Tear-Gassing Protesters During An Infectious Outbreak 'A Recipe For Disaster'

KFF Health News, June 6, 2020

Their widespread use in recent weeks while an infectious disease — for which there is no vaccine — continues to spread across the U.S., has stunned experts and physicians.

This article was first published on Friday, June 5, 2020 in Kaiser Health News.

By Will Stone

In nationwide demonstrations sparked by the killing of George Floyd in police custody, protesters have been frequently pepper-sprayed or enveloped in clouds of tear gas. These crowd-control weapons are rarely lethal, but in the middle of the coronavirus pandemic, there are strong calls for police to stop using these chemical irritants because they can damage the body in ways that can spread the coronavirus and increase the severity of COVID-19.

Even before the coronavirus pandemic, some experts said additional research was needed on the risks of tear gas — an umbrella term for several chemical “riot-control agents” used by law enforcement. It’s known that the chemicals can have both immediate and long-term health effects.

Their widespread use in recent weeks while an infectious disease — for which there is no vaccine — continues to spread across the U.S., has stunned experts and physicians. The coronavirus that causes the disease COVID-19 is highly contagious, spreads easily through the air via droplets, and can lead to severe or fatal respiratory illness. Deploying these corrosive, inhalable chemicals could harm people in several ways: exposing more people to the virus, compromising the body’s ability to fight off the infection and even causing mild infections to become more severe illnesses.

“This is a recipe for disaster,” said associate professor Sven Eric Jordt, a researcher at the Duke University School of Medicine who studies the effects of tear gas.

Jordt refers to these chemicals as “pain gases” because they activate certain pain-sensing nerves on the skin and in the mucous membranes of the eyes, mouth and nose.

“You have this excruciating pain, sneezing, coughing, the production of a lot of mucus that obstructs breathing,” Jordt said.

People who have been exposed describe a burning and stinging sensation, even a sense of asphyxiation and drowning. Sometimes the chemicals cause vomiting or allergic reactions. In law enforcement, officers generally use two types of chemicals for crowd control: CS gas and pepper spray.

The active ingredient in pepper spray, called capsaicin, is derived from chiles. It is often sprayed from cans at close quarters or lobbed into crowds in the form of “pepper balls.”

CS gas (o‐chlorobenzylidene malononitrile) is a chlorinated, organic chemical that can induce “very strong inflammation” and “chemical injury” by burning the skin and airways when inhaled, Jordt said.

“Using it in the current situation with COVID-19 around is completely irresponsible,” he added. “There are sufficient data proving that tear gas can increase the susceptibility to pathogens, to viruses.”

Jordt said research on the harms of tear gas has not kept up with its escalating use in the U.S and around the world in recent years. Many of the safety studies that law enforcement officials rely on date to the 1950s and ’60s, he said.

But a 2014 study from the U.S. Army offers an alarming glimpse into how the chemical could escalate the pandemic. The study found that recruits who were exposed to tear gas as part of a training exercise were more likely to get sick with respiratory illnesses like the common cold and the flu.

“We have a lot of antiviral defenses that can inactivate viruses and prevent them from entering cells,” he said. “These are depleted by inhalation of tear gas and also compromised.”

The findings of the Army study led the U.S. military to significantly reduce how much recruits were being exposed to the chemical.

“Even the Army realized they had done something wrong and that this was more toxic than they thought before,” Jordt said.

Even though there is a limited amount of research on this new coronavirus, there are studies from China and Italy about how other irritants, such as smoking and air pollution, affect COVID-19. These studies indicate that tear gas could also make people more likely to develop severe illness, said Dr. John Balmes, a pulmonologist at the University of California-San Francisco and an expert with the American Thoracic Society.

“I actually think we could be promoting COVID-19 by tear-gassing protesters,” said Balmes. “It causes injury and inflammation to the lining of the airways.”

Balmes said this period of inflammation sets back the body’s defenses, and makes it more likely that someone who already harbors the virus will become sick.

“It’s adding fuel to the fire,” said Balmes. “These exposures to tear gas would increase the risk of progression from the asymptomatic infection, to a symptomatic disease.”

Growing evidence shows many people who have the coronavirus are asymptomatic and don’t know they are infected, or are “presymptomatic” — infected with the virus and able to infect others, but not yet showing symptoms.

With thousands of people jammed together at mass protests, the demonstrations are already primed to be “superspreading events,” which can lead to an explosion of new cases. Outdoor gatherings typically decrease the chance of spreading the coronavirus. But activities like singing and yelling can increase the risk.

Tear gas and pepper spray can also sow confusion and panic in a crowd. People may rip off their masks and touch their faces, leading to more contamination.

Dr. Amesh Adalja, with Johns Hopkins University, said the body’s reaction to the chemicals causes people to shed more of the virus.

“If they’re coughing, the particles actually emanate and are projectiles that travel about 6 feet or so and could land on other people,” said Adalja, who is also a spokesperson for the Infectious Diseases Society of America.

“This is a way to almost induce the virus to be expelled from people when they are exposed to these agents.”

Adalja anticipates the protests will inevitably lead to a spike in infections.

“We know that any kind of social unrest, especially in the midst of an outbreak, is only going to make things worse,” he said.

He said the most recent example would be bombings in Yemen that exacerbated a cholera outbreak.

Dr. Rohini Haar, an emergency physician in Oakland, California, has studied the use of riot-control agents around the world.

“These weapons don’t actually deescalate tensions in peaceful community policing,” said Haar who is a lecturer at the University of California-Berkeley.

Haar has also been treating COVID-19 patients. She recognizes there is a danger of spreading the virus at these gatherings, but she would not discourage people from attending the protests and exercising their right to free speech.

“It’s a really tough situation,” said Haar. “I think the irony is that people are rightfully and justifiably protesting police violence and are being met with violence that is worsening the pandemic conditions we’re living under right now.”

This week, more than a thousand physicians and health care professionals signed an open letter in support of the demonstrations.

Dr. Jade Pagkas-Bather, an infectious disease expert at the University of Chicago, is one of them. She said it will be difficult to determine whether any spike in cases was a direct result of the protests, because they’re happening at a time when many states are also allowing businesses to reopen.

“In everyday life, we weigh the risks and benefits of our actions. People who are going out to protests are clearly at a critical juncture where they are saying this state-sanctioned violence is unacceptable, and I am willing to put myself and others potentially at risk,” she said.

The open letter she signed recommends ways that protesters, police and local officials can reduce the transmission of the virus. Among the major recommendations: Police should not use tear gas or pepper spray.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Efforts To Curb Congenital Syphilis Falter In COVID's Shadow

KFF Health News, June 4, 2020

A new report, released Thursday by the federal Centers for Disease Control and Prevention, aims to pinpoint the reasons so many women aren’t getting the care they need.

This article was first published on Thursday, June 4, 2020 in Kaiser Health News.

By Anna Maria Barry-Jester

U.S. public health officials are closer to identifying a road map for curbing the rising rates of syphilis infections in newborn babies, but with so many resources diverted to stopping the spread of COVID-19, many fear the rate of deadly infections will only get worse.

Congenital syphilis — the term used when a mother passes the infection to her baby during pregnancy — is often a devastating legacy, potentially leaving babies blind or in excruciating pain or with bone deformities, blood abnormalities or organ damage. It’s one of the most preventable infectious diseases, experts say. Prevention, which means treating Mom so she doesn’t pass it on to her baby, requires just a few shots of penicillin.

Yet rates of infection and death from congenital syphilis have been on the rise for years. In 2018, 1,306 babies acquired syphilis from their mothers, a 40% increase over 2017 and the largest number since 1995. Nearly 100 were stillborn or died soon after birth. Federal researchers say 2019 data will show yet another jump.

A new report, released Thursday by the federal Centers for Disease Control and Prevention, aims to pinpoint the reasons so many women aren’t getting the care they need. It found that nationally 28% of women who gave birth to a baby with syphilis in 2018 had no prenatal care and weren’t tested in time for treatment. Nearly a third of the mothers were diagnosed but didn’t receive timely or thorough treatment.

How women slip through the cracks of the public health system varies by race and geography. Syphilis rates are highest in the South and West but have been rising across the nation, particularly in rural areas of the Midwest and West.

The burden of the disease falls disproportionately on African American women and families. Nearly 40% of moms who gave birth to babies with syphilis in 2018 were black, even though they made up about 15% of deliveries.

“That falls on public health as an institution,” said Matthew Prior, communications director for the National Coalition of STD Directors. “We need to think about why we do what we do, and we need to hear from the voices we are trying to serve.”

The CDC researchers identified four core reasons that mothers who gave birth to babies with syphilis weren’t treated: lack of prenatal care; prenatal care that did not include testing; improper treatment after a positive diagnosis; and getting infected during pregnancy.

In the South, a lack of prenatal care was the most common reason white women who gave birth to infected babies didn’t get treatment, while black women tended to have been diagnosed but not treated. In the West, 41% of women of all races who gave birth to infected babies had no prenatal care.

The CDC study provides clues for how to prevent infections, but taking advantage of that information will be a challenge for many local health departments. The COVID-19 pandemic has strained the nation’s frayed public health system.

In many communities, the same people who work on preventing the spread of sexually transmitted diseases such as syphilis have been called on to help prevent the spread of COVID-19. Departments are reporting mass interruptions in STD care and prevention services.

“COVID-19 is an obstacle to a lot of the interventions that we will try to roll out,” said Rebekah Horowitz, a senior program analyst with the National Association of County and City Health Officials (NACCHO).

In mid-March, the National Coalition of STD Directors surveyed a panel of its members; 83% of responding STD programs said they had deferred services. Nearly two-thirds said they cannot keep up with their HIV and syphilis caseloads.

“A lot of our enhancement projects have been scaled back,” said Amanda Reich, congenital syphilis coordinator for Texas. “Our staff are doing the best that they can do.”

Shuttered clinics and delayed prenatal care — yet another consequence of COVID-related shutdowns — are likely to exacerbate rates of congenital syphilis and sexually transmitted diseases in general. Testing for syphilis is key since there’s often a lag between contracting the disease and developing symptoms, said Dr. Anne Kimball, a pediatrician in the Epidemic Intelligence Service of the CDC and lead author of the study. “You can have it and give it to your unborn child without knowing you have it,” she said.

Because syphilis is so easy to test for, treat and prevent, it’s often seen as the canary in the coal mine, signaling a warning about what’s happening with other infectious diseases. Cases of syphilis, gonorrhea and chlamydia combined reached an all-time national high in 2018.

“It is a symptom of under-supporting public health and STD programs for decades,” Prior said. “It’s not surprising.”

Even before the global coronavirus pandemic, many health departments around the country were working with bare-bones staffing and aggressively tracking and treating syphilis only among pregnancy-age women. Men who have sex with men have the highest rate of the disease nationally.

Arkansas reorganized its disease investigation unit after a spike in cases in 2018, assigning one person to follow up with all pregnant women with syphilis, said Brandi Roberts, the state’s STD Prevention Program Manager. She said the reorganization has been successful, and even as resources have been redeployed to COVID-19, that employee’s assignment hasn’t changed. But like many states, Arkansas has seen a decrease in reported STD cases, which Roberts believes is likely a sign of reduced testing, not a drop in cases.

NACCHO and the CDC are helping to fund and evaluate programs at six health departments — ranging from New York City to rural Tulare County, California — that they hope will offer further clues for how to curb the spread of disease.

But their success will rely on resources, said Horowitz.

“This was true two years ago, it is true now, and it will be true in the future: These missed opportunities will continue as long as we are not investing in a robust way in our public health infrastructure,” she said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

In Hard-Hit Areas, COVID's Ripple Effects Strain Mental Health Care Systems

KFF Health News, June 4, 2020

The pandemic enveloping the hospitals had a ripple effect on mental health programs and facilities.

This article was first published on Thursday, June 4, 2020 in Kaiser Health News.

By Cheryl Platzman Weinstock June 4, 2020

In late March, Marcell's girlfriend took him to the emergency room at Henry Ford Wyandotte Hospital, about 11 miles south of Detroit.

"I had [acute] paranoia and depression off the roof," said Marcell, 46, who asked to be identified only by his first name because he wanted to maintain confidentiality about some aspects of his illness.

Marcell's depression was so profound, he said, he didn't want to move and was considering suicide.

"Things were getting overwhelming and really rough. I wanted to end it," he said.

Marcell, diagnosed with schizoaffective disorder seven years ago, had been this route before but never during a pandemic. The Detroit area was a coronavirus hot spot, slamming hospitals, attracting concerns from federal public health officials and recording more than 1,000 deaths in Wayne County as of May 28. Michigan ranks fourth among states for deaths from COVID-19.

The crisis enveloping the hospitals had a ripple effect on mental health programs and facilities. The emergency room was trying to get non-COVID patients out as soon as possible because the risk of infection in the hospital was high, said Jaime White, director of clinical development and crisis services for Hegira Health, a nonprofit group offering mental health and substance abuse treatment programs. But the options were limited.

Still, the number of people waiting for beds at Detroit's crisis centers swelled. Twenty-three people in crisis had to instead be cared for in a hospital.

This situation was hardly unique. Although mental health services continued largely uninterrupted in areas with low levels of the coronavirus, behavioral health care workers in areas hit hard by COVID-19 were overburdened. Mobile crisis teams, residential programs and call centers, especially in pandemic hot spots, had to reduce or close services. Some programs were plagued by shortages of staff and protective supplies for workers.

At the same time, people battling mental health disorders became more stressed and anxious.

"For people with preexisting mental health conditions, their routines and ability to access support is super important. Whenever additional barriers are placed on them, it could be challenging and can contribute to an increase in symptoms," said White.

After eight hours in the emergency room, Marcell was transferred to COPE, a community outreach program for psychiatric emergencies for Wayne County Medicaid patients.

"We try to get patients like him into the lowest care possible with the least restrictive environment," White said. "The quicker we could get him out, the better."

Marcell was stabilized at COPE over the next three days, but his behavioral health care team couldn't get him a bed in one of two local residential crisis centers operated by Hegira. Social distancing orders had reduced the beds from 20 to 14, so Marcell was discharged home with a series of scheduled services and assigned a service provider to check on him.

However, Marcell's symptoms ― suicidal thoughts, depression, anxiety, auditory hallucinations, poor impulse control and judgment ― persisted. He was not able to meet face-to-face with his scheduled psychiatrist due to the pandemic and lack of telehealth access. So, he returned to COPE three days later. This time, the staff was able to find him a bed immediately at a Hegira residential treatment program, Boulevard Crisis Residential in Detroit.

Residents typically stay for six to eight days. Once they are stabilized, they are referred elsewhere for more treatment, if needed.

Marcell ended up staying for more than 30 days. "He got caught in the pandemic here along with a few other people," said Sherron Powers, program manager. "It was a huge problem. There was nowhere for him to go."

Marcell couldn't live with his girlfriend anymore. Homeless shelters were closed and substance abuse programs had no available beds.

"The big problem here is that all crisis services are connected to each other. If any part of that system is disrupted you can't divert a patient properly," said Travis Atkinson, a behavioral consultant with TBD Solutions, which collaborated on a survey of providers with the American Association of Suicidology, the Crisis Residential Association and the National Association of Crisis Organization Directors.

White said the crisis took a big toll on her operations. She stopped her mobile crisis team on March 14 because, she said, "we wanted to make sure that we were keeping our staff safe and our community safe."

Her staff assessed hospital patients, including Marcell, by telephone with the help of a social worker from the emergency room.

People like Marcell have struggled during the coronavirus crisis and continue to face hurdles because emergency preparedness measures didn't provide enough training, funds or thought about the acute mental health issues that could develop during a pandemic and its aftermath, said experts.

"The system isn't set up to accommodate that kind of demand," said Dr. Brian Hepburn, a psychiatrist and executive director of the National Association of State Mental Health Program Directors.

"In Detroit and other hard-hit states, if you didn't have enough protective equipment you can't expect people to take a risk. People going to work can't be thinking 'I'm going to die,'" said Hepburn.

For Marcell, "it was bad timing to have a mental health crisis," said White, the director at Hegira.

At one time Marcell, an African American man with a huge grin and a carefully trimmed goatee and mustache, had a family and a "pretty good job," Marcell said. Then "it got rough." He made some bad decisions and choices. He lost his job and got divorced. Then he began self-medicating with cocaine, marijuana and alcohol.

By the time he reached the residential center in Detroit on April 1, he was at a low point. "Schizoaffective disorder comes out more when you're kicked out of the house and it increases depression," said Powers, the program manager who along with White was authorized by Marcell to talk about his care. Marcell didn't always take his medications and his use of illicit drugs magnified his hallucinations, she said.

While in the crisis center voluntarily, Marcell restarted his prescription medications and went to group and individual therapy. "It is a really good program," he said while at the center in early May. "It's been one of the best 30 days."

Hepburn said the best mental health programs are flexible, which allows them more opportunities to respond to problems such as the pandemic. Not all programs would have been able to authorize such a long stay in residential care.

Marcell was finally discharged on May 8 to a substance abuse addiction program. "I felt good about having him do better and better. He had improved self-esteem to get the help he needed to get back to his regular life," Powers said.

But Marcell left the addiction program after only four days.

"The [recovery] process is so individualized and, oftentimes, we only see them at one point in their journey. But, recovering from mental health and substance use disorders is possible. It can just be a winding and difficult path for some," said White.

Seeking Help

If you or someone you know is in immediate danger, call 911. Below are other resources for those needing help:

— National Helpline: 1-800-662-HELP (4357) or https://findtreatment.samhsa.gov.

— National Suicide Prevention Lifeline: 1-800-273-TALK (8255).

— Disaster Distress Helpline: 1-800-985-5990 or text TalkWithUs to 66746.

Correction: This story was updated on June 4 at 7:50 a.m. ET to correct an attribution. It was Marcell who said that he had  a family and a "pretty good job" before his illness got severe.

Cheryl Platzman Weinstock: @CherylWeinstock

ICUs Become A 'Delirium Factory' For COVID Patients

KFF Health News, June 3, 2020

When doctors suspect a stroke, they usually order a brain MRI. But many ICU patients with COVID-19 are too sick to be wheeled across the hospital to a scanner.

This article was first published on Wednesday, June 3, 2020 in Kaiser Health News.

By Liz Szabo June 3, 2020

Doctors are fighting not only to save lives from COVID-19, but also to protect patients' brains.

Although COVID-19 is best known for damaging the lungs, it also increases the risk of life-threatening brain injuries — from mental confusion to hallucinations, seizures, coma, stroke and paralysis. The virus may invade the brain, as well as starve the organ of oxygen by damaging the lungs. To fight the infection, the immune system sometimes overreacts, battering the brain and other organs it normally protects.

Yet the pandemic has severely limited the ability of doctors and nurses to prevent and treat neurological complications. The severity of the disease and the heightened risk of infection have forced medical teams to abandon many of the practices that help them protect patients from delirium, a common side effect of mechanical ventilators and intensive care.

And while COVID-19 increases the risk of strokes, the pandemic has made it harder to diagnose them.

When doctors suspect a stroke, they usually order a brain MRI — a sophisticated type of scan. But many patients hospitalized with COVID-19 are too sick or unstable to be wheeled across the hospital to a scanner, said Dr. Kevin Sheth, a professor of neurology and neurosurgery at the Yale School of Medicine.

Many doctors also hesitate to request MRIs for fear that patients will contaminate the scanner and infect other patients and staff members.

"Our hands are much more tied right now than before the pandemic," said Dr. Sherry Chou, an associate professor of critical care medicine, neurology and neurosurgery at the University of Pittsburgh School of Medicine.

In many cases, doctors can't even examine patients' reflexes and coordination because patients are so heavily sedated.

"We may not know if they've had a stroke," Sheth said.

A study from Wuhan, China — where the first COVID-19 cases were detected — found 36% of patients had neurological symptoms, including headaches, changes in consciousness, strokes and lack of muscle coordination.

A smaller, French study observed such symptoms in 84% of patients, many of which persisted after people left the hospital.

Some hospitals are trying to get around these problems by using new technology to monitor and image the brain.

New York's Northwell Health is using a mobile MRI machine for COVID patients, said Dr. Richard Temes, the health system's director of neurocritical care. The scanner uses a low-field magnet, so it can be wheeled into hospital rooms and take pictures of the brain while patients are in bed.

Staffers at Northwell were also concerned about the infection risk from performing EEGs, tests that measure the brain's electrical activity and help diagnose seizures, Temes said. Typically, technicians spend 30 to 40 minutes in close contact with patients in order to place electrodes around their skulls.

To reduce the risk of infection, Northwell is using a headband covered in electrodes, which can be placed on patients in just a couple of minutes, he said.

The Brain Under Attack

"Right now, we actually don't know enough to say definitely how COVID-19 affects the brain and nervous system," said Chou, who is leading an international study of neurological effects of the virus. "Until we can answer some of the most fundamental questions, it would be too early to speculate on treatments."

Answering those questions is complicated by the limited data from patient autopsies, said Lena Al-Harthi, a professor and the chair of the microbial pathogens and immunity department at Rush Medical College in Chicago.

Authors of a recent study from Germany found the novel coronavirus in patients' brains.

But many neuropathologists are unwilling or unable to perform brain autopsies, Al-Harthi said.

That's because performing autopsies on patients who died of COVID-19 carries special risks, such as the aerosolization of the virus during brain removal. Pathologists need specialized facilities and equipment to conduct an autopsy safely.

Some of the best-known symptoms of COVID-19 might be caused by the virus invading the brain, said Dr. Robert Stevens, an associate professor of anesthesiology and critical care medicine at Johns Hopkins University.

Research shows that the coronavirus may enter a cell through a gateway known as the ACE-2 receptor. These receptors are found not only in the lung, but also on organs throughout the body, including many parts of the brain.

In a recent study, Japanese researchers reported finding the novel coronavirus in the cerebrospinal fluid that surrounds the brain and spinal cord.

Some of the most surprising symptoms of COVID-19 ― the loss of the senses of smell and taste ― remain incompletely understood, but may be related to the brain, Stevens said.

A study from Europe published in May found that 87% of patients with mild or moderate COVID-19 lost their sense of smell. Patients' loss of smell couldn't be explained by inflammation or nasal congestion, the study said. Stevens said it's possible that the coronavirus interacts with nerve pathways from the nose to the brain, potentially affecting systems involved with processing scent.

A new study in JAMA provides additional evidence that the coronavirus invades the brain. Italian researchers found abnormalities in an MRI of the brain of a COVID-19 patient who lost her sense of smell.

Many COVID patients develop "silent hypoxia," in which they are unaware that their oxygen levels have plummeted dangerously low, Stevens added.

When hypoxia occurs, regulatory centers in the brain stem — which control respiration — signal to the diaphragm and the muscles of the chest wall to work harder and faster to get more oxygen into the body and force out more carbon dioxide, Stevens said. The lack of this response in some patients with COVID-19 could indicate the brain stem is impaired.

Scientists suspect the virus is infecting the brain stem, preventing it from sending these signals, Temes said.

Collateral Damage

Well-intentioned efforts to save lives can also cause serious complications.

Many doctors put patients who are on mechanical ventilators into a deep sleep to prevent them from pulling out their breathing tubes, which would kill them, said Dr. Pratik Pandharipande, chief of anesthesiology and critical care medicine at Vanderbilt University School of Medicine in Nashville, Tennessee.

Both the disease itself and the use of sedatives can cause hallucinations, delirium and memory problems, said Dr. Jaspal Singh, a pulmonologist and critical care specialist at Atrium Health in Charlotte, North Carolina.

Many sedated patients experience terrifying hallucinations, which may return in recovery as nightmares and post-traumatic stress disorder.

Research shows 70% to 75% of patients on ventilators traditionally develop delirium. Delirious patients often "don't realize they're in the hospital," Singh said. "They don't recognize their family."

In the French study in the New England Journal of Medicine, one-third of discharged COVID-19 patients suffered from "dysexecutive syndrome," which can be characterized by inattention, disorientation or poorly organized movements in response to commands.

Research shows that patients who develop delirium — which can be an early sign of brain injury — are more likely to die than others. Those who survive often endure lengthy hospitalizations and are more likely to develop a long-term disability.

Under normal circumstances, hospitals would invite family members into the ICU to reassure patients and keep them grounded, said Dr. Carla Sevin, director of the ICU Recovery Center, also at Vanderbilt.

Just allowing a family member to hold a patient's hand can help, according to Dr. Lee Fleisher, chair of an American Society of Anesthesiologists committee on brain health. Nurses normally spend considerable time each day orienting patients by talking to them, reminding them where they are and why they're in the hospital.

"You can decrease the need for some of these drugs just by talking to patients and providing light touch and comfort," Fleisher said.

These and other innovative practices — such as helping patients to move around and get off a ventilator as soon as possible — can reduce the rate of delirium to 50%.

Hospitals have banned visitors, however, to avoid spreading the virus. That leaves COVID-19 patients to suffer alone, even though it's well known that isolation increases the risk of delirium, Fleisher said.

Although many hospitals offer patients tablets or smartphones to allow them to videoconference with family, these devices provide limited comfort and companionship.

Doctors are also positioning patients with COVID-19 on their stomachs, rather than their backs, because a prone position seems to help clear the lungs and let patients breathe more comfortably.

But a prone position also can be uncomfortable, so that patients need more medication, Pandharipande said.

All of these factors make COVID-19 patients extremely vulnerable to delirium. In a recent article in Critical Care, researchers said the intensive care unit has become a "delirium factory."

"The way we're having to care for patients right now is probably contributing to more mortality and bad outcomes than the virus itself," said Dr. Sharon Inouye, a geriatrician at Harvard Medical School and Hebrew SeniorLife, a long-term care facility in Boston. "A lot of the things we'd like to do are just very difficult."

Liz Szabo: lszabo@kff.org, @LizSzabo

Pandemic Presents New Hurdles, And Hope, For People Struggling With Addiction

KFF Health News, June 2, 2020

Rosalind Pichardo advertises a daily food giveaway service in the heart of Philadelphia's Kensington neighborhood, where more people die of drug overdoses than in any other area in the city.

This article was first published on Tuesday, June 2, 2020 in Kaiser Health News.

By Nina Feldman, WHYY

Before Philadelphia shut down to slow the spread of the coronavirus, Ed had a routine: most mornings he would head to a nearby McDonald’s to brush his teeth, wash his face and — when he had the money — buy a cup of coffee. He would bounce between homeless shelters and try to get a shower. But since businesses closed and many shelters stopped taking new admissions, Ed has been mostly shut off from that routine.

He’s still living on the streets.

“I’ll be honest, I don’t really sleep too much,” said Ed, who’s 51 and struggling with addiction. “Every four or five days I get a couple hours.”

KHN agreed not to use his last name because he uses illegal drugs.

Philadelphia has the highest overdose rate of any big city in America — in 2019, more than three people a day died of drug overdoses there, on average. Before the coronavirus began spreading across the United States, the opioid overdose epidemic was the biggest health crisis on the minds of many city officials and public health experts. The coronavirus pandemic has largely eclipsed the conversation around the opioid crisis. But the crisis still rages on despite business closures, the cancellation of in-person treatment appointments and the strain on many addiction resources in the city.

When his usual shelter wasn’t an option anymore, Ed tried to get into residential drug treatment. He figured that would be a good way to try to get back on his feet and, if nothing else, get a few good nights of rest. But he had contracted pinkeye, a symptom thought to be associated with the virus that leads to COVID-19, so the evaluation center didn’t want to place him in an inpatient facility until he’d gotten the pinkeye checked out. But he couldn’t see a doctor because he didn’t have a phone for a telehealth appointment.

“I got myself stuck, and I’m trying to pull everything back together before it totally blows up,” he said.

Rosalind Pichardo wants to help people in Ed’s situation. Before the pandemic, Pichardo would hit the streets of her neighborhood, Kensington, which has the highest drug overdose rate in Philadelphia. She’d head out with a bag full of snack bars, cookies and Narcan, the opioid overdose reversal drug.

She’d hand Narcan out to people using drugs, and people selling drugs — anyone who wanted it. Pichardo started her own organization, Operation Save Our City, which initially set out to work with survivors of gun violence in the neighborhood. When she realized that overdoses were killing people too, she began getting more involved with the harm reduction movement and started handing out Narcan through the city’s syringe exchange.

When Pennsylvania’s stay-at-home order went into effect, Pichardo and others worried that more people might start using drugs alone, and that fewer first responders would be patrolling the streets or nearby and able to revive them if they overdosed.

So, Pichardo and other harm reduction activists gave out even more Narcan. A representative for Prevention Point Philadelphia, the group that operates a large syringe exchange program in the city, said that during the first month of the city’s stay-at-home order, they handed out almost twice as much Narcan as usual.

After the lockdowns and social distancing began, Pichardo worried that more people would be using drugs alone, leading to more overdoses. But Philadelphia’s fatal overdose rate during the pandemic remains about the same as it was this time last year. Pichardo said she thinks that’s evidence that flooding the streets with Narcan is working — that people are continuing to use drugs, and maybe even using more drugs, but that users are utilizing Narcan more often and administering it to one another.

That is the hope. But Pichardo said users don’t always have a buddy to keep watch, and during the pandemic first responders have seemed much more hesitant to intervene. For example, she recently administered Narcan to three people in Kensington who overdosed near a subway station, while two police officers stood by and watched. Before the pandemic, they would often be right there with her, helping.

To reverse the overdoses, Pichardo crouched over the people who she said had started turning blue as their oxygen levels dropped. She injected the Narcan into their noses, using a disposable plastic applicator. Normally, she would perform rescue breathing, too, but since the pandemic began she has started carrying an Ambu bag, which pumps air into a person’s lungs and avoids mouth-to-mouth resuscitation. Among the three people, she said, it took six doses of Narcan to revive them. The police officers didn’t step in to help but did toss several overdose-reversal doses toward Pichardo as she worked.

“I don’t expect ’em to give ’em rescue breaths if they don’t want to, but at least administer the lifesaving drug,” Pichardo said.

In her work as a volunteer, she has reversed almost 400 overdoses, she estimated.

“There’s social distancing — to a limit,” Pichardo said, “I think when someone’s life is in jeopardy, they’re worth saving. You just can’t watch people die.”

Even before Philadelphia officially issued its stay-at-home order, city police announced they would stop making low-level arrests, including for narcotics. The idea was to reduce contact overall, help keep the jail population low and reduce the risk of the virus getting passed around inside. But Pichardo and other community activists said the decreased law enforcement emboldened drug dealers in the Kensington neighborhood, where open-air drug sales and use are common.

“You can tell they have everything down pat, from the lookout to the corner boys to the one actually holding the product — the one holding the product’s got some good PPE gear,” said Pichardo.

More dealers working openly on the street has led to more fights over territory, she added, which in turn has meant more violence. While overall crime in Philadelphia and other major cities has declined during the pandemic, gun violence has spiked.

Police resumed arrests at the beginning of May.

Now when she goes out to offer relief and hand out Narcan, Pichardo packs a few extra things in her bag of supplies: face masks, gloves and gun locks.

“It’s like the survival kit of the ’hood,” she said.

For those struggling with addiction who are ready to start recovery, newly relaxed federal restrictions have made it easier to get medications that curb opioid cravings and stem withdrawal. Several efforts are underway among Philadelphia-based public health groups and criminal justice advocacy organizations to give cellphones to people who are homeless or coming out of jail, so they can make a telehealth appointment and get quicker access to a prescription for those medicines.

During the pandemic, people taking medication-assisted treatment can renew their prescription every month instead of every week, which helps decrease trips to the pharmacy. It is too soon to know if more people are taking advantage of the new rules, and accessing medication-assisted treatment via telehealth, but if that turns out to be the case, many addiction medicine specialists argue the new rules should become permanent, even after the pandemic ends.

“If we find that these relaxed restrictions are bringing more people to the table, that presents enormous ethical questions about whether or not the DEA should reinstate these restrictive policies that they had going in the first place,” said Dr. Ben Cocchiaro, a physician who treats people with substance-use disorder.

Cocchiaro said the whole point of addiction treatment is to facilitate help as soon as someone is ready for it. He hopes if access to recovery can be made simpler during a pandemic, it can remain that way afterward.

This story is part of a partnership that includes WHYY, NPR and Kaiser Health News.

California AG Seeks More Power To Battle Merger-Hungry Health Care Chains

KFF Health News, June 2, 2020

California Attorney General Xavier Becerra has made battling healthcare consolidation a signature issue since he took office in 2017.

This article was first published on Tuesday, June 2, 2020 in Kaiser Health News.

By Rachel Bluth

California’s health care industry has a consolidation problem.

Independent physician practices, outpatient clinics and hospitals are merging or getting gobbled up by private equity firms or large health care systems. A single company can dominate an entire community, and in some cases, vast swaths of the state.

Such dominance can inflate prices, and consumers end up facing higher insurance premiums, more expensive outpatient services and bigger out-of-pocket costs to see specialists.

Now that COVID-19 has slammed the health care industry, especially the small practices that are barely seeing patients, the trend is likely to accelerate.

“I don’t see anything that’s going to stop this wave of consolidations amongst docs,” said Glenn Melnick, a health care economist at the University of Southern California.

“If this thing goes on a long time,” he said of the coronavirus, “then it becomes a tsunami.”

California Attorney General Xavier Becerra has made battling health care consolidation a signature issue since he took office in 2017. With the additional pressure that COVID-19 is putting on vulnerable practices and facilities, Becerra is now pressing the state legislature to expand his authority to slow health care mergers.

“We find that in these times of crisis, economic and health crisis, that the smaller health care players and stakeholders are oftentimes most at risk of being swallowed up by the big fish,” Becerra told California Healthline.

His success would fundamentally change how the health care industry merges and grows in California.

When a health care system, private equity firm or hedge fund plans to merge with or acquire another practice or facility — whether that means buying a small practice or joining a multistate hospital chain — Becerra wants to know about it. He wants written notice, and the ability to deny any sale that doesn’t deliver better access, cost or quality health care to Californians.

Becerra already can regulate mergers among nonprofit health care facilities. Under SB-977, a collaboration between Becerra’s office and the legislature, he would get the ability to regulate the for-profit sector as well.

“Certainly it would put California where it’s accustomed to being,” Becerra said. “At the head of the pack.”

The bill has support from organized labor and consumer advocacy groups. Gov. Gavin Newsom has come out against health care consolidation in the past but hasn’t taken an official stance on the bill.

Yet Becerra isn’t convinced passage will be smooth.

“The biggest concern I have is the legislation will be killed by the industry,” he said. “We’ll end up seeing over-consolidation because decent practices that got on the edge could not swim with sharks.”

Indeed, health care industry players are already lining up against the bill. Alex Hawthorne, a lobbyist for the California Hospital Association, said that hospitals are stretched thin because of the pandemic, and that now isn’t the time for Becerra to be meddling in routine agreements between practices.

“It bestows absolute and arbitrary discretion on the office of the attorney general,” Hawthorne said at a budget hearing in May.

In 2010, about 25% of California physicians worked in a practice owned by a hospital. By 2016, more than 40% of doctors worked in hospital-owned practices, according to research published in the journal Health Affairs in 2018.

There’s evidence that consolidation can hurt consumers. A separate 2018 study found that the cost of medical procedures in highly consolidated Northern California was 20% to 30% higher than in Southern California.

Since 2018, California’s attorney general has had the authority to regulate mergers among nonprofit health care systems, which Becerra exercised the same year when considering a merger between two health care giants: Dignity Health and Catholic Health Initiatives. He said he would approve the deal only if the systems agreed to certain requirements, such as starting a homelessness program.

Later that year, Becerra joined a suit against Sutter Health for using its market power to drive up health care costs in Northern California.

The lawsuit alleged that Sutter, which has 24 hospitals and 34 surgery centers, had spent years buying up practices and facilities, giving insurers little choice but to include them in their networks and agree to higher rates for services.

In October 2019, Becerra secured a $575 million settlement against Sutter, which has yet to be finalized or paid out, that requires Sutter to change how it charges insurance companies and give patients more information about prices.

Sutter Health opposes SB-977, which was introduced in February by state Sen. Bill Monning (D-Carmel). The measure is intended to address some of the challenges Becerra encountered with the Sutter case, Becerra said.

“The best way to prevent problems from occurring in a merger is just to prevent the merger altogether,” said Jaime King, associate dean at UC Hastings College of the Law in San Francisco. “It’s really hard to unwind a merger after you’ve already done it.”

Under the measure, the attorney general must be notified before a system, hedge fund or private equity firm attempts to enter into a merger, acquisition or another kind of affiliation change with another practice or facility. The bill defines a health care system as one with two or more hospitals in multiple counties, or three or more hospitals within one county.

That would trigger a public review process allowing supporters and opponents to make their cases to a review board. The board would assess the transaction, using criteria to determine whether it would improve access, quality and price.

The bill also would make it illegal for systems to act anti-competitively and give the attorney general the power to bring a civil suit against monopolistic systems.

The Senate Health Committee approved the bill, which is expected to be heard in another committee this week.

“Maybe it does mean consolidation should occur, but only because we’ve done the oversight to make sure it’s because of quality and access,” Becerra said. “Not because a big fish wants to make bigger profit.”

The measure includes waivers for rural practices and a fast-track review process for transactions under $500,000.

The California Chamber of Commerce opposes the bill, as does the California Medical Association, which represents doctors. While the California Medical Association is concerned about the survival of small physician practices, it believes the bill is too broad and should focus more tightly on hospital consolidation, said spokesperson Anthony York.

“This approach will only further force smaller providers out of business,” especially as the health systems respond to the COVID-19 emergency, the group’s legislative advocate, Amy Durbin, wrote in a letter of opposition.

For many independent practices struggling for survival, the debate over Becerra’s powers is academic.

Dr. Sarah Azad, who owns a women’s health practice in Mountain View, California, said at least three independent practices in her area have started the process to merge or sell since March because of dramatically lower patient volume.

Her practice is fine for now, despite the fact that her patient volume was only about 30% of normal in March and 60% of normal in April. Azad received a loan from the federal Paycheck Protection Program for small businesses so she could pay her five doctors in May.

“If you catch me on a bad month, I feel like we’re one disaster away from bankruptcy,” Azad said.

A Senator From Arizona Emerges As A Pharma Favorite

KFF Health News, May 30, 2020

Sen. Kyrsten Sinema has received almost $100,000 from drug companies in the current election cycle, a KHN analysis shows, one of the largest cash hauls in Congress.

This article was first published on Friday, May 29, 2020 in Kaiser Health News.

By Jay Hancock and Elizabeth Lucas

Sen. Kyrsten Sinema formed a congressional caucus to raise “awareness of the benefits of personalized medicine” in February. Soon after that, employees of pharmaceutical companies donated $35,000 to her campaign committee.

Amgen gave $5,000. So did Genentech and Merck. Sanofi, Pfizer and Eli Lilly all gave $2,500. Each of those companies has invested heavily in personalized medicine, which promises individually tailored drugs that can cost a patient hundreds of thousands of dollars.

Sinema is a first-term Democrat from Arizona but has nonetheless emerged as a pharma favorite in Congress as the industry steers through a new political and economic landscape formed by the coronavirus.

She is a leading recipient of pharma campaign cash even though she’s not up for reelection until 2024 and lacks major committee or subcommittee leadership posts. For the 2019-20 election cycle through March, political action committees run by employees of drug companies and their trade groups gave her $98,500 in campaign funds, Kaiser Health News’ Pharma Cash to Congress database shows.

That stands out in a Congress in which a third of the members got no pharma cash for the period and half of those who did got $10,000 or less. The contributions give companies a chance to cultivate Sinema as she restocks from a brutal 2018 election victory that cost nearly $25 million. Altogether, pharma PACs have so far given $9.2 million to congressional campaign chests in this cycle, compared with $9.4 million at this point in the 2017-18 period, a sustained surge as the industry has responded to complaints about soaring prices.

Sinema’s pharma haul was twice that of Sen. Susan Collins of Maine, considered one of the most vulnerable Republicans in November, and approached that of fellow Democrat Steny Hoyer, the powerful House majority leader from Maryland.

It all adds up to a bet by drug companies that the 43-year-old Sinema, first elected to the Senate in 2018, will gain influence in coming years and serve as an industry ally in a party that also includes many lawmakers harshly critical of high drug prices and the companies that set them.

“This is a long-term play,” said Steven Billet, a former AT&T lobbyist who teaches PAC management at George Washington University. “She’s more of a moderate than people are giving her credit for. If I’m a pharmaceutical guy, I’m saying, ‘You know what? Maybe this is somebody we can work with down the road.’”

The industry’s pivot to Sinema comes as powerful favorites such as former Sen. Orrin Hatch of Utah and retiring Rep. Greg Walden of Oregon, both Republicans, fade from the scene.

Bisexual, an LGBTQ rights advocate and a former member of the Arizona Green Party, Sinema said in 2006 that she was the most liberal member of the Arizona State Legislature, according to HuffPost. These days, representing traditionally conservative Arizona statewide, she portrays herself as a moderate. She favors better medical coverage by improving the insurance company-friendly Affordable Care Act, for example, not by scrapping it in exchange for “Medicare for All.”

“Sinema is a talented politician who knows where she needs to be politically and will get there,” said Nathan Gonzales, editor of Inside Elections, a nonpartisan newsletter.

Sinema’s spokesperson did not respond to queries from KHN.

First elected to the U.S. House in 2012, she has a history of supporting pharmaceutical and biotech firms, dozens of which have operations in Arizona. Her acceptance of drug industry campaign contributions sets her apart from Democrats such as Sen. Cory Booker of New Jersey who have pledged to reject pharma money, not to mention those who spurn all corporate cash.

“The Republican Party tends to be more receptive to pharma cash,” said Paul Jorgensen, a political science professor at the University of Texas Rio Grande Valley, who analyzes campaign finance. “You’re going to see divisions within the party on pharma on the Democratic side.”

In 2017 Sinema introduced a House bill, strongly supported by the Biotechnology Innovation Organization trade group, that would have eased financial regulation on publicly traded biotech firms with little revenue. The measure has not become law, but two weeks later BIO named Sinema “Legislator of the Year,” calling her a “stalwart advocate” for life sciences jobs.

“We welcome the opportunity to work with any policymaker who understands the value of science, the risks, costs and challenges of developing new medicines, and the need to ensure patients have access to medicines with out-of-pocket costs they can afford,” BIO spokesperson Brian Newell said.

Sinema portrayed her backing of a 2016 measure to accelerate the introduction of scarce generic drugs as a blow against high drug costs. A version became law the next year. But support for the bill by the Pharmaceutical Research and Manufacturers of America, the main brand-drug lobby, prompted some to question its potential to bring down overall drug prices.

Sinema was a strong advocate of the biggest overhaul of over-the-counter drug regulation in almost half a century. The measure became law in March with little public notice as part of the CARES Act to rescue the economy and fight the coronavirus. It gives the Food and Drug Administration new leeway to move against possibly dangerous drugs, sets up industry fees to pay for accelerated reviews and creates incentives to bring new medicines to market.

The changes drew widespread, bipartisan support. The old OTC regulation “wasn’t good for anyone,” said Joshua Sharfstein, who was deputy FDA commissioner in the Obama administration. “It wasn’t good for consumers. It wasn’t good for industry.”

The new system resembles the user-fee financing of regulation for prescription drugs. But making the FDA dependent on drug company money for OTC oversight — subject to periodic negotiation with industry — makes the agency beholden to the companies it oversees, said David Hilzenrath, chief investigative reporter for the Project on Government Oversight, a watchdog nonprofit.

Accelerating review of OTC medicines “may be a double-edged sword,” he said. “It could speed decisions that benefit the public and it could speed decisions that put the public at risk.”

Personalized medicine — also known as precision medicine — promises to use genetic characteristics and other traits to identify which treatments are best for a particular patient.

Sinema co-chairs the Personalized Medicine Caucus along with Republican Sen. Tim Scott of South Carolina and two House members. The lawmakers introduced the group in coordination with a pharma industry group, the Personalized Medicine Coalition.

“Raising awareness of the benefits of personalized medicine helps detect and prevent diseases, while making health care more affordable and accessible for Arizona families” was Sinema’s quote in the press release.

But affordability has not been a hallmark of personalized medicine so far. Like other recent pharma products, genetically targeted medicines and tests can come with extremely high prices while sometimes delivering mediocre benefits, health policy analysts say.

One of the best-known precision medicines is Merck’s Keytruda, used against a variety of cancer tumors with certain genetic profiles. It costs more than $100,000 a year.

“It’s a good drug,” said Vinay Prasad, an associate professor at the University of California-San Francisco who studies health policy and cancer drugs. “But behind it is a marketing machine that is trying to maximize its use.”

In any case, personalized medicine generally “has been a mixed bag,” with prices for cancer drugs that are “universally horrendous,” he said. Industry enthusiasm may be “motivated by the fact that when something is called precision or personalized, the regulatory bar needed to approve it is lower,” he added. “And that is often good for profits.”

Antibody Tests Were Hailed as Way to End Lockdowns. Instead, They Cause Confusion.

KFF Health News, May 28, 2020

Testing programs initially slated to test hundreds or thousands have been scaled back or put on hold.

This article was first published on Thursday, May 28, 2020 in Kaiser Health News.

By Christie Aschwanden

Aspen was an early COVID-19 hot spot in Colorado, with a cluster of cases in March linked to tourists visiting for its world-famous skiing. Tests were in short supply, making it difficult to know how the virus was spreading.

So in April, when the Pitkin County Public Health Department announced it had obtained 1,000 COVID-19 antibody tests that it would offer residents at no charge, it seemed like an exciting opportunity to evaluate the efforts underway to stop the spread of the virus.

"This test will allow us to get the epidemiological data that we've been looking for," Aspen Ambulance District director Gabe Muething said during an April 9 community meeting held online.

However, the plan soon fell apart amid questions about the reliability of the test from Aytu BioScience. Other ski towns such as Telluride, Colorado, and Jackson, Wyoming, as well as the less wealthy border community of Laredo, Texas, were also drawn to antibody testing to inform decisions about how to exit lockdown. But they, too, determined the tests weren't living up to their promise.

The allure of antibody tests is understandable. Although they can't find active cases of COVID-19, they can identify people who previously have been infected with the coronavirus that causes the disease, which could give health officials important epidemiological information about how widely it has spread in a community and the extent of asymptomatic cases. In theory, at least, antibodies would be present in such people whether they had a severe case, little more than a dry cough or no complaints at all.

Even more enticing: These tests were billed as a path to restart local economies by identifying people who might be immune to the virus and could therefore safely return to the public sphere.

But, in these and other communities, testing programs initially slated to test hundreds or thousands have been scaled back or put on hold.

"I don't think these tests are ready for clinical use yet," said University of California-San Francisco immunologist Dr. Alexander Marson, who has studied their reliability. He and his team vetted 12 different antibody tests and found all but one turned up false positives — implying that someone had antibodies when they didn't ― with false-positive rates reaching as high as 16%. (The study is preliminary and has not been peer-reviewed yet.)

More than 100 antibody tests are currently available in the U.S., including offerings by commercial labs, academic centers and small entrepreneurial ventures. As serious questions emerged earlier this month about the accuracy of the tests and the usefulness of the results, the U.S. Food and Drug Administration said it will require companies to submit validation data on their products and apply for emergency-use authorizations for their products. (Previously, companies were allowed to sell their tests without review from the FDA, as long as they did their own validation and included a disclaimer.) And the American Medical Association said on May 14 that the tests should not be used to assess an individual's immunity or when to end physical distancing.

And this week, the Centers for Disease Control and Prevention released new guidelines warning that antibody test results can have high false positive rates and should not be used to make decisions about returning people to work, schools, dorms or other places where people congregate.

Once hailed as a solution, the current crop of tests, which have not been thoroughly vetted by any regulatory agency, now seem more likely to add chaos and uncertainty to a situation already fraught with anxiety. "To give people a false sense of security has a lot of danger right now," said Dr. Travis Riddell, the health officer for Teton County, which includes Jackson, Wyoming.

Accuracy Questions Raised

The gold standard for confirming an active COVID-19 infection is to take a swab from the nasopharynx and test it for the presence of viral RNA. The antibody tests instead parse the blood for antibodies against the COVID-19 virus. It takes time for an infected person to produce antibodies, so these tests can't diagnose an ongoing infection, only indicate that a person has encountered the virus.

In Aspen, county officials knew the FDA had not approved the Aytu BioScience test, which the Colorado-based company was importing from China. So they first conducted their own validation tests, said Bill Linn, spokesperson for the Pitkin County Incident Management Team. "We weren't reassured enough by our own testing to feel like we should move ahead."

In Laredo, officials had been told by one of the community members helping to arrange the purchase of 20,000 tests from the Chinese company Anhui DeepBlue Medical Technology that they were FDA-approved, but the city's own validation trials revealed only about a 20% accuracy rate, said Laredo spokesperson Rafael Benavides. Before Laredo could pay for the tests, Benavides said, an arm of U.S. Immigration and Customs Enforcement seized them and launched an investigation.

Neither Anhui DeepBlue Medical Technology, nor Aytu returned requests for comment.

In March, Covaxx, a company led by two part-time Telluride residents, offered to test residents of the town and the surrounding county with an antibody test it had developed. But the project was suspended indefinitely when the company's testing facility fell behind on processing them.

The county is committed to doing a second round of testing but is evaluating how to proceed, said San Miguel County spokesperson Susan Lilly. "The question is how do you target it to be the most relevant clinically and for the public health team's decision-making moving forward?"

Officials Back Off, Community Members Step In

On May 4, the FDA updated its antibody test policy to require that manufacturers submit validation data, but it is still allowing the tests to be sold without the normal lengthy vetting and approval process, which includes demonstrating safety and effectiveness.

In some wealthy areas, government officials had been offering free tests from startups with local investors. In Jackson, for example, a venture capitalist with an investment in Covaxx, the test used in Telluride, offered to help the city obtain 1,000 tests. But after reviewing the offer, Teton County declined over concerns about the test's accuracy. "If a person tests positive, what does that mean? And is that useful information? We just don't know yet," Riddell said.

Covaxx spokesperson John Schaefer said in a statement that the test had been validated on more than 900 blood samples and is being reviewed by the FDA.

After Teton County officials decided against community antibody testing, a private nonprofit, Test Teton Now, sprung up to provide free COVID-19 antibody testing using the Covaxx test for roughly 8,000 people, about a third of the county's residents. As of May 22, they'd raised $396,000 and tested 843 samples. The group has "done a lot" to verify the Covaxx tests, said Test Teton Now president Shaun Andrikopoulos. "I don't want to call it validation, because we didn't go through an independent review board, but we have sent our samples out to other labs."

Organizers of Test Teton Now don't share others' concerns about the test's utility. "We don't encourage people to make any decisions about what they're going to do or how they're going to behave based on the results," said the nonprofit's spokesperson, Jennifer Ford.

What good is a test that can't be used for practical purposes? "We think knowledge is power, and data is the beginning of knowledge," Ford said. But unreliable data doesn't give knowledge, it gives an illusion of knowledge.

So many unknowns remain, and false data may be worse than none. Even a very accurate test will produce a large number of false positives when used in a population where few people have been infected. If only 4% of people have actually been infected, a test with 95% accuracy would produce nine positive results for every 100 tests, five of which are false positives.

And that creates a danger that the tests could lead people to incorrectly think that they have antibodies that make them immune, which could have disastrous consequences if they changed their behavior as a result. Consider, for example, a person falsely told she had antibodies going to work at a nursing home, believing she couldn't catch or spread the virus to anyone.

It's not even known for sure that having antibodies makes someone immune. Researchers are hopeful that exposure can confer some level of immunity, but how strong that immunity might be and how long it might last remain unknown, said Harvard epidemiologist Marc Lipsitch.

So, having been burned once, Aspen has put antibody testing on hold and is instead focusing on identifying and isolating people who are sick or at risk of becoming so. "It's actually a step back to where we started," Linn said.

Given the remaining unknowns about immunity and COVID-19, the best methods for addressing the pandemic in communities may be the most time-tested ones, Linn said. "Put the sick people in places where they can't get anyone else sick. It's the bread and butter of epidemiology."

Nearly Half of Americans Delayed Medical Care Due to Pandemic

KFF Health News, May 27, 2020

A new polls finds 48% of Americans or a family member has delayed medical care because of the pandemic and 11% said the condition worsened because of it. 

This article was first published on Wednesday, May 27, 2020 in Kaiser Health News.

By Elizabeth Lawrence

As the coronavirus threat ramped up in March, hospitals, health systems and private practices dramatically reduced inpatient, nonemergency services to prepare for an influx of COVID-19 patients. A poll released Wednesday reveals that the emptiness of medical care centers may also reflect the choices patients made to delay care.

The Kaiser Family Foundation poll found that 48% of Americans said they or a family member has skipped or delayed medical care because of the pandemic, and 11% of them said the person's condition worsened as a result of the delayed care. (KHN is an editorially independent program of the foundation.)

Medical groups have noted a sharp drop-off in emergency patients across the country. Some, including the American College of Emergency Physicians, American College of Cardiology and American Heart Association, have publicly urged people concerned about their health to seek care.

Dr. William Jaquis, president of the American College of Emergency Physicians, said the anecdotes he's heard of people delaying care have been troubling, with patients suffering heart attacks or strokes at home. He urged people not to skip going to the emergency room, and pointed out the many safety precautions hospitals are taking to curb the spread of the coronavirus.

"Don't sit at home and have a bad outcome," Jaquis said. "We're certainly there and in many ways very safe, and, especially with low volumes in some places, we're able to see people quickly. Come on in, please."

According to the poll, nearly 7 in 10 of those who had skipped seeing a medical professional expect to get care in the next three months.

Despite a significant number of adults saying they delayed care, 86% of adults said their physical health has "stayed about the same" since the onset of the outbreak in the U.S.

Nearly 40% of Americans, however, said stress related to the coronavirus has negatively affected their mental health. Women were more likely than men to say the coronavirus has had a negative impact on their mental health, and those living in urban and suburban areas were more likely to say this than those living in rural areas. Nearly half of those living in households that have experienced income or job loss said the pandemic had a negative effect on their mental health.

The poll further reports on some of the economic consequences of the pandemic. It found that about 3 in 10 adults have had trouble paying household expenses, with 13% expressing difficulty paying for food and 11% paying medical bills. Nearly 1 in 4 adults said they or a family member in the next year will likely turn to Medicaid, the federal-state health insurance program for low-income residents.

Medicaid continues to show strong support among Americans. About three-quarters said they would oppose efforts by their states to cut the program as part of cost reductions.

The poll was conducted May 13-18 among 1,189 adults. The margin of sampling error is +/-3 percentage points for the full sample.

Elizabeth Lawrence: elizabethla@kff.org

COVID-Like Cough Sent Him To ER — Where He Got A $3,278 Bill

KFF Health News, May 26, 2020

Timothy Regan, an estimator for a construction firm in Colorado, tried to do everything right when he started experiencing symptoms of COVID-19. He first called a nurse hotline, then was told to go to urgent care, and from there was triaged to the emergency room. His ER visit was coded as a Level 4, resulting in a $3,278 bill.

This article was first published on Monday, May 25, 2020 in Kaiser Health News.

By Phil Galewitz

From late March into April, Timothy Regan had severe coughing fits several times a day that often left him out of breath. He had a periodic low-grade fever, too.

Wondering if he had COVID-19, Regan called a nurse hotline run by Denver Health, a large public health system in his city. A nurse listened to him describe his symptoms and told him to immediately go to the hospital system’s urgent care facility.

When he arrived at Denver Health — where the emergency room and urgent care facility sit side by side at its main location downtown — a nurse directed him to the ER after he noted chest pain as one of his symptoms.

Regan was seen quickly and given a chest X-ray and electrocardiogram, known as an EKG, to check his lungs and heart. Both were normal. A doctor prescribed an inhaler to help his breathing and told him he might have bronchitis. The doctor advised that he had to presume he had COVID-19 and must quarantine at home for two weeks. At the time, on April 3, Denver Health reserved COVID tests for sicker patients. Two hours after arriving at the hospital, Regan was back home. His longest wait was for his inhaler prescription to be filled.

Regan wasn’t concerned just about his own health. His wife, Elissa, who is expecting their second child in August, and their 1-year-old son, Finn, also felt sick with COVID-like symptoms in April. “Nothing terrible, but enough to make me worry,” he said.

Regan, who is an estimator for a construction firm, worked throughout his sickness — including while quarantined at home. (Construction in Colorado and many states has been considered an essential business and has continued to operate.) Regan said he was worried about taking a day off and losing his job.

“I was thinking I had to make all the money I could in case we all had to be hospitalized,” he said. “All I could do was keep working in hopes that everything would be OK.”

Within a couple of weeks, the whole family, indeed, was OK. “We got lucky,” Elissa said.

Then the bill came.

The Patient: Timothy Regan, 40, an estimator for a construction company. The family has health insurance through Elissa’s job at a nonprofit in Denver.

Total Bill: Denver Health billed Regan $3,278 for the ER visit. His insurer paid $1,042, leaving Regan with $2,236 to pay based on his $3,500 in-network deductible. The biggest part of the bill was the $2,921 general ER fee.

Service Provider: Denver Health, a large public health system

Medical Service: Regan was evaluated in the emergency room for COVID-like symptoms, including a severe cough, fever and chest pain. He was given several tests to check his heart and lungs, prescribed an inhaler and sent home.

What Gives: When patients use hospital emergency rooms — even for short visits with few tests — it’s not unusual for them to get billed thousands of dollars no matter how minor the treatment received. Hospitals say the high fees come from having to staff the ER with specialists 24 hours a day and keep lifesaving equipment up to date.

Denver Health coded Timothy’s ER visit as a Level 4 — the second-highest and second-most expensive — on a 5-point scale. The other items on his bill were $225 for the EKG, $126 for the chest X-ray and $6 for his albuterol inhaler, a medication that provides quick relief for breathing problems.

The Regans knew they had a high deductible and they try to avoid unnecessarily using the ER. But, with physician offices not seeing patients with COVID-type symptoms in April, Timothy said he had little choice when Denver Health directed him first to the urgent care, then to its ER. “I felt bad, but I had been dealing with it for a while,” he said.

Elissa said they were trying hard to do everything by the book, including using a health provider in their plan’s network.

“We did not anticipate being hit with such a huge bill for the visit,” Elissa said. “We had intentionally called the nurse’s line trying to be responsible, but that did not work.”

In an effort to remove barriers from people getting tested and evaluated for COVID-19, UnitedHealthcare is one of many insurers that announced it will waive cost sharing for COVID-19 testing-related visits and treatment. But it is not clear how many people who had COVID symptoms but did not get tested when tests were in short supply have been billed as the Regans were.

Resolution: A Denver Health spokesperson said Regan was not tested for COVID because he was not admitted and did not have risk factors such as diabetes, heart disease or asthma. He was not billed as a COVID patient because he was not tested for the virus. The medical center has since expanded its testing capacity, the spokesperson said.

UnitedHealthcare officials reviewed Regan’s case at the request of KHN. Based on Regan’s symptoms and the tests performed, Denver Health should have billed them using a COVID billing code, an insurer spokesperson said. “We reprocessed Mr. Regan’s original claims after reviewing the services that he received,” a United Healthcare spokesperson said. “All cost share for that visit has been waived.”

The Regans said they were thrilled with UHC’s decision.

“That is wonderful news,” Elissa Regan said upon hearing from a KHN reporter that UHC would waive their costs. “We are very thankful. It is a huge relief.”

The Takeaway: The Regans said they initially found no satisfaction in calling the hospital or the insurer to resolve their dispute ― but it was the right thing to do.

“He’s definitely not alone,” said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. “The takeaway here is both the provider as well as insurance company are still on a learning curve with respect to this virus and how to bill and pay for it.”

Corlette said Timothy should not have second-guessed his decision to use the Denver Health ER when directed there by a nurse. That, too, was the right call.

Insurers’ moves to waive costs associated with COVID testing and related treatment is vital to stemming the outbreak — but it works only if patients can trust they won’t get stuck with a large bill, she said. “It’s a critical piece of the public health strategy to beat this disease,” Corlette said.

To help with billing, she said, patients could ask their provider to note on their medical chart when they are seeking care for possible COVID-19. But it’s not the patient’s responsibility to make sure providers use the right billing code, she said. Patients need to know they have the right to appeal costs to their insurer. They can also seek assistance from their employer’s benefits department and state insurance department.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Pages