Lucien Wiggins, 12, arrived at Tufts Children's Hospital by ambulance June 7 with chest pains, dizziness and high levels of a protein in his blood that indicated inflammation of his heart. The symptoms had begun a day earlier, the morning after his second vaccination with the Pfizer-BioNTech mRNA shot.
For Dr. Sara Ross, chief of pediatric critical care at the Boston hospital, the event confirmed a doubt she'd been nursing: Was the country pushing its luck by vaccinating children against COVID at a time when the disease was relatively mild in the young — and skepticism of vaccines was frighteningly high?
"I have practiced pediatric ICU for almost 15 years and I have never taken care of a single patient with a vaccine-related complication until now," Ross told KHN. "Our standard for safety seems to be different for all the other vaccines we expose children to."
To be sure, cases of myocarditis like Lucien's have been rare, and the reported side effects, though sometimes serious, generally resolve with pain relievers and, sometimes, infusions of antibodies. And a COVID infection itself is far more likely than a vaccine to cause myocarditis, including in younger people.
Lucien went home, on the mend, after two days on intravenous ibuprofen in intensive care. Most of the 800 or so cases of heart problems among all ages reported to a federal vaccine safety database through May 31 followed a similar course. Yet the pattern of these cases — most occurred in young males after the second Pfizer or Moderna shot — suggested that the ailment was caused by the vaccine, rather than being coincidental.
On Friday, the Centers for Disease Control and Prevention's vaccine advisory committee is set to meet to discuss the possible link and whether it merits changing its recommendations for vaccinating teenagers with the Pfizer vaccine, which the Food and Drug Administration last month authorized for children 12 and older. A similar authorization for the Moderna vaccine is pending, and both companies are conducting clinical trials that will test their vaccines on children as young as 6 months old.
At a meeting last week of an FDA advisory committee, vaccine experts suggested that the agency require the pharmaceutical companies to hold larger and longer clinical trials for the younger age groups. A few said FDA should hold off on authorizing vaccination of younger children for up to a year or two.
Interestingly, Lucien and his mother, Beth Clarke, of Rochester, New Hampshire, disagreed. Her son's reaction was "odd," she said, but "I'd rather him get a side effect [that doctors] can help with than get COVID and possibly die. And he feels that way, which is more important. He thinks all his friends should get it."
Data regarding COVID's impact on the young is somewhat messy, but at least 300 COVID-related deaths and thousands of hospitalizations have been reported in children under 18, which makes COVID's toll as large or larger than any childhood disease for which a vaccine is currently available. The American Academy of Pediatrics wants children to receive the vaccine, assuming tests show it is safe.
But healthy people under 18 have generally not suffered major COVID effects, and the number of serious cases among the young has tumbled as more adults become vaccinated. Unlike other pathogens, such as influenza, children are generally not infecting older, vulnerable adults. Under these circumstances, said Dr. Cody Meissner — who as chief of pediatric infectious diseases at Tufts consulted on Lucien's case — the benefits of COVID vaccination at this point may not outweigh the risks for children.
"We all want a pediatric vaccine, but I'm concerned about the safety issue," Meissner told fellow advisory commission members last week. An Israeli study found a five- to 25-fold increase in the heart ailment among males ages 16-24 who were vaccinated with the Pfizer shot. Most recovered within a few weeks. Two deaths occurred in vaccinated men that don't appear to have been linked to the vaccine.
Young people could experience long-term effects from the suspected vaccine side effect such as scarring, irregular heartbeat or even early heart failure, Meissner said, so it makes sense to wait until the gravity of the problem becomes clearer.
"Could the disease come back this fall? Sure. But the likelihood I think is pretty low. And our first mandate is do no harm," he said.
Ross said the biggest pandemic threats to children that her ICU has witnessed are drug overdoses and mental illness brought on by the shutdown of normal life.
"Young children are not the vectors of disease, nor are they driving the spread of the epidemic," Ross said. While eventually everyone should be vaccinated against COVID, use of the vaccines should not be expanded to children without extensive safety data, she said.
The government could authorize childhood vaccination against COVID without recommending it immediately, noted Dr. Eric Rubin, an advisory committee member who is editor-in-chief of the New England Journal of Medicine. "In September, when kids are back in school, people are indoors, and the vaccination rates are very low in certain parts of the country, who knows what things are going to look like? We may want this vaccine."
Moderna and Pfizer this summer began testing their vaccines in younger kids. A Pfizer spokesperson said the company expects to give about 2,250 children ages 6 months-11 years vaccine as part of its trial; Moderna said it would vaccinate about 3,500 children in the 2-11 age range.
Some members of the FDA advisory committee proposed that up to 10,000 kids be included in each trial. But Marion Gruber, leader of the FDA's vaccine regulatory office, pointed out that even trials that large wouldn't necessarily detect a side effect as rare as myocarditis seems to be.
At some point, federal regulators and the public must decide how much risk they are willing to accept from vaccines versus the risk of a COVID virus that continues to spread and mutate around the world, said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
"We're going to need a highly vaccinated population for years or perhaps decades," Offit said at the meeting. "It seems hard to imagine that we won't have to vaccinate children going forward."
Ross argued that it makes more sense to selectively vaccinate children who are most at-risk for serious COVID disease, such as those who are obese or have diabetes. Yet even to raise questions about the vaccination program can be a freighted decision, she said. While authorities have a duty to speak frankly about the safety of vaccines, there is also a responsibility not to frighten the public in a way that discourages them from seeking protection.
A 10-day pause in the Johnson & Johnson vaccination campaign in April, while authorities investigated a link to an occasionally fatal blood-clotting disorder, led to a major decline in public confidence in that vaccine, although as of late May authorities had detected only 28 cases among 8.7 million U.S. recipients of the vaccine. Because of the declining appetite for the Johnson & Johnson vaccine, millions of doses are in danger of passing their use-by date in refrigerators around the country.
Focusing too much attention on potential harms from the Pfizer and Moderna vaccines for children could have a tragic result, said Dr. Saad Omer, director of the Yale Institute for Global Health and an expert on vaccine hesitancy. "Very soon we could be in a situation where we really need to vaccinate this population, but it will be too late because you've already given the message that we should not be doing it," he said.
Eventually, perhaps next year, K-12 mandates might be called for, said Dr. Sean O'Leary, a professor of pediatric infectious diseases at the University of Colorado. "There's so much misinformation and propaganda spreading that people are reticent to go there, to further poke the hornet's nest," he said. But once there is robust safety data for children, "when you think about it, there's no logical or ethical reason why you wouldn't."
Dr. Leora Horwitz treats fewer and fewer COVID patients at NYU Langone Medical Center in New York City. Still, she thinks there are too many.
And they almost all have something in common.
"I've only had one patient who was vaccinated, and he was being treated for cancer with chemotherapy," she said, reflecting recent research on the vaccines' limited effectiveness for cancer patients. "Everyone else hasn't been vaccinated."
While taking care of those seriously ill with COVID, she asks patients, with sympathy and respect: Why not get vaccinated? A few of them told the internist and hospital researcher that they're concerned about vaccine safety. But mainly, she said, the responses break down into two groups: One comprises people who have been planning to get vaccinated but didn't get around to it yet. The second highlights a disturbing deficiency in the pandemic response: those eager to get vaccinated but unable to do so because they are homebound.
"For many of the older people, the people with chronic diseases, it's been very difficult for them to get out and get the vaccine," she said. And, since many such patients receive home visits from healthcare providers, she wonders why the vaccine wasn't brought to them.
"They're already connected to a healthcare organization that's coming to their home on a regular basis. It seems like that should be a strategy we should be using," said Horwitz.
Doctors in Denver, Cleveland and other cities have noted the same trend: The COVID wards are filled with unvaccinated people. According to the Centers for Disease Control and Prevention, 76% of Americans ages 65 and older have been fully vaccinated, and about 87% have had at least one dose. Cities and states have slowly been rolling out programs to reach some of the nation's estimated 4 million homebound Americans, but the programs tend to have modest goals and target only a fraction of the people who likely need outreach.
To boost the financial incentives for vaccinating people in their homes, Medicare announced Wednesday it will be reimbursing shots delivered this way at $75 per shot instead of $40 per shot.
New York City in March launched a program for reaching the homebound by working with housing agencies, private healthcare providers, the city's Department for the Aging and teams of nurses from the Fire Department. By the second week in June, the program had reached 11,000 people, according to a City Hall spokesperson.
Horwitz and others say the city's program for reaching these people appears to be working, but not as quickly and efficiently as possible.
For instance, the Visiting Nurse Service of New York, one of the area's largest home care providers, has a contract with the city to vaccinate people in Queens. Anyone homebound in Queens is eligible, whether they're a VNS client or not. But if you're in Brooklyn, Manhattan, Staten Island or the Bronx and get home care from VNS, it won't help you get vaccinated. You then must go through the central bureaucracy and get assigned to one of the other providers contracted to work in your area.
"The city and the providers we use are the primary entity for homebound vaccinations in the city," said Avery Cohen, a spokesperson for the administration of Mayor Bill de Blasio. "This is a time-consuming and intricate operation, and we're doing our best to reach as many people as quickly as we can."
A spokesperson for the Visiting Nurse Service said that over the past 10 weeks its teams of nurses had administered 2,600 doses and vaccinated 1,700 Queens residents. The contract runs through the beginning of July.
About 75% of city residents 65 and up are partially or fully vaccinated, according to the city's vaccine dashboard. That's about 10 points lower than the national average. It's difficult to say how many of the remaining 25% are homebound, but advocates say it's surely many times larger than the 23,000 people the city is targeting in its homebound vaccination effort.
Defining and counting the "homebound" is problematic. Laird Gallagher, from the Center for an Urban Future, said there are 141,000 people 60 and older who live alone and report ambulatory difficulty in New York City. Susan Dooha, with the Center for Independence of the Disabled, using a broader standard for disability, estimates there are 422,000 city residents age 65 and up who are either fully homebound or significantly impaired, including 262,000 who are at least 75.
She said the city should cast a broader net in defining the homebound and then create a network of public and private care providers to meet the vaccination needs of this population. Some who remain unvaccinated despite a desire to get a shot may tend to some needs on their own. But they may be cognitively impaired and lack the organizational wherewithal to find a shot, Horwitz said.
After raising the issue for much of the past six months, Dooha was glad the mayor announced a program but was immediately dismayed by its boundaries. "I kept asking, What are the criteria?'" she recalled. "Under the [Americans with Disabilities Act], if you need a home visit — you don't have to be absolutely homebound by a disability — you deserve an accommodation."
Manhattan Borough President Gale Brewer, who sits on a panel overseeing the vaccine rollout in Manhattan, said she has not been able to get a straight answer from the city about how it defines "homebound" and then decides who gets targeted for home visits for vaccines.
"There's been a lot of back-and-forth and confusion," Brewer said. "It's like, 'Am I homebound if I go downstairs to get my mail, but don't go out?' The real issue is transparency, and we don't know what the rules are, and we don't have any data."
Dr. Zenobia Brown, a physician and executive with Northwell Health, the state's largest hospital network, anticipates a difficult slog getting the remaining New Yorkers vaccinated.
"What we find is that there's not a single barrier, or even a simple set of barriers," Brown said. "We're to the point where this is hand-to-hand combat, to understand what the individual barriers are and then create solutions for them."
For instance, the parents of a 22-year-old man with autism wanted to get their son vaccinated, but due to very fixed routines could make him available only at limited times. Another patient, in his 90s, didn't want to trouble anyone to come to his sixth-floor walk-up apartment.
Robert Janz, 88, and his wife, Jennifer Kotter, 68, weren't shy about seeking help. As soon as city plans were announced to serve the homebound, Kotter tried to get an appointment for her husband, an artist and a poet who's bedridden due to what she describes as a "series of small medical failures," including back injuries from falling.
It took months before she could book her husband's vaccination — even though caregivers already come frequently to their fourth-floor walk-up apartment in Manhattan. One of them gave Kotter a phone number to call, which led to another phone number and then another, until she finally succeeded. On June 1, a nurse and an EMT arrived together and gave Janz the Johnson & Johnson single-injection vaccine.
Kotter has come to expect such delays as a caregiver. "When you're caring for a patient, you have to be patient," she said.
Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.
Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.
Yet SpineFrontier's success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.
In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through "sham consulting fees" that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.
Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up healthcare spending and put patients at risk of serious harm, a KHN investigation has found. These payments come in various forms, from royalties for helping to design implants to speakers' fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.
Health policy experts and regulators have focused for decades on pharmaceutical companies' payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.
Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.
"It is simply so much money that it is staggering," said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry's influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.
Device makers say the long-established practice leads to higher-quality, safer products. "Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients' lives," said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry's trade group.
But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants. Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Renner, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.
The case of Chin's company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.
Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019.
The names of hundreds more surgeons were redacted in court filings or sealed by judges.
Court filings named 35 spine surgeons who used SpineFrontier's surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It's illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don't face criminal prosecution.
Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.
"There is a court date [for the DOJ case] as ordered by a judge," Chin said via email. "If we get to that point the facts of the case will be litigated."
Back Surgeries Under Scrutiny
The nation's outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report.
Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.
In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.
Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold — though it often is marketed as more durable, or otherwise better for patients.
"The money is just phenomenal for this medical hardware," said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are "essentially the same," adding: "These are not technical instruments; [it's often] just a screw."
Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons — who make upward of $500,000 a year — bill separately and may charge $8,000 to $20,000 for major procedures.
Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.
And it doesn't stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons' relatives, paid for hunting trips — even mailed checks to their homes.
Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.
These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, agreed to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.
KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect "advisory boards" or other activities that entailed little work to justify the fees.
In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine's implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives paid a total of $6 million in penalties. The company did not respond to requests for comment.
Similarly, SpineFrontier received "the vast majority" of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a "sham" company run by Chin's wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.
Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin's interest in the company at $75 million, according to government records, though its current worth is unclear.
SpineFrontier's management thought paying doctors was "the only reliable way to steadily increase its market share and stave off competition," Charles Birchall, a former business associate of Chin's, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.
From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for "consulting," which could include the time they spent operating on patients — even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to "evaluate" the same products, though their feedback was "often minimal or nonexistent," according to the DOJ complaint.
Patient Injuries Pile Up
While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.
Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered "phony" consulting deals to surgeons who had complained about alarming defects in one of its knee implants.
Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons "to retain their business and secure their silence" about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company "emphatically denies the allegations and looks forward to presenting the real facts to the court." In a court filing, the company said the suit was "full of conclusory, vague and immaterial facts" and said it should be dismissed.
In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.
Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim "extreme mental anguish" for fear the hardware inside them will fail, according to the suit.
The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent "hush" letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: "We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail." Davis and his lawyer didn't respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.
Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.
That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.
Meade was not a defendant in the cases. But the patients accused him of misleading them about the product's safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had "participated in the design, testing, marketing, promotion and sales" of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included "promotional speaking, travel, lodging, and consulting."
In court filings, Arthrex admitted making payments to Meade for "consulting and royalties" but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.
Chin's dual roles as SpineFrontier's CEO and user of its hardware was called a "huge" conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.
In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau's spine broke in half, causing him pain and disabling injuries.
In a legal brief, Chin's lawyers argued that he regularly operates on people with disabling back problems, noting: "The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care."
Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin's lawyers disputed.
"He never told me of his bad record injuring people," Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused "debilitating and life-altering injuries." The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.
KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.
In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in "constant" pain. "Based on what my doctors have told me," she said, "I will never get back to normal." Chin denied any negligence and the case is pending.
Government Struggles to Keep Pace
Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called Open Payments. That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.
Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants. "These interactions are really essential for good outcomes in patient care and that needs to be preserved," said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS' ethics committee.
Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total — even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.
Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. "It was quite unbelievable," he said.
Rosen said while he believes a "relatively small number" of surgeons cash whopping industry checks, many who do so are influential figures who can "help direct medical care."
Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.
Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a special fraud alert that such gestures could violate anti-kickback laws.
Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS report. That changed in October, when device giant Medtronic agreed to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods. Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and "remains committed to maintaining the highest standards of ethical conduct."
KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.
Responding to written questions, a CMS spokesperson said the agency "has multiple formal compliance actions pending which it is unable to discuss further at this time."
But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.
"Some people would say if you penalize companies enough, they won't be making these offers," said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the "cost of doing business."
The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has "long advocated for stronger reporting requirements," Knickrehm said.
Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a statement in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor "who accepts money from a device manufacturer simply for using that company's products."
CASTLE POINT, Mo. — Lucretia Wilks, who runs a small day care out of her home in north St. Louis County, is used to watching young children embrace, hold hands and play together in close quarters.
But the COVID-19 pandemic made such normal toddler behavior potentially unsafe.
"It's weird that they now live in a time where they're expected to not hug and touch," said Wilks, founder of Their Future's Bright Child Development Center, which cares for about a dozen children ranging from infants to 7 years old. "They're making bonds, friendships, and that's how they show affection."
Day care and other child care providers said they are relieved to see COVID cases drop as vaccines roll out across the United States. But even as the nation reopens, mental health and child development experts wonder about what, if any, long-term mental health and development consequences young children may face.
In the short term, medical and child development experts said the pandemic has harmed even young children's mental health and caused them to miss important parts of typical social and emotional development. Besides not being able to get as close to other people as usual, many young children have seen their routines interrupted or experienced family stress when parents have lost jobs or gotten sick. The pandemic and its economic fallout have also forced many families to change caregiving arrangements.
"Coronavirus is impacting children and families in many ways mentally. The biggest and most obvious way is in the children's structure and routine," said Dr. Mini Tandon, an associate professor of psychiatry at the Washington University School of Medicine in St. Louis. "Young kids thrive in structure and routine, so when you disrupt that, things go awry pretty quickly in their day-to-day lives."
Tandon, who has spoken frequently with parents and caregivers since the pandemic began, said she and her peers have seen more severe anxiety and high levels of stress in young children than in the past.Bottom of Form
Child behavior experts pointed to a number of problems exacerbated by the pandemic in a National Center on Early Childhood Health and Wellness webinar last year, including separation anxiety and clinginess, sleep issues and challenges learning new information. Children have also shown regressive behaviors — wetting the bed even though they've been potty-trained, for example.
For young children, changes in caregiving arrangements can be a huge source of stress. And the financial strain of the pandemic forced many families to rethink how they cared for their youngest children.
The average monthly child care cost in Missouri, for example, is $584 for 4-year-olds and $837 for infants, according to Procare Solutions, which works with over 30,000 programs for children. That has been too high for some parents who lost their jobs in the pandemic. President Joe Biden's COVID relief plan signed into law in March gives monthly payments of up to $300 per child this year and his latest proposal would help reduce child care costs and increase access to preschool, if approved.
But in the many months when day care has been out of reach, some parents have had to rearrange their work schedules to care for infants or toddlers while also helping school-age children with virtual learning. Others have relied on grandparents for help, although that option was potentially dangerous before vaccines were available. Keeping children apart from grandparents has been tough for both kids and seniors.
Even when parents could afford day care, fear of getting or spreading COVID affected their choices about whether and when to send them. And some facilities closed temporarily during the pandemic.
Aimee Witzl, 34, of St. Louis, an accountant and new mom, said she and her husband were hesitant to send their daughter, Riley Witzl, to day care early in the pandemic. Riley was born prematurely in November 2019 and had to spend nine weeks in the neonatal intensive care unit before coming home. So, the couple waited until August to send her to day care part time, then until January to send her full time.
"We were already high-risk," Witzl said. "Then COVID happened, so we kept her home even longer than planned."
Fortunately, she said, no one in her family has contracted the virus.
In March 2020, the Early Childhood Development Action Network, a global collection of agencies and institutions promoting child health and safety, put out a "call to action" shared by the World Health Organization saying they were concerned about the pandemic putting "children at great risk of not reaching their full potential" because the early years are a "critical window of rapid brain development that lays the foundation for health, wellbeing and productivity throughout life."
Tandon, the Washington University psychiatrist, said she's especially worried about young children who may have been isolated in unsafe homes where they were mistreated. Maltreatment is more likely to go unnoticed, she said, when children are outside of the day cares and schools where adults are required to report child abuse and neglect.
But Tandon said the stresses of the pandemic can affect the mental health of any child, which motivated her to write a children's book about a girl dealing with anxiety during the pandemic.
Now, though COVID vaccinations still remain months away for the youngest children, a shift is occurring that may cause a new round of disruptions for them. Nancy Rotter, a child psychologist and assistant professor at Harvard University, said young children may be experiencing separation anxiety as they fully transition back into their schools and day cares after being at home with their parents.
To help kids heal, the Centers for Disease Control and Prevention suggests families make sure kids stay connected to relatives and friends. The agency also advises that parents do their best to recognize and address fear and stress in themselves and their kids and seek professional help if needed. CDC experts suggest parents talk about emotions and provide opportunities for children to express their fears in a safe place.
Yet as children and toddlers return to a new normal, it may not be as strange to them as it is for adults. Though the pandemic has presented stressors, Rotter said, children can be very resilient.
"Supportive caregivers and supportive emotional environments help with resilience in the child," she said. "Resilience is not just what's in the child, but what's within the child's environment. It's the home, religious community, school and day care environment that aid in the child's development and how they cope with changes."
And the pandemic may leave behind one benefit for children: the emphasis on washing hands. Child care experts said good hygiene habits are an important life lesson that will likely last beyond this health crisis.
As a funeral director at Ingold Funeral and Cremation in Fontana, California, Jessica Rodriguez helps families say goodbye to their loved ones. "We serve predominantly Latino families, most of them second- and third-generation" residents, said Rodriguez. "We do have quite a few that are first-generation, that don't speak any English."
Most are unaware of a federal program that offers up to $9,000, she said. And even when they know about the aid from the Federal Emergency Management Agency, the process is daunting and the bureaucracy confusing. The lack of English skills hinders some families of people who died of COVID from receiving reimbursement from FEMA for funeral expenses, so her office offers them help in Spanish.
Rodriguez herself is one of the applicants. "My father passed away from COVID. That's why I really wanted to push the program," she said. "I know firsthand what it's like to have to come up with that type of money without having planned to do so."
Rodriguez said her funeral home, in a city where nearly 70% of its 215,000 residents are Latino, kept a running list since the start of the pandemic of all of the deceased they took care of who died of COVID. "Originally, the reason we compiled a list was to see the impact," she said. "But when FEMA first announced the funeral assistance program, we made it a point to call every family that was on that list and let them know about it."
As of Monday, FEMA has approved more than $278 million for more than 41,000 eligible applicants, with the average amount per application standing at $6,756. FEMA said it does not consider ethnicity when determining eligibility, so the agency does not track that data.
Offering clients help to get some of that money is important because California's Latinos suffered more COVID deaths than any other race or ethnic group and the Latino population has faced a greater risk of exposure to COVID-19 and undergone testing at a lower rate, according to a study by Stanford University researchers. Latinos are also far more likely than non-Hispanic whites to live in a household with an essential worker, who might not have had the luxury of protecting themselves at home during the ravaging months of the pandemic.
"In my career of 35 years, I've never been in this type of situation where I have seen so much death," said Rafael Rodriguez, a funeral director in the city of Bell at Funeraria del Angel Bell, part of Dignity Memorial.
The cost of an average funeral can be as much as $15,000, he said, so the FEMA reimbursement program offers financial relief for many clients. But it isn't easy to get the money.
Rodriguez and the funeral home's office manager, Norma Huerta, said they have been receiving calls daily from people confused about how to apply. "These are humble people who don't have access to the internet or know how to use a computer," said Huerta. "They already trust me since I helped them with the funeral process. How could I say no?"
Even though the FEMA helpline offers instructions in Spanish, uploading, emailing or even faxing the necessary documents has been a challenge, said Huerta. "I can spend three to four hours a day helping families with their applications." Just sending over a fax cover sheet is frustrating, she said. "I tell them it takes a while, but to have patience and I'll help them get it done."
Families call to request duplicate contracts and receipts and ask for clarification about death certificates. The hardest part for some has been proving their family member's death was COVID-related, said Huerta. If the death certificate doesn't specifically state that, they won't qualify. Death certificates can be amended to receive reimbursement, but that process is also complicated and time-consuming.
Manuela Galvez, a 61-year-old originally from Sinaloa, Mexico, is one of the applicants Huerta helped. She lost her son Luis Alberto Vasquez to COVID on April 22, 2020. The 36-year-old managed a cleaning crew that disinfected assisted living facilities, which is where Galvez suspects her son got COVID.
Galvez said she heard about the FEMA checks from family members but didn't understand the process. "Norma did me a huge favor filling out that paperwork," Galvez said in Spanish. "I wouldn't have been able to do it myself because I'm completely lost when it comes to technology."
Those who need help the most are the most disconnected, said Rafael Fernández de Castro Medina, director of University of California-San Diego's Center for U.S.-Mexican Studies. "Many times they are people who not only don't speak English, but at times, don't even speak Spanish well," said Medina. "Like people who come from Yucatán who speak Maya."
Isaias Hernandez, executive director of Eastmont Community Center in East Los Angeles, said many of the people asking him for help feel overwhelmed by the process. "Most have never buried a loved one, so they're emotional and still dealing with the trauma," said Hernandez. "Just gathering the documents seems complicated to them."
Undocumented immigrants and those who hold temporary visas are not eligible for FEMA's funeral assistance, even though advocates like Hernandez say these are the people who kept the country afloat during the pandemic. "They work in the grocery stores, the day cares and schools," he said. "They're the essential workers." Hernandez said his office has received only a few calls from people inquiring about legal-status qualifications.
He said it's not just about having access to technology, but also access to people who can support them. "People in our community are extremely dependent on the younger generation who can help them navigate basic computer functions," he said.
For Galvez, that person was her late son, Luis Alberto. "He was the one who was the most patient with me," she said.
Galvez is waiting to hear back from FEMA on whether she qualifies to be reimbursed for the $5,400 she spent on her son's funeral. "If they can't give me any money, that's OK," said Galvez. "It's help they're offering that I wasn't expecting to get anyway. It's in God's hands."
Training on how to interact with disabled people varies, but the basics include identifying such individuals early in an encounter instead of relying on use of force.
This article was published on Tuesday, June 15, 2021 in Kaiser Health News.
Nearly a year after police officers in Loveland, Colorado, injured an elderly woman with dementia and then laughed at footage of her arrest, two of those officers are facing criminal charges while the rest of the department undergoes additional training. The fallout has drawn national attention to a problem that experts say is widespread across law enforcement agencies: Police often lack the skills to interact with people with mental and physical disabilities.
Last June, a Walmart employee called police after Karen Garner, 73 at the time, tried to leave without paying for $14 worth of items. Soon after, Officer Austin Hopp's body camera video showed, he pulled over beside her as she walked down a road and wrestled her to the ground in handcuffs after she failed to respond to his questions. Afterward, Garner's lawyers say, she sat in jail for several hours with a dislocated and fractured shoulder as Hopp and two other officers laughed while watching the body camera video.
According to a federal complaint, Garner has dementia and also suffers from sensory aphasia, which impairs her ability to understand. Her violent arrest has other elderly people worried about potential encounters with police, Loveland resident June Dreith told Police Chief Robert Ticer during a public meeting last month.
"They are now seriously afraid of the police department," Dreith said.
Hopp resigned and faces felony charges of assault and attempting to influence a public servant — a charge related to allegations of omissions when reporting the arrest — as well as official misconduct, a misdemeanor. Another officer, Daria Jalali, also resigned and is charged with three misdemeanors: failure to report excessive force, failure to intervene and official misconduct. Neither has entered a plea in court. A third officer, who watched the video with them, resigned but has not been charged.
An independent assessment of the Loveland Police Department by a third-party consultant is underway. The city and involved officers face a federal lawsuit, filed by Garner in April, alleging excessive use of force and violations of the Americans With Disabilities Act.
Ticer declined to be interviewed, but through his public information officer he characterized the Garner incident as a problem with an individual officer, not with the department's operations.
"Our training currently, in the past and present, is always to make sure our officers are up to speed on as much training as they can on how to interact with people in crisis who may have mental health issues," Ticer said during the public meeting in May at department headquarters.
Loveland's police department, like many others, requires officers to be trained to respond to people with mental illness and developmental disabilities. But no national standards exist. That means the amount of training law enforcement officers receive on interacting with disabled people varies widely.
"On the whole, we're doing terrible," said Jim Burch, president of the National Police Foundation, a nonprofit organization focused on police research and training. "We have to do much, much better at being able to recognize these types of issues and being more sensitive to them."
While comprehensive data on the frequency of negative interactions between police and people with mental disabilities is lacking, interactions with the criminal justice system are common. The Bureau of Justice Statistics has estimated about 3 in 10 state and federal prisoners and 4 in 10 local jail inmates have at least one disability.
"There's a very large number of people that police are coming into contact with that have an intellectual disability or mental health challenge," Burch said. "Do we have a systemic problem? We think that we do."
Colorado requires a minimum of two hours of training on interacting with people with disabilities, although legislation aims to improve on that by creating a commission to recommend new statewide standards.
Loveland's officers are certified in crisis intervention training. The department also has a co-responder program, which pairs law enforcement officers with mental health clinicians, although this team was not called during Garner's arrest. Since that incident, questions remain about the department's readiness to interact with disabled citizens.
"We could always use more and more training. We could train every single week for eight hours a day, but we could do that all the time and never go out on calls," said Sgt. Brandon Johnson, who oversees training. "It's just balancing our available workforce and our time and our service to the community and our staffing levels."
Loveland police officers are now undergoing Alzheimer's awareness training, and five staff members will be trained as de-escalation instructors, department officials said.
Training on how to interact with disabled people varies, but the basics include identifying such individuals early in an encounter instead of relying on use of force.
"It's scary, because you don't know why they're not following your commands," said Ali Thompson, a former deputy with the Boulder County Sheriff's Office who now serves on the Colorado Developmental Disabilities Council. "So, your adrenaline starts pumping and you think … 'They're not listening to my commands because they have a warrant or because they have a gun on them,' or you come up with all of these scenarios to explain it."
Garner's rough arrest is "not an isolated incident by any means," Thompson said. She said she would not have thought to attribute noncompliance to conditions like autism or dementia when she was a young patrol officer.
"We need to start bringing those possibilities into those 'what if' scenarios," Thompson said.
In addition to teaching how to identify disabled people, organizations such as the International Association of Chiefs of Police help prepare officers for such situations by showing them how to speak in short phrases, refrain from touching, and turn off sirens and flashing lights. Research on which disability-specific efforts actually reduce bad outcomes is scant, but experts point to other types of curricula as relevant, too, including crisis intervention training, instruction on de-escalating tensions and sessions on mental illness.
"Just training in and of itself is not going to create that long-term change that we are hoping for," said Lee Ann Davis, director of criminal justice initiatives at The ARC, a national disability advocacy organization.
That means going beyond officer training to address the many areas in which people with disabilities are not being identified and supported, she said. One of The ARC's programs, Pathways to Justice, brings in not only law enforcement officials but also attorneys and victim service providers for instruction.
"So our goal is to help communities understand that this is a communitywide issue, that there's not one specific spoke within the criminal justice system or in our communities that can address it adequately alone," Davis said.
Johnson, the Loveland sergeant in charge of training, said officers have been engaged for years in community outreach such as supporting the Special Olympics.
Despite the actions of the three officers who resigned, Johnson believes the department is adequately prepared to interact with disabled citizens. At the same time, he acknowledges limitations.
"We have to be the first responder. We have to have a good foundational understanding of all of it," he said. "But we're also not … we're also not experts."
For more than a year, public health officials have repeatedly told us that masks save lives. They've warned us to keep our distance from our neighbors, who've morphed into disease vectors before our eyes.
Now they are telling us that if we're vaccinated, we no longer need to wear masks or physically distance ourselves in most cases — even indoors. To many people, myself included, this seems hard to reconcile with so many long months of masking and physical distancing and sacrificing our social lives for fear of COVID-19.
What is an anxious, pandemic-weary (and wary) soul to do?
First, it's important to stress that the dramatic rollback of mask-wearing and physical distancing recommended last month by the Centers for Disease Control and Prevention — a policy California has adopted starting Tuesday as part of a broader reopening — applies only to people who have been fully vaccinated.
Even if you are vaccinated, though, you don't need to change your behavior one iota if doing so makes you uncomfortable.
"Nothing in the CDC guidelines says to stop wearing a mask," says Dr. José Mayorga, executive director of the UCI Health Family Health Centers. "It's a recommendation, but if you choose to wear one, that's OK. You shouldn't be stigmatized."
Mayorga has lost five relatives to COVID, including a favorite aunt, and he knows from personal experience how hard it can be to rush back into so-called normalcy.
"Many people have not been directly impacted by COVID," he says. "But for those of us who have been, it's natural to have concern or fear, thinking, 'Oh, I can take my mask off? But is it really safe?'"
Some people are just cautious by nature and won't be rushing to jettison their masks and rub elbows with unmasked strangers. "I know that, realistically, I can do pretty much anything once I'm fully vaccinated, but mentally it's scary," says 36-year-old Sacramento resident Shannon Albers, who got her second dose of the Pfizer vaccine on May 27. "It's going to be weird, after a year of them drilling into us 'Wear a mask, wear a mask, wear a mask,' to be around a bunch of people who aren't wearing masks."
Early in the pandemic, the CDC said masks were not necessary. Then, it changed its guidance so emphatically that masks became an indispensable part of our wardrobes. Now the advice has changed again.
"For scientists, it is very understandable that there is this revision of recommendations based on new research," says Roxane Cohen Silver, a professor of psychology, public health and medicine at the University of California-Irvine. "But for the general public, that could sound very confusing."
Early on, many people feared catching the coronavirus from surfaces and even disinfected groceries before putting them away. Now, the virus is believed to spread mainly through the air, and the notion of spraying or wiping down everything you bring into the house seems silly.
We don't know how long the vaccines' protection lasts, but it is increasingly clear that being vaccinated reduces the risk of infecting others.
"Vaccinated people have very little risk of infection; they can do what they want to do," says Dr. George Rutherford, a professor of epidemiology at the University of California–San Francisco. "I think we're in pretty good shape, and I think it's going to be pretty much a disease-free summer."
In California, the rate of positive COVID tests has dropped from a seven-day average of over 17% in early January, at the peak of the winter surge, to under 1% now. The number of hospitalized COVID patients statewide has fallen from over 22,000 to below 1,300 in the same period.
Around 46% of Golden State residents have been fully vaccinated, lagging behind numerous other states but ahead of the national rate of just under 43%. Some millions more have built up immunity after a COVID infection.
As more people get protection, the COVID virus finds fewer susceptible bodies, further reducing transmission and producing a downward spiral in the number of cases.
If you are indoors with other people you know to be vaccinated, you can dispense with masks. Want to cook dinner for a group of vaccinated friends you haven't seen for several months? Carpe diem — and don't worry about wearing masks or sitting spaced apart.
But if you are in a mixed crowd — say, a grocery store — and don't know who's vaccinated, wear a mask, even though your personal risk is low. If the workers are wearing masks, it's a matter of respect to wear one yourself. Some people may be nervous about being there — those who are immune-compromised, for example, or can't get vaccinated for some other health reason — and they won't know if you've had your shots.
"Forget about the medical benefit," says Bradley Pollock, associate dean for Public Health Sciences at the UC-Davis School of Medicine. "If you are wearing a mask, people who are not vaccinated don't need to feel uncomfortable around you. So, it's kind of a courtesy issue."
The presence of children is another good reason to mask up. Most kids ages 12 to 16 haven't been vaccinated yet, and those under 12 can't be, yet. They'll probably have to wear masks in school this fall.
And though children have not been hit by COVID nearly as hard as adults, and are not efficient transmitters of the virus, thousands of kids have been hospitalized with it nonetheless — including about 4,000 nationwide diagnosed with a frightening multisystem inflammatory syndrome.
Mayorga, who is fully vaccinated and has young children, says he wears a mask "to protect them and to model good behavior."
Public health experts agree that vaccinating as many people as possible, including children, is the way out of the pandemic.
But the rate of vaccinations has slowed recently. One of the biggest contributions you can make to the public good right now is to get vaccinated — and help others do the same.
Some people aren't vaccinated because they lack mobility and can't get to an appointment. Check in with elderly neighbors, and if they haven't been vaccinated and need a ride, offer to drive them. You can also check with your local department on aging, community groups that serve the elderly, public health agencies or hospitals to ask if they are seeking drivers.
Perhaps the biggest impact you can have is persuading friends and loved ones to get the vaccine – and then urging them to persuade others.
If they think the vaccines were rolled out too fast to be safe, tell them that related coronavirus vaccine research has been going on for more than a decade. Point out that hundreds of millions of COVID shots have now been given and serious side effects are rare — and are being carefully monitored by officials.
You might also need to rebut the widespread notion that the vaccine could suddenly produce some terrible, unforeseen health impact a few years down the road. "That just doesn't happen," Pollock says.
Expect to encounter resistance at first, but be persistent. It can take numerous conversations to assuage anxieties, but your close friends will listen.
"If your best friend tells you they did this, that's highly influential — more than some talking head," Pollock says.
Missoula began sending a special crew on emergency mental health calls in November as a pilot project, and next month the program will become permanent.
This article was published on Monday, June 14, 2021 in Kaiser Health News.
By the time Kiki Radermacher, a mental health therapist, arrived at a Missoula, Montana, home on an emergency 911 call in late May, the man who had called for help was backed into a corner and yelling at police officers.
The home, which he was renting, was about to be sold. He had called 911 when his fear of becoming homeless turned to thoughts of killing himself.
"I asked him, 'Will you sit with me?'" recalled Radermacher, a member of the city's mobile crisis response team who answered the call with a medic and helped connect the man with support services. "We really want to empower people, to find solutions."
Missoula began sending this special crew on emergency mental health calls in November as a pilot project, and next month the program will become permanent. It's one of six mobile crisis response initiatives in Montana — up from one at the start of 2019. And four more local governments applied for state grants this year to form teams.
Nationwide, more communities are creating units in which mental health professionals are the main responders to psychiatric crises instead of cops, though no official count exists of the teams that are up and running.
More support is on the way. The COVID relief package President Joe Biden signed in March offers states Medicaid funding to jump-start such services. By July 2022, a national 988 hotline, modeled on 911, is slated to launch for people to reach trained suicide prevention specialists and mental health counselors.
Protests against police brutality in the past year have helped propel the shift across the United States. While one rallying cry has been to "defund the police," these crisis intervention programs — the sort that employ therapists like Radermacher — are often funded in addition to law enforcement departments, not drawing from existing policing budgets.
Studies suggest such services enable people in crisis to get help instead of being transported away in handcuffs. But the move away from policing mental health is still a national experiment, with ongoing debate about who should be part of the response, and limited research on which model is best. Even then, not all communities can afford and staff separate mental health teams.
"I don't know that there's a consensus of what the best approach is at this point," said Amy Watson, a professor of social work at the University of Wisconsin-Milwaukee who has studied such crisis intervention. "We need to move towards figuring out what are the important elements of these models, where are the pieces of variation and where those variations make sense."
The federal Substance Abuse and Mental Health Services Administration sets minimum expectations for teams, such as including a healthcare professional and connecting people to more services, if needed. Ideally, the guidelines suggest, the team should include a crisis response specialist who has personally experienced mental health challenges, and the team should respond to the calls without law enforcement.
Still, crisis response teams vary significantly in their makeup and approach. For more than 40 years, the Los Angeles Police Department has deployed teams in which police officers and mental health workers respond together. It boasts the program is one of the nation's earliest to do so. A program out of Eugene, Oregon, which has been copied across the U.S., teams a crisis intervention worker with a nurse, paramedic or emergency medical technician. In Georgia, 911 emergency dispatchers steer calls to a statewide crisis center that can deploy mobile units that include professionals with backgrounds in social work, counseling and nursing. In Montana, teams are based within law enforcement departments, medical facilities or crisis homes.
"Mobile crisis response, in whatever format it looks like, is becoming more and more the norm," said Kari Auclair, an area director for Western Montana Mental Health Center, a nonprofit treatment program. "In some communities, it's going to be the church group that's going to be part of a crisis response, because that's who people go to and that's what they've got."
Defenders of the various models tout reasons for their teams' makeups and match-ups: Medics can recognize a diabetic blood sugar crash that might mimic substance misuse or a mental health crisis; police can watch for danger if tensions escalate; and crews tethered to hospitals' behavioral health units have a team of doctors on standby they can consult.
Many crisis teams still work directly with law enforcement, sometimes responding together when called or staying on the scene after officers leave. In Montana, for example, 61% of the calls that crisis teams handled also involved law enforcement, according to state data.
Zoe Barnard, administrator for Montana's addictive and mental disorders division, said her state is still establishing a baseline for what works well there. Even after they've worked out a standard, she added, local governments will continue to need flexibility in how they set up their programs.
"I'm a realist," Barnard said. "There will be parts of the state that are going to have limitations related to workforce, and trying to put them into a cookie-cutter model might keep some from doing something that really does the job well."
In some areas, recruiting mental health workers to such teams is nearly impossible. Federal data shows 125 million people live in areas with a shortage of mental health professionals, a problem exacerbated in rural America. That lack of expertise and support can fuel the crises that warrant emergency help.
In Helena, Montana's capital, for example, a crisis crew that formed in November must still fill two positions before services can run round-the-clock. All across the U.S., with these sorts of high-stress jobs often paid through cobbled-together grants, retaining staff is a challenge.
Being flexible will be key for programs as they develop, said Jeffrey Coots, who directs an initiative at John Jay College of Criminal Justice in New York City to prevent unnecessary imprisonment.
"We're trying to figure our way out of historical inequities in mental healthcare services," Coots said. "The best thing to do is to run that demonstration project, and then adapt your team based on the data."
And for the people in these crises who need help, having an alternative to a police officer can mean a big difference, said Tyler Steinebach, executive director of Hope Health Alliance Inc., which offers behavioral crisis training for medics across Montana. He knows firsthand because he has both bipolar and post-traumatic stress disorders and has had to call 911 when his own mental health has plummeted.
"You know cops are coming, almost certainly," Steinebach said, from his personal experience. "You're trying to figure out what to say to them because you're trying to fight for yourself to get treatment or to get somewhere where you can talk to somebody — but you're also trying to not get hauled off in handcuffs."
Gallatin County Sheriff Dan Springer also noticed the benefits after two mental health professionals started to respond to 911 calls in Bozeman and the surrounding area in 2019. Although deputies in his department are trained in crisis intervention, he said that goes only so far.
"When I hear deputies say the mental health provider is a godsend, or they came in and were able to extend the capabilities of the response, that means something to me," Springer said. "And I hear that routinely now."
Erica Gotcher, a medic on the mental health response team in Missoula, recalled a day recently when her team was wrapping up a call and received three new alerts: A man was considering suicide, a teen was spiraling into crisis and someone else needed follow-up mental health services. They knew the suicide risk call would take time as responders talked to the person by phone to get more details, so they responded to the teen hitting walls first and saw all three people before their shift was done.
Gotcher said being busy is a good sign that her team — and teams like it — are becoming just one more form of first response.
"Sometimes we roll up on a scene and there are three cop cars, an ambulance and a firetruck for one person who is having a panic attack," Gotcher said. "One of the best things that we can do is briefly assess the situation and cancel all those other resources. They can go fight fires; they can go fight crime. We are the ones that need to be here."
But gaps still exist, such as not always having somewhere to take a patient who needs a stable place to recuperate or get more help. The team's shift also ends at 8 p.m., meaning, come nighttime, it's back to police officers responding alone.
Need help?
If you or someone you know is in a crisis, please call the National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or contact the Crisis Text Line by texting TALK to 741741.
HCA Healthcare's activation fees run as high as $50,000 per patient and are sometimes 10 times greater than those at other hospitals, according to publicly posted price lists.
This article was published on Monday, June 14, 2021 in Kaiser Health News.
After falling from a ladder and cutting his arm, Ed Knight said, he found himself at Richmond, Virginia's Chippenham Hospital surrounded by nearly a dozen doctors, nurses and technicians — its crack "trauma team" charged with saving the most badly hurt victims of accidents and assaults.
But Knight's wound, while requiring about 30 stitches, wasn't life-threatening. Hospital records called it "mild." The people in white coats quickly scattered, he remembered, and he went home about three hours later.
"Basically, it was just a gash on my arm," said Knight, 71. "The emergency team that they assembled didn't really do anything."
Nevertheless, Chippenham, owned by for-profit chain HCA Healthcare, included a $17,000 trauma team "activation" fee on Knight's bill, which totaled $52,238 and included three CT scans billed at $14,000. His care should have cost closer to $3,500 total, according to claims consultant WellRithms, which analyzed the charges for KHN.
HCA Healthcare's activation fees run as high as $50,000 per patient and are sometimes 10 times greater than those at other hospitals, according to publicly posted price lists. Such charges have made trauma centers, once operated mainly by established teaching hospitals, a key part of the company's growth and profit-generating strategy, corporate officials have said. HCA's stock has doubled in three years. The biggest U.S. hospital operator along with the Department of Veterans Affairs, HCA has opened trauma centers in more than half its 179 hospitals and says it runs 1 of every 20 such facilities in the country.
And it's not slowing down.
HCA "has basically taken a position that all of their hospitals should be trauma centers," said Dr. Robert Winchell, describing conversations he had with HCA officials. Winchell is a trauma surgeon and former chairman of the trauma evaluation and planning committee at the American College of Surgeons.Bottom of Form
Trauma patients are typically those severely injured in automobile accidents or falls or wounded by knives or guns.
State or local regulators confer the designation "trauma center," often in concert with standards verified by the American College of Surgeons. The status allows a cascade of lucrative reimbursement, including activation fees billed on top of regular charges for medical care. Trauma centers are mostly exempt from 1970s-era certificate-of-need laws enacted to limit excessive hospital spending and expansion. The bills for all this — reaching into tens of thousands of dollars — go to private insurers, Medicare or Medicaid, or patients themselves.
"Once a hospital has a trauma designation, it can charge thousands of dollars in activation fees for the same care seen in the same emergency room," said Stacie Sasso, executive director of the Health Services Coalition, made up of unions and employers fighting trauma center expansion by HCA and others in Nevada.
HCA's expansion into trauma centers alarms health policy analysts who suggest its motive is more about chasing profit than improving patient care. Data collected by the state of Florida, analyzed by KHN, shows that regional trauma cases and expensive trauma bills rise sharply after HCA opens such centers, suggesting that many patients classified as trauma victims would have previously been treated less expensively in a regular emergency room.
Patients admitted to HCA and other for-profit hospitals in Florida with a trauma-team activation were far more likely to be only mildly or moderately injured than those at not-for-profit hospitals, researchers have found.
HCA is "cherry-picking patients," said Ed Jimenez, CEO of the University of Florida Health Shands, which runs a Level I trauma center, the highest designation. "What you find is an elderly person who fell and broke their hip who could be perfectly well treated at their local hospital now becomes a trauma patient."
HCA's trauma center expansion makes superior care available to more patients, providing "lifesaving clinical services while treating all critically injured patients," said company spokesperson Harlow Sumerford.
Richmond's population "is booming," said Chippenham spokesperson Jeffrey Caldwell. "This increase in demand requires that the regional healthcare system keep up."
Trauma Is Big Business
HCA's trauma center boom picked up speed in Florida a decade ago and has spread to its hospitals in Virginia, Nevada, Texas and other states. It has sparked fierce fights over who handles highly profitable trauma cases and debates over whether costs will soar and care suffer when rival centers go head-to-head competing for patients.
"There's no question it's a money grab" by HCA, said Jimenez, who was part of a largely unsuccessful effort to stop HCA's trauma center expansion in Florida. "It was clear that their trauma activation fees were five or six times larger than ours."
In a process shielded from public view in Virginia, Chippenham recently applied for and won the highest trauma center designation, Level I, providing the most sophisticated care — and putting it squarely in competition with nearby VCU Health. VCU has run the region's only Level I facility for decades. In October, Chippenham announced a contract for its own helicopter ambulance, which gives it another way to increase its trauma business, by flying patients in from miles away. The Virginia Department of Health rejected KHN's request to review HCA's Chippenham trauma center application and related documents.
"This is a corporate strategy" by HCA "to grow revenue, maximize reimbursement and meet the interest of stockholders," said Dr. Arthur Kellermann, CEO of VCU Health, who says his nonprofit, state-run facility is sufficient for the region's trauma care needs. "Many people in the state should be concerned that the end result will be a dilution of care, higher costs and poorer outcomes."
Chippenham's Caldwell said the "redundancy" with VCU "allows the region to be better prepared for mass trauma events."
Studies show trauma centers need high volumes of complex cases to stay sharp. Researchers call it the "practice makes perfect" effect. Patients treated for traumatic brain injuries at hospitals seeing fewer than six such cases a year died at substantially higher rates than such patients in more experienced hospitals, according to a 2013 study published in the Journal of Neurosurgery.
Another study, published in the Annals of Surgery, showed that a decrease as small as 1% in trauma center volume — because of competition or other reasons — substantially increased the risk that patients would die.
By splitting a limited number of cases, a competing, cross-town trauma center could set the stage for subpar results at both hospitals, goes the argument. The number of VCU's admitted adult trauma patients decreased from nearly 3,600 in 2014, before Chippenham attained Level II status, to 3,200 in 2019, VCU officials said.
Chippenham was the only Level I center in Virginia that declined to disclose its trauma patient volume to KHN.
"People are trying to push the [trauma center] designation process beyond what may be good for the major hospitals that are already providing trauma care," said Dr. David Hoyt, executive director of the American College of Surgeons, speaking generally. Local authorities who make those decisions, he said, can be "pressured by a hospital system that has a lot of economic pull in a community."
Unlike regular emergency departments, Level I and Level II trauma centers make trauma surgeons, neurosurgeons and special equipment available round-the-clock. Centers with Levels III or IV designations offer fewer services but are still more capable than many emergency rooms, with round-the-clock lab services and extra training, for example.
Hospitals defend trauma team activation fees as necessary to cover the overhead of having a team of elite emergency specialists at the ready. At HCA hospitals they can run more than $40,000 per case, according to publicly posted charge lists, although the amount paid by insurers and patients is often less, depending on the coverage.
"Fees associated with trauma activation are based on our costs to immediately deploy lifesaving resources and measures 24/7," said HCA spokesperson Sumerford, adding that low-income and uninsured patients often pay nothing for trauma care. "What patients actually pay for their hospital care has more to do with their insurance plan" than the total charges, he said.
There is no standard accounting for trauma-related costs incurred by hospitals. One method involves multiplying hourly pay for members of the trauma team by the potential hours worked. Hospitals don't reveal calculations, but the wide variation in fees suggests they are often set with an eye on revenue rather than true costs, say industry analysts.
Reasonable charges for Knight's total bill would have been $3,537, not $52,238, according to the analysis by WellRithms, a claims consulting firm that examined his medical records and Chippenham's costs filed with Medicare. Given his minor injury, the $17,000 trauma activation fee "is not necessary," said Dr. Ira Weintraub, WellRithms' chief medical officer.
Often insurers pay substantially less than billed charges, especially Medicare, Knight's insurer. He paid nothing out-of-pocket, and Chippenham collected a total of $1,138 for his care, HCA officials said after this article was initially published. But hospitals can maximize revenue by charging high trauma fees to all insurers, including those required to pay a percentage of charges, say medical billing consultants.
VCU Health charges up to $13,455 for trauma activation, according to its charge list.
Average HCA trauma activation charges are $26,000 in states where the company does business — three times higher than those of non-HCA hospitals, according to data from Hospital Pricing Specialists, a consulting firm that analyzed trauma charges in Medicare claims for KHN.
The findings are similar to those reported by the Tampa Bay Times in 2014, early in HCA's trauma center expansion. The Times found that Florida HCA trauma centers were charging patients and insurers tens of thousands of dollars more per case than other hospitals.
Treating trauma patients in the ER is only the beginning of the revenue stream. Intensive inpatient treatment and long patient recoveries add to the income.
"We have more Level I, Level II trauma centers today than we have ever had in the company history," HCA's then-CEO, Milton Johnson, told stock analysts in 2016. "That strategy in turn feeds surgical growth. That strategy in turn feeds neurosciences growth, it feeds rehab growth." Trauma centers attract "a certain cadre of high-value patients," Dr. Jonathan Perlin, HCA's chief medical officer, told analysts at a 2017 conference.
Patients at HCA's largely suburban hospitals are more likely than those at an average hospital to carry private insurance, which pays much more than Medicare and Medicaid. More than half the company's revenue in 2020 came from private insurers, regulatory filings show. Hospitals, in general, collect a little more than a third of their revenue from private insurers, according to the Department of Health and Human Services.
HCA's trauma cases can fit the same profile. At Chippenham, in south Richmond, trauma cases are "90% blunt trauma," according to the hospital's online job posting last year for a trauma medical director. Blunt-trauma patients are generally victims of car accidents and falls and tend to have good insurance, analysts say.
VCU and other urban hospitals, on the other hand, treat a higher share of patients with gun and knife injuries — penetrating trauma — who are more often uninsured or covered by Medicaid. About 75% of VCU's trauma cases are classified as blunt trauma, hospital officials said.
The 90% figure is "not accurate today," Caldwell said. "Chippenham's current mix of trauma type is aligned with that of other trauma centers in the region, and we treat traumas ranging from motor vehicle accidents to gunshots, stabbings and other critical injuries regularly."
'Trauma Drama' in Florida and Beyond
HCA's growth strategy is part of a wider trend. From 2010 to 2020 the number of Level I and Level II trauma centers verified by the American College of Surgeons nationwide increased from 343 to 567.
Nowhere has HCA added trauma centers more aggressively or the fight over trauma center growth been more acrimonious than in Florida. The state's experience over the past decade may offer a preview of what's to come in Virginia and elsewhere.
In the thick of the controversy, legislators stepped in to broker a 2018 truce — but only after the number of HCA trauma centers in the state had grown from one to 11 over more than a decade and helped spark an explosion in trauma cases, according to Florida Department of Health data.
News headlines called it "trauma drama." Hospitals with existing centers repeatedly filed legal challenges to stop the expansion, with little effect. Florida's governor at the time was Rick Scott, former chief executive of Columbia/HCA, a predecessor company to HCA.
After launching Level II centers across the state, HCA officials urged Florida regulators not to adopt CDC guidelines recommending severely injured patients be treated at the highest level of trauma care in a region — Level I, if available.
HCA "kept on working, working, working, working for 10 years" to gain trauma center approvals over objections, said Mark Delegal, who helped broker the legislative settlement as a lobbyist for large safety-net hospitals. "Once they had what they wanted, they were happy to lock the door behind them."
HCA hospitals "serve the healthcare needs of their communities and adjust or expand services as those needs evolve," said Sumerford.
As HCA added trauma centers, trauma-activation billings and the number of trauma cases spiked, according to Florida Department of Health data analyzed by KHN. Statewide, inpatient trauma cases doubled to 35,102 in the decade leading up to 2020, even though the population rose by only 15%. HCA's share of statewide trauma cases jumped from 4% to 24%, the data shows.
Charges for trauma activations, also known as trauma alerts, for HCA's Florida hospitals averaged $26,890 for inpatients in 2019 while the same fees averaged $9,916 for non-HCA Florida hospitals, the data shows. Total average charges, including medical care, were $282,600 per case in 2019 for inpatient trauma cases at HCA hospitals, but $139,000 for non-HCA hospitals.
HCA's substantially higher charges didn't necessarily result from patients with especially severe injuries, public university research found.
Over three years ending in 2014, Florida patients with sprains, mild cuts and other non-life-threatening injuries were "significantly more likely" to be admitted under trauma alerts at HCA hospitals and other for-profit hospitals than at nonprofit hospitals, according to research by University of South Florida economist Etienne Pracht and colleagues. HCA hospitals have admitted emergency department Medicare patients at substantially higher-than-average rates since 2011, suggesting that at other hospitals many would have been sent home, new research by the Service Employees International Union found.
"What's going on with HCA is the Wall Street model they're following," said Pracht, who provided KHN with additional Florida Department of Health data showing soaring trauma cases. "And Wall Street's not happy unless you're expanding. They're driven by the motive to keep the stock price high."
Lobbying and Campaign Dollars
In Virginia, healthcare organizations need to go through a lengthy and public application process to add something as basic as a $1 million MRI imaging machine.
But to open or upgrade a trauma center, all that's needed is the approval of the health commissioner after a confidential qualification procedure. Chippenham did not seek or obtain Level I verification from the American College of Surgeons before getting Level I approval from the state. It is ACS-verified as a Level II center and, Caldwell said, is seeking Level I status with ACS.
Virginia requires an "extensive application" and "in-depth" site reviews by experts before a hospital gains status as a trauma center, Dr. M. Norman Oliver, the commissioner, said in an email. "Chippenham Hospital met the requirements" to become a Level I center, he said.
Nearly 80% of HCA's Level I and Level II trauma centers have been verified by the American College of Surgeons "and the others currently are pursuing this verification," said HCA spokesperson Sumerford.
As in other states, HCA invests heavily in Virginia in political influence. Eleven Virginia lobbyists are registered with the state to advocate on HCA's behalf. One lobbyist spent more than $5,000 from December 2019 through February 2020 treating public officials to reception spreads and meals at posh Richmond restaurants such as L'Opossum and Morton's the Steakhouse, lobbying records submitted to Virginia's Conflict of Interest and Ethics Advisory Council show. HCA's political action committee donated $160,000 to state candidates last year, according to the records.
Like other hospital systems, HCA hires former paramedics for "EMS relations" or "EMS outreach" jobs. HCA's EMS liaisons are expected to develop a "business plan, driving service line growth," according to its employment ads.
Chippenham's decision to start a helicopter ambulance operation last year to compete with others in transporting trauma patients surprised some public officials. HCA and its contractor had filed paperwork for the operation to be reimbursed by insurers when Richmond City Council members learned about it. Members "were not up to speed on this matter," council member Kristen Larson told a May 2020 meeting of the Richmond Ambulance Authority, according to the minutes.
Chippenham's air ambulance partner, private equity-owned Med-Trans, has been the subject of numerous media reports of patients saddled with tens of thousands of dollars in out-of-network surprise bills. It's not unusual for air ambulances to charge $30,000 or more for transporting a patient from a highway accident or just across town, according to news reports.
Last year, 85% of Med-Trans flights for Virginia patients with health insurance were in-network, said a company spokesperson. But Med-Trans is out of network for Virginia members of Aetna and UnitedHealthcare, two of the state's biggest carriers, said spokespeople for those companies. Med-Trans is part of Anthem Blue Cross Blue Shield's network, an Anthem spokesperson said.
HCA runs trauma centers "really well," said Winchell, who runs the Level I trauma center at NewYork-Presbyterian Weill Cornell Medical Center.
But "there are clearly areas of oversupply" for trauma centers generally, he said.
Instead of letting a drive for profits dictate trauma center expansion, health authorities need "objective and transparent metrics" to guide the designation of trauma centers, Winchell recently wrote in the Journal of the American College of Surgeons.
Free-market advocate "Adam Smith might have been a good economist," he wrote, "but he would have been a very poor designer of trauma systems."
KHN data editor Elizabeth Lucas contributed to this report.
SAN LUIS VALLEY, Colo. — A woman with pregnancy complications needed permission from her boss to visit a doctor. Community health volunteers were turned away from delivering food and COVID information to worker housing. A farmworker had a serious allergic reaction but was afraid to seek treatment.
To Nicole Civita, policy director with Colorado advocacy group Project Protect Food Systems Workers, such stories encapsulate an entrenched power dynamic that COVID-19 has brought into focus: Farmworkers are "essential but treated as expendable," including when it comes to accessing health care.
Her organization is one of many that supported Colorado legislation dubbed the Farmworker Bill of Rights. Among its provisions is a requirement that the more than 3,000 Colorado farmworkers who live in employer-provided housing be able to visit, or be visited by, medical professionals and community health workers. Employers must also provide transportation to medical visits for those without vehicles. The bill passed the legislature Tuesday and is now off to the governor.
States including Florida, Maryland, Oregon and Wisconsin have guaranteed farmworkers the right to see health care providers where they live. The pandemic spurred North Carolina to reiterate that employers cannot bar health care providers from visiting farmworkers living on their property.
Augusto Basterrechea, who does outreach to farmworkers for the Colorado Department of Labor and Employment in the San Luis Valley, an agricultural hub, said that in his eight years in the role he had never heard of a farmworker being unable to get medical care, even during the pandemic.
But former farmworker Anita Rodriguez clearly remembers a call she received at 2 a.m. in September, when the harvest was in full swing in the region bordered by snow-capped mountains and known for its high-altitude crops of potatoes, lettuce and spinach. It was from a man working on a farm. "He was freaking out."
His body was covered in large red hives and his face was swollen. He could barely open his eyes. He wanted medical attention, she said, but was worried about being caught sneaking out of his employer-provided housing, which is surrounded by tall chain-link fencing, much of it topped with razor wire. A foreman watched over the camp and allowed just three or four workers to leave each day, he told Rodriguez, who volunteers as a community outreach worker and recounted the story to lawmakers in March.
Amy Kunugi, general manager of Southern Colorado Farms, said that the razor wire is intended to deter break-ins during the off-season and that the farm has never policed employees' comings and goings. However, COVID protocols had banned visitors unless approved by managers and limited the number of employees who could leave for essential trips at a given time.
"I'm just kind of gobsmacked," said Kunugi, who first learned of the story at the March legislative hearing on the bill. She said she hasn't found any employees who are familiar with the story. "We always would transport people if they needed health care."
Linda Rossi with Fresh Harvest, the company that recruits farmworkers for Kunugi's farm, added: "There is no way this allegation has any merit, and if anyone so much as said they had the hiccups last year, we responded."
Still, Rodriguez said, this man having a medical emergency on his day off felt scared enough about seeking urgent care that he hatched a plan with her: They waited until later that morning, when he was sure he could sneak out unnoticed. They met at the dollar store down the street, and Rodriguez drove him to an urgent care clinic in the next town over.
"He was afraid to get caught because he didn't want to lose his visa," she said. "That's how he supports his family."
After the man received treatment for his severe allergic reaction, she said, they drove back toward the worker housing. He slunk down in his seat and asked that Rodriguez drive by slowly, so that he could make sure the foreman's car was not outside. Then, she said, he "jumped out of my car like a bat out of hell" and sprinted back inside.
The U.S. Department of Agriculture estimates the nation has 3.2 million farmworkers, with more than 36,700 in Colorado. Nationally, according to the Department of Labor's National Agricultural Workers Survey of 2015-16, about 15% of crop workers lived in employer-provided housing, and a little under half said they had health insurance. While about 40% of respondents said they had not used health care services in the U.S. in the previous couple of years, around 87% said they'd needed it.
About half of crop workers in that survey were undocumented, leaving them vulnerable to abuse and intimidation by their employers. Even those with agricultural work visas can find their movements restricted: The international migrant rights organization Centro de los Derechos del Migrante found that more than a third of 100 workers surveyed in 2019 reported that their employer determined when they could leave their housing or job site.
Jenifer Rodriguez, managing attorney with the nonprofit Colorado Legal Services (no relation to Anita Rodriguez), said that, in addition to barriers like lack of health insurance and the cost of treatment, farmworkers are vulnerable to employer retaliation. In her 14 years representing farmworkers in Colorado, she's spoken to, among others, a sheepherder whose employer wouldn't give him a ride to a doctor for what turned out to be a brain tumor, and health care providers prevented from entering farm property to visit workers even when they were off the clock. "There are a lot of employers that deny them access to do that," she said.
Growers balked at the Farmworker Bill of Rights, primarily over its requirement to provide overtime pay. "The way it was introduced, it probably would have put the majority of the industry out of business. Literally," said Marilyn Bay Drake, executive director of the Colorado Fruit and Vegetable Growers Association.
Drake said members also worry that the medical access provisions could interfere with growers' ability to follow the federal Food Safety Modernization Act, which includes requirements meant to prevent visitors from introducing foodborne illness to farms.
At the state Senate hearing in March, some farmers testified they were "embarrassed" and "shaken" to hear stories of worker mistreatment. Potato farmer Harry Strohauer repeated a common refrain: "There may be a few bad apples in our group, but I don't see it. None of us have seen it. We believe that we do a good job. We believe we take care of our people."
Civita, with Project Protect, finds that argument problematic. "So often we get stuck, when we're trying to dismantle structural racism in the law, on who's a good employer and who's a bad employer," she said. "But even the ones who stack up as good compared to others are really used to maintaining pretty significant power gaps."
Civita said those power gaps were institutionalized in the 1930s with two federal laws, the National Labor Relations Act and Fair Labor Standards Act, that promised workers a minimum wage, overtime pay and the right to organize. According to research from Loyola University Chicago, while the measures originally included all workers, a group of Southern congressmen pushed to exclude domestic workers and farmworkers — positions primarily held then by African Americans.
At the time, congressional records show, a Florida representative said, "You cannot put the Negro and the white man on the same basis and get away with it."
Nearly a century later, farmworkers in 40 states, including Colorado, still have no right to organize and no more than a handful of states guarantee them overtime pay. Only half of states, including Colorado, require employers to provide workers' compensation for job injuries. Farmworkers are also excluded from several federal safety standards — such as ladder safety and falling protections — even though they work in an industry the U.S. Labor Department considers among the most hazardous.
Rodriguez, the lawyer with Colorado Legal Services, points to an undocumented Colorado dairy worker who recently died when the tractor he was driving fell into a manure pit that reportedly had no guardrails. Rodriguez hopes the right to organize would help workers advocate for health and safety measures to prevent such tragedies. "People just aren't willing to step up and do it because, you know, fear of losing their job."
A farmworker who asked to remain anonymous because she's undocumented and fears deportation if her identity is revealed told KHN she had been working for a potato producer in the San Luis Valley for 10 years when she became pregnant.
"That's when everything changed," she said in Spanish. "They were annoyed."
Because she lived in employer-provided housing, she said, she had to ask for permission to go to every doctor's appointment, even when she started having complications with the pregnancy. "It wasn't fair, but we relied on our jobs because we were living in farm housing," she said.
On a winter morning, she went into labor. As her husband drove her to the hospital, he called his supervisor, who told him he was expected at work by noon. "Obviously he couldn't," she said. "I was in labor for 12 hours."
When her husband reported back the following workday, he was scolded for missing work. Within a week, they were both fired.
"We were left without work, and we were left without a home with a newborn baby," she said.
She doubts the new bill would change conditions for workers like her.
"The companies are going to do everything possible to fight," she said. "They don't care if you have problems, if you're sick or if a parent has died. They're only interested in the work."