As the nation's hospitals fill and emergency rooms overflow with critically ill COVID-19 patients, the non-COVID-19 patients have become collateral damage.
This article was published on Wednesday, September 15, 2021 in ProPublica.
What first struck Nathaniel Osborn when he and his wife took their son, Seth, to the emergency room this summer was how packed the waiting room was for a Wednesday at 1 p.m.
The Florida hospital's emergency room was so crowded there weren't enough chairs for the family to all sit as they waited. And waited.
Hours passed and 12-year-old Seth's condition worsened, his body quivering from the pain shooting across his lower belly. Osborn said his wife asked why it was taking so long to be seen. A nurse rolled her eyes and muttered, "COVID."
Seth was finally diagnosed with appendicitis more than six hours after arriving at Cleveland Clinic Martin Health North Hospital in late July. Around midnight, he was taken by ambulance to a sister hospital about a half-hour away that was better equipped to perform pediatric emergency surgery, his father said.
But by the time the doctor operated in the early morning hours, Seth's appendix had burst — a potentially fatal complication.
As the nation's hospitals fill and emergency rooms overflow with critically ill COVID-19 patients, it is the non-COVID-19 patients, like Seth, who have become collateral damage. They, too, need emergency care, but the sheer number of COVID-19 cases is crowding them out. Treatment has often been delayed as ERs scramble to find a bed that may be hundreds of miles away.
Some health officials now worry about looming ethical decisions. Last week, Idaho activated a "crisis standard of care," which one official described as a "last resort." It allows overwhelmed hospitals to ration care, including "in rare cases, ventilator (breathing machines) or intensive care unit (ICU) beds may need to be used for those who are most likely to survive, while patients who are not likely to survive may not be able to receive one," the state's website said.
The federal government's latest data shows Alabama is at 100% of its intensive care unit capacity, with Texas, Georgia, Mississippi and Arkansas at more than 90% ICU capacity. Florida is just under 90%.
It's the COVID-19 cases that are dominating. In Georgia, 62% of the ICU beds are now filled with just COVID-19 patients. In Texas, the percentage is nearly half.
To have so many ICU beds pressed into service for a single diagnosis is "unheard of," said Dr. Hasan Kakli, an emergency room physician at Bellville Medical Center in Bellville, Texas, about an hour from Houston. "It's approaching apocalyptic."
In Texas, state data released Monday showed there were only 319 adult and 104 pediatric staffed ICU beds available across a state of 29 million people.
Hospitals need to hold some ICU beds for other patients, such as those recovering from major surgery or other critical conditions such as stroke, trauma or heart failure.
"This is not just a COVID issue," said Dr. Normaliz Rodriguez, pediatric emergency physician at Johns Hopkins All Children's Hospital in St. Petersburg, Florida. "This is an everyone issue."
While the latest hospital crisis echoes previous pandemic spikes, there are troubling differences this time around.
Before, localized COVID-19 hot spots led to bed shortages, but there were usually hospitals in the region not as affected that could accept a transfer.
Now, as the highly contagious delta variant envelops swaths of low-vaccination states all at once, it becomes harder to find nearby hospitals that are not slammed.
"Wait times can now be measured in days," said Darrell Pile, CEO of the SouthEast Texas Regional Advisory Council, which helps coordinate patient transfers across a 25-county region.
Recently, Dr. Cedric Dark, a Houston emergency physician and assistant professor of emergency medicine at Baylor College of Medicine, said he saw a critically ill COVID-19 patient waiting in the emergency room for an ICU bed to open. The doctor worked eight hours, went home and came in the next day. The patient was still waiting.
Holding a seriously ill patient in an emergency room while waiting for an in-patient bed to open is known as boarding. The longer the wait, the more dangerous it can be for the patient, studies have found.
Not only do patients ultimately end up staying in the hospital or the ICU longer, some research suggests that long waits for a bed will worsen their condition and may increase the risk of in-hospital death.
That's what happened last month in Texas.
On Aug. 21, around 11:30 a.m., Michelle Puget took her adult son, Daniel Wilkinson, to the Bellville Medical Center's emergency room as a pain in his abdomen became unbearable. "Mama," he said, "take me to the hospital."
Wilkinson, a 46-year-old decorated Army veteran who did two tours of duty in Afghanistan, was ushered into an exam room about half an hour later. Kakli, the emergency room physician there, diagnosed gallstone pancreatitis, a serious but treatable condition that required a specialist to perform a surgical procedure and an ICU bed.
In other times, the transfer to a larger facility would be easy. But soon Kakli found himself on a frantic, six-hour quest to find a bed for his patient. Not only did he call hospitals across Texas, but he also tried Kansas, Missouri, Oklahoma and Colorado.
It was like throwing darts at a map and hoping to get lucky, he told ProPublica. But no one could or would take the transfer.
By 2:30 p.m., Wilkinson's condition was deteriorating. Kakli told Puget to come back to the hospital. "I have to tell you," she said he told her, "Your son is a very, very sick man. If he doesn't get this procedure he will die." She began to weep.
Two hours later, Wilkinson's blood pressure was dropping, signaling his organs were failing, she said.
Kakli went on Facebook and posted an all-caps plea to physician groups around the nation: "GETTING REJECTED BY ALL HOSPITALS IN TEXAS DUE TO NO ICU BEDS. PLEASE HELP. MESSAGE ME IF YOU HAVE A BED. PATIENT IS IN ER NOW. I AM THE ER DOC. WILL FLY ANYWHERE."
The doctor tried Michael E. DeBakey VA Medical Center in Houston for a second time. This time he found a bed.
Around 7 p.m., Wilkinson, still conscious but in grave condition, was flown by helicopter to the hospital. He was put in a medically induced coma. Through the night and into the next morning, medical teams worked to stabilize him enough to perform the procedure. They could not.
Doctors told his family the internal damage was catastrophic. "We made the decision we had to let him go," Puget said.
Time of death: 1:37 p.m. Aug. 22 — 26 hours after he first arrived in the emergency room.
The story was first reported by CBS News. Kakli told ProPublica last week he still sometimes does the math in his head: It should have been 40 minutes from diagnosis in Bellville to transfer to the ICU in Houston. "If he had 40 minutes to wait instead of six hours, I strongly believe he would have had a different outcome."
Another difference with the latest surge is how it's affecting children.
Last year, schools were closed, and children were more protected because they were mostly isolated at home. In fact, children's hospitals were often so empty during previous spikes they opened beds to adult patients.
Now, families are out more. Schools have reopened, some with mask mandates, some without. Vaccines are not yet available to those under 12. Suddenly the numbers of hospitalized children are on the rise, setting up the same type of competition for resources between young COVID-19 patients and those with other illnesses such as new onset diabetes, trauma, pneumonia or appendicitis.
Dr. Rafael Santiago, a pediatric emergency physician in Central Florida, said at Lakeland Regional Health Medical Center, the average number of children coming into the emergency room is around 130 per day. During the lockdown last spring, that number dropped to 33. Last month — "the busiest month ever" — the average daily number of children in the emergency room was 160.
Pediatric transfers are not yet as fraught as adult ones, Santiago said, but it does take more calls than it once did to secure a bed.
Seth Osborn, the 12-year-old whose appendix burst after a long wait, spent five days and four nights in the hospital as doctors pumped his body full of antibiotics to stave off infection from the rupture. The typical hospitalization for a routine appendectomy is about 24 hours.
The initial hospital bill for the stay came to more than $48,000, Nathaniel Osborn said. Although insurance paid for most of it, he said the family still borrowed against its house to cover the more than $5,000 in out-of-pocket costs so far.
While the hospital system where Seth was treated declined to comment about his case because of patient privacy laws, it did email a statement about the strain the pandemic is creating.
"Since July 2021, we have seen a tremendous spike in COVID-19 patients needing care and hospitalization. In mid-August, we saw the highest number of patients hospitalized with COVID-19 across the Cleveland Clinic Florida region, a total of 395 COVID-19 patients in four hospitals. Those hospitals have approximately 1,000 total beds," the email to ProPublica said. "We strongly encourage vaccination. Approximately 90% of our patients hospitalized due to COVID-19 are unvaccinated."
On Sunday, The Washington Post reported that a hospital in Alabama called 43 others across three states before finding a bed for Ray DeMonia, a critically ill heart patient who later died. In his obituary his family wrote: "In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies. ... He would not want any other family to go through what his did."
Today, Seth is mostly recovered. "Twelve-year-old boys bounce back," his father said. Still, the experience has left Nathaniel Osborn shaken.
The high school history teacher said he likes to stay upbeat and apolitical in his social media musings, posting about Florida wildlife preservation and favorite books. But on Sept. 7, he tweeted: "My 12-year-old had appendicitis. The ER was overwhelmed with unvaccinated COVID patients and we had to wait 6+ hours. While waiting, his appendix ruptured and had to spend 5 days in hospital. ... So yeah, your decision to not vaccinate does affect others."
It was retweeted 34,700 times, with 143,000 likes. Most comments were sympathetic and wished his child a speedy recovery. Some, though, went straight to hate, apparently triggered by his last line. He was attacked personally and accused of making up the story: "Good try with the guilt, jerk."
Osborn, who is vaccinated, as are his wife and son, told ProPublica he only shared Seth's story on Twitter to encourage vaccinations.
"I have no ill will towards the hospitals or the care received at either hospital," he said this week, "but had these hospitals not been so crowded with COVID patients, we wouldn't have had to wait so long and perhaps my son's appendix would not have burst."
When the coronavirus first swept across Florida last year, Angela Gambrel did everything she could to lock down her home in Sumter County, northeast of Tampa.
Her 10-year-old grandson Jayden has a rare brain disease that disrupts his immune system and impairs his memory, making it harder for him to process complex tasks. His doctors urged her to take every possible precaution against the virus. No more supermarket runs. No more football scrimmages with his Special Olympics team.
Jayden's school, like others across the state, halted in-person instruction, distributing worksheets to students to complete at home. The only time Jayden was around other people was when he had bloodwork done or underwent his monthly treatment about an hour away at Tampa General Hospital.
When schools reopened last fall, Gambrel, who's been Jayden's guardian since he was a toddler, kept him and his brother home, unwilling to risk exposing Jayden to a virus the world was just beginning to understand.
But without the intensive in-person instruction that he had been receiving for years, Jayden struggled, unable to keep up with his coursework.
Watching him languish, Gambrel knew he needed to go back to school as soon as it was safe, and so she was relieved to hear last month that the Centers for Disease Control and Prevention was advising school districts to have students and teachers mask and socially distance and to vaccinate staff. Jayden, she thought, could finally go back to school in person.
But a few days later, her plans were scuttled by Florida Gov. Ron DeSantis, a Republican, who imposed a statewide ban on mask mandates in schools. Without assurances that all the students in Jayden's school would be masked, Gambrel decided she could not take the risk of sending him back to the classroom.
"If they could just require masks, then these boys could have a life," Gambrel said.
As children have begun returning to classes this month in many parts of the country, the delta variant has dashed hopes of restoring something approaching normal life, upending school reopening plans everywhere and reigniting bitter fights over masking and other public health precautions.
For families whose children are too young to be eligible for vaccinations, the delta surge has once again left many parents weighing the risks of in-person learning, especially in states that are bucking federal recommendations to impose universal masking in schools. Some families have reluctantly shifted back to virtual instruction. Others have pulled their children out of the public school system altogether, opting for home-schooling.
But for families like the Gambrels, the stakes are exponentially higher. Children like Jayden, with complex health conditions, often are among those most in need of direct, specialized instruction that can only be delivered in person. Those same health conditions can also put children like Jayden at higher risk of infection and illness.
Nationwide, about 7.3 million students have significant disabilities that impact their education. About 15% of these students receive special education services for health conditions that limit their ability to learn, which include common conditions like diabetes, asthma or epilepsy, as well as rare disorders.
COVID-19, of course, is a new disease and researchers are a long way from fully understanding how it affects people with underlying medical conditions, especially children, who in the first waves were less likely to be sickened by the coronavirus. But the CDC says the "evidence suggests that children with medical complexity, with genetic, neurologic, metabolic conditions, or with congenital heart disease can be at increased risk for severe illness from COVID-19."
Chronic diseases affect millions of children nationwide. For example, more than 6 million kids suffer from asthma, over 200,000 live with Type 1 diabetes and more than 14 million are obese.
For medically vulnerable children, schoolwide masking is essential to allow them to safely return to school, health experts say. And being forced to stay at home while other students are able to learn in person could run counter to federal education law, which prohibits children like Jayden from being unnecessarily isolated because of their disabilities.
"All people with disabilities should receive services in the most integrated setting appropriate," said Ron Hager, managing attorney for education and employment at the National Disability Rights Network. "If not for the mask mandate, these kids could be educated in the most integrated setting."
With infections surging among children just as they are returning to classes, the fight over mask mandates is intensifying. Parents and civil rights groups have launched legal challenges against mandates in several states. Administrators in some school districts are ignoring state bans and imposing universal masking. And in Washington, President Biden has decried the politicization of public health measures like masking and directed his administration to ensure that state officials are taking the necessary steps for students to safely return to the classroom.
"We are not going to sit by as governors try to block and intimidate educators protecting our children," Biden said last week at a White House news conference.
Four years ago, Jayden entered first grade as an energetic 6-year-old who loved learning so much that he assigned himself extra homework after school. Soon after, he began to have episodes of extreme agitation, crawling on the floor and even hallucinating. When he stopped eating and sleeping, he was hospitalized; doctors diagnosed him with autoimmune encephalitis, a rare disease in which his own immune system attacks healthy brain cells and tissues.
The effects have been profound. His memory is impaired. His cognition has slowed. His behavior has turned erratic. "In the blink of an eye, he can go from being calm to all of a sudden he's destroying the house," said his grandmother.
"The warrior soldiers in your body," Gambrel said, recounting how she explained the disease to her grandson, "their job is to protect your body and fight off germs and ickies, but your warrior soldiers are crazy, they attack the good guys."
When Jayden returned to school after his diagnosis, Gambrel met with the administration to create a formal plan, known as an Individualized Education Program or IEP. Not only was Jayden learning at a slower pace, he also required one-on-one assistance throughout the day. Jayden started to improve, particularly after he began a new treatment of intravenous immunotherapy. He retained information better and engaged more with other kids.
But when the pandemic shut down schools, Jayden and his 9-year-old brother, Eli, who has autism, were thrust into a bubble of isolation to keep Jayden safe. "He misses kids, he misses people," she said, but "a lot of people were dying, and he didn't want it to be him."
The district, which serves about 9,000 students, gave Gambrel three options: in-person schooling, a remote live classroom or a full virtual program where children could learn at their own pace. Worried about COVID-19 as well as Jayden's limited attention span, Gambrel opted for the full virtual program, which used curriculum and software from Florida Virtual School, a statewide online education provider.
Gambrel understood that her grandsons would not have the one-on-one support required in their IEPs, but she did not expect the year to be the "nightmare" she experienced. Though online instructors graded worksheets and tests and could troubleshoot technology issues, they did not provide direct instruction and were difficult to track down for help with lessons, she said. The teaching fell on Gambrel, 56, who also worked from home as a medical billing administrator.
The pace of the online curriculum also moved too quickly for her grandsons. Gambrel said she felt that her family had been abandoned.
"It just becomes overwhelming, and they shut down and want no part of it," she said. "We were falling so far behind that we pretty much had to give up."
Hailey Fitch, a spokesperson for Florida Virtual School, said that its "courses are designed to offer students the flexibility to move at their own pace, but teachers play a critical role in ensuring the success of students."
Gambrel knew that her grandsons needed to be in school learning from an experienced teacher, and when she saw the federal guidance recommending that students wear masks and socially distance this fall, she believed the precautions would allow her boys to return to school.
Pediatricians and virus experts have backed the federal guidance, especially on masking in the classroom. Dr. Lawrence Kleinman, a professor of pediatrics at Rutgers Robert Wood Johnson Medical School in New Jersey, said that until vaccines are authorized for young children, masking is the most effective preventive measure.
"In a world in which children are not vaccinated and the virus is circulating in the community, both teachers and kids as well as staff need to be masked," he said. "From the very beginning we began this with a myth: that the virus spared kids. That myth has infected our thinking even as we've learned that it's not true."
But Gambrel's plan to send her grandsons back to school changed when DeSantis announced that no Florida school district would be permitted to mandate masks. "We should protect the freedoms and statutory rights of students and parents," the governor wrote in his order, claiming that giving parents the choice of whether to mask their children would help kids with disabilities and medical ailments, who would be harmed by wearing a mask.
In a statement this week to ProPublica, DeSantis' press secretary, Christina Pushaw, inaccurately claimed that there is no evidence that "mask mandates work to keep kids safe and healthy" and said health experts were giving families a false sense of security: "This is nothing more than government-sanctioned misinformation, and it's potentially dangerous."
In criticizing those recommendations, which she said were "unfair to parents of immune-compromised kids," Pushaw mentioned only "cloth face coverings." Some other types of widely available masks, such as surgical and KN95 masks, are more effective at preventing transmission, but experts have said a face covering of any sort is better than none.
Gambrel's district followed the governor's order, opening schools with masks optional. She was dismayed. "The state's attitude is to send them in, no problem," she said. "And they do need to be in-person, but they've not taken any measures to make it safe, especially with delta."
While Sumter County has abided by the governor's order, several other districts in Florida have defied it. At least seven districts, including those that include Fort Lauderdale, West Palm Beach and Tampa, have started the school year with some kind of masking requirement. In response, DeSantis has threatened to withhold state dollars from the districts, prompting the Biden administration to offer additional federal relief funds to districts that receive financial penalties.
DeSantis' approach to masking has also prompted legal challenges. In early August, a handful of parents of children with disabilities and complex medical needs sued the state, claiming the ban violates the Americans with Disabilities Act.
"Preventing my kid from going to school safely is a violation of federal law," said Judi Hayes, a plaintiff in the lawsuit and a mother of a child with Down syndrome. "Parents are terrified. ... We feel like we're ticking time bombs."
In response to the lawsuit, Pushaw defended the governor's position, saying that "under Florida law, parents have the right to make health and educational decisions for their own children."
Once Gambrel knew her grandsons would be virtual again, she recognized they would need more support than what they had received in virtual instruction last year, so a week before school began, she reached out to the district to discuss her options. No one responded, so she called the state education department, which told her, she said, that when she signed a home-schooling form to opt in to the virtual program last year, she had effectively withdrawn her grandsons from the public school. And that meant they were no longer entitled to the disability accommodations and services that were part of their IEPs. The Florida Department of Education did not respond to specific questions about services for students with disabilities in virtual schools.
Gambrel was baffled. She recalled signing a form indicating that she was selecting home school, but she didn't realize that by selecting the virtual program the district was pushing, she was taking her grandkids out of the local school system.
"I didn't expect to have all of their needs met through virtual, but I never dreamed that we would sign our rights away," she said.
Deborah Moffitt, the assistant superintendent of Sumter County School District, said that her staff spent ample time explaining to families the various learning options, which had been presented to the school board. In response to ProPublica's questions about accommodations for students with disabilities, she said the district is "no longer obligated to provide services to students when their parents enroll them in home education utilizing the asynchronous model of virtual education," adding that families had to sign a form indicating their intention to home-school.
For this year, Gambrel has kept her grandsons in the same program as last year, while looking for a new online program that will accommodate their needs.
As schools have slowly opened up across the country this fall, reports of classroom outbreaks and overwhelmed pediatric units have rattled the nerves of parents, many of whom are alarmed that the highly transmissible delta variant may affect children more than previous iterations of the virus. In Sumter County, 164 students and 31 staff members tested positive in the first two weeks of school, according to the district's public reporting.
Dr. Dean Blumberg, chief of pediatric infectious diseases at UC Davis Children's Hospital, said children with certain underlying conditions are at higher risk for severe COVID and are the pediatric patients most ending up in intensive care units.
Blumberg said masking in schools is common sense.
"It makes sense to take advantage of every tool possible to decrease transmission to make sure kids can go to school safely and to prevent children from being required to do distance learning," he said.
According to the American Academy of Pediatrics, new child infections have increased about 820% over the past seven weeks, with 180,000 cases reported last week, compared with only 19,500 cases tallied for the first week of July. As cases in children climb, many districts are scrambling to reintroduce remote schooling for quarantined children.
In some of the states that have banned mask mandates, officials had already decided to limit or eliminate virtual options in an effort to ensure students returned to in-person learning. But many of those decisions were made before the surge in infections from delta, and that has left many districts ill-equipped to pivot back to virtual learning.
Texas Gov. Greg Abbott, a Republican, has been one of the country's most vocal opponents of mask mandates, and his administration has stopped providing funding for remote learning. This has forced districts that want to resume online schooling to pay for it themselves.
In McKinney Independent School District in the northern suburbs of Dallas, schooling is only offered in-person, leading some families to feel pushed out of the public education system altogether.
When Colandra Ashley, a mother of two girls, ages 6 and 8, both with moderate asthma, learned that the district would not have a mask requirement, she realized that she and her daughters were stuck.
Ashley had been hospitalized as a child because of asthma, and she did not want to risk her own daughters' health. Her family had also lost five members to the virus. "To lose so many people and to have people be so careless, it frustrates me," she said. Her family's loss compelled every remaining adult to get vaccinated as soon as it was available, but her daughters are still too young.
Without a mask mandate, Ashley said, she is not comfortable sending her daughters to school. "I feel my hands are tied," she said.
The district, which spent nearly $70 million on a new high school football stadium that opened in 2018, said that it would not provide an online option for parents, citing a lack of state funding. The district did not respond to a request for comment.
Ashley, who before the pandemic was studying to be a teacher, withdrew her daughters from the district last week and started home-schooling them with the help of her mother. They have already planned field trips to local parks and ordered biology labs. When her daughters are able to be vaccinated, she intends to reenroll them for in-person school.
Collin County, home to McKinney ISD, has refused to institute a mask requirement in response to the delta variant, even as the region experiences ICU bed shortages. Facing criticism on how the lack of a mandate might impact schools, top county official Chris Hill defended his decision, stating "freedom is more important than education."
Other districts in Texas have created virtual programs to address the needs of families who do not feel safe sending their children back into schools. The Fort Bend school district, southwest of Houston, is using federal relief funds to pay for a remote learning program for a small group of students. The district said on its website that the virtual program will cost an estimated $10 million, including loss of funding from the state.
Sherry Williams, the district's spokesperson, said the virtual program is limited to students with a medical history or diagnosed condition that puts them at a higher risk of severe illness from COVID-19. The district is continuing to review the 5,000 applications it received for the program, of which 1,041 students have qualified as of Aug. 19.
On Monday, Fort Bend's school board approved a mask requirement for students and staff. Last week, the Texas Supreme Court had allowed mask mandates put in place by local officials to remain in place while the state challenges them.
Separately, a group of 14 students with disabilities filed a lawsuit last week against Abbott and the state's education commissioner, Mike Morath, asserting the mask mandate ban violates students' rights and excludes them from participating in public education.
"Governor Abbott has been clear that the time for mask mandates is over; now is the time for personal responsibility," said Renae Eze, the governor's press secretary, in an emailed response to ProPublica's questions. "Parents and guardians have the right to decide whether their child will wear a mask or not, just as with any other decision in their child's life."
Eze said that districts in Texas are implementing a variety of safety precautions, from learning pods to enhanced hygiene, and that families of immunocompromised children also have the option of virtual learning, though the enrollment for these programs is limited. Eze did not respond to questions about the impending suit.
"Governor Abbott cares deeply about the health and safety of disabled students, as he does for all Texas students," she said. "Since his accident that left him paralyzed, the Governor has worked throughout his career to protect the rights of all those with disabilities in Texas."
Other states have backtracked on earlier decisions around masks. New Jersey Gov. Phil Murphy, a Democrat, announced in June that there would be no statewide mask mandate for students returning to school in the fall. Instead, the decision would be left up to individual school districts.
Amid rising case numbers, in large part driven by the delta variant, Murphy reversed course in early August, implementing a statewide mask mandate for schools.
"Anyone telling you that we can safely reopen our schools without requiring everyone inside to wear a mask is, quite simply, lying to you," Murphy said in his announcement. "Because we can't."
Last April, the Arkansas State Legislature passed a statewide ban on mask mandates. In August, Gov. Asa Hutchinson, a Republican, asked legislators to amend the law to allow school districts with students under the age of 12 to require masks. He said he signed the April law, in part, because cases were down at the time.
"Everything has changed now," he said. "And yes, in hindsight I wish it had not become the law, but it is the law, and the only chance we have is either to amend it or for the courts to say it has an unconstitutional foundation."
Legislators chose not to change the law, but a judge has temporarily blocked Arkansas from enforcing the ban.
As of Wednesday, 16 states had mandated masks in schools and eight states had banned mask mandates. Other states are leaving the decision to counties or individual school districts.
In Ohio, Gov. Mike DeWine, a Republican, said in July that he did not believe he had the authority to mandate masks in schools. At a press conference last week, he urged schools to implement their own mask requirements, at least for the next few weeks while case numbers are high.
"To all those who are making decisions right now about our schools, if you do not require masks, please, please, please think about this again," he said.
Even in districts that have recently instituted last-minute mask mandates, often defying their states' orders against them, some parents of children with medical needs have lost confidence in their public school systems.
When the pandemic initially shut down schools, Vanessa Perry, whose son Ryan was diagnosed with the rare autoimmune disorder Henoch-Schönlein purpura last year, opted for remote learning. This summer, she hoped that his district, Richland One in Columbia, South Carolina, would institute a mask mandate, so he could return to the classroom.
But in the weeks leading up to the school year, the district made masking optional, in compliance with the state's ban on universal mandates. Two days before school was supposed to start, the Richland County Council defied the state and passed an emergency ordinance mandating masks in all public and private schools that serve children between the ages of 2 and 14.
But it was too late for Perry. She had already enrolled her son in a virtual program for this fall and purchased textbooks and supplies. And with the emergency ordinance's mandate expiring on Oct. 15, she didn't want to risk the possibility that it wouldn't be extended, or that it might be revoked before then.
"At this point, I don't know if I trust things to be handled correctly," she said. "You have always viewed school as a safe place for children. Why aren't we listening to scientists and the professionals?"
Annie Waldman is a reporter at ProPublica covering education.
A May 1 decision by the CDC to only track breakthrough infections that lead to hospitalization or death has left the nation with a muddled understanding of COVID-19's impact on the vaccinated.
This article was published on Friday, August 20, 2021 in Kaiser Health News.
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Meggan Ingram was fully vaccinated when she tested positive for COVID-19 early this month. The 37-year-old's fever had spiked to 103 and her breath was coming in ragged bursts when an ambulance rushed her to an emergency room in Pasco, Washington, on Aug. 10. For three hours she was given oxygen and intravenous steroids, but she was ultimately sent home without being admitted.
Seven people in her house have now tested positive. Five were fully vaccinated and two of the children are too young to get a vaccine.
As the pandemic enters a critical new phase, public health authorities continue to lack data on crucial questions, just as they did when COVID-19 first tore through the United States in the spring of 2020. Today there remains no full understanding on how the aggressively contagious delta variant spreads among the nearly 200 million partially or fully vaccinated Americans like Ingram, or on how many are getting sick.
The nation is flying blind yet again, critics say, because on May 1 of this year — as the new variant found a foothold in the U.S. — the Centers for Disease Control and Prevention mostly stopped tracking COVID-19 in vaccinated people, also known as breakthrough cases, unless the illness was severe enough to cause hospitalization or death.
Individual states now set their own criteria for collecting data on breakthrough cases, resulting in a muddled grasp of COVID-19's impact, leaving experts in the dark as to the true number of infections among the vaccinated, whether or not vaccinated people can develop long-haul illness, and the risks to unvaccinated children as they return to school.
"It's like saying we don't count," said Ingram after learning of the CDC's policy change. COVID-19 roared through her household, yet it is unlikely any of those cases will show up in federal data because no one died or was admitted to a hospital.
The CDC told ProPublica in an email that it continues to study breakthrough cases, just in a different way. "This shift will help maximize the quality of the data collected on cases of greatest clinical and public health importance," the email said.
In addition to the hospitalization and death information, the CDC is working with Emerging Infections Program sites in 10 states to study breakthrough cases, including some mild and asymptomatic ones, the agency's email said.
Under pressure from some health experts, the CDC announced Wednesday that it will create a new outbreak analysis and forecast center, tapping experts in the private sector and public health to guide it to better predict how diseases spread and to act quickly during an outbreak.
Tracking only some data and not releasing it sooner or more fully, critics say, leaves a gaping hole in the nation's understanding of the disease at a time when it most needs information.
"They are missing a large portion of the infected," said Dr. Randall Olsen, medical director of molecular diagnostics at Houston Methodist Hospital in Texas. "If you're limiting yourself to a small subpopulation with only hospitalizations and deaths, you risk a biased viewpoint."
On Wednesday, the CDC released a trio of reports that found that while the vaccine remained effective at keeping vaccinated people out of the hospital, the overall protection appears to be waning over time, especially against the delta variant.
Among nursing home residents, one of the studies showed vaccine effectiveness dropped from 74.7% in the spring to just 53.1% by midsummer. Similarly, another report found that the overall effectiveness among vaccinated New York adults dropped from 91.7% to just under 80% between May and July.
The new findings prompted the Biden administration to announce on Wednesday that people who got a Moderna or Pfizer vaccine will be offered a booster shot eight months after their second dose. The program is scheduled to begin the week of Sept. 20 but needs approval from the Food and Drug Administration and a CDC advisory committee.
This latest development is seen by some as another example of shifting public health messaging and backpedaling that has accompanied every phase of the pandemic for 19 months through two administrations. A little more than a month ago, the CDC and the FDA released a joint statement saying that those who have been fully vaccinated "do not need a booster shot at this time."
The vaccine rollout late last year came with cautious optimism. No vaccine is 100% percent effective against transmission, health officials warned, but the three authorized vaccines proved exceedingly effective against the original COVID-19 strain. The CDC reported a breakthrough infection rate of 0.01% for the months between January and the end of April, although it acknowledged it could be an undercount.
As summer neared, the White House signaled it was time for the vaccinated to celebrate and resume their pre-pandemic lives.
Trouble, though, was looming. Outbreaks of a new, highly contagious variant swept India in the spring and soon began to appear in other nations. It was only a matter of time before it struck here, too.
"The world changed," said Dr. Eric Topol, director of the Scripps Research Translational Institute, "when delta invaded."
The current crush of U.S. cases — well over 100,000 per day — has hit the unvaccinated by far the hardest, leaving them at greater risk of serious illness or death. The delta variant is considered at least two or three times more infectious than the original strain of the coronavirus. For months much of the focus by health officials and the White House has been on convincing the resistant to get vaccinated, an effort that has so far produced mixed results.
Yet as spring turned to summer, scattered reports surfaced of clusters of vaccinated people testing positive for the coronavirus. In May, eight vaccinated members of the New York Yankees tested positive. In June, 11 employees of a Las Vegas hospital became infected, eight of whom were fully vaccinated. And then 469 people who visited the Provincetown, Massachusetts, area between July 3 and July 17 became infected even though 74% of them were fully vaccinated, according to the CDC's Morbidity and Mortality Weekly Report.
While the vast majority of those cases were relatively mild, the Massachusetts outbreak contributed to the CDC reversing itself on July 27 and recommending that even vaccinated people wear masks indoors — 11 weeks after it had told them they could jettison the protection.
And as the new CDC data showed, vaccines continue to effectively shield vaccinated people against the worst outcomes. But those who get the virus are, in fact, often miserably sick and may chafe at the notion that their cases are not being fully counted.
"The vaccinated are not as protected as they think," said Topol, "They are still in jeopardy."
The CDC tracked all breakthrough cases until the end of April, then abruptly stopped without making a formal announcement. A reference to the policy switch appeared on the agency's website in May about halfway down the homepage.
"I was shocked," said Dr. Leana Wen, a physician and visiting professor of health policy and management at George Washington University. "I have yet to hear a coherent explanation of why they stopped tracking this information."
The CDC said in an emailed statement to ProPublica that it decided to focus on the most serious cases because officials believed more targeted data collection would better inform "response research, decisions, and policy."
Sen. Edward Markey, D-Mass., became alarmed after the Provincetown outbreak and wrote to CDC director Dr. Rochelle Walensky on July 22, questioning the decision to limit investigation of breakthrough cases. He asked what type of data was being compiled and how it would be shared publicly.
"The American public must be informed of the continued risk posed by COVID-19 and variants, and public health and medical officials, as well as healthcare providers, must have robust data and information to guide their decisions on public health measures," the letter said.
Markey asked the agency to respond by Aug. 12. So far the senator has received no reply, and the CDC did not answer ProPublica's question about it.
When the CDC halted its tracking of all but the most severe cases, local and state health departments were left to make up their own rules.
There is now little consistency from state to state or even county to county on what information is gathered about breakthrough cases, how often it is publicly shared, or if it is shared at all.
"We've had a patchwork of information between states since the beginning of the pandemic," said Jen Kates, senior vice president and director of global health and HIV policy at Kaiser Family Foundation.
She is co-author of a July 30 study that found breakthrough cases across the U.S. remained rare, especially those leading to hospitalization or death. However, the study acknowledged that information was limited because state reporting was spotty. Only half the states provide some data on COVID-19 illnesses in vaccinated people.
"There is no single, public repository for data by state or data on breakthrough infections, since the CDC stopped monitoring them," the report said.
In Texas, where COVID-19 cases are skyrocketing, a state Health and Human Services Commission spokesperson told ProPublica in an email the state agency was "collecting COVID-19 vaccine breakthrough cases of heightened public health interest that result in hospitalization or fatality only."
Other breakthrough case information is not tracked by the state, so it is unclear how often breakthroughs occur or how widely cases are spreading among the vaccinated. And while Texas reports breakthrough deaths and hospitalizations to the CDC, the information is not included on the state's public dashboard.
"We will be making some additions to what we are posting, and these data could be included in the future," the spokesperson said.
South Carolina, on the other hand, makes public its breakthrough numbers on hospitalizations and deaths. Milder breakthrough cases may be included in the state's overall COVID-19 numbers but they are not labeled as such, said Jane Kelly, an epidemiologist at the South Carolina Department of Health and Environmental Control.
"We agree with the CDC," she said, "there's no need to spend public health resources investigating every asymptomatic or mild infection."
In Utah, state health officials take a different view. "From the beginning of the pandemic we have been committed to being transparent with our data reporting and … the decision to include breakthrough case data on our website is consistent with that approach," said Tom Hudachko, director of communications for the Utah Department of Health.
Some county-level officials said they track as many breakthrough cases as possible even if their state and the CDC does not.
For instance, in Clark County, Nevada, home of Las Vegas, the public health website reported that as of last week there were 225 hospitalized breakthrough cases but 4,377 vaccinated people overall who have tested positive for the coronavirus.
That means that less than 5% of reported breakthrough cases resulted in hospitalization. "The Southern Nevada Health District tracks the total number of fully vaccinated individuals who test positive for COVID-19 and it is a method to provide a fuller picture of what is occurring in our community," said Stephanie Bethel, a spokesperson for the health district in an email.
Sara Schmidt, a 44-year-old elementary school teacher in Alton, Illinois, is another person who has likely fallen through the data hole.
"I thought, 'COVID is over and I'm going to Disney World,'" she said. She planned a five-day trip for the end of July with her parents. Not only had she been fully vaccinated, receiving her second shot in March, she is also sure she had COVID-19 in the summer of 2020. Back then she had all the symptoms but had a hard time getting tested. When she finally did, the result came back negative, but her doctor told her to assume it was inaccurate.
"My guard was down," she said. She was less vigilant about wearing a mask in the Florida summer heat, assuming she was protected by the vaccination and her presumed earlier infection.
On the July 29 plane trip home, she felt mildly sick. Within days she was "absolutely miserable." Her coughing continued to worsen, and each time she coughed her head pounded. On Aug. 1 she tested positive. Her parents were negative.
Now, three weeks later, she is far from fully recovered and classes are about to begin at her school. There's a school mask mandate, but her students are too young to be vaccinated. "I'm worried I will give it to them, or I will get it for a third time," she said.
But it is doubtful her case will be tracked because she was never hospitalized. That infuriates her, she said, because it downplays what is happening.
"Everyone has a right to know how many breakthrough cases there are," she said, "I was under the impression that if I did get a breakthrough case, it would just be sniffles. They make it sound like everything is under control and it's not."
Do you or someone you know have a pacemaker, defibrillator, implanted prosthetic, or other lifesaving device? Do you work with or in the medical device industry? Help us report.
This article was published on Thursday, August 5, 2021 in ProPublica.
Hundreds of thousands of people rely on lifesaving medical devices, from pacemakers and defibrillators to implanted prosthetics. The U.S. regulatory system is supposed to protect all of them from unsafe devices and unscrupulous actors.
But our latest investigation into the $400 billion medical device industry showed that, thanks to ineffective oversight, vulnerable people may be getting hurt. We uncovered that the FDA took no decisive action as a heart pump was implanted inside thousands of people, even though the agency knew it didn’t meet federal standards.
Now, we need your help continuing to hold medical device companies and regulatory systems accountable. We want to hear from people who know this system best: patients, doctors, people who work for device companies and federal employees. We’re particularly interested in device marketing and communication around recalls. If you have insights that could help guide our reporting, or if you know about other problems we should investigate, please fill out the brief questionnaire below.
A settlement is about to shield members of the Sackler family from civil litigation regarding their alleged roles in the opioid crisis. So it’s a good time to release the full video of Richard Sackler’s 2015 deposition.
This article was published on Wednesday, August 4, 2021 in ProPublica.
A settlement close to being finalized in a bankruptcy case would provide a shield from civil litigation to the members of the Sackler family who own OxyContin maker Purdue Pharma. The development means that family members will be significantly less likely to be questioned under oath about their role in the marketing of the potent prescription painkiller blamed for fueling a nationwide opioid epidemic.
Despite years of litigation alleging some Sacklers pushed Purdue to aggressively and inappropriately market OxyContin, members of the family successfully avoided most attempts to force them to answer questions about their stewardship of Purdue or the multibillion-dollar fortune they amassed as OxyContin became a bestselling pain medicine. They have repeatedly denied acting inappropriately, and the settlement under consideration in U.S. Bankruptcy Court in White Plains, New York, does not require the Sacklers to admit wrongdoing. Family members would pay $4.5 billion over nine years to resolve civil lawsuits filed by states, cities, insurers and families impacted by the opioid crisis.
An exception occurred in 2015, when Dr. Richard Sackler was questioned for more than eight hours by lawyers representing the state of Kentucky in a lawsuit against Purdue. Richard Sackler served as president of Purdue Pharma and was a longtime board member.
Purdue fought for years to keep the deposition secret, unsuccessfully appealing the case to the Kentucky Supreme Court after a lower court ruled it should be released. Although a transcript of the deposition was released by a Kentucky court, the video was not. It was obtained in 2019 by ProPublica, which posted selected passages from the video.
In the deposition, Sackler is asked about his role in launching and overseeing the marketing of OxyContin, how Purdue incentivized its sales force to sell the drug, and a decision he supported not to correct the false belief among doctors that OxyContin is weaker than morphine.
Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.
This article was published on Thursday, August 5, 2021 in ProPublica.
John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died two days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to healthcare providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient-focused,” said Dr. William Maisel, the director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make CEO Geoffrey Martha or president of mechanical heart support Nnamdi Njoku available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued, “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. Medtronic said it will also offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
Warning Signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A No-Brainer”
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-Led Oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, Not Penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run Its Course”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
Bots filing bogus applications in bulk, teams of fraudsters in foreign countries making phony claims, online forums peddling how-to advice on identity theft: Inside the infrastructure of perhaps the largest fraud wave in history.
This article was published on Monday, July 26, 2021 in ProPublica.
by Cezary Podkul
A Bronx man allegedly received $1.5 million in just ten months. A California real estate broker raked in more than $500,000 within half a year. A Nigerian government official is accused of pocketing over $350,000 in less than six weeks.
What they all had in common, according to federal prosecutors, was participation in what may turn out to be the biggest fraud wave in U.S. history: filing bogus claims for unemployment insurance benefits during the COVID-19 pandemic. (The broker has pleaded guilty, while the Bronx man and Nigerian official have pleaded not guilty.)
Fraudsters have filed in high volumes, sometimes obtaining payments from multiple states, despite the fact that a jobless person is barred from getting assistance in more than one state. One person, according to the U.S. Department of Labor, used a single Social Security number to file unemployment insurance claims in 40 states. Twenty-nine states paid up, sending $222,532.
But the problem extends far beyond a plague of solo scammers. A ProPublica investigation reveals that much of the fraud has been organized — both in the U.S. and abroad. Fraudsters have used bots to file online claims in bulk. And others, located as far away as China and West Africa, have organized low-wage teams to file phony claims.
In addition, the fraud has been enabled by a burgeoning online infrastructure, whose existence has not previously been reported in the mainstream press. Much of it is geared toward exploiting aging or obsolete state unemployment systems whose weaknesses have drawn warnings for decades. Communities have sprouted on messaging apps such as Telegram, where fraudsters trade tips on how to cash in. Hustlers advertise their techniques — or “sauces” (apparently short for “secret sauce”) — for filing bogus claims, along with state-specific instructions on how to get around security checks, according to a ProPublica review of messages on more than 25 such chat forums.
Some of the forums have thousands of participants and regularly offer stolen identities for sale, alongside tech tips, screenshots that ostensibly prove the methods work and advice on which states are easiest to game and which are “lit” — that is, still paying out fake claims. Users have created two Telegram channels in which they trade tips for filing claims in Maryland, whose labor department recently said it detected some 508,000 potentially fraudulent jobless claims between the start of May and mid-June. Participants in those forums have been talking about turning their efforts to Pennsylvania, where officials recently said they have “noticed an uptick” in fraudulent claims.
Telegram did not respond to requests for comment. But after ProPublica’s inquiry, 10 of the channels we asked about suddenly went dark, marked with this notice: “This channel can’t be displayed because it violated Telegram’s Terms of Service.”
Nobody has yet come close to putting a definitive number on the dollar value of fraud relating to pandemic-era unemployment benefits. But ProPublica performed a data analysis that hints at the massive scope. In state after state, the volume of initial jobless claims has far exceeded the number of estimated job losses. Across the U.S. from March to December 2020, the number of initial claims equated to 68% of the country’s labor force, which stood at around 164 million before the pandemic. In five states — Arizona, Georgia, Hawaii, Nevada and Rhode Island — the initial claims outnumbered the entire pool of civilian workers. By contrast, about 23% of American workers were out of a job or underemployed at the peak of the pandemic, according to the Bureau of Labor Statistics; in the most recent report that figure is just under 10%. (There are innocent explanations for at least some of the disparity: If a person loses a job more than once during a given year, they can legitimately file for benefits more than once during that time.)
The fraud estimates provided by states so far range from high to jaw-dropping. In Vermont, as many as 90% of claims in some months were determined to be fraudulent, state officials said in June. Rhode Island’s labor agency said in March that it suspected fraud in 43% of the claims it had received. The equivalent agency in California has confirmed fraud in about 10% of its payments and said it’s investigating a further 17%. The numbers have tailed off in Texas, whose agency says it now suspects fraud in about 14% of its claims.
“The system was the victim of what is one of the largest internet crimes in history, perpetrated against all 50 states at extraordinary levels,” said James Bernsen, a spokesperson for the Texas Workforce Commission. (Bernsen and officials for other states say the damage could’ve been even worse: They say they’ve been able to stop billions of dollars’ worth of bogus claims before they got paid.)
The U.S. Department of Labor’s inspector general estimates that at least $87 billion in fraudulent and improper payments will have made their way through the system by the time pandemic-linked jobless aid programs expire in September. That estimate is based on a historic assumption that fraud and waste eat up about 10% of unemployment insurance aid. The inspector general acknowledges that figure is likely too conservative in an environment where unemployment insurance fraud has “exploded” to “unprecedented” levels.
Other experts anticipate a dramatically higher tally. “From my experience, when this is all said and done, we are going to be counting in the hundreds of billions of dollars, not the tens of billions,” said Jon Coss, who heads a unit within Thomson Reuters that is helping states detect fake unemployment insurance claims.
Coss bases that assessment on the widespread fraudulent activity he’s seen. He said one U.S. state, which he declined to name, received fake claims — all purportedly from state residents — that originated from IP addresses in nearly 170 countries. They included countries historically linked to fraud, such as China, Nigeria and Russia, as well as more surprising ones, such as Cuba, Eritrea, Fiji and Monaco. Overall, Coss said, between 40% and 50% of the claims his group has analyzed seem highly suspect. He added, “It’s mind-boggling the level of fraud that we’re seeing.”
Defrauding unemployment insurance, or UI, programs, which pay out weekly benefits to workers who’ve lost jobs through no fault of their own, is likely as old as the programs themselves. But the rise of internet-based crime over the past 25 years or so, particularly the use of stolen identities to file fake claims on someone else’s behalf, opened the way to fraud on an epic scale.
The problem was already described as ongoing as early as 1998, when the Labor Department’s inspector general warned about the “continued proliferation of UI fraud schemes.” Four years later, a report by the inspector general said, “We are particularly concerned with identity theft or imposter schemes, which occur when individual identities are stolen and then used to apply for UI benefits.” The report noted that “individuals have the opportunity to defraud multiple states from a single location.”
In 2015, the agency detailed the “systemic weaknesses” that make UI programs vulnerable to fraud. (More on those later.) At least twice during the Obama administration, the Labor Department proposed reforms to Congress to address some of these inadequacies, primarily by boosting information sharing among states and federal agencies. Both times these efforts went nowhere. President Donald Trump included similar reforms in each of his four budget proposals to Congress. They, too, were never enacted.
Meanwhile, states’ funding for unemployment insurance administration was falling, largely because the economy strengthened and unemployment fell. At the start of the pandemic, funding for states’ unemployment insurance administration stood at a 30-year low, according to the National Association of State Workforce Agencies.
The funding squeeze led to some predictable results. California, which had hired Coss’s firm to help detect fraud, canceled that contract in 2016 to save money. Budget cuts also trimmed the ranks of the federal Labor Department’s inspector general’s office, which lost 28% of its criminal investigators between 2012 and 2020, according to figures provided in response to a Freedom of Information Act request.
At the same time, online criminals were expanding their targets. Years ago, Agari Data, a cybersecurity firm that helps catch email scams, began tracking a Nigerian cybercrime group it dubbed “Scattered Canary.” Agari produced a timeline of the group’s evolution that looks like an ever-branching tree: It grew out of Craigslist scams (2009) into phishing (2015) and then tax return fraud and credit card fraud (2016). Scattered Canary started targeting unemployment aid, too. “Similar to how the group pivoted from individual victims to business targets during the previous three-year period,” Agari wrote in a 2019 report, “Scattered Canary again set their sights on a new type of target in 2017 — government agencies.”
A steady procession of large-scale hacks of corporations and governments over the past decade provided the raw material needed to defraud government benefit programs. What scammers call “fullz” — a suite of data ranging from a person’s name and address to their Social Security number, date of birth and more — was increasingly easy to obtain. The Privacy Rights Clearinghouse, which tracks data breaches, tallied 2,229 hacks from 2010 to 2019, according to a database of such incidents. Those hacks exposed nearly 6.9 billion records.
When the pandemic seemed to threaten the foundations of the economy in March 2020, Congress responded quickly, launching the biggest expansion of unemployment insurance since the system was created amid the Great Depression. Lawmakers created three massive programs that workers could tap as states shut down to halt the spread of the deadly virus.
One program provided workers 13 additional weeks of aid once they exhausted their regular unemployment benefits. Another gave laid-off workers an extra $600 per week on top of existing benefits. A third, known as Pandemic Unemployment Assistance, funded 39 weeks of jobless benefits for workers traditionally excluded from unemployment insurance, such as self-employed “gig economy” contractors.
As of July 17, 2021, the three programs have collectively paid out about $604 billion, a total projected to reach up to $873 billion by the time the programs expire in September. That’s on top of states’ regular unemployment insurance plans, which paid out another $166 billion in jobless benefits between March 2020 and June 2021. That means total payments to the jobless could add up to about $1 trillion over 18 months.
Augmenting UI payments was not an unusual move for Congress — but the scale and speed were vastly different. For example, in the aftermath of the 2008 financial crisis, Congress funded an extra $25 a week on top of regular state unemployment benefits, then averaging around $300 a week. This time, Congress authorized a weekly $600 payment that was automatically added to regular UI payments, which require verification of prior income and employment.
But in its urgency to get cash to people with no work, Congress chose not to require such verification in the PUA program. It requested only self-certification of eligibility and no proof of income or identity. And successful applicants could get the extra $600 weekly payment, too.
With its loose application requirements, PUA instantly drew throngs of scammers. California state authorities have said that 95% of its confirmed fraudulent UI payments originated in PUA claims. Pennsylvania’s agency estimated that nearly 84% of its PUA claims were phony.
A scroll through the thousands of messages exchanged in Telegram chat forums provides a vivid illustration of what state unemployment agencies have been up against. The forums are easy to find: Simply searching for the acronym “PUA” can lead any Telegram user to a bunch of them (even after Telegram shut 10 of them in the wake of our questions). They have proliferated since the start of the pandemic, providing bustling marketplaces for criminals looking to obtain stolen IDs, methods for filing fake jobless claims or other advice. The most common products sold on the forums — state-specific sauces for filing claims — are hawked with daily frequency.
A Telegram user who posts under the handle “VerifiedFraud” recently offered his 1,300 chat room participants a new sauce for Pennsylvania’s system that he said would pay $700 a week. (VerifiedFraud also posted an earnest “new month prayer” on July 1, asking God to help his customers: “My prayer is all your sleepless night & day coming to this forum working & praying to God shall come through and Success will locate u.”)
Pennsylvania said it’s unable to speak to the validity of the guide. When ProPublica asked about the guide, VerifiedFraud responded with two emojis: 🙄🙄. Fifteen minutes later, he posted a message in his channel that seemed to rationalize fraud: “Virtually all these wealthy entrepreneurs you see around 90% of them started with something illegal to make enough money to run their business.”
The guides available on Telegram include lengthy step-by-step directions and screenshots detailing where to input stolen information. They offer advice on how to avoid triggering anti-fraud software, such as not to fill out part of the application on one device or from one IP address, then switch to another. One guide for filing claims in New York state warns users, “Don’t Copy and Paste in the text box. Type in the details while filling the text boxes. A script monitors activities like Copy&Paste to raise red flags.”
When such guides outlive their usefulness, new ones quickly pop up. “New CALI SAUCE WAVE,” read one of several messages posted in late June alongside a screenshot of what purported to be a successful unemployment aid application for California. The ad, offered by someone who calls himself the “King of Cali,” touted a video guide and a PDF walk-through. California’s Employment Development Department declined to comment.
Many of the pitches are blunt. One ad features the 2021 edition of a “Fraud Bible” for sale alongside 19 other sauces, including a guide for obtaining loans under the government’s Paycheck Protection Program, another frequent fraud target. The PPP loan program ended on May 31, underscoring the risk that the people selling the Fraud Bible may not be on the up and up. (When ProPublica requested comment, the seller or sellers of the Fraud Bible responded with variations of “fuck you.” The “King of Cali” responded by asking, “Are you ready to pay? I’ll give you everything you need.” Hours later, his profile was deleted and replaced with a warning: “Many users reported this account as a scam or a fake account. Please be careful, especially if it asks you for money.”)
Concerns about fraud are rampant inside the forums — but only insofar as the users fear they could become victims of it rather than perpetrators, say, by paying for a fraud strategy that no longer works. One Telegram forum called “$CAM C3NT£R” promises a “trusted” escrow service that clears sales of sauces, stolen identities and other services to make sure participants don’t rip each other off while preparing to rip the government off. (The administrator of $CAM C3NT£R told ProPublica he’s just trying to stop fraud inside his channel: “lot of fake people around and I’m doing escrow to protect my people.”)
To convey the success of their methods, sellers frequently post photos of wads of cash or screenshots of unemployment payments seemingly landing in their bank accounts or mobile payment apps. One user who recently advertised a Michigan sauce elegantly arranged $20 bills in the shape of the words “tap in” to encourage users to pay $200 via Bitcoin for his method, along with a screenshot of Michigan’s jobless aid website and the claim that “Michigan still hittin and is payin good money.” (A spokesperson for Michigan’s Unemployment Insurance Agency said the state is having success stopping fraudulent payments before they’re made and that “these type of messages amount to false advertising in order to elicit money from those who would steal identities.”)
Social Security numbers, names and dates of birth are frequently exposed in the forums by sellers wishing to give buyers a taste of what they’ve got. Sometimes users post links to files of data purportedly stolen via corporate hacks. In another dark web forum called White House Market, some participants offer to create identity profiles tailored to specific states where buyers want to file jobless claims. “No guarantee in success, but all pros would be made just for you,” read one such ad. The asking price was $70 per profile.
Such forums have attracted users from around the world, but user messages suggest that one country in particular appears to provide a significant set of followers: Nigeria.
That’s where Abidemi Rufai was bound on the evening of May 14 when he was getting ready to board the first-class cabin of a flight at John F. Kennedy International Airport after visiting his brother in New York. Instead, he was arrested by FBI agents and charged with stealing more than $350,000 in unemployment benefits from Washington state.
Details of that indictment shed light on how federal prosecutors believe such schemes are carried out, and the sheer variety of participants they have attracted: Rufai serves as a senior special assistant to the governor of a Nigerian state.
He allegedly used stolen identities to file fake unemployment benefits in 11 states, including over 100 applications in Washington, where state auditors have tallied a total of $1.1 billion in possible imposter fraud from nearly 250,000 potentially bogus claims.
Prosecutors say Rufai filed his claims using variations on the same email, sandytangy58@gmail.com, which he modified by inserting periods in different places, like san.dyta.ngy58@gmail.com or sa.ndyt.a.ngy58@gmail.com. Servers for state unemployment agencies treat those as different email addresses, but Google disregards periods when routing messages to a gmail account. That allowed Rufai and his co-conspirators the convenience of filing in multiple states while handling all of their correspondence from one email account. It’s a popular strategy: Another Nigerian national allegedly used it to claim more than $489,000 of unemployment payouts from 15 states, according to an affidavit filed in a similar case.
When completing unemployment benefit applications, Rufai and his co-conspirators directed states to pay benefits into Green Dot online banking accounts, one of several fintech platforms favored by criminals for their ability to quickly link debit cards with checking accounts that can be used to receive government benefit payments. In other cases, they directed payments into bank accounts controlled by “money mules,” people who would receive funds and then transfer them to Rufai and his co-conspirators in exchange for a fee. (Green Dot Chief Risk Officer Philip Lerma said the company has been working with state agencies to combat fraudulent activity. “This is an ongoing process of learning and refinement across the industry,” he said in a statement.)
Prosecutors said Rufai’s email account contained a “staggering” amount of stolen information, including passwords to people’s email accounts, security questions and answers, driver’s license numbers, and bank account and routing numbers, as well as more than 1,000 stolen tax returns.
Rufai had also used his gmail account to submit claims for Federal Emergency Management Agency disaster relief in 2017, according to prosecutors, followed by fraudulent submissions to the Small Business Administration and the Internal Revenue Service. After Rufai was charged, investigators at the IRS disclosed they had been investigating the sandytangy58@gmail.com account for several years. They told prosecutors that the agency had received 652 applications for fraudulent tax refunds from “dot variants” of that email, totaling $1.6 million. Of that, about $900,000 was approved for payment.
Rufai has pleaded not guilty. His lawyer, Michael Barrows, did not respond to repeated requests for comment. Barrows wrote in a bail filing in late June that Rufai has no criminal record and that prosecutors are offering “intentionally false and/or misleading information in an effort to exaggerate the crimes alleged while tarnishing the reputation of a well-respected Nigerian government official.”
Some scammers employ similar techniques on a mass scale by writing computer scripts, or bots, to automatically populate stolen identities into states’ application portals. New York suffered an attack from one such bot, which was able to repeatedly navigate and complete its application process, according to a person familiar with the episode. New York’s labor commissioner has said that the state is “aggressively deploying advanced resources” to fight fraud, including computer algorithms of its own.
Other fraudsters outsource such activity to human labor farms in low-wage countries, according to cybersecurity firm F5. Patterns of UI applications indicate workers in China, Brazil, Bolivia, Mexico and West African nations have been hired to input data into U.S. unemployment portals, according to Carlos Asuncion, F5’s director of solutions engineering. Asuncion said job ads to do that kind of work often pop up on websites catering to “microworkers” — people who earn pennies per task for such actions as creating gmail accounts, inputting email addresses or zip codes and solving captchas (the latter for as little as five hundredths of a cent per captcha). The labor can be even cheaper, according to Asuncion, than developing and updating a computer algorithm. As he put it, “It’s kind of an arms race.”
State unemployment agencies, burdened by aging technologies and siloed databases that don’t effectively communicate with each other, have been unable to keep up with any sort of arms race.
Federal rules require states to cross-check applicants’ information against a handful of databases when determining eligibility for jobless benefits. These include a national directory of new hires, quarterly wage records submitted by employers, and an immigration database that allows states to verify applicants’ citizenship status. The Labor Department also recommends that states check a database aimed at preventing claims in multiple states, as well as the Social Security Administration, prisoner records and an interstate data hub meant to help flag foreign IP addresses, suspicious email domains and applicants, according to a May 2020 compliance bulletinbulletin.
But performing all those checks requires modern technology. Many states are running their UI systems on software so obsolete that it’s hard to even find anyone able to service it. North Dakota had to recruit programmers from Latvia to prop up its systems last year, since the tiny Eastern European nation is one of the few places that still teaches the software used by the state’s unemployment insurance system. The clunky mainframe was “miraculously patched together, at considerable cost, to get us through the pandemic surge,” the state’s governor said in his December 2020 budget proposal, which sought to replace the system.
Amid the surge in claims, databases frequently froze up or slowed to a crawl, according to the Labor Department’s inspector general. States also reported not having the mainframe capacity to perform cross-matches for the large volumes of claims they were getting.
The result was that many cross-checks simply didn’t happen. Twenty states did not perform all the required database cross-matches, and 44 states did not perform all recommended ones, the inspector general found.
Even when states perform the checks, they can still be fooled. After all, the extent of identity theft means that criminals often input the information of a real person. Validating that the data is accurate doesn’t necessarily verify whether the claim was filed by the person whose data was used. “Verification and validation are two different things,” said John Pallasch, an assistant secretary of labor during the Trump administration. “That was the inherent flaw in all of this.”
Violinist Philip Payton got caught on the wrong end of this after he lost his job playing in Disney’s “Frozen” musical. When the pandemic shut down all Broadway performances in March 2020, word got around the orchestra that musicians could apply for unemployment insurance. By early April, Payton was receiving $504 a week plus the extra $600 authorized by Congress, his account shows. “This just helped me stay normal,” he said. “I could pay my bills and pay my half of the rent.”
But things changed in mid-September when the weekly payments suddenly stopped. He called New York’s Department of Labor and was told, he said, that he had a claim in another state. The agent didn’t tell him which state. A follow-up conversation in October ended the same way.
Many have shared Payton’s plight. In 2020, consumers filed nearly 400,000 complaints claiming their identities were stolen and used to claim government benefits. That was up more than 2,900% from about 13,000 such complaints in 2019, according to Federal Trade Commission data.
Unsure what to do, Payton kept calling until he finally got through to someone who told him the other claim was in Texas. Payton called the Texas Workforce Commission’s fraud line, but couldn’t get through to anyone.
By then, it was January and Payton was beginning to run low on cash. He kept calling and leaving messages but couldn’t get a call back. Eventually, through a chain of contacts, Payton reached an agent at the Texas commission, who told him he was listed as having filed claims in multiple states. The agent told him to call New York’s labor department to get his benefits restarted.
That prompted yet another round of phone calls. It was now early April. Payton had drained his savings and was falling behind on rent. Sometimes he’d spend three to four hours a day on hold while practicing violin or browsing job ads on the internet. He also started contacting organizations he thought might be able to help. Eventually, he connected with a paralegal at the Legal Aid Society, who sent an email to two New York labor department officials asking to expedite his case.
A day later, after eight months of missed payments and little work, Payton’s unemployment benefits finally restarted (and covered the earlier missed payments). But the experience shook his faith in the program. “There just has to be a better system,” Payton said.
The state unemployment agencies in New York and Texas both declined to comment on Payton’s situation, citing privacy restrictions. But Bernsen, the spokesperson for the Texas Workforce Commission, said in a statement that the state generally blocks suspicious claims by placing a “fraud block” on them. “This becomes a problem when the legitimate person needs to access those funds.” He added, “Fundamentally, the system is trying to do two things simultaneously that are at odds with one another: ensure quick payments to individuals and prevent fraud.”
Of the two issues, fraud prevention is now much more on the minds of officials in Washington. Gene Sperling, President Biden’s top official in charge of the pandemic response, said the issue goes beyond just unemployment insurance. The deluge of fraudulent claims has slowed as the surge in federal aid draws to a close, but he sees the proliferation of identity theft for government benefits as the larger threat. “It’s always a bad thing when somebody cheats and gets a few thousand dollars by doing this or that,” Sperling told ProPublica. “But we seem to be seeing something much larger and systemic.”
Sperling said the White House asked federal agencies to provide preliminary recommendations by mid-July on what the government can do to prevent criminal syndicates from using stolen identities to access government aid, whether unemployment benefits, small business loans or disaster aid given out by FEMA.
One idea that’s already being implemented is improving the Labor Department inspector general’s access to states’ unemployment compensation data, so that federal watchdogs can analyze claims for fraud in real time instead of individually subpoenaing states for the data.
The administration is also planning to spend $2 billion to modernize states’ unemployment insurance programs and strengthen them against fraud. The Labor Department is still figuring out how to allocate the funds, which were appropriated under the $1.9 trillion coronavirus stimulus bill enacted in March. One approach under consideration involves having the federal government develop centralized technology to help the 53 states and territories manage their jobless aid programs, instead of having them all fend for themselves and scramble to implement changes during crises.
Recent increases in funding to bolster fraud detection have also been a boon for ID.me, a company that has been hired by 27 states since mid-2020 and recently won a $1 billion federal contract to provide its services to more states. ID.me verifies that claimants are who they say they are by having them take selfies or asking them to appear on video and checking to make sure their faces match the photos on identity documents used to apply for benefits.
ID.me’s chief executive, Blake Hall, made headlines last month when he told Axios that he thinks taxpayers’ losses from UI fraud will top $400 billion. Hall defends that estimate, which some commentators criticized as wildly inflated. Hall based the figure on the precipitous drop-offs in new claim applications that states have experienced after implementing ID.me verification. In New York, for instance, state data confirms that new claims for PUA fell by 89% after ID.me went live in late March. And more than 50% of people who have already filed for UI benefits don’t even try to confirm their identities when asked to do so, according to Hall, who cited data from five states the company has worked with.
Fraudsters are trying to adapt. Telegram forums have lit up with offers of sauces and software that sellers claim can bypass ID.me. Hall said his firm monitors such ads and maintained that he has yet to find any that work. “There is no bypass,” he asserted.
That may be true today. But, as one recent post on a dark web marketplace noted, “The fraud business is an ever-changing type of business, meaning methods are constantly being updated because of new security implementations on the market.”
Florida's chief financial officer must name new board members for the Birth-Related Neurological Injury Compensation Association, as his office undertakes an audit and an investigation prompted by our reporting.
This article was published on Friday, July 23, 2021 in ProPublica.
by Carol Marbin Miller and Daniel Chang, Miami Herald
Now that the Florida Legislature and governor have taken action to overhaul a Florida program that serves families with brain-damaged children, its future could pivot on a state Cabinet member following through on his promise to make the program answer to the parents of disabled children.
Florida Chief Financial Officer Jimmy Patronis, whose office oversees the Birth-Related Neurological Injury Compensation Association, initiated an audit and an investigation of the program after the Miami Herald and the journalism nonprofit ProPublica published a series of stories this year showing how NICA had amassed nearly $1.5 billion in assets while frequently denying care to children it serves.
Patronis, who demanded that NICA “do better” the day the series began publishing, is expected to name at least five board members to oversee the program — three to replace members who resigned last month and two new ones authorized by a law passed in the most recent legislative session.
“For a public official, this is truly an opportunity to have real impact in a positive sense for the people this program was designed to benefit,” said Pat Wear, a former director of the Florida Advocacy Center for Persons with Disabilities who, as Kentucky’s commissioner of mental health, oversaw that state’s Traumatic Brain Injury Trust Fund. “He can do great things here by appointing people who have insight into these families’ tremendous needs.”
But Patronis, Wear said, faces a choice: He “can serve the system, or he can serve the people.”
On Tuesday, Patronis announced his first new board appointment, and the move suggests he may be listening to disability advocates such as Wear. He added Jim DeBeaugrine, who oversaw the state Agency for Persons with Disabilities before becoming a consultant and lobbyist. Recently DeBeaugrine served as interim CEO of the Arc of Florida, an advocacy group for people with developmental and intellectual disabilities.
In an interview with the Herald on Wednesday, DeBeaugrine said he anticipates the NICA board will undergo significant changes, both in its composition and in its orientation toward the children and families who depend on the program for care.
“I will be going into this with a critical eye, to change the focus of this organization,” DeBeaugrine said. “Everything about how it operates needs to be on the table. If I didn’t think that, I probably wouldn’t take the assignment.”
He added, “We have an opportunity to go in and make some fundamental changes in how the organization interacts with the families it serves.”
The leader of a Tallahassee-based advocacy group praised the appointment, saying DeBeaugrine will rightly focus on the needs of children and their families.
“He has a strong sense of wrong and right,” Lori Fahey, president of The Family Cafe, said of DeBeaugrine, who is the chairman of her board of directors. “His priorities are set on providing what is best for individuals with disabilities and their families.” The Family Cafe provides information and networking opportunities for people with disabilities and their families, and advocates for better care and services.
DeBeaugrine, Fahey said, has volunteered with the Special Olympics, as well as other service groups. For many years, he’s also cared for his brother-in-law, who is disabled. “Above all,” she said, “he’s a family member.”
Florida lawmakers created NICA in 1988 to immunize obstetricians — who claimed their malpractice premiums had become prohibitively high — from the consequences of a tragic birth that results in severe and lifelong brain damage. In most cases, parents are barred from suing the doctor who delivered their baby and the hospital where their child was born. In exchange, NICA promises to provide all “medically necessary” and “reasonable” care.
The Herald and ProPublica detailed how NICA earned more from its investments than it spent on profoundly disabled children who were routinely deprived of care, including medication, therapy, in-home nursing and equipment such as wheelchairs.
Within weeks of publication, Florida lawmakers rewrote the statute that governs the program, requiring administrators to cease delaying and denying care and making NICA more responsive to the needs of parents and family members.
Among other things, the new law says NICA must cover up to $10,000 a year in mental health care for family members of people in the program, spend up to $100,000 to make families’ homes accessible for wheelchairs and medical equipment, and make it easier for families to get and pay for care. The law also creates an avenue for appeal when treatment or therapy is denied.
It is a near-complete overhaul for an agency that has operated under the radar for 33 years, sometimes infuriating parents struggling to raise children with extraordinary needs.
Gov. Ron DeSantis signed the measure on June 21, and it took effect immediately. Now that the statute spells out how NICA must prioritize the health and best interests of children in the program, it’s up to the board of directors to set the tone for the program’s longtime administrators and case managers.
But the board, historically dominated by insurance and health care executives, is not functioning at the moment.
The legislation limits the tenure of the nonpaid board members to “no more than six consecutive years.” The provision affects four members of the board. Three of the four resigned in June, leaving the board without a quorum and forcing the cancellation of a meeting last month.
Those who resigned are Robert E. White Jr., who is the chief operating officer of The Doctors Company malpractice insurer; Dr. Steven Dukes, an obstetrician who is covered by NICA; and Bryan Anderson, vice president for government relations at hospital giant HCA Healthcare.
All had served more than six years consecutively. None of the three responded to an email from the Herald.
Filling at least five board seats presents Patronis with an opportunity to shape the program for years to come.
Even with its $1.5 billion in assets, NICA has remained one of the most obscure programs in state government, though certainly not free from politics and influence. The program has paid nearly $900,000 to lobbyists since 2011. It has paid nearly $200,000 to a public relations firm since 2020.
Though the new legislation greatly limits the discretion of NICA’s executive director, Kenney Shipley, to deny care and services to covered families, the Tallahassee-based program has not seen such a significant change in governance in its history. In the course of filling the two newly created board slots — one to be held by a NICA parent and another by an advocate for children with disabilities, which DeBeaugrine now fills — plus the three vacancies, Patronis can effectively transform the program’s oversight.
For some parents, a change in NICA’s management and culture is key to any meaningful reform, and that begins with the tone at the top.
“A change in leadership and governance is the only option,” said Michelle Perez, an Orlando-area mother of a 1-year-old boy in the NICA program.
“I hope that [Patronis] appoints board members who are qualified and impartial to both sides,” she added. Families served by the program “need a director to advocate for them too.”
NICA did not respond to a request for comment for this story.
As he seeks reelection to a second term, Patronis faces perhaps the most daunting task of his political career.
The son of a prominent Panama City family, Patronis managed his family’s seafood restaurant when term limits left then-House Speaker Allan Bense’s seat vacant in 2006. Patronis ran for the seat and won it, and he was reelected three times before he was term limited. His early endorsement of a little-known hospital executive, his longtime friend Rick Scott, for governor was rewarded in 2015 with an appointment to the Public Service Commission, which regulates utilities.
Scott propelled his career again in June 2017 by appointing Patronis — who has called Scott his mentor — to complete the term of Jeff Atwater, who resigned as CFO to take a similar job for Florida Atlantic University in Boca Raton. He beat his Democratic opponent, Broward businessman Jeremy Ring, in the 2018 election.
As the state’s top financial watchdog, Patronis’ office oversees NICA, but he had not previously made it a priority. In January 2019, shortly after Patronis’ election, the mother of a young woman with severe physical disabilities whose medical care is reimbursed by NICA asked Patronis in an email to “take notice, and, hopefully, take action” to reform the program.
Patricia Parrish of Titusville, whose daughter Delaina is now 23, told Patronis that NICA administrators showed favoritism toward some families, failed to apprise parents of benefits to which they were entitled, had failed for years to update written guidelines — when there were any — and lacked transparency.
“Our only option for ANY grievance, no matter how big or small, is [to appeal to an administrative judge], which is a burdensome and excessive demand on a parent whose job is the caregiving for one who is severely disabled,” Parrish wrote.
She added, “I don’t believe the original intent of NICA was to alienate and burden families who best know the needs of their children.”
Parrish, whose husband, Jesse J. Parrish III, has applied to be on the board, told the Herald that Patronis never responded.
The day the series was published, Patronis vowed in a prepared statement to “do some good on behalf of these families.” He initiated an audit of NICA’s finances, spending and investments, and announced a separate investigation by his office’s consumer advocate, Tasha Carter.
“NICA has got to do better,” Patronis wrote in the statement. “I cannot imagine or understand how difficult it is for families of children with neurological injuries, but we’ve got to figure out a way to make things easier for them.”
He added, “This program needs to treat these children with kindness instead of treating them as though they’re a liability for shareholders.”
After the resignations, the two remaining NICA board members were Dr. Samuel Wolf, an obstetrician who is covered by NICA and has served on the board since 2020, and Charles Lydecker, Foundation Risk Partners’ CEO, who has been on the board since September 2008. Lydecker, chairman of the board, has not only served more than six consecutive years, but his tenure would appear to be in jeopardy for another reason: The new law explicitly bars any representative of “a casualty insurer” from serving on the board’s “citizen” seat, which Lydecker now holds.
On April 30, one day after lawmakers passed the NICA reform bill, Lydecker contributed $1,000 to Patronis’ reelection campaign; four executives of his Foundation Risk Partners insurance agency added an additional $4,000 that day. Lydecker did not respond to phone calls and an email.
Previously, on April 5, Lydecker gave $25,000 to a political action committee, Treasure Florida, that is affiliated with Patronis. During the 2018 election cycle, Foundation Risk Partners gave $30,000 to Patronis.
Patronis’ spokesman, Frank Collins, declined Friday to discuss whether Lydecker wishes to remain on the board or whether Patronis will seek his removal. When asked whether the campaign contributions from Lydecker and his firm might influence those decisions, Collins said, “Absolutely not.”
“The appointments process is ongoing,” Collins said.
Michelle Perez, the Orlando-area NICA mother pushing for a clean slate at the top, said she experienced firsthand the difficulty getting needed equipment for her son, who turns 2 on Monday.
Perez said a hematoma at birth compressed her son’s spinal cord, resulting in permanent neurological damage. Jace cannot walk or talk, and he is cognitively impaired, though she does not believe severely.
Because Jace is so young, Perez said, both Medicaid and the boy’s private insurer rejected her request for a wheelchair, though both Jace’s pediatrician and physical therapist said he needed one. Jace is so floppy physically that he slumps in his stroller, and his doctor fears this will lead to scoliosis, a serious risk for youngsters in his condition.
“They were pointing fingers at each other,” she said. “We were getting the runaround.”
After reading stories in the Herald, Perez said, she contacted the consumer advocate in Patronis’ office, who called NICA on her behalf. She said NICA then agreed to pay for the wheelchair, which should be ready in about a month.
They are two sisters in two states. Both are dedicated healthcare professionals who watched in horror as COVID-19 swept through the nation's nursing homes, killing a staggering number of residents and staff alike.
One sister is now vaccinated. The other is not.
"Dude. Get vaccinated!" Heidi Lucas texted her sister Ashley in May from her home in Jefferson City, Missouri.
"Nope lol," Ashley Lucas texted back from Orbisonia, Pennsylvania.
"Don't you work with old people?"
"Yeah"
"What if you killed one of them? Get vaccinated," Heidi wrote.
Neither sister is budging as the Delta variant brings a new spike in coronavirus numbers across the nation.
Their divide mirrors America's larger one, where the vaccine to combat COVID-19 is eagerly embraced by some, yet eyed with suspicion and rejected by others.
It is the refusal group, including a significant percentage who work in the nation's nursing homes, that has confounded and alarmed healthcare officials who are at a loss as to how to sway them.
Nursing homes faced a shocking mortality rate during the pandemic. In the U.S., COVID-19 killed more than 133,000 residents and nearly 2,000 staff members between May 31, 2020 and this July 4, according to Centers for Medicare & Medicaid Services reports. The true toll is thought to be even higher as data gathering lagged in the early months of the crisis, health experts say.
Working in a nursing home became one of the "most dangerous jobs" in America in 2020, according to an analysis of work-related deaths by Scientific American.
Yet seven months after the first vaccines became available to medical professionals, only 59% of staff at the nation's nursing homes and other long-term care facilities are fully or partially vaccinated — with eight states reporting an average rate of less than half, according to CMS data updated last week.
Twenty-three individual facilities had vaccination rates of under 1%, the data showed.
Staff vaccinations have lagged even as the overall rate for residents climbed to 83%, according to the CMS data.
The strong vaccination percentage among nursing home residents is credited, in part, to an early campaign to bring the vaccine directly to facilities. That suggests availability is not necessarily the issue behind staff going without.
So, what is?
The question defies easy answers. Vaccine refusal is regional and often aligns not only with individuals' political alignment but also with their preferred news sources and which social media they follow.
Last week, President Joe Biden took aim at Facebook and other social media giants for failing to police vaccine misinformation that amplifies conspiracy theories and discourages people from getting vaccinated. "They're killing people," he said, directly blaming the platforms. On Monday, he recast the accusation to say it was specific individuals posting dangerous information who are culpable.
On Tuesday, U.S. Sen. Mitch McConnell, R-Ky., pleaded to "anyone out there willing to listen: Get vaccinated." While not mentioning skeptics specifically — including those in his own party — the Republican leader urged the unvaccinated to ignore "demonstrably bad advice."
COVID-19 cases are now surging in every state, with new hospitalizations and deaths almost entirely occurring among the unvaccinated. "This is becoming a pandemic of the unvaccinated," Centers for Disease Control and Prevention Director Rochelle Walensky warned last week during a White House briefing.
In May, CMS began requiring weekly reports on vaccinations of residents and staff at nursing homes and other long-term care facilities. The emerging data confirms many healthcare experts' worst fears, especially for Southern states.
Louisiana has the lowest statewide average: Just 44.5% of the staff at its long-term care facilities have been at least partially vaccinated, according to CMS data released last week.
Florida, the second lowest-vaccinated state, had a rate of just under 46% among its nursing home and long-term care staff, with Missouri, Oklahoma, Tennessee, Georgia, Mississippi and Wyoming all showing rates of less than 50 percent, according to the data.
Vaccination rates in assisted living facilities are not included in the data.
A separate American Association of Retired Persons analysis, released last week, showed that only one in five of the nation's more than 15,000 nursing homes were able to hit a goal, set by two industry trade groups, of vaccinating 75% of their staff by the end of June.
While cases in nursing homes have recently slowed, and most of the new COVID-19 infections are among younger people, some experts still worry of a return to darker days.
The CDC recently launched an investigation into deaths of residents at several western Colorado senior facilities possibly linked to unvaccinated staff, the Associated Press reported Wednesday.
"We need to sound the alarm," said Susan Reinhard, senior vice president of AARP and director of its Public Policy Institute. "Nursing homes were devastated by COVID-19, and many residents remain highly vulnerable to the virus."
Nationally, more than 89% of people 65 or older have received at least partial vaccination, the CDC reported this week. Still, public health experts have warned that even if fully vaccinated, the elderly may be vulnerable to "breakthrough" coronavirus infection because of compromised immune systems and other underlying health problems.
In Missouri's southern region, the overall rate of full vaccination in some rural counties is less than 20%, according to state health department and CDC tracking. The latest surge of the delta variant has turned the area into a "tinderbox," Steven Edwards, CEO of the CoxHealth hospital system in Springfield, recently told reporters.
On Thursday, 160 patients were being treated for COVID-19 at CoxHealth, a spokesperson told ProPublica. On May 14, there were 18.
Heidi Lucas directs the Missouri Nurses Association. She is pro-vaccine and has been pushing hard for nurses to get vaccinated, especially those on the front lines of patient care.
Lucas said it is impossible to separate the lack of vaccination among staff from the lack of vaccinations in individual communities. "Nurses are people too," she said. "They are on social media and are inundated with false information. How do you fight it?"
Her sister, Ashley Lucas, lives 900 miles away in Orbisonia, a small town of around 500 people about an hour south of State College. She's a traveling certified nursing assistant at area nursing homes and chose to skip the vaccine.
Her fiance and her children, ages 12 and 13, are also unvaccinated. "I don't consider myself an anti-vaxxer," she told ProPublica, bristling that some might see her as reckless or ill-informed.
Instead, she said her decision was carefully considered. It never made sense to her, she said, that the virus seemed to strike randomly, with some residents getting sick while others did not. She said she is not convinced the vaccine would change the odds.
She's also concerned after hearing that the vaccine could interfere with fertility — a contention that has been deemed false by the Centers for Disease Control and Prevention and the World Health Organization. It all leads her to believe more research is needed into the vaccines' long-term effects.
"This is just a personal choice and I feel it should be a free choice," she said. "I think it's been forced on us way too much."
Certified nursing assistants make up the largest group of employees working in nursing homes and other long-term care facilities, providing roughly 90 percent of direct patient care. They are typically overworked and underpaid, most earning about $13 per hour and receiving no paid sick leave or other benefits, said Lori Porter, co-founder and CEO of the National Association of Healthcare Assistants.
Porter said she is not completely surprised by the low vaccination rate. It comes down to trust, she said, both of the vaccines and of facility administrators who now say staff must get vaccinated. Refusal may feel like empowerment. "It's the first time ever they have had the ball in their court," Porter said.
On March 31, Houston Methodist Hospital mandated that all of its 26,000 employees be vaccinated by June 7 or lose their jobs. Jennifer Bridges, a nurse, sued along with 116 other employees, claiming the healthcare system had overstepped its rights and that she and the others refused to be "human guinea pigs," evoking the Nuremberg Code, a set of ethical standards established in response to Nazi medical experimentation in concentration camps.
On June 12, U.S. District Judge Lynn N. Hughes dismissed the closely watched case, taking offense to likening the vaccine to the Holocaust, which he called "reprehensible." Ten days later, 153 Houston Methodist employees either were fired or quit after refusing the vaccine. The judge's ruling has been appealed.
A handful of long-term care chains have similarly sought to mandate worker vaccines, but such action is far from widespread in the industry. One sticking point has been whether vaccination can legally be required, since all three available vaccines have only emergency use authorization, not full approval from the U.S. Food and Drug Administration.
The thornier issue, though, is whether the facilities can risk losing staff when they're already short-handed. Many workers have vowed to quit rather than be forced into vaccinations.
Aegis Living, a long-term senior care provider in three Western states, made vaccines mandatory for its roughly 2,600 employees on July 1. Dwayne Clark, founder and CEO, said initially 400 employees refused but when the deadline arrived, only about 100 left rather than be vaccinated.
"We lost some staff that we didn't want to lose," Clark told ProPublica, "but it felt like the right moral protocol to impose."
Recently the U.S. Equal Employment Opportunity Commission issued guidelines stating that employers can require workers to be vaccinated as long as medical or religious exemptions are permitted.
"Nursing home workers certainly have the right to make decisions about their own health and welfare, but they don't have the right to place vulnerable residents at risk," said Lawrence Gostin, a health law professor at Georgetown University. "Nursing homes don't just have the power to require vaccinations, they have the duty."
Still, the issue is far from resolved.
"America is a highly litigious country," Gostin said, "I expect the courts to consistently uphold nursing home mandates, because they are entirely lawful and justified. But there will likely be lawsuits at least until it is quite clear they are futile."
Diane Peters is a registered nurse in the Chicago suburbs who last year worked at a nursing home and is now working at a senior rehabilitation center. She does not trust the science behind the vaccine and is unvaccinated. So is her fiance.
Everything about the rollout felt like propaganda, she said. Development was too rushed. Clinical trials typically take years, she said, not months. "I don't think it's safe right now, it needs more time," she said she tells patients if they ask.
Most don't, she said. Neither do her co-workers. She has only been asked once by her employer if she was vaccinated, she said, declining to name the company.
Peters guesses about 40 percent of her colleagues are also unvaccinated, but said no one likes to talk about it because the divide surrounding the vaccine is "surreal." Staff members are tested regularly and are required to wear masks, she said.
She is doubtful mandates would stick. "They can threaten," she said, "but a lot of nurses would walk."
She trusts her instincts and her own research for now. When asked what would change her mind, she had one word: "Nothing."
Amid the current surge in COVID-19 cases in Missouri, a recent Facebook conversation between two Republican state lawmakers is telling.
Around Independence Day, State Rep. Bill Kidd, from the Kansas City suburbs, revealed that he has been infected by the coronavirus.
“And no, we didn’t get the vaccine,” he wrote in a post that has since been deleted. “We’re Republicans 😆”
State Rep. Brian Seitz, a Republican from Taney County, home to the tourist destination of Branson, commented on the post by falsely claiming that the virus had been developed by top government scientist Anthony Fauci and billionaire Microsoft founder Bill Gates. They “knew what was coming,” Seitz wrote.
“The jury is still out on the ‘vaccine’ (who knows what’s in that),” he wrote.
As the number of coronavirus infections rises around the country, lawmakers like Kidd and Seitz have adopted responses that trouble many health officials. In Tennessee, Republicans legislators threatened to shut down the state health department, saying it was targeting minors for mass vaccinations without the consent of parents. In Ohio, lawmakers allowed a doctor to testify at a legislative hearing last month that coronavirus vaccines could leave people magnetized (they can’t). During a hearing in the Montana Senate, a senator said he had read articles about “putting a chip in the vaccine.” (There are no chips in vaccines.)
Just as with his insistence that he won the election, former president Donald Trump’s attitudes about COVID-19 hold great sway with his supporters. Trump routinely bashed Fauci and infectious disease experts throughout the pandemic and questioned the severity of the coronavirus.
He also strongly carried Missouri’s southwest corner in the November election. While Trump beat Joe Biden by 15.4 percentage points statewide, in rural Taney County, the margin was 57.8 points.
Those supporters now tend to oppose efforts to get everyone vaccinated, believing they are being led by Democrats, said Ken Warren, a professor of political science at Saint Louis University who tracks state and local politics. “It’s a sad reality,” he said. “We can’t get together on anything, even fighting COVID.”
Such attitudes are accelerating an anti-vaccine sentiment that has run strong in the state legislature for years, particularly with lawmakers from the area of Missouri now facing increased infection rates. In 2018, Republican state Rep. Lynn Morris, a pharmacist from southwest Missouri, pushed a proposal to prohibit discrimination against unvaccinated children. Public school children are required to be vaccinated against several diseases, but families can claim a medical or religious exemption. The Legislature took up a similar proposal in 2019. Each failed.
Late last year, state Rep. Suzie Pollock, a Republican from south-central Missouri, proposed a bill to prohibit discrimination against people who choose not to be vaccinated against the coronavirus. She claimed the vaccine against the virus had “been rushed” and that its efficacy was “in question,” myths that have been relentlessly amplified by right-wing media.
The bill did not advance, but Gov. Mike Parson signed into law a related bill blocking local governments from requiring proof of coronavirus vaccination for people seeking to access transportation systems or other public services.
It’s not enough for some. “Now people are pushing back even against the idea of private employers like hospitals and health care providers telling their employees you have to be vaccinated,” said state Rep. Shamed Dogan, a Republican from the St. Louis suburbs. “I think that some of the legitimate concerns of government overreach have turned into this broader resistance to any vaccination, which is something I don’t agree with.”
Late in this year’s legislative session, Pollack pushed a proposal that would allow more parents to opt out of vaccinating their children against diseases including polio, measles and mumps. Pollock insisted she was not against vaccines, but said that people should have the freedom to choose. The House Elementary and Secondary Education Committee voted 10-6 in favor of the bill.
The full House defeated it on April 28 in a 79-67 vote.
“There is a tremendous skepticism about the good that government can do,” said Dan Ponder, a political science professor at Drury University in Springfield and director of the Meador Center for Politics & Citizenship there.
Ponder said many residents of southwest Missouri question the motives behind the policies that governments are pushing and show “a tremendous skepticism about information.” He added, “People don’t believe the vaccines are working. People don’t believe the federal government isn’t going to come down here and … basically strong-arm them into taking a vaccine.”
Indeed, when the Centers for Disease Control and Prevention deployed a two-person “surge response” team to southwest Missouri this month to combat an outbreak attributed to the dangerous delta variant, both Parson and U.S. Rep. Jason Smith, from south-central Missouri, tweeted opposition to federal agents going door to door to compel vaccines, something President Joe Biden’s administration said it never had any intent to do.
On Sunday, Springfield Mayor Ken McClure told CBS’ Face the Nation that his community was “being hurt” by rampant vaccine misinformation. He said people were sharing “health-related fears, what it might do to them later on in their lives, what might be contained in the vaccinations. And that information is just incorrect.”
Taney County is near the heart of the surge of the delta variant, which health officials say spreads more easily than earlier versions of the virus. The county is leading the state with the highest rate of coronavirus cases over the past seven days, according to Missouri health department data. Surrounding counties have similarly high rates, raising alarms for federal health officials.
Despite the spike, just 28% of Taney County’s residents are fully vaccinated, below the state average of 40%.
Seitz, who once owned a newspaper that promoted Branson’s entertainment industry, boasted in an interview that the Ozark tourist town was doing gangbuster business after a year of being mostly shut down.
“There were 27,000 people at our July 3 celebration,” he said, noting that he attended with U.S. Rep. Billy Long and “he said something like, ‘I’m so glad to see there are very few chin diapers in the crowd.’ The roar was huge … we’re so happy not to be forced by government to either wear a mask or take a vaccine.”
Seitz said he had no business telling his constituents how to live. The media has shifted its focus from deaths to the raw numbers of cases, he said, glossing over that most people who catch the virus don’t die. While 600,000 American deaths have been attributed to COVID-19, Seitz questioned whether people were dying from the disease or from existing health problems: “If a person is grossly overweight and caught a very virulent virus, did they die because they were in very ill health or did they die because of the virus?”
Seitz falsely claimed that COVID vaccines have not been tested and are unsafe. He backed down on his comment about Fauci on Kidd’s Facebook post, acknowledging that the virology expert did not create the coronavirus but asserting that he had been engaged for years in experiments to make viruses more dangerous or transmissible. Fauci has insisted the U.S. government did not participate in experiments that could have caused the pandemic.
Seitz said he had nothing against people who take the vaccine or wear masks. It’s their choice, he said. He said it wasn’t his job to keep people safe, but to keep people free.
“I haven't had the flu even since 1994,” he said. “Why would I take a vaccine? ... My life was normal for the past year, very few instances of wearing a mask, and so forth, and I’m just fine.”
Betsy Fogle, who recently completed her first session as a Democratic state representative from Springfield, said it was “fascinating kind of watching the narrative and the rhetoric” in the state capital of Jefferson City surrounding COVID-19, “and then watching it all get politicized and polarized. And then seeing that real-life impact that has on our neighbors back in Springfield when our hospitals are full and our hospital CEOs are begging people to get vaccinated and people just aren’t doing it.”
She said there was a mentality among Republican leaders “that COVID is a hoax, or that vaccines are a hoax, and that trickles down.”
She said she has several constituents who didn’t get vaccinated “because they think that this is a joke, and then these people reach out a month later to say, ‘I’m sorry I didn’t listen.’”
Kidd, the Republican from the Kansas City area, posted almost two weeks after his initial Facebook post that he was seeking prayers because he was “having a difficult time with COVID” and “really sick.” Kidd posted again on Thursday that he was “doing better” after the virus “kicked my butt.” He did not respond to a message from a reporter.
Fogle said she hoped Kidd recovered, “but that’s the frustrating part about it, is that our hospitals, our doctors, our people who are in charge of making these decisions are telling us how severe it is, and we refuse to accept that severity.”
She said she makes daily calls to everyone she knows who isn’t vaccinated “and what I hear is, ‘No, it’s my right, it’s my body, it’s my choice, like, stop bringing this up.’ And it’s hard to win those arguments.”
