The indictment alleges that SpineFrontier, Chin and Humad paid surgeons between $250 and $1,000 per hour in sham consulting fees for work they did not perform.
This article was published on Wednesday, September 8, 2021 in Kaiser Health News.
A Florida orthopedic surgeon and designer of costly spinal surgery implants was arrested Tuesday and charged with paying millions of dollars in kickbacks and bribes to surgeons who agreed to use his company's devices.
Dr. Kingsley R. Chin, 57, of Fort Lauderdale, Florida, is the founder, chief executive officer and owner of SpineFrontier, a device company based in Malden, Massachusetts. He and the company's chief financial officer, Aditya Humad, 36, of Cambridge, Massachusetts, were each indicted on one count of conspiring to violate federal anti-kickback laws, six counts of violating the kickback statute and one count of conspiracy to commit money laundering, officials said.
The indictment alleges that SpineFrontier, Chin and Humad paid surgeons between $250 and $1,000 per hour in sham consulting fees for work they did not perform. In exchange, the surgeons agreed to use SpineFrontier's products in operations paid for by federal healthcare programs such as Medicare and Medicaid. Surgeons accepted between $32,625 and $978,000 in improper payments, according to the indictment.
"Kickback arrangements pollute federal healthcare programs and take advantage of patient needs for financial gains," said Nathaniel Mendell, acting U.S. attorney for the District of Massachusetts.
"Medical device manufacturers must play by the rules, and we will keep pursuing those who fail to do so, regardless of how their corruption is disguised."
Chin and SpineFrontier were the subjects of a KHN investigation published in June that found that manufacturers of hardware for spinal implants, artificial knees and hip joints had paid more than $3.1 billion to orthopedic and neurosurgeons from August 2013 through 2019. These surgeons collected more than half a billion dollars in industry consulting fees, federal payment records show.
Chin, a self-styled "doctorpreneur," formed SpineFrontier about a decade after completing his training at Harvard Medical School.
Chin has patented dozens of pieces of spine surgery hardware, such as doughnut-shaped plastic cages, titanium screws and other products that generated some $100 million in sales for SpineFrontier, according to government officials. In 2018, SpineFrontier valued Chin's ownership of the company at $75 million, though its current worth is unclear. He maintains a medical practice in Hollywood, Florida. Neither Chin nor Humad could be reached for comment Tuesday.
Seth Orkand, a Boston attorney who represents Humad, said his client "denies all charges, and looks forward to his day in court."
The Department of Justice filed a civil lawsuit against Chin and SpineFrontier in March 2020, accusing the company of illegally funneling more than $8 million to nearly three dozen spine surgeons through the "sham" consulting fees. Chin and SpineFrontier have yet to file a response to that suit.
However, at least six surgeons have admitted wrongdoing in the civil case and paid a total of $3.3 million in penalties. Another, Dr. Jason Montone, 45, of Lawson, Missouri, pleaded guilty to criminal kickback charges and is set to be sentenced early next year. Federal law prohibits doctors from accepting anything of value from a device-maker for agreeing to use its products, though most offenders don't face criminal prosecution.
The grand jury indictment lists seven surgeons as having received bribes totaling $2,747,463 to serve as "sham consultants." One doctor, identified only as "surgeon 7," received $978,831, according to the indictment. Many of the illicit payments were made through a Fort Lauderdale company controlled by Chin and Humad, according to the indictment.
The SpineFrontier executives set up the separate company partly to evade requirements for device companies to report payments to surgeons to the government, according to the indictment. Some surgeons were told they could bill for more consulting hours if they used more expensive SpineFrontier products, officials said.
Conspiring to violate the kickback laws can bring a sentence of up to five years in prison, while violating the kickback laws can result in a sentence of up to 10 years, officials said.
"Kickbacks paid to surgeons as sham medical consultants, as alleged in this case, cheat patients and taxpayers alike," said Phillip Coyne, special agent in charge of the U.S. Department of Health and Human Services Office of Inspector General.
"Working with our law enforcement partners, we will continue to investigate kickback schemes that threaten the integrity of our federal healthcare system, no matter how those schemes are disguised."
OAKLAND, Calif. — Living unmedicated with schizophrenia and bipolar disorder, Eugenia Hunter has a hard time recalling how long she's been staying in the tent she calls home at the bustling intersection of San Pablo Avenue and Martin Luther King Jr. Way in Oakland's hip Uptown neighborhood. Craft coffee shops and weed dispensaries are plentiful here and one-bedroom apartments push $3,000 per month.
"At least the rats aren't all over me in here," the 59-year-old Oakland native said on a bright August afternoon, stretching her arm to grab the zipper to her front door. It was hot inside and the stench of wildfire smoke hung in the air. Still, after sleeping on a nearby bench for the better part of a year, she felt safer here, Hunter explained as she rolled a joint she'd use to ease the pain from also living with what she said is untreated pancreatic cancer.
Hunter has been hospitalized repeatedly, including once last summer after she overdosed on alcohol and lay unconscious on a sidewalk until someone stopped to help. But she is reluctant to see a doctor or use Medi-Cal, California's health insurance program for low-income and disabled people, largely because it would force her to leave her tent.
"My stuff keeps on getting taken when I'm not around and, besides, I'm waiting until I got a place to live to start taking my medication again," Hunter said, tearing up. "I can't get anything right out here."
Hunter's long and complex list of ailments, combined with her mistrust of the healthcare system, make her an incredibly difficult and expensive patient to treat. But she is exactly the kind of person California intends to prioritize under an ambitious experiment to move Medi-Cal beyond traditional doctor visits and hospital stays into the realm of social services. Under the program, vulnerable patients like Hunter will be assigned a personal care manager to coordinate their healthcare treatments and daily needs like paying bills and buying groceries. And they will receive services that aren't typically covered by health insurance plans, such as getting security deposits paid, receiving deliveries of fruits and vegetables, and having toxic mold removed from homes to reduce asthma flare-ups.
Over the next five years, California is plowing nearly $6 billion in state and federal money into the plan, which will target just a sliver of the 14 million low-income Californians enrolled in Medi-Cal: homeless people or those at risk of losing their homes; heavy users of hospital emergency rooms; children and seniors with complicated physical and mental health conditions; and people in — or at risk of landing in — expensive institutions like jails, nursing homes or mental health crisis centers.
Gov. Gavin Newsom is trumpeting the first-in-the-nation initiative as the centerpiece of his ambitious healthcare agenda — and vows it will help fix the mental health and addiction crisis on the streets and get people into housing, all while saving taxpayer money. His top healthcare advisers have even cast it as an antidote to California's worsening homelessness crisis.
But the first-term Democrat, who faces a Sept. 14 recall election, is making a risky bet. California does not have the evidence to prove this approach will work statewide, nor the workforce or infrastructure to make it happen on such a large scale.
Critics also fear the program will do nothing to improve care for the millions of other Medi-Cal enrollees who won't get help from this initiative. Medi-Cal has been slammed for failing to provide basic services, including vaccinations for kids, timely appointments for rural residents and adequate mental health treatment for Californians in crisis. Yet the managed-care insurance companies responsible for most enrollees' health will nonetheless be given massive new power as they implement this experiment. The insurers will decide which services to offer and which high-needs patients to target, likely creating disparities across regions and further contributing to an unequal system of care in California.
"This will leave a lot of people behind," said Linda Nguy, a policy advocate at the Western Center on Law & Poverty.
"We haven't seen health plans excel in even providing basic preventative services to healthy people," she said. "I mean, do your basic job first. How can they be expected to successfully take on these additional responsibilities for people with very high health needs?"
This revolution in Medi-Cal's scope and mission is taking place alongside a parallel initiative to hold insurance companies more accountable for providing quality healthcare. State health officials are forcing Medi-Cal managed-care plans to reapply and meet stricter standards if they want to continue doing business in the program. Together, these initiatives will fundamentally reinvent the biggest Medicaid program in the country, which serves about one-third of the state population at a cost of $124 billion this fiscal year.
If California's experiment succeeds, other states will likely follow, national Medicaid experts say. But if the richest state in the country can't pull off better health outcomes and cost savings, the movement to put health insurers into the business of social work will falter.
When Newsom signed the "California Advancing and Innovating Medi-Cal" initiative into law in late July — "CalAIM" for short — he celebrated it as a "once-in-a-generation opportunity to completely transform the Medicaid system in California." He declined an interview request.
Beginning next year, public and private managed healthcare plans will pick high-need Medi-Cal enrollees to receive nontraditional services from among 14 broad categories, including housing and food benefits, addiction care and home repairs.
The approach is known as "whole person care," and insurers will be required to assign patients a personal care manager to help them navigate the system. Insurers will receive incentive payments to offer new services and boost provider networks and, over time, the program will expand to more people and services. For instance, members of Native American tribes will eventually be eligible to receive treatment for substance misuse from natural healers, and inmates will be enrolled in Medi-Cal automatically upon release.
The insurers — currently 25 are participating — will focus most intensely on developing housing programs to combat the state's worsening homelessness epidemic. The state was home to at least 162,000 homeless people in 2020, a 6.8% increase since Newsom took office in 2019.
Jacey Cooper, the state's Medicaid director, said all Medi-Cal members will eventually be eligible for housing services. Initially, though, they will be available only to the costliest patients. State Medi-Cal expenditure data shows that 1% of Medi-Cal enrollees, many of the homeless patients who frequently land in hospitals, account for a staggering 21% of overall spending. And 5% account for 44% of the budget.
"You really need to focus on your top 1% to 5% of utilizers — that's your most vulnerable," Cooper said. "If you generally focus on that group, you will be able to yield better health outcomes for those individuals and, ultimately, cost savings."
State officials do not have a savings estimate for the program, nor a projection of how many people will be enrolled.
The plan, Cooper said, builds on more than 25 successful regional experiments underway since 2016. From Los Angeles to rural Shasta, big and small counties have provided vulnerable Medi-Cal patients with different services based on their communities' needs, from job placement services to providing a safe place for a homeless person to get sober.
Cooper highlighted interim data from the experiments that showed patients hospitalized due to mental illness were more likely to receive follow-up care, obtain treatment for substance abuse, avoid hospitalizations and emergency department visits, and see improvements in chronic diseases like diabetes.
She argued that data — even though it is not comprehensive — is enough to prove the initiative will work on a statewide scale.
However, studies of similar programs elsewhere have yielded mixed results. New York provided housing services to high-cost Medicaid enrollees with chronic diseases and mental health and substance use disorders and found major reductions in hospital admissions and emergency department visits between 2012 and 2017, and saw a 15% reduction in Medicaid spending.
In Camden, New Jersey, an early test of the "whole person care" approach provided expensive Medicaid patients with intensive care coordination, but not nontraditional services. A study concluded in 2020 that it hadn't lowered hospital readmissions — and thus didn't save healthcare dollars.
"We found we just couldn't help people with housing as quickly as they needed help," said Kathleen Noonan, CEO of the Camden Coalition of Healthcare Providers. "Many of these clients have bad credit, they may have a record, and they're still using. Those are huge challenges."
California may find success where the coalition hadn't because it will offer social services, she said, which the coalition has also started doing.
But it will take time. California will have five years to prove to the federal government it can save money and improve healthcare quality. Insurers will be required to track health outcomes and savings, and can boost services over time or drop programs that don't work.
So far, the regional experiments have failed to serve low-income Black and Latino residents, according to the interim assessments conducted by Nadereh Pourat, director of the UCLA Center for Health Policy Research. She concluded that they have primarily benefited white, English-speaking, middle-aged men.
Consider Eugenia Hunter, who is African American, and whose many untreated mental and physical illnesses, intertwined with her addictions, mean it will take a herculean effort — and cost — to get her off the street.
Hunter has been homeless for at least three years. Or maybe it's five; her mental illness clouds her memory, and she erupts in anger when pressed for details. She eases her frustration sometimes with sleep, sometimes by smoking crystal meth.
A stack of unopened health insurance letters sat beside Hunter one evening in late August. Her eyes were glassy when she struggled to remember when she received a cancer diagnosis — if she ever did at all.
Health insurers will not be required to offer social services to patients like Hunter because federal law requires nontraditional Medicaid services to be optional. But California is enticing insurers with bigger payouts and higher state rankings.
"We are asking the plans and providers to stretch. We're asking them to reform," Cooper said.
The state is urging insurers to start with the roughly 130,500 Medi-Cal patients already enrolled in the local experiments. To prepare, they are cobbling together networks of nonprofits and social service organizations to provide food, housing and other services — much as they do with doctors and hospitals contracted to deliver medical care.
Services will vary by insurer and region. The Inland Empire Health Plan, for example, will offer some patients home repairs that reduce asthma triggers, such as mold removal and installing air filters. But Partnership HealthPlan of California will not offer those benefits in its wildfire-prone Northern California region because it doesn't have an adequate network of organizations equipped to provide those services.
In interviews with nearly all of California's Medi-Cal managed-care plans, executives said they support the dual goals of helping patients get healthier while saving money, but "it is a lot to take on," said Richard Sanchez, CEO of CalOptima, which serves Orange County and will start modestly, primarily with housing services. "The last thing I want to do is make promises that we can do all these things and not come through."
Nearly all the health plans will offer housing services right away, focusing on three categories of aid: helping enrollees secure housing and rent subsidies; providing temporary rent and security deposit payments; and helping tenants stay housed, like intervening with a landlord if a patient misses rent.
Partnership HealthPlan, which serves 616,000 Medi-Cal patients in 14 Northern California counties, will prioritize its most at-risk enrollees with housing services, food deliveries and a "homemaker" benefit to help them cook dinner, do laundry and pay bills.
"It's a great deal of money for a small number of members and, frankly, there's no guarantee it's going to work," said Dr. Robert Moore, the plan's chief medical officer. "We are building something extraordinarily ambitious quickly, without the infrastructure in place to make it successful."
Even if offering new services costs more money than it saves, it's a worthwhile investment, said John Baackes, CEO of L.A. Care Health Plan, the largest Medi-Cal plan, which serves more than 2 million patients in Los Angeles County.
"When somebody has congestive heart failure, their diet should be structured around alleviating that chronic condition," he said, explaining his plan to offer patients healthful food. "What are we going to do — let them eat ramen noodles for the rest of their lives?"
In Alameda County, two plans are available to serve Hunter. The Alameda Alliance for Health, a public insurer established by the county, and Anthem Blue Cross, a private insurance company, will expand housing services.
"People like Eugenia Hunter are exactly who we want to serve, and we're prepared to go out and help her," said Scott Coffin, CEO of the Alameda Alliance, who is also on a local street medicine team.
But they'd have to find her first — chaos and homeless encampment sweeps force her to move her tent frequently. And then they'd have to win her trust.
In one moment, Hunter angrily described how health plans have tried to enroll her in services, but she declined, mistrustful of their motives. In the next moment, fighting back voices in her head, she said she desperately wants care.
"Someone is going to help me?" she asked. "All I want to do is pay my rent and succeed."
Of the 203 million people who have received at least one dose of a COVID-19 vaccine, more than 9 million have enrolled in a program to share information about their health since getting the shot.
The initiative was created for the COVID-19 vaccines to complement the Centers for Disease Control and Prevention's vaccine safety monitoring system. Known as v-safe, the registry lets inoculated people report their experiences, including serious suspected side effects, directly to the CDC through smartphones, adding to the data gathered from clinical trials and other safety monitoring systems.
So how does v-safe strengthen the nation's existing safety checks and how well is it working?
Going in, some public health experts expressed doubts about its effectiveness. But since the tool's Dec. 13 release, reviews have mostly been positive.
"There never has been so much scrutiny of vaccines and so much reporting and so much tailored information," she added.
How Is Vaccine Safety Traditionally Monitored?
The federal government has various systems to monitor the safety of vaccines as well as other pharmaceutical products once they reach the marketplace. For starters, the Vaccine Adverse Event Reporting System, jointly run by the CDC and the Food and Drug Administration, since 1990 has served as a repository for reports on health problems that may be side effects of vaccines. Healthcare providers are required by federal law to report certain adverse events, but patients, their family members or caregivers can also submit a report online.
VAERS helped spot unexpected cases of rare blood clots in several people who received the Johnson & Johnson vaccine. After studying the VAERS reports, the CDC listed what experts later identified as thrombosis with thrombocytopenia syndrome as a serious but rare health problem associated with the J&J vaccine.
Then there's the Vaccine Safety Datalink, which uses electronic health data from nine large healthcare organizations across the country, including various Kaiser Permanente systems on the West Coast and Harvard Pilgrim Healthcare in Massachusetts. According to Minnesota-based HealthPartners, another participating organization, the VSD network looks at data for 3% of the U.S. population, or roughly 12 million people — everything from medical and pharmacy claims to vital records. National Geographic reported that analyses are done weekly so signals of adverse events are quickly noted.
What Does V-Safe Add to the Mix?
Launched the day before COVID vaccines were first available to the public, v-safe allows the CDC to track people over time to see how they fare.
Some vaccine safety experts have criticized the U.S. for leaning too heavily on a "passive" system that relies on people reporting issues that may or may not be related to the shots as opposed to "active" surveillance that scans large volumes of electronic health data and compares adverse events in people who receive the vaccine to those who didn't.
V-safe requires individuals to opt in, with no control group for comparison. But some still view the tool as a step forward.
"It is a little bit more of a proactive monitoring system," said Andrea Carcelén, an assistant scientist at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.
Here's how it works: People register with the v-safe program on their smartphone or computer after receiving their first vaccine dose. The CDC then sends them daily text messages the first week, and weekly ones for six weeks after that. Additional follow-up texts are sent at the three-, six- and 12-month marks.
Every message includes a brief health survey, always asking: "How are you feeling today?" The first week, participants are asked whether they have experienced symptoms — chills, headache, joint pain or something not listed. They are also asked if they were unable to work or attend school or perform "normal daily activities," or if they sought a physician's care.
Over time, the check-ins focus on new or worsening symptoms or health conditions and compare participants' health before and after vaccination. Participants are also asked whether they have tested positive for COVID since the previous survey.
CDC scientists then study responses, looking for patterns of problems that go beyond what the clinical trials predicted. And the data may provide a fuller snapshot of vaccine outcomes because it reflects not only reports of side effects but also of people who had no complaints, said Carcelén.
Even as these investigations proceed, people who reported a problem may not ever hear directly from the CDC, and v-safe is not intended to offer medical advice. The CDC requests and reviews medical records, death certificates and autopsy reports only for serious adverse events, said Martha Sharan, a CDC spokesperson. "If a report is a hoax, it is quickly caught," she said.
And what has v-safe shown so far? "The findings in normal, regular people that got the vaccine were pretty reflective of what you saw in the clinical trials," said Vanderbilt's Edwards. Edwards also served on an independent safety data monitoring committee for the Pfizer-BioNTech vaccine, now branded as Comirnaty.
How Is the V-Safe Data Used?
Unlike VAERS, v-safe data is not published without context. Meaning, no one can just sort through the database and interpret the numbers as they please, as many do with VAERS data. It is, however, publicly shared through CDC studies and presentations given during meetings held by the CDC's independent panel of experts, the Advisory Committee on Immunization Practices.
And like VAERS reports, v-safe data is susceptible to misinterpretation. One post that circulated on social media inaccurately said "3,150 persons were paralyzed" based on an ACIP presentation slide. Reuters debunked the post, saying it is a "misinterpretation of the CDC health events."
Information gleaned from v-safe has been used in several safety analyses, including one focused on adolescents. That analysis, published Aug. 6, found that serious adverse events are rare among adolescents, partly based on v-safe surveys from tens of thousands of people ages 12 to 17. The analysis also found that a minority reported being unable to perform "normal daily activities" the day after receiving a second dose.
V-safe has perhaps been most helpful at providing real-world evidence that the COVID-19 vaccines are safe during pregnancy. This is important because there was little information on how the vaccines affected pregnancy when they were first authorized, said Dr. Dana Meaney-Delman, a member of the CDC's vaccine task force, in a recent call with clinicians.
Pregnant women were excluded from the initial clinical trials that led to the emergency use authorization of the Pfizer, Moderna and J&J vaccines, and misinformation was rampant.
Because pregnant healthcare workers got vaccinated and enrolled in v-safe, Meaney-Delman said, there is more evidence that indicates the benefits of getting vaccinated during pregnancy outweigh any potential risks. Following the publication of an analysis that leaned on v-safe's vaccine pregnancy registry, the CDC recommended on Aug. 11 that people who are pregnant, lactating or trying to become pregnant get vaccinated against COVID.
More than 9.2 million people have enrolled in v-safe as of Aug. 9, or roughly 5% of the U.S. population who received at least one dose of a COVID vaccine. This seemingly low participation rate is often linked to weak advertising and public education programs about v-safe. Also, a segment of the vaccinated public likely considered it tedious or had privacy concerns. The number also excludes people who do not have smartphones.
People who line up for an additional vaccine dose — often referred to as a booster but representing the same formula as previously administered — will have another opportunity to sign up for v-safe.
Meanwhile, as nationwide vaccination efforts continue, some v-safe participants said they joined the effort because they wanted to help.
John Beeler, 44, of Atlanta, considered it a "public good." He reported experiencing tinnitus — a condition that was part of his medical history — after receiving his first Moderna dose. He was never contacted but hopes his report proved helpful. Still, he appreciated being checked on, even via automation.
"Dr. Fauci is not reading my response. But the feeling is there," said Beeler.
The Allie Henderson who stepped out of her mother's car to a driveway full of cheering friends and family holding "Welcome Home" signs was a wisp of her former self.
After 10 days in the hospital with a near-fatal case of COVID inflammatory syndrome, the then-13-year-old softball phenom and beloved, straight-A student was lethargic and frail and braced herself against the car's door frame.
But six months later, as the highly contagious delta variant swarms Mississippi, the state has one of the highest per capita infection rates in the nation and one of the lowest vaccination rates. In Hinds County, where the Hendersons live, the vaccination rate is 45%, well below the national average of 53%, as of last week. Some of Allie's closest friends and family remain unvaccinated.
"I feel like it hasn't been tested enough," said Erin Acey, 16, of the vaccine. Erin is a cousin of Allie's who lives a block away and grew up playing whiffle ball with Allie in the backyard.
Erin's parents are also not vaccinated, nor is another cousin, Cara McClure, 23, a hairstylist in nearby Clinton who is suspicious of conflicting information she's heard about the vaccine.
"I try not to watch the news. I get it from Facebook," said McClure. "I really try not to talk about it at work because it's like politics: You don't talk about politics at work."Bottom of Form
The gravity of Allie's condition last winter became clear when the prayer requests went out, months before vaccines were widely available.
Congregations across the area in Crystal Springs, Hazelhurst, Wesson and Georgetown prayed for Allie; teachers at her small, independent Christian school in Gallman, Copiah Academy, prayed before class.
Allie's grandmother texted Wayne Hall, the pastor at Jackson First, where the Hendersons have been regular parishioners. Allie was a fixture in the Children's Ministry, a vivacious child always in the middle of the action, and the Hendersons are an admired family of go-getters. "Please pray," the text said. "Allie is in the hospital."
"When the request went out, it was all hands on deck," said Hall, who hunts with Allie's dad, Brook. He said his own prayers: "We believe in God to heal her body and are praying for Mom and Dad, who are walking through this, because there are a lot of unknowns."
Allie had felt crummy at school on a Monday in late January but still managed to play in a basketball game that evening. A few days later, she was doubled over with stomach pain and no remedy — Tylenol, Motrin, baths — would break her 104-degree fever. LeAnn Henderson, Allie's mother, asked her best friend, Caroline Young, a nurse and fellow softball mom, "Why can't we get this fever to go away?"
At the emergency room, Allie tested negative for COVID, strep and influenza, and doctors settled on removing her inflamed appendix. But soon after the surgery, her fever spiked again, her blood pressure and oxygen levels dropped, her eyes were eerily bloodshot, her hands splotchy.
"Allie was so weak, she was talking about giving up," said LeAnn.
An ambulance whisked Allie to Children's of Mississippi, a hospital in Jackson with a pediatric intensive care unit where doctors diagnosed her with multisystem inflammatory syndrome in children. MIS-C, as it is known, appears to affect children two to eight weeks after an asymptomatic or mild COVID-19 infection. A blood test found COVID antibodies, and Allie began receiving steroids, blood pressure medication and intravenous antibiotics to fight the syndrome.
McClure, who often styled Allie's hair and took her to the local waterpark, video chatted with her cousin. "She looked tired, drained, her face was white," said McClure. Already thin, Allie was losing weight. At the hair salon, McClure tried to keep the unfolding family crisis away from clients already spooked by the pandemic. Her co-workers would see her crying between appointments.
Outside the hospital windows, friends and family stood on the grass and held up signs that Allie could see from her room. There was an endless stream of food deliveries for the family: Chick-fil-A, chili from Wendy's, seafood pasta from Biaggi's.
"Everybody in Allie's world knew about this — softball, school, church — it was on our doorstep," said LeAnn. "People had known adults who had gotten sick and been in the hospital, but not sick like Allie. I think it was like, 'Wow, this is real and this happened to her.' They know how strong and athletic [she is]. She's a power hitter.
At Copiah Academy, Allie's absence registered with growing fear. "Parents began to get scared," said Rita Henley, a school administrator. The school had taken precautions, sanitizing classrooms, requiring students to wear masks and to physically distance. Students who tested positive for COVID and those who shared classrooms or sports teams had to quarantine at home. "Some of the parents embraced it and some didn't," said Henley. "It reflected the differences in opinion that we have right now in our country."
As Allie came in and out of consciousness at the hospital, she fretted about her grades and missing the remainder of basketball season and the upcoming softball season.
"Allie is a very aggressive athlete, always ready to practice and play hard," said Caroline Young, LeAnn's friend whose daughter plays on the same travel softball team as Allie. "That was the most poignant thing about the illness — we saw a really strong teammate become weak."
On Feb. 7, LeAnn drove her daughter home to the cheers and open arms of a loving gaggle of friends and family. "I started crying, she started crying, everyone started crying," said Allie's cousin Erin.
LeAnn shared her family's ordeal with a local television station. "I immediately went to the media and said, 'This is something else COVID can do. This happened to my 13-year-old. We need to look out for this.'"
Allie returned to school for a few hours each day and grew stronger. On occasion, she was overcome by seizures, passing out once in the bathroom at home and once on her way to her bedroom. One night, Allie woke and couldn't feel her legs. "I was screaming," LeAnn said, whose usual unflappable disposition had finally caved. By spring break, in mid-March, after neurology appointments and brain scans and heart scans, Allie started coming back to herself. She and her family got the vaccines when they became available.
At school, the questions overwhelmed her. "We had a little joke. I said I had a bad haircut and couldn't come to school," Allie said. But she didn't feel the urge to proselytize about the dangers of COVID. "I don't like to go public about personal stuff."
She suited up for a softball scrimmage and could barely hoist the bat above her shoulder. "It was very difficult because I couldn't do what I could do before," said Allie. She told her mom, "I just suck at this." The crowd of softball dads teared up when Allie tried to swing the bat. "It's amazing that she's out there," LeAnn said they told her.
Students returned to Copiah Academy in early August. Masks are not required, nor is the COVID vaccine for those eligible. "Our internal conversation is that we do not feel we can require the vaccine unless the state requires it," said Henley. But "because of Allie, people — without question — know that this is a real thing."
Still, the shifting nature of the pandemic — the arrival of the delta variant, the news that vaccinated people can spread COVID — has brewed confusion. "I truly think that we see too much back-and-forth on the news. I think it hurts people," said Henley, who is vaccinated. "People don't know what to believe."
Federal health officials say millions of Americans have been safely vaccinated, and vaccination reduces the risk of severe complications from COVID.
Pastor Hall is reluctant to direct his parishioners to get vaccinated. "We believe in healing, we believe in the power of God, and we also know God gives wisdom," he said. "If the CDC is saying things we need to abide by, we need to really listen." He added, "Allie's story has helped a lot of people really understand, 'Hey, this is not a pick-and-choose kind of deal. It can hit home anywhere.'"
At the hair salon in Clinton, McClure shares more openly now about her cousin's illness with her clients. "I'll say my little cousin had it and we get to talking about it," said McClure. But she doesn't push it. "When clients come in, we want it to be about them. We ask, 'Are you going on vacation?' We focus on them to make them feel good."
But she notices those around her have dropped their guard. "They take everything for granted. 'Oh, we're good. We're fine. We don't have to sanitize,'" she said. "Even now at the salon we try to make people sanitize, and they're like, 'Ugh.'"
McClure had a mild COVID infection last Thanksgiving — headache and nausea — but it passed. Even now, she's in no rush to get vaccinated. "Even with the vaccine, you can still get it. Every day I feel like something about it is changing, there's a new strand," she said.
Erin, Allie's 16-year-old cousin, isn't sure when — or if — she'll get vaccinated. She's nervous about the side effects and wants to wait and see. In her view, the pandemic has "died down" and she's unfamiliar with the delta variant. "I'd rather read about it and see it myself," she said.
"I know she has a different perspective," Allie said about her cousin Erin. "I would have a different perspective if it hadn't happened to me. I just know some people are like, 'My body, my choice.' Everything these days is about politics and nobody likes to be wrong. It's very confusing for my part. I want people to get vaccinated because I know what it feels like."
Some of her closest friends have gotten the vaccine. Was it because of what happened to her? Allie responded, "Yes, ma'am."
Gov. Gavin Newsom's first term in office has been defined by his response to the COVID-19 pandemic, which has claimed the lives of more than 65,400 Californians.
The Democratic governor issued the first statewide stay-at-home order in the nation, and his policies kept most public school students at home last year. But his own children attended private school in person and, in a move that has haunted him since, he dined with friends and lobbyists at the ritzy French Laundry restaurant in the Napa Valley in November — even though state guidelines discouraged people from mixing with others outside their household.
More recently, Newsom has required all healthcare workers to get fully vaccinated by the end of the month. But he has not ordered a new statewide mask mandate, despite the deadly spread of the virus's delta variant.
Newsom has said his policies are driven by science, but they have helped land him in an unexpectedly competitive recall election. A Public Policy Institute of California poll released Wednesday shows that about 58% of likely voters want to keep him in office. Voters, who have been mailed ballots, have until the Sept. 14 election date to return them.
Many of Newsom's Republican rivals, including talk-radio host Larry Elder, businessman John Cox and former San Diego mayor Kevin Faulconer, are focusing their opposition on Newsom's mask and vaccine policies.
Just how much is the pandemic playing into voters' decisions? KHN reporters fanned out across the Golden State — visiting a fire evacuee camp in Placerville, outdoor malls in the Silicon Valley, Olvera Street in downtown Los Angeles and an urban park in Sacramento — to find out.
Placerville
In the Sierra Nevada foothills, many voters describe Newsom as a big-city elitist who issued pandemic mandates for the masses but played by his own rulebook.
"RECALL NEWSOM SAVE CALIFORNIA" signs line busy roads and plaster fences and storefronts in Placerville, home to about 11,000 people some 40 miles from California's capital.
Even a few evacuees from the raging Caldor Fire — whose homes and livelihoods are at stake — display anti-Newsom signs on their RVs and vans at their temporary outpost in the Walmart parking lot.
The deep anger facing Newsom in El Dorado County isn't unexpected. The area draws on Gold Rush-era independence: Several businesses flouted public health orders that required masks indoors.Bottom of Form
"Whatever edict he put out there never applied to him," said Denise Byer, 55, a volunteer at a wildfire evacuation site whose children missed nearly a year of in-person high school and competitive sports. "His own children went back to school. He's an elite. He's a hypocrite."
That was the overwhelming sentiment at two Placerville evacuation sites, where several people commented but asked not to be identified, some for fear of workplace repercussions. Newsom "sat up on high," said a county worker. The governor wants to impose broad mandates on Californians that should be up to the people, said an evacuee who, like other state workers, must be vaccinated or submit to weekly COVID tests. Newsom "has ruled like a king," chimed in an evacuee who didn't know whether his home would survive the fires.
— Samantha Young
Silicon Valley
On a sunny, late-August Sunday, Palo Alto's luxe University Avenue and San Jose's trendy Santana Row, an outdoor shopping mall, were jammed, and the broad streets have been taken over by shopping, outdoor dining and live music. Signs occasionally reminded patrons to mask up in stores, but there was little evidence of the pandemic, and even less of the impending recall election.
When it comes to the recall, there was only one answer: No. Obviously no. Have you seen who he's running against?
"I'm really frustrated that the recall is even happening. The people who are running to replace him are going to undo a lot of his work and make it a lot riskier to be in California," said Meghan Purdy, a 34-year-old product manager in Palo Alto. "I have friends in Texas, and I worry about them. I have a dad in Florida. They have horrible governors, and the fact that it could happen to us is scary."
In a small but crowded park on Santana Row, Michael Burrows, a 56-year-old database administrator, listened to a band while a coffee line snaked around the musicians.
Newsom handled the pandemic as well as he could have, Burrows said. The recall is a waste of time, and anti-maskers and anti-vaxxers are trying to tarnish Newsom's reputation on a national stage, he said.
"Nobody likes to wear a mask — I don't like to wear a mask — but it's what you have to do," Burrows said. "You have to have an adult in the room."
— Rachel Bluth
Los Angeles
The sound of salsa music lingered in the air as people wandered the cobblestone paths along Olvera Street in downtown Los Angeles. The historical Mexican marketplace was a ghost town of shuttered shops during the height of the pandemic, but now bustles with customers— most of them Latino.
Some had no idea about the recall election. Others said they favored the governor but wouldn't be able to vote because they are undocumented immigrants. Most expressed support for Newsom.
Antonio Ramos, 57, and Isabel Ceja, 48, a couple from Novato, California, were visiting family in Los Angeles on Saturday. Some of their relatives have had COVID, and they said they know what it's like to worry if they will survive.
"What he's done for the community has been beneficial," Ramos said in Spanish. "Like getting the vaccines out to everyone and the mask mandate. It's for the safety of everyone."
The couple plan to vote against the recall. "I like him because he's Catholic and does everything with transparency," Ceja added. "He isn't two-faced."
Veronica Ayón, 28, a Los Angeles mother of three, disagreed. "I think he says one thing and then does another," she said in Spanish.
Ayón isn't vaccinated but said she always wears a mask. She is breastfeeding her baby girl and fears what a vaccine could do to her. (The Centers for Disease Control and Prevention recommend pregnant and breastfeeding women get vaccinated.)
She said she will probably vote against Newsom. "He wants to make it mandatory for kids to get vaccinated at 12," said Ayón, whose eldest child is about to turn 12. "She's my daughter. It's my decision."
— Heidi de Marco
Sacramento
In Sacramento's Oak Park, a largely African American, inner-city neighborhood that is rapidly gentrifying, people don't seem motivated to vote. Anti-recall signs backing Newsom pepper grassy lawns in the city's wealthier neighborhoods, but none were visible here, though there are Black Lives Matter signs on nearly every block — a couple of them praising Dolly Parton.
Many Oak Park residents said Newsom has failed them.
"I tore up my ballot and threw it in the trash," said 52-year-old Regina Davis, who gathered with friends at a park filled with people barbecuing and jamming to music — a Sunday tradition in the neighborhood. She backed Newsom in 2018 but said she doesn't plan to vote, arguing that Newsom has prioritized wealthy Californians during the pandemic.
Others said they hadn't decided whether to vote.
"He needs to step up," said Cleo Brown, 39, who supported Newsom when he ran for governor but said she now feels let down because Newsom has not invested in day care and after-school programs that could help her and her two kids, ages 15 and 18.
Her message to Newsom: "Do something for our kids. They're still hurting from the school shutdowns."
Emma Patterson, 57, voted for Newsom in 2018 but said she has other things to worry about than the recall. "He needs us to show up for him, but Black families are struggling," Patterson said.
Her apartment burned down in July, and she's renting a room for herself and her two grandkids for $150 a week. "Voting isn't even on my mind," she said.
Allison Hansen had just gone through a breakup with her boyfriend last year when she discovered she was pregnant. She already had an 8-year-old son and did not want another child.
Hansen called the Planned Parenthood facility near her home in Savannah, Georgia, to inquire about abortion services and was told the procedure would cost $500 and require four to six hours at the clinic.
Hansen didn't have that kind of time. Her son was at home, attending school online, and needed supervision. While Googling for alternatives, she came across Carafem — a nonprofit that delivers abortion pills to a patient's home after a telemedicine visit for $375 or less.
"It just seemed almost too good to be true," Hansen recalled.
Patients like Hansen have benefited from a quiet but monumental shift in abortion access enabled by the COVID-19 pandemic. In July 2020, in response to advocates' concerns about the risks posed by in-person visits in a pandemic, a federal court placed on hold a long-standing FDA rule that required mifepristone — the first pill in a two-step regimen used in medical abortions — to be dispensed in clinics. After the Trump administration appealed that decision, the conservative-majority Supreme Court agreed to reinstate the rule, with Chief Justice John Roberts writing that courts should defer to government experts who set the rules. The Biden administration put the rule back on hold in April during the remaining public health emergency and said it is reviewing the agency's restriction.
In the meantime, telemedicine abortion operations are growing in some places, although not in such states as Texas and Alabama with strict laws designed to curb or end abortions.
A new slate of digital abortion options like Just the Pill, Hey Jane, Abortion on Demand and Choix proliferated, mailing abortion pills to patients in many states after a telemedicine visit. Carafem, which had been mailing the pills to patients in Georgia before the pandemic as part of a research project, streamlined its process for patients who are eligible for medical abortions.
These services can be a lifeline for patients who haven't hit the 10- or 11-week threshold typically used for medical abortion and who can't get to a clinic or need a less expensive choice. But reproductive health advocates worry that telemedicine abortion options don't reach the patients who need it the most because they live in states with laws that actively discourage abortions and have made in-clinic care harder to access. At the same time, these new options could be endangering brick-and-mortar clinics by siphoning away the first-trimester visits that make up more than 90% of abortions.
"If [clinics] lose a considerable amount of the clientele for first-trimester abortions, they might have to close, or some of them will," said Carole Joffe, a professor focusing on reproductive health at the University of California-San Francisco and co-author of "Obstacle Course: The Everyday Struggle to Get an Abortion in America." "Potentially, we see people needing second-trimester procedures, not to mention even later ones, with literally nowhere to go."
Many clinics, which charge higher prices to support the costs of running a building and providing security, are closing around the country amid an avalanche of state restrictions. That is especially true of independent clinics, which perform 58% of abortions, according to the Abortion Care Network, an association of independent providers. Since 2012, the number of independent abortion clinics has dropped by 34%.
Concerns about access to abortion deepened this week when a Texas law took effect banning abortions after six weeks of pregnancy and a divided Supreme Court did not block it, at least for now. The court is also scheduled to hear a case this term on Mississippi's 15-week abortion ban. If the justices allow either state law to stand, it would likely lead other states to further restrict abortion, forcing patients in many conservative states across the South, Midwest and West to travel for services or seek out overseas options like Aid Access, according to Mary Ziegler, a Florida State University law professor who focuses on legal issues surrounding reproductive health and sexuality.
"If you're in New York or California or Boston, you can get abortion pills online, you can go to a clinic — there are tons of options. Whereas if you're in a state like Alabama, you're probably going to be worried that you can't do any of those things," Ziegler said.
Carafem, which operates clinics in Georgia, Illinois, Tennessee and Maryland, began mailing abortion pills to patients in Georgia in 2019 when it joined the TelAbortion Study, an ongoing project run by the reproductive health nonprofit Gynuity that received federal permission to study the safety of telemedicine abortions. Over four years, abortion providers mailed 1,390 medication packages to patients in 13 states and Washington, D.C. Researchers reported that 95% of tracked participants had a complete abortion without a procedure. They reported 10 serious adverse events, including five cases of patients needing blood transfusions, none of which could have been avoided by an in-person visit, the researchers said. Participants made 70 unplanned visits to emergency rooms or urgent care centers.
Anti-abortion advocates, however, stress that medical abortion should require in-person exams.
"Women deserve excellent healthcare, and excellent healthcare does not involve talking to someone online," said Dr. Christina Francis, board chair of the American Association of Pro-Life Obstetricians and Gynecologists. "It involves actually being seen and being evaluated to make sure that if she's going to make this decision, she's an appropriate candidate to make this decision and she's not putting herself at severe risk by taking these medications."
Many states require in-person counseling or ultrasounds before an abortion, forcing patients to make more than one trip to a clinic. In 19 states, laws require a physician who prescribes a medical abortion to be physically present when the medication is administered.
Alabama is one of those states. "I use telemedicine all the time because I'm a full-spectrum OB-GYN," said Dr. Sanithia Williams, an abortion provider at Alabama Women's Center for Reproductive Alternatives in Huntsville. "But for the abortion portion of my practice, it just is completely nonexistent."
Even in states with relatively few abortion restrictions, patients with medical risk factors, unreliable periods, unsafe living situations or pregnancies beyond 11 weeks generally can't get care online. "There will always be a need for clinic-based healthcare," said Melissa Grant, chief operations officer of Carafem. "This is not a panacea."
On a Thursday morning in late June, Leah Coplon, a certified nurse midwife, sat down in the Augusta office of Maine Family Planning for a televisit with a patient seeking an abortion who was in her home miles away. The young patient nodded and messaged her boyfriend, telling him to go buy her menstrual pads, as Coplon ran through a detailed list of warning signs like excessive bleeding that should prompt a call to the clinic or trip to an emergency room. "This is all very rare, but I've got to tell you the scary things. That's my job," Coplon said, the blue light of the monitor reflecting off her glasses.
For uninsured patients, the out-of-pocket cost for a telemedicine visit like this is $500, about average for brick-and-mortar clinics.
Maine is among a minority of states that cover abortions under Medicaid. The state also requires private plans to cover abortion if they cover prenatal care. Yet even here, with 8% of the population uninsured, cost is the biggest barrier Coplon's patients face, she said. To meet the needs of low-income patients, clinics like hers haven't raised their out-of-pocket rates in years. If the price of abortion had kept pace with medical inflation, a procedure that cost $200 in 1974 would cost $2,686 today, according to a Bloomberg Businessweek calculation last year.
Maine Family Planning has 18 locations across the sprawling, mostly rural state. In 2014, it became one of the first clinics to launch a telehealth pilot program. When COVID struck, providers like Coplon used existing telemedicine equipment to shift to a "no-test" protocol, bypassing ultrasounds and blood tests that research shows can be safely skipped in order to minimize contact with patients.
For many patients choosing between a clinic and an online service, cost will be a deciding factor — and that concerns Dr. Jamie Phifer, founder of Abortion on Demand, which serves patients in 20 states and Washington, D.C. Like many other digital options, Phifer's service does not take insurance, but she worries her low out-of-pocket price — $239, or less than half of what a typical clinic charges — could put abortion clinics out of business.
"I am very worried that in-person clinics are already bearing the brunt of the challenges of abortion access," Phifer said. "They already have to hire security and deal with protesters, and they have been on the ground working for access for 50 years, longer than I have been around."
Phifer, who lost her job as a primary care doctor following a profile of her work on Abortion on Demand in a magazine, plans to donate 60% of the profits from her business to the Abortion Care Network to support brick-and-mortar clinics.
"I didn't want to contribute to creating a two-tiered system," Phifer said.
If you live in one of the rural communities tucked into the forested hillsides along the Oregon-California border and need serious medical care, you'll probably wind up at Asante Rogue Regional Medical Center. It serves about nine counties on either side of the border.
It is one of three hospitals Asante owns in the region. All three ICUs are 100% full of COVID patients, according to staff members.
"We've had two deaths today. So, it's a very grim, difficult time," Dr. Michael Blumhardt, medical director of the hospital's intensive care unit, said on a recent Tuesday in August. "The delta virus is passing through the region like a buzzsaw."
Unlike earlier COVID waves, he said, patients are in their 20s, 30s, 40s and 50s.
"We're seeing clusters of families being admitted. We had a father and an adult daughter admitted to the intensive care unit and he passed away. Right before, I had to put the daughter on life support," he said.
Overall, vaccination rates in many states look pretty good. Oregon and California both have vaccination rates above the national average. But zoom in on any state, and you'll see a checkerboard effect with huge differences among counties. In Oregon, around big-city Portland, two-thirds of all residents are fully vaccinated. But rural counties aren't even close to that. Jackson County, on the California border, has the largest number of unvaccinated individuals in Oregon. That's pushing hospitals to their limits.
Blumhardt blames the current surge on the delta variant, but also a widespread rejection of the vaccine.
"This is far more severe for this region than the prior COVID waves," he said.
Inside the Asante ICU, Chelsea Orr, a registered nurse, closely monitors patients, "just trying to keep people alive," she said. "We're taking care of a lot of ventilated patients here that are super sick."
What feels different about this stage of the pandemic, she said, is the incredible loss of life: "We're working harder than we've ever worked before and still losing."
Down the hallway, Justin McCoy waited outside another patient's isolation room. "I've been an ICU nurse for 10 years. I've never seen anything like this," McCoy said. "It's really terrible seeing these patients who can't breathe. That is a very difficult thing to watch. It's really terrifying for them, and it's really difficult for us to see day in and day out."
Blumhardt said the vast majority of their COVID patients are unvaccinated.
"We admit nine unvaccinated to every one vaccinated individual. So clearly the vaccine is protecting against hospital admission," he said.
Jackson County has been seeing record numbers of new COVID infections. Within weeks, many of those people may need hospital care — and a new forecast from Oregon Health & Science University predicts that by Labor Day the state will face a shortfall of 400 to 500 staffed hospital beds.
Blumhardt said smaller hospitals in Oregon are trying to transfer their sickest patients to Asante, but so far they've had to decline around 200 people because of lack of space.
Even though Asante has already postponed some surgeries, staffers are simply worn out, said emergency room physician Dr. Courtney Wilson.
"I think people are frustrated," Wilson said. "It feels discouraging that we have had a vaccine available for a really long time in this community and we have a really low vaccination rate here."
Oregon Democratic Gov. Kate Brown recently sent National Guard troops to overwhelmed counties, to help with nonmedical tasks, including about 150 soldiers to southern Oregon. Medical leaders at Asante and another local hospital system, Providence, have asked for the state to set up a 300-bed field hospital.
"I don't know how we're going to get everybody taken care of. That's the bottom line. We're all hands on deck at every level of the organization," Blumhardt said.
Residents of Jackson County are starting to respond to the crisis. The rate of new vaccinations here has grown to about twice that of the Portland area. But thousands of people still need to be vaccinated to catch up.
If you live in one state, does it matter that the doctor treating you online is in another? Surprisingly, the answer is yes, and the ability to conduct certain virtual appointments may be nearing an end.
Televisits for medical care took off during the worst days of the pandemic, quickly becoming commonplace. Most states and the Centers for Medicare & Medicaid Services temporarily waived rules requiring licensed clinicians to hold a valid license in the state where their patient is located. Those restrictions don't keep patients from visiting doctors' offices in other states, but problems could arise if those same patients used telemedicine.
Now states are rolling back many of those pandemic workarounds.
Johns Hopkins Medicine in Baltimore, for example, recently scrambled to notify more than 1,000 Virginia patients that their telehealth appointments were "no longer feasible," said Dr. Brian Hasselfeld, medical director of digital health and telemedicine at Johns Hopkins. Virginia is among the states where the emergency orders are expiring or being rolled back.
At least 17 states still have waivers in effect, according to a tracker maintained by the Alliance for Connected Care, a lobbying group representing insurers, tech companies and pharmacies.
As those rules end, "it risks increasing barriers" to care, said Hasselfeld. Johns Hopkins, he added, hosted more than 1 million televisits, serving more than 330,000 unique patients, since the pandemic began. About 10% of those visits were from states where Johns Hopkins does not operate facilities.
The rollbacks come amid a longer and larger debate over states' authority around medical licensing that the pandemic — with its widespread adoption of telehealth services — has put front and center.
"Consumers don't know about these regulations, but if you all of a sudden pull the rug out from these services, you will definitely see a consumer backlash," said Dr. Harry Greenspun, chief medical officer for the consultancy Guidehouse.
Still, finding a way forward pits high-powered stakeholders against one another, and consumers' input is likely to be muted.
State medical boards don't want to cede authority, saying their power to license and discipline medical professionals boosts patient safety. Licensing is also a source of state revenue.
Providers have long been split on whether to change cross-state licensing rules. Different state requirements — along with fees — make it cumbersome and expensive for doctors, nurses and other clinicians to get licenses in multiple states, leading to calls for more flexibility. Even so, those efforts have faced pushback from within the profession, with opposition from other clinicians who fear the added competition that could come from telehealth could lead to losing patients or jobs.
"As with most things in medicine, it's a bottom-line issue. The reason telehealth has been blocked across state lines for many years related fundamentally to physicians wanting to protect their own practices," said Greenspun.
But the pandemic changed the equation.
Even though the initial spike in telehealth visits has eased, utilization remains 38 times higher than before the pandemic, attracting not only patients, but also venture capitalists seeking to join the hot business opportunity, according to a report from consulting firm McKinsey and Co.
Patients' experience with televisits coupled with the growing interest by investors is focusing attention on this formerly inside-baseball issue of cross-state licensing.
Greenspun predicts consumers will ultimately drive the solution by "voting with their wallets," aided by giant, consumer-focused retailers like Amazon and Walmart, both of which in recent months made forays into telemedicine.
In the short term, however, the focus is on both the protections and the barriers state regulations create.
"The whole challenge is to ensure maximum access to health while assuring quality," said Barak Richman, a Duke University law professor, who said laws and policies haven't been updated to reflect new technological realities partly because state boards want to hang onto their authority.
Patients and their doctors are getting creative, with some consumers simply driving across state lines, then making a Zoom call from their vehicle.
"It's not ideal, but some patients say they are willing to drive a mile or two and sit in a parking lot in a private space and continue to get my care," said Dr. Shabana Khan, director of telepsychiatry at NYU Langone Health's department of child and adolescent psychiatry and a member of the American Psychiatric Association's Telepsychiatry Committee. She and other practitioners ask their patients about their locations, mainly for safety reasons, but also to check that they are in-state.
Still, for some patients, driving to another state for an in-person or even a virtual appointment is not an option.
Khan worries about people whose care is interrupted by the changes, especially those reluctant to seek out new therapists or who cannot find any clinicians taking new patients.
Austin Smith hopes that doesn't happen to him.
After initial treatment for what he calls a "weird flavor of cancer" didn't help reduce his gastrointestinal stromal tumors, he searched out other experts, landing in a clinical trial. But it was in San Diego and the 28-year-old salesman lives in Phoenix.
Although he drives more than five hours each way every couple of months for treatment and to see his doctors, he does much of his other follow-up online. The only difference is "if I was in person, and I said I was hurting here, the doctor could poke me," he said.
And if the rules change? He'll make the drive. "I'll do anything to beat this," he said of his cancer.
But will doctors, whose patients have spent the past year or more growing comfortable with virtual visits, also be willing to take steps that could likely involve extra costs and red tape?
To get additional licenses, for instance, practitioners must submit applications in every state where their patients reside, each of which can take weeks or months to process. They must pay application fees and keep up with a range of requirements such as continuing education, which vary by state.
States say their traditional role as overseer ensures that all applicants meet educational requirements and pass background checks. They also investigate complaints and argue there's an advantage to keeping local officials in charge.
"It's closer to home," said Lisa Robin, chief advocacy officer with the Federation of State Medical Boards. "There's a remedy for residents of the state with their own state officials."
Doctor groups such as the American Medical Association agree.
Allowing a change that doesn't put centralized authority in a patient's home state would raise "serious enforcement issues as states do not have interstate policing authority and cannot investigate incidents that happen in another state," said then-AMA President-elect Jack Resneck during a congressional hearing in March.
But others want more flexibility and say it can be done safely.
Hasselfeld, at Johns Hopkins, said there is precedent for easing multistate licensing requirements. The Department of Veterans Affairs, for example, allows medical staffers who are properly licensed in at least one state to treat patients in any VA facility.
The Alliance for Connected Care and other advocates are pushing states to extend their pandemic rules. A few have done so. Arizona, for example, made permanent the rules allowing out-of-state medical providers to practice telemedicine for Arizona residents, as long as they register with the state and their home-state license is in good standing. Connecticut's similar rules have now been stretched until June 2023.
The alliance and others also back legislation stalled in Congress that would temporarily allow medical professionals licensed in one state to treat — either in person or via televisits — patients in any other state.
Because such fixes are controversial, voluntary interstate pacts have gained attention. Several already exist: one each for nurses, doctors, physical therapists and psychologists. Proponents say they are a simple way to ensure state boards retain authority and high standards, while making it easier for licensed medical professionals to expand their geographic range.
The nurses' compact, enacted by 37 states and Guam, allows registered nurses with a valid license in one state to have it recognized by all the others in the pact.
A different kind of model is the Interstate Physician Licensure Compact, which has been enacted by 33 states, plus the District of Columbia and Guam, and has issued more than 21,000 licenses since it began in 2017, said Robin, of the Federation of State Medical Boards.
While it speeds the paperwork process, it does not eliminate the cost of applying for licenses in each state.
The compact simplifies the process by having the applicant physician's home state confirm his or her eligibility and perform a criminal background check. If the applicant is eligible, the home state sends a letter of qualification to the new state, which then issues a license, Robin said. Physicians must meet all rules and laws in each state, such as requirements for continuing medical education. Additionally, they cannot have a history of disciplinary actions or currently be under investigation.
"It's a fairly high bar," said Robin.
Such compacts — especially if they are bolstered by new legislation at the federal level — could help the advances in telehealth made during the pandemic stick around for good, expanding access to care for both mental health services and medical care across the U.S. "What's at stake if we get this right," said Richman at Duke, "is making sure we have an innovative marketplace that fully uses virtual technology and a regulatory system that encourages competition and quality."
In the rural northeastern corner of Missouri, Scotland County Hospital has been so low on staff that it sometimes had to turn away patients amid a surge in COVID-19 cases.
The national COVID staffing crunch means CEO Dr. Randy Tobler has hired more travel nurses to fill the gaps. And the prices are steep — what he called "crazy" rates of $200 an hour or more, which Tobler said his small rural hospital cannot afford.
A little over 60% of his staff is fully vaccinated. Even as COVID cases rise, though, a vaccine mandate is out of the question.
"If that becomes our differential advantage, we probably won't have one until we're forced to have one," Tobler said. "Maybe that's the thing that will keep nurses here."
As of Thursday, about 39% of U.S. hospitals had announced vaccine mandates, said Colin Milligan, a spokesperson for the American Hospital Association. Across Missouri and the nation, hospitals are weighing more than patient and caregiver health in deciding whether to mandate COVID vaccines for staffers.
The market for healthcare labor, strained by more than a year and a half of coping with the pandemic, continues to be pinched. While urban hospitals with deeper pockets for shoring up staff have implemented vaccine mandates, and may even use them as a selling point to recruit staffers and patients, their rural and regional counterparts are left with hard choices as cases surge again.
"Obviously, it's going to be a real challenge for these small, rural hospitals to mandate a vaccine when they're already facing such significant workforce shortages," said Alan Morgan, head of the National Rural Health Association.
Without vaccine mandates, this could lead to a desperate cycle: Areas with fewer vaccinated residents likely have fewer vaccinated hospital workers, too, making them more likely to be hard hit by the delta variant sweeping America. In the short term, mandates might drive away some workers. But the surge could also squeeze the hospital workforce further as patients flood in and staffers take sick days.
Rural COVID mortality rates were almost 70% higher on average than urban ones for the week ending Aug. 15, according to the Rural Policy Research Institute.
Despite the scientific knowledge that COVID vaccinations sharply lower the risk of infection, hospitalization and death, the lack of a vaccine mandate can serve as a hospital recruiting tool. In Nebraska, the state veterans affairs' agency prominently displays the lack of a vaccine requirement for nurses on its job site, The Associated Press reported.
It all comes back to workforce shortages, especially in more vaccine-hesitant communities, said Jacy Warrell, executive director of the Rural Health Association of Tennessee. She pointed out that some regional healthcare systems don't qualify for staffing assistance from the National Guard as they have fewer than 200 beds. A potential vaccine mandate further endangers their staffing numbers, she said.
"They're going to have to think twice about it," Warrell said. "They're going to have to weigh the risk and benefit there."
The mandates are having ripple effects throughout the healthcare industry. The federal government has mandated that all nursing homes require COVID vaccinations or risk losing Medicare and Medicaid reimbursements, and industry groups have warned that workers may jump to other healthcare settings. Meanwhile, Montana has banned vaccine mandates altogether, and the Montana Hospital Association has gotten one call from a healthcare worker interested in working in the state because of it, said spokesperson Katy Peterson.
It's not just nurses at stake with vaccine mandates. Respiratory techs, nursing assistants, food service employees, billing staff and other healthcare workers are already in short supply. According to the latest KFF/The Washington Post Frontline Healthcare Workers Survey, released in April, at least one-third of healthcare workers who assist with patient care and administrative tasks have considered leaving the workforce.
The combination of burnout and added stress of people leaving their jobs has worn down the healthcare workers the public often forgets about, said interventional radiology tech Joseph Brown, who works at Sutter Roseville Medical Center outside Sacramento, California.
This has a domino effect, Brown said: More of his co-workers are going on stress and medical leave as their numbers dwindle and while hospitals run out of beds. He said nurses' aides already doing backbreaking work are suddenly forced to care for more patients.
"Explain to me how you get 15 people up to a toilet, do the vitals, change the beds, provide the care you're supposed to provide for 15 people in an eight-hour shift and not injure yourself," he said.
In Missouri, Tobler said his wife, Heliene, is training to be a volunteer certified medical assistant to help fill the gap in the hospital's rural health clinic.
Tobler is waiting to see if the larger St. Louis hospitals lose staff in the coming weeks as their vaccine mandates go into effect, and what impact that could have throughout the state.
In the hard-hit southwestern corner of Missouri, CoxHealth president and CEO Steve Edwards said his health system headquartered in Springfield is upping its minimum wage to $15.25 an hour to compete for workers.
While the estimated $25 million price tag of such a salary boost will take away about half the hospital system's bottom line, Edwards said, the investment is necessary to keep up with the competitive labor market and cushion the blow of the potential loss of staffers to the hospital's upcoming Oct. 15 vaccine mandate.
"We're asking people to take bedpans and work all night and do really difficult work and maybe put themselves in harm's way," he said. "It seems like a much harder job than some of these 9-to-5 jobs in an Amazon distribution center."
Two of his employees died from COVID. In July alone, Edwards said 500 staffers were out, predominantly due to the virus. The vaccine mandate could keep that from happening, Edwards said.
"You may have the finest neurosurgeon, but if you don't have a registration person everything stops," he said. "We're all interdependent on each other."
But California's Brown, who is vaccinated, said he worries about his colleagues who may lose their jobs because they are unwilling to comply with vaccine mandates.
California has mandated that healthcare workers complete their COVID vaccination shots by the end of September. The state is already seeing traveling nurses turn down assignments there because they do not want to be vaccinated, CalMatters reported.
Since the mandate applies statewide, workers cannot go work at another hospital without vaccine requirements nearby. Brown is frustrated that hospital administrators and lawmakers, who have "zero COVID exposure," are the ones making those decisions.
"Hospitals across the country posted signs that said 'Healthcare heroes work here.' Where is the reward for our heroes?" he asked. "Right now, the hospitals are telling us the reward for the heroes: 'If you don't get the vaccine, you're fired.'"
After a decade of living with chronic kidney disease, Vonita McGee knows her body is wearing out.
At 63, McGee undergoes dialysis sessions three times each week at a Northwest Kidney Centers site near her Burien, Washington, home to rid her blood of waste and water. She has endured the placement of more than a dozen ports, or access sites, in her arms and chest as sites became scarred and unusable. Late last month, doctors performed surgery to install yet another port near her left elbow, but no one is certain it will hold.
"Because of scar tissue, I was told this is my last viable access," she said.
Without ongoing dialysis, McGee knows she could face death within days or weeks. But, unlike many of the nearly 500,000 U.S. patients who require dialysis, McGee said she's had help making peace with the process.
"I know that things are coming," she said. "I'm in awe of death, but I'm not afraid of it anymore."
That's largely attributed to a novel effort in Washington state that embeds palliative care within a kidney center whose clinics treat patients living with kidney disease; and then later pair dying patients with hospice care without forcing them to forgo the comfort that dialysis may still provide.
Traditional hospice services require kidney patients to abandon dialysis, a decision that hastens death, and almost inevitably comes with acute symptoms, including muscle spasms and nausea.
McGee is one of 400 patients enrolled since 2019 in a first-in-the-nation palliative care program housed at Northwest Kidney Centers, a Seattle-based operation with clinics throughout the region. The organization founded the first dialysis center in the U.S. — and the world — nearly 50 years ago.
Chronic kidney disease, or CKD, encompasses five stages, from mild damage in the organs' functioning in stage 1 to complete kidney failure in stage 5. Most patients start preparing for dialysis — and kidney failure — in stage 4. Dialysis does not cure kidney failure. The only other option for treatment is an organ transplant.
Dialysis patients typically face distressing physical, emotional and spiritual symptoms throughout their treatment, ranging from pain, shortness of breath and intense itching to depression and panic. The symptoms can grow dire as years pass.
But only a fraction of those patients, 4% or fewer, ever receive specialized palliative care that can effectively target those issues, said Dr. Daniel Lam, the University of Washington nephrologist and palliative care expert who launched the program with the help of a two-year, $180,000 grant from the Cambia Health Foundation. Attention to palliative care in nephrology has lagged behind its use for advanced cancer, for instance.
That's especially true for Black patients and other minorities, who are disproportionately more likely than white patients to require dialysis, but far less likely to receive quality palliative or end-of-life care.
"We're trying to address this current and projected gap," Lam said. "What we are doing is asking people how do they want to live their lives and what's most important to them."
If McGee's condition deteriorates to the point that she has a prognosis of six months or less to live, she will then be a candidate for a related partnership between the kidney center and the nonprofit Providence Hospice of Seattle, which would allow her to continue to receive dialysis even after hospice care begins.
While the goal of both hospice and palliative care is pain and symptom relief, hospice has traditionally been regarded as comfort care without the intent to treat or cure the primary disease. The nuance with dialysis is that it is central to keeping a kidney patient's body functioning; discontinuing it abruptly results in death within days.
"The goal of this program is to provide kind of a smooth off-ramp from curative dialysis to the end of their lives," said Mackenzie "Mack" Daniek, who co-directs the hospice.
Most dialysis patients face a harrowing choice between continuing dialysis or receiving hospice services. That's because the Medicare hospice benefit, which took effect in 1983, provides palliative care and support for terminally ill patients who have six months or less to live — and who agree to forgo curative or life-prolonging care.
That rigid requirement could change in the future. The Centers for Medicare & Medicaid Services has approved an experimental model that will allow concurrent care for some patients starting next year. But, for now, Medicare will not simultaneously pay for dialysis and hospice care for patients with a terminal diagnosis of kidney failure.
Hospices receive a daily per-patient rate from Medicare, typically $200 or less, and must use it to cover all services related to the terminal diagnosis. Dialysis can easily cost $250 a session, which means only the largest hospices, those with 500 or more patients, can absorb the costs of providing concurrent care. Only about 1% of the more than 4,500 hospices in the U.S. meet that mark.
The result? About a quarter of dialysis patients receive hospice care, compared with about half of the general Medicare population. And their median time spent in hospice care is about five days compared with more than 17 days for the general population. This means that dialysis patients often receive aggressive medical treatment until the very end of life, missing out on the comfort of targeted end-of-life care.
"What's happened through the years is when a dialysis patient is ready to stop treatment, that's when they come to hospice," said Dr. Keith Lagnese, chief medical officer of the University of Pittsburgh Medical Center Family Hospice. "They're forced to draw that line in the sand. Like many things in life, it's not easy to do."
Lagnese said the Seattle program is among the first in the U.S. to address palliative and hospice care among dialysis patients. His UPMC program, which has experimented with concurrent care, allows patients up to 10 dialysis treatments after they enter hospice care.
In the Washington state program, there's no limit on the number of sessions a patient can receive. That helps ease the patient into the new arrangement, instead of abruptly halting the treatment they've been receiving, often for years.
"If they're faced with immediately stopping, they feel like they're falling off of a cliff," said Lam, the program's founder.
In McGee's case, she's had the benefit of palliative care for three years to help negotiate the daily struggles that come with dialysis. The care focuses on relieving the physical side effects, and emotional symptoms such as depression and anxiety. It also addresses spiritual needs, which McGee said has helped augment the comfort she finds as a member of the Baha'i religious faith.
"They provide mental support, and they inform you what you need to do to do things properly, and they're your liaisons," McGee said. "Basically, I was just living before without knowing the information."
When she considers her degenerating medical condition and the possibility that it will become too difficult, even impossible, to continue dialysis long term, she said she welcomes the option to ease into the final stage of her life.
"Do I feel scared? At one point, I did," McGee said. "But they are assuring me that my rights will be honored, they will be advocates for me when it happens. By having that support, it gives me my time to live."