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."

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.

Vanderbilt University Medical Center conducted much of the COVID-19 testing in Tennessee during the early days through several designated outpatient clinics in Davidson and Williamson Counties, sometimes testing as many as 750 people a day.

This article was first published on Friday, May 22, 2020 in Kaiser Health News.

By Blake Farmer, Nashville Public Radio

Hospitals around the country are afraid to send out hundreds of thousands of bills related to COVID-19 testing. That’s because Congress mandated there would be no copays and no out-of-pocket costs for patients. But many employers with self-funded health plans seem to believe they’re exempt from the rules.

When testing kits were still scarce, Vanderbilt University Medical Center in Nashville, Tennessee, fired up its clinical labs. It almost single-handedly took over testing in much of Tennessee. Other health systems didn’t even try to compete, although the tests were supposed to be covered by insurance.

In late March, Congress passed two laws, the Families First Coronavirus Response Act and the CARES Act, that essentially stated that not only does testing have to be covered, but patients shouldn’t have to pay a dime. Yet VUMC has found that’s frequently not the case.

“As many as half of those patients potentially have some out-of-pocket [cost], either for the tests or for companion services with the test,” VUMC Chief Financial Officer Cecelia Moore said.

VUMC is holding back bills for these patients, Moore said, rather than face a backlash of anger at surprise billing during the pandemic.

The issue comes down to an interpretation of whether the new federal legislation applies to health plans offered by larger employers. Those companies, which usually have at least a few hundred employees, often use their own money to pay claims as a way to drive down costs. A survey by the Kaiser Family Foundation finds a majority of Americans with health coverage are in this type of plan. (Kaiser Health News is an editorially independent program of the foundation.)

So BlueCross BlueShield of Tennessee may be on an employee’s insurance card, but the insurer is just managing the payments. The employer’s money pays the claims; these plans are often called self-funded or self-insured, and it may not be clear to employees that they are in such a plan.

According to multiple sources, many of the companies with those plans are operating as if they’re exempt from the new federal rules.

“In this case, it appears that the law may have left self-insured employers out of certain elements,” said Mike Thompson, CEO of the National Alliance of Healthcare Purchaser Coalitions.

The National Alliance represents employers with self-funded health plans. He said some are not waiving copays and other bills. Most are, he said, though sometimes only bills for the COVID-19 test itself and not for the doctor’s visit or the test to rule out the flu.

“Many of them have opted to cover on a first-dollar basis, but in different ways. They may or may not have included the related treatment elements,” Thompson said. He acknowledges the distinction would be lost on patients. “I get why it’s causing confusion.”

Other associations representing employer-funded health plans, including the Business Group on Health, said their members are generally following the spirit of the law.

Health policy experts don’t see any room for interpretation.

“It doesn’t matter if it’s a self-funded plan or a fully insured plan, if you get it from a small employer or a large employer, if you buy it on your own in the marketplace,” said Karen Pollitz, a senior fellow with KFF. “All private insurance has to cover 100% of the cost of COVID-19 testing.”

Pollitz said she is miffed that employers are trying to argue otherwise.

Still, it’s happening, and not only in Tennessee.

Duke Health in North Carolina confirms it’s not billing claims related to COVID testing or treatment, citing a lack of clarity in what the patient is responsible for paying. In California, UCSF Medical Center is also holding off on billing, and UCLA Medical Center is pressing health plans to pay their part.

“UCLA Health does not bill COVID-19 patients for testing even if their health plan erroneously does not pay,” spokesperson Enrique Rivero said in a written statement. “Our practice is to notify insurers of their error and request that they reprocess claims consistent with CARES Act guidelines.”

NYU Langone Health and Cleveland Clinic said they won’t bill patients any cost sharing for testing, even if that means they have to bear the cost.

The issue extends beyond academic medical centers. Envision Health, a Nashville-based firm that staffs and operates hundreds of emergency rooms around the country, is holding back 200,000 bills related to COVID-19 testing because of confusion about coverage of cost sharing.

So, many would-be surprise medical bills are still waiting to be sent out. At Vanderbilt alone, the medical center has held back more than $6 million in billing since mid-March.

“I know I’m supposed to be shaking everybody down, but we’re not right now,” said Heather Dunn, VUMC’s vice president of revenue cycle services.

Given the growing disdain for surprise medical bills, she expects a backlash from vulnerable patients.

“My greatest fear is [for] patients who are already suffering from the COVID virus or issues after or have lost their job. I’m hesitant to also say, ‘Your insurance company has passed along this $50 copay,’” she said.

Sometimes, the patient is also left with a large deductible to pay, in the hundreds of dollars.

Dunn said that she can’t delay billing forever and that just because the tests are supposed to be free to patients doesn’t mean they have no cost.

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

To determine whether a vaccine prevents disease, the study's subjects need to be exposed to the pathogen as it circulates in the population.

This article was first published on Thursday, May 21, 2020 in Kaiser Health News.

By Arthur Allen

If there is a silver lining to the flawed U.S. response to the coronavirus pandemic, it is this: The relatively high number of new cases being diagnosed daily — upward of 20,000 — will make it easier to test new vaccines.

To determine whether a vaccine prevents disease, the study's subjects need to be exposed to the pathogen as it circulates in the population. Reopening the economy will likely result in the faster spread of the coronavirus and therefore more opportunities to test a vaccine's efficacy in trial subjects.

Under a proposal under discussion by a committee set up by the National Institutes of Health, each of four or five experimental vaccines would be tested on about 20,000 trial participants with a placebo group of 10,000 for each vaccine. Some 50 U.S. medical centers — and perhaps an equal number overseas — would participate in these trials.

On Monday, Moderna, the biotech company, reported promising results in the first eight of 45 people enrolled in an initial test of the safety and immune responses to its vaccine. Analysts attributed a 900-point jump in the Dow that day at least partly to this very preliminary data, so eager are investors for any signs of progress in efforts to control the pandemic.

Moderna is running animal and human studies simultaneously and plans to invest hundreds of millions of dollars to build laboratories where the vaccine will be produced even before it's approved. The Food and Drug Administration on May 12 promised an accelerated review of Moderna's vaccine, which works by injecting pieces of synthetic viral RNA into the body to stimulate an immune response to the virus.

The speed in developing vaccines for widespread testing this summer is impressive, certainly compared with the nation's inadequate, delayed response to providing coronavirus testing and personal protective equipment to health care providers.

Still, many scientists have expressed skepticism at the breakneck timetable put forward by some Trump administration officials, who say that 100 million doses of a vaccine could be available by November. Even the normally sober Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a Senate committee on May 12 that a vaccine could have proven safety and efficacy by then.

Running a trial of the size and speed contemplated by the NIH will be an immense undertaking. Just setting up trial locations and getting common consent and data-entry forms into shape usually take months. Enrolling 30,000 people for a single vaccine trial is a big challenge.

In addition, defining success in a vaccine against COVID-19 will be no simple matter. As scientists design vaccine trials, they first have to set the "endpoints" that determine success or failure. Death? Length of illness? Hospitalization? Number of days in which a subject is infectious?

If there is little virus circulating where a trial is being run, even a vast study won't prove anything. On the other hand, if a vaccine trial had started in early April in New York City, where roughly 10,000 cases a day were reported for weeks, 30,000 participants would have been plenty to show whether the vaccine protected against the disease.

In all likelihood, the big NIH trials will focus on rates of infection as well as clinical symptoms such as fever and cough. To discover whether the vaccine prevents severe disease, which is relatively rare, is harder. COVID-19, according to one account, kills about 0.6% of those it infects, while perhaps six times that many require hospitalization.

People who take part in a trial will be given clear instructions to protect themselves against infection through social distancing, face masks, frequent hand-washing and so on. That will lower the number of people infected during the study.

"You'd have to ask all the people enrolled in a trial to practice good hygiene," said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "You don't want them to get infected — but you do."

When Jonas Salk announced the successful trial of his polio vaccine in 1955, the nation celebrated a vaccine that could virtually eliminate a deadly infectious disease overnight. A new coronavirus vaccine may not provide that kind of overnight success. Instead, it may be more akin to the flu vaccine, which reduces the risk or severity of the illness but requires a new shot each year.

Vaccinating 20,000 people in a trial can reveal whether a vaccine is clearly dangerous to a general population. But when 200 million receive the same vaccine, less common side effects could still affect thousands. Botched batches of polio vaccines released after Salk's trial permanently paralyzed 200 people and killed 10. Early vaccines against measles caused tens of thousands of cases of grave illness in the 1960s.

Maurice Hilleman, the vaccine pioneer who developed successful vaccines against measles, mumps, hepatitis A and B and other diseases, once said he never breathed a sigh of relief "until the first 3 million doses" had been delivered.

Unexpected problems naturally bedevil quick rollouts, as this one will almost certainly be as the nation searches for a way to check a pandemic that is killing tens of thousands of Americans and paralyzing the economy. But as Gregory Poland, the leader of Mayo Clinic's vaccine research, told me, "There is an irresolvable tension of speed versus safety."

Allen is the San Francisco editor for California Healthline, produced by Kaiser Health News, and the author of "Vaccine: The Controversial Story of Medicine's Greatest Lifesaver."

Arthur Allen: ArthurA@kff.org