Heidi de Marco, Kaiser Health News

It was Saturday morning at Southbay Tattoo and Body Piercing in Carson, California, and owner Efrain Espinoza Diaz Jr. was prepping for his first tattoo of the day — a memorial portrait of a man that his widow wanted on her forearm.

Diaz, known as “Rock,” has been a tattoo artist for 26 years but still gets a little nervous when doing memorial tattoos, and this one was particularly sensitive. Diaz was inking a portrait of Philip Martin Martinez, a fellow tattoo artist and friend who was 45 when he died of covid-19 in August.

“I need to concentrate,” said Diaz, 52. “It’s a picture of my friend, my mentor.”

Martinez, known to his friends and clients as “Sparky,” was a tattoo artist of some renown in nearby Wilmington, in Los Angeles’ South Bay region. A tattoo had brought Sparky and Anita together; Sparky gave Anita her first tattoo — a portrait of her father — in 2012, and the experience sparked a romance. Over the years of their relationship, he had covered her body with intertwining roses and a portrait of her mother.

Now his widow, she was getting the same photograph that was etched on Sparky’s tomb inked into her arm. And this would be her first tattoo that Sparky had not applied.

“It feels a little odd, but Rock has been really good to us,” Anita Martinez said. Rock and Sparky “grew up together.” They met in the 1990s, at a time when there were no Mexican-American-owned tattoo shops in their neighborhood but Sparky was gaining a reputation. “It was artists like Phil that would inspire a lot of us to take that step into the professional tattoo industry,” Rock said.

After Sparky got sick, Anita wasn’t allowed in her husband’s hospital room, an isolating experience shared by hundreds of thousands of Americans who lost a loved one to covid. They let her in only at the very end.

“I got cheated out of being with him in his last moments,” said Martinez, 43. “When I got there, I felt he was already gone. We never got to say goodbye. We never got to hug.”

“I don’t even know if I’m ever going to heal,” she said, as Diaz began sketching the outlines of the portrait below her elbow, “but at least I’ll get to see him every day.”

According to a 2015 Harris Poll, almost 30% of Americans have at least one tattoo, a 10% increase from 2011. At least 80% of tattoos are for commemoration, said Deborah Davidson, a professor of sociology at York University in Toronto who has been researching memorial tattoos since 2009.

“Memorial tattoos help us speak our grief, bandage our wounds and open dialogue about death,” she said. “They help us integrate loss into our lives to help us heal.”

Covid, sadly, has provided many opportunities for such memorials.

Juan Rodriguez, a tattoo artist who goes by “Monch,” has been seeing twice as many clients as before the pandemic and is booked months in advance at his parlor in Pacoima, an L.A. neighborhood in the San Fernando Valley. Memorial tattoos, which can include names, portraits and special artwork, are common in his line of work, but there’s been an increase in requests due to the pandemic. “One client called me on the way to his brother’s funeral,” Rodriguez said.

Rodriguez thinks memorial tattoos help people process traumatic experiences. As he moves his needle over the arms, legs and backs of his clients, and they share stories of their loved ones, he feels he is part artist, part therapist.

Healthy grievers do not resolve grief by detaching from the deceased but by creating a new relationship with them, said Jennifer R. Levin, a therapist in Pasadena, California, who specializes in traumatic grief. “Tattoos can be a way of sustaining that relationship,” she said.

It’s common for her patients in the 20-to-50 age range to get memorial tattoos, she said. “It’s a powerful way of acknowledging life, death and legacy.”

Sazalea Martinez, a kinesiology student at Antelope Valley College in Palmdale, California, came to Rodriguez in September to memorialize her grandparents. Her grandfather died of covid in February, her grandmother in April. She chose to have Rodriguez tattoo an image of azaleas with “I love you” written in her grandmother’s handwriting.

The azaleas, which are part of her name, represent her grandfather, she said. Sazalea decided not to get a portrait of her grandmother because the latter didn’t approve of tattoos. “The ‘I love you’ is something simple and it’s comforting to me,” she said. “It’s going to let me heal and I know she would have understood that.”

Sazalea teared up as the needle moved across her forearm, tracing her grandmother’s handwriting. “It’s still super fresh,” she said. “They basically raised me. They impacted who I am as a person, so to have them with me will be comforting.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Sofie Kodner

In the middle of a rainy Michigan night, 88-year-old Dian Wurdock walked out the front door of her son’s home in Grand Rapids, barefoot and coatless. Her destination was unknown even to herself.

Wurdock was several years into a dementia diagnosis that turned out to be Alzheimer’s disease. By luck, her son woke up and found her before she stepped too far down the street. As the Alzheimer’s progressed, so did her wandering and with it, her children’s anxiety.

“I was losing it,” said her daughter, Deb Weathers-Jablonski. “I needed to keep her safe, especially at night.”

Weathers-Jablonski installed a monitoring system with nine motion sensors around the house — in her mother’s bedroom, the hallway, kitchen, living room, dining room and bathroom and near three doors that led outside. They connected to an app on her phone, which sent activity alerts and provided a log of her mother’s movements.

“When I went to bed at night, I didn’t have to guess what she was doing,” Weathers-Jablonski said. “I was actually able to get some sleep.”

New monitoring technology is helping family caregivers manage the relentless task of looking out for older adults with cognitive decline. Setting up an extensive monitoring system can be expensive — Weathers-Jablonski’s system from People Power Co. costs $299 for the hardware and $40 a month for use of the app. With scores of companies selling such gear, including SentryTell and Caregiver Smart Solutions, they are readily available to people who can pay out-of-pocket.

But that’s not an option for everyone. While the technology is in line with President Joe Biden’s plan to direct billions of dollars toward helping older and disabled Americans live more independently at home, the costs of such systems aren’t always covered by private insurers and rarely by Medicare or Medicaid.

Monitoring also raises ethical questions about privacy and quality of care. Still, the systems make it possible for many older people to stay in their home, which can cost them far less than institutional care. Living at home is what most people prefer, especially in light of the toll the covid-19 pandemic took on nursing homes.

Technology could help fill a huge gap in home care for the elderly. Paid caregivers are in short supply to meet the needs of the aging population, which is expected to more than double in coming decades. The shortage is fueled by low pay, meager benefits and high rates of burnout.

And for the nearly 1 in 5 U.S adults who are caregivers to a family member or friend over age 50, the gadgets have made a hard job just a little easier.

Passive surveillance systems are replacing the “I’ve fallen and I can’t get up” medical alert buttons. Using artificial intelligence, the new devices can automatically detect something is wrong and make an emergency call unasked. They also can monitor pill dispensers and kitchen appliances using motion sensors, like EllieGrid and WallFlower. Some systems include wearable watches for fall detection, such as QMedic, or can track GPS location, like SmartSole’s shoe insoles. Others are video cameras that record. People use surveillance systems like Ring inside the home.

Some caregivers may be tempted to use technology to replace care, as researchers in England found in a recent study. A participant who had visited his father every weekend began visiting less often after his dad started wearing a fall detector around his wrist. Another participant believed her father was active around the house, as evidenced by activity sensor data. She later realized the app was showing not her father’s movement, but his dog’s. The monitoring system picked up the dog’s movements in the living room and logged it as activity.

Technology isn’t a substitute for face-to-face interaction, stressed Crista Barnett Nelson, executive director of Senior Advocacy Services, a nonprofit group that helps older adults and their families in the North Bay area outside San Francisco. “You can’t tell if someone has soiled their briefs with a camera. You can’t tell if they’re in pain, or if they just need an interaction,” she said.

In some instances, people being monitored changed their habits in response to technology. Clara Berridge, a professor of social work at the University of Washington who studies the use of technology in elder care, interviewed a woman who stopped her usual practice of falling asleep on the recliner because the technology would falsely alert her family that something was wrong based on inactivity deemed abnormal by the system. Another senior reported rushing in the bathroom for fear an alert would go out if they took too long.

The technology presents another worry for those being monitored. “A caregiver is generally going to be really concerned about safety. Older adults are often very concerned about safety too, but they may also weigh privacy really heavily, or their sense of identity or dignity,” Berridge said.

Charles Vergos, 92 and living in Las Vegas, is uncomfortable with video cameras in his house and wasn’t interested in wearing gadgets. But he liked the idea that someone would know if something went wrong while he was alone. His niece, who lives in Palo Alto, California, suggested Vergos install a home sensor system so she could monitor him from afar.

“The first question I asked is, does it take pictures?” Vergos recalled. Because the sensors don’t have a video component, he was fine with them. “Actually, after you have them in the house for a while, you don’t even think about it,” Vergos said.

The sensors also have made conversations with his niece more convenient for him. She knows he likes to talk on the phone while he’s in his chair in the den, so she’ll check his activity on her iPad to determine whether it’s a good time to call.

People making audio and video recordings must abide by state privacy laws, which typically require the consent of the person being recorded. It’s not as clear, however, if consent is needed to collect the activity data that sensors gather. That falls into a gray area of the law, similar to data collected through internet browsing.

Then there is the problem of how to pay for it all. Medicaid, the federal-state health program for low-income people, does cover some passive monitoring for home care, but it’s not clear how many states have opted to pay for such service.

Some seniors also lack access to robust internet broadband, putting much of the more sophisticated technology out of reach, noted Karen Lincoln, founder of Advocates for African American Elders at the University of Southern California.

The relief monitoring devices bring caregivers may be the most compelling reason for their use. Delaine Whitehead, who lives in Orange County, California, started taking medication for anxiety about a year after her husband, Walt, was diagnosed with Alzheimer’s.

Like Weathers-Jablonski, Whitehead sought technology to help, finding peace of mind in sensors installed on the toilets in her home.

Her husband often flushed too many times, causing the toilets to overflow. Before Whitehead installed the sensors in 2019, Walt had caused $8,000 worth of water damage in their bathroom. With the sensors, Whitehead received an alert on her phone when the water got too high.

“It did ease up a lot of my stress,” she said.

Sofie Kodner is a writer with the Investigative Reporting Program at the University of California-Berkeley Graduate School of Journalism. The IRP reported this story through a grant from The SCAN Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Overpriced doctors and other medical providers who can’t charge a reasonable rate for their services could be put out of business when new rules against surprise medical bills take effect in January, and that’s a good thing, Health and Human Services Secretary Xavier Becerra told KHN, in defending the regulations.

The proposed rules represent the Biden administration’s plan to carry out the No Surprises Act, which Congress passed to spare patients from the shockingly high bills they get when one or more of their providers unexpectedly turn out to be outside their insurance plan’s network.

The law shields patients from those bills, requiring providers and insurers to work out how much the physicians or hospitals should be paid, first through negotiation and then, if they can’t agree, arbitration. Doctor groups and medical associations, however, have lashed out at the interim final rules that HHS unveiled last month, saying they favor insurance companies in the arbitration phase. That’s because, although the rules tell arbiters to take many factors into account, they are instructed to start with a benchmark largely determined by insurers: the median rate negotiated for similar services among in-network providers.

The doctor groups say giving the insurers the upper hand will let them drive payment rates down and potentially force doctors out of networks or even out of business, reducing access to health care.

The department has heard those concerns, Becerra said, but the bottom line is protecting patients. Medical providers who have taken advantage of a complicated system to charge exorbitant rates will have to bear their share of the cost, or close if they can’t, he said.

“I don’t think when someone is overcharging, that it’s going to hurt the overcharger to now have to [accept] a fair price,” Becerra said. “Those who are overcharging either have to tighten their belt and do it better, or they don’t last in the business.”

“It’s not fair to say that we have to let someone gouge us in order for them to be in business,” he added.

Nonetheless, Becerra said he did not foresee a wave of closures, or diminished access for consumers. Instead, he suggested that a competitive, market-driven process will find a balance, especially when consumers know better what they are paying for.

“We’re willing to pay a fair price,” he said. But he emphasized that “I’ll pay for the best, but I don’t want to have to pay for the best and then three times more on top of that and get blindsided by the bill.”

Becerra also pointed to a report on surprise medical bills that HHS released Monday and that was provided to KHN in advance, highlighting the impacts of negotiation and arbitration laws already in effect in 18 states.

The report, which aggregates previous research, found people getting hit with surprise bills averaging $1,219 for anesthesiologists, $2,633 for surgical assistants, $744 for childbirth and north of $24,000 for air ambulances.

In the states that use benchmarks similar to what doctors are suggesting HHS use, such as New York and New Jersey, the report found costs rising. New York has a “baseball-style” system in which the arbiter chooses between the offers presented by the provider and the insurer, although the arbiter is told to consider the offer closest to the 80th percentile of charges. “Since the amount providers charge is typically much higher than the actual negotiated rate, this approach risks leading to significantly higher overall costs,” the report found. In New Jersey, billed charges or “usual and customary” rates are considered.

“When the arbitration process is wide open, no boundaries, at the end of the day health care costs go up, not down,” Becerra said of the methods doctors prefer. “We want costs to go down. And so we want to set up a system that helps provide the guideposts to keep us efficient, transparent and cost-effective.”

The system chosen by the Biden administration was expected to push insurance premiums down by 0.5% to 1%, the Congressional Budget Office estimated.

“Everyone has to give a little to get to a good place,” Becerra said. “That sweet spot, I hope, is one where patients … are extracted from that food fight. And if there continues to be a food fight, the arbitration process will help settle it in a way that is efficient, but it also will lead to lower costs.”

While the administration chose a benchmark that physician and hospital groups don’t like, the law does specify that other factors should be considered, such as a provider’s experience, the market and the complexity of a case. Becerra said those factors help ensure arbitration is fair.

“What we simply did was set up a rule that says, ‘Show the evidence,’” Becerra said. “It has to be relevant, material evidence. And let the best person win in that fight in arbitration.”

The interim final rules were published Oct. 7, giving stakeholders 60 days to comment and seek changes. More than 150 members of Congress, many of them doctors, have asked HHS and other relevant federal agencies to reconsider before the law takes effect Jan. 1. The lawmakers charge that the administration is not adhering to the spirit of the compromises Congress made in passing the law.

Rules that are this far along tend to go into effect with little or no changes, but Becerra said his department was still listening. “If we think there’s a need to make any changes, we are prepared to do so,” the secretary said.

The HHS report also noted that the law requires extensive monthly and annual reporting to regulators and Congress to determine if the regulations are out of whack or have undesirable consequences like those the physicians are warning of.

Becerra said he thinks the rules strike the right balance, favoring not insurers or doctors, but the people who need medical care.

“We want it to be transparent, so we can lead to more competition, and keep costs low — not just for the payer, the insurer, not just for the provider, the hospital or doctor, but for the patients especially,” he said.

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Amanda Michelle Gomez

A mile northeast of Capitol Hill in Washington, D.C., along what’s known as the H Street corridor, about half the people crowding the sidewalks are wearing masks. Perhaps it’s because they know that when they step into any business or establishment here, they will have to put one on anyway. The capital, after all, is one of the few remaining cities or states nationwide that mandate masks for public indoor spaces — at least it has, until today.

“We have a bunch of rule followers,” said Claire Bengur, the owner of Atlas Salon, which has been in the neighborhood since 2018. “I am so thankful that my salon is in D.C.” She’s been glad to have a mask requirement, she said, because it’s impossible to do clients’ hair without standing close to them.

Bengur is unsure how to feel about Mayor Muriel Bowser’s decision to roll back the mandate. As the covid-19 pandemic has worn on, many Washingtonians have come to view masking as something between a habit and a security blanket. Even when the rule was lifted for about two months starting in May, many people continued to use masks in places like grocery stores. While face coverings will still be required in select spaces, such as public transit and schools, the District of Columbia will no longer require them in private businesses like Atlas Salon. And that has triggered mixed feelings.

Bengur had been debating whether to continue to ask clients to wear masks because the district gives businesses that option. But at the same time, “there is a certain level of excitement … like I don’t want to wear masks forever.” She ultimately decided to let clients choose for themselves. Bengur and her staff feel more at ease than they did earlier in the pandemic because her salon requires proof of vaccination.

A block away at the H Street Northeast location of Solidcore, a boutique fitness chain that started in the district, CEO Bryan Myers had an it’s-about-time take. “This will be game-changing for our clients’ comfort while working out and the health of our industry,” he said.

On the whole, Washington has been especially cautious when it comes to covid, which has helped the city avoid the worst of the pandemic. Now, the mayor is moving away from ordering protective measures and instead offering recommendations based on vaccination status.

This change can partly be explained by adjustments in the district health department’s goal, which no longer is to reach zero cases. Viewing covid as more of an “endemic” disease — one regularly found in particular populations — Bowser explained her decision this way: “This does not mean that everyone needs to stop wearing their masks. But it does mean that we are shifting the government’s response to providing you risk-based information.” While she’s reserved the right to reinstate the mandate, Bowser has doubled down on her decision. “Quite frankly, I don’t expect many D.C. residents will change their current behavior,” she said Friday during an interview on a local radio show.

The shift has some residents feeling perplexed, if not nervous, especially given the timing.

Children ages 5 to 11 just became eligible for vaccination, so they are not fully immunized yet, and infections are likely to climb with the holidays coming. Cases have already increased in half the states. That neighboring Montgomery County reinstated its mask mandate over the weekend leaves some people all the more baffled. A majority of district council members are already pushing the mayor to reconsider. Meanwhile, the White House, just steps from the mayor’s office, is not lifting its mask requirement, noting that the Centers for Disease Control and Prevention recommends one given the substantial level of community transmission.

“I’m a little bit iffy about the whole thing,” said Sandra Basanti, co-owner of Pie Shop, which offers fresh pies and live music on H Street.

Basanti has two young children who are not yet fully vaccinated. She’s unsure whether she’ll require customers to wear masks but expects to — at least at first. She’s hesitant because staffers received pushback when Pie Shop became one of the first venues in town to impose a vaccine requirement. She would like to see Washington follow New York City’s example and require proof of vaccination to enter public spaces such as shopping centers, sports arenas and theaters.

“We were just kind of waiting for the city to make that call for us so that we wouldn’t have to fight people on it, and they never did,” said Basanti. “I just don’t want to make the staff feel like they now also have to be the mask police again.”

“Being the mask police sucks,” she added.

The owner of the dive bar across the street agrees. “I’m very exhausted with arguing with people about masks and all the different things,” said Tony Tomelden of the Pug, which will not require patrons to wear masks but will insist that they be vaccinated. “Once a week, at least, there’s some kind of argument with some customer.”

Tomelden worries that talk of endemic covid means leaders are moving on without addressing all the pandemic-induced needs of small businesses beyond masking. “I’m so tired of begging for a break on bills and for grants and that kind of thing, but we’re still not fully recovered,” he said.

Like residents, public health experts are not in agreement on whether the district is acting prematurely.

“It makes sense,” Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, said of the mayor’s decision. She reasoned that, thanks to vaccination, the district has few covid hospitalizations and deaths. “At the same time … we don’t really know how it’s going to go.”

Meanwhile, Dr. David Dowdy, an associate professor of epidemiology at Johns Hopkins Bloomberg School of Public Health, said he generally recommends against easing restrictions at a time like this. “My expectation is that we’re likely to see something of an increase in cases over the winter,” he said, “and then this probably is going to become after that point in time something of an endemic disease.”

“We’ve come this far. It probably is not too difficult to keep our guard up for a couple more months,” he added. “But the flip side of that is we’ve been doing this for a really long time and people are very tired.”

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, sees Washington’s experience as emblematic of what can happen when leaders do not clearly explain their response to covid or why mask mandates are imposed or withdrawn.

Part of the challenge, Osterholm said, is that the explanations are unsatisfying. “We do not understand why surges start or stop,” he said. “Why they start and stop surely can’t be tied to human mitigation strategies. What can be tied to those is how big those surges get.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them.

“We want to try to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. Its test is still in early development. On the advice of consultants, the company is weighing an alternative route through the FDA to the U.S. market.

“It’s just the way our government works,” Hendrix said, which is a challenge for businesses that are “anxious to get started and think they’ve got something that can help.”

The U.S. produced covid-19 vaccines in record time, but, nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection, though they are widely available in Europe. Experts say the paucity of tests and their high prices undermine efforts in the U.S. to return to normal life.

Some experts say the FDA’s approach to clearing rapid tests has been onerous and overly focused on exceptional accuracy to detect positive results, rather than on what would really benefit people en masse: speedy results. The main use of rapid tests is to screen people so they can safely attend work, school, meetings or gatherings. This screening can then be followed up with a more sensitive, lab-based polymerase chain reaction (PCR) test for diagnosis.

The FDA has authorized just 12 over-the-counter options for rapid tests. But the problems go beyond that agency: The Biden administration recently put $3 billion toward boosting the supply of rapid tests, but public health and industry experts say the government didn’t move quickly enough early in the pandemic to support development and manufacturing.

“Should we have had an equivalent of Operation Warp Speed for testing?” asked Mara Aspinall, a co-founder of life sciences fund BlueStone Venture Partners and a board member for OraSure Technologies, which received FDA authorization for an over-the-counter rapid test. “Absolutely. … For too long, people thought of testing as an extra and not the core, and it needs to be thought of as the core.”

During the pandemic, the FDA has received more than 4,500 emergency use authorization and related requests for covid tests, according to FDA spokesperson Jim McKinney. The agency says it is prioritizing reviews of at-home and point-of-care tests that can be produced in high volumes. Two recently authorized tests alone could boost availability by as much as 13 million tests a day, McKinney said, adding that it would “efficiently review the submissions that will have the biggest impact on the nation’s testing needs.”

In addition to the slow pace of approvals, manufacturing bottlenecks created by materials and labor shortages are keeping prices high. Prices of rapid tests range from $14 for a two-pack to well over $50 a test, far from affordable for regular use.

The FDA says it can’t move more quickly as it balances ensuring that safe and useful devices reach the marketplace with the urgent need to deliver options for widespread daily testing.

“The FDA carefully weighs the known and potential risks and … benefits of emergency use authorization for COVID-19 diagnostic tests based on sound science,” McKinney said in response to questions. But he noted many submissions “are incomplete or contain insufficient information.”

Startups said navigating the ins and outs of this regulatory apparatus is daunting. E25Bio of Cambridge, Massachusetts, is developing a low-cost antigen test, which detects covid by identifying proteins called antigens. Since July 2020, the company has repeatedly adjusted its FDA application as the agency updates its recommendations. The requirement that test results be reported directly to federal health authorities has added to delays.

“As a smaller company, we didn’t have the capabilities to develop that technology at first,” said Bobby Brooke Herrera, co-founder and chief science officer. E25Bio now has a mobile app that verifies results and sends the anonymized data to public health authorities.

Another speed bump: The FDA requires U.S. clinical trials, making the company’s data from Latin America unusable.

Herrera hopes to sell the over-the-counter rapid test in the U.S. for less than $5, cheaper than anything currently on the market.

Hendrix said Blink Science is considering a different path to FDA approval. Known as de novo, it can be used to bring novel, low-risk medical devices to market. For now, he said, the company is likely to prioritize approval in developing countries where vaccination rates are much lower than in the U.S.

Steradian Technologies, which hopes to launch a 30-second breath test, says it was told by regulatory consultants and others who ran into snags in the EUA process that it “might not be worth it” because the agency is so backed up, according to Tra Tran, the company’s director of development and clinical affairs. The FDA’s regular approval process might be the best option.

“We don’t have the budget to spend on doing an EUA and then being told, ‘Well, actually you wasted six months and hundreds of thousands of dollars,’” she said. “Only certain people have the capital to be able to afford staying in this FDA regulatory process for forever.”

The Companies’ View

Several public health experts and people in the testing industry said that the Biden administration’s recent moves will help supply but that meeting demand will take time.

Australian test-maker Ellume received $232 million in federal funds in February to boost U.S. manufacturing of its rapid at-home test, but the company says its new plant in Frederick, Maryland, won’t start production until December. It could eventually manufacture 15 million tests a month.

The FDA authorized Ellume’s over-the-counter covid test in December 2020, but the road has been rocky: The company recalled 2.2 million tests in the U.S. because of “higher-than-acceptable false positive” results, the FDA said, and the FDA warned that their use “may cause serious adverse health consequences or death.” All came from Ellume’s Australian facility.

IHealth Labs, which received FDA authorization Nov. 5 for a test priced at $14 for a two-pack, says that by January it will be able to make 200 million tests a month.

OraSure aims to make 4 million covid tests a month by January and 8 million a month by June. It plans to scale up to 200 million covid tests annually — but not until 2024.

Scott Gleason, OraSure’s interim chief financial officer, said the company faces headwinds at its plant in Pennsylvania’s Lehigh Valley. “We’re having some challenges with hiring enough people to work in our factories to meet the demand,” he said. A two-pack has recently retailed between $14 and $24, and that price won’t drop anytime soon, Gleason said.

Ellume has faced shortages of swabs, steel for its facility and electronics components for the tests.

The View From the FDA

The FDA has authorized more than 400 covid tests, including at-home options and those processed by a medical provider or a lab. The FDA is still getting more than 100 EUA submissions for covid tests per month, many from overseas. But, McKinney said, the vast majority are not for the type most needed now: tests for over-the-counter use.

The FDA may be reluctant to ease its scrutiny. The pandemic’s first-iteration rapid tests, like Abbott Laboratories’ ID Now, raised safety and accuracy concerns, and the FDA has sent warning letters to at least six companies selling bogus rapid tests and has issued numerous recalls. Separately, the agency put over 260 tests that detect covid antibodies on a “do not use” list.

“If we did to antigen tests what happened with antibody tests, we would completely destroy the credibility of the test,” said Aspinall, the venture capitalist. “As frustrating as this is, I have to respect the FDA for ensuring that we continue to have quality tests.”

The agency’s review times for covid test EUA applications have improved, according to an assessment by consulting firm Booz Allen Hamilton. Approvals were generally cleared faster than denials. As of March, the median time for the FDA to grant authorization was seven days and 38 days for denials. When the country isn’t in a national emergency, getting through the FDA’s reviews might take months or years.

Nonetheless, the bottlenecks are felt by Americans trying to keep their employees and families safe.

LabCentral — a biotech co-working facility in Cambridge, Massachusetts, that was part of E25Bio’s testing study — requires participating startups to test workers twice a week. That’s a costly safety measure for a nonprofit, said Celina Chang, LabCentral’s vice president, so it recently bought rapid tests from Germany for $1.50 each.

“In order to test people twice a week on a regular basis for months on end,” she said, “we need it to be, just the same as anyone, affordable.”

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Dan Weissmann

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Click here for a transcript of the episode.

Matthew Lientz was an engineer for Boeing for over 30 years. When he was diagnosed with a rare form of cancer, he needed surgery from an expert doctor in another state. Although the surgery was his only option, his insurance denied the claim. That’s when his wife, Diane, contacted Laurie Todd, who calls herself the “Insurance Warrior.” 

Together, the three of them made the case for Lientz’s life. Fourteen years later, the speeches they gave in a conference room full of executives are a master class in winning insurance appeals — and living to tell the tale. 

Through this battle, Todd learned that taking on your health insurance provider often means going up against your employer. That’s because most large companies “self-insure.” 

And in this case, that employer was one of the biggest businesses in the world.

For the origin story of the “Insurance Warrior,” check out our previous episode.

“An Arm and a Leg” is a co-production of KHN and Public Road Productions.

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