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.
Georgia Gov. Brian Kemp's plan for a conservative alternative to Obamacare's Medicaid expansion has cost taxpayers at least $26 million so far, with more than 90% going toward administrative and consulting costs rather than medical care for low-income people.
Kemp's Georgia Pathways to Coverage offers government health insurance to people earning up to the federal poverty level — $15,060 for an individual adult — if they can document that they're working, in school, or performing other qualifying activities.
Since July, when the program began, about 3,500 people have signed up, according to state officials. That's a small fraction of the Georgians who could enroll if the state expanded Medicaid without such requirements.
Republican leaders in several states have sought to require that people who are eligible for Medicaid through expansion work, arguing the health program for low-income Americans shouldn't be a handout. Kemp's experiment, aimed at single adults with low incomes who aren't already eligible for Medicaid, is the only current effort to survive legal challenges. But critics say it creates obstacles for people in need of health care while wasting taxpayer dollars on technology, consultants, and attorney's fees.
The Pathways program is "fiscally foolish and anti-family," said Joan Alker, executive director and co-founder of Georgetown University's Center for Children and Families. She noted that full-time caregiving does not qualify someone for eligibility into the program. "A lot of taxpayer money has been wasted," she said, "and not on health care for people who need it."
The state projected that administrative costs will increase to $122 million over four years, mostly in federal spending, as it rolls out key features of the program, including the collection of premiums and verifying enrollees' eligibility, according to an internal planning document dated December 2022 obtained by KFF Health News. The primary consultant for the project is Deloitte, which is collecting hefty fees.
Georgia's GOP-led state legislature has rejected what Democrats say would be a far simpler way to cover the state's low-income workers: expanding Medicaid under the Affordable Care Act. That could make at least 359,000 uninsured people in Georgia newly eligible for Medicaid, according to KFF data. In addition, Georgia could reduce state spending by $710 million over two years, according to KFF research from 2021.
Despite Georgia's rocky implementation experience, state Republican leaders have put off considering a full Medicaid expansion. And such conservative states as Mississippi, Idaho, and South Dakota are weighing similar work requirements.
"You're spending money, primarily here, to put people through an extra set of hoops before they get coverage," said Benjamin Sommers, a professor of health care economics at Harvard T.H. Chan School of Public Health.
The low enrollment for Pathways has disappointed supporters, as the state projected more than 25,000 residents would enroll during its first year and 52,000 by the end of five years, according to its application to the federal government.
Chris Denson, director of policy and research at the conservative Georgia Public Policy Foundation, which supports Pathways, said the low enrollment numbers are "just part of the ramping up."
The program was intended to start in July 2021 but was delayed two years due to legal wrangling. In December 2022, Georgia officials told the federal Centers for Medicare & Medicaid Services that it would cost at least $51 million over two years to design, develop, and implement an eligibility system, funds that would largely be channeled to Deloitte Consulting, according to the documents KFF Health News obtained.
About 45% of Pathways applications were still waiting to be processed, based on the state's most recent monthly reports, said Leah Chan, director of health justice at the Georgia Budget and Policy Institute, a nonprofit research organization that supports full Medicaid expansion.
The eligibility system, she said, "the thing that we've spent the most money on, is actually one of the things standing in the way of the program seeing higher enrollment."
The state Department of Community Health reported $26.6 million in Pathways spending through Dec. 31, of which more than 80% was paid for using federal funds. Deloitte was paid $2.4 million to prepare and submit the application to the federal government. Just $2 million was paid to insurers to cover medical care. In the fourth quarter, administrative costs alone rose by more than $6 million.
The total costs do not include legal fees for defending the Pathways program. The state attorney general's office said that as of Feb. 7 those costs surpass $230,000.
In striking contrast, North Carolina has enrolled 380,000 beneficiaries in its Medicaid expansion as of March 1, according to that state's Department of Health and Human Services. North Carolina became the 40th state to expand Medicaid under the ACA on Dec. 1, a move that has prompted fresh debate over expansion in a handful of other Southern holdout states.
Georgia, which has one of the highest uninsured rates among states, is currently the only state that requires people in its Medicaid expansion population to prove they are working or doing other qualifying activities to gain health coverage.
A spokesperson for Kemp, Carter Chapman, told KFF Health News that the governor "remains committed to implementing Georgia Pathways, an innovative program expanding coverage to tens of thousands of otherwise ineligible, low-income Georgians, despite the Biden administration's continued efforts to disrupt its rollout."
In February, citing the delays in implementation, Georgia filed a suit against the federal government to ensure the work requirement program could continue running through 2028 instead of 2025, when it was originally scheduled to end. CMS refused to comment because of pending litigation.
Georgia's cost estimates are in line with what other states anticipated for administrative spending for Medicaid work requirement programs, including Kentucky's projected spending of $272 million, according to a 2019 report from the Government Accountability Office, a federal agency that recommended CMS consider administrative costs in such applications.
In Arkansas, administrative costs for the state's work requirement program were nearly 30% higher than costs of running standard Medicaid in 2016, according to a report from the Arkansas Center for Health Improvement, a nonpartisan health policy group in the state. People struggled to prove they qualified because setting up online accounts was difficult and confusing and many had limited access to the internet, said Robin Rudowitz, a vice president at KFF and director of the Program on Medicaid and the Uninsured. Arkansas' work requirement program ended in 2019 after a judge blocked it, but not before 18,000 people lost coverage. Unlike Arkansas, which placed a work requirement on a population already receiving Medicaid expansion benefits, Georgia is offering coverage to new people who qualify. But the program's expense may not be worth sustaining it, Sommers said.
Typically, in Medicaid, administrative costs range from 12% to 16% of overall program spending, said Laura Colbert, executive director of the advocacy group Georgians for a Healthy Future, which supports full Medicaid expansion.
"It's reasonable to expect that at least 80% of costs of a public or private health insurance plan to go toward health care and services," she said.
Clinicians worry that the CDC is repeating past mistakes as it develops guidelines that providers will apply to control the spread of infectious diseases.
This article was published on Tuesday, March 19, 2024 in KFF Health News.
Four years after hospitals in New York City overflowed with COVID-19 patients, emergency physician Sonya Stokes remains shaken by how unprepared and misguided the American health system was.
Hospital leadership instructed health workers to forgo protective N95 masks in the early months of 2020, as COVID cases mounted. "We were watching patients die," Stokes said, "and being told we didn't need a high level of protection from people who were not taking these risks."
Droves of front-line workers fell sick as they tried to save lives without proper face masks and other protective measures. More than 3,600 died in the first year. "Nurses were going home to their elderly parents, transmitting COVID to their families," Stokes recalled. "It was awful."
Across the country, hospital leadership cited advice from the Centers for Disease Control and Prevention on the limits of airborne transmission. The agency's early statements backed employers' insistence that N95 masks, or respirators, were needed only during certain medical procedures conducted at extremely close distances.
Such policies were at odds with doctors' observations, and they conflicted with advice from scientists who study airborne viral transmission. Their research suggested that people could get COVID after inhaling SARS-CoV-2 viruses suspended in teeny-tiny droplets in the air as infected patients breathed.
Now, Stokes and many others worry that the CDC is repeating past mistakes as it develops a crucial set of guidelines that hospitals, nursing homes, prisons, and other facilities that provide health care will apply to control the spread of infectious diseases. The guidelines update those established nearly two decades ago. They will be used to establish protocols and procedures for years to come.
"This is the foundational document," said Peg Seminario, an occupational health expert and a former director at the American Federation of Labor and Congress of Industrial Organizations, which represents some 12 million active and retired workers. "It becomes gospel for dealing with infectious pathogens."
Late last year, the committee advising the CDC on the guidelines pushed forward its final draft for the agency's consideration. Unions, aerosol scientists, and workplace safety experts warned it left room for employers to make unsafe decisions on protection against airborne infections.
"If we applied these draft guidelines at the start of this pandemic, there would have been even less protection than there is now — and it's pretty bad now," Seminario said.
In an unusual move in January, the CDC acknowledged the outcry and returned the controversial draft to its committee so that it could clarify points on airborne transmission. The director of the CDC's National Institute for Occupational Safety and Health asked the group to "make sure that a draft set of recommendations cannot be misread to suggest equivalency between facemasks and NIOSH Approved respirators, which is not scientifically correct."
The CDC also announced it would expand the range of experts informing their process. Critics had complained that most members of last year's Healthcare Infection Control Practices Advisory Committee represent large hospital systems. And about a third of them had published editorials arguing against masks in various circumstances. For example, committee member Erica Shenoy, the infection control director at Massachusetts General Hospital, wrote in May 2020, "We know that wearing a mask outside health care facilities offers little, if any, protection from infection."
Although critics are glad to see last year's draft reconsidered, they remain concerned. "The CDC needs to make sure that this guidance doesn't give employers leeway to prioritize profits over protection," said Jane Thomason, the lead industrial hygienist at the union National Nurses United.
She's part of a growing coalition of experts from unions, the American Public Health Association, and other organizations putting together an outside statement on elements that ought to be included in the CDC's guidelines, such as the importance of air filtration and N95 masks.
But that input may not be taken into consideration.
The CDC has not publicly announced the names of experts it added this year. It also hasn't said whether those experts will be able to vote on the committee's next draft — or merely provide advice. The group has met this year, but members are barred from discussing the proceedings. The CDC did not respond to questions and interview requests from KFF Health News.
A key point of contention in the draft guidance is that it recommends different approaches for airborne viruses that "spread predominantly over short distances" versus those that "spread efficiently over long distances." In 2020, this logic allowed employers to withhold protective gear from many workers.
For example, medical assistants at a large hospital system in California, Sutter Health, weren't given N95 masks when they accompanied patients who appeared to have COVID through clinics. After receiving a citation from California's occupational safety and health agency, Sutter appealed by pointing to the CDC's statements suggesting that the virus spreads mainly over short distances.
A distinction based on distance reflects a lack of scientific understanding, explained Don Milton, a University of Maryland researcher who specializes in the aerobiology of respiratory viruses. In general, people may be infected by viruses contained in someone's saliva, snot, or sweat — within droplets too heavy to go far. But people can also inhale viruses riding on teeny-tiny, lighter droplets that travel farther through the air. What matters is which route most often infects people, the concentration of virus-laden droplets, and the consequences of getting exposed to them, Milton said. "By focusing on distance, the CDC will obscure what is known and make bad decisions."
Front-line workers were acutely aware they were being exposed to high levels of the coronavirus in hospitals and nursing homes. Some have since filed lawsuits, alleging that employers caused illness, distress, and death by failing to provide personal protective equipment.
One class-action suit brought by staff was against Soldiers' Home, a state-owned veterans' center in Holyoke, Massachusetts, where at least 76 veterans died from COVID and 83 employees were sickened by the coronavirus in early 2020.
"Even at the end of March, when the Home was averaging five deaths a day, the Soldiers' Home Defendants were still discouraging employees from wearing PPE," according to the complaint.
It details the experiences of staff members, including a nursing assistant who said six veterans died in her arms. "She remembers that during this time in late March, she always smelled like death. When she went home, she would vomit continuously."
Researchers have repeatedly criticized the CDC for its reluctance to address airborne transmission during the pandemic. According to a new analysis, "The CDC has only used the words ‘COVID' and ‘airborne' together in one tweet, in October 2020, which mentioned the potential for airborne spread.'"
It's unclear why infection control specialists on the CDC's committee take a less cautious position on airborne transmission than other experts, industrial hygienist Deborah Gold said. "I think these may be honest beliefs," she suggested, "reinforced by the fact that respirators triple in price whenever they're needed."
Critics fear that if the final guidelines don't clearly state a need for N95 masks, hospitals won't adequately stockpile them, paving the way for shortages in a future health emergency. And if the document isn't revised to emphasize ventilation and air filtration, health facilities won't invest in upgrades.
"If the CDC doesn't prioritize the safety of health providers, health systems will err on the side of doing less, especially in an economic downturn," Stokes said. "The people in charge of these decisions should be the ones forced to take those risks."
Billy Abbott, a retired Army medic, wakes at 6 every morning, steps on the bathroom scale, and uses a cuff to take his blood pressure.
The devices send those measurements electronically to his doctor in Gulf Shores, Alabama, and a health technology company based in New York, to help him control his high blood pressure.
Nurses with the company, Cadence, remotely monitor his readings along with the vital signs of about 17,000 other patients around the nation. They call patients regularly and follow up if anything appears awry. If needed, they can change a patient's medication or dosage without first alerting their doctor.
Abbott, 85, said he likes that someone is watching out for him outside his regular doctor appointments. "More doctors should recommend this to their patients," he said.
Increasingly, they are.
Dozens of tech companies have streamed in, pushing their remote monitoring service to primary care doctors as a way to keep tabs on patients with chronic illnesses and free up appointment time, and as a new source of Medicare revenue.
But some experts say remote monitoring's huge growth — spurred on during the covid-19 pandemic, when patients were hesitant to sit in crowded doctors' waiting rooms — has outpaced oversight and evidence of how the technology is best used.
"It is the wild West where any patient can get it if a doctor decides it is reasonable or necessary," said Caroline Reignley, a partner with the law firm McDermott Will & Emery who advises health providers.
In 2019, Medicare made it easier for doctors to bill for monitoring routine vital signs such as blood pressure, weight, and blood sugar. Previously, Medicare coverage for remote monitoring was limited to certain patients, such as those with a pacemaker.
Medicare also began allowing physicians to get paid for the service even when the monitoring is done by clinical staff who work in different places than the physician — an adjustment advocated by telemedicine companies.
In just the first two full years, remote monitoring services billed to Medicare grew from fewer than 134,000 to 2.4 million in 2021, according to federal records analyzed by KFF Health News.
Total Medicare payments for the four most common billing codes for remote monitoring rose from $5.5 million in 2019 to $101.4 million in 2021, the latest year for which data is available.
Part of the allure is that Medicare will pay for remote monitoring indefinitely regardless of patients' health conditions as long as their doctors believe it will help.
For doctors with 2,000 to 3,000 patients, the money can add up quickly, with Medicare paying an average of about $100 a month per patient for the monitoring, plus more for setting up the device, several companies confirmed.
Medicare enrollees may face 20% in cost sharing for the devices and monthly monitoring, though certain private plans through Medicare Advantage and Medicare supplement policies may cover those costs. The government allowed insurers to waive the patient cost sharing during the pandemic.
About 400 doctors and other providers repeatedly billed Medicare for remote patient monitoring in 2019. Two years later, that had mushroomed to about 3,700 providers, according to Medicare data analyzed by KFF Health News. (The data tracks providers who billed more than 10 patients for at least one type of remote monitoring.)
Federal law enforcement officials say they are conducting investigations after a surge in complaints about some remote patient monitoring companies but would not provide details.
The Department of Health and Human Services' Office of Inspector General in November issued a consumer alert about companies signing up Medicare enrollees without their doctors' knowledge: "Unscrupulous companies are signing up Medicare enrollees for this service, regardless of medical necessity," and bill Medicare even when no monitoring occurs.
In a statement to KFF Health News, Meena Seshamani, director of the federal Center for Medicare, part of the Centers for Medicare & Medicaid Services, did not say how CMS is ensuring only patients who can benefit from remote monitoring receive it. She said the agency balances the need to give patients access to emerging technology that can improve health outcomes with the need to combat fraud and make proper payments to providers.
While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.
"The research evidence is not as robust as we would like to show that it is beneficial," said Ateev Mehrotra, a Harvard Medical School researcher.
A January report by the Bipartisan Policy Center, a Washington, D.C.-based think tank, warned about "a lack of robust evidence on the optimal use of remote monitoring" and said some policy and medical experts "question whether we are effectively ‘rightsizing' the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways."
Denton Shanks, a medical director at the American Academy of Family Physicians, said remote monitoring helps patients manage their diseases and helps physician practices be more efficient. He has used it for the past two years as a doctor at the University of Kansas Health System.
It has worked well, he said, though sometimes it can be challenging to persuade patients to sign up if they have to pay for it.
"For the vast majority of patients, once they are enrolled, they see a benefit, and we see a benefit as their vital signs come in the normal range," Shanks said.
The size of the market is tantalizing.
About two-thirds of the more than 66 million Medicare beneficiaries have high blood pressure, the most common metric monitored remotely, according to physicians and the monitoring companies.
"The patient need is so enormous," Cadence CEO Chris Altchek said. The company has about 40 nurses, medical assistants, and other providers monitoring patients in 17 states. He said patients enrolled in remote monitoring experience a 40% reduction in emergency room visits. Cadence says 82% of its patients use the devices at least once every two days.
Timothy Mott, a family physician in Foley, Alabama, said valuable appointment times in his office open up as patients who previously needed vital signs to be checked there turn to remote monitoring.
Cadence nurses regularly contact Mott's patients and monitor their readings and make changes as needed.
"I was concerned early on whether they were going to make the right decisions with our patients," Mott said. "But over time the dosage changes or changes in medication they are making are following the best guidelines on effectiveness."
At the six-month mark, about 75% of patients have stayed with the monitoring, Mott said.
The advantages are apparent even to some providers who do not get paid by Medicare to offer the service. Frederick Health, a Maryland health system, provides remote monitoring to 364 high-risk patients and estimates the program saves the nonprofit system $10 million a year by reducing hospital admissions and ER visits. That estimate is based on comparisons of patients' Medicare claims before they started the program and after, said Lisa Hogan, who runs the program.
The hospital pays for the program and does not bill Medicare, she said.