she recalled in an interview. “The critics said it will never be a drug. When I did these discoveries, my salary was lower than the technicians working next to me.”

Eventually, the University of Pennsylvania sublicensed the patent to Cellscript, a biotech company in Wisconsin, much to the dismay of Weissman and Karikó, who had started their own company to try to commercialize the discovery. Moderna and BioNTech later would each pay $75 million to Cellscript for the RNA modification patent, Karikó said. Though unhappy with her treatment at Penn, she remained there until 2013 — partly because her daughter, Susan Francia, was making a name for herself on the school’s rowing team. Francia would go on to win two Olympic gold medals in the sport. Karikó is now a senior officer at BioNTech.

In addition to RNA modification and the lipid nanoparticle, the third key contribution to the mRNA vaccines — as well as those made by Novavax, Sanofi and Johnson & Johnson —- is the bioengineered protein developed by Graham and his collaborators. It has proved in tests so far to elicit an immune response that could prevent the virus from causing infections and disease.

The protein design was based on the observation that so-called fusion proteins — the pieces of the virus that enable it to invade a cell — are shape-shifters, presenting different surfaces to the immune system after the virus fuses with and infects cells. Graham and his colleagues learned that antibodies against the post-fusion protein are far less effective at stopping an infection.

The discovery arose in part through Graham’s studies of a 54-year-old tragedy — the failed 1966 trial of an NIH vaccine against respiratory syncytial virus, or RSV. In a clinical trial, not only did that vaccine fail to protect against the common childhood disease, but most of the 21 children who received it were hospitalized with acute allergic reactions, and two died.

About a decade ago, Graham, now deputy director of NIH’s Vaccine Research Center, took a new stab at the RSV problem with a postdoctoral fellow, Jason McLellan. After isolating and obtaining three-dimensional models of the RSV’s fusion protein, they worked with Chinese scientists to identify an appropriate neutralizing antibody against it.

“We were sitting in Xiamen, China, when Jason got the first image up on his laptop, and I was like, oh my God, it’s coming together,” Graham recalled. The prefusion antibodies they discovered were 16 times more potent than the post-fusion form contained in the faulty 1960s vaccine.

Two 2013 papers the team published in Science earned them a runner-up prize in the prestigious journal’s Breakthrough of the Year award. Their papers, which showed it was possible to plan and create a vaccine at the microscopic structural level, set the NIH’s Vaccine Research Center on a path toward creating a generalizable, rapid way to design vaccines against emerging pandemic viruses, Graham said.

In 2016, Graham, McLellan and other scientists, including Andrew Ward at the Scripps Research Institute, advanced their concept further by publishing the prefusion structure of a coronavirus that causes the common cold and a patent was filed for its design by NIH, Scripps and Dartmouth — where McLellan had set up his own lab. NIH and the University of Texas — where McLellan now works — filed an additional patent this year for a similar design change in the virus that causes COVID-19.

Graham’s NIH lab, meanwhile, had started working with Moderna in 2017 to design a rapid manufacturing system for vaccines. In January, they were preparing a demonstration project, a clinical trial to test whether Graham’s protein design and Moderna’s mRNA platform could be used to create a vaccine against Nipah, a deadly virus spread by bats in Asia.

Their plans changed rapidly when they learned on Jan. 7 that the epidemic of respiratory disease in China was being caused by a coronavirus.

“We agreed immediately that the demonstration project would focus on this virus” instead of Nipah, Graham said. Moderna produced a vaccine within six weeks. The first patient was vaccinated in an NIH-led clinical study on March 16; early results from Moderna’s 30,000-volunteer late-stage trial showed it was nearly 95% effective at preventing COVID-19.

Although other scientists have advanced proposals for what may be even more potent vaccine antigens, Graham is confident that carefully designed vaccines using nucleic acids like RNA reflect the future of new vaccines. Already, two major drug companies are doing advanced clinical trials for RSV vaccines based on the designs his lab discovered, he said.

In a larger sense, the pandemic could be the event that paves the way for better, perhaps cheaper and more plentiful vaccines.

“It’s a silver lining, but I think we are definitely pushing forward the way everyone is thinking about vaccines,” said Michael Farzan, chair of the department of immunology and microbiology at Scripps Research’s Florida campus. “Certain techniques that have been waiting in the wings, under development but never achieving the kind of funding they needed for major tests, will finally get their chance to shine.”

Under a 1980 law, the NIH will obtain no money from the coronavirus vaccine patent. How much money will eventually go to the discoverers or their institutions isn’t clear. Any existing licensing agreements haven’t been publicized; patent disputes among some of the companies will likely last years. HHS’ big contracts with the vaccine companies are not transparent, and Freedom of Information Act requests have been slow-walked and heavily redacted, said Duke University law professor Arti Rai.

Some basic scientists involved in the enterprise seem to accept the potentially lopsided financial rewards.

“Having public-private partnerships is how things get done,” Graham said. “During this crisis, everything is focused on how can we do the best we can as fast as we can for the public health. All this other stuff is going to have to be figured out later.”

“It’s not a good look to become extremely wealthy off a pandemic,” McLellan said, noting the big stock sales by some vaccine company executives after they received hundreds of millions of dollars in government assistance. Still, “the companies should be able to make some money.”

For Graham, the lesson of the coronavirus vaccine response is that a few billion dollars a year spent on additional basic research could prevent a thousand times as much loss in death, illness and economic destruction.

“Basic research informs what we do, and planning and preparedness can make such a difference in how we get ahead of these epidemics,” he said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Long-Term Care Workers, Grieving and Under Siege, Brace for COVID’s Next Round

In the middle of the night, Stefania Silvestri lies in bed remembering her elderly patients’ cries.

“Help me.”

“Please don’t leave me.”

“I need my family.”

Months of caring for older adults in a Rhode Island nursing home ravaged by COVID-19 have taken a steep toll on Silvestri, 37, a registered nurse.

She can’t sleep, as she replays memories of residents who became ill and died. She’s gained 45 pounds. “I have anxiety. Some days I don’t want to get out of bed,” she said.

Now, as the coronavirus surges around the country, Silvestri and hundreds of thousands of workers in nursing homes and assisted living centers are watching cases rise in long-term care facilities with a sense of dread.

Many of these workers struggle with grief over the suffering they’ve witnessed, both at work and in their communities. Some, like Silvestri, have been infected with the coronavirus and recovered physically — but not emotionally.

Since the start of the pandemic, more than 616,000 residents and employees at long-term care facilities have been struck by COVID-19, according to the latest data from KFF. Just over 91,000 have died as the coronavirus has invaded nearly 23,000 facilities. (KHN is an editorially independent program of KFF.)

At least 1,000 of those deaths represent certified nursing assistants, nurses and other people who work in institutions that care for older adults, according to a recent analysis of government data by Harold Pollack, a professor at the School of Social Service Administration at the University of Chicago. This is almost certainly an undercount, he said, because of incomplete data reporting.

How are long-term care workers affected by the losses they’re experiencing, including the deaths of colleagues and residents they’ve cared for, often for many years?

Edwina Gobewoe, a certified nursing assistant who has worked at Charlesgate Nursing Center in Providence, Rhode Island, for nearly 20 years, acknowledged “it’s been overwhelming for me, personally.”

At least 15 residents died of COVID-19 at Charlesgate from April to June, many of them suddenly. “One day, we hear our resident has breathing problems, needs oxygen, and then a few days later they pass,” she said. “Families couldn’t come in. We were the only people with them, holding their hands. It made me very, very sad.”

Every morning, Gobewoe would pray with a close friend at work. “We asked the Lord to give us strength so we could take care of these people who needed us so much.” When that colleague was struck by COVID-19 in the spring, Gobewoe prayed for her recovery and was glad when she returned to work several weeks later.

But sorrow followed in early September: Gobewoe’s friend collapsed and died at home while complaining of unusual chest pain. Gobewoe was told that her death was caused by blood clots, which can be a dangerous complication of COVID-19.

She would “do anything for any resident,” Gobewoe remembered, sobbing. “It’s too much, something you can’t even talk about,” describing her grief.

I first spoke to Kim Sangrey, 52, of Lancaster, Pennsylvania, in July. She was distraught over the deaths of 36 residents in March and April at the nursing home where she’s worked for several decades — most of them due to COVID-19 and related complications. Sangrey, a recreational therapist, asked me not to name the home, where she continues to be employed.

“You know residents like family — their likes and dislikes, the food they prefer, their families, their grandchildren,” she explained. “They depend on us for everything.”

When COVID-19 hit, “it was horrible,” she said. “You’d go into residents’ rooms and they couldn’t breathe. Their families wanted to see them, and we’d set up Zoom wearing full gear, head to toe. Tears are flowing under your mask as you watch this person that you loved dying — and the family mourning their death through a tablet.”

“It was completely devastating. It runs through your memory — you think about it all the time.”

Mostly, Sangrey said, she felt empty and exhausted. “You feel like this is never going to end — you feel defeated. But you have to continue moving forward,” she told me.

Three months later, when we spoke again, COVID-19 cases were rising in Pennsylvania but Sangrey sounded resolute. She’d had six sessions with a grief counselor and said it had become clear that “my purpose at this point is to take every ounce of strength I have and move through this second wave of COVID.”

“As human beings, it is our duty to be there for each other,” she continued. “You say to yourself, OK, I got through this last time, I can get through it again.”

That doesn’t mean that fear is absent. “All of us know COVID-19 is coming. Every day we say, ‘Is today the day it will come back? Is today the day I’ll find out I have it?’ It never leaves you.”

To this day, Silvestri feels horrified when she thinks about the end of March and early April at Greenville Center in Rhode Island, where up to 79 residents became ill with COVID-19 and at least 20 have died.

The coronavirus moved through the facility like wildfire. “You’re putting one patient on oxygen and the patient in the next room is on the floor but you can’t go to them yet,” Silvestri remembered. “And the patient down the hall has a fever of 103 and they’re screaming, ‘Help me, help me.’ But you can’t go to him either.”

“I left work every day crying. It was heartbreaking — and I felt I couldn’t do enough to save them.”

Then, there were the body bags. “You put this person who feels like family in a plastic body bag and wheel them out on a frame with wheels through the facility, by other residents’ rooms,” said Silvestri, who can’t smell certain kinds of plastic without reliving these memories. “Thinking back on it makes me feel physically ill.”

Silvestri, who has three children, developed a relatively mild case of COVID-19 in late April and returned to work several weeks later. Her husband, Michael, also became ill and lost his job as a truck driver. After several months of being unemployed, he’s now working at a construction site.

Since July 1, the family has gone without health insurance, “so I’m not able to get counseling to deal with the emotional side of what’s happened,” Silvestri said.

Although her nursing home set up a hotline number that employees could call, that doesn’t appeal to her. “Being on the phone with someone you don’t know, that doesn’t do it for me,” she said. “We definitely need more emotional support for health care workers.”

What does help is family. “I’ve leaned on my husband a lot and he’s been there for me,” Silvestri said. “And the children are OK. I’m grateful for what I have — but I’m really worried about what lies ahead.”

The Navigating Aging column last week focused on how nursing homes respond to grief sweeping through their facilities.

Join Judith Graham for a Facebook Live event on grief and bereavement during the coronavirus pandemic on Monday, Nov. 16, at 1 p.m. ET. You can watch the conversation here and submit questions in advance here.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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¿Es hora de discutir los potenciales efectos secundarios de las vacunas para COVID? Científicos dicen que sí

Se espera que la farmacéutica Pfizer solicite permiso federal para lanzar su vacuna para COVID-19 a fines de noviembre. Una medida que promete acorralar la pandemia, pero que no ofrece mucho tiempo para asegurarse de que los consumidores estén bien informados.

Esta vacuna, y probablemente las otras, requerirá de dos dosis para funcionar, inyecciones que deben administrarse con semanas de diferencia, según muestran los protocolos de la compañía.

Los científicos anticipan que las vacunas causarán efectos secundarios parecidos a los de la gripe, que incluyen dolor en los brazos, dolores musculares y fiebre, que podrían durar días e impedir trabajar o estudiar.

E incluso si una vacuna demuestra una efectividad del 90%, la tasa que Pfizer promociona para su producto, uno de cada 10 receptores seguiría siendo vulnerable. Eso significa que, al menos a corto plazo, a medida que aumenta la inmunidad a nivel de la población, las personas no pueden dejar de usar máscaras y respetar el distanciamiento social.

Por el impulso de tener una vacuna lo antes posible, se ha dejado de lado un plan a gran escala para comunicar de manera efectiva sobre esos temas con anticipación, dijo el doctor Saad Omer, director del Instituto Yale para la Salud Global.

“Necesitas estar listo”, dijo. “No puedes buscar tus materiales de comunicación el día después que se autorice la vacuna”.

Omer, quien no quiso comentar sobre informes que indican que está siendo considerado para un puesto en la nueva administración del presidente electo Joe Biden, pidió el lanzamiento de una sólida campaña de mensajes basada en la mejor evidencia científica sobre las dudas, y la aceptación, de la vacuna.

Los Centros para el Control y Prevención de Enfermedades (CDC) han creado una estrategia llamada “Vacunar con confianza”, pero carece de los recursos necesarios, dijo Omer.

“Necesitamos comunicarnos, y necesitamos comunicarnos de manera efectiva, y debemos comenzar a planificar esto ahora”, dijo.

Este alcance amplio será necesario en un país donde, a mediados de octubre, solo la mitad de los estadounidenses dijeron que estarían dispuestos a recibir una vacuna para COVID-19.

Al principio, las dosis iniciales de cualquier vacuna serían limitadas, pero expertos predicen que pueden estar disponibles de manera amplia a mediados del próximo año. Discutir los posibles efectos secundarios temprano podría contrarrestar la información errónea que exagera o distorsiona el riesgo.

“La mayor tragedia sería si tuviéramos una vacuna segura y eficaz que la gente no se atreva a recibir”, dijo la doctora Preeti Malani, directora de salud y profesora de medicina de la Universidad de Michigan en Ann Arbor.

Pfizer y su socio, la firma alemana BioNTech, dijeron el lunes 9 de noviembre que su vacuna parece proteger a nueve de cada 10 personas de contraer el coronavirus que causa COVID-19, aunque no revelaron datos subyacentes. Es la primera de cuatro vacunas para COVID en la etapa de pruebas de eficacia a gran escala en los Estados Unidos en publicar resultados.

Los datos de los primeros ensayos de varias vacunas contra COVID-19 sugieren que los consumidores deberán estar preparados para los efectos secundarios que, aunque técnicamente leves, podrían alterar la vida diaria.

Un alto ejecutivo de Pfizer dijo al sitio de noticias Stat que los efectos secundarios parecen ser comparables al de las vacunas estándar para adultos, pero peores que la vacuna contra la neumonía de la compañía, Prevnar, o las vacunas típicas contra la gripe.

Por ejemplo, la vacuna Shingrix, de dos dosis, que protege a los adultos mayores contra el virus que causa el doloroso herpes zóster o culebrilla, provoca dolor en los brazos en el 78% de los receptores y dolor muscular y fatiga en más del 40% de los que la reciben.

Las vacunas contra la gripe común, y Prevnar, pueden causar dolor en el área de la inyección, molestias y fiebre.

“Les pedimos a las personas que se pongan una vacuna que va a doler”, dijo el doctor William Schaffner, profesor de medicina preventiva y políticas de salud en el Centro Médico de la Universidad de Vanderbilt. “Hay muchos brazos adoloridos y un número considerable de personas que se sienten mal, con dolores de cabeza y dolores musculares, durante uno o dos días”.

Persuadir a las personas que experimentan estos síntomas para que regresen en tres o cuatro semanas para una segunda dosis, y una segunda ronda de síntomas similares a los de la gripe, podría ser difícil de lograr, dijo Schaffner.

La forma en que expertos en salud pública expliquen estos efectos es importante, dijo Omer. “Hay evidencia que sugiere que si se enmarca el dolor como un indicador de la efectividad, es útil”, dijo. “Si te duele un poco, está funcionando”.

Al mismo tiempo, una buena comunicación ayudará a los consumidores a planificar en base a estos potenciales efectos. Se espera que una vacuna para COVID-19 se distribuya primero al personal de atención médica y a otros trabajadores esenciales, que es posible que no puedan trabajar si se sienten enfermos, dijo el doctor Eli Perencevich, profesor de medicina interna y epidemiología en la Universidad de Atención de Salud de Iowa.

“Mucha gente no tiene licencia por enfermedad. Muchos de nuestros trabajadores esenciales no tienen seguro médico”, dijo, y sugirió que a estos empleados se les debería otorgar tres días de licencia paga después de recibir la vacuna. “Estas son las cosas que debería proporcionar un gobierno que funciona bien, para que nuestra economía vuelva a funcionar”.

También es crucial asegurarse de que los consumidores sepan que una vacuna para COVID-19 probablemente requerirá dos dosis, y que podría tomar un mes para que se active la efectividad total.

El ensayo de fase 3 de Pfizer, que ha inscrito a casi 44,000 personas, comenzó a finales de julio. Los participantes recibieron una segunda dosis 21 días después de la primera. La eficacia informada del 90% se midió siete días después de la segunda dosis.

La comunicación eficaz será vital para garantizar que los consumidores se coloquen la segunda dosis y, suponiendo que se aprueben varias vacunas, que la primera y segunda dosis sean del mismo fabricante.

Omer dijo que, hasta que se active la protección total, las personas deben seguir tomando medidas para protegerse: usar máscaras, lavarse las manos, respetar el distanciamiento social. Es importante que las personas sepan que tomar las medidas adecuadas ahora brindará frutos más adelante.

“Si solo les mostramos el túnel, no la luz, entonces eso da como resultado esta negación masiva”, dijo. “Necesitamos decir, ‘tendrás que continuar haciendo esto a mediano plazo, pero el panorama futuro es bueno”.

Puede haber una mejor comunicación una vez que se presenten los datos completos del ensayo de Pfizer y otros, señaló el doctor Paul Offit, experto en vacunas del Hospital Infantil de Philadelphia, que forma parte del consejo asesor de la Administración de Alimentos y Medicamentos (FDA), que evalúa las vacunas para COVID-19.

“Cuando observas esos datos, puedes definir con mayor precisión qué grupos de personas tienen más probabilidades de tener efectos secundarios, cuál es la eficacia, qué sabemos sobre cuánto dura esa eficacia, por cuánto tiempo se ha analizado la seguridad”, dijo. “Creo que tienes que prepararte para comunicar eso. Y puedes empezar a prepararte ahora”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes.

Drugmaker Pfizer is expected to seek federal permission to release its COVID-19 vaccine by the end of November, a move that holds promise for quelling the pandemic, but also sets up a tight time frame for making sure consumers understand what it will mean to actually get the shots.

This story also ran on NBC News. It can be republished for free.

This vaccine, and likely most others, will require two doses to work, injections that must be given weeks apart, company protocols show. Scientists anticipate the shots will cause enervating flu-like side effects — including sore arms, muscle aches and fever — that could last days and temporarily sideline some people from work or school. And even if a vaccine proves 90% effective, the rate Pfizer touted for its product, 1 in 10 recipients would still be vulnerable. That means, at least in the short term, as population-level immunity grows, people can’t stop social distancing and throw away their masks.

Left out so far in the push to develop vaccines with unprecedented speed has been a large-scale plan to communicate effectively about those issues in advance, said Dr. Saad Omer, director of the Yale Institute for Global Health.

“You need to be ready,” he said. “You can’t look for your communication materials the day after the vaccine is authorized.”

Omer, who declined to comment on reports he’s being considered for a post in the new administration of President-elect Joe Biden, called for the rollout of a robust messaging campaign based on the best scientific evidence about vaccine hesitancy and acceptance. The Centers for Disease Control and Prevention has created a strategy called “Vaccinate with Confidence,” but it lacks the necessary resources, Omer said.

“We need to communicate, and we need to communicate effectively, and we need to start planning for this now,” he said.

Such broad-based outreach will be necessary in a country where, as of mid-October, only half of Americans said they’d be willing to get a COVID-19 vaccine. Initial doses of any vaccine would be limited at first, but experts predict they may be widely available by the middle of next year. Discussing potential side effects early could counter misinformation that overstates or distorts the risk.

“The biggest tragedy would be if we have a safe and effective vaccine that people are hesitant to get,” said Dr. Preeti Malani, chief health officer and a professor of medicine at the University of Michigan in Ann Arbor.

Pfizer and its partner, the German firm BioNTech, on Monday said their vaccine appears to protect 9 in 10 people from getting COVID-19, although they didn’t release underlying data. It’s the first of four COVID-19 vaccines in large-scale efficacy tests in the U.S. to post results.

Data from early trials of several COVID-19 vaccines suggests that consumers will need to be prepared for side effects that, while technically mild, could disrupt daily life. A senior Pfizer executive told the news outlet Stat that side effects from the company’s COVID-19 vaccine appear to be comparable to standard adult vaccines but worse than the company’s pneumonia vaccine, Prevnar, or typical flu shots.

The two-dose Shingrix vaccine, for instance, which protects older adults against the virus that causes painful shingles, results in sore arms in 78% of recipients and muscle pain and fatigue in more than 40% of those who take it. Prevnar and common flu shots can cause injection-site pain, aches and fever.

“We are asking people to take a vaccine that is going to hurt,” said Dr. William Schaffner, a professor of preventive medicine and health policy at Vanderbilt University Medical Center. “There are lots of sore arms and substantial numbers of people who feel crummy, with headaches and muscle pain, for a day or two.”

Persuading people who experience these symptoms to return in three to four weeks for a second dose — and a second round of flu-like symptoms — could be a tough sell, Schaffner said.

How public health experts explain such effects is important, Omer said. “There’s evidence that suggests that if you frame pain as a proxy of effectiveness, it’s helpful,” he said. “If it’s hurting a little, it’s working.”

At the same time, good communication will help consumers plan for such effects. A COVID-19 vaccine is expected to be distributed first to health care staffers and other essential workers, who may not be able to work if they feel sick, said Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care.

“A lot of folks don’t have sick leave. A lot of our essential workers don’t have health insurance,” he said, suggesting that essential workers should be granted three days of paid leave after they’re vaccinated. “These are the things a well-functioning government should provide for to get our economy going again.”

Making sure consumers know that a COVID-19 vaccine likely will require two doses — and that it could take a month for full effectiveness to kick in — is also crucial. The Pfizer phase 3 trial, which has enrolled nearly 44,000 people, started in late July. Participants received a second dose 21 days after the first. The reported 90% efficacy was measured seven days after the second dose.

Communicating effectively will be vital to ensuring that consumers follow through with the shots and — assuming several vaccines are approved — that their first and second doses are from the same maker. Until full protection kicks in, Omer said, people should continue to take measures to protect themselves: wearing masks, washing hands, social distancing. It’s important to let people know that taking appropriate action now will pay off later.

“If we just show them the tunnel, not the light, then that results in this mass denial,” he said. “We need to say, ‘You’ll have to continue to do this in the medium term, but the long term looks good.”

The best communication can occur once full data from the Pfizer trial and others are presented, noted Dr. Paul Offit, a vaccinologist at the Children’s Hospital of Philadelphia who sits on the federal Food and Drug Administration’s advisory board considering COVID-19 vaccines.

“When you look at those data, you can more accurately define what groups of people are most likely to have side effects, what the efficacy is, what we know about how long the efficacy lasts, what we know about how long the safety data have been tested,” he said. “I think you have to get ready to communicate that. You can start getting ready now.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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