From spring break parties to Mardi Gras, many people remember the last major "normal" thing they did before the novel coronavirus pandemic dawned, forcing governments worldwide to issue stay-at-home advisories and shutdowns.
Even before the first case of COVID-19 was detected in the U.S., fears and uncertainties helped spur misinformation's rapid spread. In March 2020, schools closed, employers sent staff to work from home, and grocery stores called for physical distancing to keep people safe. But little halted the flow of misleading claims that sent fact-checkers and public health officials into overdrive.
Some people falsely asserted COVID's symptoms were associated with 5G wireless technology. Faux cures and untested treatments populated social media and political discourse. Amid uncertainty about the virus's origins, some people proclaimed COVID didn't exist at all. PolitiFact named "downplay and denial" about the virus its 2020 "Lie of the Year."
Four years later, people's lives are largely free of the extreme public health measures that restricted them early in the pandemic. But COVID misinformation persists, although it's now centered mostly on vaccines and vaccine-related conspiracy theories.
"From a misinformation researcher perspective, [there has been] shifting levels of trust," said Tara Kirk Sell, a senior scholar at the Johns Hopkins Center for Health Security. "Early on in the pandemic, there was a lot of: ‘This isn't real,' fake cures, and then later on, we see more vaccine-focused mis- and disinformation and a more partisan type of disinformation and misinformation."
Here are some of the most persistent COVID misinformation narratives we see today:
A Loss of Trust in the Vaccines
COVID vaccines were quickly developed, with U.S. patients receiving the first shots in December 2020, 11 months after the first domestic case was detected.
Experts credit the speedy development with helping to save millions of lives and preventing hospitalizations. Researchers at the University of Southern California and Brown University calculated that vaccines saved 2.4 million lives in 141 countries starting from the vaccines' rollout through August 2021 alone. Centers for Disease Control and Prevention data shows there were 1,164 U.S. deaths provisionally attributed to COVID the week of March 2, down from nearly 26,000 at the pandemic's height in January 2021, as vaccines were just rolling out.
But on social media and in some public officials' remarks, misinformation about COVID vaccine efficacy and safety is common. U.S. presidential candidate Robert F. Kennedy Jr. has built his 2024 campaign on a movement that seeks to legitimize conspiracy theories about the vaccines. PolitiFact made that its 2023 "Lie of the Year."
PolitiFact has seen claims that spike proteins from vaccines are replacing sperm in vaccinated males. (That's false.) We've researched the assertion that vaccines can change your DNA. (That's misleading and ignores evidence). Social media posts poked fun at Kansas City Chiefs tight end Travis Kelce for encouraging people to get vaccinated, asserting that the vaccine actually shuts off recipients' hearts. (No, it doesn't.) And some people pointed to an American Red Cross blood donation questionnaire as evidence that shots are unsafe. (PolitiFact rated that False.)
Experts say this misinformation has real-world effects.
A September 2023 survey by KFF found that 57% of Americans "say they are very or somewhat confident" in COVID vaccines. And those who distrust them are more likely to identify as politically conservative: Thirty-six percent of Republicans compared with 84% of Democrats say they are very or somewhat confident in the vaccine.
Immunization rates for routine vaccines for other conditions have also taken a hit. Measles had been eradicated for more than 20 years in the U.S. but there have been recent outbreaks in states including Florida, Maryland, and Ohio. Florida's surgeon general has expressed skepticism about vaccines and rejectedguidance from the CDC about how to contain potentially deadly disease spread.
The vaccination rate among kindergartners has declined from 95% in the 2019-20 school year to 93% in 2022-23, according to the CDC. Public health officials have set a 95% vaccination rate target to prevent and reduce the risk of disease outbreaks. The CDC also found exemptions had risen to 3%, the highest rate ever recorded in the U.S.
Unsubstantiated Claims That Vaccines Cause Deaths or Other Illness
PolitiFact has seen repeated and unsubstantiated claims that COVID vaccines have caused mass numbers of deaths.
A recent widely shared post claimed 17 million people had died because of the vaccine, despite contrary evidence from multiple studies and institutions such as the World Health Organization and CDC that the vaccines are safe and help to prevent severe illness and death.
Another online post claimed the booster vaccine had eight strains of HIV and would kill 23% of the population. Vaccine manufacturers publish the ingredient lists; they do not include HIV. People living with HIV were among the people given priority access during early vaccine rollout to protect them from severe illness.
COVID vaccines also have been blamed for causing Alzheimer's and cancer. Experts have found no evidence the vaccines cause either conditions.
"You had this remarkable scientific or medical accomplishment contrasted with this remarkable rejection of that technology by a significant portion of the American public," said Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.
More than three years after vaccines became available, about 70% of Americans have completed a primary series of COVID vaccination, according to CDC figures. About 17% have gotten the most recent bivalent booster.
False claims often pull from and misuse data from the Vaccine Adverse Event Reporting System. The database, run by the CDC and the FDA, allows anybody to report reactions after any vaccine. The reports themselves are unverified, but the database is designed to help researchers find patterns for further investigation.
An October 2023 survey published in November by the Annenberg Public Policy Center at the University of Pennsylvania found 63% of Americans think "it is safer to get the COVID-19 vaccine than the COVID-19 disease" — that was down from 75% in April 2021.
Celebrity Deaths Falsely Attributed to Vaccines
Betty White, Bob Saget, Matthew Perry, and DMX are just a few of the many celebrities whose deaths were falsely linked to the vaccine. The anti-vaccine film "Died Suddenly" tried to give credence to false claims that the vaccine causes people to die shortly after receiving it.
Céline Gounder, editor-at-large for public health at KFF Health News and an infectious disease specialist, said these claims proliferate because of two things: cognitive bias and more insidious motivated reasoning.
"It's like saying ‘I had an ice cream cone and then I died the next day; the ice cream must have killed me," she said. And those with preexisting beliefs about the vaccine seek to attach sudden deaths to the vaccine.
Gounder experienced this personally when her husband, the celebrated sports journalist Grant Wahl, died while covering the 2022 World Cup in Qatar. Wahl died of a ruptured aortic aneurysm but anti-vaccine accounts falsely linked his death to a COVID vaccine, forcing Gounder to publicly set the record straight.
"It is very clear that this is about harming other people," said Gounder, who was a guest at United Facts of America in 2023. "And in this case, trying to harm me and my family at a point where we were grieving my husband's loss. What was important in that moment was to really stand up for my husband, his legacy, and to do what I know he would have wanted me to do, which is to speak the truth and to do so very publicly."
Out-of-Control Claims About Government Control
False claims that the pandemic was planned by government leaders and those in power abound.
At any given moment, Microsoft Corp. co-founder and philanthropist Bill Gates, World Economic Forum head Klaus Schwab, or Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, are blamed for orchestrating pandemic-related threats.
In November, Rep. Matt Rosendale (R-Mont.) falsely claimed Fauci "brought" the virus to his state a year before the pandemic. There is no evidence of that. Gates, according to the narratives, is using dangerous vaccines to push a depopulation agenda. That's false. And Schwab has not said he has an "agenda" to establish a totalitarian global regime using the coronavirus to depopulate the Earth and reorganize society. That's part of a conspiracy theory that's come to be called "The Great Reset" that has been debunkedmanytimes.
The United Nations' World Health Organization is frequently painted as a global force for evil, too, with detractors saying it is using vaccination to control or harm people. But the WHO has not declared that a new pandemic is happening, as some have claimed. Its current pandemic preparedness treaty is in no way positioned to remove human rights protections or restrict freedoms, as one post said. And the organization has not announced plans to deploy troops to corral people and forcibly vaccinate them. The WHO is, however, working on a new treaty to help countries improve coordination in response to future pandemics.
GRINNELL, Iowa — A for-profit company has proposed turning a boarded-up former nursing home here into a psychiatric hospital, joining a national trend toward having such hospitals owned by investors instead of by state governments or nonprofit health systems.
The companies see a business opportunity in the shortage of inpatient beds for people with severe mental illness.
The scarcity of inpatient psychiatric care is evident nationwide, especially in rural areas. People in crisis often are held for days or weeks in emergency rooms or jails, then transported far from their hometowns when a bed opens in a distant hospital.
Eight nonprofit Iowa hospitals have shuttered their psychiatric units since 2007, often citing staffing and financial challenges. Iowa closed two of its four mental health institutions in 2015.
The state now ranks last in the nation for access to state-run psychiatric hospitals, according to the Treatment Advocacy Center. The national group, which promotes improving care for people with severe mental illness, recommends states have at least 50 state-run psychiatric beds per 100,000 people. Iowa has just two such beds per 100,000 residents, the group said.
Two out-of-state companies have developed psychiatric hospitals in Iowa in the past four years, and now a third company has obtained a state "certificate of need" to open a 60-bed facility in Grinnell.
Before 2020, Iowa had no privately owned, free-standing psychiatric hospitals. But several national companies specialize in developing such facilities, which treat people in crisis from conditions such as depression, schizophrenia, or bipolar disorder, sometimes compounded by drug or alcohol abuse. One of the companies operating in Iowa, Universal Health Services, says it has mental health facilities in 39 states.
Lisa Dailey, the Treatment Advocacy Center's executive director, said that for-profit hospitals don't necessarily provide worse care than nonprofit ones but that they tend to be less transparent and more motivated by money. "Private facilities are private," she said. "As a result, you may not have a great insight into why they make the decisions that they make."
Dailey said solid data on privately run mental health hospitals nationwide is scarce. But she has heard for-profit companies have recently set up free-standing psychiatric hospitals in several states, including California. The California Department of Public Health confirmed three such facilities have opened there since 2021, in Aliso Viejo, Madera, and Sacramento.
The latest Iowa psychiatric hospital would be housed in a vacant nursing home on the outskirts of Grinnell, a college town of 9,500 people in a rural region of the state. The project's developers noted there are no other inpatient mental health facilities in Poweshiek County, where Grinnell is located, or in any of the eight surrounding counties. The nearest inpatient mental health facilities are 55 miles west in Des Moines.
The Indiana-based company proposing the hospital, Hickory Recovery Network, primarily runs addiction treatment centers in Indiana. But it opened psychiatric hospitals in Ohioand Texas in 2023 and 2024, and it told Iowa regulators it could open the Grinnell hospital by August.
An affiliated company ran the facility as a nursing home, called the Grinnell Health Care Center, until 2022, according to a Hickory Recovery Network filing with Iowa regulators.
Medicare rated the nursing home's overall quality at just two out of five stars. And in 2020, the facility was suspended indefinitely from Iowa's Medicaid program because of billing issues, state records show.
Officials from Hickory Recovery Network responded only briefly to KFF Health News inquiries, including about how the former Iowa nursing home's spotty record could affect the proposed psychiatric hospital.
In a short telephone interview in February, Melissa Durkin, the company's chief operating officer, declined to say who owns Hickory Recovery Network.
Durkin denied in the interview that her organization was associated with the company that ran the defunct and troubled Grinnell nursing home.
However, Hickory Recovery's application for a certificate of need refers to the nursing home operator as "Hickory's affiliated company." In testimony before Iowa regulators, Durkin made a similar reference as she expressed confidence her organization could find sufficient staff to reopen the facility as a psychiatric hospital. "We have a history with that building. We operated a nursing home there before," she said at the video-recorded hearing.
Durkin said in the interview that company leaders had not decided for sure to redevelop the vacant Iowa nursing home into a psychiatric hospital, although they twice went through the complicated process of applying for a state "certificate of need" for the project. The first attempt was stymied in 2023 by a tie vote of the board that considers such permits, which are a major hurdle for large health care projects. The second application was approved by a unanimous vote after a hearing on Jan. 25.
Keri Lyn Powers, a Hickory executive, told regulators the company planned to spend $1.5 million to remodel the building. The main changes would include making rooms safe for people who might be suicidal, she said.
The company predicted in its application that 90% of the hospital's patient revenues would come from Medicare or Medicaid, public programs for seniors or people who have low incomes or disabilities. It doesn't mention that the nursing home was suspended from Iowa's Medicaid program, which covers about half of the state's nursing home residents.
Iowa authorities suspended the Grinnell Health Care Center nursing home in 2020 for failing to repay nearly $25,000 in overpayments from Medicaid, state records show. When the nursing home closed in 2022, its former medical director told the local newspaper part of the reason for its demise was its inability to collect Medicaid reimbursements. Iowa administrators recently notified the owners that the former nursing home owed $284,676 to Medicaid. A state spokesperson said in March that neither amount had been repaid.
The proposal to reopen the building as a psychiatric hospital won support from patient advocates, Grinnell's nonprofit community hospital, and the regional mental health coordinator.
The only opposition at the state hearing came from Kevin Pettit, leader of one of Iowa's two other private free-standing psychiatric hospitals. Pettit is chief executive officer of Clive Behavioral Health Hospital, a 100-bed facility in suburban Des Moines that opened in 2021. Pettit told regulators he supports expanding mental health services, but he predicted the proposed Grinnell facility would struggle to hire qualified employees.
He said despite strong demand for care, many Iowa psychiatric facilities are limiting admissions. "The beds exist, but they're not actually open, … because we're dealing with staffing issues throughout the state," Pettit testified.
Overall, Iowa has 901 licensed inpatient mental health beds, including in psychiatric units at community hospitals, in free-standing psychiatric hospitals, and in the two remaining state mental health institutes, according to the Iowa Department of Health and Human Services. But as of January, just 738 of those beds were staffed and being used.
Pettit's facility is run by Pennsylvania-based Universal Health Services in partnership with MercyOne, a hospital system based in the Des Moines area.
In an interview, Pettit said his hospital only has enough staff to use about half of its beds. He said it's especially difficult to recruit nurses and therapists, even in an urban area with a relatively robust labor supply.
State inspectors have cited problems at the Clive facility, including four times declaring that deficiencies put patients' safety in "immediate jeopardy." Those issues included insufficient staff to properly monitor patients and insufficient safeguards to prevent access to items patients could use to choke or cut themselves.
Pettit said such citations are not unusual in the tightly regulated industry. He said the organization is committed to patient safety. "We value the review by our regulatory entities during the survey process and view any finding as an opportunity for continuous improvement of our operations," he wrote in an email.
Iowa's other privately owned psychiatric hospital, Eagle View Behavioral Health in Bettendorf, also has been cited by state inspectors. The 72-bed hospital was purchased in 2022 by Summit BHC from Strategic Behavioral Health, which opened the facility in 2020. Both companies are based in Tennessee.
State inspectors have cited the Bettendorf facility twice for issues posing "immediate jeopardy" to patient safety. In 2023, inspectors cited the facility for insufficient supervision of patients, "resulting in inappropriate sexual activity" between adult and adolescent patients. In 2021, the facility was cited for insufficient safety checks to prevent suicide attempts and sexual misconduct.
Eagle View officials did not respond to requests for comment.
Advocates for Iowa patients have supported the development of free-standing psychiatric hospitals.
Leslie Carpenter of Iowa City, whose adult son has been hospitalized repeatedly for severe mental illness, spoke in favor of the Grinnell facility's application for a certificate of need.
In an interview afterward, Carpenter said she was optimistic the new facility could find enough staff to help address Iowa's critical shortage of inpatient psychiatric care.
She said she would keep a close eye on how the new facility fares. "I think if a company were willing to come in and do the job well, it could be a game changer."
Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up healthcare costs.
This article was published on Monday, April 1, 2024 in KFF Health News.
Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
It's a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.
Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients' insurance plans.
Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.
"Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well," said Gerard Anderson, a hospital finance expert at Johns Hopkins University.
"They are the ideal patient, from the hospitals' perspective."
Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.
"Every time we see these models expand, we are contracting the availability of primary care doctors for the general population," said Jewel Mullen, associate dean for health equity at the University of Texas-Austin's Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions' reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. "It helps hospitals secure a bigger piece of their market," she said.
Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.
Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.
"High-end donors wanted to make sure they have doctors to care for them," he said.
Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.
"My philosophy is: It's better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients," Klein said.
Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.
One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.
Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.
Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.
For hospitals, "this is an extension of them consolidating the market," said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state's largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.
George Salem, 70, of McLean, Virginia, has been a patient in Inova's concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.
"I loved my internist before, but it was impossible to get to see him," Salem said. Immediate access to his doctor "very much gives me peace of mind," he said.
Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova's program has 6,000 patients.
Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.
"Inova has an incredible primary care network for those who can't afford the concierge care," he said. "We are still providing all that is necessary in primary care for those who need it."
Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.
NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. "We found a need in this community for those who wanted a more personalized health care experience," said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.
NCH patients whose doctors convert to concierge and who don't want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.
When she was in ninth grade, Fiona Lu fell into a depression. She had trouble adjusting to her new high school in Orange County, California, and felt so isolated and exhausted that she cried every morning.
Lu wanted to get help, but her Medi-Cal plan wouldn't cover therapy unless she had permission from a parent or guardian.
Her mother — a single parent and an immigrant from China — worked long hours to provide for Fiona, her brother, and her grandmother. Finding time to explain to her mom what therapy was, and why she needed it, felt like too much of an obstacle.
"I wouldn't want her to have to sign all these forms and go to therapy with me," said Lu, now 18 and a freshman at UCLA. "There's a lot of rhetoric in immigrant cultures that having mental health concerns and getting treatment for that is a Western phenomenon."
By her senior year of high school, Lu turned that experience into activism. She campaigned to change state policy to allow children 12 and older living in low-income households to get mental health counseling without their parents' consent.
In October of last year, Gov. Gavin Newsom signed a new law expanding access to young patients covered by Medicaid, which is called Medi-Cal in California.
Teenagers with commercial insurance have had this privilege in the state for more than a decade. Yet parents of children who already had the ability to access care on their own were among the most vocal in opposing the expansion of that coverage by Medi-Cal.
Many parents seized on the bill to air grievances about how much control they believe the state has over their children, especially around gender identity and care.
One mother appeared on Fox News last spring calling school therapists "indoctrinators" and saying the bill allowed them to fill children's heads with ideas about "transgenderism" without their parents knowing.
Those arguments were then repeated on social media and at protests held across California and in other parts of the country in late October.
At the California Capitol, several Republican lawmakers voted against the bill, AB 665. One of them was Assembly member James Gallagher of Sutter County.
"If my child is dealing with a mental health crisis, I want to know about it," Gallagher said while discussing the bill on the Assembly floor last spring. "This misguided, and I think wrongful, trend in our policy now that is continuing to exclude parents from that equation and say they don't need to be informed is wrong."
State lawmaker salaries are too high for them or their families to qualify for Medi-Cal. Instead, they are offered a choice of 15 commercial health insurance plans, meaning children like Gallagher's already have the privileges that he objected to in his speech.
To Lu, this was frustrating and hypocritical. She said she felt that the opponents lining up against AB 665 at legislative hearings were mostly middle-class parents trying to hijack the narrative.
"It's inauthentic that they were advocating against a policy that won't directly affect them," Lu said. "They don't realize that this is a policy that will affect hundreds of thousands of other families."
Sponsors of AB 665 presented the bill as a commonsense update to an existing law. In 2010, California lawmakers had made it easier for young people to access outpatient mental health treatment and emergency shelters without their parents' consent by removing a requirement that they be in immediate crisis.
But at the last minute, lawmakers in 2010 removed the expansion of coverage for teenagers by Medi-Cal for cost reasons. More than a decade later, AB 665 is meant to close the disparity between public and private insurance and level the playing field.
"This is about equity," said Assembly member Wendy Carrillo, a Los Angeles Democrat and the bill's author.
The original law, which regulated private insurance plans, passed with bipartisan support and had little meaningful opposition in the legislature, she said. The law was signed by a Republican governor, Arnold Schwarzenegger.
"Since then, the extremes on both sides have gotten so extreme that we have a hard time actually talking about the need for mental health," she said.
After Carrillo introduced the bill last year, her office faced death threats. She said the goal of the law is not to divide families but to encourage communication between parents and children through counseling.
More than 20 other states allow young people to consent to outpatient mental health treatment without their parents' permission, including Colorado, Ohio, Tennessee, and Alabama, according to a 2015 paper by researchers at Rowan University.
To opponents of the new law, like Erin Friday, a San Francisco Bay Area attorney, AB 665 is part of a broader campaign to take parents' rights away in California, something she opposes regardless of what kind of health insurance children have.
Friday is a self-described lifelong Democrat. But then she discovered her teenager had come out as transgender at school and for months had been referred to by a different name and different pronouns by teachers, without Friday's knowledge. She devoted herself to fighting bills that she saw as promoting "transgender ideology." She said she plans to sue to try to overturn the new California law before it takes effect this summer.
"We're giving children autonomy they should never have," Friday said.
Under the new law, young people will be able to talk to a therapist about gender identity without their parents' consent. But they cannot get residential treatment, medication, or gender-affirming surgery without their parents' OK, as some opponents have suggested.
Nor can minors run away from home or emancipate themselves under the law, as opponents have also suggested.
"This law is not about inpatient psychiatric facilities. This law is not about changing child custody laws," said Rachel Velcoff Hults, an attorney and the director of health of the National Center for Youth Law, which supported AB 665.
"This law is about ensuring when a young person needs counseling or needs a temporary roof over their head to ensure their own safety and well-being, that we want to make sure they have a way to access it," she said.
Removing the parental consent requirement could also expand the number of mental health clinicians in California willing to treat young people on Medi-Cal. Without parental consent, under the old rules, clinicians could not be paid by Medi-Cal for the counseling they provided, either in a private practice or a school counselor's office.
Esther Lau struggled with mental health as a high school student in Fremont. Unlike Lu, she had her parents' support, but she couldn't find a therapist who accepted Medi-Cal. As the only native English speaker in her family, she had to navigate the health care bureaucracy on her own.
For her, AB 665 will give clinicians incentive to accept more young people from low-income households into their practices.
"For the opposition, it's just about political tactics and furthering their agenda," Lau said. "The bill was designed to expand access to Medi-Cal youth, period."
When she was in ninth grade, Fiona Lu fell into a depression. She had trouble adjusting to her new high school in Orange County, California, and felt so isolated and exhausted that she cried every morning.
Lu wanted to get help, but her Medi-Cal plan wouldn't cover therapy unless she had permission from a parent or guardian.
Her mother — a single parent and an immigrant from China — worked long hours to provide for Fiona, her brother, and her grandmother. Finding time to explain to her mom what therapy was, and why she needed it, felt like too much of an obstacle.
"I wouldn't want her to have to sign all these forms and go to therapy with me," said Lu, now 18 and a freshman at UCLA. "There's a lot of rhetoric in immigrant cultures that having mental health concerns and getting treatment for that is a Western phenomenon."
By her senior year of high school, Lu turned that experience into activism. She campaigned to change state policy to allow children 12 and older living in low-income households to get mental health counseling without their parents' consent.
In October of last year, Gov. Gavin Newsom signed a new law expanding access to young patients covered by Medicaid, which is called Medi-Cal in California.
Teenagers with commercial insurance have had this privilege in the state for more than a decade. Yet parents of children who already had the ability to access care on their own were among the most vocal in opposing the expansion of that coverage by Medi-Cal.
Many parents seized on the bill to air grievances about how much control they believe the state has over their children, especially around gender identity and care.
One mother appeared on Fox News last spring calling school therapists "indoctrinators" and saying the bill allowed them to fill children's heads with ideas about "transgenderism" without their parents knowing.
Those arguments were then repeated on social media and at protests held across California and in other parts of the country in late October.
At the California Capitol, several Republican lawmakers voted against the bill, AB 665. One of them was Assembly member James Gallagher of Sutter County.
"If my child is dealing with a mental health crisis, I want to know about it," Gallagher said while discussing the bill on the Assembly floor last spring. "This misguided, and I think wrongful, trend in our policy now that is continuing to exclude parents from that equation and say they don't need to be informed is wrong."
State lawmaker salaries are too high for them or their families to qualify for Medi-Cal. Instead, they are offered a choice of 15 commercial health insurance plans, meaning children like Gallagher's already have the privileges that he objected to in his speech.
To Lu, this was frustrating and hypocritical. She said she felt that the opponents lining up against AB 665 at legislative hearings were mostly middle-class parents trying to hijack the narrative.
"It's inauthentic that they were advocating against a policy that won't directly affect them," Lu said. "They don't realize that this is a policy that will affect hundreds of thousands of other families."
Sponsors of AB 665 presented the bill as a commonsense update to an existing law. In 2010, California lawmakers had made it easier for young people to access outpatient mental health treatment and emergency shelters without their parents' consent by removing a requirement that they be in immediate crisis.
But at the last minute, lawmakers in 2010 removed the expansion of coverage for teenagers by Medi-Cal for cost reasons. More than a decade later, AB 665 is meant to close the disparity between public and private insurance and level the playing field.
"This is about equity," said Assembly member Wendy Carrillo, a Los Angeles Democrat and the bill's author.
The original law, which regulated private insurance plans, passed with bipartisan support and had little meaningful opposition in the legislature, she said. The law was signed by a Republican governor, Arnold Schwarzenegger.
"Since then, the extremes on both sides have gotten so extreme that we have a hard time actually talking about the need for mental health," she said.
After Carrillo introduced the bill last year, her office faced death threats. She said the goal of the law is not to divide families but to encourage communication between parents and children through counseling.
More than 20 other states allow young people to consent to outpatient mental health treatment without their parents' permission, including Colorado, Ohio, Tennessee, and Alabama, according to a 2015 paper by researchers at Rowan University.
To opponents of the new law, like Erin Friday, a San Francisco Bay Area attorney, AB 665 is part of a broader campaign to take parents' rights away in California, something she opposes regardless of what kind of health insurance children have.
Friday is a self-described lifelong Democrat. But then she discovered her teenager had come out as transgender at school and for months had been referred to by a different name and different pronouns by teachers, without Friday's knowledge. She devoted herself to fighting bills that she saw as promoting "transgender ideology." She said she plans to sue to try to overturn the new California law before it takes effect this summer.
"We're giving children autonomy they should never have," Friday said.
Under the new law, young people will be able to talk to a therapist about gender identity without their parents' consent. But they cannot get residential treatment, medication, or gender-affirming surgery without their parents' OK, as some opponents have suggested.
Nor can minors run away from home or emancipate themselves under the law, as opponents have also suggested.
"This law is not about inpatient psychiatric facilities. This law is not about changing child custody laws," said Rachel Velcoff Hults, an attorney and the director of health of the National Center for Youth Law, which supported AB 665.
"This law is about ensuring when a young person needs counseling or needs a temporary roof over their head to ensure their own safety and well-being, that we want to make sure they have a way to access it," she said.
Removing the parental consent requirement could also expand the number of mental health clinicians in California willing to treat young people on Medi-Cal. Without parental consent, under the old rules, clinicians could not be paid by Medi-Cal for the counseling they provided, either in a private practice or a school counselor's office.
Esther Lau struggled with mental health as a high school student in Fremont. Unlike Lu, she had her parents' support, but she couldn't find a therapist who accepted Medi-Cal. As the only native English speaker in her family, she had to navigate the health care bureaucracy on her own.
For her, AB 665 will give clinicians incentive to accept more young people from low-income households into their practices.
"For the opposition, it's just about political tactics and furthering their agenda," Lau said. "The bill was designed to expand access to Medi-Cal youth, period."
Christian Espinoza, director of a Southern California drug-treatment provider, recently began employing a powerful new assistant: an artificial intelligence algorithm that can perform eye exams with pictures taken by a retinal camera. It makes quick diagnoses, without a doctor present.
His clinics, Tarzana Treatment Centers, are among the early adopters of an AI-based system that promises to dramatically expand screening for diabetic retinopathy, the leading cause of blindness among working-age adults and a threat to many of the estimated 38 million Americans with diabetes.
"It's been a godsend for us," said Espinoza, the organization's director of clinic operations, citing the benefits of a quick and easy screening that can be administered with little training and delivers immediate results.
His patients like it, too. Joseph Smith, who has Type 2 diabetes, recalled the cumbersome task of taking the bus to an eye specialist, getting his eyes dilated, and then waiting a week for results. "It was horrible," he said. "Now, it takes minutes."
Amid all the buzz around artificial intelligence in health care, the eye-exam technology is emerging as one of the first proven use cases of AI-based diagnostics in a clinical setting. While the FDA has approved hundreds of AI medical devices, adoption has been slow as vendors navigate the regulatory process, insurance coverage, technical obstacles, equity concerns, and challenges of integrating them into provider systems.
The eye exams show that the AI's ability to provide immediate results, as well as the cost savings and convenience of not needing to make an extra appointment, can have big benefits for both patients and providers. Of about 700 eye exams conducted during the past year at Espinoza's clinics, nearly one-quarter detected retinopathy, and patients were referred to a specialist for further care.
Diabetic retinopathy results when high blood sugar harms blood vessels in the retina. While managing a patient's diabetes can often prevent the disease — and there are treatments for more advanced stages — doctors say regular screenings are crucial for catching symptoms early. An estimated 9.6 million people in the U.S. have the disease.
The three companies with FDA-approved AI eye exams for diabetic retinopathy — Digital Diagnostics, based in Coralville, Iowa; Eyenuk of Woodland Hills, California; and Israeli software company AEYE Health — have sold systems to hundreds of practices nationwide. A few dozen companies have conducted research in the narrow field, and some have regulatory clearance in other countries, including tech giants like Google.
Digital Diagnostics, formerly Idx, received FDA approval for its system in 2018, following decades of research and a clinical trial involving 900 patients diagnosed with diabetes. It was the first fully autonomous AI system in any field of medicine, making its approval "a landmark moment in medical history," said Aaron Lee, a retina specialist and an associate professor at the University of Washington.
The system, used by Tarzana Treatment Centers, can be operated by someone with a high school degree and a few hours of training, and it takes just a few minutes to produce a diagnosis, without any eye dilation most of the time, said John Bertrand, CEO of Digital Diagnostics.
The setup can be placed in any dimly lit room, and patients place their face on the chin and forehead rests and stare into the camera while a technician takes images of each eye.
The American Diabetes Association recommends that people with Type 2 diabetes get screened every one to two years, yet only about 60% of people living with diabetes get yearly eye exams, said Robert Gabbay, the ADA's chief scientific and medical officer. The rates can be as low as 35% for people with diabetes age 21 or younger.
In swaths of the U.S., a shortage of optometrists and ophthalmologists can make appointments hard to schedule, sometimes booking for months out. Plus, the barriers of traveling to an additional appointment to get their eyes dilated — which means time off work or school and securing transportation — can be particularly tricky for low-income patients, who also have a higher risk of Type 2 diabetes.
"Ninety percent of our patients are blue-collar," said Espinoza of his Southern California clinics, which largely serve minority populations. "They don't eat if they don't work."
One potential downside of not having a doctor do the screening is that the algorithm solely looks for diabetic retinopathy, so it could miss other concerning diseases, like choroidal melanoma, Lee said. The algorithms also generally "err on the side of caution" and over-refer patients.
But the technology has shown another big benefit: Follow-up after a positive result is three times as likely with the AI system, according to a recent study by Stanford University.
That's because of the "proximity of the message," said David Myung, an associate professor of ophthalmology at the Byers Eye Institute at Stanford. When it's delivered immediately, rather than weeks or even months later, it's much more likely to be heard by the patient and acted upon.
Myung launched Stanford's automated teleophthalmology program in 2020, originally focusing on telemedicine and then shifting to AI in its Bay Area clinics. That same year, the National Committee for Quality Assurance expanded its screening standard for diabetic retinopathy to include the AI systems.
Myung said it took about a year to sift through the Stanford health system's cybersecurity and IT systems to integrate the new technology. There was also a learning curve, especially for taking quality photos that the AI can decipher, Myung said.
"Even with hitting our stride, there's always something to improve," he added.
The AI test has been bolstered by a reimbursement code from the Centers for Medicare & Medicaid Services, which can be difficult and time-consuming to obtain for breakthrough devices. But health care providers need that government approval to get reimbursement.
In 2021, CMS set the national payment rate for AI diabetic retinopathy screenings at $45.36 — quite a bit below the median privately negotiated rate of $127.81, according to a recent New England Journal of Medicine AI study. Each company has a slightly different business model, but they generally charge providers subscription or licensing fees for their software.
The companies declined to share what they charge for their software. The cameras can cost up to $20,000 and are either purchased separately or wrapped into the software subscription as a rental.
The greater compliance with screening recommendations that the machines make possible, along with a corresponding increase in referrals to specialists, makes it worthwhile, said Lindsie Buchholz, clinical informatics lead at Nebraska Medicine, which in mid-December began using Eyenuk's system.
"It kind of helps the camera pay for itself," she said.
Today, Digital Diagnostics' system is in roughly 600 sites nationwide, according to the company. AEYE Health said its eye exam is used by "low hundreds" of U.S. providers. Eyenuk declined to share specifics about its reach.
The technology continues to advance, with clinical studies for additional cameras — including a handheld imager that can screen patients in the field — and looking at other eye diseases, like glaucoma. The innovations put ophthalmology alongside radiology, cardiology, and dermatology as specialties in which AI innovation is happening fast.
"They are going to come out in the near future — cameras that you can use in street medicine — and it's going to help a lot of people," said Espinoza.
One January morning in 2021, Carol Rosen took a standard treatment for metastatic breast cancer. Three gruesome weeks later, she died in excruciating pain from the very drug meant to prolong her life.
Rosen, a 70-year-old retired schoolteacher, passed her final days in anguish, enduring severe diarrhea and nausea and terrible sores in her mouth that kept her from eating, drinking, and, eventually, speaking. Skin peeled off her body. Her kidneys and liver failed. "Your body burns from the inside out," said Rosen's daughter, Lindsay Murray, of Andover, Massachusetts.
Rosen was one of more than 275,000 cancer patientsin the United States who are infused each year with fluorouracil, known as 5-FU, or, as in Rosen's case, take a nearly identical drug in pill form called capecitabine. These common types of chemotherapy are no picnic for anyone, but for patients who are deficient in an enzyme that metabolizes the drugs, they can be torturous or deadly.
Those patients essentially overdose because the drugs stay in the body for hours rather than being quickly metabolized and excreted. The drugs kill an estimated 1 in 1,000 patients who take them — hundreds each year — and severely sicken or hospitalize 1 in 50. Doctors can test for the deficiency and get results within a week — and then either switch drugs or lower the dosage if patients have a genetic variant that carries risk.
Yet a recent survey found that only 3% of U.S. oncologists routinely order the tests before dosing patients with 5-FU or capecitabine. That's because the most widely followed U.S. cancer treatment guidelines — issued by the National Comprehensive Cancer Network — don't recommend preemptive testing.
The FDA added new warnings about the lethal risks of 5-FU to the drug's label on March 21 following queries from KFF Health News about its policy. However, it did not require doctors to administer the test before prescribing the chemotherapy.
The agency, whose plan to expand its oversight of laboratory testing was the subject of a House hearing, also March 21, has said it could not endorse the 5-FU toxicity tests because it's never reviewed them.
But the FDA at present does not review most diagnostic tests, said Daniel Hertz, an associate professor at the University of Michigan College of Pharmacy. For years, with other doctors and pharmacists, he has petitioned the FDA to put a black box warning on the drug's label urging prescribers to test for the deficiency.
"FDA has responsibility to assure that drugs are used safely and effectively," he said. The failure to warn, he said, "is an abdication of their responsibility."
The update is "a small step in the right direction, but not the sea change we need," he said.
Europe Ahead on Safety
British and European Union drug authorities have recommended the testing since 2020. A small but growing number of U.S. hospital systems, professional groups, and health advocates, including the American Cancer Society, also endorse routine testing. Most U.S. insurers, private and public, will cover the tests, which Medicare reimburses for $175, although tests may cost more depending on how many variants they screen for.
In its latest guidelines on colon cancer, the Cancer Network panel noted that not everyone with a risky gene variant gets sick from the drug, and that lower dosing for patients carrying such a variant could rob them of a cure or remission. Many doctors on the panel, including the University of Colorado oncologist Wells Messersmith, have said they have never witnessed a 5-FU death.
In European hospitals, the practice is to start patients with a half- or quarter-dose of 5-FU if tests show a patient is a poor metabolizer, then raise the dose if the patient responds well to the drug. Advocates for the approach say American oncology leaders are dragging their feet unnecessarily, and harming people in the process.
"I think it's the intransigence of people sitting on these panels, the mindset of 'We are oncologists, drugs are our tools, we don't want to go looking for reasons not to use our tools,'" said Gabriel Brooks, an oncologist and researcher at the Dartmouth Cancer Center.
Oncologists are accustomed to chemotherapy's toxicity and tend to have a "no pain, no gain" attitude, he said. 5-FU has been in use since the 1950s.
Yet "anybody who's had a patient die like this will want to test everyone," said Robert Diasio of the Mayo Clinic, who helped carry out major studies of the genetic deficiency in 1988.
Oncologists often deploy genetic tests to match tumors in cancer patients with the expensive drugs used to shrink them. But the same can't always be said for gene tests aimed at improving safety, said Mark Fleury, policy director at the American Cancer Society's Cancer Action Network.
When a test can show whether a new drug is appropriate, "there are a lot more forces aligned to ensure that testing is done," he said. "The same stakeholders and forces are not involved" with a generic like 5-FU, first approved in 1962, and costing roughly $17 for a month's treatment.
Oncology is not the only area in medicine in which scientific advances, many of them taxpayer-funded, lag in implementation. For instance, few cardiologists test patients before they go on Plavix, a brand name for the anti-blood-clotting agent clopidogrel, although it doesn't prevent blood clots as it's supposed to in a quarter of the 4 million Americans prescribed it each year. In 2021, the state of Hawaii won an $834 million judgment from drugmakers it accused of falsely advertising the drug as safe and effective for Native Hawaiians, more than half of whom lack the main enzyme to process clopidogrel.
The fluoropyrimidine enzyme deficiency numbers are smaller — and people with the deficiency aren't at severe risk if they use topical cream forms of the drug for skin cancers. Yet even a single miserable, medically caused death was meaningful to the Dana-Farber Cancer Institute, where Carol Rosen was among more than 1,000 patients treated with fluoropyrimidine in 2021.
Her daughter was grief-stricken and furious after Rosen's death. "I wanted to sue the hospital. I wanted to sue the oncologist," Murray said. "But I realized that wasn't what my mom would want."
Instead, she wrote Dana-Farber's chief quality officer, Joe Jacobson, urging routine testing. He responded the same day, and the hospital quickly adopted a testing system that now covers more than 90% of prospective fluoropyrimidine patients. About 50 patients with risky variants were detected in the first 10 months, Jacobson said.
Dana-Farber uses a Mayo Clinic test that searches for eight potentially dangerous variants of the relevant gene. Veterans Affairs hospitals use a 11-variant test, while most others check for only four variants.
Different Tests May Be Needed for Different Ancestries
The more variants a test screens for, the better the chance of finding rarer gene forms in ethnically diverse populations. For example, different variants are responsible for the worst deficiencies in people of African and European ancestry, respectively. There are tests that scan for hundreds of variants that might slow metabolism of the drug, but they take longer and cost more.
These are bitter facts for Scott Kapoor, a Toronto-area emergency room physician whose brother, Anil Kapoor, died in February 2023 of 5-FU poisoning.
Anil Kapoor was a well-known urologist and surgeon, an outgoing speaker, researcher, clinician, and irreverent friend whose funeral drew hundreds. His death at age 58, only weeks after he was diagnosed with stage 4 colon cancer, stunned and infuriated his family.
In Ontario, where Kapoor was treated, the health system had just begun testing for four gene variants discovered in studies of mostly European populations. Anil Kapoor and his siblings, the Canadian-born children of Indian immigrants, carry a gene form that's apparently associated with South Asian ancestry.
Scott Kapoor supports broader testing for the defect — only about half of Toronto's inhabitants are of European descent — and argues that an antidote to fluoropyrimidine poisoning, approved by the FDA in 2015, should be on hand. However, it works only for a few days after ingestion of the drug and definitive symptoms often take longer to emerge.
Most importantly, he said, patients must be aware of the risk. "You tell them, ‘I am going to give you a drug with a 1 in 1,000 chance of killing you. You can take this test. Most patients would be, ‘I want to get that test and I'll pay for it,' or they'd just say, ‘Cut the dose in half.'"
Alan Venook, the University of California-San Francisco oncologist who co-chairs the National Comprehensive Cancer Network, has led resistance to mandatory testing because the answers provided by the test, in his view, are often murky and could lead to undertreatment.
"If one patient is not cured, then you giveth and you taketh away," he said. "Maybe you took it away by not giving adequate treatment."
Instead of testing and potentially cutting a first dose of curative therapy, "I err on the latter, acknowledging they will get sick," he said. About 25 years ago, one of his patients died of 5-FU toxicity and "I regret that dearly," he said. "But unhelpful information may lead us in the wrong direction."
In September, seven months after his brother's death, Kapoor was boarding a cruise ship on the Tyrrhenian Sea near Rome when he happened to meet a woman whose husband, Atlanta municipal judge Gary Markwell, had died the year before after taking a single 5-FU dose at age 77.
"I was like … that's exactly what happened to my brother."
Murray senses momentum toward mandatory testing. In 2022, the Oregon Health & Science University paid $1 million to settle a suit after an overdose death.
"What's going to break that barrier is the lawsuits, and the big institutions like Dana-Farber who are implementing programs and seeing them succeed," she said. "I think providers are going to feel kind of bullied into a corner. They're going to continue to hear from families and they are going to have to do something about it."
Lawyers from the conservative Christian group that won the case to overturn Roe v. Wade are returning to the U.S. Supreme Court today in pursuit of an urgent priority: shutting down access to abortion pills for women across the country.
Viewed across decades of anti-abortion activism, the case brought by the Alliance Defending Freedom represents a "moonshot" couched in technical arguments about pharmaceutical oversight and the resuscitation of an 1873 anti-obscenity law. A victory would lay the groundwork for a de facto nationwide abortion ban.
Abortion is illegal in 14 states, but abortion pills have never been more widely available.
During the covid-19 pandemic, the FDA suspended — and later formally lifted — the requirement that patients be at a healthcare facility when taking mifepristone, the first of two pills used in medication abortion. Physicians can now prescribe the drug online through telemedicine and pharmacies can dispense it through the mail.
"You don't need to be handed the pill in the office," said Linda Prine, a family medicine physician, sitting on a couch in her Manhattan apartment answering texts and calls from patients about abortion care.
"It's very effective," she said. "I don't even have medications that are 98 to 99% effective. Our blood pressure medicines aren't effective like that."
Prine, a co-founder of the Miscarriage and Abortion Hotline, works with other doctors operating under New York state's shield law to prescribe and send abortion pills to people across the country. A review of Prine's call log, stripped of personal information, showed hundreds of requests for pills from Texas, Louisiana, Tennessee, and other states where it is illegal for women to stop a pregnancy.
Anti-abortion groups unsuccessfully petitioned the FDA at least twice before, in 2002 and 2019, to revoke mifepristone's approval and curtail its availability. But in November 2022, following its victory in overturning federal abortion rights, the Alliance Defending Freedom filed a federal lawsuit in Amarillo, Texas, claiming the FDA's safety review of mifepristone was flawed.
U.S. District Judge Matthew Kacsmaryk, who was appointed by President Donald Trump and openly opposes abortion, ruled to invalidate the FDA's approval of mifepristone. An appeals court later said the drug should remain available, but it reinstated restrictions, including prohibitions on telehealth prescriptions and mailing the medication. That ruling was put on hold while the Supreme Court considers the case.
The Biden administration and a manufacturer of mifepristone, Danco Laboratories, have argued in legal filings to the Supreme Court that federal judges do not have the scientific and health expertise to evaluate drug safety and that allowing them to do so undermines the FDA's regulatory authority.
That view is supported by food and drug legal scholars who wrote in court filings that the lower courts had replaced the "FDA's scientific and medical expertise with the courts' own interpretations of the scientific evidence." In doing so, they wrote, the courts "upend the drug regulatory scheme established by Congress and implemented by FDA."
In his ruling, Kacsmaryk cited two studies purporting to show an increase in emergency room visits and a greater risk of hospitalizations from medication abortion. They were retracted in February by medical publisher Sage Perspectives. The journal said the researchers erred in their methodology and analysis of the data and invalidated the papers "in whole or in part."
The research, supported by the Charlotte Lozier Institute, an anti-abortion group that filed a brief in the mifepristone case, "made claims that were not supported by the data," said Ushma Upadhyay, a professor of reproductive sciences at the University of California-San Francisco.
Legal scholars say the Supreme Court's conservative justices have demonstrated a willingness to accept discredited abortion-related health claims. Justice Samuel Alito, writing the majority opinion in Dobbs v. Jackson Women's Health Organization, which overturned the constitutional right to abortion, cited statements about harm to maternal health presented by the state of Mississippi that contradict mainstream medical consensus.
"If this case is successful, it will be because the Supreme Court decided to ignore evidence that demonstrated mifepristone's safety and said to a federal agency, the expert on drug safety, ‘You were wrong,'" said Rachel Rebouché, dean of Temple University Beasley School of Law.
The mifepristone case crystallizes "the politicization of science" in abortion regulation, Rebouché said. "But the stakes are getting higher as we have courts willing to strip federal agencies of their ability to make expert decisions."
Rebouché said that if the Supreme Court overrides the FDA's expertise in regulating a 24-year-old drug like mifepristone, anti-abortion groups, like Students for Life of America, could find judges receptive to false claims that birth control pills, intrauterine devices, emergency contraception, and other forms of hormonal birth control cause abortion. They do not, according to reproductive scientists and U.S. and international regulatory agencies.
Justice Clarence Thomas wrote in his concurring opinion in Dobbs that the Supreme Court should reconsider the 1965 decision that guaranteed a constitutional right to contraception, Griswold v. Connecticut, and decide whether to return the power to allow or regulate access to birth control to the states.
Tucked into the Alliance Defending Freedom's filings is what scholars describe as an audacious legal strategy once on the fringes of the conservative Christian movement: an appeal to the Supreme Court's conservative members to determine that the Comstock Act, a dormant 1873 anti-vice law, effectively bans medical and procedural abortion nationwide.
Passed at a time when the federal government did not give women the right to vote and the prevailing medical literature summed up women's sexuality by saying that "the majority of women (happily for them) are not very much troubled with sexual feelings of any kind," the long unenforced law carried a five-year prison sentence for anyone mailing "every article, instrument, substance, drug, medicine or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion."
References to the Comstock Act appear throughout anti-abortion legal filings and rulings: Kacsmaryk wrote that the act "plainly forecloses mail-order abortion in the present"; the 5th Circuit Court of Appeals wrote if Comstock was "strictly understood" then "there is no public interest in the perpetuation of illegality"; Republican attorneys general threatened legal action against Walgreens and CVS last year citing Comstock as did anti-abortion cases in New Mexico and Texas.
"State attorneys general need to go after and prosecute those who are illegally mailing abortion drugs into their state," said Kristan Hawkins, president of Students for Life of America.
"It's very simple. If your state has passed a law saying that preborn human beings deserve, at the very minimum, the right not to be starved and killed," she said, "then those who are committing those crimes and violating the federal Comstock Act by shipping chemical abortion pills over state lines, there should be consequences."
Tracking abortion pills by mail is difficult — and that's the point, Rebouché said.
"These more diffuse and mobile ways to terminate a pregnancy," she said, "really threaten the control that anti-abortion advocates seek to exercise over who and where and how someone can seek an abortion."
Ballad Health, a 20-hospital system in the Tri-Cities region of Tennessee and Virginia, benefits from the largest state-sanctioned hospital monopoly in the nation.
This article was published on Monday, March 25, 2024 in KFF Health News.
In the small Appalachian city of Bristol, Virginia, City Council member Neal Osborne left a meeting on the morning of Jan. 3 and rushed himself to the hospital.
Osborne, 36, has Type 1 diabetes. His insulin pump had malfunctioned, and without a steady supply of this essential hormone, Osborne's blood sugar skyrocketed and his body was shutting down.
Osborne went to the nearest hospital, Bristol Regional Medical Center. He said he settled into a wheelchair in the emergency room waiting area, where over the next few hours he drifted in and out of consciousness and retched up vomit, then bile, then blood. After 12 hours in the waiting room, Osborne said, he was moved to an ER bed, where he stayed until he was sent to the intensive care unit the next day. In total, the council member was in the ER for about 30 hours, he said.
Osborne said his ordeal echoes stories he's heard from constituents for years. In his next crisis, Osborne said, he plans to leave Bristol for an ER about two hours away.
"I want to go to Knoxville or I want to go to Roanoke, because I do not want to further risk my life and die at a Ballad hospital," he said. "The wait times just to get in and see a doctor in the ER have grown exponentially."
Ballad Health, a 20-hospital system in the Tri-Cities region of Tennessee and Virginia, benefits from the largest state-sanctioned hospital monopoly in the United States. In the six years since lawmakers in both states waived anti-monopoly laws and Ballad was formed, ER visits for patients sick enough to be hospitalized grew more than three times as long and now far exceed the criteria set by state officials, according to Ballad reports released by the Tennessee Department of Health.
Tennessee and Virginia have so far announced no steps to reduce time spent in Ballad ERs. The Tennessee health department, which has a more direct role in regulating Ballad, has each year issued a report saying the agreement that gave Ballad a monopoly "continues to provide a Public Advantage." Department officials have twice declined to comment to KFF Health News on Ballad's performance.
According to Ballad's latest annual report, which was released this month and spans from July 2022 to June 2023, the median time that patients spend in Ballad ERs before being admitted to the hospital is nearly 11 hours. This statistic includes both time spent waiting and time being treated in the ER and excludes patients who weren't admitted or left the ER without receiving care.
The federal government once tracked ER speed the same way. When compared against the latest corresponding federal data from 2019, which includes more than 4,000 hospitals but predates the covid-19 pandemic, Ballad ranks among the 100 hospitals with the slowest ERs. More current federal data is not available because the Centers for Medicare & Medicaid Services retired this statistic in 2020 in favor of other measurements.
Newer data tells a similar story. The Joint Commission, a nonprofit that accredits health care organizations, collected this same measurement for 2022 from about 250 hospitals that volunteered the data, finding a median ER speed of five hours and 41 minutes — or about five hours faster than Ballad's latest annual report.
Ballad Health spokesperson Molly Luton said in an email statement that, by holding patients in the ER, where they are observed while waiting for a bed, Ballad avoids "overwhelming" its staff. Luton said ER delays are also caused by two nationwide crises: a nursing shortage and fewer admissions at nursing homes and similar facilities, which can create a backlog of patients awaiting discharge from the hospital.
Luton added that Ballad's ER time for admitted patients has dropped to about 7½ hours in the months since the company's latest annual report.
"On those issues Ballad Health can directly control, our performance has rebounded from 2022, and is now among the best in the nation," Luton said.
Luton also noted that Ballad performs better than or close to the national average on several other measurements of ER performance, including having fewer patients who leave without being treated. CMS data shows the national average is about 3%. Ballad reported 1.4% in its latest annual report.
Osborne, the Bristol council member, attributed this statistic to Ballad's monopoly.
"Just because they aren't leaving the ER doesn't mean they are happy where they are," he said. "It just means they don't have anywhere else they could be."
Ballad's Big Monopoly
Ballad Health was formed in 2018 after state officials approved the nation's biggest hospital merger based on a so-called Certificate of Public Advantage, or COPA, agreement. COPAs have been used in about 10 hospital mergers over the past three decades, but none has involved as many hospitals as Ballad's.
State lawmakers in Tennessee and Virginia waived federal anti-monopoly laws so rival hospital systems — Mountain States Health Alliance and Wellmont Health System — could merge into a single company with no competition. Ballad is now the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina.
The Federal Trade Commission warns that hospital monopolies lead to increased prices and decreased quality of care. To offset the perils of Ballad's monopoly, officials required the new company to commit to a long list of special conditions, including dozens of quality-care metrics spelled out with specific benchmarks.
In its latest annual report, Ballad improved on many quality-of-care metrics over the prior year, including several that the company prioritized, but still fell short on 56 of 75 benchmarks.
ER time for admitted patients is one of those. The benchmark was set at three hours and 47 minutes in the original COPA agreement. Ballad met or nearly met this goal for three years, according to its annual reports. Then the ERs slowed.
In 2022, Ballad reported a median ER time for admitted patients of about six hours.
In 2023, it reported the same statistic at seven hours and 40 minutes.
In the latest report, ER time for admitted patients had reached 10 hours and 45 minutes.
CMS, which grades thousands of hospitals nationwide, warns on its website that timely ER care is "essential for good patient outcomes," and that more time spent in the ER has been linked to higher complication rates and delays in patients getting pain medication and antibiotics.
Ben Harder, chief of health analysis for U.S. News & World Report, said extensive ER times can be a symptom of slowdowns throughout a hospital, including in the operating room.
"A long delay in getting patients admitted is both a risk in itself, in that a test may not get conducted as promptly," Harder said. "But it's also an indication that the hospital is backed up, and that there are problems getting patients moved from one unit to another."
Bill Christian, a spokesperson for the Tennessee Department of Health, said Ballad's rising ER times had been "noted" but did not say if the agency had taken or was considering any action. Christian directed questions about Ballad's latest stats to the company itself.
'A Nightmare for Community Members'
Ballad has also fallen short — by about $191 million over the past five years — of its obligation to Tennessee to provide charity care, which is free or discounted care for low-income patients, according to health department documents and Ballad's latest report. The health department waived this obligation in each of the past four fiscal years. Ballad has said it would ask for another this year.
In a two-hour interview last year, Ballad CEO Alan Levine defended his company and said that because the Tri-Cities region could not support two competing hospital companies, the COPA merger had likely prevented at least three hospital closures. Levine attributed Ballad's failure to meet quality benchmarks to the pressure of the covid pandemic and said charity care shortfalls were partly caused by Medicaid changes beyond Ballad's control.
"Our critics say, 'No Ballad. We don't want Ballad.' Well, then what?" Levine said. "Because the hospitals were on their way to being closed."
Some residents see Ballad as a savior. John King, who runs a physical therapy clinic in the core of Ballad's region, said at a public hearing last June that in multiple visits to Ballad ERs, including one for a stroke, he found their care to be quick and compassionate.
"If it weren't for Ballad Health, I literally would not be here today," King said, according to a hearing transcript.
Ballad's failures to live up to the terms of the COPA agreement were detailed in a KFF Health News investigation last September, and the company faced a new wave of criticism in the months that followed.
Local leaders in Carter County, Tennessee, in October debated but did not pass a resolution calling for Ballad to be better regulated or broken up. Tennessee Attorney General Jonathan Skrmetti, a Republican, said in an interview with the Tennessee Lookout published in November that Ballad must be constantly monitored in light of community complaints. Earlier this month, Tennessee state Rep. David Hawk (R-Greeneville), who represents a region within Ballad's monopoly, called for Levine's resignation, according to wjhl.com.
In response, Ballad Health said in a statement it has "strong relationships with the majority of elected officials" in Carter County and welcomed scrutiny from the Tennessee attorney general. Ballad said Hawk's "opinion certainly does not reflect our broader relationships" within the area. Tennessee lawmakers are also considering legislation to forbid future COPA mergers in the state, which Ballad said "risks putting more hospitals at risk for closure."
The bill was introduced by state Sen. Heidi Campbell (D-Nashville) and state Rep. Gloria Johnson (D-Knoxville), who is running for the U.S. Senate. Johnson said the bill would end Ballad's protection from antitrust laws.
"It's just been a nightmare for community members out there," Johnson said. "And they have no other option."
President Joe Biden has been making his case for reelection to voters by telling them he is good for their pocketbooks, including at the pharmacy counter.
During his State of the Union address, Biden said legislation he signed gave Medicare the power to negotiate lower prescription drug prices.
"That's not just saving seniors money and taxpayers money," Biden said, a reference to the Inflation Reduction Act, which passed in 2022. "We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma."
Biden added, "This year, Medicare is negotiating lower prices for some of the costliest drugs." He called for giving Medicare the power to negotiate prices for 500 drugs over the next decade.
In August, the federal government announced the first 10 drugs that it will negotiate for lower prices as part of the Inflation Reduction Act. A respected source of legislation analysis projects the change will save the government a lot of money, but those dollars haven't been realized.
There is a reason Biden touted this legislation during his address: Polling by KFF shows that people, regardless of their political leanings, overwhelmingly support the idea of allowing Medicare to negotiate drug prices. But most people don't know that such negotiations are underway.
Impact of Inflation Reduction Act Will Take Many Years
In August 2022, Biden signed the Inflation Reduction Act, which will allow the federal government to negotiate prices with drugmakers for Medicare. Biden kept his promise to repeal the law that barred Medicare from negotiating prices.
The nonpartisan Congressional Budget Office projects a 10-year cumulative savings of $161.7 billion from two provisions of the Iaw: a phased-in effort to negotiate with drugmakers for lower prices and a rebate for price increases above the overall inflation rate. (The White House has previously pointed to this analysis.)
However, not all the savings will be permanent. About $44.3 billion over 10 years will be funneled into related provisions that expand access and lower out-of-pocket costs for Medicare beneficiaries.
"Negotiations are still ramping up, so the savings generated by the Inflation Reduction Act negotiation provisions are still in the future," said Matthew Fiedler, a Brookings Institution expert on the economy and health studies. "The Congressional Budget Office did expect the inflation rebate provisions of the IRA (which are encompassed in the $160 billion) to begin generating modest savings during 2023 and 2024, but there, too, most of the savings are in the future."
The legislation involves price negotiations for 10 brand-name medications that lack generic equivalents. Those drugs include the blood thinners Eliquis and Xarelto; the diabetes drugs Januvia, Jardiance, and NovoLog; Enbrel, for rheumatoid arthritis; the blood-cancer drug Imbruvica; Entresto, for heart failure; Stelara, for psoriasis and Crohn's disease; and Farxiga, a drug for diabetes, heart failure, and chronic kidney disease.
The CBO has estimated that the negotiated prices will translate to nearly $100 billion in federal savings from 2026 to 2031.
"Biden is jumping the gun on claiming savings for seniors," said Joe Antos, an expert on health care at the conservative American Enterprise Institute. "Price negotiations haven't been completed; the new prices for selected drugs aren't in place until 2026."
Biden said the legislation is "saving seniors money and taxpayers money," which could be interpreted to mean it is saving them money now on prescription drugs. But the negotiations for these drugs would define the prices to be paid for prescriptions starting in 2026. For 2027 and 2028, 15 more drugs per year will be chosen for price negotiations. Starting in 2029, 20 more will be chosen a year.
That said, other provisions in the legislation have already led to savings for seniors, said Tricia Neuman, a senior vice president at KFF:
Certain recommended adult vaccines covered under Medicare Part D, such as shingles, are covered at no cost.
The act established a cap on Part D spending that begins phasing in this year. This year, Part D enrollees will pay no more than $3,300 on brand-name drugs. In 2025, the cap for all covered Part D drugs drops to $2,000.
The Inflation Reduction Act included the $35-a-month insulin cap, improvements in coverage for low-income beneficiaries, and the inflation rebate.
When we pressed the White House to provide examples of savings that have already occurred, a spokesperson pointed to the insulin cap.
Meanwhile, Antos said that although the Part D rebate has kicked in, the savings come from a small subset of Part D drugs taken by older Americans and that the government reaps the savings, not older Americans.
"There is no reason to expect that seniors will see significant savings since there's no obligation for the feds to distribute savings to Part D enrollees," Antos said.
Our Ruling
Biden said, "We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma."
Biden's statement omits the time frame; the savings have not been realized. The CBO projected 10-year cumulative savings of $161.7 billion from two provisions of the legislation. And as for saving older Americans money on their prescriptions, that hasn't happened yet. The federal government is negotiating the first 10 drugs with the new prices set to take effect in 2026.